#aadth ,,congress #b;d ,session ,in the ,house of ,representatives1 ,u4 ,s41 ,november #cj1 #bjaf ,,house ,,amendment ,,to ,,senate ,,amendment3 ,that the ,house agree to the amendment of the ,senate to the bill 7,h4,r4 #cd7 entitled ,an ,act to authorize and strengthen the tsunami detection1 forecast1 warning1 research1 and mitigation program of the ,national ,oceanic and ,atmospheric ,administration1 and for other purposes41 with the following ,in lieu of the matter proposed to be added after the enacting clause1 insert the following3 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the #bast ,century ,cures ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,division ,a--#bast ,century ,cures ,sec4 #ajjj4 ,short title4 ,title ,i--,innovation ,projects and ,state ,responses to ,opioid ,abuse ,sec4 #ajja4 ,,nih innovation projects4 ,sec4 #ajjb4 ,,fda innovation projects4 ,sec4 #ajjc4 ,account for the state response to the opioid abuse crisis4 ,sec4 #ajjd4 ,budgetary treatment4 ,title ,,ii--,discovery ,subtitle ,a--,national ,institutes of ,health ,reauthorization ,sec4 #bjja4 ,national ,institutes of ,health ,reauthorization4 ,sec4 #bjjb4 ,,eureka prize competitions4 ,subtitle ,b--,advancing precision medicine ,sec4 #bjaa4 ,precision ,medicine ,initiative4 ,sec4 #bjab4 ,privacy protection for human research subjects4 ,sec4 #bjac4 ,protection of identifiable and sensitive information4 ,sec4 #bjad4 ,data sharing4 ,subtitle ,c--,supporting young emerging scientists ,sec4 #bjba4 ,investing in the next generation of researchers4 ,sec4 #bjbb4 ,improvement of loan repayment program4 ,subtitle ,d--,national ,institutes of ,health planning and administration ,sec4 #bjca4 ,national ,institutes of ,health strategic plan4 ,sec4 #bjcb4 ,triennial reports4 ,sec4 #bjcc4 ,increasing accountability at the ,national ,institutes of ,health4 ,sec4 #bjcd4 ,reducing administrative burden for researchers4 ,sec4 #bjce4 ,exemption for the ,national ,institutes of ,health from the ,paperwork ,reduction ,act requirements4 ,sec4 #bjcf4 ,high-risk1 high-reward research4 ,sec4 #bjcg4 ,national ,center for ,advancing ,translational ,sciences4 ,sec4 #bjch4 ,collaboration and coordination to enhance research4 ,sec4 #bjci4 ,enhancing the rigor and reproducibility of scientific research4 ,sec4 #bjdj4 ,improving medical rehabilitation research at the ,national ,institutes of ,health4 ,sec4 #bjda4 ,task force on research specific to pregnant women and lactating women4 ,sec4 #bjdb4 ,streamlining ,national ,institutes of ,health reporting requirements4 ,sec4 #bjdc4 ,reimbursement for research substances and living organisms4 ,sec4 #bjdd4 ,sense of ,congress on increased inclusion of underrepresented populations in clinical trials4 ,subtitle ,e--,advancement of the ,national ,institutes of ,health research and data access ,sec4 #bjea4 ,technical updates to clinical trials database4 ,sec4 #bjeb4 ,compliance activities reports4 ,sec4 #bjec4 ,updates to policies to improve data4 ,sec4 #bjed4 ,consultation4 ,subtitle ,f--,facilitating collaborative research ,sec4 #bjfa4 ,national neurological conditions surveillance system4 ,sec4 #bjfb4 ,tick-borne diseases4 ,sec4 #bjfc4 ,accessing1 sharing1 and using health data for research purposes4 ,subtitle ,g--,promoting pediatric research ,sec4 #bjga4 ,national pediatric research network4 ,sec4 #bjgb4 ,global pediatric clinical study network4 ,title ,,iii--,development ,subtitle ,a--,patient-,focused ,drug ,development ,sec4 #cjja4 ,patient experience data4 ,sec4 #cjjb4 ,patient-focused drug development guidance4 ,sec4 #cjjc4 ,streamlining patient input4 ,sec4 #cjjd4 ,report on patient experience drug development4 ,subtitle ,b--,advancing new drug therapies ,sec4 #cjaa4 ,qualification of drug development tools4 ,sec4 #cjab4 ,targeted drugs for rare diseases4 ,sec4 #cjac4 ,reauthorization of program to encourage treatments for rare pediatric diseases4 ,sec4 #cjad4 ,,gao study of priority review voucher programs4 ,sec4 #cjae4 ,amendments to the ,orphan ,drug grants4 ,sec4 #cjaf4 ,grants for studying continuous drug manufacturing4 ,subtitle ,c--,modern ,trial ,design and ,evidence ,development ,sec4 #cjba4 ,novel clinical trial designs4 ,sec4 #cjbb4 ,real world evidence4 ,sec4 #cjbc4 ,protection of human research subjects4 ,sec4 #cjbd4 ,informed consent waiver or alteration for clinical investigations4 ,subtitle ,d--,patient access to therapies and information ,sec4 #cjca4 ,summary level review4 ,sec4 #cjcb4 ,expanded access policy4 ,sec4 #cjcc4 ,accelerated approval for regenerative advanced therapies4 ,sec4 #cjcd4 ,guidance regarding devices used in the recovery1 isolation1 or delivery of regenerative advanced therapies4 ,sec4 #cjce4 ,report on regenerative advanced therapies4 ,sec4 #cjcf4 ,standards for regenerative medicine and regenerative advanced therapies4 ,sec4 #cjcg4 ,health care economic information4 ,sec4 #cjch4 ,combination product innovation4 ,subtitle ,e--,antimicrobial innovation and stewardship ,sec4 #cjda4 ,antimicrobial resistance monitoring4 ,sec4 #cjdb4 ,limited population pathway4 ,sec4 #cjdc4 ,prescribing authority4 ,sec4 #cjdd4 ,susceptibility test interpretive criteria for microorganisms2 antimicrobial susceptibility testing devices4 ,subtitle ,f--,medical device innovations ,sec4 #cjea4 ,breakthrough devices4 ,sec4 #cjeb4 ,humanitarian device exemption4 ,sec4 #cjec4 ,recognition of standards4 ,sec4 #cjed4 ,certain class ,i and class ,,ii devices4 ,sec4 #cjee4 ,classification panels4 ,sec4 #cjef4 ,institutional review board flexibility4 ,sec4 #cjeg4 ,,clia waiver improvements4 ,sec4 #cjeh4 ,least burdensome device review4 ,sec4 #cjei4 ,cleaning instructions and validation data requirement4 ,sec4 #cjfj4 ,clarifying medical software regulation4 ,subtitle ,g--,improving ,scientific ,expertise and ,outreach at ,,fda ,sec4 #cjga4 ,silvio ,o4 ,conte ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service4 ,sec4 #cjgb4 ,hiring authority for scientific1 technical1 and professional personnel4 ,sec4 #cjgc4 ,establishment of ,food and ,drug ,administration ,intercenter ,institutes4 ,sec4 #cjgd4 ,scientific engagement4 ,sec4 #cjge4 ,drug surveillance4 ,sec4 #cjgf4 ,reagan-,udall ,foundation for the ,food and ,drug ,administration4 ,subtitle ,h--,medical countermeasures innovation ,sec4 #cjha4 ,medical countermeasure guidelines4 ,sec4 #cjhb4 ,clarifying ,,barda contracting authority4 ,sec4 #cjhc4 ,countermeasure budget plan4 ,sec4 #cjhd4 ,medical countermeasures innovation4 ,sec4 #cjhe4 ,streamlining ,project ,bio,shield procurement4 ,sec4 #cjhf4 ,encouraging treatments for agents that present a national security threat4 ,sec4 #cjhg4 ,paperwork ,reduction ,act waiver during a public health emergency4 ,sec4 #cjhh4 ,clarifying ,food and ,drug ,administration emergency use authorization4 ,subtitle ,i--,vaccine ,access1 ,certainty1 and ,innovation ,sec4 #cjia4 ,predictable review timelines of vaccines by the ,advisory ,committee on ,immunization ,practices4 ,sec4 #cjib4 ,review of processes and consistency of ,advisory ,committee on ,immunization ,practices recommendations4 ,sec4 #cjic4 ,encouraging vaccine innovation4 ,subtitle ,j--,technical corrections ,sec4 #caja4 ,technical corrections4 ,sec4 #cajb4 ,completed studies4 ,title ,,iv--,delivery ,sec4 #djja4 ,assisting doctors and hospitals in improving quality of care for patients4 ,sec4 #djjb4 ,transparent reporting on usability1 security1 and functionality4 ,sec4 #djjc4 ,interoperability4 ,sec4 #djjd4 ,information blocking4 ,sec4 #djje4 ,leveraging electronic health records to improve patient care4 ,sec4 #djjf4 ,empowering patients and improving patient access to their electronic health information4 ,sec4 #djjg4 ,,gao study on patient matching4 ,sec4 #djjh4 ,,gao study on patient access to health information4 ,sec4 #djji4 ,improving ,medicare local coverage determinations4 ,sec4 #djaj4 ,medicare pharmaceutical and technology ombudsman4 ,sec4 #djaa4 ,medicare site-of-service price transparency4 ,sec4 #djab4 ,telehealth services in ,medicare4 ,title ,v--,savings ,sec4 #ejja4 ,savings in the ,medicare ,improvement ,fund4 ,sec4 #ejjb4 ,medicaid reimbursement to ,states for durable medical equipment4 ,sec4 #ejjc4 ,penalties for violations of grants1 contracts1 and other agreements4 ,sec4 #ejjd4 ,reducing overpayments of infusion drugs4 ,sec4 #ejje4 ,increasing oversight of termination of ,medicaid providers4 ,sec4 #ejjf4 ,requiring publication of fee-for-service provider directory4 ,sec4 #ejjg4 ,fairness in ,medicaid supplemental needs trusts4 ,sec4 #ejjh4 ,eliminating ,federal financial participation with respect to expenditures under ,medicaid for agents used for cosmetic purposes or hair growth4 ,sec4 #ejji4 ,amendment to the ,prevention and ,public ,health ,fund4 ,sec4 #ejaj4 ,strategic ,petroleum ,reserve drawdown4 ,sec4 #ejaa4 ,rescission of portion of ,,aca territory funding4 ,sec4 #ejab4 ,medicare coverage of home infusion therapy4 ,division ,b--,helping ,families in ,mental ,health ,crisis ,sec4 #fjjj4 ,short title4 ,title ,,vi--,strengthening ,leadership and ,accountability ,subtitle ,a--,leadership ,sec4 #fjja4 ,assistant ,secretary for ,mental ,health and ,substance ,use4 ,sec4 #fjjb4 ,strengthening the leadership of the ,substance ,abuse and ,mental ,health ,services ,administration4 ,sec4 #fjjc4 ,chief ,medical ,officer4 ,sec4 #fjjd4 ,improving the quality of behavioral health programs4 ,sec4 #fjje4 ,strategic plan4 ,sec4 #fjjf4 ,biennial report concerning activities and progress4 ,sec4 #fjjg4 ,authorities of centers for mental health services1 substance abuse prevention1 and substance abuse treatment4 ,sec4 #fjjh4 ,advisory councils4 ,sec4 #fjji4 ,peer review4 ,subtitle ,b--,oversight and accountability ,sec4 #fjba4 ,improving oversight of mental and substance use disorders programs through the ,assistant ,secretary for ,planning and ,evaluation4 ,sec4 #fjbb4 ,reporting for protection and advocacy organizations4 ,sec4 #fjbc4 ,,gao study4 ,subtitle ,c--,interdepartmental ,serious ,mental ,illness ,coordinating ,committee ,sec4 #fjca4 ,interdepartmental ,serious ,mental ,illness ,coordinating ,committee4 ,title ,,vii--,,ensuring ,,mental ,,and ,,substance ,,use ,,disorders ,,prevention1 ,,treatment1 ,,and ,,recovery ,,programs ,,keep ,,pace ,,with ,,science ,,and ,,technology ,sec4 #gjja4 ,encouraging innovation and evidence-based programs4 ,sec4 #gjjb4 ,promoting access to information on evidence-based programs and practices4 ,sec4 #gjjc4 ,priority mental health needs of regional and national significance4 ,sec4 #gjjd4 ,priority substance use disorder treatment needs of regional and national significance4 ,sec4 #gjje4 ,priority substance use disorder prevention needs of regional and national significance4 ,title ,,viii--,,supporting ,,state ,,prevention ,,activities ,,and ,,responses ,,to ,,mental ,,health ,,and ,,substance ,,use ,,disorder ,,needs ,sec4 #hjja4 ,community mental health services block grant4 ,sec4 #hjjb4 ,substance abuse prevention and treatment block grant4 ,sec4 #hjjc4 ,additional provisions related to the block grants4 ,sec4 #hjjd4 ,study of distribution of funds under the substance abuse prevention and treatment block grant and the community mental health services block grant4 ,title ,,ix--,,promoting ,,access ,,to ,,mental ,,health ,,and ,,substance ,,use ,,disorder ,,care ,subtitle ,a--,helping ,individuals and ,families ,sec4 #ijja4 ,grants for treatment and recovery for homeless individuals4 ,sec4 #ijjb4 ,grants for jail diversion programs4 ,sec4 #ijjc4 ,promoting integration of primary and behavioral health care4 ,sec4 #ijjd4 ,projects for assistance in transition from homelessness4 ,sec4 #ijje4 ,national ,suicide ,prevention ,lifeline ,program4 ,sec4 #ijjf4 ,connecting individuals and families with care4 ,sec4 #ijjg4 ,strengthening community crisis response systems4 ,sec4 #ijjh4 ,garrett ,lee ,smith ,memorial ,act reauthorization4 ,sec4 #ijji4 ,adult suicide prevention4 ,sec4 #ijaj4 ,mental health awareness training grants4 ,sec4 #ijaa4 ,sense of ,congress on prioritizing ,american ,indians and ,alaska ,native youth within suicide prevention programs4 ,sec4 #ijab4 ,evidence-based practices for older adults4 ,sec4 #ijac4 ,national violent death reporting system4 ,sec4 #ijad4 ,assisted outpatient treatment4 ,sec4 #ijae4 ,assertive community treatment grant program4 ,sec4 #ijaf4 ,sober truth on preventing underage drinking reauthorization4 ,sec4 #ijag4 ,center and program repeals4 ,subtitle ,b--,strengthening the ,health ,care ,workforce ,sec4 #ijba4 ,mental and behavioral health education and training grants4 ,sec4 #ijbb4 ,strengthening the mental and substance use disorders workforce4 ,sec4 #ijbc4 ,clarification on current eligibility for loan repayment programs4 ,sec4 #ijbd4 ,minority fellowship program4 ,sec4 #ijbe4 ,liability protections for health professional volunteers at community health centers4 ,sec4 #ijbf4 ,reports4 ,subtitle ,c--,mental ,health on ,campus ,improvement ,sec4 #ijca4 ,mental health and substance use disorder services on campus4 ,sec4 #ijcb4 ,interagency ,working ,group on ,college ,mental ,health4 ,sec4 #ijcc4 ,improving mental health on college campuses4 ,title ,x--,strengthening ,mental and ,substance ,use ,disorder ,care for ,children and ,adolescents ,sec4 #ajjja4 ,programs for children with a serious emotional disturbance4 ,sec4 #ajjjb4 ,increasing access to pediatric mental health care4 ,sec4 #ajjjc4 ,substance use disorder treatment and early intervention services for children and adolescents4 ,sec4 #ajjjd4 ,children's recovery from trauma4 ,sec4 #ajjje4 ,screening and treatment for maternal depression4 ,sec4 #ajjjf4 ,infant and early childhood mental health promotion1 intervention1 and treatment4 ,title ,,xi--,compassionate communication on ,,hipaa ,sec4 #aajja4 ,sense of ,congress4 ,sec4 #aajjb4 ,confidentiality of records4 ,sec4 #aajjc4 ,clarification on permitted uses and disclosures of protected health information4 ,sec4 #aajjd4 ,development and dissemination of model training programs4 ,title ,,xii--,medicaid ,mental ,health ,coverage ,sec4 #abjja4 ,rule of construction related to ,medicaid coverage of mental health services and primary care services furnished on the same day4 ,sec4 #abjjb4 ,study and report related to ,medicaid managed care regulation4 ,sec4 #abjjc4 ,guidance on opportunities for innovation4 ,sec4 #abjjd4 ,study and report on ,medicaid emergency psychiatric demonstration project4 ,sec4 #abjje4 ,providing ,,epsdt services to children in ,i,m,ds4 ,sec4 #abjjf4 ,electronic visit verification system required for personal care services and home health care services under ,medicaid4 ,title ,,xiii--,mental ,health ,parity ,sec4 #acjja4 ,enhanced compliance with mental health and substance use disorder coverage requirements4 ,sec4 #acjjb4 ,action plan for enhanced enforcement of mental health and substance use disorder coverage4 ,sec4 #acjjc4 ,report on investigations regarding parity in mental health and substance use disorder benefits4 ,sec4 #acjjd4 ,,gao study on parity in mental health and substance use disorder benefits4 ,sec4 #acjje4 ,information and awareness on eating disorders4 ,sec4 #acjjf4 ,education and training on eating disorders4 ,sec4 #acjjg4 ,clarification of existing parity rules4 ,title ,,xiv--,mental health and safe communities ,subtitle ,a--,mental health and safe communities ,sec4 #adjja4 ,law enforcement grants for crisis intervention teams1 mental health purposes4 ,sec4 #adjjb4 ,assisted outpatient treatment programs4 ,sec4 #adjjc4 ,federal drug and mental health courts4 ,sec4 #adjjd4 ,mental health in the judicial system4 ,sec4 #adjje4 ,forensic assertive community treatment initiatives4 ,sec4 #adjjf4 ,assistance for individuals transitioning out of systems4 ,sec4 #adjjg4 ,co-occurring substance abuse and mental health challenges in drug courts4 ,sec4 #adjjh4 ,mental health training for ,federal uniformed services4 ,sec4 #adjji4 ,advancing mental health as part of offender reentry4 ,sec4 #adjaj4 ,school mental health crisis intervention teams4 ,sec4 #adjaa4 ,active-shooter training for law enforcement4 ,sec4 #adjab4 ,co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs4 ,sec4 #adjac4 ,mental health and drug treatment alternatives to incarceration programs4 ,sec4 #adjad4 ,national criminal justice and mental health training and technical assistance4 ,sec4 #adjae4 ,improving ,department of ,justice data collection on mental illness involved in crime4 ,sec4 #adjaf4 ,reports on the number of mentally ill offenders in prison4 ,sec4 #adjag4 ,codification of due process for determinations by secretary of veterans affairs of mental capacity of beneficiaries4 ,sec4 #adjah4 ,reauthorization of appropriations4 ,subtitle ,b--,comprehensive ,justice and ,mental ,health ,sec4 #adjba4 ,sequential intercept model4 ,sec4 #adjbb4 ,prison and jails4 ,sec4 #adjbc4 ,allowable uses4 ,sec4 #adjbd4 ,law enforcement training4 ,sec4 #adjbe4 ,federal law enforcement training4 ,sec4 #adjbf4 ,,gao report4 ,sec4 #adjbg4 ,evidence based practices4 ,sec4 #adjbh4 ,transparency1 program accountability1 and enhancement of local authority4 ,sec4 #adjbi4 ,grant accountability4 ,division ,c--,increasing ,choice1 ,access1 and ,quality in ,health ,care for ,americans ,sec4 #aejjj4 ,short title4 ,title ,,xv--,provisions ,relating to ,medicare ,part ,a ,sec4 #aejja4 ,development of ,medicare ,,hcpcs version of ,,ms-,,drg codes for similar hospital services4 ,sec4 #aejjb4 ,establishing beneficiary equity in the ,medicare hospital readmission program4 ,sec4 #aejjc4 ,five-year extension of the rural community hospital demonstration program4 ,sec4 #aejjd4 ,regulatory relief for ,l,t,c,hs4 ,sec4 #aejje4 ,savings from ,,ipps ,,macra pay-for through not applying documentation and coding adjustments4 ,sec4 #aejjf4 ,extension of certain ,,ltch ,medicare payment rules4 ,sec4 #aejjg4 ,application of rules on the calculation of hospital length of stay to all ,l,t,c,hs4 ,sec4 #aejjh4 ,change in ,medicare classification for certain hospitals4 ,sec4 #aejji4 ,temporary exception to the application of the ,medicare ,,ltch site neutral provisions for certain spinal cord specialty hospitals4 ,sec4 #aejaj4 ,temporary extension to the application of the ,medicare ,,ltch site neutral provisions for certain discharges with severe wounds4 ,title ,,xvi--,provisions ,relating to ,medicare ,part ,b ,sec4 #afjja4 ,continuing ,medicare payment under ,,hopd prospective payment system for services furnished by mid-build off-campus outpatient departments of providers4 ,sec4 #afjjb4 ,treatment of cancer hospitals in off-campus outpatient department of a provider policy4 ,sec4 #afjjc4 ,treatment of eligible professionals in ambulatory surgical centers for meaningful use and ,,mips4 ,sec4 #afjjd4 ,continuing ,access to ,hospitals ,act of #bjaf4 ,sec4 #afjje4 ,delay of implementation of ,medicare fee schedule adjustments for wheelchair accessories and seating systems when used in conjunction with complex rehabilitation technology 7,,crt7 wheelchairs4 ,sec4 #afjjf4 ,allowing physical therapists to utilize locum tenens arrangements under ,medicare4 ,sec4 #afjjg4 ,extension of the transition to new payment rates for durable medical equipment under the ,medicare program4 ,sec4 #afjjh4 ,requirements in determining adjustments using information from competitive bidding programs4 ,title ,,xvii--,other ,medicare ,provisions ,sec4 #agjja4 ,delay in authority to terminate contracts for ,medicare ,advantage plans failing to achieve minimum quality ratings4 ,sec4 #agjjb4 ,requirement for enrollment data reporting for ,medicare4 ,sec4 #agjjc4 ,updating the ,welcome to ,medicare package4 ,sec4 #agjjd4 ,no payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area4 ,sec4 #agjje4 ,preservation of ,medicare beneficiary choice under ,medicare ,advantage4 ,sec4 #agjjf4 ,allowing end-stage renal disease beneficiaries to choose a ,medicare ,advantage plan4 ,sec4 #agjjg4 ,improvements to the assignment of beneficiaries under the ,medicare ,shared ,savings ,program4 ,title ,,xviii--,other ,provisions ,sec4 #ahjja4 ,exception from group health plan requirements for qualified small employer health reimbursement arrangements4 ,a #bast ,century ,cures #ajjj4 ,short title ,this ,division may be cited as the #bast ,century ,cures ,act4 ,i ,innovation ,projects and ,state ,responses to ,opioid ,abuse #ajja4 ,,nih innovation projects 7a7 ,in general ,the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,director of ,,nih7 shall use any funds appropriated pursuant to the authorization of appropriations in subsection 7b77#c7 to carry out the ,national ,institutes of ,health innovation projects described in subsection 7b77#d7 7referred to in this section as the ,,nih ,innovation ,projects74 7b7 ,national institutes of health innovation account 7#a7 ,establishment of ,,nih innovation account ,there is established in the ,treasury an account1 to be known as the ,,nih ,innovation ,account 7referred to in this subsection as the ,account71 for purposes of carrying out the ,,nih ,innovation ,projects described in paragraph 7#d74 7#b7 ,transfer of direct spending savings 7,a7 ,in general ,the following amounts shall be transferred to the ,account from the general fund of the ,treasury3 7i7 ,for fiscal year #bjag1 #ceb1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #dif1jjj1jjj4 7iii7 ,for fiscal year #bjai1 #gaa1jjj1jjj4 7iv7 ,for fiscal year #bjbj1 #dib1jjj1jjj4 7v7 ,for fiscal year #bjba1 #djd1jjj1jjj4 7vi7 ,for fiscal year #bjbb1 #dif1jjj1jjj4 7vii7 ,for fiscal year #bjbc1 #a1jhe1jjj1jjj4 7viii7 ,for fiscal year #bjbd1 #djg1jjj1jjj4 7ix7 ,for fiscal year #bjbe1 #abg1jjj1jjj4 7x7 ,for fiscal year #bjbf1 #bbf1jjj1jjj4 7,b7 ,amounts deposited ,any amounts transferred under subparagraph 7,a7 shall remain unavailable in the ,account until such amounts are appropriated pursuant to paragraph 7#c74 7#c7 ,appropriations 7,a7 ,authorization of appropriations ,for each of the fiscal years #bjag through #bjbf1 there is authorized to be appropriated from the ,account to the ,director of ,,nih1 for the purpose of carrying out the ,,nih ,innovation ,projects1 an amount not to exceed the total amount transferred to the ,account under paragraph 7#b77;,a71 to remain available until expended4 7,b7 ,offsetting future appropriations ,for any of fiscal years #bjag through #bjbf1 for any discretionary appropriation under the heading ,,nih ,innovation ,account provided to the ,director of ,,nih pursuant to the authorization of appropriations under subparagraph 7,a7 for the purpose of carrying out the ,,nih ,innovation ,projects1 the total amount of such appropriations for the applicable fiscal year 7not to exceed the total amount remaining in the ,account7 shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the ,congressional ,budget and ,impoundment ,control ,act of #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and the amount transferred to the ,account shall be reduced by the same amount4 7#d7 ,,nih innovation projects ,,nih ,innovation ,projects authorized to be funded under this section shall consist of the following and1 of the total amounts authorized to be appropriated under paragraph 7#c71 there are authorized to be appropriated to each such project a total amount not to exceed the following1 over the period of fiscal years #bjag through #bjbf3 7,a7 ,for the ,precision ,medicine ,initiative1 including for the advancement of a cohort of individuals to support the goals of the ,precision ,medicine ,initiative1 not to exceed a total of #a1dee1jjj1jjj1 as follows3 7i7 ,for fiscal year #bjag1 #dj1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #ajj1jjj1jjj4 7iii7 ,for fiscal year #bjai1 #ahf1jjj1jjj4 7iv7 ,for fiscal year #bjbj1 #adi1jjj1jjj4 7v7 ,for fiscal year #bjba1 #aji1jjj1jjj4 7vi7 ,for fiscal year #bjbb1 #aej1jjj1jjj4 7vii7 ,for fiscal year #bjbc1 #dai1jjj1jjj4 7viii7 ,for fiscal year #bjbd1 #bce1jjj1jjj4 7ix7 ,for fiscal year #bjbe1 #cf1jjj1jjj4 7x7 ,for fiscal year #bjbf1 #ca1jjj1jjj4 7,b7 ,for the ,brain ,research through ,advancing ,innovative ,neurotechnologies ,initiative 7known as the ,,brain ,initiative71 not to exceed a total of #a1eaa1jjj1jjj1 as follows3 7i7 ,for fiscal year #bjag1 #aj1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #hf1jjj1jjj4 7iii7 ,for fiscal year #bjai1 #aae1jjj1jjj4 7iv7 ,for fiscal year #bjbj1 #adj1jjj1jjj4 7v7 ,for fiscal year #bjba1 #ajj1jjj1jjj4 7vi7 ,for fiscal year #bjbb1 #aeb1jjj1jjj4 7vii7 ,for fiscal year #bjbc1 #dej1jjj1jjj4 7viii7 ,for fiscal year #bjbd1 #agb1jjj1jjj4 7ix7 ,for fiscal year #bjbe1 #ia1jjj1jjj4 7x7 ,for fiscal year #bjbf1 #aie1jjj1jjj4 7,c7 ,to support cancer research1 such as the development of cancer vaccines1 the development of more sensitive diagnostic tests for cancer1 immunotherapy and the development of combination therapies1 and research that has the potential to transform the scientific field1 that has inherently higher risk1 and that seeks to address major challenges related to cancer1 not to exceed a total of #a1hjj1jjj1jjj1 as follows3 7i7 ,for fiscal year #bjag1 #cjj1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #cjj1jjj1jjj4 7iii7 ,for fiscal year #bjai1 #djj1jjj1jjj4 7iv7 ,for fiscal year #bjbj1 #aie1jjj1jjj4 7v7 ,for fiscal year #bjba1 #aie1jjj1jjj4 7vi7 ,for fiscal year #bjbb1 #aid1jjj1jjj4 7vii7 ,for fiscal year #bjbc1 #baf1jjj1jjj4 7,d7 ,for the ,national ,institutes of ,health1 in coordination with the ,food and ,drug ,administration1 to award grants and contracts for clinical research to further the field of regenerative medicine using adult stem cells1 including autologous stem cells1 for which grants and contracts shall be contingent upon the recipient making available non-,federal contributions toward the costs of such research in an amount not less than #a for each #a of ,federal funds provided in the award1 not to exceed a total of #cj1jjj1jjj1 as follows3 7i7 ,for fiscal year #bjag1 #b1jjj1jjj4 7ii7 ,for each of fiscal years #bjah and #bjai1 #aj1jjj1jjj4 7iii7 ,for fiscal year #bjbj1 #h1jjj1jjj4 7iv7 ,for each of fiscal years #bjba through #bjbf1 #j4 7c7 ,accountability and oversight 7#a7 ,work plan 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,director of ,,nih shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 a work plan including the proposed allocation of funds authorized to be appropriated pursuant to subsection 7b77#c7 for each of fiscal years #bjag through #bjbf for the ,,nih ,innovation ,projects and the contents described in subparagraph 7,b74 7,b7 ,contents ,the work plan submitted under subparagraph 7,a7 shall include-- 7i7 recommendations from the ,advisory ,committee described in subparagraph 7,c72 7ii7 the amount of money to be obligated or expended in each fiscal year for each ,,nih ,innovation ,project2 7iii7 a description and justification of each such project2 and 7iv7 a description of how each such project supports the strategic research priorities identified in the ,,nih ,strategic ,plan under subsection 7m7 of section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb71 as added by section #bjca4 7,c7 ,recommendations ,prior to submitting the work plan under this paragraph1 the ,director of ,,nih shall seek recommendations from the ,advisory ,committee to the ,director of ,,nih appointed under section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a7 on-- 7i7 the allocations of funds appropriated pursuant to the authorization of appropriations under subsection 7b77#c7 for each of fiscal years #bjag through #bjbf2 and 7ii7 on the contents of the proposed work plan4 7#b7 ,reports 7,a7 ,annual reports ,not later than ,october #a of each of fiscal years #bjah through #bjbg1 the ,director of ,,nih shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 a report including-- 7i7 the amount of money obligated or expended in the prior fiscal year for each ,,nih ,innovation ,project2 7ii7 a description of any such project using funds provided pursuant to the authorization of appropriations under subsection 7b77#c72 and 7iii7 whether such projects are advancing the strategic research priorities identified in the ,,nih ,strategic ,plan under subsection 7m7 of section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb71 as added by section #bjca4 7,b7 ,additional reports ,at the request of the ,committee on ,health1 ,education1 ,labor1 and ,pensions or the ,committee on ,appropriations of the ,senate1 or the ,committee on ,energy and ,commerce or the ,committee on ,appropriations of the ,house of ,representatives1 the ,director of ,,nih shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the ,,nih ,innovation ,projects4 7d7 ,limitations ,notwithstanding any transfer authority authorized by this ,act or any appropriations ,act1 any funds made available pursuant to the authorization of appropriations under subsection 7b77#c7 may not be used for any purpose other than a ,,nih ,innovation ,project4 7e7 ,sunset ,this section shall expire on ,september #cj1 #bjbf4 #ajjb4 ,,fda innovation projects 7a7 ,in general ,the ,commissioner of ,food and ,drugs 7referred to in this section as the ,commissioner7 shall use any funds appropriated pursuant to the authorization of appropriations under subsection 7b77#c7 to carry out the activities described in subsection 7b77#d74 7b7 ,,fda innovation account 7#a7 ,establishment of ,,fda innovation account ,there is established in the ,treasury an account1 to be known as the ,,fda ,innovation ,account 7referred to in this subsection as the ,account71 for purposes of carrying out the activities described in paragraph 7#d74 7#b7 ,transfer of direct spending savings 7,a7 ,in general ,for each of fiscal years #bjag through #bjbe1 the following amounts shall be transferred to the ,account from the general fund of the ,treasury3 7i7 ,for fiscal year #bjag1 #bj1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #fj1jjj1jjj4 7iii7 ,for fiscal year #bjai1 #gj1jjj1jjj4 7iv7 ,for fiscal year #bjbj1 #ge1jjj1jjj4 7v7 ,for fiscal year #bjba1 #gj1jjj1jjj4 7vi7 ,for fiscal year #bjbb1 #ej1jjj1jjj4 7vii7 ,for fiscal year #bjbc1 #ej1jjj1jjj4 7viii7 ,for fiscal year #bjbd1 #ej1jjj1jjj4 7ix7 ,for fiscal year #bjbe1 #ee1jjj1jjj4 7,b7 ,amounts deposited ,any amounts transferred under subparagraph 7,a7 shall remain unavailable in the ,account until such amounts are appropriated pursuant to paragraph 7#c74 7#c7 ,appropriations 7,a7 ,authorization of appropriations ,for each of the fiscal years #bjag through #bjbe1 there is authorized to be appropriated from the ,account to the ,commissioner1 for the purpose of carrying out the activities described in paragraph 7#e71 an amount not to exceed the total amount transferred to the ,account under paragraph 7#b77;,a71 to remain available until expended4 7,b7 ,offsetting future appropriations ,for any of fiscal years #bjag through #bjbe1 for any discretionary appropriation under the heading ,,fda ,innovation ,account provided to the ,commissioner pursuant to the authorization of appropriations under subparagraph 7,a7 for the purpose of carrying out the projects activities described in paragraph 7#d71 the total amount of such appropriations in the applicable fiscal year 7not to exceed the total amount remaining in the ,account7 shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the ,congressional ,budget and ,impoundment ,control ,act of #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and the amount transferred to the ,account shall be reduced by the same amount4 7#d7 ,,fda activities ,the activities authorized to be funded under this section are the activities under subtitles ,a through ,f 7including the amendments made by such subtitles7 of title ,,iii of this ,act and section #ajad of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #cjgc of this ,act4 7c7 ,accountability and oversight 7#a7 ,work plan 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,commissioner shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection 7b77#c7 for each of fiscal years #bjag through #bjbe and the contents described in subparagraph 7,b74 7,b7 ,contents ,the work plan submitted under subparagraph 7,a7 shall include-- 7i7 recommendations from the ,advisory ,committee described in subparagraph 7,c72 7ii7 the amount of money to be obligated or expended in each fiscal year for each activity described in subsection 7b77#d72 and 7iii7 a description and justification of each such project activity4 7,c7 ,recommendations ,prior to submitting the work plan under this paragraph1 the ,commissioner shall seek recommendations from the ,science ,board to the ,food and ,drug ,administration1 on the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection 7b77#c7 for each of fiscal years #bjag through #bjbe and on the contents of the proposed work plan4 7#b7 ,reports 7,a7 ,annual reports ,not later than ,october #a of each of fiscal years #bjah through #bjbf1 the ,commissioner shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 a report including-- 7i7 the amount of money obligated or expended in the prior fiscal year for each activity described in subsection 7b77#d72 7ii7 a description of all such activities using funds provided pursuant to the authorization of appropriations under subsection 7b77#c72 and 7iii7 how the activities are advancing public health4 7,b7 ,additional reports ,at the request of the ,committee on ,health1 ,education1 ,labor1 and ,pensions or the ,committee on ,appropriations of the ,senate1 or the ,committee on ,energy and ,commerce or the ,committee on ,appropriations of the ,house of ,representatives1 the ,commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the activities undertaken with such funding4 7d7 ,limitations ,notwithstanding any transfer authority authorized by this ,act or any appropriations ,act1 any funds made available pursuant to the authorization of appropriations in subsection 7b77#c7 shall not be used for any purpose other than an activity described in subsection 7b77#d74 7e7 ,sunset ,this section shall expire on ,september #cj1 #bjbe4 #ajjc4 ,account for the state response to the opioid abuse crisis 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall use any funds appropriated pursuant to the authorization of appropriations under subsection 7b7 to carry out the grant program described in subsection 7c7 for purposes of addressing the opioid abuse crisis within the ,states4 7b7 ,account for the state response to the opioid abuse crisis 7#a7 ,establishment ,there is established in the ,treasury an account1 to be known as the ,account ,for the ,state ,response to the ,opioid ,abuse ,crisis 7referred to in this subsection as the ,account71 to carry out the opioid grant program described in subsection 7c74 7#b7 ,transfer of direct spending savings 7,a7 ,in general ,the following amounts shall be transferred to the ,account from the general fund of the ,treasury3 7i7 ,for fiscal year #bjag1 #ejj1jjj1jjj4 7ii7 ,for fiscal year #bjah1 #ejj1jjj1jjj4 7,b7 ,amounts deposited ,any amounts transferred under subparagraph 7,a7 shall remain unavailable in the ,account until such amounts are appropriated pursuant to paragraph 7#c74 7#c7 ,appropriations 7,a7 ,authorization of appropriations ,in each of the fiscal years #bjag and #bjah1 there is authorized to be appropriated from the ,account to the ,secretary1 for the grant program described in subsection 7c71 an amount not to exceed the total amount transferred to the ,account under paragraph 7#b77;,a71 to remain available until expended4 7,b7 ,offsetting future appropriations ,in each of fiscal years #bjag and #bjah1 for any discretionary appropriation under the heading ,account ,for the ,state ,response to the ,opioid ,abuse ,crisis for the grant program described in subsection 7c71 the total amount of such appropriations in the applicable fiscal year 7not to exceed the total amount remaining in the ,account7 shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the ,congressional ,budget and ,impoundment ,control ,act of #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and the amount transferred to the ,account shall be reduced by the same amount4 7c7 ,opioid grant program 7#a7 ,state response to the opioid abuse crisis ,subject to the availability of appropriations1 the ,secretary shall award grants to ,states for the purpose of addressing the opioid abuse crisis within such ,states1 in accordance with subparagraph 7,b74 ,in awarding such grants1 the ,secretary shall give preference to ,states with an incidence or prevalence of opioid use disorders that is substantially higher relative to other ,states4 7#b7 ,opioid grants ,grants awarded to a ,state under this subsection shall be used for carrying out activities that supplement activities pertaining to opioids undertaken by the ,state agency responsible for administering the substance abuse prevention and treatment block grant under subpart ,,ii of part ,b of title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ba et seq471 which may include public health-related activities such as the following3 7,a7 ,improving ,state prescription drug monitoring programs4 7,b7 ,implementing prevention activities1 and evaluating such activities to identify effective strategies to prevent opioid abuse4 7,c7 ,training for health care practitioners1 such as best practices for prescribing opioids1 pain management1 recognizing potential cases of substance abuse1 referral of patients to treatment programs1 and overdose prevention4 7,d7 ,supporting access to health care services1 including those services provided by ,federally certified opioid treatment programs or other appropriate health care providers to treat substance use disorders4 7,e7 ,other public health-related activities1 as the ,state determines appropriate1 related to addressing the opioid abuse crisis within the ,state4 7d7 ,accountability and oversight ,a ,state receiving a grant under subsection 7c7 shall include in a report related to substance abuse submitted to the ,secretary pursuant to section #aidb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#eb71 a description of-- 7#a7 the purposes for which the grant funds received by the ,state under such subsection for the preceding fiscal year were expended and a description of the activities of the ,state under the program2 and 7#b7 the ultimate recipients of amounts provided to the ,state in the grant4 7e7 ,limitations ,any funds made available pursuant to the authorization of appropriations under subsection 7b7-- 7#a7 notwithstanding any transfer authority in any appropriations ,act1 shall not be used for any purpose other than the grant program in subsection 7c72 and 7#b7 shall be subject to the same requirements as substance abuse prevention and treatment programs under titles ,v and ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq41 #cjjw et seq474 7f7 ,sunset ,this section shall expire on ,september #cj1 #bjbf4 #ajjd4 ,budgetary treatment 7a7 ,statutory paygo scorecards ,the budgetary effects of division ,a of this ,act shall not be entered on either ,,paygo scorecard maintained pursuant to section #d7;d7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj4 7b7 ,senate paygo scorecards ,the budgetary effects of division ,a of this ,act shall not be entered on any ,,paygo scorecard maintained for purposes of section #bja of ,s4 ,con4 ,res4 #ba 7#aajth ,congress74 7c7 ,reservation of savings ,none of the funds in the ,,nih ,innovation ,account1 the ,,fda ,innovation ,account1 or the ,account ,for the ,state ,response to the ,opioid ,abuse ,crisis established by this title shall be made available except to the extent provided in advance in appropriations ,acts1 and legislation or an ,act that rescinds or reduces amounts in such accounts shall not be estimated as a reduction in direct spending under the ,congressional ,budget and ,impoundment ,control ,act of #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe4 ,,ii ,discovery ,a ,national ,institutes of ,health ,reauthorization #bjja4 ,national ,institutes of ,health ,reauthorization ,section #djb;,a7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7a77#a77 is amended-- 7#a7 in subparagraph 7,b71 by striking and at the end2 7#b7 in subparagraph 7,c71 by striking the period at the end and inserting a semicolon2 and 7#c7 by adding at the end the following new subparagraphs3 7,d7 #cd1hea1jjj1jjj for fiscal year #bjah2 7,e7 #ce1ehe1hga1jjj for fiscal year #bjai2 and 7,f7 #cf1dgb1ddb1gge for fiscal year #bjbj4 4 #bjjb4 ,,eureka prize competitions 7a7 ,in general ,pursuant to the authorities and processes established under section #bd of the ,stevenson-,wydler ,technology ,innovation ,act of #aihj 7#ae ,u4,s4,c4 #cgai71 the ,director of the ,national ,institutes of ,health shall support prize competitions for one or both of the following goals3 7#a7 ,identifying and funding areas of biomedical science that could realize significant advancements through a prize competition4 7#b7 ,improving health outcomes1 particularly with respect to human diseases and conditions-- 7,a7 for which public and private investment in research is disproportionately small relative to ,federal ,government expenditures on prevention and treatment activities with respect to such diseases and conditions1 such that ,federal expenditures on health programs would be reduced2 7,b7 that are serious and represent a significant disease burden in the ,united ,states2 or 7,c7 for which there is potential for significant return on investment to the ,united ,states4 7b7 ,tracking2 reporting ,the ,director of the ,national ,institutes of ,health shall-- 7#a7 collect information on-- 7,a7 the effect of innovations funded through the prize competitions under this section in advancing biomedical science or improving health outcomes pursuant to subsection 7a72 and 7,b7 the effect of the innovations on ,federal expenditures2 and 7#b7 include the information collected under paragraph 7#a7 in the triennial report under section #djc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7 7as amended by section #bjcb74 ,b ,advancing precision medicine #bjaa4 ,precision ,medicine ,initiative ,part ,h of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi et seq47 is amended by adding at the end the following3 #dih;,e4 ,precision ,medicine ,initiative 7a7 ,in general ,the ,secretary is encouraged to establish and carry out an initiative1 to be known as the ,precision ,medicine ,initiative 7in this section referred to as the ,initiative71 to augment efforts to address disease prevention1 diagnosis1 and treatment4 7b7 ,components ,the ,initiative described under subsection 7a7 may include-- 7#a7 developing a network of scientists to assist in carrying out the purposes of the ,initiative2 7#b7 developing new approaches for addressing scientific1 medical1 public health1 and regulatory science issues2 7#c7 applying genomic technologies1 such as whole genomic sequencing1 to provide data on the molecular basis of disease2 7#d7 collecting information voluntarily provided by a diverse cohort of individuals that can be used to better understand health and disease2 and 7#e7 other activities to advance the goals of the ,initiative1 as the ,secretary determines appropriate4 7c7 ,authority of the secretary ,in carrying out this section1 the ,secretary may-- 7#a7 coordinate with the ,secretary of ,energy1 private industry1 and others1 as the ,secretary determines appropriate1 to identify and address the advanced supercomputing and other advanced technology needs for the ,initiative2 7#b7 develop and utilize public-private partnerships2 and 7#c7 leverage existing data sources4 7d7 ,requirements ,in the implementation of the ,initiative under subsection 7a71 the ,secretary shall-- 7#a7 ensure the collaboration of the ,national ,institutes of ,health1 the ,food and ,drug ,administration1 the ,office of the ,national ,coordinator for ,health ,information ,technology1 and the ,office for ,civil ,rights of the ,department of ,health and ,human ,services2 7#b7 comply with existing laws and regulations for the protection of human subjects involved in research1 including the protection of participant privacy2 7#c7 implement policies and mechanisms for appropriate secure data sharing across systems that include protections for privacy and security of data2 7#d7 consider the diversity of the cohort to ensure inclusion of a broad range of participants1 including consideration of biological1 social1 and other determinants of health that contribute to health disparities2 7#e7 ensure that only authorized individuals may access controlled or sensitive1 identifiable biological material and associated information collected or stored in connection with the ,initiative2 and 7#f7 on the appropriate ,internet website of the ,department of ,health and ,human ,services1 identify any entities with access to such information and provide information with respect to the purpose of such access1 a summary of the research project for which such access is granted1 as applicable1 and a description of the biological material and associated information to which the entity has access4 7e7 ,report ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall submit a report on the relevant data access policies and procedures to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,such report shall include steps the ,secretary has taken to consult with experts or other heads of departments or agencies of the ,federal ,government in the development of such policies4 4 #bjab4 ,privacy protection for human research subjects 7a7 ,in general ,subsection 7d7 of section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7 is amended to read as follows3 7d7 7#a7 7,a7 ,if a person is engaged in biomedical1 behavioral1 clinical1 or other research1 in which identifiable1 sensitive information is collected 7including research on mental health and research on the use and effect of alcohol and other psychoactive drugs71 the ,secretary1 in coordination with other agencies1 as applicable-- 7i7 shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the ,federal ,government2 and 7ii7 may1 upon application by a person engaged in research1 issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded4 7,b7 ,except as provided in subparagraph 7,c71 any person to whom a certificate is issued under subparagraph 7,a7 to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information1 document1 or biospecimen that contains identifiable1 sensitive information about such an individual and that was created or compiled for purposes of the research4 7,c7 ,the disclosure prohibition in subparagraph 7,b7 shall not apply to disclosure or use that is-- 7i7 required by ,federal1 ,state1 or local laws1 excluding instances described in subparagraph 7,d72 7ii7 necessary for the medical treatment of the individual to whom the information1 document1 or biospecimen pertains and made with the consent of such individual2 7iii7 made with the consent of the individual to whom the information1 document1 or biospecimen pertains2 or 7iv7 made for the purposes of other scientific research that is in compliance with applicable ,federal regulations governing the protection of human subjects in research4 7,d7 ,any person to whom a certificate is issued under subparagraph 7,a7 to protect the privacy of an individual described in such subparagraph shall not1 in any ,federal1 ,state1 or local civil1 criminal1 administrative1 legislative1 or other proceeding1 disclose or provide the name of such individual or any such information1 document1 or biospecimen that contains identifiable1 sensitive information about the individual and that was created or compiled for purposes of the research1 except in the circumstance described in subparagraph 7,c77iii74 7,e7 ,identifiable1 sensitive information protected under subparagraph 7,a71 and all copies thereof1 shall be immune from the legal process1 and shall not1 without the consent of the individual to whom the information pertains1 be admissible as evidence or used for any purpose in any action1 suit1 or other judicial1 legislative1 or administrative proceeding4 7,f7 ,identifiable1 sensitive information collected by a person to whom a certificate has been issued under subparagraph 7,a71 and all copies thereof1 shall be subject to the protections afforded by this section for perpetuity4 7,g7 ,the ,secretary shall take steps to minimize the burden to researchers1 streamline the process1 and reduce the time it takes to comply with the requirements of this subsection4 7#b7 ,the ,secretary shall coordinate with the heads of other applicable ,federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph 7#a7 and other requirements of this subsection4 7#c7 ,nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual's participation in the research4 7#d7 ,for purposes of this subsection1 the term identifiable1 sensitive information means information that is about an individual and that is gathered or used during the course of research described in paragraph 7#a77;,a7 and-- 7,a7 through which an individual is identified2 or 7,b7 for which there is at least a very small risk1 as determined by current scientific practices or statistical methods1 that some combination of the information1 a request for the information1 and other available data sources could be used to deduce the identity of an individual4 4 7b7 ,applicability ,beginning #ahj days after the date of enactment of this ,act1 all persons engaged in research and authorized by the ,secretary of ,health and ,human ,services to protect information under section #cja7;d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7;d77 prior to the date of enactment of this ,act shall be subject to the requirements of such section 7as amended by this ,act74 #bjac4 ,protection of identifiable and sensitive information ,section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7 is amended by adding at the end the following3 7f7 7#a7 ,the ,secretary may exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code1 biomedical information that is about an individual and that is gathered or used during the course of biomedical research if-- 7,a7 an individual is identified2 or 7,b7 there is at least a very small risk1 as determined by current scientific practices or statistical methods1 that some combination of the information1 the request1 and other available data sources could be used to deduce the identity of an individual4 7#b7 7,a7 ,each determination of the ,secretary under paragraph 7#a7 to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination4 7,b7 ,each such determination and statement of basis shall be available to the public1 upon request1 through the ,office of the ,chief ,,foia ,officer of the ,department of ,health and ,human ,services4 7#c7 ,nothing in this subsection shall be construed to limit a research participant's access to information about such participant collected during the participant's participation in the research4 4 #bjad4 ,data sharing 7a7 ,in general ,section #djb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b77 is amended-- 7#a7 in paragraph 7#bc71 by striking and at the end2 7#b7 in paragraph 7#bd71 by striking the period and inserting 2 and2 and 7#c7 by inserting after paragraph 7#bd7 the following3 7#be7 may require recipients of ,national ,institutes of ,health awards to share scientific data1 to the extent feasible1 generated from such ,national ,institutes of ,health awards in a manner that is consistent with all applicable ,federal laws and regulations1 including such laws and regulations for the protection of-- 7,a7 human research participants1 including with respect to privacy1 security1 informed consent1 and protected health information2 and 7,b7 proprietary interests1 confidential commercial information1 and the intellectual property rights of the funding recipient4 4 7b7 ,confidentiality ,nothing in the amendments made by subsection 7a7 authorizes the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret1 or other privileged or confidential information1 described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code1 or be construed to require recipients of grants or cooperative agreements through the ,national ,institutes of ,health to share such information4 ,c ,supporting young emerging scientists #bjba4 ,investing in the next generation of researchers 7a7 ,in general ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,m4 ,next generation of researchers 7a7 ,next ,generation of ,researchers ,initiative ,there shall be established within the ,office of the ,director of the ,national ,institutes of ,health1 the ,next ,generation of ,researchers ,initiative 7referred to in this section as the ,initiative71 through which the ,director shall coordinate all policies and programs within the ,national ,institutes of ,health that are focused on promoting and providing opportunities for new researchers and earlier research independence4 7b7 ,activities ,the ,director of the ,national ,institutes of ,health1 through the ,initiative shall-- 7#a7 promote policies and programs within the ,national ,institutes of ,health that are focused on improving opportunities for new researchers and promoting earlier research independence1 including existing policies and programs1 as appropriate2 7#b7 develop1 modify1 or prioritize policies1 as needed1 within the ,national ,institutes of ,health to promote opportunities for new researchers and earlier research independence1 such as policies to increase opportunities for new researchers to receive funding1 enhance training and mentorship programs for researchers1 and enhance workforce diversity2 7#c7 coordinate1 as appropriate1 with relevant agencies1 professional and academic associations1 academic institutions1 and others1 to improve and update existing information on the biomedical research workforce in order to inform programs related to the training1 recruitment1 and retention of biomedical researchers2 and 7#d7 carry out other activities1 including evaluation and oversight of existing programs1 as appropriate1 to promote the development of the next generation of researchers and earlier research independence4 4 7b7 ,consideration of recommendations ,in carrying out activities under section #djd,m7b7 of the ,public ,health ,service ,act1 the ,director of the ,national ,institutes of ,health shall take into consideration the recommendations made by the ,national ,academies of ,sciences1 ,engineering1 and ,medicine as part of the comprehensive study on policies affecting the next generation of researchers under the ,department of ,health and ,human ,services ,appropriations ,act1 #bjaf 7,public ,law #aad-aac71 and submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate1 and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 with respect to any actions taken by the ,national ,institutes of ,health based on the recommendations not later than #b years after the completion of the study required pursuant to the ,department of ,health and ,human ,services ,appropriations ,act1 #bjaf4 #bjbb4 ,improvement of loan repayment program 7a7 ,intramural loan repayment program ,section #dhg;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh-a7 is amended-- 7#a7 by amending the section heading to read as follows3 ,intramural loan repayment program2 7#b7 in subsection 7a7-- 7,a7 by striking ,the ,secretary shall carry out a program and inserting ,the ,director of the ,national ,institutes of ,health shall1 as appropriate and based on workforce and scientific priorities1 carry out a program through the subcategories listed in subsection 7b77#a7 7or modified subcategories as provided for in subsection 7b77#b772 7,b7 by striking conduct and inserting conduct research2 7,c7 by striking research with respect to acquired immune deficiency syndrome2 and 7,d7 by striking #ce1jjj and inserting #ej1jjj2 7#c7 by redesignating subsection 7b7 as subsection 7d72 7#d7 by inserting after subsection 7a71 the following3 7b7 ,subcategories of research 7#a7 ,in general ,in carrying out the program under subsection 7a71 the ,director of the ,national ,institutes of ,health-- 7,a7 shall continue to focus on-- 7i7 general research2 7ii7 research on acquired immune deficiency syndrome2 and 7iii7 clinical research conducted by appropriately qualified health professional who are from disadvantaged backgrounds2 and 7,b7 may focus on an area of emerging scientific or workforce need4 7#b7 ,elimination or establishment of subcategories ,the ,director of the ,national ,institutes of ,health may eliminate one or more subcategories provided for in paragraph 7#a7 due to changes in workforce or scientific needs related to biomedical research4 ,the ,director may establish other subcategory areas based on workforce and scientific priorities if the total number of subcategories does not exceed the number of subcategories listed in paragraph 7#a74 7c7 ,limitation ,the ,director of the ,national ,institutes of ,health may not enter into a contract with a health professional pursuant to subsection 7a7 unless such professional has a substantial amount of education loans relative to income 7as determined pursuant to guidelines issued by the ,director74 2 and 7#e7 by adding at the end the following3 7e7 ,availability of appropriations ,amounts available for carrying out this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which such amounts are made available4 4 7b7 ,extramural loan repayment program ,section #dhg;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh-b7 is amended-- 7#a7 by amending the section heading to read as follows3 ,extramural loan repayment program2 7#b7 in subsection 7a7-- 7,a7 by striking ,the ,secretary1 in consultation with the ,director of the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development1 shall establish a program and inserting ,in general4--,the ,director of the ,national ,institutes of ,health shall1 as appropriate and based on workforce and scientific priorities1 carry out a program through the subcategories listed in subsection 7b77#a7 7or modified subcategories as provided for in subsection 7b77#b7712 7,b7 by striking 7including graduate students72 7,c7 by striking with respect to contraception1 or with respect to infertility12 and 7,d7 by striking service1 not more than #ce1jjj and inserting research1 not more than #ej1jjj2 7#c7 by redesignating subsections 7b7 and 7c7 as subsections 7d7 and 7e71 respectively2 7#d7 by inserting after subsection 7a71 the following3 7b7 ,subcategories of research 7#a7 ,in general ,in carrying out the program under subsection 7a71 the ,director of the ,national ,institutes of ,health-- 7,a7 shall continue to focus on-- 7i7 contraception or infertility research2 7ii7 pediatric research1 including pediatric pharmacological research2 7iii7 minority health disparities research2 7iv7 clinical research2 and 7v7 clinical research conducted by appropriately qualified health professional who are from disadvantaged backgrounds2 and 7,b7 may focus on an area of emerging scientific or workforce need4 7#b7 ,elimination or establishment of subcategories ,the ,director of the ,national ,institutes of ,health may eliminate one or more subcategories provided for in paragraph 7#a7 due to changes in workforce or scientific needs related to biomedical research4 ,the ,director may establish other subcategory areas based on workforce and scientific priorities if the total number of subcategories does not exceed the number of subcategories listed in paragraph 7#a74 7c7 ,limitation ,the ,director of the ,national ,institutes of ,health may not enter into a contract with a health professional pursuant to subsection 7a7 unless such professional has a substantial amount of education loans relative to income 7as determined pursuant to guidelines issued by the ,director74 2 7#e7 in subsection 7d7 7as so redesignated71 by striking ,the provisions and inserting ,applicability of certain provisions regarding obligated service4--,the provisions2 and 7#f7 in subsection 7e7 7as so redesignated71 by striking ,amounts and inserting ,availability of appropriations4--,amounts4 7c7 ,technical and conforming amendments ,title ,,iv of the ,public ,health ,service ,act is amended-- 7#a7 by striking section #dfdz-#e 7#db ,u4,s4,c4 #bhet-#b72 7#b7 by striking section #dhg;,c 7#db ,u4,s4,c4 #bhh-c72 7#c7 by striking section #dhg;,e 7#db ,u4,s4,c4 #bhh-e72 7#d7 by striking section #dhg;,f 7#db ,u4,s4,c4 #bhh-e;a71 as added by section #bje of ,public ,law #ajf-eje1 relating to loan repayment for clinical researchers2 and 7#e7 by striking section #dhg;,f 7#db ,u4,s4,c4 #bhh-f71 as added by section #ajjb7;b7 of ,public ,law #ajf-caj relating to pediatric research loan repayment4 7d7 ,,gao report ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the efforts of the ,national ,institutes of ,health to attract1 retain1 and develop emerging scientists1 including underrepresented individuals in the sciences1 such as women1 racial and ethnic minorities1 and other groups4 ,such report shall include an analysis of the impact of the additional authority provided to the ,secretary of ,health and ,human ,services under this ,act to address workforce shortages and gaps in priority research areas1 including which centers and research areas offered loan repayment program participants the increased award amount4 ,d ,national ,institutes of ,health planning and administration #bjca4 ,national ,institutes of ,health strategic plan 7a7 ,strategic plan ,section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7 is amended-- 7#a7 in subsection 7b77#e71 by inserting before the semicolon the following3 1 and through the development1 implementation1 and updating of the strategic plan developed under subsection 7m72 and 7#b7 by adding at the end the following3 7m7 ,national ,institutes of ,health strategic plan 7#a7 ,in general ,not later than #b years after the date of enactment of the #bast ,century ,cures ,act1 and at least every #f years thereafter1 the ,director of the ,national ,institutes of ,health shall develop and submit to the appropriate committees of ,congress and post on the ,internet website of the ,national ,institutes of ,health1 a coordinated strategy 7to be known as the ,national ,institutes of ,health ,strategic ,plan7 to provide direction to the biomedical research investments made by the ,national ,institutes of ,health1 to facilitate collaboration across the institutes and centers1 to leverage scientific opportunity1 and to advance biomedicine4 7#b7 ,requirements ,the strategy under paragraph 7#a7 shall-- 7,a7 identify strategic research priorities and objectives across biomedical research1 including-- 7i7 an assessment of the state of biomedical and behavioral research1 including areas of opportunity with respect to basic1 clinical1 and translational research2 7ii7 priorities and objectives to advance the treatment1 cure1 and prevention of health conditions2 7iii7 emerging scientific opportunities1 rising public health challenges1 and scientific knowledge gaps2 and 7iv7 the identification of near-1 mid-1 and long-term scientific needs2 7,b7 consider1 in carrying out subparagraph 7,a7-- 7i7 disease burden in the ,united ,states and the potential for return on investment to the ,united ,states2 7ii7 rare diseases and conditions2 7iii7 biological1 social1 and other determinants of health that contribute to health disparities2 and 7iv7 other factors the ,director of ,national ,institutes of ,health determines appropriate2 7,c7 include multi-institute priorities1 including coordination of research among institutes and centers2 7,d7 include strategic priorities for funding research through the ,common ,fund1 in accordance with section #djb;,a7c77#a77;,c72 7,e7 address the ,national ,institutes of ,health's proposed and ongoing activities related to training and the biomedical workforce2 and 7,f7 describe opportunities for collaboration with other agencies and departments1 as appropriate4 7#c7 ,use of plans ,strategic plans developed and updated by the national research institutes and national centers of the ,national ,institutes of ,health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection4 ,such plans developed by and updated by the national research institutes and national centers shall have a common template4 7#d7 ,consultation ,the ,director of ,national ,institutes of ,health shall develop the strategic plan under paragraph 7#a7 in consultation with the directors of the national research institutes and national centers1 researchers1 patient advocacy groups1 and industry leaders4 4 7b7 ,conforming amendment ,section #djb;,a7c77#a77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7c77#a77;,c77 is amended by striking ,not later than ,june #a1 #bjjg1 and every #b years thereafter1 and inserting ,as part of the ,national ,institutes of ,health ,strategic ,plan required under section #djb7m714 7c7 ,strategic plan ,section #dib;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;a77 is amended by adding at the end the following3 7#c7 ,strategic planning 7,a7 ,in general ,the directors of the national institutes and national centers shall consult at least once annually with the ,director of the ,national ,institute on ,minority ,health and ,health ,disparities and the ,director of the ,office of ,research on ,women's ,health regarding objectives of the national institutes and national centers to ensure that future activities by such institutes and centers take into account women and minorities and are focused on reducing health disparities4 7,b7 ,strategic plans ,any strategic plan issued by a national institute or national center shall include details on the objectives described in subparagraph 7,a74 4 #bjcb4 ,triennial reports ,section #djc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7 is amended-- 7#a7 in the section heading1 by striking ,biennial and inserting ,triennial 2 and 7#b7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking biennial and inserting triennial2 7,b7 by amending paragraph 7#c7 to read as follows3 7#c7 ,a description of intra-,national ,institutes of ,health activities1 including-- 7,a7 identification of the percentage of funds made available by each national research institute and national center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration between the institute or center and #a or more other national research institutes or national centers2 and 7,b7 recommendations for promoting coordination of information among the centers of excellence4 2 7,c7 in paragraph 7#d7-- 7i7 in subparagraph 7,b71 by striking demographic variables and other variables and inserting demographic variables1 including biological and social variables and relevant age categories 7such as pediatric subgroups71 and determinants of health12 and 7ii7 in subparagraph 7,c77v7-- 7,i7 by striking demographic variables and such and inserting demographic variables1 including relevant age categories 7such as pediatric subgroups71 information submitted by each national research institute and national center to the ,director of ,national ,institutes of ,health under section #dib;,b7f71 and such2 and 7,,ii7 by striking 7regarding inclusion of women and minorities in clinical research7 and inserting and other applicable requirements regarding inclusion of demographic groups2 and 7,d7 in paragraph 7#f7-- 7i7 in the matter preceding subparagraph 7,a71 by striking the following3 and inserting the following--2 7ii7 in subparagraph 7,a7-- 7,i7 by striking ,an evaluation and inserting an evaluation2 and 7,,ii7 by striking the period and inserting 2 and2 7iii7 by striking subparagraphs 7,b7 and 7,d72 7iv7 by redesignating subparagraph 7,c7 as subparagraph 7,b72 and 7v7 in subparagraph 7,b71 as redesignated by clause 7iv71 by striking ,recommendations and inserting recommendations4 #bjcc4 ,increasing accountability at the ,national ,institutes of ,health 7a7 ,appointment and terms of directors of national research institutes and national centers ,subsection 7a7 of section #dje of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7 is amended to read as follows3 7a7 ,appointment 7#a7 ,in general ,the ,director of the ,national ,cancer ,institute shall be appointed by the ,president1 and the ,directors of the other national research institutes and national centers shall be appointed by the ,secretary1 acting through the ,director of ,national ,institutes of ,health4 ,each ,director of a national research institute or national center shall report directly to the ,director of ,national ,institutes of ,health4 7#b7 ,appointment 7,a7 ,term ,a ,director of a national research institute or national center who is appointed by the ,secretary1 acting through the ,director of ,national ,institutes of ,health1 shall be appointed for #e years4 7,b7 ,reappointment ,at the end of the term of a ,director of a national research institute or national center1 the ,director may be reappointed in accordance with standards applicable to the relevant appointment mechanism4 ,there shall be no limit on the number of terms that a ,director may serve4 7,c7 ,vacancies ,if the office of a ,director of a national research institute or national center becomes vacant before the end of such ,director's term1 the ,director appointed to fill the vacancy shall be appointed for a #e-year term starting on the date of such appointment4 7,d7 ,current directors ,each ,director of a national research institute or national center who is serving on the date of enactment of the #bast ,century ,cures ,act shall be deemed to be appointed for a #e-year term under this subsection beginning on such date of enactment4 7,e7 ,rule of construction ,nothing in this subsection shall be construed to limit the authority of the ,secretary or the ,director of ,national ,institutes of ,health to terminate the appointment of a director referred to in subparagraph 7,a7 before the expiration of such director's #e-year term4 7,f7 ,nature of appointment ,appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the ,national ,institutes of ,health and its components1 including compliance with any legal requirement that the ,secretary or ,director of ,national ,institutes of ,health determines relevant4 7#c7 ,nonapplication of certain provision ,the restrictions contained in section #bjb of the ,departments of ,labor1 ,health and ,human ,services1 and ,education1 and ,related ,agencies ,appropriations ,act1 #aiic 7,public ,law #ajb-cid2 #db ,u4,s4,c4 #bch;f note7 related to consultants and individual scientists appointed for limited periods of time shall not apply to ,directors appointed under this subsection4 4 7b7 ,review of certain awards by directors ,section #dje7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7;b77 is amended by adding at the end the following3 7#c7 ,before an award is made by a national research institute or by a national center for a grant for a research program or project 7commonly referred to as an ,r-series grant71 other than an award constituting a noncompetitive renewal of such a grant1 or a noncompetitive administrative supplement to such a grant1 the ,director of such national research institute or national center shall1 consistent with the peer review process-- 7,a7 review and make the final decision with respect to making the award2 and 7,b7 take into consideration1 as appropriate-- 7i7 the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section #djb7m72 7ii7 programs or projects funded by other agencies on similar research topics2 and 7iii7 advice by staff and the advisory council or board of such national research institute or national center4 4 7c7 ,report on duplication in ,federal biomedical research ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary71 shall1 not later than #b years after the date of enactment of this ,act1 submit a report to ,congress on efforts to prevent and eliminate duplicative biomedical research that is not necessary for scientific purposes4 ,such report shall-- 7#a7 describe the procedures in place to identify such duplicative research1 including procedures for monitoring research applications and funded research awards to prevent unnecessary duplication2 7#b7 describe the steps taken to improve the procedures described in paragraph 7#a71 in response to relevant recommendations made by the ,comptroller ,general of the ,united ,states2 7#c7 describe how the ,secretary operationally distinguishes necessary and appropriate scientific replication from unnecessary duplication2 and 7#d7 provide examples of instances where the ,secretary has identified unnecessarily duplicative research and the steps taken to eliminate the unnecessary duplication4 #bjcd4 ,reducing administrative burden for researchers 7a7 ,plan ,preparation and implementation of measures ,to reduce administrative burdens 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall-- 7,a7 lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest1 including the minimum threshold for reporting financial conflicts of interest2 7,b7 make revisions1 as appropriate1 to harmonize existing policies and reduce administrative burden on researchers while maintaining the integrity and credibility of research findings and protections of human participants2 and 7,c7 confer with the ,office of the ,inspector ,general about the activities of such office related to financial conflicts of interest involving research funding agencies4 7#b7 ,considerations ,in updating policies under paragraph 7#a77;,b71 the ,secretary shall consider-- 7,a7 modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by institutions receiving grant or cooperative agreement funding from the ,national ,institutes of ,health2 7,b7 ensuring that financial interest disclosure reporting requirements are appropriate for1 and relevant to1 awards that will directly fund research1 which may include modification of the definition of the term investigator for purposes of the regulations and policies described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a72 and 7,c7 updating any applicable training modules of the ,national ,institutes of ,health related to ,federal financial interest disclosure4 7b7 ,monitoring of subrecipients of funding from the national institutes of health ,the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,director of ,national ,institutes of ,health7 shall implement measures to reduce the administrative burdens related to monitoring of subrecipients of grants by primary awardees of funding from the ,national ,institutes of ,health1 which may incorporate findings and recommendations from existing and ongoing activities4 ,such measures may include1 as appropriate-- 7#a7 an exemption from subrecipient monitoring requirements1 upon request from the primary awardees1 provided that-- 7,a7 the subrecipient is subject to ,federal audit requirements pursuant to the ,uniform ,guidance of the ,office of ,management and ,budget2 7,b7 the primary awardee conducts1 pursuant to guidance of the ,national ,institutes of ,health1 a pre-award evaluation of each subrecipient's risk of noncompliance with ,federal statutes and regulations1 the conditions of the subaward1 and any recurring audit findings2 and 7,c7 such exemption does not absolve the primary awardee of liability for misconduct by subrecipients2 and 7#b7 the implementation of alternative grant structures that obviate the need for subrecipient monitoring1 which may include collaborative grant models allowing for multiple primary awardees4 7c7 ,reporting of financial expenditures ,the ,secretary1 in consultation with the ,director of ,national ,institutes of ,health1 shall evaluate financial expenditure reporting procedures and requirements for recipients of funding from the ,national ,institutes of ,health and take action1 as appropriate1 to avoid duplication between department and agency procedures and requirements and minimize burden to funding recipients4 7d7 ,animal care and use in research ,not later than #b years after the date of enactment of this ,act1 the ,director of ,national ,institutes of ,health1 in collaboration with the ,secretary of ,agriculture and the ,commissioner of ,food and ,drugs1 shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions1 as appropriate1 to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals4 ,in carrying out this effort1 the ,director of the ,national ,institutes of ,health shall seek the input of experts1 as appropriate4 ,the ,director of the ,national ,institutes of ,health shall-- 7#a7 identify ways to ensure such regulations and policies are not inconsistent1 overlapping1 or unnecessarily duplicative1 including with respect to inspection and review requirements by ,federal agencies and accrediting associations2 7#b7 take steps to eliminate or reduce identified inconsistencies1 overlap1 or duplication among such regulations and policies2 and 7#c7 take other actions1 as appropriate1 to improve the coordination of regulations and policies with respect to research with laboratory animals4 7e7 ,documentation of personnel expenses ,the ,secretary shall clarify the applicability of the requirements under the ,office of ,management and ,budget ,uniform ,guidance for management and certification systems adopted by entities receiving ,federal research grants through the ,department of ,health and ,human ,services regarding documentation of personnel expenses1 including clarification of the extent to which any flexibility to such requirements specified in such ,uniform ,guidance applies to entities receiving grants through the ,department of ,health and ,human ,services4 7f7 ,research policy board 7#a7 ,establishment ,not later than #a year after the date of enactment of this ,act1 the ,director of the ,office of ,management and ,budget shall establish an advisory committee1 to be known as the ,research ,policy ,board 7referred to in this subsection as the ,board71 to provide ,federal ,government officials with information on the effects of regulations related to ,federal research requirements4 7#b7 ,membership 7,a7 ,in general ,the ,board shall include not more than #aj ,federal members1 including each of the following ,federal members or their designees3 7i7 ,the ,administrator of the ,office of ,information and ,regulatory ,affairs of the ,office of ,management and ,budget4 7ii7 ,the ,director of the ,office of ,science and ,technology ,policy4 7iii7 ,the ,secretary of ,health and ,human ,services4 7iv7 ,the ,director of the ,national ,science ,foundation4 7v7 ,the secretaries and directors of other departments and agencies that support or regulate scientific research1 as determined by the ,director of the ,office of ,management and ,budget4 7,b7 ,non-,federal members ,the ,board shall be comprised of not less than #i and not more than #ab representatives of academic research institutions1 other private1 nonprofit research institutions1 or other nonprofit organizations with relevant expertise4 ,such members shall be appointed by a formal process1 to be established by the ,director of the ,office of ,management and ,budget1 in consultation with the ,federal membership1 and that incorporates-- 7i7 nomination by members of the nonprofit scientific research community1 including academic research institutions2 and 7ii7 procedures to fill membership positions vacated before the end of a member's term4 7#c7 ,purpose and responsibilities ,the ,board shall make recommendations regarding the modification and harmonization of regulations and policies having similar purposes across research funding agencies to ensure that the administrative burden of such research policy and regulation is minimized to the greatest extent possible and consistent with maintaining responsible oversight of federally funded research4 ,activities of the ,board may include-- 7,a7 providing thorough and informed analysis of regulations and policies2 7,b7 identifying negative or adverse consequences of existing policies and making actionable recommendations regarding possible improvement of such policies2 7,c7 making recommendations with respect to efforts within the ,federal ,government to improve coordination of regulation and policy related to research2 7,d7 creating a forum for the discussion of research policy or regulatory gaps1 challenges1 clarification1 or harmonization of such policies or regulation1 and best practices2 and 7,e7 conducting ongoing assessment and evaluation of regulatory burden1 including development of metrics1 periodic measurement1 and identification of process improvements and policy changes4 7#d7 ,expert subcommittees ,the ,board may form temporary expert subcommittees1 as appropriate1 to develop timely analysis on pressing issues and assist the ,board in anticipating future regulatory challenges1 including challenges emerging from new scientific advances4 7#e7 ,reporting requirements ,not later than #b years after the date of enactment of this ,act1 and once thereafter1 the ,board shall submit a report to the ,director of the ,office of ,management and ,budget1 the ,administrator of the ,office of ,information and ,regulatory ,affairs of the ,office of ,management and ,budget1 the ,director of the ,office of ,science and ,technology ,policy1 the heads of relevant ,federal departments and agencies1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives containing formal recommendations on the conceptualization1 development1 harmonization1 and reconsideration of scientific research policy1 including the regulatory benefits and burdens4 7#f7 ,sunset ,the ,board shall terminate on ,september #cj1 #bjba4 7#g7 ,,gao report ,not later than #d years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation of the activities carried out by the ,board pursuant to this subsection and submit to the appropriate committees of ,congress a report regarding the results of the independent evaluation4 ,such report shall review and assess the ,board's activities with respect to the responsibilities described in paragraph 7#c74 #bjce4 ,exemption for the ,national ,institutes of ,health from the ,paperwork ,reduction ,act requirements ,section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda71 as amended by section #bjac1 is further amended by adding at the end the following3 7g7 ,subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the voluntary collection of information during the conduct of research by the ,national ,institutes of ,health4 4 #bjcf4 ,high-risk1 high-reward research 7a7 ,in general ,section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb71 as amended by section #bjca1 is further amended by adding at the end the following3 7n7 ,unique research initiatives 7#a7 ,in general ,the ,director of ,,nih may approve1 after consideration of a proposal under paragraph 7#b77;,a71 requests by the national research institutes and centers1 or program officers within the ,office of the ,director to engage in transactions other than a contract1 grant1 or cooperative agreement with respect to projects that carry out-- 7,a7 the ,precision ,medicine ,initiative under section #dih;,e2 or 7,b7 section #djb7;b77#g71 except that not more than #ej percent of the funds available for a fiscal year through the ,common ,fund under section #djb;,a7c77#a7 for purposes of carrying out such section #djb7;b77#g7 may be used to engage in such other transactions4 7#b7 ,requirements ,the authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph 7#a7 using the other transactions authority described in such paragraph if the institute1 center1 or office-- 7,a7 submits a proposal to the ,director of ,,nih for the use of such authority before conducting or supporting the research1 including why the use of such authority is essential to promoting the success of the project2 7,b7 receives approval for the use of such authority from the ,director of ,,nih2 and 7,c7 for each year in which the institute1 center1 or office has used such authority in accordance with this subsection1 submits a report to the ,director of ,,nih on the activities of the institute1 center1 or office relating to such research4 4 7b7 ,report to ,congress ,not later than ,september #cj1 #bjbj1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall conduct an evaluation of the activities under subsection 7n7 of section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb71 as added by subsection 7a71 and submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the results of such evaluation4 7c7 ,duties of directors of institutes ,section #dje7;b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd7;b77#a77 is amended-- 7#a7 by redesignating subparagraphs 7,c7 through 7,l7 as subparagraphs 7,d7 through 7,m71 respectively2 and 7#b7 by inserting after subparagraph 7,b71 the following3 7,c7 shall1 as appropriate1 conduct and support research that has the potential to transform the scientific field1 has inherently higher risk1 and that seeks to address major current challenges2 4 #bjcg4 ,national ,center for ,advancing ,translational ,sciences 7a7 ,in general ,section #dgi7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg7;b77 is amended-- 7#a7 in paragraph 7#a71 by striking phase ,,iia and inserting phase ,,iib2 and 7#b7 in paragraph 7#b7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking phase ,,iib and inserting phase ,,iii2 7,b7 in subparagraph 7,a71 by striking phase ,,iib and inserting phase ,,iii2 7,c7 in subparagraph 7,b71 by striking phase ,,iia and inserting phase ,,iib2 and 7,d7 in subparagraph 7,c71 by striking phase ,,iib and inserting phase ,,iii4 7b7 ,increased transparency ,section #dgi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#d77;,d71 by striking and at the end2 7,b7 in paragraph 7#e71 by striking the period and inserting a semicolon2 and 7,c7 by adding at the end the following3 7#f7 the methods and tools1 if any1 that have been developed since the last biennial report was prepared2 and 7#g7 the methods and tools1 if any1 that have been developed and are being utilized by the ,food and ,drug ,administration to support medical product reviews4 2 and 7#b7 by adding at the end the following3 7d7 ,inclusion of list ,the first biennial report submitted under this section after the date of enactment of the #bast ,century ,cures ,act shall include a complete list of all of the methods and tools1 if any1 which have been developed by research supported by the ,center4 7e7 ,rule of construction ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret1 or other privileged or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 #bjch4 ,collaboration and coordination to enhance research 7a7 ,research priorities2 collaborative research projects ,section #djb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b77 is amended-- 7#a7 by amending paragraph 7#d7 to read as follows3 7#d7 shall assemble accurate data to be used to assess research priorities1 including-- 7,a7 information to better evaluate scientific opportunity1 public health burdens1 and progress in reducing health disparities2 and 7,b7 data on study populations of clinical research1 funded by or conducted at each national research institute and national center1 which-- 7i7 specifies the inclusion of-- 7,i7 women2 7,,ii7 members of minority groups2 7,,iii7 relevant age categories1 including pediatric subgroups2 and 7,,iv7 other demographic variables as the ,director of the ,national ,institutes of ,health determines appropriate2 7ii7 is disaggregated by research area1 condition1 and disease categories2 and 7iii7 is to be made publicly available on the ,internet website of the ,national ,institutes of ,health2 2 and 7#b7 in paragraph 7#h7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 and 7,b7 by adding at the end the following3 7,c7 foster collaboration between clinical research projects funded by the respective national research institutes and national centers that-- 7i7 conduct research involving human subjects2 and 7ii7 collect similar data2 and 7,d7 encourage the collaboration described in subparagraph 7,c7 to-- 7i7 allow for an increase in the number of subjects studied2 and 7ii7 utilize diverse study populations1 with special consideration to biological1 social1 and other determinants of health that contribute to health disparities2 4 7b7 ,reporting ,section #dib;,b7f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;f77 is amended-- 7#a7 by striking biennial each place such term appears and inserting triennial2 7#b7 by striking ,the advisory council and inserting the following3 7#a7 ,in general ,the advisory council 2 and 7#c7 by adding at the end the following3 7#b7 ,contents ,each triennial report prepared by an advisory council of each national research institute as described in paragraph 7#a7 shall include each of the following3 7,a7 ,the number of women included as subjects1 and the proportion of subjects that are women1 in any project of clinical research conducted during the applicable reporting period1 disaggregated by categories of research area1 condition1 or disease1 and accounting for single-sex studies4 7,b7 ,the number of members of minority groups included as subjects1 and the proportion of subjects that are members of minority groups1 in any project of clinical research conducted during the applicable reporting period1 disaggregated by categories of research area1 condition1 or disease and accounting for single-race and single-ethnicity studies4 7,c7 ,for the applicable reporting period1 the number of projects of clinical research that include women and members of minority groups and that-- 7i7 have been completed during such reporting period2 and 7ii7 are being carried out during such reporting period and have not been completed4 7,d7 ,the number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection 7c77#b77;,a74 4 7c7 ,coordination ,section #dhf7;c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg;d7c77#b77 is amended by striking designees and inserting senior-level staff designees4 7d7 ,in general ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq471 as amended by section #bjba1 is further amended by adding at the end the following3 #djd,n4 ,population focused research ,the ,director of the ,national ,institutes of ,health shall1 as appropriate1 encourage efforts to improve research related to the health of sexual and gender minority populations1 including by-- 7#a7 facilitating increased participation of sexual and gender minority populations in clinical research supported by the ,national ,institutes of ,health1 and reporting on such participation1 as applicable2 7#b7 facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations2 and 7#c7 addressing methodological challenges4 4 7e7 ,reporting 7#a7 ,in general ,the ,secretary1 in collaboration with the ,director of the ,national ,institutes of ,health1 shall as appropriate-- 7,a7 continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations2 and 7,b7 not later than #b years after the date of enactment of this ,act1 disseminate and make public such measures4 7#b7 ,national academy of medicine recommendations ,in developing the measures described in paragraph 7#a77;,a71 the ,secretary shall take into account recommendations made by the ,national ,academy of ,medicine4 7f7 ,improving coordination related to minority health and health disparities ,section #dfdz-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhet7 is amended-- 7#a7 by redesignating subsection 7h71 relating to interagency coordination1 that follows subsection 7j7 as subsection 7k72 and 7#b7 in subsection 7k7 7as so redesignated7-- 7,a7 in the subsection heading1 by striking ,interagency and inserting ,intra-,national ,institutes of ,health2 7,b7 by striking as the primary ,federal officials and inserting as the primary ,federal official2 7,c7 by inserting a comma after review2 7,d7 by striking ,institutes and ,centers of the ,national ,institutes of ,health and inserting national research institutes and national centers2 and 7,e7 by adding at the end the following3 ,the ,director of the ,institute may foster partnerships between the national research institutes and national centers and may encourage the funding of collaborative research projects to achieve the goals of the ,national ,institutes of ,health that are related to minority health and health disparities44 7g7 ,basic research 7#a7 ,developing policies ,not later than #b years after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,director of the ,national ,institutes of ,health71 taking into consideration the recommendations developed under section #bjci1 shall develop policies for projects of basic research funded by ,national ,institutes of ,health to assess-- 7,a7 relevant biological variables including sex1 as appropriate2 and 7,b7 how differences between male and female cells1 tissues1 or animals may be examined and analyzed4 7#b7 ,revising policies ,the ,director of the ,national ,institutes of ,health may update or revise the policies developed under paragraph 7#a7 as appropriate4 7#c7 ,consultation and outreach ,in developing1 updating1 or revising the policies under this section1 the ,director of the ,national ,institutes of ,health shall-- 7,a7 consult with-- 7i7 the ,office of ,research on ,women's ,health2 7ii7 the ,office of ,laboratory ,animal ,welfare2 and 7iii7 appropriate members of the scientific and academic communities2 and 7,b7 conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research1 including feedback on when it is appropriate for projects of basic research involving cells1 tissues1 or animals to include both male and female cells1 tissues1 or animals4 7#d7 ,additional requirements ,the ,director of the ,national ,institutes of ,health shall-- 7,a7 ensure that projects of basic research funded by the ,national ,institutes of ,health are conducted in accordance with the policies developed1 updated1 or revised under this section1 as applicable2 and 7,b7 encourage that the results of such research1 when published or reported1 be disaggregated as appropriate with respect to the analysis of any sex differences4 7h7 ,clinical research 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health1 in consultation with the ,director of the ,office of ,research on ,women's ,health and the ,director of the ,national ,institute on ,minority ,health and ,health ,disparities1 shall update the guidelines established under section #dib;,b7d7 of ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;d77 in accordance with paragraph 7#b74 7#b7 ,requirements ,the updated guidelines described in paragraph 7#a7 shall-- 7,a7 reflect the science regarding sex differences2 7,b7 improve adherence to the requirements under section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b71 including the reporting requirements under subsection 7f7 of such section2 and 7,c7 clarify the circumstances under which studies should be designed to support the conduct of analyses to detect significant differences in the intervention effect due to demographic factors related to section #dib;,b of the ,public ,health ,service ,act1 including in the absence of prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the effects of the absence of such analyses on the availability of data related to demographic differences4 7i7 ,appropriate age groupings in clinical research 7#a7 ,input from experts ,not later than #ahj days after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall convene a workshop of experts on pediatric and older populations to provide input on-- 7,a7 appropriate age groups to be included in research studies involving human subjects2 and 7,b7 acceptable justifications for excluding participants from a range of age groups from human subjects research studies4 7#b7 ,policy updates ,not later than #ahj days after the conclusion of the workshop under paragraph 7#a71 the ,director of the ,national ,institutes of ,health shall make a determination with respect to whether the policies of the ,national ,institutes of ,health on the inclusion of relevant age groups in clinical studies need to be updated1 and shall update such policies as appropriate4 ,in making the determination1 the ,director of the ,national ,institutes of ,health shall take into consideration whether such policies-- 7,a7 address the consideration of age as an inclusion variable in research involving human subjects2 and 7,b7 identify the criteria for justification for any age-related exclusions in such research4 7#c7 ,public ,availability of ,findings and ,conclusions ,the ,director of the ,national ,institutes of ,health shall-- 7,a7 make the findings and conclusions resulting from the workshop under paragraph 7#a7 and updates to policies in accordance with paragraph 7#b71 as applicable1 available to the public on the ,internet website of the ,national ,institutes of ,health2 and 7,b7 ensure that age-related data reported in the triennial report under section #djc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7 7as amended by section #bjcb7 are made available to the public on the ,internet website of the ,national ,institutes of ,health4 #bjci4 ,enhancing the rigor and reproducibility of scientific research 7a7 ,establishment ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall convene a working group under the ,advisory ,committee to the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,advisory ,committee71 appointed under section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 to develop and issue recommendations through the ,advisory ,committee for a formal policy1 which may incorporate or be informed by relevant existing and ongoing activities1 to enhance rigor and reproducibility of scientific research funded by the ,national ,institutes of ,health4 7b7 ,considerations ,in developing and issuing recommendations through the ,advisory ,committee under subsection 7a71 the working group established under such subsection shall consider1 as appropriate-- 7#a7 preclinical experiment design1 including analysis of sex as a biological variable2 7#b7 clinical experiment design1 including-- 7,a7 the diversity of populations studied for clinical research1 with respect to biological1 social1 and other determinants of health that contribute to health disparities2 7,b7 the circumstances under which summary information regarding biological1 social1 and other factors that contribute to health disparities should be reported2 and 7,c7 the circumstances under which clinical studies1 including clinical trials1 should conduct an analysis of the data collected during the study on the basis of biological1 social1 and other factors that contribute to health disparities2 7#c7 applicable levels of rigor in statistical methods1 methodology1 and analysis2 7#d7 data and information sharing in accordance with applicable privacy laws and regulations2 and 7#e7 any other matter the working group determines relevant4 7c7 ,policies ,not later than #ah months after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall consider the recommendations developed by the working group and issued by the ,advisory ,committee under subsection 7a7 and develop or update policies as appropriate4 7d7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall issue a report to the ,secretary of ,health and ,human ,services1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding recommendations developed under subsection 7a7 and any subsequent policy changes implemented1 to enhance rigor and reproducibility in scientific research funded by the ,national ,institutes of ,health4 7e7 ,confidentiality ,nothing in this section authorizes the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret1 or other privileged or confidential information1 described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #bjdj4 ,improving medical rehabilitation research at the ,national ,institutes of ,health 7a7 ,in general ,section #deb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;g-#d7 is amended-- 7#a7 in subsection 7b71 by striking conduct and support and inserting conduct1 support1 and coordination2 7#b7 in subsection 7c77#a77;,c71 by striking of the ,center and inserting within the ,center2 7#c7 in subsection 7d7-- 7,a7 by striking 7d77#a7 ,in consultation and all that follows through the end of paragraph 7#a7 and inserting the following3 7d7 7#a7 ,the ,director of the ,center1 in consultation with the ,director of the ,institute1 the coordinating committee established under subsection 7e71 and the advisory board established under subsection 7f71 shall develop a comprehensive plan 7referred to in this section as the ,research ,plan7 for the conduct1 support1 and coordination of medical rehabilitation research4 2 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking 2 and and inserting a semicolon2 7ii7 in subparagraph 7,b71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,c7 include goals and objectives for conducting1 supporting1 and coordinating medical rehabilitation research1 consistent with the purpose described in subsection 7b74 2 7,c7 by striking paragraph 7#d7 and inserting the following3 7#d7 ,the ,director of the ,center1 in consultation with the ,director of the ,institute1 the coordinating committee established under subsection 7e71 and the advisory board established under subsection 7f71 shall revise and update the ,research ,plan periodically1 as appropriate1 or not less than every #e years4 ,not later than #cj days after the ,research ,plan is so revised and updated1 the ,director of the ,center shall transmit the revised and updated ,research ,plan to the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,d7 by adding at the end the following3 7#e7 ,the ,director of the ,center1 in consultation with the ,director of the ,institute1 shall1 prior to revising and updating the ,research ,plan1 prepare a report for the coordinating committee established under subsection 7e7 and the advisory board established under subsection 7f7 that describes and analyzes the progress during the preceding fiscal year in achieving the goals and objectives described in paragraph 7#b77;,c7 and includes expenditures for rehabilitation research at the ,national ,institutes of ,health4 ,the report shall include recommendations for revising and updating the ,research ,plan1 and such initiatives as the ,director of the ,center and the ,director of the ,institute determine appropriate4 ,in preparing the report1 the ,director of the ,center and the ,director of the ,institute shall consult with the ,director of the ,national ,institutes of ,health4 2 7#d7 in subsection 7e7-- 7,a7 in paragraph 7#b71 by inserting periodically host a scientific conference or workshop on medical rehabilitation research and after ,the ,coordinating ,committee shall2 and 7,b7 in paragraph 7#c71 by inserting the ,director of the ,division of ,program ,coordination1 ,planning1 and ,strategic ,initiatives within the ,office of the ,director of the ,national ,institutes of ,health1 after shall be composed of2 7#e7 in subsection 7f77#c77;,b7-- 7,a7 by redesignating clauses 7ix7 through 7xi7 as clauses 7x7 through 7xii71 respectively2 and 7,b7 by inserting after clause 7viii7 the following3 7ix7 ,the ,director of the ,division of ,program ,coordination1 ,planning1 and ,strategic ,initiatives4 2 and 7#f7 by adding at the end the following3 7g7 7#a7 ,the ,secretary and the heads of other ,federal agencies shall jointly review the programs carried out 7or proposed to be carried out7 by each such official with respect to medical rehabilitation research and1 as appropriate1 enter into agreements preventing duplication among such programs4 7#b7 ,the ,secretary shall1 as appropriate1 enter into interagency agreements relating to the coordination of medical rehabilitation research conducted by agencies of the ,national ,institutes of ,health and other agencies of the ,federal ,government4 7h7 ,for purposes of this section1 the term medical rehabilitation research means the science of mechanisms and interventions that prevent1 improve1 restore1 or replace lost1 underdeveloped1 or deteriorating function4 4 7b7 ,conforming amendment ,section #c of the ,national ,institutes of ,health ,amendments of #aiij 7#db ,u4,s4,c4 #bhe;g-#d note7 is amended-- 7#a7 in subsection 7a71 by striking ,in ,general4--2 and 7#b7 by striking subsection 7b74 #bjda4 ,task force on research specific to pregnant women and lactating women 7a7 ,task force on research specific to pregnant women and lactating women 7#a7 ,establishment ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish a task force1 in accordance with the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 to be known as the ,task ,force on ,research ,specific to ,pregnant ,women and ,lactating ,women 7in this section referred to as the ,task ,force74 7#b7 ,duties ,the ,task ,force shall provide advice and guidance to the ,secretary regarding ,federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women1 including the development of such therapies and the collaboration on and coordination of such activities4 7#c7 ,membership 7,a7 ,federal members ,the ,task ,force shall be composed of each of the following ,federal members1 or the designees of such members3 7i7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7ii7 ,the ,director of the ,national ,institutes of ,health1 the ,director of the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development1 and the directors of such other appropriate national research institutes4 7iii7 ,the ,commissioner of ,food and ,drugs4 7iv7 ,the ,director of the ,office on ,women's ,health4 7v7 ,the ,director of the ,national ,vaccine ,program ,office4 7vi7 ,the head of any other research-related agency or department not described in clauses 7i7 through 7v7 that the ,secretary determines appropriate1 which may include the ,department of ,veterans ,affairs and the ,department of ,defense4 7,b7 ,non-,federal members ,the ,task ,force shall be composed of each of the following non-,federal members1 including-- 7i7 representatives from relevant medical societies with subject matter expertise on pregnant women1 lactating women1 or children2 7ii7 nonprofit organizations with expertise related to the health of women and children2 7iii7 relevant industry representatives2 and 7iv7 other representatives1 as appropriate4 7,c7 ,limitations ,the non-,federal members described in subparagraph 7,b7 shall-- 7i7 compose not more than one-half1 and not less than one-third1 of the total membership of the ,task ,force2 and 7ii7 be appointed by the ,secretary4 7#d7 ,termination 7,a7 ,in general ,subject to subparagraph 7,b71 the ,task ,force shall terminate on the date that is #b years after the date on which the ,task ,force is established under paragraph 7#a74 7,b7 ,extension ,the ,secretary may extend the operation of the ,task ,force for one additional #b-year period following the #b-year period described in subparagraph 7,a71 if the ,secretary determines that the extension is appropriate for carrying out the purpose of this section4 7#e7 ,meetings ,the ,task ,force shall meet not less than #b times each year and shall convene public meetings1 as appropriate1 to fulfill its duties under paragraph 7#b74 7#f7 ,task force report to congress ,not later than #ah months after the date on which the ,task ,force is established under paragraph 7#a71 the ,task ,force shall prepare and submit to the ,secretary1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes each of the following3 7,a7 ,a plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women1 including the development of such therapies4 7,b7 ,ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research4 7,c7 ,effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women4 7,d7 ,identification of ,federal activities1 including-- 7i7 the state of research on pregnancy and lactation2 7ii7 recommendations for the coordination of1 and collaboration on research related to pregnant women and lactating women2 7iii7 dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public2 and 7iv7 existing ,federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women1 lactating women1 and related birth and pediatric outcomes1 including with respect to pharmacokinetics1 pharmacodynamics1 and toxicities4 7,e7 ,recommendations to improve the development of safe and effective therapies for pregnant women and lactating women4 7b7 ,confidentiality ,nothing in this section shall authorize the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret1 or other privileged or confidential information1 described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7c7 ,updating protections for pregnant women and lactating women in research 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 considering any recommendations of the ,task ,force available at such time and in consultation with the heads of relevant agencies of the ,department of ,health and ,human ,services1 shall1 as appropriate1 update regulations and guidance1 as applicable1 regarding the inclusion of pregnant women and lactating women in clinical research4 7#b7 ,criteria for excluding pregnant or lactating women ,in updating any regulations or guidance described in paragraph 7#a71 the ,secretary shall consider any appropriate criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women or lactating women as a study population requiring additional protections from participating in human subject research4 #bjdb4 ,streamlining ,national ,institutes of ,health reporting requirements 7a7 ,trans-,national ,institutes of ,health research reporting ,section #djb;,a7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7c77#b77 is amended-- 7#a7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,reporting ,not later than #b years after the date of enactment of #bast ,century ,cures ,act1 the head of each national research institute or national center shall submit to the ,director of the ,national ,institutes of ,health a report1 to be included in the triennial report under section #djc1 on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and #a or more other national research institutes or national centers4 2 and 7#b7 in subparagraphs 7,d7 and 7,e7 by striking 7,b77i7 each place it appears and inserting 7,b74 7b7 ,fraud and abuse reporting ,section #djc;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc;a-#a7 is amended-- 7#a7 by striking subsection 7b72 7#b7 by redesignating subsection 7c7 as subsection 7b72 and 7#c7 in subsection 7b7 7as so redesignated71 by striking subsections 7a7 and 7b7 and inserting subsection 7a74 7c7 ,doctoral degrees reporting ,section #djc;,c7a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc;a-#b7;a77#b77 is amended by striking 7not including any leaves of absence74 7d7 ,vaccine reporting ,section #djd;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc;d7 is amended-- 7#a7 by striking subsection 7b72 and 7#b7 by striking 7a7 ,development of ,new ,vaccines4--,the ,secretary and inserting ,the ,secretary4 7e7 ,national center for advancing translational sciences ,section #dgi7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg7;c77 is amended-- 7#a7 in the subsection heading1 by striking ,annual and inserting ,biennial2 and 7#b7 in the matter preceding paragraph 7#a71 by striking an annual report and inserting a report on a biennial basis4 7f7 ,review of centers of excellence 7#a7 ,repeal ,section #djd;,h of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc;j7 is repealed4 7#b7 ,conforming amendment ,section #cii;,,ee7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj-d7;c77 is amended by striking #cii;,,cc1 #djd;,h1 and inserting #cii;,,cc4 7g7 ,rapid ,,hiv test report ,section #ejb7;a7 of the ,ryan ,white ,,care ,act ,amendments of #bjjj 7#db ,u4,s4,c4 #cjj;cc note7 is amended-- 7#a7 by striking paragraph 7#b72 and 7#b7 by redesignating paragraph 7#c7 as paragraph 7#b74 7h7 ,national ,institute of ,nursing ,research 7#a7 ,repeal ,section #dfd,y of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bheq-#c7 is repealed4 7#b7 ,conforming amendment ,section #dfd,x7g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bheq-#b7;g77 is amended by striking biennial report made under section #dfd,y1 and inserting triennial report made under section #djc4 #bjdc4 ,reimbursement for research substances and living organisms ,section #cja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda71 as amended by section #bjce1 is further amended-- 7#a7 in the flush matter at the end of subsection 7a7-- 7,a7 by redesignating such matter as subsection 7h77#a72 and 7,b7 by moving such matter so as to appear at the end of such section2 and 7#b7 in subsection 7h7 7as so redesignated71 by adding at the end the following3 7#b7 ,where research substances and living organisms are made available under paragraph 7#a7 through contractors1 the ,secretary may direct such contractors to collect payments on behalf of the ,secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the ,secretary1 in the time and manner specified by the ,secretary4 7#c7 ,amounts collected under paragraph 7#b7 shall be credited to the appropriations accounts that incurred the costs to make available the research substances and living organisms involved1 and shall remain available until expended for carrying out activities under such accounts4 4 #bjdd4 ,sense of ,congress on increased inclusion of underrepresented populations in clinical trials ,it is the sense of ,congress that the ,national ,institute on ,minority ,health and ,health ,disparities should include within its strategic plan under section #djb7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7m77 ways to increase representation of underrepresented populations in clinical trials4 ,e ,advancement of the ,national ,institutes of ,health research and data access #bjea4 ,technical updates to clinical trials database ,section #djb7;j77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77#b77;,d77 is amended-- 7#a7 in clause 7ii77,i71 by inserting before the semicolon 1 unless the responsible party affirmatively requests that the ,director of the ,national ,institutes of ,health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval2 and 7#b7 by adding at the end the following3 7iii7 ,option to make certain clinical trial information available earlier ,the ,director of the ,national ,institutes of ,health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval1 in accordance with clause 7ii77,i74 7iv7 ,combination products ,an applicable clinical trial for a product that is a combination of drug1 device1 or biological product shall be considered-- 7,i7 an applicable drug clinical trial1 if the ,secretary determines under section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act that the primary mode of action of such product is that of a drug or biological product2 or 7,,ii7 an applicable device clinical trial1 if the ,secretary determines under such section that the primary mode of action of such product is that of a device4 4 #bjeb4 ,compliance activities reports 7a7 ,definitions ,in this section3 7#a7 ,applicable clinical trial ,the term applicable clinical trial has the meaning given the term in section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j774 7#b7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7b7 ,report on activities ,to encourage compliance ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 acting through the ,director of the ,national ,institutes of ,health and in collaboration with the ,commissioner of ,food and ,drugs1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that describes education and outreach1 guidance1 enforcement1 and other activities undertaken to encourage compliance with section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j774 7c7 ,reports on clinical trials 7#a7 ,in general ,not later than #b years after the final compliance date under the final rule implementing section #djb7;j7 of the ,public ,health ,service ,act1 and every #b years thereafter for the next #d years1 the ,secretary1 acting through the ,director of the ,national ,institutes of ,health and in collaboration with the ,commissioner of ,food and ,drugs1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report describing-- 7,a7 the total number of applicable clinical trials with complete data bank registration information registered during the period for which the report is being prepared 7broken down by each year of such reporting period72 7,b7 the total number of applicable clinical trials registered during the period for which the report is being prepared for which results have been submitted to the data bank 7broken down by each year of such reporting period72 7,c7 the activities undertaken by the ,secretary to educate responsible persons about data bank registration and results submission requirements1 including through issuance of guidance documents1 informational meetings1 and training sessions2 and 7,d7 the activities described in the report submitted under subsection 7b74 7#b7 ,actions to enforce compliance ,after the ,secretary has undertaken the educational activities described in paragraph 7#a77;,c71 the ,secretary shall include in subsequent reports submitted under paragraph 7#a7 the number of actions taken by the ,secretary during the period for which the report is being prepared to enforce compliance with data bank registration and results submission requirements4 #bjec4 ,updates to policies to improve data ,section #dib;,b7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;c77 is amended-- 7#a7 by striking ,in the case and inserting the following3 7#a7 ,in general ,in the case 2 and 7#b7 by adding at the end the following3 7#b7 ,reporting requirements ,for any new and competing project of clinical research subject to the requirements under this section that receives a grant award #a year after the date of enactment of the #bast ,century ,cures ,act1 or any date thereafter1 for which a valid analysis is provided under paragraph 7#a7-- 7,a7 and which is an applicable clinical trial as defined in section #djb7;j71 the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section #djb7;j77#c71 and the ,director of the ,national ,institutes of ,health shall1 as appropriate1 consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity1 including pursuant to section #djb7;j77#e77;,a77ii7 when applicable2 and 7,b7 the ,director of the ,national ,institutes of ,health shall encourage the reporting of the results of such valid analysis described in paragraph 7#a7 through any additional means determined appropriate by the ,director4 4 #bjed4 ,consultation ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall consult with relevant ,federal agencies1 including the ,food and ,drug ,administration1 the ,office of the ,national ,coordinator for ,health ,information ,technology1 and the ,national ,institutes of ,health1 as well as other stakeholders 7including patients1 researchers1 physicians1 industry representatives1 and developers of health information technology7 to receive recommendations with respect to enhancements to the clinical trial registry data bank under section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j771 including with respect to usability1 functionality1 and search capability4 ,f ,facilitating collaborative research #bjfa4 ,national neurological conditions surveillance system ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by inserting after section #cii,s the following3 #cii,s-#a4 ,surveillance of neurological diseases 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other agencies as the ,secretary determines1 shall1 as appropriate-- 7#a7 enhance and expand infrastructure and activities to track the epidemiology of neurological diseases2 and 7#b7 incorporate information obtained through such activities into an integrated surveillance system1 which may consist of or include a registry1 to be known as the ,national ,neurological ,conditions ,surveillance ,system4 7b7 ,research ,the ,secretary shall ensure that the ,national ,neurological ,conditions ,surveillance ,system is designed in a manner that facilitates further research on neurological diseases4 7c7 ,content ,in carrying out subsection 7a71 the ,secretary-- 7#a7 shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the ,united ,states2 7#b7 to the extent practicable1 shall provide for the collection and storage of other available information on neurological diseases1 including information related to persons living with neurological diseases who choose to participate1 such as-- 7,a7 demographics1 such as age1 race1 ethnicity1 sex1 geographic location1 family history1 and other information1 as appropriate2 7,b7 risk factors that may be associated with neurological diseases1 such as genetic and environmental risk factors and other information1 as appropriate2 and 7,c7 diagnosis and progression markers2 7#c7 may provide for the collection and storage of information relevant to analysis on neurological diseases1 such as information concerning-- 7,a7 the natural history of the diseases2 7,b7 the prevention of the diseases2 7,c7 the detection1 management1 and treatment approaches for the diseases2 and 7,d7 the development of outcomes measures2 7#d7 may address issues identified during the consultation process under subsection 7d72 and 7#e7 initially may address a limited number of neurological diseases4 7d7 ,consultation ,in carrying out this section1 the ,secretary shall consult with individuals with appropriate expertise1 which may include-- 7#a7 epidemiologists with experience in disease surveillance or registries2 7#b7 representatives of national voluntary health associations that-- 7,a7 focus on neurological diseases2 and 7,b7 have demonstrated experience in research1 care1 or patient services2 7#c7 health information technology experts or other information management specialists2 7#d7 clinicians with expertise in neurological diseases2 and 7#e7 research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes4 7e7 ,grants ,the ,secretary may award grants to1 or enter into contracts or cooperative agreements with1 public or private nonprofit entities to carry out activities under this section4 7f7 ,coordination with other federal1 state1 and local agencies ,subject to subsection 7h71 the ,secretary shall-- 7#a7 make information and analysis in the ,national ,neurological ,conditions ,surveillance ,system available1 as appropriate-- 7,a7 to ,federal departments and agencies1 such as the ,national ,institutes of ,health and the ,department of ,veterans ,affairs2 and 7,b7 to ,state and local agencies2 and 7#b7 identify1 build upon1 leverage1 and coordinate among existing data and surveillance systems1 surveys1 registries1 and other ,federal public health infrastructure1 wherever practicable4 7g7 ,public access ,subject to subsection 7h71 the ,secretary shall ensure that information and analysis in the ,national ,neurological ,conditions ,surveillance ,system are available1 as appropriate1 to the public1 including researchers4 7h7 ,privacy ,the ,secretary shall ensure that information and analysis in the ,national ,neurological ,conditions ,surveillance ,system are made available only to the extent permitted by applicable ,federal and ,state law1 and in a manner that protects personal privacy1 to the extent required by applicable ,federal and ,state privacy law1 at a minimum4 7i7 ,reports 7#a7 ,report on information and analyses ,not later than #a year after the date on which any system is established under this section1 the ,secretary shall submit an interim report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding aggregate information collected pursuant to this section and epidemiological analyses1 as appropriate4 ,such report shall be posted on the ,internet website of the ,department of ,health and ,human ,services and shall be updated biennially4 7#b7 ,implementation report ,not later than #d years after the date of the enactment of this section1 the ,secretary shall submit a report to the ,congress concerning the implementation of this section4 ,such report shall include information on-- 7,a7 the development and maintenance of the ,national ,neurological ,conditions ,surveillance ,system2 7,b7 the type of information collected and stored in the surveillance system2 7,c7 the use and availability of such information1 including guidelines for such use2 and 7,d7 the use and coordination of databases that collect or maintain information on neurological diseases4 7j7 ,definition ,in this section1 the term national voluntary health association means a national nonprofit organization with chapters1 other affiliated organizations1 or networks in ,states throughout the ,united ,states with experience serving the population of individuals with neurological disease and have demonstrated experience in neurological disease research1 care1 and patient services4 7k7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjah through #bjbb4 4 #bjfb4 ,tick-borne diseases 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall continue to conduct or support epidemiological1 basic1 translational1 and clinical research related to vector-borne diseases1 including tick-borne diseases4 7b7 ,reports ,the ,secretary shall ensure that each triennial report under section #djc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7 7as amended by section #bjcb7 includes information on actions undertaken by the ,national ,institutes of ,health to carry out subsection 7a7 with respect to tick-borne diseases4 7c7 ,tick-borne diseases working group 7#a7 ,establishment ,the ,secretary shall establish a working group1 to be known as the ,tick-,borne ,disease ,working ,group 7referred to in this section as the ,working ,group71 comprised of representatives of appropriate ,federal agencies and other non-,federal entities1 to provide expertise and to review all efforts within the ,department of ,health and ,human ,services related to all tick-borne diseases1 to help ensure interagency coordination and minimize overlap1 and to examine research priorities4 7#b7 ,responsibilities ,the working group shall-- 7,a7 not later than #b years after the date of enactment of this ,act1 develop or update a summary of-- 7i7 ongoing tick-borne disease research1 including research related to causes1 prevention1 treatment1 surveillance1 diagnosis1 diagnostics1 duration of illness1 and intervention for individuals with tick-borne diseases2 7ii7 advances made pursuant to such research2 7iii7 ,federal activities related to tick-borne diseases1 including-- 7,i7 epidemiological activities related to tick-borne diseases2 and 7,,ii7 basic1 clinical1 and translational tick-borne disease research related to the pathogenesis1 prevention1 diagnosis1 and treatment of tick-borne diseases2 7iv7 gaps in tick-borne disease research described in clause 7iii77,,ii72 7v7 the ,working ,group's meetings required under paragraph 7#d72 and 7vi7 the comments received by the ,working ,group2 7,b7 make recommendations to the ,secretary regarding any appropriate changes or improvements to such activities and research2 and 7,c7 solicit input from ,states1 localities1 and nongovernmental entities1 including organizations representing patients1 health care providers1 researchers1 and industry regarding scientific advances1 research questions1 surveillance activities1 and emerging strains in species of pathogenic organisms4 7#c7 ,membership ,the members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members3 7,a7 ,federal members ,seven ,federal members1 consisting of one or more representatives of each of the following3 7i7 ,the ,office of the ,assistant ,secretary for ,health4 7ii7 ,the ,food and ,drug ,administration4 7iii7 ,the ,centers for ,disease ,control and ,prevention4 7iv7 ,the ,national ,institutes of ,health4 7v7 ,such other agencies and offices of the ,department of ,health and ,human ,services as the ,secretary determines appropriate4 7,b7 ,non-,federal public members ,seven non-,federal public members1 consisting of representatives of the following categories3 7i7 ,physicians and other medical providers with experience in diagnosing and treating tick-borne diseases4 7ii7 ,scientists or researchers with expertise4 7iii7 ,patients and their family members4 7iv7 ,nonprofit organizations that advocate for patients with respect to tick-borne diseases4 7v7 ,other individuals whose expertise is determined by the ,secretary to be beneficial to the functioning of the ,working ,group4 7#d7 ,meetings ,the ,working ,group shall meet not less than twice each year4 7#e7 ,reporting ,not later than #b years after the date of enactment of this ,act1 and every #b years thereafter until termination of the ,working ,group pursuant to paragraph 7#g71 the ,working ,group shall-- 7,a7 submit a report on its activities under paragraph 7#b77;,a7 and any recommendations under paragraph 7#b77;,b7 to the ,secretary1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 and 7,b7 make such report publicly available on the ,internet website of the ,department of ,health and ,human ,services4 7#f7 ,applicability of ,,faca ,the ,working ,group shall be treated as an advisory committee subject to the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#g7 ,sunset ,the ,working ,group under this section shall terminate #f years after the date of enactment of this ,act4 #bjfc4 ,accessing1 sharing1 and using health data for research purposes 7a7 ,guidance related to ,remote ,access ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue guidance clarifying that subparagraph 7,b7 of section #afd4eab7;i77#a77;ii7 of part #afd of the ,rule 7prohibiting the removal of protected health information by a researcher7 does not prohibit remote access to health information by a researcher for such purposes as described in section #afd4eab7;i77#a77;ii7 of part #afd of the ,rule so long as-- 7#a7 at a minimum1 security and privacy safeguards1 consistent with the requirements of the ,rule1 are maintained by the covered entity and the researcher2 and 7#b7 the protected health information is not copied or otherwise retained by the researcher4 7b7 ,guidance related to ,streamlining ,authorization ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue guidance on the following3 7#a7 ,authorization for use and disclosure of health information ,clarification of the circumstances under which the authorization for the use or disclosure of protected health information1 with respect to an individual1 for future research purposes contains a sufficient description of the purpose of the use or disclosure1 such as if the authorization-- 7,a7 sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research2 7,b7 either-- 7i7 states that the authorization will expire on a particular date or on the occurrence of a particular event2 or 7ii7 states that the authorization will remain valid unless and until it is revoked by the individual2 and 7,c7 provides instruction to the individual on how to revoke such authorization at any time4 7#b7 ,reminder of the right to revoke ,clarification of the circumstances under which it is appropriate to provide an individual with an annual notice or reminder that the individual has the right to revoke such authorization4 7#c7 ,revocation of authorization ,clarification of appropriate mechanisms by which an individual may revoke an authorization for future research purposes1 such as described in paragraph 7#a77;,c74 7c7 ,working group on protected health information for research 7#a7 ,establishment ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall convene a working group to study and report on the uses and disclosures of protected health information for research purposes1 under the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia74 7#b7 ,members ,the working group shall include representatives of-- 7,a7 relevant ,federal agencies1 including the ,national ,institutes of ,health1 the ,centers for ,disease ,control and ,prevention1 the ,food and ,drug ,administration1 and the ,office for ,civil ,rights2 7,b7 the research community2 7,c7 patients2 7,d7 experts in civil rights1 such as privacy rights2 7,e7 developers of health information technology2 7,f7 experts in data privacy and security2 7,g7 health care providers2 7,h7 bioethicists2 and 7,i7 other experts and entities1 as the ,secretary determines appropriate4 7#c7 ,report ,not later than #a year after the date on which the working group is convened under paragraph 7#a71 the working group shall conduct a review and submit a report to the ,secretary containing recommendations on whether the uses and disclosures of protected health information for research purposes should be modified to allow protected health information to be available1 as appropriate1 for research purposes1 including studies to obtain generalizable knowledge1 while protecting individuals' privacy rights4 ,in conducting the review and making recommendations1 the working group shall-- 7,a7 address1 at a minimum-- 7i7 the appropriate manner and timing of authorization1 including whether additional notification to the individual should be required when the individual's protected health information will be used or disclosed for such research2 7ii7 opportunities for individuals to set preferences on the manner in which their protected health information is used in research2 7iii7 opportunities for patients to revoke authorization2 7iv7 notification to individuals of a breach in privacy2 7v7 existing gaps in statute1 regulation1 or policy related to protecting the privacy of individuals1 and 7vi7 existing barriers to research related to the current restrictions on the uses and disclosures of protected health information2 and 7,b7 consider1 at a minimum-- 7i7 expectations and preferences on how an individual's protected health information is shared and used2 7ii7 issues related to specific subgroups of people1 such as children1 incarcerated individuals1 and individuals with a cognitive or intellectual disability impacting capacity to consent2 7iii7 relevant ,federal and ,state laws2 7iv7 models of facilitating data access and levels of data access1 including data segmentation1 where applicable2 7v7 potential impacts of disclosure and non-disclosure of protected health information on access to health care services2 and 7vi7 the potential uses of such data4 7#d7 ,report submission ,the ,secretary shall submit the report under paragraph 7#c7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and shall post such report on the appropriate ,internet website of the ,department of ,health and ,human ,services4 7#e7 ,termination ,the working group convened under paragraph 7#a7 shall terminate the day after the report under paragraph 7#c7 is submitted to ,congress and made public in accordance with paragraph 7#d74 7d7 ,definitions ,in this section3 7#a7 ,the rule ,references to the ,rule refer to part #afj or part #afd1 as appropriate1 of title #de1 ,code of ,federal ,regulations 7or any successor regulation74 7#b7 ,part #afd ,references to a specified section of part #afd1 refer to such specified section of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor section74 ,g ,promoting pediatric research #bjga4 ,national pediatric research network ,section #dji;,d7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd;h7d77 is amended-- 7#a7 in paragraph 7#a71 by striking in consultation with the ,director of the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research1 may provide for the establishment of and inserting in collaboration with the national research institutes and national centers that carry out activities involving pediatric research1 shall support2 and 7#b7 in paragraph 7#b77;,a7 and the first sentence of paragraph 7#b77;,e71 by striking may each place such term appears and inserting shall4 #bjgb4 ,global pediatric clinical study network ,it is the sense of ,congress that-- 7#a7 the ,national ,institutes of ,health should encourage a global pediatric clinical study network by providing grants1 contracts1 or cooperative agreements to support new and early stage investigators who participate in the global pediatric clinical study network2 7#b7 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 should engage with clinical investigators and appropriate authorities outside of the ,united ,states1 including authorities in the ,european ,union1 during the formation of the global pediatric clinical study network to encourage the participation of such investigator and authorities2 and 7#c7 once a global pediatric clinical study network is established and becomes operational1 the ,secretary should continue to encourage and facilitate the participation of clinical investigators and appropriate authorities outside of the ,united ,states1 including in the ,european ,union1 to participate in the network with the goal of enhancing the global reach of the network4 ,,iii ,development ,a ,patient-,focused ,drug ,development #cjja4 ,patient experience data ,section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the subsection heading1 by striking ,in general and inserting ,patient ,engagement in ,drugs and ,devices2 7,b7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively1 and moving such subparagraphs #b ems to the right2 and 7,c7 by striking ,the ,secretary and inserting the following3 7#a7 ,in ,general ,the ,secretary 2 7#b7 by redesignating subsections 7b7 through 7e7 as paragraphs 7#b7 through 7#e71 respectively1 and moving such paragraphs #b ems to the right2 and 7#c7 by adding at the end the following3 7b7 ,statement of patient experience 7#a7 ,in general ,following the approval of an application that was submitted under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act at least #ahj days after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall make public a brief statement regarding the patient experience data and related information1 if any1 submitted and reviewed as part of such application4 7#b7 ,data and information ,the data and information referred to in paragraph 7#a7 are-- 7,a7 patient experience data2 7,b7 information on patient-focused drug development tools2 and 7,c7 other relevant information1 as determined by the ,secretary4 7c7 ,patient experience data ,for purposes of this section1 the term patient experience data includes data that-- 7#a7 are collected by any persons 7including patients1 family members and caregivers of patients1 patient advocacy organizations1 disease research foundations1 researchers1 and drug manufacturers72 and 7#b7 are intended to provide information about patients' experiences with a disease or condition1 including-- 7,a7 the impact of such disease or condition1 or a related therapy1 on patients' lives2 and 7,b7 patient preferences with respect to treatment of such disease or condition4 4 #cjjb4 ,patient-focused drug development guidance 7a7 ,publication of guidance documents ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 shall develop a plan to issue draft and final versions of one or more guidance documents1 over a period of #e years1 regarding the collection of patient experience data1 and the use of such data and related information in drug development4 ,not later than #ah months after the date of enactment of this ,act1 the ,secretary shall issue a draft version of at least one such guidance document4 ,not later than #ah months after the public comment period on the draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7b7 ,patient experience data ,for purposes of this section1 the term patient experience data has the meaning given such term in section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #cjja74 7c7 ,contents ,the guidance documents described in subsection 7a7 shall address-- 7#a7 methodological approaches that a person seeking to collect patient experience data for submission to1 and proposed use by1 the ,secretary in regulatory decisionmaking may use1 that are relevant and objective and ensure that such data are accurate and representative of the intended population1 including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection1 reporting1 management1 and analysis2 7#b7 methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease1 burden of treatment1 and the benefits and risks in the management of the patient's disease2 7#c7 approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials2 7#d7 methodologies1 standards1 and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking2 7#e7 how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the ,secretary may submit such proposed draft guidance to the ,secretary2 7#f7 the format and content required for submissions under this section to the ,secretary1 including with respect to the information described in paragraph 7#a72 7#g7 how the ,secretary intends to respond to submissions of information described in paragraph 7#a71 if applicable1 including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response2 and 7#h7 how the ,secretary1 if appropriate1 anticipates using relevant patient experience data and related information1 including with respect to the structured risk-benefit assessment framework described in section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d771 to inform regulatory decisionmaking4 #cjjc4 ,streamlining patient input ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection of information to which a response is voluntary1 that is initiated by the ,secretary under section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 7as amended by section #cjja7 or section #cjjb4 #cjjd4 ,report on patient experience drug development ,not later than ,june #a of #bjba1 #bjbf1 and #bjca1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall prepare and publish on the ,internet website of the ,food and ,drug ,administration a report assessing the use of patient experience data in regulatory decisionmaking1 in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of applications approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 ,b ,advancing new drug therapies #cjaa4 ,qualification of drug development tools 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,f the following new section3 #ejg4 ,qualification of drug development tools 7a7 ,process for qualification 7#a7 ,in general ,the ,secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which-- 7,a7 7i7 a requestor initiates such process by submitting a letter of intent to the ,secretary2 and 7ii7 the ,secretary accepts or declines to accept such letter of intent2 7,b7 7i7 if the ,secretary accepts the letter of intent1 a requestor submits a qualification plan to the ,secretary2 and 7ii7 the ,secretary accepts or declines to accept the qualification plan2 and 7,c7 7i7 if the ,secretary accepts the qualification plan1 the requestor submits to the ,secretary a full qualification package2 7ii7 the ,secretary determines whether to accept such qualification package for review2 and 7iii7 if the ,secretary accepts such qualification package for review1 the ,secretary conducts such review in accordance with this section4 7#b7 ,acceptance and review of submissions 7,a7 ,in general ,subparagraphs 7,b71 7,c71 and 7,d7 shall apply with respect to the treatment of a letter of intent1 a qualification plan1 or a full qualification package submitted under paragraph 7#a7 7referred to in this paragraph as qualification submissions74 7,b7 ,acceptance factors2 nonacceptance ,the ,secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission4 ,a determination not to accept a submission under paragraph 7#a7 shall not be construed as a final determination by the ,secretary under this section regarding the qualification of a drug development tool for its proposed context of use4 7,c7 ,prioritization of qualification review ,the ,secretary may prioritize the review of a full qualification package submitted under paragraph 7#a7 with respect to a drug development tool1 based on factors determined appropriate by the ,secretary1 including-- 7i7 as applicable1 the severity1 rarity1 or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition2 and 7ii7 the identification1 by the ,secretary or by biomedical research consortia and other expert stakeholders1 of such a drug development tool and its proposed context of use as a public health priority4 7,d7 ,engagement of external experts ,the ,secretary may1 for purposes of the review of qualification submissions1 through the use of cooperative agreements1 grants1 or other appropriate mechanisms1 consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph 7#a7 or the review of any full qualification package under paragraph 7#c74 7#c7 ,review of full qualification package ,the ,secretary shall-- 7,a7 conduct a comprehensive review of a full qualification package accepted under paragraph 7#a77;,c72 and 7,b7 determine whether the drug development tool at issue is qualified for its proposed context of use4 7#d7 ,qualification ,the ,secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph 7#c74 7b7 ,effect of qualification 7#a7 ,in general ,a drug development tool determined to be qualified under subsection 7a77#d7 for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph 7#b74 7#b7 ,use of a drug development tool ,subject to paragraph 7#c71 a drug development tool qualified under this section may be used for-- 7,a7 supporting or obtaining approval or licensure 7as applicable7 of a drug or biological product 7including in accordance with section #ejf7;c77 under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,b7 supporting the investigational use of a drug or biological product under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act4 7#c7 ,rescission or modification 7,a7 ,in general ,the ,secretary may rescind or modify a determination under this section to qualify a drug development tool if the ,secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor4 ,such a determination may be based on new information that calls into question the basis for such qualification4 7,b7 ,meeting for review ,if the ,secretary rescinds or modifies under subparagraph 7,a7 a determination to qualify a drug development tool1 the requestor involved shall1 on request1 be granted a meeting with the ,secretary to discuss the basis of the ,secretary's decision to rescind or modify the determination before the effective date of the rescission or modification4 7c7 ,transparency 7#a7 ,in general ,subject to paragraph 7#c71 the ,secretary shall make publicly available1 and update on at least a biannual basis1 on the ,internet website of the ,food and ,drug ,administration the following3 7,a7 ,information with respect to each qualification submission under the qualification process under subsection 7a71 including-- 7i7 the stage of the review process applicable to the submission2 7ii7 the date of the most recent change in stage status2 7iii7 whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package2 and 7iv7 submissions from requestors under the qualification process under subsection 7a71 including any data and evidence contained in such submissions1 and any updates to such submissions4 7,b7 ,the ,secretary's formal written determinations in response to such qualification submissions4 7,c7 ,any rescissions or modifications under subsection 7b77#c7 of a determination to qualify a drug development tool4 7,d7 ,summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection 7a74 7,e7 ,a comprehensive list of-- 7i7 all drug development tools qualified under subsection 7a72 and 7ii7 all surrogate endpoints which were the basis of approval or licensure 7as applicable7 of a drug or biological product 7including in accordance with section #ejf7;c77 under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7#b7 ,relation to ,trade ,secrets ,act ,information made publicly available by the ,secretary under paragraph 7#a7 shall be considered a disclosure authorized by law for purposes of section #aije of title #ah1 ,united ,states ,code4 7#c7 ,applicability ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information contained in an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act that is confidential commercial or trade secret information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7d7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to alter the standards of evidence under subsection 7c7 or 7d7 of section #eje1 including the substantial evidence standard in such subsection 7d71 or under section #cea of the ,public ,health ,service ,act 7as applicable72 or 7#b7 to limit the authority of the ,secretary to approve or license products under this ,act or the ,public ,health ,service ,act1 as applicable 7as in effect before the date of the enactment of the #bast ,century ,cures ,act74 7e7 ,definitions ,in this section3 7#a7 ,biomarker ,the term biomarker-- 7,a7 means a characteristic 7such as a physiologic1 pathologic1 or anatomic characteristic or measurement7 that is objectively measured and evaluated as an indicator of normal biologic processes1 pathologic processes1 or biological responses to a therapeutic intervention2 and 7,b7 includes a surrogate endpoint4 7#b7 ,biomedical research consortia ,the term biomedical research consortia means collaborative groups that may take the form of public-private partnerships and may include government agencies1 institutions of higher education 7as defined in section #aja7;a7 of the ,higher ,education ,act of #aife71 patient advocacy groups1 industry representatives1 clinical and scientific experts1 and other relevant entities and individuals4 7#c7 ,clinical outcome assessment ,the term clinical outcome assessment means-- 7,a7 a measurement of a patient's symptoms1 overall mental state1 or the effects of a disease or condition on how the patient functions2 and 7,b7 includes a patient-reported outcome4 7#d7 ,context of use ,the term context of use means1 with respect to a drug development tool1 the circumstances under which the drug development tool is to be used in drug development and regulatory review4 7#e7 ,drug development tool ,the term drug development tool includes-- 7,a7 a biomarker2 7,b7 a clinical outcome assessment2 and 7,c7 any other method1 material1 or measure that the ,secretary determines aids drug development and regulatory review for purposes of this section4 7#f7 ,patient-reported outcome ,the term patient-reported outcome means a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person4 7#g7 ,qualification ,the terms qualification and qualified mean a determination by the ,secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this ,act4 7#h7 ,requestor ,the term requestor means an entity or entities1 including a drug sponsor or a biomedical research consortia1 seeking to qualify a drug development tool for a proposed context of use under this section4 7#i7 ,surrogate endpoint ,the term surrogate endpoint means a marker1 such as a laboratory measurement1 radiographic image1 physical sign1 or other measure1 that is not itself a direct measurement of clinical benefit1 and-- 7,a7 is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product2 or 7,b7 is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section #ejf7;c74 4 7b7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 in consultation with biomedical research consortia 7as defined in subsection 7e7 of section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 and other interested parties through a collaborative public process1 issue guidance to implement such section #ejg that-- 7,a7 provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph 7#c72 7,b7 with respect to the qualification process under such section #ejg-- 7i7 describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process2 7ii7 outlines reasonable timeframes for the ,secretary's review of letters1 qualification plans1 or full qualification packages submitted under such process2 and 7iii7 establishes a process by which such entities or the ,secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the ,secretary in the review of qualification plans and full qualification submissions under such section2 and 7,c7 includes such other information as the ,secretary determines appropriate4 7#b7 ,timing ,not later than #c years after the date of the enactment of this ,act1 the ,secretary shall issue draft guidance under paragraph 7#a7 on the implementation of section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,the ,secretary shall issue final guidance on the implementation of such section not later than #f months after the date on which the comment period for the draft guidance closes4 7#c7 ,taxonomy 7,a7 ,in general ,for purposes of informing guidance under this subsection1 the ,secretary shall1 in consultation with biomedical research consortia and other interested parties through a collaborative public process1 establish a taxonomy for the classification of biomarkers 7and related scientific concepts7 for use in drug development4 7,b7 ,public availability ,not later than #b years after the date of the enactment of this ,act1 the ,secretary shall make such taxonomy publicly available in draft form for public comment4 ,the ,secretary shall finalize the taxonomy not later than #a year after the close of the public comment period4 7c7 ,meeting and report 7#a7 ,meeting ,not later than #b years after the date of the enactment of this ,act1 the ,secretary shall convene a public meeting to describe and solicit public input regarding the qualification process under section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 7#b7 ,report ,not later than #e years after the date of the enactment of this ,act1 the ,secretary shall make publicly available on the ,internet website of the ,food and ,drug ,administration a report4 ,such report shall include1 with respect to the qualification process under section #ejg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 information on-- 7,a7 the number of requests submitted1 as a letter of intent1 for qualification of a drug development tool 7as defined in subsection 7e7 of such section #ejg72 7,b7 the number of such requests accepted and determined to be eligible for submission of a qualification plan or full qualification package 7as such terms are defined in subsection 7e7 of such section #ejg71 respectively2 7,c7 the number of such requests for which external scientific experts were utilized in the development of a qualification plan or review of a full qualification package2 7,d7 the number of qualification plans and full qualification packages1 respectively1 submitted to the ,secretary2 and 7,e7 the drug development tools qualified through such qualification process1 specified by type of tool1 such as a biomarker or clinical outcome assessment 7as such terms are defined in subsection 7e7 of such section #ejg74 #cjab4 ,targeted drugs for rare diseases ,subchapter ,b of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is amended by inserting after section #ebi the following3 #ebi;,a4 ,targeted drugs for rare diseases 7a7 ,purpose ,the purpose of this section1 through the approach provided for in subsection 7b71 is to-- 7#a7 facilitate the development1 review1 and approval of genetically targeted drugs and variant protein targeted drugs to address an unmet medical need in one or more patient subgroups1 including subgroups of patients with different mutations of a gene1 with respect to rare diseases or conditions that are serious or life-threatening2 and 7#b7 maximize the use of scientific tools or methods1 including surrogate endpoints and other biomarkers1 for such purposes4 7b7 ,leveraging of data from previously approved drug application or applications ,the ,secretary may1 consistent with applicable standards for approval under this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 allow the sponsor of an application under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information-- 7#a7 previously developed by the same sponsor 7or another sponsor that has provided the sponsor with a contractual right of reference to such data and information72 and 7#b7 submitted by a sponsor described in paragraph 7#a7 in support of one or more previously approved applications that were submitted under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act1 for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject of an application or applications described in paragraph 7#b7 or for a variant protein targeted drug that is the same or incorporates or utilizes the same variant protein targeted drug1 as the drug or drugs that are the subject of an application or applications described in paragraph 7#b74 7c7 ,definitions ,for purposes of this section-- 7#a7 the term genetically targeted drug means a drug that-- 7,a7 is the subject of an application under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for the treatment of a rare disease or condition 7as such term is defined in section #ebf7 that is serious or life-threatening2 7,b7 may result in the modulation 7including suppression1 up-regulation1 or activation7 of the function of a gene or its associated gene product2 and 7,c7 incorporates or utilizes a genetically targeted technology2 7#b7 the term genetically targeted technology means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups1 including subgroups of patients with different mutations of a gene1 with the same disease or condition1 including a disease or condition due to other variants in the same gene2 and 7#c7 the term variant protein targeted drug means a drug that-- 7,a7 is the subject of an application under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for the treatment of a rare disease or condition 7as such term is defined in section #ebf7 that is serious or life-threatening2 7,b7 modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition2 and 7,c7 is intended to treat one or more patient subgroups1 including subgroups of patients with different mutations of a gene1 with the same disease or condition4 7d7 ,rule of construction ,nothing in this section shall be construed to-- 7#a7 alter the authority of the ,secretary to approve drugs pursuant to this ,act or section #cea of the ,public ,health ,service ,act 7as authorized prior to the date of enactment of the #bast ,century ,cures ,act71 including the standards of evidence1 and applicable conditions1 for approval under such applicable ,act2 or 7#b7 confer any new rights1 beyond those authorized under this ,act or the ,public ,health ,service ,act prior to enactment of this section1 with respect to the permissibility of a sponsor referencing information contained in another application submitted under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act4 4 #cjac4 ,reauthorization of program to encourage treatments for rare pediatric diseases 7a7 ,in ,general ,section #ebi7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is amended by striking paragraph 7#e7 and inserting the following3 7#e7 ,termination of authority ,the ,secretary may not award any priority review vouchers under paragraph 7#a7 after ,september #cj1 #bjbj1 unless the rare pediatric disease product application-- 7,a7 is for a drug that1 not later than ,september #cj1 #bjbj1 is designated under subsection 7d7 as a drug for a rare pediatric disease2 and 7,b7 is1 not later than ,september #cj1 #bjbb1 approved under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act4 4 7b7 ,report ,the ,advancing ,hope ,act of #bjaf 7,public ,law #aad-bbi7 is amended by striking section #c4 #cjad4 ,,gao study of priority review voucher programs 7a7 ,study ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall conduct a study addressing the effectiveness and overall impact of the following priority review voucher programs1 including any such programs amended or established by this ,act3 7#a7 ,the neglected tropical disease priority review voucher program under section #ebd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn74 7#b7 ,the rare pediatric disease priority review voucher program under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff74 7#c7 ,the medical countermeasure priority review voucher program under section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #cjhf4 7b7 ,issuance of report ,not later than ,january #ca1 #bjbj1 the ,comptroller ,general shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study under subsection 7a74 7c7 ,contents of reports ,the report submitted under subsection 7b7 shall address-- 7#a7 for each drug for which a priority review voucher has been awarded as of initiation of the study-- 7,a7 the indications for which the drug is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c771 pursuant to an application under section #eje7;b77#a7 of such ,act1 or licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 whether1 and to what extent1 the voucher impacted the sponsor's decision to develop the drug2 and 7,c7 whether1 and to what extent1 the approval or licensure of the drug1 as applicable and appropriate-- 7i7 addressed a global unmet need related to the treatment or prevention of a neglected tropical disease1 including whether the sponsor of a drug coordinated with international development organizations2 7ii7 addressed an unmet need related to the treatment of a rare pediatric disease2 or 7iii7 affected the ,nation's preparedness against a chemical1 biological1 radiological1 or nuclear threat1 including naturally occurring threats2 7#b7 for each drug for which a priority review voucher has been used-- 7,a7 the indications for which such drug is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c771 pursuant to an application under section #eje7;b77#a7 of such ,act1 or licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7,b7 the value of the voucher1 if transferred2 and 7,c7 the length of time between the date on which the voucher was awarded and the date on which the voucher was used2 and 7#c7 an analysis of the priority review voucher programs described in subsection 7a71 including-- 7,a7 the resources used by the ,food and ,drug ,administration in reviewing drugs for which vouchers were used1 including the effect of the programs on the ,food and ,drug ,administration's review of drugs for which priority review vouchers were not awarded or used2 7,b7 whether any improvements to such programs are necessary to appropriately target incentives for the development of drugs that would likely not otherwise be developed1 or developed in as timely a manner1 and1 as applicable and appropriate-- 7i7 address global unmet needs related to the treatment or prevention of neglected tropical diseases1 including in countries in which neglected tropical diseases are endemic2 or 7ii7 address unmet needs related to the treatment of rare pediatric diseases2 and 7,c7 whether the sunset of the rare pediatric disease program and medical countermeasure program has had an impact on the program1 including any potential unintended consequences4 7d7 ,protection of national security ,the ,comptroller ,general shall conduct the study and issue reports under this section in a manner that does not compromise national security4 #cjae4 ,amendments to the ,orphan ,drug grants ,section #e of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7 is amended-- 7#a7 in subsection 7a71 by striking paragraph 7#a7 and inserting the following3 7#a7 defraying the costs of developing drugs for rare diseases or conditions1 including qualified testing expenses1 2 and 7#b7 in subsection 7b77#a7-- 7,a7 in subparagraph 7,a77ii71 by striking 8and0 after the semicolon2 7,b7 in subparagraph 7,b71 by striking the period and inserting 82 and02 and 7,c7 by adding at the end the following3 7,c7 prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy1 including studies and analyses to-- 7i7 develop or validate a drug development tool related to a rare disease or condition2 or 7ii7 understand the full spectrum of the disease manifestations1 including describing genotypic and phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition4 4 #cjaf4 ,grants for studying continuous drug manufacturing 7a7 ,in general ,the ,secretary of ,health and ,human ,services may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques4 7b7 ,definitions ,in this section-- 7#a7 the term drug has the meaning given such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#b7 the term biological product has the meaning given such term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i772 and 7#c7 the term institution of higher education has the meaning given such term in section #aja7;a7 of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja7;a774 ,c ,modern ,trial ,design and ,evidence ,development #cjba4 ,novel clinical trial designs 7a7 ,proposals for use of novel clinical trial designs for drugs and biological products ,for purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 and biological products under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conduct a public meeting and issue guidance in accordance with subsection 7b74 7b7 ,guidance addressing use of novel clinical trial designs 7#a7 ,in general ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products4 7#b7 ,contents ,the guidance under paragraph 7#a7 shall address-- 7,a7 the use of complex adaptive and other novel trial designs1 including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 how sponsors may obtain feedback from the ,secretary on technical issues related to modeling and simulations prior to-- 7i7 completion of such modeling or simulations2 or 7ii7 the submission of resulting information to the ,secretary2 7,c7 the types of quantitative and qualitative information that should be submitted for review2 and 7,d7 recommended analysis methodologies4 7#c7 ,public meeting ,prior to updating or issuing the guidance required by paragraph 7#a71 the ,secretary shall consult with stakeholders1 including representatives of regulated industry1 academia1 patient advocacy organizations1 consumer groups1 and disease research foundations1 through a public meeting to be held not later than #ah months after the date of enactment of this ,act4 7#d7 ,timing ,the ,secretary shall update or issue a draft version of the guidance required by paragraph 7#a7 not later than #ah months after the date of the public meeting required by paragraph 7#c7 and finalize such guidance not later than #a year after the date on which the public comment period for the draft guidance closes4 #cjbb4 ,real world evidence ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,e 7#ba ,u4,s4,c4 #cee;f7 the following3 #eje;,f4 ,utilizing real world evidence 7a7 ,in general ,the ,secretary shall establish a program to evaluate the potential use of real world evidence-- 7#a7 to help to support the approval of a new indication for a drug approved under section #eje7;c72 and 7#b7 to help to support or satisfy postapproval study requirements4 7b7 ,real world evidence defined ,in this section1 the term real world evidence means data regarding the usage1 or the potential benefits or risks1 of a drug derived from sources other than randomized clinical trials4 7c7 ,program framework 7#a7 ,in general ,not later than #b years after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall establish a draft framework for implementation of the program under this section4 7#b7 ,contents of framework ,the framework shall include information describing-- 7,a7 the sources of real world evidence1 including ongoing safety surveillance1 observational studies1 registries1 claims1 and patient-centered outcomes research activities2 7,b7 the gaps in data collection activities2 7,c7 the standards and methodologies for collection and analysis of real world evidence2 and 7,d7 the priority areas1 remaining challenges1 and potential pilot opportunities that the program established under this section will address4 7#c7 ,consultation 7,a7 ,in general ,in developing the program framework under this subsection1 the ,secretary shall consult with regulated industry1 academia1 medical professional organizations1 representatives of patient advocacy organizations1 consumer organizations1 disease research foundations1 and other interested parties4 7,b7 ,process ,the consultation under subparagraph 7,a7 may be carried out through approaches such as-- 7i7 a public-private partnership with the entities described in such subparagraph in which the ,secretary may participate2 7ii7 a contract1 grant1 or other arrangement1 as the ,secretary determines appropriate1 with such a partnership or an independent research organization2 or 7iii7 public workshops with the entities described in such subparagraph4 7d7 ,program implementation ,the ,secretary shall1 not later than #b years after the date of enactment of the #bast ,century ,cures ,act and in accordance with the framework established under subsection 7c71 implement the program to evaluate the potential use of real world evidence4 7e7 ,guidance for industry ,the ,secretary shall-- 7#a7 utilize the program established under subsection 7a71 its activities1 and any subsequent pilots or written reports1 to inform a guidance for industry on-- 7,a7 the circumstances under which sponsors of drugs and the ,secretary may rely on real world evidence for the purposes described in paragraphs 7#a7 and 7#b7 of subsection 7a72 and 7,b7 the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes2 7#b7 not later than #e years after the date of enactment of the #bast ,century ,cures ,act1 issue draft guidance for industry as described in paragraph 7#a72 and 7#c7 not later than #ah months after the close of the public comment period for the draft guidance described in paragraph 7#b71 issue revised draft guidance or final guidance4 7f7 ,rule of construction 7#a7 ,in general ,subject to paragraph 7#b71 nothing in this section prohibits the ,secretary from using real world evidence for purposes not specified in this section1 provided the ,secretary determines that sufficient basis exists for any such nonspecified use4 7#b7 ,standards of evidence and ,secretary's authority ,this section shall not be construed to alter-- 7,a7 the standards of evidence under-- 7i7 subsection 7c7 or 7d7 of section #eje1 including the substantial evidence standard in such subsection 7d72 or 7ii7 section #cea7;a7 of the ,public ,health ,service ,act2 or 7,b7 the ,secretary's authority to require postapproval studies or clinical trials1 or the standards of evidence under which studies or trials are evaluated4 4 #cjbc4 ,protection of human research subjects 7a7 ,in general ,in order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 to the extent practicable and consistent with other statutory provisions1 harmonize differences between the ,,hhs ,human ,subject ,regulations and the ,,fda ,human ,subject ,regulations in accordance with subsection 7b74 7b7 ,avoiding regulatory duplication and unnecessary delays ,the ,secretary shall1 as appropriate-- 7#a7 make such modifications to the provisions of the ,,hhs ,human ,subject ,regulations1 the ,,fda ,human ,subject ,regulations1 and the vulnerable populations rules as may be necessary-- 7,a7 to reduce regulatory duplication and unnecessary delays2 7,b7 to modernize such provisions in the context of multisite and cooperative research projects2 and 7,c7 to protect vulnerable populations1 incorporate local considerations1 and support community engagement through mechanisms such as consultation with local researchers and human research protection programs1 in a manner consistent with subparagraph 7,b72 and 7#b7 ensure that human subject research that is subject to the ,,hhs ,human ,subject ,regulations and to the ,,fda ,human ,subject ,regulations may-- 7,a7 use joint or shared review2 7,b7 rely upon the review of-- 7i7 an independent institutional review board2 or 7ii7 an institutional review board of an entity other than the sponsor of the research2 or 7,c7 use similar arrangements to avoid duplication of effort4 7c7 ,consultation ,in harmonizing or modifying regulations or guidance under this section1 the ,secretary shall consult with stakeholders 7including researchers1 academic organizations1 hospitals1 institutional research boards1 pharmaceutical1 biotechnology1 and medical device developers1 clinical research organizations1 patient groups1 and others74 7d7 ,timing ,the ,secretary shall complete the harmonization described in subsection 7a7 not later than #c years after the date of enactment of this ,act4 7e7 ,progress report ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall submit to ,congress a report on the progress made toward completing such harmonization4 7f7 ,definitions 7#a7 ,human subject regulations ,in this section3 7,a7 ,,fda human subject regulations ,the term ,,fda ,human ,subject ,regulations means the provisions of parts #ej1 #ef1 #cab1 and #hab of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,,hhs human subject regulations ,the term ,,hhs ,human ,subject ,regulations means the provisions of subpart ,a of part #df of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7,c7 ,vulnerable population rules ,the term vulnerable population rules means-- 7i7 except in the case of research described in clause 7ii71 the provisions of subparts ,b through ,d of part #df1 ,code of ,federal ,regulations 7or any successor regulations72 and 7ii7 in the case of research that is subject to ,,fda ,human ,subject ,regulations1 the provisions applicable to vulnerable populations under part #ef of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 and subpart ,d of part #ej of such title #ba 7or any successor regulations74 7#b7 ,institutional review board defined ,in this section1 the term institutional review board has the meaning that applies to the term institutional review board under the ,,hhs ,human ,subject ,regulations4 #cjbd4 ,informed consent waiver or alteration for clinical investigations 7a7 ,devices ,section #ebj7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77#c77 is amended-- 7#a7 in subparagraph 7,d71 by striking except where subject to such conditions as the ,secretary may prescribe1 the investigator and inserting the following3 8except where1 subject to such conditions as the ,secretary may prescribe-- 7i7 the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights1 safety1 and welfare of the human subject2 or 7ii7 the investigator 2 and 7#b7 in the matter following subparagraph 7,d71 by striking subparagraph 7,d7 and inserting subparagraph 7,d77ii74 7b7 ,drugs ,section #eje7;i77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77#d77 is amended by striking except where it is not feasible or it is contrary to the best interests of such human beings and inserting except where it is not feasible1 it is contrary to the best interests of such human beings1 or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights1 safety1 and welfare of such human beings4 ,d ,patient access to therapies and information #cjca4 ,summary level review 7a7 ,,ffdca ,section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 is amended by adding at the end the following3 7#e7 7,a7 ,the ,secretary may rely upon qualified data summaries to support the approval of a supplemental application1 with respect to a qualified indication for a drug1 submitted under subsection 7b71 if such supplemental application complies with subparagraph 7,b74 7,b7 ,a supplemental application is eligible for review as described in subparagraph 7,a7 only if-- 7i7 there is existing data available and acceptable to the ,secretary demonstrating the safety of the drug2 and 7ii7 all data used to develop the qualified data summaries are submitted to the ,secretary as part of the supplemental application4 7,c7 ,the ,secretary shall post on the ,internet website of the ,food and ,drug ,administration and update annually-- 7i7 the number of applications reviewed solely under subparagraph 7,a7 or section #cea7;a77#b77;,e7 of the ,public ,health ,service ,act2 7ii7 the average time for completion of review under subparagraph 7,a7 or section #cea7;a77#b77;,e7 of the ,public ,health ,service ,act2 7iii7 the average time for review of supplemental applications where the ,secretary did not use review flexibility under subparagraph 7,a7 or section #cea7;a77#b77;,e7 of the ,public ,health ,service ,act2 and 7iv7 the number of applications reviewed under subparagraph 7,a7 or section #cea7;a77#b77;,e7 of the ,public ,health ,service ,act for which the ,secretary made use of full data sets in addition to the qualified data summary4 7,d7 ,in this paragraph-- 7i7 the term qualified indication means an indication for a drug that the ,secretary determines to be appropriate for summary level review under this paragraph2 and 7ii7 the term qualified data summary means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication4 4 7b7 ,,phsa ,section #cea7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77#b77 is amended by adding at the end the following3 7,e7 7i7 ,the ,secretary may rely upon qualified data summaries to support the approval of a supplemental application1 with respect to a qualified indication for a drug1 submitted under this subsection1 if such supplemental application complies with the requirements of subparagraph 7,b7 of section #eje7;c77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7ii7 ,in this subparagraph1 the terms qualified indication and qualified data summary have the meanings given such terms in section #eje7;c77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 #cjcb4 ,expanded access policy ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #efa 7#ba ,u4,s4,c4 #cfj;bbb7 the following3 #efa;,a4 ,expanded access policy required for investigational drugs 7a7 ,in general ,the manufacturer or distributor of one or more investigational drugs for the diagnosis1 monitoring1 or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section #efa7;b7 for provision of such a drug4 7b7 ,public availability of expanded access policy ,the policies under subsection 7a7 shall be made public and readily available1 such as by posting such policies on a publicly available ,internet website4 ,such policies may be generally applicable to all investigational drugs of such manufacturer or distributor4 7c7 ,content of policy ,a policy described in subsection 7a7 shall include-- 7#a7 contact information for the manufacturer or distributor to facilitate communication about requests described in subsection 7a72 7#b7 procedures for making such requests2 7#c7 the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients1 and for responses to such requests2 7#d7 the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests2 and 7#e7 a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section #djb7;j77#b77;,a77ii77,,ii77gg7 of the ,public ,health ,service ,act4 7d7 ,no guarantee of access ,the posting of policies by manufacturers and distributors under subsection 7a7 shall not serve as a guarantee of access to any specific investigational drug by any individual patient4 7e7 ,revised policy ,nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time4 7f7 ,application ,this section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of-- 7#a7 the date that is #fj calendar days after the date of enactment of the #bast ,century ,cures ,act2 or 7#b7 the first initiation of a phase #b or phase #c study 7as such terms are defined in section #cab4ba7;b7 and 7c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 with respect to such investigational drug4 4 #cjcc4 ,accelerated approval for regenerative advanced therapies 7a7 ,in general ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended-- 7#a7 by transferring subsection 7e7 7relating to construction7 so that it appears before subsection 7f7 7relating to awareness efforts72 and 7#b7 by adding at the end the following3 7g7 ,regenerative advanced therapy 7#a7 ,in general ,the ,secretary1 at the request of the sponsor of a drug1 shall facilitate an efficient development program for1 and expedite review of1 such drug if the drug qualifies as a regenerative advanced therapy under the criteria described in paragraph 7#b74 7#b7 ,criteria ,a drug is eligible for designation as a regenerative advanced therapy under this subsection if-- 7,a7 the drug is a regenerative medicine therapy 7as defined in paragraph 7#h772 7,b7 the drug is intended to treat1 modify1 reverse1 or cure a serious or life-threatening disease or condition2 and 7,c7 preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition4 7#c7 ,request for designation ,the sponsor of a drug may request the ,secretary to designate the drug as a regenerative advanced therapy concurrently with1 or at any time after1 submission of an application for the investigation of the drug under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act4 7#d7 ,designation ,not later than #fj calendar days after the receipt of a request under paragraph 7#c71 the ,secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph 7#b74 ,if the ,secretary determines that the drug meets the criteria1 the ,secretary shall designate the drug as a regenerative advanced therapy and shall take such actions as are appropriate under paragraph 7#a74 ,if the ,secretary determines that a drug does not meet the criteria for such designation1 the ,secretary shall include with the determination a written description of the rationale for such determination4 7#e7 ,actions ,the sponsor of a regenerative advanced therapy shall be eligible for the actions to expedite development and review of such therapy under subsection 7a77#c77;,b71 including early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of an application for the product under subsection 7c74 7#f7 ,access to expedited approval pathways ,an application for a regenerative advanced therapy under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act may be-- 7,a7 eligible for priority review1 as described in the ,manual of ,policies and ,procedures of the ,food and ,drug ,administration and goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjab2 and 7,b7 eligible for accelerated approval under subsection 7c71 as agreed upon pursuant to subsection 7a77#c77;,b71 through1 as appropriate-- 7i7 surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit2 or 7ii7 reliance upon data obtained from a meaningful number of sites1 including through expansion to additional sites1 as appropriate4 7#g7 ,postapproval requirements ,the sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to the postapproval requirements under subsection 7c7 may1 as appropriate1 fulfill such requirements1 as the ,secretary may require1 through-- 7,a7 the submission of clinical evidence1 clinical studies1 patient registries1 or other sources of real world evidence1 such as electronic health records2 7,b7 the collection of larger confirmatory data sets1 as agreed upon pursuant to subsection 7a77#c77;,b72 or 7,c7 postapproval monitoring of all patients treated with such therapy prior to approval of the therapy4 7#h7 ,definition ,for purposes of this section1 the term regenerative medicine therapy includes cell therapy1 therapeutic tissue engineering products1 human cell and tissue products1 and combination products using any such therapies or products1 except for those regulated solely under section #cfa of the ,public ,health ,service ,act and part #abga of title #ba1 ,code of ,federal ,regulations4 4 7b7 ,rule of construction ,nothing in this section and the amendments made by this section shall be construed to alter the authority of the ,secretary of ,health and ,human ,services-- 7#a7 to approve drugs pursuant to the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 as authorized prior to the date of enactment of the #bast ,century ,cures ,act1 including the standards of evidence1 and applicable conditions1 for approval under such ,acts2 or 7#b7 to alter the authority of the ,secretary to require postapproval studies pursuant to such ,acts1 as authorized prior to the date of enactment of the #bast ,century ,cures ,act4 7c7 ,conforming amendment ,section #ejf7;e77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;e77#a77 is amended by inserting and the #bast ,century ,cures ,act after ,food and ,drug ,administration ,safety and ,innovation ,act4 #cjcd4 ,guidance regarding devices used in the recovery1 isolation1 or delivery of regenerative advanced therapies 7a7 ,draft guidance ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue draft guidance clarifying how1 in the context of regenerative advanced therapies1 the ,secretary will evaluate devices used in the recovery1 isolation1 or delivery of regenerative advanced therapies4 ,in doing so1 the ,secretary shall specifically address-- 7#a7 how the ,food and ,drug ,administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products2 7#b7 what1 if any1 intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class ,,iii device2 7#c7 when the ,food and ,drug ,administration considers it is necessary1 if ever1 for the intended use of a device to be limited to a specific intended use with only one particular type of cell2 and 7#d7 application of the least burdensome approach to demonstrate how a device may be used with more than one cell type4 7b7 ,final guidance ,not later than #ab months after the close of the period for public comment on the draft guidance under subsection 7a71 the ,secretary of ,health and ,human ,services shall finalize such guidance4 #cjce4 ,report on regenerative advanced therapies 7a7 ,report to ,congress ,before ,march #a of each calendar year1 the ,secretary of ,health and ,human ,services shall1 with respect to the previous calendar year1 submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on-- 7#a7 the number and type of applications for approval of regenerative advanced therapies filed1 approved or licensed as applicable1 withdrawn1 or denied2 and 7#b7 how many of such applications or therapies1 as applicable1 were granted accelerated approval or priority review4 7b7 ,regenerative ,advanced ,therapy ,in this section1 the term regenerative advanced therapy has the meaning given such term in section #ejf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #cjcc of this ,act4 #cjcf4 ,standards for regenerative medicine and regenerative advanced therapies ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,f the following3 #ejf;,g4 ,standards for regenerative medicine and regenerative advanced therapies 7a7 ,in general ,not later than #b years after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary1 in consultation with the ,national ,institute of ,standards and ,technology and stakeholders 7including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors1 contract manufacturers1 academic institutions1 practicing clinicians1 regenerative medicine and advanced therapies industry organizations1 and standard setting organizations71 shall facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms1 through a public process1 to support1 through regulatory predictability1 the development1 evaluation1 and review of regenerative medicine therapies and regenerative advanced therapies1 including with respect to the manufacturing processes and controls of such products4 7b7 ,activities 7#a7 ,in general ,in carrying out this section1 the ,secretary shall continue to-- 7,a7 identity opportunities to help advance the development of regenerative medicine therapies and regenerative advanced therapies2 7,b7 identify opportunities for the development of laboratory regulatory science research and documentary standards that the ,secretary determines would help support the development1 evaluation1 and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability2 and 7,c7 work with stakeholders1 such as those described in subsection 7a71 as appropriate1 in the development of such standards4 7#b7 ,regulations and guidance ,not later than #a year after the development of standards as described in subsection 7a71 the ,secretary shall review relevant regulations and guidance and1 through a public process1 update such regulations and guidance as the ,secretary determines appropriate4 7c7 ,definitions ,for purposes of this section1 the terms regenerative medicine therapy and regenerative advanced therapy have the meanings given such terms in section #ejf7;g74 4 #cjcg4 ,health care economic information ,section #ejb7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 is amended-- 7#a7 by striking 7a7 ,if its and inserting 7a77#a7 ,if its2 7#b7 by striking a formulary committee1 or other similar entity1 in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations and inserting a payor1 formulary committee1 or other similar entity with knowledge and expertise in the area of health care economic analysis1 carrying out its responsibilities for the selection of drugs for coverage or reimbursement2 7#c7 by striking directly relates and inserting relates2 7#d7 by striking and is based on competent and reliable scientific evidence4 ,the requirements set forth in section #eje7;a7 or in section #cea7;a7 of the ,public ,health ,service ,act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph and inserting 1 is based on competent and reliable scientific evidence1 and includes1 where applicable1 a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section #eje or under section #cea of the ,public ,health ,service ,act4 ,the requirements set forth in section #eje7;a7 or in subsections 7a7 and 7k7 of section #cea of the ,public ,health ,service ,act shall not apply to health care economic information provided to such a payor1 committee1 or entity in accordance with this paragraph2 and 7#e7 by striking ,in this paragraph1 the term and all that follows and inserting the following3 7#b7 7,a7 ,for purposes of this paragraph1 the term health care economic information means any analysis 7including the clinical data1 inputs1 clinical or other assumptions1 methods1 results1 and other components underlying or comprising the analysis7 that identifies1 measures1 or describes the economic consequences1 which may be based on the separate or aggregated clinical consequences of the represented health outcomes1 of the use of a drug4 ,such analysis may be comparative to the use of another drug1 to another health care intervention1 or to no intervention4 7,b7 ,such term does not include any analysis that relates only to an indication that is not approved under section #eje or under section #cea of the ,public ,health ,service ,act for such drug4 4 #cjch4 ,combination product innovation 7a7 ,in general ,section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is amended-- 7#a7 by striking paragraph 7#c72 7#b7 by redesignating paragraph 7#b7 as paragraph 7#g72 7#c7 by redesignating paragraphs 7#d7 and 7#e7 as paragraphs 7#h7 and 7#i71 respectively2 7#d7 by striking 7g77#a7 and all that follows through the end of paragraph 7#a7 and inserting the following3 7g7 7#a7 7,a7 ,the ,secretary shall1 in accordance with this subsection1 assign a primary agency center to regulate products that constitute a combination of a drug1 device1 or biological product4 7,b7 ,the ,secretary shall conduct the premarket review of any combination product under a single application1 whenever appropriate4 7,c7 ,for purposes of this subsection1 the term primary mode of action means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product4 7,d7 ,the ,secretary shall determine the primary mode of action of the combination product4 ,if the ,secretary determines that the primary mode of action is that of-- 7i7 a drug 7other than a biological product71 the agency center charged with premarket review of drugs shall have primary jurisdiction2 7ii7 a device1 the agency center charged with premarket review of devices shall have primary jurisdiction2 or 7iii7 a biological product1 the agency center charged with premarket review of biological products shall have primary jurisdiction4 7,e7 ,in determining the primary mode of action of a combination product1 the ,secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body4 7,f7 ,if a sponsor of a combination product disagrees with the determination under subparagraph 7,d7-- 7i7 such sponsor may request1 and the ,secretary shall provide1 a substantive rationale to such sponsor that references scientific evidence provided by the sponsor and any other scientific evidence relied upon by the ,secretary to support such determination2 and 7ii7 7,i7 the sponsor of the combination product may propose one or more studies 7which may be nonclinical1 clinical1 or both7 to establish the relevance1 if any1 of the chemical action in achieving the primary mode of action of such product2 7,,ii7 if the sponsor proposes any such studies1 the ,secretary and the sponsor of such product shall collaborate and seek to reach agreement1 within a reasonable time of such proposal1 not to exceed #ij calendar days1 on the design of such studies2 and 7,,iii7 if an agreement is reached under subclause 7,,ii7 and the sponsor conducts one or more of such studies1 the ,secretary shall consider the data resulting from any such study when reevaluating the determination of the primary mode of action of such product1 and unless and until such reevaluation has occurred and the ,secretary issues a new determination1 the determination of the ,secretary under subparagraph 7,d7 shall remain in effect4 7#b7 7,a7 7i7 ,to establish clarity and certainty for the sponsor1 the sponsor of a combination product may request a meeting on such combination product4 ,if the ,secretary concludes that a determination of the primary mode of action pursuant to paragraph 7#a77;,d7 is necessary1 the sponsor may request such meeting only after the ,secretary makes such determination4 ,if the sponsor submits a written meeting request1 the ,secretary shall1 not later than #ge calendar days after receiving such request1 meet with the sponsor of such combination product4 7ii7 ,a meeting under clause 7i7 may-- 7,i7 address the standards and requirements for market approval or clearance of the combination product2 7,,ii7 address other issues relevant to such combination product1 such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product2 and 7,,iii7 identify elements under subclauses 7,i7 and 7,,ii7 that may be more appropriate for discussion and agreement with the ,secretary at a later date given that scientific or other information is not available1 or agreement is otherwise not feasible regarding such elements1 at the time a request for such meeting is made4 7iii7 ,any agreement under this subparagraph shall be in writing and made part of the administrative record by the ,secretary4 7iv7 ,any such agreement shall remain in effect1 except-- 7,i7 upon the written agreement of the ,secretary and the sponsor or applicant2 or 7,,ii7 pursuant to a decision by the director of the reviewing division of the primary agency center1 or a person more senior than such director1 in consultation with consulting centers and the ,office1 as appropriate1 that an issue essential to determining whether the standard for market clearance or other applicable standard under this ,act or the ,public ,health ,service ,act applicable to the combination product has been identified since the agreement was reached1 or that deviating from the agreement is otherwise justifiable based on scientific evidence1 for public health reasons4 7#c7 ,for purposes of conducting the premarket review of a combination product that contains an approved constituent part described in paragraph 7#d71 the ,secretary may require that the sponsor of such combination product submit to the ,secretary only data or information that the ,secretary determines is necessary to meet the standard for clearance or approval1 as applicable1 under this ,act or the ,public ,health ,service ,act1 including any incremental risks and benefits posed by such combination product1 using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with paragraph 7#e74 7#d7 ,for purposes of paragraph 7#c71 an approved constituent part is-- 7,a7 a drug constituent part of a combination product being reviewed in a single application or request under section #eae1 #eaj7k71 or #eac7;f77#b7 7submitted in accordance with paragraph 7#e771 that is an approved drug1 provided such application or request complies with paragraph 7#e72 7,b7 a device constituent part approved under section #eae that is referenced by the sponsor and that is available for use by the ,secretary under section #ebj7;h77#d72 or 7,c7 any constituent part that was previously approved1 cleared1 or classified under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act for which the sponsor has a right of reference or any constituent part that is a nonprescription drug1 as defined in section #gfj7;a77#b74 7#e7 7,a7 ,if an application is submitted under section #eae or #eaj7k7 or a request is submitted under section #eac7;f77#b71 consistent with any determination made under paragraph 7#a77;,d71 for a combination product containing as a constituent part an approved drug-- 7i7 the application or request shall include the certification or statement described in section #eje7;b77#b72 and 7ii7 the applicant or requester shall provide notice as described in section #eje7;b77#c74 7,b7 ,for purposes of this paragraph and paragraph 7#d71 the term approved drug means an active ingredient-- 7i7 that was in an application previously approved under section #eje7;c72 7ii7 where such application is relied upon by the applicant submitting the application or request described in subparagraph 7,a72 7iii7 for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph 7,a72 and 7iv7 for which the applicant submitting the application or request described in subparagraph 7,a7 has not obtained a right of reference or use from the person by or for whom the investigations described in clause 7iii7 were conducted4 7,c7 ,the following provisions shall apply with respect to an application or request described in subparagraph 7,a7 to the same extent and in the same manner as if such application or request were an application described in section #eje7;b77#b7 that referenced the approved drug3 7i7 ,subparagraphs 7,a71 7,b71 7,c71 and 7,d7 of section #eje7;c77#c74 7ii7 ,clauses 7ii71 7iii71 and 7iv7 of section #eje7;c77#c77;,e74 7iii7 ,subsections 7b7 and 7c7 of section #eje;,a4 7iv7 ,section #eje;,e7a74 7v7 ,section #ebg7;a74 7,d7 ,notwithstanding any other provision of this subsection1 an application or request for classification for a combination product described in subparagraph 7,a7 shall be considered an application submitted under section #eje7;b77#b7 for purposes of section #bga7;e77#b77;,a7 of title #ce1 ,united ,states ,code4 7#f7 ,nothing in this subsection shall be construed as prohibiting a sponsor from submitting separate applications for the constituent parts of a combination product1 unless the ,secretary determines that a single application is necessary4 2 7#e7 in paragraph 7#h7 7as redesignated by paragraph 7#c77-- 7,a7 in subparagraph 7,c7-- 7i7 by amending clause 7i7 to read as follows3 7i7 ,in carrying out this subsection1 the ,office shall help to ensure timely and effective premarket review that involves more than one agency center by coordinating such reviews1 overseeing the timeliness of such reviews1 and overseeing the alignment of feedback regarding such reviews4 2 7ii7 in clause 7ii71 by inserting and alignment after the timeliness each place it appears2 and 7iii7 by adding at the end the following new clauses3 7iii7 ,the ,office shall ensure that1 with respect to a combination product1 a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product4 ,the ,office shall also coordinate communications to and from any consulting center involved in such premarket review1 if requested by such primary agency center or any such consulting center4 ,agency communications and commitments1 to the extent consistent with other provisions of law and the requirements of all affected agency centers1 from the primary agency center shall be considered as communication from the ,secretary on behalf of all agency centers involved in the review4 7iv7 ,the ,office shall1 with respect to the premarket review of a combination product-- 7,i7 ensure that any meeting between the ,secretary and the sponsor of such product is attended by each agency center involved in the review1 as appropriate2 7,,ii7 ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner2 and 7,,iii7 ensure that each consulting center follows the guidance described in clause 7vi7 and advises1 as appropriate1 on other relevant regulations1 guidances1 and policies4 7v7 ,in seeking agency action with respect to a combination product1 the sponsor of such product-- 7,i7 shall identify the product as a combination product2 and 7,,ii7 may request in writing the participation of representatives of the ,office in meetings related to such combination product1 or to have the ,office otherwise engage on such regulatory matters concerning the combination product4 7vi7 ,not later than #d years after the date of enactment of the #bast ,century ,cures ,act1 and after a public comment period of not less than #fj calendar days1 the ,secretary shall issue a final guidance that describes-- 7,i7 the structured process for managing pre-submission interactions with sponsors developing combination products2 7,,ii7 the best practices for ensuring that the feedback in such pre-submission interactions represents the ,agency's best advice based on the information provided during such pre-submission interactions2 7,,iii7 the information that is required to be submitted with a meeting request under paragraph 7#b71 how such meetings relate to other types of meetings in the ,food and ,drug ,administration1 and the form and content of any agreement reached through a meeting under such paragraph 7#b72 2 and 7,b7 in subparagraph 7,g7-- 7i7 in the matter preceding clause 7i71 by inserting 7except with respect to clause 7iv71 beginning not later than one year after the date of the enactment of the #bast ,century ,cures ,act7 after enactment of this paragraph2 7ii7 in clause 7ii71 by striking and at the end2 7iii7 in clause 7iii71 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following new clause3 7iv7 identifying the percentage of combination products for which a dispute resolution1 with respect to premarket review1 was requested by the combination product's sponsor4 2 and 7#f7 in paragraph 7#i7 7as redesignated by paragraph 7#c77-- 7,a7 in subparagraph 7,c7-- 7i7 in clause 7i71 by striking the comma at the end and inserting a semicolon2 7ii7 in clause 7ii71 by striking 1 and at the end and inserting a semicolon2 7iii7 in clause 7iii71 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following3 7iv7 de novo classification under section #eac7;a77#a74 2 and 7,b7 by adding at the end the following3 7,d7 ,the terms premarket review and reviews include all activities of the ,food and ,drug ,administration conducted prior to approval or clearance of an application1 notification1 or request for classification submitted under section #eje1 #eaj7k71 #eac7;f77#b71 #eae1 or #ebj of this ,act or under section #cea of the ,public ,health ,service ,act1 including with respect to investigational use of the product4 4 7b7 ,information for approval of combination products ,section #ebj7;h77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7h77#d77 is amended-- 7#a7 in subparagraph 7,a71 by striking ,any information and inserting 8,subject to subparagraph 7,c71 any information02 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,no information contained in an application for premarket approval filed with the ,secretary pursuant to section #eae7;c7 may be used to approve or clear any application submitted under section #eae or #eaj7k7 or to classify a product under section #eac7;f77#b7 for a combination product containing as a constituent part an approved drug 7as defined in section #ejc7;g77#e77;,b77 unless-- 7i7 the application includes the certification or statement referenced in section #ejc7;g77#e77;,a72 7ii7 the applicant provides notice as described in section #ejc7;g77#e77;,a72 and 7iii7 the ,secretary's approval of such application is subject to the provisions in section #ejc7;g77#e77;,c74 4 7c7 ,variations ,from ,,cgmp ,streamlined ,approach ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall identify types of combination products and manufacturing processes with respect to which the ,secretary proposes that good manufacturing processes may be adopted that vary from the requirements set forth in section #d4d of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 or that the ,secretary proposes can satisfy the requirements in section #d4d through alternative or streamlined mechanisms4 ,the ,secretary shall identify such types1 variations from such requirements1 and such mechanisms1 in a proposed list published in the ,federal ,register4 ,after a public comment period regarding the appropriate good manufacturing practices for such types1 the ,secretary shall publish a final list in the ,federal ,register1 notwithstanding section #eec of title #e1 ,united ,states ,code4 ,the ,secretary shall evaluate such types1 variations1 and mechanisms using a risk-based approach4 ,the ,secretary shall periodically review such final list4 ,e ,antimicrobial innovation and stewardship #cjda4 ,antimicrobial resistance monitoring 7a7 ,in general ,section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended-- 7#a7 by redesignating subsections 7f7 and 7g7 as subsections 7l7 and 7m71 respectively2 and 7#b7 by inserting after subsection 7e71 the following3 7f7 ,monitoring at ,federal health care facilities ,the ,secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the ,department of ,defense1 the ,department of ,veterans ,affairs1 and the ,indian ,health ,service and shall provide technical assistance to the ,secretary of ,defense and the ,secretary of ,veterans ,affairs1 as appropriate and upon request4 7g7 ,report on antimicrobial resistance in humans and use of antimicrobial drugs ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 and annually thereafter1 the ,secretary shall prepare and make publicly available data and information concerning-- 7#a7 aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs1 including such drugs approved under section #ejf7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#b7 antimicrobial stewardship1 which may include summaries of ,state efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship2 and 7#c7 coordination between the ,director of the ,centers for ,disease ,control and ,prevention and the ,commissioner of ,food and ,drugs with respect to the monitoring of-- 7,a7 any applicable resistance under paragraph 7#a72 and 7,b7 drugs approved under section #ejf7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7h7 ,information related to antimicrobial stewardship programs ,the ,secretary shall1 as appropriate1 disseminate guidance1 educational materials1 or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities1 such as nursing homes and other long-term care facilities1 ambulatory surgical centers1 dialysis centers1 outpatient clinics1 and hospitals1 including community and rural hospitals4 7i7 ,supporting state-,based activities ,to combat antimicrobial resistance ,the ,secretary shall continue to work with ,state and local public health departments on statewide or regional programs related to antimicrobial resistance4 ,such efforts may include activities to related to-- 7#a7 identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs2 7#b7 preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs2 and 7#c7 promoting antimicrobial stewardship4 7j7 ,antimicrobial ,resistance and ,stewardship activities 7#a7 ,in general ,for the purposes of supporting stewardship activities1 examining changes in antimicrobial resistance1 and evaluating the effectiveness of section #ejf7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 the ,secretary shall-- 7,a7 provide a mechanism for facilities to report data related to their antimicrobial stewardship activities 7including analyzing the outcomes of such activities72 and 7,b7 evaluate-- 7i7 antimicrobial resistance data using a standardized approach2 and 7ii7 trends in the utilization of drugs approved under such section #ejf7;h7 with respect to patient populations4 7#b7 ,use of systems ,the ,secretary shall use available systems1 including the ,national ,healthcare ,safety ,network or other systems identified by the ,secretary1 to fulfill the requirements or conduct activities under this section4 7k7 ,antimicrobial ,for purposes of subsections 7f7 through 7j71 the term antimicrobial includes any antibacterial or antifungal drugs1 and may include drugs that eliminate or inhibit the growth of other microorganisms1 as appropriate4 4 7b7 ,availability of data ,the ,secretary shall make the data collected pursuant to this subsection public4 ,nothing in this subsection shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #cjdb4 ,limited population pathway ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef71 as amended by section #cjcc1 is further amended by adding at the end the following3 7h7 ,limited population pathway for antibacterial and antifungal drugs 7#a7 ,in general ,the ,secretary may approve an antibacterial or antifungal drug1 alone or in combination with one or more other drugs1 as a limited population drug pursuant to this subsection only if-- 7,a7 the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs2 7,b7 the standards for approval under section #eje7;c7 and 7d71 or the standards for licensure under section #cea of the ,public ,health ,service ,act1 as applicable1 are met2 and 7,c7 the ,secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection4 7#b7 ,benefit-risk consideration ,the ,secretary's determination of safety and effectiveness of an antibacterial or antifungal drug shall reflect the benefit-risk profile of such drug in the intended limited population1 taking into account the severity1 rarity1 or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population4 ,such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population4 7#c7 ,additional requirements ,a drug approved under this subsection shall be subject to the following requirements1 in addition to any other applicable requirements of this ,act3 7,a7 ,labeling ,to indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population-- 7i7 all labeling and advertising of an antibacterial or antifungal drug approved under this subsection shall contain the statement ,limited ,population in a prominent manner and adjacent to1 and not more prominent than-- 7,i7 the proprietary name of such drug1 if any2 or 7,,ii7 if there is no proprietary name1 the established name of the drug1 if any1 as defined in section #ejc7;e77#c71 or1 in the case of a drug that is a biological product1 the proper name1 as defined by regulation2 and 7ii7 the prescribing information for the drug required by section #bja4eg of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 shall also include the following statement3 ,this drug is indicated for use in a limited and specific population of patients44 7,b7 ,promotional material ,the sponsor of an antibacterial or antifungal drug subject to this subsection shall submit to the ,secretary copies of all promotional materials related to such drug at least #cj calendar days prior to dissemination of the materials4 7#d7 ,other programs ,a sponsor of a drug that seeks approval of a drug under this subsection may also seek designation or approval1 as applicable1 of such drug under other applicable sections or subsections of this ,act or the ,public ,health ,service ,act4 7#e7 ,guidance ,not later than #ah months after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall issue draft guidance describing criteria1 processes1 and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs4 ,the ,secretary shall publish final guidance within #ah months of the close of the public comment period on such draft guidance4 ,the ,secretary may approve antibacterial and antifungal drugs under this subsection prior to issuing guidance under this paragraph4 7#f7 ,advice ,the ,secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval1 and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population4 7#g7 ,termination of limitations ,if1 after approval of a drug under this subsection1 the ,secretary approves a broader indication for such drug under section #eje7;b7 or section #cea7;a7 of the ,public ,health ,service ,act1 the ,secretary may remove any postmarketing conditions1 including requirements with respect to labeling and review of promotional materials under paragraph 7#c71 applicable to the approval of the drug under this subsection4 7#h7 ,rules of construction ,nothing in this subsection shall be construed to alter the authority of the ,secretary to approve drugs pursuant to this ,act or section #cea of the ,public ,health ,service ,act1 including the standards of evidence and applicable conditions for approval under such ,acts1 the standards of approval of a drug under such ,acts1 or to alter the authority of the ,secretary to monitor drugs pursuant to such ,acts4 7#i7 ,reporting and accountability 7,a7 ,biennial reporting ,the ,secretary shall report to ,congress not less often than once every #b years on the number of requests for approval1 and the number of approvals1 of an antibacterial or antifungal drug under this subsection4 7,b7 ,,gao report ,not later than ,december #bjba1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate a report on the coordination of activities required under section #cai;,e of the ,public ,health ,service ,act4 ,such report shall include a review of such activities1 and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial or antifungal drugs for limited populations1 if such pathway has functioned as intended1 if such pathway has helped provide for safe and effective treatment for patients1 if such premarket approval would be appropriate for other categories of drugs1 and if the authorities under this subsection have affected antibacterial or antifungal resistance4 4 #cjdc4 ,prescribing authority ,nothing in this subtitle1 or an amendment made by this subtitle1 shall be construed to restrict the prescribing of antimicrobial drugs or other products1 including drugs approved under subsection 7h7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 7as added by section #cjdb71 by health care professionals1 or to limit the practice of health care4 #cjdd4 ,susceptibility test interpretive criteria for microorganisms2 antimicrobial susceptibility testing devices 7a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eaa the following3 #eaa;,a4 ,susceptibility test interpretive criteria for microorganisms 7a7 ,purpose2 ,identification of criteria 7#a7 ,purpose ,the purpose of this section is to clarify the ,secretary's authority to-- 7,a7 efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health1 due to1 among other things1 the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients1 which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies2 7,b7 provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards2 and 7,c7 clear under section #eaj7k71 classify under section #eac7;f77#b71 or approve under section #eae1 antimicrobial susceptibility testing devices utilizing updated1 recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria1 fungi1 or other microorganisms1 as applicable1 to antimicrobial drugs4 7#b7 ,identification of criteria ,the ,secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs-- 7,a7 if such criteria are available on the date of approval of the drug under section #eje of this ,act or licensure of the drug under section #cea of the ,public ,health ,service ,act 7as applicable71 upon such approval or licensure2 or 7,b7 if such criteria are unavailable on such date1 on the date on which such criteria are available for such drug4 7#c7 ,bases for initial identification ,the ,secretary shall identify appropriate susceptibility test interpretive criteria under paragraph 7#b71 based on the ,secretary's review of1 to the extent available and relevant-- 7,a7 preclinical and clinical data1 including pharmacokinetic1 pharmacodynamic1 and epidemiological data2 7,b7 the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used2 and 7,c7 such other evidence and information as the ,secretary considers appropriate4 7b7 ,susceptibility test ,interpretive ,criteria ,website 7#a7 ,in general ,not later than #a year after the date of the enactment of the #bast ,century ,cures ,act1 the ,secretary shall establish1 and maintain thereafter1 on the website of the ,food and ,drug ,administration1 a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria in accordance with paragraph 7#b7 7referred to in this section as the ,interpretive ,criteria ,website74 7#b7 ,listing of susceptibility test interpretive criteria standards and interpretive criteria 7,a7 ,in general ,the list described in paragraph 7#a7 shall consist of any new or updated susceptibility test interpretive criteria standards that are-- 7i7 established by a nationally or internationally recognized standard development organization that-- 7,i7 establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking2 7,,ii7 holds open meetings to ensure that there is an opportunity for public input by interested parties1 and establishes and maintains processes to ensure that such input is considered in decisionmaking2 and 7,,iii7 permits its standards to be made publicly available1 through the ,national ,library of ,medicine or another similar source acceptable to the ,secretary2 and 7ii7 recognized in whole1 or in part1 by the ,secretary under subsection 7c74 7,b7 ,other list ,the ,interpretive ,criteria ,website shall1 in addition to the list described in subparagraph 7,a71 include a list of interpretive criteria1 if any1 that the ,secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs1 where-- 7i7 the ,secretary does not recognize1 in whole or in part1 an interpretive criteria standard described under subparagraph 7,a7 otherwise applicable to such a drug2 7ii7 the ,secretary withdraws under subsection 7c77#a77;,a7 recognition of a standard1 in whole or in part1 otherwise applicable to such a drug2 7iii7 the ,secretary approves an application under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable1 with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the ,secretary under subsection 7c72 or 7iv7 because the characteristics of such a drug differ from other drugs with the same active ingredient1 the interpretive criteria with respect to such drug-- 7,i7 differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph 7,a7 or interpretive criteria otherwise listed under this subparagraph2 and 7,,ii7 are determined by the ,secretary to be appropriate for the drug4 7,c7 ,required statements ,the ,interpretive ,criteria ,website shall include statements conveying-- 7i7 that the website provides information about the in vitro susceptibility of bacteria1 fungi1 or other microorganisms1 as applicable to a certain drug 7or drugs72 7ii7 that-- 7,i7 the safety and efficacy of such drugs in treating clinical infections due to such bacteria1 fungi1 or other microorganisms1 as applicable1 may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause 7i7 to be included on the website2 and 7,,ii7 the clinical significance of such susceptibility information in such instances is unknown2 7iii7 that the approved product labeling for specific drugs provides the uses for which the ,secretary has approved the product2 and 7iv7 any other information that the ,secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website4 7#c7 ,notice ,not later than the date on which the ,interpretive ,criteria ,website is established1 the ,secretary shall publish a notice of that establishment in the ,federal ,register4 7#d7 ,inapplicability of misbranding provision ,the inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the ,interpretive ,criteria ,website1 in and of itself1 shall not cause the drug to be misbranded in violation of section #ejb4 7#e7 ,trade secrets and confidential information ,nothing in this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7c7 ,recognition of susceptibility test interpretive criteria 7#a7 ,evaluation and publication 7,a7 ,in general ,beginning on the date of the establishment of the ,interpretive ,criteria ,website1 and at least every #f months thereafter1 the ,secretary shall-- 7i7 evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection 7b77#b77;,a77i72 and 7ii7 publish on the public website of the ,food and ,drug ,administration a notice-- 7,i7 withdrawing recognition of any different susceptibility test interpretive criteria standard1 in whole or in part2 7,,ii7 recognizing the new or updated standards2 7,,iii7 recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard2 and 7,,iv7 making any necessary updates to the lists under subsection 7b77#b74 7,b7 ,upon approval of a drug ,upon the approval of an initial or supplemental application for an antimicrobial drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable1 where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized1 or from those otherwise listed1 by the ,secretary pursuant to this subsection1 or for which there are no relevant interpretive criteria standards recognized1 or interpretive criteria otherwise listed1 by the ,secretary pursuant to this subsection1 the ,secretary shall update the lists under subparagraphs 7,a7 and 7,b7 of subsection 7b77#b7 to include the susceptibility test interpretive criteria upon which such approval was based4 7#b7 ,bases for updating interpretive criteria standards ,in evaluating new or updated susceptibility test interpretive criteria standards under paragraph 7#a77;,a71 the ,secretary may consider-- 7,a7 the ,secretary's determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient2 7,b7 information provided by interested third parties1 including public comment on the annual compilation of notices published under paragraph 7#c72 7,c7 any bases used to identify susceptibility test interpretive criteria under subsection 7a77#b72 and 7,d7 such other information or factors as the ,secretary determines appropriate4 7#c7 ,annual compilation of notices ,each year1 the ,secretary shall compile the notices published under paragraph 7#a77;,a7 and publish such compilation in the ,federal ,register and provide for public comment4 ,if the ,secretary receives comments1 the ,secretary shall review such comments and1 if the ,secretary determines appropriate1 update pursuant to this subsection susceptibility test interpretive criteria standards or criteria-- 7,a7 recognized by the ,secretary under this subsection2 or 7,b7 otherwise listed on the ,interpretive ,criteria ,website under subsection 7b77#b74 7#d7 ,relation to section #ead7;c7 ,any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection 7b77#b77;,b7 shall be deemed to be recognized as a standard by the ,secretary under section #ead7;c77#a74 7#e7 ,voluntary use of interpretive criteria ,nothing in this section prohibits a person from seeking approval or clearance of a drug or device1 or changes to the drug or the device1 on the basis of susceptibility test interpretive criteria which differ from those contained in a standard recognized1 or from those otherwise listed1 by the ,secretary pursuant to subsection 7b77#b74 7d7 ,antimicrobial drug labeling 7#a7 ,drugs marketed prior to establishment of ,interpretive ,criteria ,website 7,a7 ,in general ,with respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the ,interpretive ,criteria ,website1 a holder of an approved application under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as applicable1 for each such drug1 not later than #a year after establishment of the ,interpretive ,criteria ,website described in subsection 7b77#a71 shall remove susceptibility test interpretive criteria1 if any1 and related information from the approved drug labeling and replace it with a reference to the ,interpretive ,criteria ,website4 7,b7 ,labeling changes ,the labeling changes required by this section shall be considered a minor change under section #cad4gj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 that may be implemented through documentation in the next applicable annual report4 7#b7 ,drugs marketed subsequent to establishment of ,interpretive ,criteria ,website ,with respect to antimicrobial drugs approved on or after the date of the establishment of the ,interpretive ,criteria ,website described in subsection 7b77#a71 the labeling for such a drug shall include1 in lieu of susceptibility test interpretive criteria and related information1 a reference to such ,website4 7e7 ,special condition for marketing of antimicrobial susceptibility testing devices 7#a7 ,in general ,notwithstanding sections #eja1 #ejb1 #eje1 #eaj1 #eac1 and #eae1 if the conditions specified in paragraph 7#b7 are met 7in addition to other applicable provisions under this chapter7 with respect to an antimicrobial susceptibility testing device described in subsection 7f77#a71 the ,secretary may authorize the marketing of such device for a use described in such subsection4 7#b7 ,conditions applicable to antimicrobial susceptibility testing devices ,the conditions specified in this paragraph are the following3 7,a7 ,the device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are-- 7i7 included in a standard recognized by the ,secretary under subsection 7c72 or 7ii7 otherwise listed on the ,interpretive ,criteria ,website under subsection 7b77#b74 7,b7 ,the labeling of such device includes statements conveying-- 7i7 that the device provides information about the in vitro susceptibility of bacteria1 fungi1 or other microorganisms1 as applicable to antimicrobial drugs2 7ii7 that-- 7,i7 the safety and efficacy of such drugs in treating clinical infections due to such bacteria1 fungi1 or other microorganisms1 as applicable1 may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria1 fungi1 or other microorganisms1 as applicable1 to such drugs2 and 7,,ii7 the clinical significance of such susceptibility information in those instances is unknown2 7iii7 that the approved labeling for drugs tested using such a device provides the uses for which the ,secretary has approved such drugs2 and 7iv7 any other information the ,secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph 7,a74 7,c7 ,the antimicrobial susceptibility testing device meets all other requirements to be cleared under section #eaj7k71 classified under section #eac7;f77#b71 or approved under section #eae4 7f7 ,definitions ,in this section3 7#a7 ,the term antimicrobial susceptibility testing device means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug 7or drugs74 7#b7 ,the term qualified infectious disease product means a qualified infectious disease product designated under section #eje;,e7d74 7#c7 ,the term susceptibility test interpretive criteria means-- 7,a7 one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested2 and 7,b7 related categorizations of such susceptibility1 including categorization of the drug as susceptible1 intermediate1 resistant1 or such other term as the ,secretary determines appropriate4 7#d7 7,a7 ,the term antimicrobial drug means1 subject to subparagraph 7,b71 a systemic antibacterial or antifungal drug that-- 7i7 is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus2 7ii7 may include a qualified infectious disease product designated under section #eje;,e7d72 and 7iii7 is subject to section #ejc7;b77#a74 7,b7 ,if provided by the ,secretary through regulations1 such term may include-- 7i7 drugs other than systemic antibacterial and antifungal drugs2 and 7ii7 biological products 7as such term is defined in section #cea of the ,public ,health ,service ,act7 to the extent such products exhibit antimicrobial activity4 7#e7 ,the term interpretive criteria standard means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection 7b77#b77;,a77i74 7g7 ,rule of construction ,nothing in this section shall be construed to-- 7#a7 alter the standards of evidence under subsection 7c7 or 7d7 of section #eje 7including the substantial evidence standard under section #eje7;d77 or under section #cea of the ,public ,health ,service ,act 7as applicable72 or 7#b7 with respect to clearing devices under section #eaj7k71 classifying devices under section #eac7;f77#b71 or approving devices under section #eae-- 7,a7 apply with respect to any drug1 device1 or biological product1 in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria1 fungi1 or other microorganisms1 as applicable1 to such drug to reflect patient morbidity and mortality in accordance with this section2 or 7,b7 unless specifically stated1 have any effect on authorities provided under other sections of this ,act1 including any regulations issued under such sections4 4 7b7 ,conforming amendments 7#a7 ,repeal of prior related authority ,section #aaaa of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7#db ,u4,s4,c4 #bdg;d-#e;a71 relating to identification of clinically susceptible concentrations of antimicrobials1 is repealed4 7#b7 ,addition to categories of misbranded drugs ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7dd7 ,if it is an antimicrobial drug1 as defined in section #eaa;,a7f71 and its labeling fails to conform with the requirements under section #eaa;,a7d74 4 7#c7 ,recognition of interpretive criteria standard as device standard ,section #ead7;c77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77#a77;,a77 is amended by inserting after the ,secretary shall1 by publication in the ,federal ,register the following3 7or1 with respect to a susceptibility test interpretive criteria standard under section #eaa;,a1 by posting on the ,interpretive ,criteria ,website in accordance with such section74 7c7 ,report to congress ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the progress made in implementing section #eaa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a71 as added by subsection 7a74 7d7 ,requests for updates to ,interpretive ,criteria ,website ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection of information from interested parties regarding updating the lists established under section #eaa;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and posted on the ,interpretive ,criteria ,website established under section #eaa;,a7c7 of such ,act4 ,f ,medical device innovations #cjea4 ,breakthrough devices 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eae;,b1 as added by section #cjcd7;b71 the following3 #eae;,c4 ,breakthrough devices 7a7 ,purpose ,the purpose of this section is to encourage the ,secretary1 and provide the ,secretary with sufficient authority1 to apply efficient and flexible approaches to expedite the development of1 and prioritize the ,food and ,drug ,administration's review of1 devices that represent breakthrough technologies4 7b7 ,establishment of program ,the ,secretary shall establish a program to expedite the development of1 and provide for the priority review for1 devices1 as determined by the ,secretary-- 7#a7 that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions2 and 7#b7 7,a7 that represent breakthrough technologies2 7,b7 for which no approved or cleared alternatives exist2 7,c7 that offer significant advantages over existing approved or cleared alternatives1 including the potential1 compared to existing approved alternatives1 to reduce or eliminate the need for hospitalization1 improve patient quality of life1 facilitate patients' ability to manage their own care 7such as through self-directed personal assistance71 or establish long-term clinical efficiencies2 or 7,d7 the availability of which is in the best interest of patients4 7c7 ,request for designation ,a sponsor of a device may request that the ,secretary designate such device for expedited development and priority review under this section4 ,any such request for designation may be made at any time prior to the submission of an application under section #eae7;c71 a notification under section #eaj7k71 or a petition for classification under section #eac7;f77#b74 7d7 ,designation ,process 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7c71 the ,secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection 7b74 ,if the ,secretary determines that the device meets the criteria1 the ,secretary shall designate the device for expedited development and priority review4 7#b7 ,review ,review of a request under subsection 7c7 shall be undertaken by a team that is composed of experienced staff and senior managers of the ,food and ,drug ,administration4 7#c7 ,withdrawal ,the ,secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection 7b7 no longer applying because of the subsequent clearance or approval of another device that-- 7,a7 was designated under this section2 or 7,b7 was given priority review under section #eae7;d77#e71 as in effect prior to the date of enactment of the #bast ,century ,cures ,act4 7e7 ,expedited ,development and ,priority ,review 7#a7 ,actions ,for purposes of expediting the development and review of devices designated under subsection 7d7 the ,secretary shall-- 7,a7 assign a team of staff1 including a team leader with appropriate subject matter expertise and experience1 for each device for which a request is submitted under subsection 7c72 7,b7 provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection 7c7 for the device2 7,c7 adopt an efficient process for timely dispute resolution2 7,d7 provide for interactive and timely communication with the sponsor of the device during the development program and review process2 7,e7 expedite the ,secretary's review of manufacturing and quality systems compliance1 as applicable2 7,f7 disclose to the sponsor1 not less than #e business days in advance1 the topics of any consultation the ,secretary intends to undertake with external experts or an advisory committee concerning the sponsor's device and provide the sponsor the opportunity to recommend such external experts2 7,g7 provide for advisory committee input1 as the ,secretary determines appropriate 7including in response to the request of the sponsor7 for applications submitted under section #eae7;c72 and 7,h7 assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section #ebj7;g74 7#b7 ,additional actions ,in addition to the actions described in paragraph 7#a71 for purposes of expediting the development and review of devices designated under subsection 7d71 the ,secretary1 in collaboration with the device sponsor1 may1 as appropriate-- 7,a7 coordinate with the sponsor regarding early agreement on a data development plan2 7,b7 take steps to ensure that the design of clinical trials is as efficient and flexible as practicable1 when scientifically appropriate2 7,c7 facilitate1 when scientifically appropriate1 expedited and efficient development and review of the device through utilization of timely postmarket data collection with regard to application for approval under section #eae7;c72 and 7,d7 agree in writing to clinical protocols that the ,secretary will consider binding on the ,secretary and the sponsor1 subject to-- 7i7 changes to such protocols agreed to in writing by the sponsor and the ,secretary2 or 7ii7 a decision1 made by the director of the office responsible for reviewing the device submission1 that a substantial scientific issue essential to determining the safety or effectiveness of such device exists1 provided that such decision is in writing1 and is made only after the ,secretary provides to the device sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the substantial scientific issue4 7f7 ,priority ,review ,guidance 7#a7 ,content ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall issue guidance on the implementation of this section4 ,such guidance shall-- 7,a7 set forth the process by which a person may seek a designation under subsection 7d72 7,b7 provide a template for requests under subsection 7c72 7,c7 identify the criteria the ,secretary will use in evaluating a request for designation under this section2 and 7,d7 identify the criteria and processes the ,secretary will use to assign a team of staff1 including team leaders1 to review devices designated for expedited development and priority review1 including any training required for such personnel to ensure effective and efficient review4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall seek public comment on a proposed guidance4 7g7 ,rule of construction ,nothing in this section shall be construed to affect-- 7#a7 the criteria and standards for evaluating an application pursuant to section #eae7;c71 a report and request for classification under section #eac7;f77#b71 or a report under section #eaj7k71 including the recognition of valid scientific evidence as described in section #eac7;a77#c77;,b7 and consideration and application of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics1 as applicable2 7#b7 the authority of the ,secretary with respect to clinical holds under section #ebj7;g77#h77;,a72 7#c7 the authority of the ,secretary to act on an application pursuant to section #eae7;d7 before completion of an establishment inspection1 as the ,secretary determines appropriate2 or 7#d7 the authority of the ,secretary with respect to postmarket surveillance under sections #eai7;h7 and #ebb4 4 7b7 ,documentation and review of significant decisions ,section #eag;,a7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is amended by inserting a request for designation under section #eae;,c1 after application under section #eae14 7c7 ,termination of previous program 7#a7 ,in general ,section #eae7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77 is amended-- 7,a7 by striking paragraph 7#e72 and 7,b7 by redesignating paragraph 7#f7 as paragraph 7#e74 7#b7 ,conforming amendment ,section #gcg7e7 of the ,federal ,food1 ,drug1 and ,cosmetics ,act 7#ba ,u4,s4,c4 #cgi;i7#e77 is amended by striking #eae7;d77#f7 and inserting #eae7;d77#e74 7d7 ,report ,on ,january #a1 #bjai1 the ,secretary of ,health and ,human ,services shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives-- 7#a7 on the program under section #eae;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 in bringing safe and effective devices included in such program to patients as soon as possible2 and 7#b7 that includes recommendations1 if any1 to strengthen the program to better meet patient device needs in a manner as timely as possible4 #cjeb4 ,humanitarian device exemption 7a7 ,in general ,section #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended-- 7#a7 in paragraph 7#a7 by striking fewer than #d1jjj and inserting not more than #h1jjj2 7#b7 in paragraph 7#b77;,a7 by striking fewer than #d1jjj and inserting not more than #h1jjj2 and 7#c7 in paragraph 7#f77;,a77ii71 by striking #d1jjj and inserting #h1jjj4 7b7 ,guidance document on probable benefit ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall publish a draft guidance that defines the criteria for establishing probable benefit as that term is used in section #ebj7m77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#b77;,c774 #cjec4 ,recognition of standards 7a7 ,in general ,section #ead7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,b7 the following new subparagraphs3 7,c7 7i7 ,any person may submit a request for recognition under subparagraph 7,a7 of all or part of an appropriate standard established by a nationally or internationally recognized standard organization4 7ii7 ,not later than #fj calendar days after the ,secretary receives such a request1 the ,secretary shall-- 7,i7 make a determination to recognize all1 part1 or none of the standard that is the subject of the request2 and 7,,ii7 issue to the person who submitted such request a response in writing that states the ,secretary's rationale for that determination1 including the scientific1 technical1 regulatory1 or other basis for such determination4 7iii7 ,the ,secretary shall make a response issued under clause 7ii77,,ii7 publicly available1 in such a manner as the ,secretary determines appropriate4 7iv7 ,the ,secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause 7ii77,i71 in accordance with subparagraph 7,a74 7,d7 ,the ,secretary shall make publicly available1 in such manner as the ,secretary determines appropriate1 the rationale for recognition under subparagraph 7,a7 of all1 part1 or none of a standard1 including the scientific1 technical1 regulatory1 or other basis for the decision regarding such recognition4 2 and 7#b7 by adding at the end the following3 7#d7 ,the ,secretary shall provide to all employees of the ,food and ,drug ,administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this ,act1 including standards relevant to an employee's area of device review4 4 7b7 ,guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall review and update1 if necessary1 previously published guidance and standard operating procedures identifying the principles for recognizing standards1 and for withdrawing the recognition of standards1 under section #ead7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c771 taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry1 and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices4 #cjed4 ,certain class ,i and class ,,ii devices 7a7 ,class i devices ,section #eaj7l7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is amended-- 7#a7 by striking ,a report under subsection 7k7 and inserting 7#a7 ,a report under subsection 7k72 and 7#b7 by adding at the end the following new paragraph3 7#b7 ,not later than #abj calendar days after the date of enactment of the #bast ,century ,cures ,act and at least once every #e years thereafter1 as the ,secretary determines appropriate1 the ,secretary shall identify1 through publication in the ,federal ,register1 any type of class ,i device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness4 ,upon such publication-- 7,a7 each type of class ,i device so identified shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 7b7 ,class ,,ii devices ,section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 is amended-- 7#a7 by striking 7m77#a7 and all that follows through by the ,secretary4 and inserting the following3 7m7 7#a7 ,the ,secretary shall-- 7,a7 not later than #ij days after the date of enactment of the #bast ,century ,cures ,act and at least once every #e years thereafter1 as the ,secretary determines appropriate-- 7i7 publish in the ,federal ,register a notice that contains a list of each type of class ,,ii device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness2 and 7ii7 provide for a period of not less than #fj calendar days for public comment beginning on the date of the publication of such notice2 and 7,b7 not later than #baj calendar days after the date of enactment of the #bast ,century ,cures ,act1 publish in the ,federal ,register a list representing the ,secretary's final determination with respect to the devices contained in the list published under subparagraph 7,a74 2 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #a day after the date of publication of a list under this subsection1 and inserting #a calendar day after the date of publication of the final list under paragraph 7#a77;,b712 and 7,b7 by striking #cj-;day period and inserting #fj-;calendar-day period2 and 7,c7 by adding at the end the following new paragraph3 7#c7 ,upon the publication of the final list under paragraph 7#a77;,b7-- 7,a7 each type of class ,,ii device so listed shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 #cjee4 ,classification panels 7a7 ,classification panels ,paragraph 7#e7 of section #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended-- 7#a7 by striking 7#e7 and inserting 7#e77;,a72 and 7#b7 by adding at the end the following3 7,b7 ,when a device is specifically the subject of review by a classification panel1 the ,secretary shall-- 7i7 ensure that adequate expertise is represented on the classification panel to assess-- 7,i7 the disease or condition which the device is intended to cure1 treat1 mitigate1 prevent1 or diagnose2 and 7,,ii7 the technology of the device2 and 7ii7 provide an opportunity for the person whose device is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel4 7,c7 ,for purposes of subparagraph 7,b77i71 the term adequate expertise means that the membership of the classification panel includes-- 7i7 two or more voting members1 with a specialty or other expertise clinically relevant to the device under review2 and 7ii7 at least one voting member who is knowledgeable about the technology of the device4 7,d7 ,the ,secretary shall provide an annual opportunity for patients1 representatives of patients1 and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels4 4 7b7 ,panel review process ,section #eac7;b77#f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#f77 is amended-- 7#a7 in subparagraph 7,a77iii71 by inserting before the period at the end 1 including1 subject to the discretion of the panel chairperson1 by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information1 and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided2 and 7#b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 7i7 ,any meeting of a classification panel with respect to the review of a device shall-- 7,i7 provide adequate time for initial presentations by the person whose device is specifically the subject of such review and by the ,secretary2 and 7,,ii7 encourage free and open participation by all interested persons4 7ii7 ,following the initial presentations described in clause 7i71 the panel may-- 7,i7 pose questions to a designated representative described in subparagraph 7,a77iii72 and 7,,ii7 consider the responses to such questions in the panel's review of the device4 4 #cjef4 ,institutional review board flexibility ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended-- 7#a7 in subsection 7g77#c7-- 7,a7 in subparagraph 7,a77i7-- 7i7 by striking local2 and 7ii7 by striking which has been2 and 7,b7 in subparagraph 7,b71 by striking a local institutional and inserting an institutional2 and 7#b7 in subsection 7m77#d7-- 7,a7 by striking subparagraph 7,a7 and inserting the following3 7,a7 in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the ,secretary2 and 2 7,b7 in subparagraph 7,b71 by striking a local institutional and inserting an institutional2 and 7,c7 in the matter following subparagraph 7,b71 by striking local4 #cjeg4 ,,clia waiver improvements 7a7 ,draft revised guidance ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall publish a draft guidance that-- 7#a7 revises ,section ,v4 ,demonstrating ,insignificant ,risk of an ,erroneous ,result - ,accuracy of the guidance entitled ,recommendations for ,clinical ,laboratory ,improvement ,amendments of #aihh 7,,clia7 ,waiver ,applications for ,manufacturers of ,in ,vitro ,diagnostic ,devices and dated ,january #cj1 #bjjh2 and 7#b7 includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy4 7b7 ,final revised guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall finalize the draft guidance published under subsection 7a7 not later than #a year after the comment period for such draft guidance closes4 #cjeh4 ,least burdensome device review 7a7 ,in general ,section #eac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is amended by adding at the end the following3 7j7 ,training and oversight of least burdensome requirements 7#a7 ,the ,secretary shall-- 7,a7 ensure that each employee of the ,food and ,drug ,administration who is involved in the review of premarket submissions1 including supervisors1 receives training regarding the meaning and implementation of the least burdensome requirements under subsections 7a77#c77;,d7 and 7i77#a77;,d7 of this section and section #eae7;c77#e72 and 7,b7 periodically assess the implementation of the least burdensome requirements1 including the employee training under subparagraph 7,a71 to ensure that the least burdensome requirements are fully and consistently applied4 7#b7 ,not later than #ah months after the date of enactment of the #bast ,century ,cures ,act1 the ombudsman for any organizational unit of the ,food and ,drug ,administration responsible for the premarket review of devices shall-- 7,a7 conduct an audit of the training described in paragraph 7#a77;,a71 including the effectiveness of such training in implementing the least burdensome requirements2 7,b7 include in such audit interviews of persons who are representatives of the device industry regarding their experiences in the device premarket review process1 including with respect to the application of least burdensome concepts to premarket review and decisionmaking2 7,c7 include in such audit a list of the measurement tools the ,secretary uses to assess the implementation of the least burdensome requirements1 including under paragraph 7#a77;,b7 and section #eag;,a7a77#c71 and may also provide feedback on the effectiveness of such tools in the implementation of the least burdensome requirements2 7,d7 summarize the findings of such audit in a final audit report2 and 7,e7 within #cj calendar days of completion of such final audit report1 make such final audit report available-- 7i7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7ii7 on the ,internet website of the ,food and ,drug ,administration4 4 7b7 ,premarket applications ,section #eae7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77 is amended by adding at the end the following3 7#e7 7,a7 ,in requesting additional information with respect to an application under this section1 the ,secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness4 7,b7 ,for purposes of subparagraph 7,a71 the term necessary means the minimum required information that would support a determination by the ,secretary that an application provides a reasonable assurance of the safety and effectiveness of the device4 7,c7 ,for purposes of this paragraph1 the ,secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness4 7,d7 ,nothing in this paragraph alters the standards for premarket approval of a device4 4 7c7 ,rationale for significant decisions regarding devices ,section #eag;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77 is amended by adding at the end the following3 7#c7 ,application of least burdensome requirements ,the substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section #eac7;i77#a77;,d71 section #eac7;a77#c77;,d71 and section #eae7;c77#e71 as applicable4 4 #cjei4 ,cleaning instructions and validation data requirement 7a7 ,in general ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended by adding at the end the following3 7q7 ,reusable medical devices 7#a7 ,in general ,not later than #ahj days after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall identify and publish a list of reusable device types for which reports under subsection 7k7 are required to include-- 7,a7 instructions for use1 which have been validated in a manner specified by the ,secretary2 and 7,b7 validation data1 the types of which shall be specified by the ,secretary2 regarding cleaning1 disinfection1 and sterilization1 and for which a substantial equivalence determination may be based4 7#b7 ,revision of list ,the ,secretary shall revise the list under paragraph 7#b71 as the ,secretary determines appropriate1 with notice in the ,federal ,register4 7#c7 ,content of reports ,reports under subsection 7k7 that are submitted after the publication of the list described in paragraph 7#a71 for devices or types of devices included on such list1 shall include such instructions for use and validation data4 4 7b7 ,device modifications ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue final guidance regarding when a premarket notification under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 is required to be submitted for a modification or change to a legally marketed device4 ,such final guidance shall be issued not later than #a year after the date on which the comment period closes for the draft guidance on such subject4 #cjfj4 ,clarifying medical software regulation 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7o7 ,regulation of medical and certain decisions support software 7#a7 ,the term device1 as defined in section #bja7;h71 shall not include a software function that is intended-- 7,a7 for administrative support of a health care facility1 including the processing and maintenance of financial records1 claims or billing information1 appointment schedules1 business analytics1 information about patient populations1 admissions1 practice and inventory management1 analysis of historical claims data to predict future utilization or cost-effectiveness1 determination of health benefit eligibility1 population health management1 and laboratory workflow2 7,b7 for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or condition2 7,c7 to serve as electronic patient records1 including patient-provided information1 to the extent that such records are intended to transfer1 store1 convert formats1 or display the equivalent of a paper medical chart1 so long as-- 7i7 such records were created1 stored1 transferred1 or reviewed by health care professionals1 or by individuals working under supervision of such professionals2 7ii7 such records are part of health information technology that is certified under section #cjja7;c77#e7 of the ,public ,health ,service ,act2 and 7iii7 such function is not intended to interpret or analyze patient records1 including medical image data1 for the purpose of the diagnosis1 cure1 mitigation1 prevention1 or treatment of a disease or condition2 7,d7 for transferring1 storing1 converting formats1 or displaying clinical laboratory test or other device data and results1 findings by a health care professional with respect to such data and results1 general information about such findings1 and general background information about such laboratory test or other device1 unless such function is intended to interpret or analyze clinical laboratory test or other device data1 results1 and findings2 or 7,e7 unless the function is intended to acquire1 process1 or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system1 for the purpose of-- 7i7 displaying1 analyzing1 or printing medical information about a patient or other medical information 7such as peer-reviewed clinical studies and clinical practice guidelines72 7ii7 supporting or providing recommendations to a health care professional about prevention1 diagnosis1 or treatment of a disease or condition2 and 7iii7 enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient4 7#b7 ,in the case of a product with multiple functions that contains-- 7,a7 at least one software function that meets the criteria under paragraph 7#a7 or that otherwise does not meet the definition of device under section #bja7;h72 and 7,b7 at least one function that does not meet the criteria under paragraph 7#a7 and that otherwise meets the definition of a device under section #bja7;h71 the ,secretary shall not regulate the software function of such product described in subparagraph 7,a7 as a device4 ,notwithstanding the preceding sentence1 when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph 7,b71 the ,secretary may assess the impact that the software function or functions described in subparagraph 7,a7 have on such device function or functions4 7#c7 7,a7 ,notwithstanding paragraph 7#a71 a software function described in subparagraph 7,c71 7,d71 or 7,e7 of paragraph 7#a7 shall not be excluded from the definition of device under section #bja7;h7 if-- 7i7 the ,secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences2 and 7ii7 the software function has been identified in a final order issued by the ,secretary under subparagraph 7,b74 7,b7 ,subparagraph 7,a7 shall apply only if the ,secretary-- 7i7 publishes a notification and proposed order in the ,federal ,register2 7ii7 includes in such notification the ,secretary's finding1 including the rationale and identification of the evidence on which such finding was based1 as described in subparagraph 7,a77i72 and 7iii7 provides for a period of not less than #cj calendar days for public comment before issuing a final order or withdrawing such proposed order4 7,c7 ,in making a finding under subparagraph 7,a77i7 with respect to a software function1 the ,secretary shall consider-- 7i7 the likelihood and severity of patient harm if the software function were to not perform as intended2 7ii7 the extent to which the software function is intended to support the clinical judgment of a health care professional2 7iii7 whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function2 and 7iv7 the intended user and user environment1 such as whether a health care professional will use a software function of a type described in subparagraph 7,e7 of paragraph 7#a74 7#d7 ,nothing in this subsection shall be construed as limiting the authority of the ,secretary to-- 7,a7 exercise enforcement discretion as to any device subject to regulation under this ,act2 7,b7 regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans2 or 7,c7 regulate software as a device under this ,act if such software meets the criteria under section #eac7;a77#a77;,c74 4 7b7 ,reports ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary71 after consultation with agencies and offices of the ,department of ,health and ,human ,services involved in health information technology1 shall publish a report1 not later than #b years after the date of enactment of this ,act and every #b years thereafter1 that-- 7#a7 includes input from outside experts1 such as representatives of patients1 consumers1 health care providers1 startup companies1 health plans or other third-party payers1 venture capital investors1 information technology vendors1 health information technology vendors1 small businesses1 purchasers1 employers1 and other stakeholders with relevant expertise1 as determined by the ,secretary2 7#b7 examines information available to the ,secretary on any risks and benefits to health associated with software functions described in section #ebj7o77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 7as amended by subsection 7a772 and 7#c7 summarizes findings regarding the impact of such software functions on patient safety1 including best practices to promote safety1 education1 and competency related to such functions4 7c7 ,classification of accessories ,section #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended by adding at the end the following3 7#i7 ,the ,secretary shall classify an accessory under this section based on the intended use of the accessory1 notwithstanding the classification of any other device with which such accessory is intended to be used4 4 7d7 ,conforming amendment ,section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 is amended by adding at the end the following3 ,the term device does not include software functions excluded pursuant to section #ebj7o744 ,g ,improving ,scientific ,expertise and ,outreach at ,,fda #cjga4 ,silvio ,o4 ,conte ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service 7a7 ,hiring and retention authority ,section #bbh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcg7 is amended-- 7#a7 in the section heading1 by inserting and ,biomedical ,product ,assessment after ,research2 7#b7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by striking ,silvio ,o4 ,conte ,senior ,biomedical ,research ,service1 not to exceed #ejj members and inserting ,silvio ,o4 ,conte ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service 7in this section referred to as the ,service71 not to exceed #b1jjj members1 the purpose of which is to recruit and retain outstanding and qualified scientific and technical experts in the fields of biomedical research1 clinical research evaluation1 and biomedical product assessment2 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,the authority established in paragraph 7#a7 may not be construed to require the ,secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the ,service4 2 and 7,c7 by adding at the end the following3 7#c7 ,the ,secretary shall assign experts under this section to agencies within the ,department of ,health and ,human ,services taking into account the need for the expertise of such expert4 2 7#c7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking or clinical research evaluation and inserting 1 clinical research evaluation1 or biomedical product assessment2 and 7,b7 in paragraph 7#a71 by inserting or a doctoral or master's level degree in engineering1 bioinformatics1 or a related or emerging field1 after the comma2 7#d7 in subsection 7d77#b71 by striking and shall not exceed the rate payable for level ,i of the ,executive ,schedule unless approved by the ,president under section #ecgg7;d77#b7 of title #e1 ,united ,states ,code and inserting and shall not exceed the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code2 7#e7 by striking subsection 7e72 and 7#f7 by redesignating subsections 7f7 and 7g7 as subsections 7e7 and 7f71 respectively4 7b7 ,,gao study 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of the amendments to section #bbh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcg7 made by subsection 7a7 and the impact of such amendments1 if any1 on all agencies or departments of the ,department of ,health and ,human ,services1 and1 not later than #d years after the date of enactment of this ,act1 shall submit a report based on such study to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#b7 ,content of study and report ,the study and report under paragraph 7#a7 shall include an examination of the extent to which recruitment and retention of outstanding and qualified scientific1 medical1 or technical experts in the fields of biomedical research1 clinical research evaluation1 and biomedical product assessment have improved or otherwise have been affected by the amendments to section #bbh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcg7 made by subsection 7a71 including by determining1 during the period between the date of enactment of this ,act and the completion of the study-- 7,a7 the total number of members recruited and retained under the ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service under such section #bbh1 and the effect of increasing the number of members eligible for such ,service2 7,b7 the number of members of such ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service hired with a doctoral level degree in biomedicine or a related field1 and the number of such members hired with a doctoral or master's level degree in engineering1 bioinformatics1 or a related or emerging field2 and 7,c7 the number of ,senior ,biomedical ,research and ,biomedical ,product ,assessment ,service members that have been hired by each agency or department of the ,department of ,health and ,human ,services1 and how such ,department assigns such members to each agency or department4 #cjgb4 ,hiring authority for scientific1 technical1 and professional personnel 7a7 ,in general ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #gad 7#ba ,u4,s4,c4 #cgi;d-#c7 the following3 #gad;,a4 ,hiring authority for scientific1 technical1 and professional personnel 7a7 ,in general ,the ,secretary may1 notwithstanding title #e1 ,united ,states ,code1 governing appointments in the competitive service1 appoint outstanding and qualified candidates to scientific1 technical1 or professional positions that support the development1 review1 and regulation of medical products4 ,such positions shall be within the competitive service4 7b7 ,compensation 7#a7 ,in general ,notwithstanding any other provision of law1 including any requirement with respect to ,general ,schedule pay rates under subchapter ,,iii of chapter #ec of title #e1 ,united ,states ,code1 and consistent with the requirements of paragraph 7#b71 the ,commissioner of ,food and ,drugs may determine and set-- 7,a7 the annual rate of pay of any individual appointed under subsection 7a72 and 7,b7 for purposes of retaining qualified employees1 the annual rate of pay for any qualified scientific1 technical1 or professional personnel appointed to a position described in subsection 7a7 before the date of enactment of the #bast ,century ,cures ,act4 7#b7 ,limitation ,the annual rate of pay established pursuant to paragraph 7#a7 may not exceed the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code4 7#c7 ,public availability ,the annual rate of pay provided to an individual in accordance with this section shall be publicly available information4 7c7 ,rule of construction ,the authorities under this section shall not be construed to affect the authority provided under section #gad4 7d7 ,report on workforce planning 7#a7 ,in general ,not later than #ah months after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall submit a report on workforce planning to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives that examines the extent to which the ,food and ,drug ,administration has a critical need for qualified individuals for scientific1 technical1 or professional positions1 including-- 7,a7 an analysis of the workforce needs at the ,food and ,drug ,administration and the ,secretary's strategic plan for addressing such needs1 including through use of the authority under this section2 and 7,b7 a recruitment and retention plan for hiring qualified scientific1 technical1 and professional candidates1 which may include the use of-- 7i7 recruitment through nongovernmental recruitment or placement agencies2 7ii7 recruitment through academic institutions2 7iii7 recruitment or hiring bonuses1 if applicable2 7iv7 recruitment using targeted direct hiring authorities2 and 7v7 retention of qualified scientific1 technical1 and professional employees using the authority under this section1 or other applicable authorities of the ,secretary4 7#b7 ,recommendations ,the report under paragraph 7#a7 may include the recommendations of the ,commissioner of ,food and ,drugs that would help the ,food and ,drug ,administration to better recruit and retain qualified individuals for scientific1 technical1 or professional positions at the agency4 4 7b7 ,,gao study and report 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study of the ability of the ,food and ,drug ,administration to hire1 train1 and retain qualified scientific1 technical1 and professional staff1 not including contractors1 necessary to fulfill the mission of the ,food and ,drug ,administration to protect and promote public health4 ,not later than ,january #a1 #bjbb1 the ,comptroller ,general shall submit a report on such study to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#b7 ,contents of study ,the ,comptroller ,general shall include in the study and report under paragraph 7#a7-- 7,a7 information about the progress of the ,food and ,drug ,administration in recruiting and retaining qualified scientific1 technical1 and professional staff outstanding in the field of biomedical research1 clinical research evaluation1 and biomedical product assessment2 7,b7 the extent to which critical staffing needs exist at the ,food and ,drug ,administration1 and barriers to hiring1 training1 and retaining qualified staff1 if any2 7,c7 an examination of the recruitment and retention strategies of the ,food and ,drug ,administration1 including examining any strategic workforce plan1 focused on improving scientific1 technical1 and professional staff recruitment and retention2 and 7,d7 recommendations for potential improvements that would address staffing needs of the ,food and ,drug ,administration4 #cjgc4 ,establishment of ,food and ,drug ,administration ,intercenter ,institutes 7a7 ,in general ,chapter ,x of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is amended by adding at the end the following3 #ajad4 ,food and ,drug ,administration ,intercenter ,institutes 7a7 ,in general ,the ,secretary shall establish one or more ,intercenter ,institutes within the ,food and ,drug ,administration 7referred to in this section as an ,institute7 for a major disease area or areas4 ,with respect to the major disease area of focus of an ,institute1 such ,institute shall develop and implement processes for coordination of activities1 as applicable to such major disease area or areas1 among the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,center for ,devices and ,radiological ,health 7for the purposes of this section1 referred to as the ,centers74 ,such activities may include-- 7#a7 coordination of staff from the ,centers with diverse product expertise in the diagnosis1 cure1 mitigation1 treatment1 or prevention of the specific diseases relevant to the major disease area of focus of the ,institute2 7#b7 streamlining1 where appropriate1 the review of medical products to diagnose1 cure1 mitigate1 treat1 or prevent the specific diseases relevant to the major disease area of focus of the ,institute1 applying relevant standards under sections #eje1 #eaj7k71 #eac7;f77#b71 and #eae of this ,act and section #cea of the ,public ,health ,service ,act1 and other applicable authorities2 7#c7 promotion of scientific programs within the ,centers related to the major disease area of focus of the ,institute2 7#d7 development of programs and enhancement of strategies to recruit1 train1 and provide continuing education opportunities for the personnel of the ,centers with expertise related to the major disease area of focus of the ,institute2 7#e7 enhancement of the interactions of the ,centers with patients1 sponsors1 and the external biomedical community regarding the major disease area of focus of the ,institute2 and 7#f7 facilitation of the collaborative relationships of the ,centers with other agencies within the ,department of ,health and ,human ,services regarding the major disease area of focus of the ,institute4 7b7 ,public process ,the ,secretary shall provide a period for public comment during the time that each ,institute is being implemented4 7c7 ,timing ,the ,secretary shall establish at least one ,institute under subsection 7a7 before the date that is #a year after the date of enactment of the #bast ,century ,cures ,act4 7d7 ,termination of institutes ,the ,secretary may terminate any ,institute established pursuant to this section if the ,secretary determines such ,institute is no longer benefitting the public health4 ,not less than #fj days prior to so terminating an ,institute1 the ,secretary shall provide public notice1 including the rationale for such termination4 4 7b7 ,technical amendments ,chapter ,x of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is amended-- 7#a7 by redesignating section #ajab as section #ajac2 and 7#b7 by redesignating the second section #ajaa 7with respect to improving the training of ,state1 local1 territorial1 and tribal food safety officials71 as added by section #bji7;a7 of the ,,fda ,food ,safety ,modernization ,act 7,public ,law #aaa-cec71 as section #ajab4 #cjgd4 ,scientific engagement 7a7 ,in general ,scientific meetings that are attended by scientific or medical personnel1 or other professionals1 of the ,department of ,health and ,human ,services for whom attendance at such meeting is directly related to their professional duties and the mission of the ,department-- 7#a7 shall not be considered conferences for the purposes of complying with ,federal reporting requirements contained in annual appropriations ,acts or in this section2 and 7#b7 shall not be considered conferences for purposes of a restriction contained in an annual appropriations ,act1 based on ,office of ,management and ,budget ,memorandum ,m-#ab-ab or any other regulation restricting travel to such meeting4 7b7 ,limitation ,nothing in this section shall be construed to exempt travel for scientific meetings from ,federal regulations relating to travel4 7c7 ,reports ,not later than #ij days after the end of the fiscal year1 each operating division of the ,department of ,health and ,human ,services shall prepare1 and post on an ,internet website of the operating division1 an annual report on scientific meeting attendance and related travel spending for each fiscal year4 ,such report shall include-- 7#a7 general information concerning the scientific meeting activities involved2 7#b7 information concerning the total amount expended for such meetings2 7#c7 a description of all such meetings that were attended by scientific or medical personnel1 or other professionals1 of each such operating division where the total amount expended by the operating division associated with each such meeting were in excess of #cj1jjj1 including-- 7,a7 the total amount of meeting expenses incurred by the operating division for such meeting2 7,b7 the location of such meeting2 7,c7 the date of such meeting2 7,d7 a brief explanation on how such meeting advanced the mission of the operating division2 and 7,e7 the total number of individuals whose travel expenses or other scientific meeting expenses were paid by the operating division2 and 7#d7 with respect to any such meeting where the total expenses to the operating division exceeded #aej1jjj1 a description of the exceptional circumstances that necessitated the expenditure of such amounts4 #cjge4 ,drug surveillance 7a7 ,new drugs ,section #eje7k77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7k77#e771 as amended by section #bjgd1 is further amended-- 7#a7 in subparagraph 7,a71 by striking 1 bi-weekly screening and inserting screenings2 7#b7 in subparagraph 7,b71 as redesignated by section #bjgd7a77;,c71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,c7 make available on the ,internet website of the ,food and ,drug ,administration-- 7i7 guidelines1 developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs1 that detail best practices for drug safety surveillance using the ,adverse ,event ,reporting ,system2 and 7ii7 criteria for public posting of adverse event signals4 4 7b7 ,,faers revision ,section #eje7r77#b77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7r77#b77;,d77 is amended by striking 1 by #ah months and all that follows through the semicolon at the end of the subparagraph and inserting and making publicly available on the ,internet website established under paragraph 7#a7 best practices for drug safety surveillance activities for drugs approved under this section or section #cea of the ,public ,health ,service ,act24 7c7 ,risk evaluation and mitigation strategies ,section #eje-a7;f77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f77#e77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by inserting or other advisory committee after 7or successor committee72 and 7#b7 in subparagraph 7,b71 by striking at least annually1 and inserting periodically4 #cjgf4 ,reagan-,udall ,foundation for the ,food and ,drug ,administration 7a7 ,board of ,directors 7#a7 ,composition and size ,section #ggj7;d77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c77 is amended-- 7,a7 by redesignating clause 7ii7 as clause 7iii72 7,b7 by inserting after clause 7i7 the following3 7ii7 ,additional members ,the ,board1 through amendments to the bylaws of the ,foundation1 may provide that the number of voting members of the ,board shall be a number 7to be specified in such amendment7 greater than #ad4 ,any ,board positions that are established by any such amendment shall be appointed 7by majority vote7 by the individuals who1 as of the date of such amendment1 are voting members of the ,board and persons so appointed may represent any of the categories specified in subclauses 7,i7 through 7,v7 of clause 7i71 so long as no more than #cj percent of the total voting members of the ,board 7including members whose positions are established by such amendment7 are representatives of the general pharmaceutical1 device1 food1 cosmetic1 and biotechnology industries4 2 and 7,c7 in clause 7iii77,i71 as redesignated by subparagraph 7,a71 by striking ,the ex officio members shall ensure and inserting ,the ex officio members1 acting pursuant to clause 7i71 and the ,board1 acting pursuant to clause 7ii71 shall ensure4 7#b7 ,federal employees allowed to serve on ,board ,clause 7iii77,,ii7 of section #ggj7;d77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#a77;,c771 as redesignated by paragraph 7#a77;,a71 is amended by adding at the end the following3 ,for purposes of this section1 the term employee of the ,federal ,government does not include a special ,government employee1 as that term is defined in section #bjb7;a7 of title #ah1 ,united ,states ,code44 7#c7 ,staggered terms ,subparagraph 7,a7 of section #ggj7;d77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7d77#c77 is amended to read as follows3 7,a7 ,term ,the term of office of each member of the ,board appointed under paragraph 7#a77;,c77i71 and the term of office of any member of the ,board whose position is established pursuant to paragraph 7#a77;,c77ii71 shall be #d years1 except that-- 7i7 the terms of offices for the members of the ,board initially appointed under paragraph 7#a77;,c77i7 shall expire on a staggered basis as determined by the ex officio members2 and 7ii7 the terms of office for the persons initially appointed to positions established pursuant to paragraph 7#a77;,c77ii7 may be made to expire on a staggered basis1 as determined by the individuals who1 as of the date of the amendment establishing such positions1 are members of the ,board4 4 7b7 ,executive ,director compensation ,section #ggj7;g77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7g77#b77 is amended by striking but shall not be greater than the compensation of the ,commissioner4 7c7 ,separation of ,funds ,section #ggj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;dd7m77 is amended by striking are held in separate accounts from funds received from entities under subsection 7i7 and inserting are managed as individual programmatic funds under subsection 7i71 according to best accounting practices4 ,h ,medical countermeasures innovation #cjha4 ,medical countermeasure guidelines ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a71 by adding at the end the following3 7#c7 ,utilization guidelines ,the ,secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures 7as defined in section #cai;,f-#a71 qualified pandemic and epidemic products 7as defined in section #cai;,f-#c71 and security countermeasures 7as defined in subsection 7c771 including for such products in the stockpile4 2 and 7#b7 in subsection 7g7-- 7,a7 by amending paragraph 7#d7 to read as follows3 7#d7 ,report on security countermeasure procurement ,not later than ,march #a of each year in which the ,secretary determines that the amount of funds available for procurement of security countermeasures is less than #a1ejj1jjj1jjj1 the ,secretary shall submit to the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have-- 7,a7 in meeting the security countermeasure needs identified under this section2 and 7,b7 on the annual ,public ,health ,emergency ,medical ,countermeasures ,enterprise and ,strategy ,implementation ,plan 7pursuant to section #bhaa7;d774 4 #cjhb4 ,clarifying ,,barda contracting authority 7a7 ,in general ,section #cai;,f-#b7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7g77 is amended by adding at the end the following3 7#e7 ,clarification on contracting authority ,the ,secretary1 acting through the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 shall carry out the programs funded by the special reserve fund 7for the procurement of security countermeasures under subsection 7c7 and for carrying out section #cai,l71 including the execution of procurement contracts1 grants1 and cooperative agreements pursuant to this section and section #cai,l4 4 7b7 ,,barda contracting authority ,section #cai,l7c77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;c7 is amended by inserting 1 including the execution of procurement contracts1 grants1 and cooperative agreements pursuant to this section before the period4 #cjhc4 ,countermeasure budget plan ,section #bhaa7;b77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by striking the first sentence and inserting ,develop1 and update not later than ,march #a of each year1 a coordinated #e-year budget plan based on the medical countermeasure priorities described in subsection 7d71 including with respect to chemical1 biological1 radiological1 and nuclear agent or agents that may present a threat to the ,nation1 including such agents that are novel or emerging infectious diseases1 and the corresponding efforts to develop qualified countermeasures 7as defined in section #cai;,f-#a71 security countermeasures 7as defined in section #cai;,f-#b71 and qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7 for each such threat42 7#b7 in subparagraph 7,c71 by striking 2 and and inserting a semicolon2 7#c7 in subparagraph 7,d71 by striking to the appropriate committees of ,congress upon request4 and inserting 1 not later than ,march #ae of each year1 to the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and2 and 7#d7 by adding at the end the following3 7,e7 not later than ,march #ae of each year1 be made publicly available in a manner that does not compromise national security4 4 #cjhd4 ,medical countermeasures innovation ,section #cai,l7c77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77 is amended by adding at the end the following3 7,e7 ,medical countermeasures innovation partner 7i7 ,in general ,to support the purposes described in paragraph 7#b71 the ,secretary1 acting through the ,director of ,,barda1 may enter into an agreement 7including through the use of grants1 contracts1 cooperative agreements1 or other transactions as described in paragraph 7#e77 with an independent1 nonprofit entity to-- 7,i7 foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products1 including through the use of strategic venture capital practices and methods2 7,,ii7 promote the development of new and promising technologies that address urgent medical countermeasure needs1 as identified by the ,secretary2 7,,iii7 address unmet public health needs that are directly related to medical countermeasure requirements1 such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics1 prophylaxis1 vaccines1 and therapeutics2 and 7,,iv7 provide expert consultation and advice to foster viable medical countermeasure innovators1 including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical1 biological1 radiological1 and nuclear countermeasure products4 7ii7 ,eligibility 7,i7 ,in general ,to be eligible to enter into an agreement under clause 7i7 an entity shall-- 7aa7 be an independent1 nonprofit entity2 7bb7 have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the ,federal ,government2 7cc7 have experience in promoting novel technology innovation2 7dd7 be problem-driven and solution-focused based on the needs1 requirements1 and problems identified by the ,secretary under clause 7iv72 7ee7 demonstrate the ability1 or the potential ability1 to promote the development of medical countermeasure products2 7ff7 demonstrate expertise1 or the capacity to develop or acquire expertise1 related to technical and regulatory considerations with respect to medical countermeasures2 and 7gg7 not be within the ,department of ,health and ,human ,services4 7,,ii7 ,partnering experience ,in selecting an entity with which to enter into an agreement under clause 7i71 the ,secretary shall place a high value on the demonstrated experience of the entity in partnering with the ,federal ,government to meet identified strategic needs4 7iii7 ,not agency ,an entity that enters into an agreement under clause 7i7 shall not be deemed to be a ,federal agency for any purpose1 including for any purpose under title #e1 ,united ,states ,code4 7iv7 ,direction ,pursuant to an agreement entered into under this subparagraph1 the ,secretary1 acting through the ,director of ,,barda1 shall provide direction to the entity that enters into an agreement under clause 7i74 ,as part of this agreement the ,director of ,,barda shall-- 7,i7 communicate the medical countermeasure needs1 requirements1 and problems to be addressed by the entity under the agreement2 7,,ii7 develop a description of work to be performed by the entity under the agreement2 7,,iii7 provide technical feedback and appropriate oversight over work carried out by the entity under the agreement1 including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph2 7,,iv7 ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent1 as applicable and appropriate under applicable provisions of this section2 and 7,v7 ensure1 as a condition of the agreement that the entity-- 7aa7 has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability2 7bb7 protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest1 ethics1 disclosure1 and reporting requirements2 7cc7 provides monthly accounting on the use of funds provided under such agreement2 and 7dd7 provides on a quarterly basis1 reports regarding the progress made toward meeting the identified needs set forth in the agreement4 7v7 ,supplement not supplant ,activities carried out under this subparagraph shall supplement1 and not supplant1 other activities carried out under this section4 7vi7 ,no establishment of entity ,to prevent unnecessary duplication and target resources effectively1 nothing in this subparagraph shall be construed to authorize the ,secretary to establish within the ,department of ,health and ,human ,services an entity for the purposes of carrying out this subparagraph4 7vii7 ,transparency and oversight ,upon request1 the ,secretary shall provide to ,congress the information provided to the ,secretary under clause 7iv77,v77dd74 7viii7 ,independent evaluation ,not later than #d years after the date of enactment of the #bast ,century ,cures ,act1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the ,secretary and the appropriate committees of ,congress a report1 concerning the activities conducted under this subparagraph4 ,such report shall include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph4 7ix7 ,sunset ,this subparagraph shall have no force or effect after ,september #cj1 #bjbb4 4 #cjhe4 ,streamlining ,project ,bio,shield procurement ,section #cai;,f-#b7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is amended-- 7#a7 in paragraph 7#d77;,a77ii71 by striking make a recommendation under paragraph 7#f7 that the special reserve fund as defined in subsection 7h7 be made available for the procurement of such countermeasure and inserting and subject to the availability of appropriations1 make available the special reserve fund as defined in subsection 7h7 for procurement of such countermeasure1 as applicable2 7#b7 in paragraph 7#f7-- 7,a7 by striking subparagraphs 7,a71 7,b71 and 7,e72 7,b7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,a7 and 7,b71 respectively2 7,c7 by amending subparagraph 7,a71 as so redesignated1 to read as follows3 7,a7 ,notice to appropriate congressional committees ,the ,secretary shall notify the ,committee on ,appropriations and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,appropriations and the ,committee on ,energy and ,commerce of the ,house of ,representatives of each decision to make available the special reserve fund as defined in subsection 7h7 for procurement of a security countermeasure1 including1 where available1 the number of1 the nature of1 and other information concerning potential suppliers of such countermeasure1 and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons for each such rejection4 2 and 7,d7 in the heading1 by striking ,recommendation for president's approval and inserting ,recommendations for procurement2 and 7#c7 in paragraph 7#g7-- 7,a7 by striking subparagraphs 7,a7 and 7,b7 and inserting the following3 7,a7 ,payments from special reserve fund ,the special reserve fund as defined in subsection 7h7 shall be available for payments made by the ,secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph4 2 and 7,b7 by redesignating subparagraph 7,c7 as subparagraph 7,b74 #cjhf4 ,encouraging treatments for agents that present a national security threat ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by inserting after section #efe the following3 #efe;,a4 ,priority review to encourage treatments for agents that present national security threats 7a7 ,definitions ,in this section3 7#a7 ,human drug application ,the term human drug application has the meaning given such term in section #gce7a74 7#b7 ,priority review ,the term priority review1 with respect to a human drug application1 means review and action by the ,secretary on such application not later than #f months after receipt by the ,secretary of such application1 as described in the ,manual of ,policies and ,procedures in the ,food and ,drug ,administration and goals identified in the letters described in section #aja7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act4 7#c7 ,priority review voucher ,the term priority review voucher means a voucher issued by the ,secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act after the date of approval of the material threat medical countermeasure application4 7#d7 ,material threat medical countermeasure application ,the term material threat medical countermeasure application means an application that-- 7,a7 is a human drug application for a drug intended for use-- 7i7 to prevent1 or treat harm from a biological1 chemical1 radiological1 or nuclear agent identified as a material threat under section #cai;,f-#b7;c77#b77;,a77ii7 of the ,public ,health ,service ,act2 or 7ii7 to mitigate1 prevent1 or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug1 or biological product against such agent2 and 7,b7 the ,secretary determines eligible for priority review2 7,c7 is approved after the date of enactment of the #bast ,century ,cures ,act2 and 7,d7 is for a human drug1 no active ingredient 7including any ester or salt of the active ingredient7 of which has been approved in any other application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act4 7b7 ,priority review voucher 7#a7 ,in general ,the ,secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the ,secretary of such material threat medical countermeasure application4 7#b7 ,transferability ,the sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer 7including by sale7 the entitlement to such voucher to a sponsor of a human drug for which an application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act will be submitted after the date of the approval of the material threat medical countermeasure application4 ,there is no limit on the number of times a priority review voucher may be transferred before such voucher is used4 7#c7 ,notification 7,a7 ,in general ,the sponsor of a human drug application shall notify the ,secretary not later than #ij calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application1 including the date on which the sponsor intends to submit the application4 ,such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section4 7,b7 ,transfer after notice ,the sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph 7,a7 may transfer the voucher after such notification is provided1 if such sponsor has not yet submitted the human drug application described in the notification4 7c7 ,priority review user fee 7#a7 ,in general ,the ,secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the ,secretary a fee determined under paragraph 7#b74 ,such fee shall be in addition to any fee required to be submitted by the sponsor under chapter ,,vii4 7#b7 ,fee amount ,the amount of the priority review user fee shall be determined each fiscal year by the ,secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year4 7#c7 ,annual fee setting ,the ,secretary shall establish1 before the beginning of each fiscal year beginning after ,september #cj1 #bjaf1 for that fiscal year1 the amount of the priority review user fee4 7#d7 ,payment 7,a7 ,in general ,the priority review user fee required by this subsection shall be due upon the submission of a human drug application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act for which the priority review voucher is used4 7,b7 ,complete application ,an application described under subparagraph 7,a7 for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the ,secretary's procedures for paying such fees4 7,c7 ,no waivers1 exemptions1 reductions1 or refunds ,the ,secretary may not grant a waiver1 exemption1 reduction1 or refund of any fees due and payable under this section4 7#e7 ,offsetting collections ,fees collected pursuant to this subsection for any fiscal year-- 7,a7 shall be deposited and credited as offsetting collections to the account providing appropriations to the ,food and ,drug ,administration2 and 7#f7 shall not be collected for any fiscal year except to the extent provided in advance in appropriation ,acts4 7d7 ,notice of ,issuance of ,voucher and ,approval of ,products ,under ,voucher ,the ,secretary shall publish a notice in the ,federal ,register and on the ,internet website of the ,food and ,drug ,administration not later than #cj calendar days after the occurrence of each of the following3 7#a7 ,the ,secretary issues a priority review voucher under this section4 7#b7 ,the ,secretary approves a drug pursuant to an application submitted under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for which the sponsor of the application used a priority review voucher issued under this section4 7e7 ,eligibility for other programs ,nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program1 including under this ,act1 except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this ,act with respect to such drug4 7f7 ,relation to other provisions ,the provisions of this section shall supplement1 not supplant1 any other provisions of this ,act or the ,public ,health ,service ,act that encourage the development of medical countermeasures4 7g7 ,sunset ,the ,secretary may not award any priority review vouchers under subsection 7b7 after ,october #a1 #bjbc4 4 #cjhg4 ,paperwork ,reduction ,act waiver during a public health emergency ,section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 is amended by adding at the end the following3 7f7 ,determination with respect to paperwork reduction act waiver during a public health emergency 7#a7 ,determination ,if the ,secretary determines1 after consultation with such public health officials as may be necessary1 that-- 7,a7 7i7 the criteria set forth for a public health emergency under paragraph 7#a7 or 7#b7 of subsection 7a7 has been met2 or 7ii7 a disease or disorder1 including a novel and emerging public health threat1 is significantly likely to become a public health emergency2 and 7,b7 the circumstances of such public health emergency1 or potential for such significantly likely public health emergency1 including the specific preparation for and response to such public health emergency or threat1 necessitate a waiver from the requirements of subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act71 then the requirements of such subchapter ,i with respect to voluntary collection of information shall not be applicable during the immediate investigation of1 and response to1 such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder1 including a novel and emerging public health threat1 will become a public health emergency as provided for in this paragraph4 ,the requirements of such subchapter ,i with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time4 7#b7 ,transparency ,if the ,secretary determines that a waiver is necessary under paragraph 7#a71 the ,secretary shall promptly post on the ,internet website of the ,department of ,health and ,human ,services a brief justification for such waiver1 the anticipated period of time such waiver will be in effect1 and the agencies and offices within the ,department of ,health and ,human ,services to which such waiver shall apply1 and update such information posted on the ,internet website of the ,department of ,health and ,human ,services1 as applicable4 7#c7 ,effectiveness of waiver ,any waiver under this subsection shall take effect on the date on which the ,secretary posts information on the ,internet website as provided for in this subsection4 7#d7 ,termination of waiver ,upon determining that the circumstances necessitating a waiver under paragraph 7#a7 no longer exist1 the ,secretary shall promptly update the ,internet website of the ,department of ,health and ,human ,services to reflect the termination of such waiver4 7#e7 ,limitations 7,a7 ,period of waiver ,the period of a waiver under paragraph 7#a7 shall not exceed the period of time for the related public health emergency1 including a public health emergency declared pursuant to subsection 7a71 and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection4 7,b7 ,subsequent compliance ,an initiative subject to a waiver under paragraph 7#a7 that is ongoing after the date on which the waiver expires1 shall be subject to the requirements of subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code1 and the ,secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances1 but not to exceed #cj calendar days after the expiration of the applicable waiver4 4 #cjhh4 ,clarifying ,food and ,drug ,administration emergency use authorization 7a7 ,authorization for medical products for use in emergencies ,section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is amended-- 7#a7 in subsection 7a77#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking or #eae and inserting #eab1 or #eae2 and 7ii7 by inserting or conditionally approved under section #ega of this ,act after ,public ,health ,service ,act2 and 7,b7 in subparagraph 7,b71 by inserting conditionally approved under section #ega1 after approved1 each place the term appears2 7#b7 in subsection 7b77#d71 by striking the second comma after determination2 7#c7 in subsection 7e77#c77;,b71 by striking section #ejc7;b7 and inserting subsection 7b7 or 7f7 of section #ejc or under section #ejd2 7#d7 in subsection 7f77#b7-- 7,a7 by inserting 1 or an animal to which1 after to a patient to whom2 and 7,b7 by inserting or by the veterinarian caring for such animal1 as applicable after attending physician2 7#e7 in subsection 7g77#a71 by inserting conditional approval under section #ega1 after approval12 7#f7 in subsection 7h77#a71 by striking or section #ebj7;g7and inserting #eab7;j71 or #ebj7;g72 and 7#g7 in subsection 7k71 by striking section #ebj7;g71and inserting #eab7;j71 or #ebj7;g74 7b7 ,new animal drugs ,section #eab7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7a77#a77 is amended-- 7#a7 in subparagraph 7,b71 by striking or at the end2 7#b7 in subparagraph 7,c71 by striking the period and inserting 2 or2 and 7#c7 by inserting after subparagraph 7,c7 the following3 7,d7 there is in effect an authorization pursuant to section #efd with respect to such use or intended use of such drug1 and such drug1 its labeling1 and such use conform to any conditions of such authorization4 4 7c7 ,emergency use of medical products ,section #efd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7 is amended-- 7#a7 in subsection 7a77#a77;,a71 by inserting 1 conditionally approved under section #ega1 after chapter2 and 7#b7 in subsection 7d71 by striking sections #ejc7;b7 and #ebj7;e7 and inserting subsections 7b7 and 7f7 of section #ejc1 section #ejd1 and section #ebj7;e74 7d7 ,products ,held for ,emergency ,use ,section #efd;,b7#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 by inserting or conditionally approved under section #ega of this ,act after ,public ,health ,service ,act2 and 7,b7 by striking or #eae and inserting #eab1 or #eae2 and 7#b7 in subparagraph 7,b71 by striking or #ebj and inserting #eab1 or #ebj4 ,i ,vaccine ,access1 ,certainty1 and ,innovation #cjia4 ,predictable review timelines of vaccines by the ,advisory ,committee on ,immunization ,practices 7a7 ,consideration of new vaccines ,upon the licensure of any vaccine or any new indication for a vaccine1 the ,advisory ,committee on ,immunization ,practices 7in this section referred to as the ,advisory ,committee7 shall1 as appropriate1 consider the use of the vaccine at its next regularly scheduled meeting4 7b7 ,additional information ,if the ,advisory ,committee does not make a recommendation with respect to the use of a vaccine at the ,advisory ,committee's first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine1 the ,advisory ,committee shall provide an update on the status of such committee's review4 7c7 ,consideration for breakthrough therapies and for potential use during public health emergency ,the ,advisory ,committee shall make recommendations with respect to the use of certain vaccines in a timely manner1 as appropriate1 including vaccines that-- 7#a7 are designated as a breakthrough therapy under section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 and licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 or 7#b7 could be used in a public health emergency4 7d7 ,definition ,in this section1 the terms ,advisory ,committee on ,immunization ,practices and ,advisory ,committee mean the ,advisory ,committee on ,immunization ,practices established by the ,secretary pursuant to section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 acting through the ,director of the ,centers for ,disease ,control and ,prevention404 #cjib4 ,review of processes and consistency of ,advisory ,committee on ,immunization ,practices recommendations 7a7 ,review ,the ,director of the ,centers for ,disease ,control and ,prevention shall conduct a review of the processes used by the ,advisory ,committee on ,immunization ,practices in formulating and issuing recommendations pertaining to vaccines1 including with respect to consistency4 7b7 ,considerations ,the review under subsection 7a7 shall include an assessment of-- 7#a7 the criteria used to evaluate new and existing vaccines1 including the identification of any areas for which flexibility in evaluating such criteria is necessary and the reason for such flexibility2 7#b7 the ,grading of ,recommendations1 ,assessment1 ,development1 and ,evaluation 7,,grade7 approach to the review and analysis of scientific and economic data1 including the scientific basis for such approach2 and 7#c7 the extent to which the processes used by the work groups of the ,advisory ,committee on ,immunization ,practices are consistent among such groups1 including the identification of reasons for any variation4 7c7 ,stakeholders ,in carrying out the review under subsection 7a71 the ,director of the ,centers for ,disease ,control and ,prevention shall solicit input from vaccine stakeholders4 7d7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,director of the ,centers for ,disease ,control and ,prevention shall submit to the appropriate committees of the ,congress1 and make publicly available1 a report on the results of the review under subsection 7a71 including any recommendations on improving the consistency of the processes described in such subsection4 7e7 ,definition ,in this section1 the term ,advisory ,committee on ,immunization ,practices means the ,advisory ,committee on ,immunization ,practices established by the ,secretary of ,health and ,human ,services pursuant to section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 acting through the ,director of the ,centers for ,disease ,control and ,prevention4 #cjic4 ,encouraging vaccine innovation 7a7 ,vaccine meetings ,the ,director of the ,centers for ,disease ,control and ,prevention shall ensure that appropriate staff within the relevant centers and divisions of the ,office of ,infectious ,diseases1 and others1 as appropriate1 coordinate with respect to the public health needs1 epidemiology1 and program planning and implementation considerations related to immunization1 including with regard to meetings with stakeholders related to such topics4 7b7 ,report on vaccine innovation 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in collaboration with appropriate agencies or offices within the ,department of ,health and ,human ,services1 including the ,national ,institutes of ,health1 the ,centers for ,disease ,control and ,prevention1 the ,food and ,drug ,administration1 and the ,biomedical ,advanced ,research and ,development ,authority1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and post publicly on the ,internet website of the ,department of ,health and ,human ,services1 a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious disease4 7#b7 ,contents ,the report described in paragraph 7#a7 shall review the current status of vaccine development and1 as appropriate-- 7,a7 consider the optimal process to determine which vaccines would be beneficial to public health and how information on such vaccines is disseminated to key stakeholders2 7,b7 examine and identify whether obstacles exist that inhibit the development of beneficial vaccines2 and 7,c7 make recommendations about how best to remove any obstacles identified under subparagraph 7,b7 in order to promote and incentivize vaccine innovation and development4 7#c7 ,consultation ,in preparing the report under this subsection1 the ,secretary may consult with-- 7,a7 representatives of relevant ,federal agencies and departments1 including the ,department of ,defense and the ,department of ,veterans ,affairs2 7,b7 academic researchers2 7,c7 developers and manufacturers of vaccines2 7,d7 medical and public health practitioners2 7,e7 representatives of patient1 policy1 and advocacy organizations2 and 7,f7 representatives of other entities1 as the ,secretary determines appropriate4 7c7 ,updates related to maternal immunization 7#a7 ,additional vaccines ,section #baad7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ad7;e77 is amended by adding at the end the following3 7#c7 ,vaccines recommended for use in pregnant women ,the ,secretary shall revise the ,vaccine ,injury ,table included in subsection 7a71 through the process described in subsection 7c71 to include vaccines recommended by the ,centers for ,disease ,control and ,prevention for routine administration in pregnant women and the information described in subparagraphs 7,b7 and 7,c7 of paragraph 7#b7 with respect to such vaccines4 4 7#b7 ,petition content ,section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 is amended by adding at the end the following3 7f7 ,maternal immunization 7#a7 ,in general ,notwithstanding any other provision of law1 for purposes of this subtitle1 both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine4 7#b7 ,definition ,as used in this subsection1 the term child shall have the meaning given that term by subsections 7a7 and 7b7 of section #h of title #a1 ,united ,states ,code1 except that1 for purposes of this subsection1 such section #h shall be applied as if the term include in subsection 7a7 of such section were replaced with the term mean4 4 7#c7 ,petitioners ,section #baaa7;b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;b77#b77 is amended by adding ,a covered vaccine administered to a pregnant woman shall constitute more than one administration1 one to the mother and one to each child 7as such term is defined in subsection 7f77#b77 who was in utero at the time such woman was administered the vaccine4 at the end4 ,j ,technical corrections #caja4 ,technical corrections 7a7 ,,ffdca 7#a7 ,references ,except as otherwise expressly provided1 whenever in this subsection an amendment is expressed in terms of an amendment to a section or other provision1 the reference shall be considered to be made to that section or other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7#b7 ,amendments 7,a7 ,prohibited ,acts ,section #cja7r7 7#ba ,u4,s4,c4 #cca7r77 is amended by inserting 1 drug1 after device each place the term appears4 7,b7 ,new ,drugs ,section #eje 7#ba ,u4,s4,c4 #cee7 is amended-- 7i7 in subsection 7d71 in the last sentence1 by striking premarket approval and inserting marketing approval2 and 7ii7 in subsection 7q77#e77;,a71 by striking subsection 7b77#b7 or 7j7 of the ,act or #cea7k7 and inserting subsection 7b77#b7 or 7j7 of this section or section #cea7k74 7,c7 ,risk evaluation and mitigation strategies ,section #eje-a7;h77#ba ,u4,s4,c4 #cee-a7;h77 is amended-- 7i7 in paragraph 7#b77;,a77iii7-- 7,i7 in the clause heading1 by striking label and inserting labeling2 7,,ii7 by striking label each place the term appears and inserting labeling2 and 7,,iii7 by striking sponsor and inserting responsible person2 and 7ii7 in paragraph 7#h71 by striking and 7#g74 and inserting and 7#g74 7,d7 ,pediatric study plans ,section #eje;,b 7#ba ,u4,s4,c4 #cee;c7 is amended-- 7i7 in subsection 7e7-- 7,i7 in paragraph 7#b7-- 7aa7 in subparagraph 7,a71 by inserting study after initial pediatric each place the term appears2 and 7bb7 in subparagraph 7,b71 in the subparagraph heading1 by striking initial plan and inserting initial pediatric study plan2 7,,ii7 in paragraph 7#e71 in the paragraph heading1 by inserting agreed initial pediatric study before plan2 and 7,,iii7 in paragraph 7#f71 by striking agreed initial pediatric plan and inserting agreed initial pediatric study plan2 and 7ii7 in subsection 7f77#a71 by inserting and any significant amendments to such plans1 after agreed initial pediatric study plans14 7,e7 ,discontinuance or interruption in the production of live-saving drugs ,section #ejf;,c 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7i7 in subsection 7c71 by striking discontinuation and inserting discontinuance2 and 7ii7 in subsection 7g77#a71 by striking section #eje7;j7 that could help and inserting section #eje7;j71 that could help4 7,f7 ,annual reporting on drug shortages ,section #ejf;,c-#a7;a7 7#ba ,u4,s4,c4 #cca7;a77 is amended1 in the matter before paragraph 7#a7-- 7i7 by striking ,not later than the end of calendar year #bjac1 and not later than the end of each calendar year thereafter1 and inserting ,not later than ,march #ca of each calendar year1 2 and 7ii7 by inserting 1 with respect to the preceding calendar year1 after a report4 7,g7 ,drug shortage list ,section #ejf;,e7b77#c77;,e7 7#ba ,u4,s4,c4 #cef;e7b77#c77;,e77 is amended by striking discontinuation and inserting discontinuance4 7,h7 ,inspections of establishments ,section #eaj7;h7 7#ba ,u4,s4,c4 #cfj7;h77 is amended-- 7i7 in paragraph 7#d71 in the matter preceding subparagraph 7,a71 by striking establishing the risk-based scheduled and inserting establishing a risk-based schedule2 and 7ii7 in paragraph 7#f7-- 7,i7 in subparagraph 7,a71 by striking fiscal and inserting calendar each place the term appears2 and 7,,ii7 in subparagraph 7,b71 by striking an active ingredient of a drug1 a finished drug product1 or an excipient of a drug and inserting an active ingredient of a drug or a finished drug product4 7,i7 ,classification of devices intended for human use ,section #eac7;f77#b77;,a7 7#ba ,u4,s4,c4 #cfj;c7f77#b77;,a77 is amended-- 7i7 in clause 7i71 by striking within #cj days2 and 7ii7 in clause 7iv71 by striking low-moderate and inserting low to moderate4 7,j7 ,premarket approval ,section #eae7;a77#a7 7#ba ,u4,s4,c4 #cfj;e7a77#a77 is amended by striking subject to a an order and inserting subject to an order4 7,k7 ,program to improve the device recall system ,section #eah;,a 7#ba ,u4,s4,c4 #cfj;h-#a7 is amended-- 7i7 by striking subsection 7c72 and 7ii7 by redesignating subsection 7d7 as subsection 7c74 7,l7 ,unique device identifier ,section #eai7;f7 7#ba ,u4,s4,c4 #cfj;i7f77 is amended by striking and life sustaining and inserting or life sustaining4 7,m7 ,priority review to encourage treatments for tropical diseases ,section #ebd7;c77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7c77#d77;,a77 is amended by striking ,services ,act and inserting ,service ,act4 7,n7 ,priority review for qualified infectious disease products ,section #ebd;,a 7#ba ,u4,s4,c4 #cfjn-#a7 is amended-- 7i7 by striking ,if the ,secretary and inserting the following3 7a7 ,in ,general ,if the ,secretary 2 7ii7 by striking any and inserting the first2 and 7iii7 by adding at the end the following3 7b7 ,construction ,nothing in this section shall prohibit the ,secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section #eje7;b7 that otherwise meets the criteria for the ,secretary to grant priority review4 4 7,o7 ,consultation with external experts on rare diseases1 targeted therapies1 and genetic targeting of treatments ,section #efi7;a77#b77;,a7 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77;,a77 is amended1 in the first sentence1 by striking subsection 7c7 and inserting subsection 7b74 7,p7 ,optimizing global clinical trials ,section #efi;,a7c7 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7c77 is amended by inserting or under the ,public ,health ,service ,act after this ,act4 7,q7 ,use of clinical investigation data from outside the ,united ,states ,section #efi;,b 7#ba ,u4,s4,c4 #cfj;bbb-#h;b7 is amended by striking drug or device and inserting drug1 biological product1 or device each place the term appears4 7,r7 ,medical gases definitions ,section #ege7a77;,h7 7#ba ,u4,s4,c4 #cfj;ddd7#a77;,h77 is amended-- 7i7 by inserting for a new drug after any period of exclusivity2 and 7ii7 by inserting or any period of exclusivity for a new animal drug under section #eab7;c77#b77;,f71 after section #eje;,a14 7,s7 ,regulation of medical gases ,section #egf7;a7 7#ba ,u4,s4,c4 #cfj;ddd-#a7;a77 is amended-- 7i7 in the matter preceding subparagraph 7,a7 of paragraph 7#a71 by inserting who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce after any person2 and 7ii7 in paragraph 7#c7-- 7,i7 in subparagraph 7,a7-- 7aa7 in clause 7i77,,viii71 by inserting for a new drug after any period of exclusivity2 and 7bb7 in clause 7ii71 in the matter preceding subclause 7,i71 by inserting the before final use2 and 7,,ii7 in subparagraph 7,b7-- 7aa7 in clause 7i71 by inserting for a new drug after any period of exclusivity2 and 7bb7 in clause 7ii71 by inserting a comma after drug product4 7,t7 ,inapplicability of drug fees to designated medical gases ,section #egg 7#ba ,u4,s4,c4 #cfj;ddd-#b7 is amended by inserting or #gdj7;a7 after section #gcf7;a74 7,u7 ,conflicts of interest ,section #gab7;e77#a77;,b7 7#ba ,u4,s4,c4 #cgi;d-#a7;e77#a77;,b77 is amended by striking services and inserting service4 7,v7 ,authority to assess and use biosimilar biological product fees ,section #gdd;,h7a7 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7i7 in paragraph 7#a77;,a77v71 by striking ,biosimilars ,user ,fee ,act of #bjab and inserting ,biosimilar ,user ,fee ,act of #bjab2 and 7ii7 in paragraph 7#b77;,b71 by striking ,biosimilars ,user ,fee ,act of #bjab and inserting ,biosimilar ,user ,fee ,act of #bjab4 7,w7 ,registration of commercial importers 7i7 ,amendment ,section #hja7s77#b7 7#ba ,u4,s4,c4 #cha7s77#b77 is amended by adding at the end the following3 7,d7 ,effective date ,in establishing the effective date of the regulations under subparagraph 7,a71 the ,secretary shall1 in consultation with the ,secretary of ,homeland ,security acting through ,u4,s4 ,customs and ,border ,protection1 as determined appropriate by the ,secretary of ,health and ,human ,services1 provide a reasonable period of time for an importer of a drug to comply with good importer practices1 taking into account differences among importers and types of imports1 including based on the level of risk posed by the imported product4 4 7ii7 ,conforming amendment ,section #gad of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add2 #abf ,stat4 #ajgd7 is amended by striking subsection 7d74 7,x7 ,recognition of foreign government inspections ,section #hji7;a77#b7 7#ba ,u4,s4,c4 #chd;e7a77#b77 is amended by striking conduction and inserting conducting4 7b7 ,,fdasia 7#a7 ,findings relating to drug approval ,section #ija7;a77#a77;,a7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add2 #ba ,u4,s4,c4 #cef note7 is amended by striking serious and life-threatening diseases and inserting serious or life-threatening diseases4 7#b7 ,reporting of inclusion of demographic subgroups ,section #ijg of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add2 #abf ,stat4 #ajib1 #ajic7 is amended-- 7,a7 in the section heading1 by striking ,biologics in the heading and inserting ,biological ,products2 and 7,b7 in subsection 7a77#b77;,b71 by striking applications for new drug applications and inserting new drug applications4 7#c7 ,combating prescription drug abuse ,section #aabb of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add2 #abf ,stat4 #aaab1 #aaac7 is amended-- 7,a7 in subsection 7a77#b71 by striking dependance and inserting dependence2 and 7,b7 in subsection 7c71 by striking promulgate and inserting issue4 #cajb4 ,completed studies ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje7k77#e7 7#ba ,u4,s4,c4 #cee7k77#e77-- 7,a7 in subparagraph 7,a71 by inserting and after the semicolon2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating subparagraph 7,c7 as subparagraph 7,b72 7#b7 in section #eje;,a 7#ba ,u4,s4,c4 #cee;a71 by striking subsection 7p72 7#c7 in section #eje;,b 7#ba ,u4,s4,c4 #cee;c7-- 7,a7 by striking subsection 7l72 and 7,b7 by redesignating subsection 7m7 as subsection 7l72 and 7#d7 in section #ebc 7#ba ,u4,s4,c4 #cfjm71 by striking subsection 7d74 ,,iv ,delivery #djja4 ,assisting doctors and hospitals in improving quality of care for patients 7a7 ,in general ,the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7title ,,xiii of division ,a of ,public ,law #aaa-e7 is amended-- 7#a7 by adding at the end of part #a of subtitle ,a the following3 #acajc4 ,assisting doctors and hospitals in improving quality of care for patients 7a7 ,reduction in burdens goal ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with providers of health services1 health care suppliers of services1 health care payers1 health professional societies1 health information technology developers1 health care quality organizations1 health care accreditation organizations1 public health entities1 ,states1 and other appropriate entities1 shall1 in accordance with subsection 7b7-- 7#a7 establish a goal with respect to the reduction of regulatory or administrative burdens 7such as documentation requirements7 relating to the use of electronic health records2 7#b7 develop a strategy for meeting the goal established under paragraph 7#a72 and 7#c7 develop recommendations for meeting the goal established under paragraph 7#a74 7b7 ,strategy and recommendations 7#a7 ,in general ,to achieve the goal established under subsection 7a77#a71 the ,secretary1 in consultation with the entities described in such subsection1 shall1 not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 develop a strategy and recommendations to meet the goal in accordance with this subsection4 7#b7 ,strategy ,the strategy developed under paragraph 7#a7 shall address the regulatory and administrative burdens 7such as documentation requirements7 relating to the use of electronic health records4 ,such strategy shall include broad public comment and shall prioritize-- 7,a7 7i7 incentives for meaningful use of certified ,,ehr technology for eligible professionals and hospitals under sections #ahdh7;a77#g7 and #ahhf7;b77#c77;,b77ix71 respectively1 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g71 #acieww7b77#c77;,b77ix772 7ii7 the program for making payments under section #aijc7;a77#c77;,f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a77#c77;,f77 to encourage the adoption and use of certified ,,ehr technology by ,medicaid providers2 7iii7 the ,merit-based ,incentive ,payment ,system under section #ahdh7q7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q772 7iv7 alternative payment models 7as defined in section #ahcc7z77#c77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7z77#c77;,c772 7v7 the ,hospital ,value-,based ,purchasing ,program under section #ahhf7o7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o772 and 7vi7 other value-based payment programs1 as the ,secretary determines appropriate2 7,b7 health information technology certification2 7,c7 standards and implementation specifications1 as appropriate2 7,d7 activities that provide individuals access to their electronic health information2 7,e7 activities related to protecting the privacy of electronic health information2 7,f7 activities related to protecting the security of electronic health information2 7,g7 activities related to facilitating health and clinical research2 7,h7 activities related to public health2 7,i7 activities related to aligning and simplifying quality measures across ,federal programs and other payers2 7,j7 activities related to reporting clinical data for administrative purposes2 and 7,k7 other areas1 as the ,secretary determines appropriate4 7#c7 ,recommendations ,the recommendations developed under paragraph 7#a7 shall address-- 7,a7 actions that improve the clinical documentation experience2 7,b7 actions that improve patient care2 7,c7 actions to be taken by the ,secretary and by other entities2 and 7,d7 other areas1 as the ,secretary determines appropriate1 to reduce the reporting burden required of health care providers4 7#d7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall not apply to the development of the goal1 strategies1 or recommendations described in this section4 7c7 ,application of certain regulatory requirements ,a physician 7as defined in section #ahfa7r77#a7 of the ,social ,security ,act71 to the extent consistent with applicable ,state law1 may delegate electronic medical record documentation requirements specified in regulations promulgated by the ,centers for ,medicare ,medicaid ,services to a person performing a scribe function who is not such physician if such physician has signed and verified the documentation4 2 and 7#b7 in the table of contents in section #acjja7;b71 by inserting after the item relating to section #acajb the following3 #acajc4 ,assisting doctors and hospitals in improving the quality and care for patients4 4 7b7 ,certification of health information technology for medical specialties and sites of service ,section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77#e77 is amended by adding at the end the following3 7,c7 ,health information technology for medical specialties and sites of service 7i7 ,in general ,the ,national ,coordinator shall encourage1 keep1 or recognize1 through existing authorities1 the voluntary certification of health information technology under the program developed under subparagraph 7,a7 for use in medical specialties and sites of service for which no such technology is available or where more technological advancement or integration is needed4 7ii7 ,specific medical specialties ,the ,secretary shall accept public comment on specific medical specialties and sites of service1 in addition to those described in clause 7i71 for the purpose of selecting additional specialties and sites of service as necessary4 7iii7 ,health information technology for pediatrics ,not later than #ah months after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary1 in consultation with relevant stakeholders1 shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of children4 ,not later than #b years after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall adopt certification criteria under section #cjjd to support the voluntary certification of health information technology for use by pediatric health providers to support the health care of children4 4 7c7 ,meaningful use statistics 7#a7 ,in general ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,,hit ,advisory ,committee of the ,office of the ,national ,coordinator for ,health ,information ,technology1 a report concerning attestation statistics for the ,medicare and ,medicaid ,,ehr ,meaningful ,use ,incentive programs to assist in informing standards adoption and related practices4 ,such statistics shall include attestation information delineated by ,state1 including1 to the extent practicable1 the number of providers who did not meet the minimum criteria necessary to attest for the ,medicare and ,medicaid ,,ehr ,meaningful ,use ,incentive programs for a calendar year1 and shall be made publicly available on the ,internet website of the ,secretary on at least a quarterly basis4 7#b7 ,authority to alter format ,the ,secretary of ,health and ,human ,services may alter the format of the reports on the attestation of eligible health care professionals following the first performance year of the ,merit-based ,incentive ,payment ,system to account for changes arising from the implementation of such payment system4 #djjb4 ,transparent reporting on usability1 security1 and functionality 7a7 ,enhancements to certification ,section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa71 as amended by section #djja7;b71 is further amended by adding at the end the following3 7,d7 ,conditions of certification ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary1 through notice and comment rulemaking1 shall require1 as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph1 consistent with other conditions and requirements under this title1 that the health information technology developer or entity-- 7i7 does not take any action that constitutes information blocking as defined in section #cjbb7;a72 7ii7 provides assurances satisfactory to the ,secretary that such developer or entity1 unless for legitimate purposes specified by the ,secretary1 will not take any action described in clause 7i7 or any other action that may inhibit the appropriate exchange1 access1 and use of electronic health information2 7iii7 does not prohibit or restrict communication regarding-- 7,i7 the usability of the health information technology2 7,,ii7 the interoperability of the health information technology2 7,,iii7 the security of the health information technology2 7,,iv7 relevant information regarding users' experiences when using the health information technology2 7,v7 the business practices of developers of health information technology related to exchanging electronic health information2 and 7,,vi7 the manner in which a user of the health information technology has used such technology2 7iv7 has published application programming interfaces and allows health information from such technology to be accessed1 exchanged1 and used without special effort through the use of application programming interfaces or successor technology or standards1 as provided for under applicable law1 including providing access to all data elements of a patient's electronic health record to the extent permissible under applicable privacy laws2 7v7 has successfully tested the real world use of the technology for interoperability 7as defined in section #cjjj7 in the type of setting in which such technology would be marketed2 7vi7 provides to the ,secretary an attestation that the developer or entity-- 7,i7 has not engaged in any of the conduct described in clause 7i72 7,,ii7 has provided assurances satisfactory to the ,secretary in accordance with clause 7ii72 7,,iii7 does not prohibit or restrict communication as described in clause 7iii72 7,,iv7 has published information in accordance with clause 7iv72 7,v7 ensures that its technology allows for health information to be exchanged1 accessed1 and used1 in the manner described in clause 7iv72 and 7,,vi7 has undertaken real world testing as described in clause 7v72 and 7vii7 submits reporting criteria in accordance with section #cjji;,a7b74 4 7,e7 ,compliance with conditions of certification ,the ,secretary may encourage compliance with the conditions of certification described in subparagraph 7,d7 and take action to discourage noncompliance1 as appropriate4 4 7b7 ,,ehr significant hardship exception 7#a7 ,application to eligible professionals 7,a7 ,in case of decertification ,section #ahdh7;a77#g77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77;,b77 is amended by inserting after the first sentence the following new sentence3 ,the ,secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph 7,a7 with respect to a year1 subject to annual renewal1 if the ,secretary determines that compliance with the requirement for being a meaningful ,,ehr user is not possible because the certified ,,ehr technology used by such professional has been decertified under a program kept or recognized pursuant to section #cjja7;c77#e7 of the ,public ,health ,service ,act44 7,b7 ,continued application under ,,mips ,section #ahdh7o77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7o77#b77;,d77 is amended by adding at the end the following new sentence3 ,the provisions of subparagraphs 7,b7 and 7,d7 of subsection 7a77#g71 shall apply to assessments of ,,mips eligible professionals under subsection 7q7 with respect to the performance category described in subsection 7q77#b77;,a77iv7 in an appropriate manner which may be similar to the manner in which such provisions apply with respect to payment adjustments made under subsection 7a77#g77;,a744 7#b7 ,application to eligible hospitals ,section #ahhf7;b77#c77;,b77ix77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77ix77,,ii77 is amended by inserting after the first sentence the following new sentence3 ,the ,secretary shall exempt an eligible hospital from the application of the payment adjustment under subclause 7,i7 with respect to a fiscal year1 subject to annual renewal1 if the ,secretary determines that compliance with the requirement for being a meaningful ,,ehr user is not possible because the certified ,,ehr technology used by such hospital is decertified under a program kept or recognized pursuant to section #cjja7;c77#e7 of the ,public ,health ,service ,act44 7c7 ,electronic health record reporting program ,subtitle ,a of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa et seq47 is amended by adding at the end the following3 #cjji;,a4 ,electronic health record reporting program 7a7 ,reporting criteria 7#a7 ,convening of stakeholders ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall convene stakeholders1 as described in paragraph 7#b71 for the purpose of developing the reporting criteria in accordance with paragraph 7#c74 7#b7 ,development of reporting criteria ,the reporting criteria under this subsection shall be developed through a public1 transparent process that reflects input from relevant stakeholders1 including-- 7,a7 health care providers1 including primary care and specialty care health care professionals2 7,b7 hospitals and hospital systems2 7,c7 health information technology developers2 7,d7 patients1 consumers1 and their advocates2 7,e7 data sharing networks1 such as health information exchanges2 7,f7 authorized certification bodies and testing laboratories2 7,g7 security experts2 7,h7 relevant manufacturers of medical devices2 7,i7 experts in health information technology market economics2 7,j7 public and private entities engaged in the evaluation of health information technology performance2 7,k7 quality organizations1 including the consensus based entity described in section #ahij of the ,social ,security ,act2 7,l7 experts in human factors engineering and the measurement of user-centered design2 and 7,m7 other entities or individuals1 as the ,secretary determines appropriate4 7#c7 ,considerations for reporting criteria ,the reporting criteria developed under this subsection-- 7,a7 shall include measures that reflect categories including-- 7i7 security2 7ii7 usability and user-centered design2 7iii7 interoperability2 7iv7 conformance to certification testing2 and 7v7 other categories1 as appropriate to measure the performance of electronic health record technology2 7,b7 may include categories such as-- 7i7 enabling the user to order and view the results of laboratory tests1 imaging tests1 and other diagnostic tests2 7ii7 submitting1 editing1 and retrieving data from registries such as clinician-led clinical data registries2 7iii7 accessing and exchanging information and data from and through health information exchanges2 7iv7 accessing and exchanging information and data from medical devices2 7v7 accessing and exchanging information and data held by ,federal1 ,state1 and local agencies and other applicable entities useful to a health care provider or other applicable user in the furtherance of patient care2 7vi7 accessing and exchanging information from other health care providers or applicable users2 7vii7 accessing and exchanging patient generated information2 7viii7 providing the patient or an authorized designee with a complete copy of their health information from an electronic record in a computable format2 7ix7 providing accurate patient information for the correct patient1 including exchanging such information1 and avoiding the duplication of patients records2 and 7x7 other categories regarding performance1 accessibility1 as the ,secretary determines appropriate2 and 7,c7 shall be designed to ensure that small and startup health information technology developers are not unduly disadvantaged by the reporting criteria4 7#d7 ,modifications ,after the reporting criteria have been developed under paragraph 7#c71 the ,secretary may convene stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such paragraph4 7b7 ,participation ,as a condition of maintaining certification under section #cjja7;c77#e77;,d71 a developer of certified electronic health records shall submit to an appropriate recipient of a grant1 contract1 or agreement under subsection 7c77#a7 responses to the criteria developed under subsection 7a71 with respect to all certified technology offered by such developer4 7c7 ,reporting program 7#a7 ,in general ,not later than #a year after the date of enactment of the #bast ,century ,cures ,act1 the ,secretary shall award grants1 contracts1 or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection 7a77#b71 collect the information required to be reported in accordance with the criteria established as described subsection 7a77#c71 and develop and implement a process in accordance with paragraph 7#e7 and report such information to the ,secretary4 7#b7 ,applications ,an independent entity that seeks a grant1 contract1 or agreement under this subsection shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 including a description of-- 7,a7 the proposed method for reviewing and summarizing information gathered based on reporting criteria established under subsection 7a72 7,b7 if applicable1 the intended focus on a specific subset of certified electronic health record technology users1 such as health care providers1 including primary care1 specialty care1 and care provided in rural settings2 hospitals and hospital systems2 and patients1 consumers1 and patients and consumer advocates2 7,c7 the plan for widely distributing reports described in paragraph 7#f72 7,d7 the period for which the grant1 contract1 or agreement is requested1 which may be up to #b years2 and 7,e7 the budget for reporting program participation1 and whether the eligible independent entity intends to continue participation after the period of the grant1 contract1 or agreement4 7#c7 ,considerations for independent entities ,in awarding grants1 contracts1 and agreements under paragraph 7#a71 the ,secretary shall give priority to independent entities with appropriate expertise in health information technology usability1 interoperability1 and security 7especially entities with such expertise in electronic health records7 with respect to-- 7,a7 health care providers1 including primary care1 specialty care1 and care provided in rural settings2 7,b7 hospitals and hospital systems2 and 7,c7 patients1 consumers1 and patient and consumer advocates4 7#d7 ,limitations 7,a7 ,assessment and redetermination ,not later than #d years after the date of enactment of the #bast ,century ,cures ,act and every #b years thereafter1 the ,secretary1 in consultation with stakeholders1 shall-- 7i7 assess performance of the recipients of the grants1 contracts1 and agreements under paragraph 7#a7 based on quality and usability of reports described in paragraph 7#f72 and 7ii7 re-determine grants1 contracts1 and agreements as necessary4 7,b7 ,prohibitions on ,participation ,the ,secretary may not award a grant1 contract1 or cooperative agreement under paragraph 7#a7 to-- 7i7 a proprietor of certified health information technology or a business affiliate of such a proprietor2 7ii7 a developer of certified health information technology2 or 7iii7 a ,state or local government agency4 7#e7 ,feedback ,based on reporting criteria established under subsection 7a71 the recipients of grants1 contracts1 and agreements under paragraph 7#a7 shall develop and implement a process to collect and verify confidential feedback on such criteria from-- 7,a7 health care providers1 patients1 and other users of certified electronic health record technology2 and 7,b7 developers of certified electronic health record technology4 7#f7 ,reports 7,a7 ,development of reports ,each recipient of a grant1 contract1 or agreement under paragraph 7#a7 shall report on the information reported to such recipient pursuant to subsection 7a7 and the user feedback collected under paragraph 7#e7 by preparing summary reports and detailed reports of such information4 7,b7 ,distribution of reports ,each recipient of a grant1 contract1 or agreement under paragraph 7#a7 shall submit the reports prepared under subparagraph 7,a7 to the ,secretary for public distribution in accordance with subsection 7d74 7d7 ,publication ,the ,secretary shall distribute widely1 as appropriate1 and publish1 on the ,internet website of the ,office of the ,national ,coordinator-- 7#a7 the reporting criteria developed under subsection 7a72 and 7#b7 the summary and detailed reports under subsection 7c77#f74 7e7 ,review ,each recipient of a grant1 contract1 or agreement under paragraph 7#a7 shall develop and implement a process through which participating electronic health record technology developers may review and recommend changes to the reports created under subsection 7c77#f7 for products developed by such developer prior to the publication of such report under subsection 7d74 7f7 ,additional resources ,the ,secretary may provide additional resources on the ,internet website of the ,office of the ,national ,coordinator to better inform consumers of health information technology4 ,such reports may be carried out through partnerships with private organizations with appropriate expertise4 4 7d7 ,authorization of ,appropriations ,there is authorized to be appropriated #ae1jjj1jjj for purposes of carrying out subparagraph 7,d7 of section #cjja7;c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7 7as added by subsection 7a77 and section #cjji;,a of the ,public ,health ,service ,act 7as added by subsection 7b771 including for purposes of administering any contracts1 grants1 or agreements1 to remain available until expended4 #djjc4 ,interoperability 7a7 ,definition ,section #cjjj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj7 is amended-- 7#a7 by redesignating paragraphs 7#aj7 through 7#ad71 as paragraphs 7#aa7 through 7#ae71 respectively2 and 7#b7 by inserting after paragraph 7#i7 the following3 7#aj7 ,interoperability ,the term interoperability1 with respect to health information technology1 means such health information technology that-- 7,a7 enables the secure exchange of electronic health information with1 and use of electronic health information from1 other health information technology without special effort on the part of the user2 7,b7 allows for complete access1 exchange1 and use of all electronically accessible health information for authorized use under applicable ,state or ,federal law2 and 7,c7 does not constitute information blocking as defined in section #cjbb7;a74 4 7b7 ,support for interoperable network exchange ,section #cjja7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77 is amended by adding at the end the following3 7#i7 ,support for interoperable networks exchange 7,a7 ,in general ,the ,national ,coordinator shall1 in collaboration with the ,national ,institute of ,standards and ,technology and other relevant agencies within the ,department of ,health and ,human ,services1 for the purpose of ensuring full network-to-network exchange of health information1 convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework1 including a common agreement among health information networks nationally4 ,such convention may occur at a frequency determined appropriate by the ,secretary4 7,b7 ,establishing a trusted exchange framework 7i7 ,in general ,not later than #f months after the date of enactment of the #bast ,century ,cures ,act1 the ,national ,coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks4 ,the common agreement may include-- 7,i7 a common method for authenticating trusted health information network participants2 7,,ii7 a common set of rules for trusted exchange2 7,,iii7 organizational and operational policies to enable the exchange of health information among networks1 including minimum conditions for such exchange to occur2 and 7,,iv7 a process for filing and adjudicating noncompliance with the terms of the common agreement4 7ii7 ,technical assistance ,the ,national ,coordinator1 in collaboration with the ,national ,institute of ,standards and ,technology1 shall provide technical assistance on how to implement the trusted exchange framework and common agreement under this paragraph4 7iii7 ,pilot testing ,the ,national ,coordinator1 in consultation with the ,national ,institute of ,standards and ,technology1 shall provide for the pilot testing of the trusted exchange framework and common agreement established or supported under this subsection 7as authorized under section #acbja of the ,health ,information ,technology for ,economic and ,clinical ,health ,act74 ,the ,national ,coordinator1 in consultation with the ,national ,institute of ,standards and ,technology1 may delegate pilot testing activities under this clause to independent entities with appropriate expertise4 7,c7 ,publication of a trusted exchange framework and common agreement ,not later than #a year after convening stakeholders under subparagraph 7,a71 the ,national ,coordinator shall publish on its public ,internet website1 and in the ,federal register1 the trusted exchange framework and common agreement developed or supported under subparagraph 7,b74 ,such trusted exchange framework and common agreement shall be published in a manner that protects proprietary and security information1 including trade secrets and any other protected intellectual property4 7,d7 ,directory of participating health information networks 7i7 ,in general ,not later than #b years after convening stakeholders under subparagraph 7,a71 and annually thereafter1 the ,national ,coordinator shall publish on its public ,internet website a list of the health information networks that have adopted the common agreement and are capable of trusted exchange pursuant to the common agreement developed or supported under paragraph 7,b74 7ii7 ,process ,the ,secretary shall1 through notice and comment rulemaking1 establish a process for health information networks that voluntarily elect to adopt the trusted exchange framework and common agreement to attest to such adoption of the framework and agreement4 7,e7 ,application of the trusted exchange framework and common agreement ,as appropriate1 ,federal agencies contracting or entering into agreements with health information exchange networks may require that as each such network upgrades health information technology or trust and operational practices1 such network may adopt1 where available1 the trusted exchange framework and common agreement published under subparagraph 7,c74 7,f7 ,rule of construction 7i7 ,general adoption ,nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement4 7ii7 ,adoption when exchange of information is within network ,nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement for the exchange of electronic health information between participants of the same network4 7iii7 ,existing frameworks and agreements ,the trusted exchange framework and common agreement published under subparagraph 7,c7 shall take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks4 7iv7 ,application by ,federal agencies ,notwithstanding clauses 7i71 7ii71 and 7iii71 ,federal agencies may require the adoption of the trusted exchange framework and common agreement published under subparagraph 7,c7 for health information exchanges contracting with or entering into agreements pursuant to subparagraph 7,e74 7v7 ,consideration of ongoing work ,in carrying out this paragraph1 the ,secretary shall ensure the consideration of activities carried out by public and private organizations related to exchange between health information exchanges to avoid duplication of efforts4 4 7c7 ,provider digital contact information index 7#a7 ,in general ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall1 directly or through a partnership with a private entity1 establish a provider digital contact information index to provide digital contact information for health professionals and health facilities4 7#b7 ,use of existing index ,in establishing the initial index under paragraph 7#a71 the ,secretary may utilize an existing provider directory to make such digital contact information available4 7#c7 ,contact information ,an index established under this subsection shall ensure that contact information is available at the individual health care provider level and at the health facility or practice level4 7#d7 ,rule of construction 7,a7 ,in general ,the purpose of this subsection is to encourage the exchange of electronic health information by providing the most useful1 reliable1 and comprehensive index of providers possible4 ,in furthering such purpose1 the ,secretary shall include all health professionals and health facilities applicable to provide a useful1 reliable1 and comprehensive index for use in the exchange of health information4 7,b7 ,limitation ,in no case shall exclusion from the index of providers be used as a measure to achieve objectives other the objectives described in subparagraph 7,a74 7d7 ,standards development organizations ,section #cjjd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ad7 is amended by adding at the end the following3 7c7 ,deference to standards development organizations ,in adopting and implementing standards under this section1 the ,secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards bodies4 4 7e7 ,health ,information ,technology advisory committee 7#a7 ,in general ,title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj et seq47 is amended by striking sections #cjjb 7#db ,u4,s4,c4 #cjj;jj-#ab7 and #cjjc 7#db ,u4,s4,c4 #cjj;jj-#ac7 and inserting the following3 #cjjb4 ,health information technology advisory committee 7a7 ,establishment ,there is established a ,health ,information ,technology ,advisory ,committee 7referred to in this section as the ,,hit ,advisory ,committee7 to recommend to the ,national ,coordinator1 consistent with the implementation of the strategic plan described in section #cjja7;c77#c71 policies1 and1 for purposes of adoption under section #cjjd1 standards1 implementation specifications1 and certification criteria1 relating to the implementation of a health information technology infrastructure1 nationally and locally1 that advances the electronic access1 exchange1 and use of health information4 ,such ,committee shall serve to unify the roles of1 and replace1 the ,,hit ,policy ,committee and the ,,hit ,standards ,committee1 as in existence before the date of the enactment of the #bast ,century ,cures ,act4 7b7 ,duties 7#a7 ,recommendations on policy framework to advance an interoperable health information technology infrastructure 7,a7 ,in general ,the ,,hit ,advisory ,committee shall recommend to the ,national ,coordinator a policy framework for adoption by the ,secretary consistent with the strategic plan under section #cjja7;c77#c7 for advancing the target areas described in this subsection4 ,such policy framework shall seek to prioritize achieving advancements in the target areas specified in subparagraph 7,b7 of paragraph 7#b7 and may1 to the extent consistent with this section1 incorporate policy recommendations made by the ,,hit ,policy ,committee1 as in existence before the date of the enactment of the #bast ,century ,cures ,act4 7,b7 ,updates ,the ,,hit ,advisory ,committee shall propose updates to such recommendations to the policy framework and make new recommendations1 as appropriate4 7#b7 ,general duties and target areas 7,a7 ,in general ,the ,,hit ,advisory ,committee shall recommend to the ,national ,coordinator for purposes of adoption under section #cjjd1 standards1 implementation specifications1 and certification criteria and an order of priority for the development1 harmonization1 and recognition of such standards1 specifications1 and certification criteria4 ,such recommendations shall include recommended standards1 architectures1 and software schemes for access to electronic individually identifiable health information across disparate systems including user vetting1 authentication1 privilege management1 and access control4 7,b7 ,priority target areas ,for purposes of this section1 the ,,hit ,advisory ,committee shall make recommendations under subparagraph 7,a7 with respect to at least each of the following target areas3 7i7 ,achieving a health information technology infrastructure1 nationally and locally1 that allows for the electronic access1 exchange1 and use of health information1 including through technology that provides accurate patient information for the correct patient1 including exchanging such information1 and avoids the duplication of patient records4 7ii7 ,the promotion and protection of privacy and security of health information in health information technology1 including technologies that allow for an accounting of disclosures and protections against disclosures of individually identifiable health information made by a covered entity for purposes of treatment1 payment1 and health care operations 7as such terms are defined for purposes of the regulation promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif71 including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care4 7iii7 ,the facilitation of secure access by an individual to such individual's protected health information and access to such information by a family member1 caregiver1 or guardian acting on behalf of a patient1 including due to age-related and other disability1 cognitive impairment1 or dementia4 7iv7 ,subject to subparagraph 7,d71 any other target area that the ,,hit ,advisory ,committee identifies as an appropriate target area to be considered under this subparagraph4 7,c7 ,additional target areas ,for purposes of this section1 the ,,hit ,advisory ,committee may make recommendations under subparagraph 7,a71 in addition to areas described in subparagraph 7,b71 with respect to any of the following areas3 7i7 ,the use of health information technology to improve the quality of health care1 such as by promoting the coordination of health care and improving continuity of health care among health care providers1 reducing medical errors1 improving population health1 reducing chronic disease1 and advancing research and education4 7ii7 ,the use of technologies that address the needs of children and other vulnerable populations4 7iii7 ,the use of electronic systems to ensure the comprehensive collection of patient demographic data1 including at a minimum1 race1 ethnicity1 primary language1 and gender information4 7iv7 ,the use of self-service1 telemedicine1 home health care1 and remote monitoring technologies4 7v7 ,the use of technologies that meet the needs of diverse populations4 7vi7 ,the use of technologies that support-- 7,i7 data for use in quality and public reporting programs2 7,,ii7 public health2 or 7,,iii7 drug safety4 7vii7 ,the use of technologies that allow individually identifiable health information to be rendered unusable1 unreadable1 or indecipherable to unauthorized individuals when such information is transmitted in a health information network or transported outside of the secure facilities or systems where the disclosing covered entity is responsible for security conditions4 7viii7 ,the use of a certified health information technology for each individual in the ,united ,states4 7,d7 ,authority for temporary additional priority target areas ,for purposes of subparagraph 7,b77iv71 the ,,hit ,advisory ,committee may identify an area to be considered for purposes of recommendations under this subsection as a target area described in subparagraph 7,b7 if-- 7i7 the area is so identified for purposes of responding to new circumstances that have arisen in the health information technology community that affect the interoperability1 privacy1 or security of health information1 or affect patient safety2 and 7ii7 at least #cj days prior to treating such area as if it were a target area described in subparagraph 7,b71 the ,national ,coordinator provides adequate notice to ,congress of the intent to treat such area as so described4 7,e7 ,focus of ,committee ,work ,it is the sense of ,congress that the ,,hit ,advisory ,committee shall focus its work on the priority areas described in subparagraph 7,b7 before proceeding to other work under subparagraph 7,c74 7#c7 ,rules relating to recommendations for standards1 implementation specifications1 and certification criteria 7,a7 ,in general ,the ,,hit ,advisory ,committee shall recommend to the ,national ,coordinator standards1 implementation specifications1 and certification criteria described in subsection 7a71 which may include standards1 implementation specifications1 and certification criteria that have been developed1 harmonized1 or recognized by the ,,hit ,advisory ,committee or predecessor committee4 ,the ,,hit ,advisory ,committee shall update such recommendations and make new recommendations as appropriate1 including in response to a notification sent under section #cjjd7;a77#b77;,b74 ,such recommendations shall be consistent with the latest recommendations made by the ,committee4 7,b7 ,harmonization ,the ,,hit ,advisory ,committee may recognize harmonized or updated standards from an entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of the standards and implementation specification4 7,c7 ,pilot testing of standards and implementation specifications ,in the development1 harmonization1 or recognition of standards and implementation specifications1 the ,,hit ,advisory ,committee for purposes of recommendations under paragraph 7#b77;,b71 shall1 as appropriate1 provide for the testing of such standards and specifications by the ,national ,institute for ,standards and ,technology under section #acbja7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act4 7,d7 ,consistency ,the standards1 implementation specifications1 and certification criteria recommended under paragraph 7#b77;,b7 shall be consistent with the standards for information transactions and data elements adopted pursuant to section #aagc of the ,social ,security ,act4 7,e7 ,special rule related to interoperability ,any recommendation made by the ,,hit ,advisory ,committee after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with interoperability as described in section #cjjj4 7#d7 ,forum ,the ,,hit ,advisory ,committee shall serve as a forum for the participation of a broad range of stakeholders with specific expertise in policies1 including technical expertise1 relating to the matters described in paragraphs 7#a71 7#b71 and 7#c7 to provide input on the development1 harmonization1 and recognition of standards1 implementation specifications1 and certification criteria necessary for the development and adoption of health information technology infrastructure nationally and locally that allows for the electronic access1 exchange1 and use of health information4 7#e7 ,schedule ,not later than #cj days after the date on which the ,,hit ,advisory ,committee first meets1 such ,,hit ,advisory ,committee shall develop a schedule for the assessment of policy recommendations developed under paragraph 7#a74 ,the ,,hit ,advisory ,committee shall update such schedule annually4 ,the ,secretary shall publish such schedule in the ,federal ,register4 7#f7 ,public input ,the ,,hit ,advisory ,committee shall conduct open public meetings and develop a process to allow for public comment on the schedule described in paragraph 7#e7 and recommendations described in this subsection4 ,under such process comments shall be submitted in a timely manner after the date of publication of a recommendation under this subsection4 7c7 ,measured progress in advancing priority areas 7#a7 ,in general ,for purposes of this section1 the ,national ,coordinator1 in collaboration with the ,secretary1 shall establish1 and update as appropriate1 objectives and benchmarks for advancing and measuring the advancement of the priority target areas described in subsection 7b77#b77;,b74 7#b7 ,annual progress reports on advancing interoperability 7,a7 ,in general ,the ,,hit ,advisory ,committee1 in consultation with the ,national ,coordinator1 shall annually submit to the ,secretary and ,congress a report on the progress made during the preceding fiscal year in-- 7i7 achieving a health information technology infrastructure1 nationally and locally1 that allows for the electronic access1 exchange1 and use of health information2 and 7ii7 meeting the objectives and benchmarks described in paragraph 7#a74 7,b7 ,content ,each such report shall include1 for a fiscal year-- 7i7 a description of the work conducted by the ,,hit ,advisory ,committee during the preceding fiscal year with respect to the areas described in subsection 7b77#b77;,b72 7ii7 an assessment of the status of the infrastructure described in subparagraph 7,a71 including the extent to which electronic health information is appropriately and readily available to enhance the access1 exchange1 and the use of electronic health information between users and across technology offered by different developers2 7iii7 the extent to which advancements have been achieved with respect to areas described in subsection 7b77#b77;,b72 7iv7 an analysis identifying existing gaps in policies and resources for-- 7,i7 achieving the objectives and benchmarks established under paragraph 7#a72 and 7,,ii7 furthering interoperability throughout the health information technology infrastructure2 7v7 recommendations for addressing the gaps identified in clause 7iii72 and 7vi7 a description of additional initiatives as the ,,hit ,advisory ,committee and ,national ,coordinator determine appropriate4 7#c7 ,significant advancement determination ,the ,secretary shall periodically1 based on the reports submitted under this subsection1 review the target areas described in subsection 7b77#b77;,b71 and1 based on the objectives and benchmarks established under paragraph 7#a71 the ,secretary shall determine if significant advancement has been achieved with respect to such an area4 ,such determination shall be taken into consideration by the ,,hit ,advisory ,committee when determining to what extent the ,committee makes recommendations for an area other than an area described in subsection 7b77#b77;,b74 7d7 ,membership and operations 7#a7 ,in general ,the ,national ,coordinator shall take a leading position in the establishment and operations of the ,,hit ,advisory ,committee4 7#b7 ,membership ,the membership of the ,,hit ,advisory ,committee shall-- 7,a7 include at least #be members1 of which-- 7i7 no fewer than #b members are advocates for patients or consumers of health information technology2 7ii7 #c members are appointed by the ,secretary1 #a of whom shall be appointed to represent the ,department of ,health and ,human ,services and #a of whom shall be a public health official2 7iii7 #b members are appointed by the majority leader of the ,senate2 7iv7 #b members are appointed by the minority leader of the ,senate2 7v7 #b members are appointed by the ,speaker of the ,house of ,representatives2 7vi7 #b members are appointed by the minority leader of the ,house of ,representatives2 and 7vii7 such other members are appointed by the ,comptroller ,general of the ,united ,states2 and 7,b7 at least reflect providers1 ancillary health care workers1 consumers1 purchasers1 health plans1 health information technology developers1 researchers1 patients1 relevant ,federal agencies1 and individuals with technical expertise on health care quality1 system functions1 privacy1 security1 and on the electronic exchange and use of health information1 including the use standards for such activity4 7#c7 ,participation ,the members of the ,,hit ,advisory ,committee shall represent a balance among various sectors of the health care system so that no single sector unduly influences the recommendations of the ,committee4 7#d7 ,terms 7,a7 ,in general ,the terms of the members of the ,,hit ,advisory ,committee shall be for #c years1 except that the ,secretary shall designate staggered terms of the members first appointed4 7,b7 ,vacancies ,any member appointed to fill a vacancy in the membership of the ,,hit ,advisory ,committee that occurs prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term4 ,a member may serve after the expiration of that member's term until a successor has been appointed4 ,a vacancy in the ,,hit ,advisory ,committee shall be filled in the manner in which the original appointment was made4 7,c7 ,limits ,members of the ,,hit ,advisory ,committee shall be limited to two #c-year terms1 for a total of not to exceed #f years of service on the ,committee4 7#e7 ,outside involvement ,the ,,hit ,advisory ,committee shall ensure an opportunity for the participation in activities of the ,committee of outside advisors1 including individuals with expertise in the development of policies and standards for the electronic exchange and use of health information1 including in the areas of health information privacy and security4 7#f7 ,quorum ,a majority of the members of the ,,hit ,advisory ,committee shall constitute a quorum for purposes of voting1 but a lesser number of members may meet and hold hearings4 7#g7 ,consideration ,the ,national ,coordinator shall ensure that the relevant and available recommendations and comments from the ,national ,committee on ,vital and ,health ,statistics are considered in the development of policies4 7#h7 ,assistance ,for the purposes of carrying out this section1 the ,secretary may provide or ensure that financial assistance is provided by the ,,hit ,advisory ,committee to defray in whole or in part any membership fees or dues charged by such ,committee to those consumer advocacy groups and not-for-profit entities that work in the public interest as a party of their mission4 7e7 ,application of ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 other than section #ad of such ,act1 shall apply to the ,,hit ,advisory ,committee4 7f7 ,publication ,the ,secretary shall provide for publication in the ,federal ,register and the posting on the ,internet website of the ,office of the ,national ,coordinator for ,health ,information ,technology of all policy recommendations made by the ,,hit ,advisory ,committee under this section4 4 7#b7 ,technical and conforming amendments ,title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj et seq47 is amended-- 7,a7 by striking-- 7i7 ,,hit ,policy ,committee and ,,hit ,standards ,committee each place that such terms appear 7other than within the term ,,hit ,policy ,committee and the ,,hit ,standards ,committee or within the term ,,hit ,policy ,committee or the ,,hit ,standards ,committee7 and inserting ,,hit ,advisory ,committee2 7ii7 ,,hit ,policy ,committee and the ,,hit ,standards ,committee each place that such term appears and inserting ,,hit ,advisory ,committee2 and 7iii7 ,,hit ,policy ,committee or the ,,hit ,standards ,committee each place that such term appears and inserting ,,hit ,advisory ,committee2 7,b7 in section #cjjj 7#db ,u4,s4,c4 #cjj;jj7-- 7i7 by striking paragraphs 7#g7 and 7#h7 and redesignating paragraphs 7#i7 through 7#ad7 as paragraphs 7#h7 through 7#ac71 respectively2 and 7ii7 by inserting after paragraph 7#f7 the following paragraph3 7#g7 ,hit advisory committee ,the term ,,hit ,advisory ,committee means such ,committee established under section #cjjb7;a74 2 7,c7 in section #cjja7;c7 7#db ,u4,s4,c4 #cjj;jj-#aa7;c77-- 7i7 in paragraph 7#a77;,a71 by striking under section #cjjc and inserting under section #cjjb2 7ii7 in paragraph 7#b71 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,hit advisory committee ,the ,national ,coordinator shall be a leading member in the establishment and operations of the ,,hit ,advisory ,committee and shall serve as a liaison between that ,committee and the ,federal ,government4 2 7,d7 in section #cjjd7;b77#c7 7#db ,u4,s4,c4 #cjj;jj-#ad7;b77#c771 by striking #cjjc7;b77#b7 and inserting #cjjb7;b77#d72 7,e7 in section #cjjg7;b7 7#db ,u4,s4,c4 #cjj;jj-#ag7;b771 by striking #cjjc7;a7 and inserting #cjjb7;a77#b72 and 7,f7 in section #cjjh 7#db ,u4,s4,c4 #cjj;jj-#ah7-- 7i7 in subsection 7b71 by striking or #cjjc2 and 7ii7 in subsection 7c71 by striking #cjjc7;b77#a77;,a7 and inserting #cjjb7;b77#b74 7#c7 ,transition to the ,,hit advisory committee ,the ,secretary of ,health and ,human ,services shall provide for an orderly and timely transition to the ,,hit ,advisory ,committee established under amendments made by this section4 7f7 ,priorities for ,adoption of ,standards1 ,implementation ,specifications1 and ,certification criteria ,title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj et seq471 as amended by subsection 7e71 is further amended by inserting after section #cjjb the following3 #cjjc4 ,setting priorities for standards adoption 7a7 ,identifying priorities 7#a7 ,in general ,not later than #f months after the date on which the ,,hit ,advisory ,committee first meets1 the ,national ,coordinator shall periodically convene the ,,hit ,advisory ,committee to-- 7,a7 identify priority uses of health information technology1 focusing on priorities-- 7i7 arising from the implementation of the incentive programs for the meaningful use of certified ,,ehr technology1 the ,merit-based ,incentive ,payment ,system1 ,alternative ,payment ,models1 the ,hospital ,value-,based ,purchasing ,program1 and any other value-based payment program determined appropriate by the ,secretary2 7ii7 related to the quality of patient care2 7iii7 related to public health2 7iv7 related to clinical research2 7v7 related to the privacy and security of electronic health information2 7vi7 related to innovation in the field of health information technology2 7vii7 related to patient safety2 7viii7 related to the usability of health information technology2 7ix7 related to individuals' access to electronic health information2 and 7x7 other priorities determined appropriate by the ,secretary2 7,b7 identify existing standards and implementation specifications that support the use and exchange of electronic health information needed to meet the priorities identified in subparagraph 7,a72 and 7,c7 publish a report summarizing the findings of the analysis conducted under subparagraphs 7,a7 and 7,b7 and make appropriate recommendations4 7#b7 ,prioritization ,in identifying such standards and implementation specifications under paragraph 7#a77;,b71 the ,,hit ,advisory ,committee shall prioritize standards and implementation specifications developed by consensus-based standards development organizations4 7#c7 ,guidelines for review of existing standards and specifications ,in consultation with the consensus-based entity described in section #ahij of the ,social ,security ,act and other appropriate ,federal agencies1 the analysis of existing standards under paragraph 7#a77;,b7 shall include an evaluation of the need for a core set of common data elements and associated value sets to enhance the ability of certified health information technology to capture1 use1 and exchange structured electronic health information4 7b7 ,review of adopted standards 7#a7 ,in general ,beginning #e years after the date of enactment of the #bast ,century ,cures ,act and every #c years thereafter1 the ,national ,coordinator shall convene stakeholders to review the existing set of adopted standards and implementation specifications and make recommendations with respect to whether to-- 7,a7 maintain the use of such standards and implementation specifications2 or 7,b7 phase out such standards and implementation specifications4 7#b7 ,priorities ,the ,,hit ,advisory ,committee1 in collaboration with the ,national ,institute for ,standards and ,technology1 shall annually and through the use of public input1 review and publish priorities for the use of health information technology1 standards1 and implementation specifications to support those priorities4 7c7 ,rule of construction ,nothing in this section shall be construed to prevent the use or adoption of novel standards that improve upon the existing health information technology infrastructure and facilitate the secure exchange of health information4 4 #djjd4 ,information blocking ,subtitle ,c of title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ea et seq47 is amended by adding at the end the following3 #cjbb4 ,information blocking 7a7 ,definition 7#a7 ,in general ,in this section1 the term information blocking means a practice that-- 7,a7 except as required by law or specified by the ,secretary pursuant to rulemaking under paragraph 7#c71 is likely to interfere with1 prevent1 or materially discourage access1 exchange1 or use of electronic health information2 and 7,b7 7i7 if conducted by a health information technology developer1 exchange1 or network1 such developer1 exchange1 or network knows1 or should know1 that such practice is likely to interfere with1 prevent1 or materially discourage the access1 exchange1 or use of electronic health information2 or 7ii7 if conducted by a health care provider1 such provider knows that such practice is unreasonable and is likely to interfere with1 prevent1 or materially discourage access1 exchange1 or use of electronic health information4 7#b7 ,practices described ,the information blocking practices described in paragraph 7#a7 may include-- 7,a7 practices that restrict authorized access1 exchange1 or use under applicable ,state or ,federal law of such information for treatment and other permitted purposes under such applicable law1 including transitions between certified health information technologies2 7,b7 implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing1 exchanging1 or using electronic health information2 and 7,c7 implementing health information technology in ways that are likely to-- 7i7 restrict the access1 exchange1 or use of electronic health information with respect to exporting complete information sets or in transitioning between health information technology systems2 or 7ii7 lead to fraud1 waste1 or abuse1 or impede innovations and advancements in health information access1 exchange1 and use1 including care delivery enabled by health information technology4 7#c7 ,rulemaking ,the ,secretary1 through rulemaking1 shall identify reasonable and necessary activities that do not constitute information blocking for purposes of paragraph 7#a74 7#d7 ,no enforcement before exception identified ,the term information blocking does not include any practice or conduct occurring prior to the date that is #cj days after the date of enactment of the #bast ,century ,cures ,act4 7#e7 ,consultation ,the ,secretary may consult with the ,federal ,trade ,commission in promulgating regulations under this subsection1 to the extent that such regulations define practices that are necessary to promote competition and consumer welfare4 7#f7 ,application ,the term information blocking1 with respect to an individual or entity1 shall not include an act or practice other than an act or practice committed by such individual or entity4 7#g7 ,clarification ,in carrying out this section1 the ,secretary shall ensure that health care providers are not penalized for the failure of developers of health information technology or other entities offering health information technology to such providers to ensure that such technology meets the requirements to be certified under this title4 7b7 ,inspector general authority 7#a7 ,in general ,the inspector general of the ,department of ,health and ,human ,services 7referred to in this section as the ,inspector ,general7 may investigate any claim that-- 7,a7 a health information technology developer of certified health information technology or other entity offering certified health information technology-- 7i7 submitted a false attestation under section #cjja7;c77#e77;,d77vii72 or 7ii7 engaged in information blocking2 7,b7 a health care provider engaged in information blocking2 or 7,c7 a health information exchange or network engaged in information blocking4 7#b7 ,penalties 7,a7 ,developers1 networks1 and exchanges ,any individual or entity described in subparagraph 7,a7 or 7,c7 of paragraph 7#a7 that the ,inspector ,general1 following an investigation conducted under this subsection1 determines to have committed information blocking shall be subject to a civil monetary penalty determined by the ,secretary for all such violations identified through such investigation1 which may not exceed #a1jjj1jjj per violation4 ,such determination shall take into account factors such as the nature and extent of the information blocking and harm resulting from such information blocking1 including1 where applicable1 the number of patients affected1 the number of providers affected1 and the number of days the information blocking persisted4 7,b7 ,providers ,any individual or entity described in subparagraph 7,b7 of paragraph 7#a7 determined by the ,inspector ,general to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable ,federal law1 as the ,secretary sets forth through notice and comment rulemaking4 7,c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act 7other than subsections 7a7 and 7b7 of such section7 shall apply to a civil money penalty applied under this paragraph in the same manner as such provisions apply to a civil money penalty or proceeding under such section #aabh;,a7a74 7,d7 ,recovered penalty funds ,the amounts recovered under this paragraph shall be allocated as follows3 7i7 ,annual operating expenses ,each year following the establishment of the authority under this subsection1 the ,office of the ,inspector ,general shall provide to the ,secretary an estimate of the costs to carry out investigations under this section4 ,such estimate may include reasonable reserves to account for variance in annual amounts recovered under this paragraph4 ,there is authorized to be appropriated for purposes of carrying out this section an amount equal to the amount specified in such estimate for the fiscal year4 7ii7 ,application to other programs ,the amounts recovered under this paragraph and remaining after amounts are made available under clause 7i7 shall be transferred to the ,federal ,hospital ,insurance ,trust ,fund under section #ahag of the ,social ,security ,act and the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of such ,act1 in such proportion as the ,secretary determines appropriate4 7,e7 ,authorization of appropriations ,there is authorized to be appropriated to the ,office of the ,inspector ,general to carry out this section #aj1jjj1jjj1 to remain available until expended4 7#c7 ,resolution of claims 7,a7 ,in general ,the ,office of the ,inspector ,general1 if such ,office determines that a consultation regarding the health privacy and security rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 will resolve an information blocking claim1 may refer such instances of information blocking to the ,office for ,civil ,rights of the ,department of ,health and ,human ,services for resolution4 7,b7 ,limitation on liability ,if a health care provider or health information technology developer makes information available based on a good faith reliance on consultations with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services pursuant to a referral under subparagraph 7,a71 with respect to such information1 the health care provider or developer shall not be liable for such disclosure or disclosures made pursuant to subparagraph 7,a74 7c7 ,identifying barriers ,to exchange of certified health information technology 7#a7 ,trusted exchange defined ,in this section1 the term trusted exchange with respect to certified electronic health records means that the certified electronic health record technology has the technical capability to enable secure health information exchange between users and multiple certified electronic health record technology systems4 7#b7 ,guidance ,the ,national ,coordinator1 in consultation with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall issue guidance on common legal1 governance1 and security barriers that prevent the trusted exchange of electronic health information4 7#c7 ,referral ,the ,national ,coordinator and the ,office for ,civil ,rights of the ,department of ,health and ,human ,services may refer to the ,inspector ,general instances or patterns of refusal to exchange health information with an individual or entity using certified electronic health record technology that is technically capable of trusted exchange and under conditions when exchange is legally permissible4 7d7 ,additional provisions 7#a7 ,information sharing provisions ,the ,national ,coordinator may serve as a technical consultant to the ,inspector ,general and the ,federal ,trade ,commission for purposes of carrying out this section4 ,the ,national ,coordinator may1 notwithstanding any other provision of law1 share information related to claims or investigations under subsection 7b7 with the ,federal ,trade ,commission for purposes of such investigations and shall share information with the ,inspector ,general1 as required by law4 7#b7 ,protection from disclosure of information ,any information that is received by the ,national ,coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information-- 7,a7 shall not be disclosed by the ,national ,coordinator except as may be necessary to carry out the purpose of this section2 7,b7 shall be exempt from mandatory disclosure under section #eeb of title #e1 ,united ,states ,code1 as provided by subsection 7b77#c7 of such section2 and 7,c7 may be used by the ,inspector ,general or ,federal ,trade ,commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information4 7#c7 ,standardized process 7,a7 ,in general ,the ,national ,coordinator shall implement a standardized process for the public to submit reports on claims of-- 7i7 health information technology products or developers of such products 7or other entities offering such products to health care providers7 not being interoperable or resulting in information blocking2 7ii7 actions described in subsection 7b77#a7 that result in information blocking as described in subsection 7a72 and 7iii7 any other act described in subsection 7a74 7,b7 ,collection of information ,the standardized process implemented under subparagraph 7,a7 shall provide for the collection of such information as the originating institution1 location1 type of transaction1 system and version1 timestamp1 terminating institution1 locations1 system and version1 failure notice1 and other related information4 7#d7 ,nonduplication of penalty structures ,in carrying out this subsection1 the ,secretary shall1 to the extent possible1 ensure that penalties do not duplicate penalty structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section4 4 #djje4 ,leveraging electronic health records to improve patient care 7a7 ,requirement relating to registries 7#a7 ,in general ,to be certified in accordance with title ,,xxx of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj et seq471 electronic health records shall be capable of transmitting to1 and where applicable1 receiving and accepting data from1 registries in accordance with standards recognized by the ,office of the ,national ,coordinator for ,health ,information ,technology1 including clinician-led clinical data registries1 that are also certified to be technically capable of receiving and accepting from1 and where applicable1 transmitting data to certified electronic health record technology in accordance with such standards4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to require the certification of registries beyond the technical capability to exchange data in accordance with applicable recognized standards4 7b7 ,definition ,for purposes of this ,act1 the term clinician-led clinical data registry means a clinical data repository-- 7#a7 that is established and operated by a clinician-led or controlled1 tax-exempt 7pursuant to section #eja7;c7 of the ,internal ,revenue ,code of #aihf71 professional society or other similar clinician-led or -controlled organization1 or such organization's controlled affiliate1 devoted to the care of a population defined by a particular disease1 condition1 exposure or therapy2 7#b7 that is designed to collect detailed1 standardized data on an ongoing basis for medical procedures1 services1 or therapies for particular diseases1 conditions1 or exposures2 7#c7 that provides feedback to participants who submit reports to the repository2 7#d7 that meets standards for data quality including-- 7,a7 systematically collecting clinical and other health care data1 using standardized data elements and having procedures in place to verify the completeness and validity of those data2 and 7,b7 being subject to regular data checks or audits to verify completeness and validity2 and 7#e7 that provides ongoing participant training and support4 7c7 ,treatment of health information technology developers with respect to patient safety organizations 7#a7 ,in general ,in applying part ,c of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ba et seq471 a health information technology developer shall be treated as a provider 7as defined in section #iba of such ,act7 for purposes of reporting and conducting patient safety activities concerning improving clinical care through the use of health information technology that could result in improved patient safety1 health care quality1 or health care outcomes4 7#b7 ,report ,not later than #d years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report concerning best practices and current trends voluntarily provided1 without identifying individual providers or disclosing or using protected health information or individually identifiable information1 by patient safety organizations to improve the integration of health information technology into clinical practice4 #djjf4 ,empowering patients and improving patient access to their electronic health information 7a7 ,use of health information exchanges for patient access ,section #cjji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#ai7 is amended by adding at the end the following3 7c7 ,promoting patient access to electronic health information through health information exchanges 7#a7 ,in general ,the ,secretary shall use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers1 health plans1 and other appropriate entities with the goal of offering patients access to their electronic health information in a single1 longitudinal format that is easy to understand1 secure1 and may be updated automatically4 7#b7 ,education of providers ,the ,secretary1 in coordination with the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall-- 7,a7 educate health care providers on ways of leveraging the capabilities of health information exchanges 7or other relevant platforms7 to provide patients with access to their electronic health information2 7,b7 clarify misunderstandings by health care providers about using health information exchanges 7or other relevant platforms7 for patient access to electronic health information2 and 7,c7 to the extent practicable1 educate providers about health information exchanges 7or other relevant platforms7 that employ some or all of the capabilities described in paragraph 7#a74 7#c7 ,requirements ,in carrying out paragraph 7#a71 the ,secretary1 in coordination with the ,office for ,civil ,rights1 shall issue guidance to health information exchanges related to best practices to ensure that the electronic health information provided to patients is-- 7,a7 private and secure2 7,b7 accurate2 7,c7 verifiable2 and 7,d7 where a patient's authorization to exchange information is required by law1 easily exchanged pursuant to such authorization4 7#d7 ,rule of construction ,nothing in this subsection shall be construed to preempt ,state laws applicable to patient consent for the access of information through a health information exchange 7or other relevant platform7 that provide protections to patients that are greater than the protections otherwise provided for under applicable ,federal law4 7d7 ,efforts ,to promote access to health information ,the ,national ,coordinator and the ,office for ,civil ,rights of the ,department of ,health and ,human ,services shall jointly promote patient access to health information in a manner that would ensure that such information is available in a form convenient for the patient1 in a reasonable manner1 without burdening the health care provider involved4 7e7 ,accessibility of patient records 7#a7 ,accessibility and updating of information 7,a7 ,in general ,the ,secretary1 in consultation with the ,national ,coordinator1 shall promote policies that ensure that a patient's electronic health information is accessible to that patient and the patient's designees1 in a manner that facilitates communication with the patient's health care providers and other individuals1 including researchers1 consistent with such patient's consent4 7,b7 ,updating education on accessing and exchanging personal health information ,to promote awareness that an individual has a right of access to inspect1 obtain a copy of1 and transmit to a third party a copy of such individual's protected health information pursuant to the ,health ,information ,portability and ,accountability ,act1 ,privacy ,rule 7subpart ,e of part #afd of title #de1 ,code of ,federal ,regulations71 the ,director of the ,office for ,civil ,rights1 in consultation with the ,national ,coordinator1 shall assist individuals and health care providers in understanding a patient's rights to access and protect personal health information under the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia71 including providing best practices for requesting personal health information in a computable format1 including using patient portals or third-party applications and common cases when a provider is permitted to exchange and provide access to health information4 4 7#b7 ,certifying usability for patients ,in carrying out certification programs under section #cjja7;c77#e71 the ,national ,coordinator may require that-- 7,a7 the certification criteria support-- 7i7 patient access to their electronic health information1 including in a single longitudinal format that is easy to understand1 secure1 and may be updated automatically2 7ii7 the patient's ability to electronically communicate patient-reported information 7such as family history and medical history72 and 7iii7 patient access to their personal electronic health information for research at the option of the patient2 and 7,b7 the ,,hit ,advisory ,committee develop and prioritize standards1 implementation specifications1 and certification criteria required to help support patient access to electronic health information1 patient usability1 and support for technologies that offer patients access to their electronic health information in a single1 longitudinal format that is easy to understand1 secure1 and may be updated automatically4 4 7b7 ,access to information in an electronic format ,section #acdje7;e7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agice7 is amended-- 7#a7 in paragraph 7#a71 by striking and at the end2 7#b7 by redesignating paragraph 7#b7 as paragraph 7#c72 and 7#c7 by inserting after paragraph 7#a71 the following3 7#b7 if the individual makes a request to a business associate for access to1 or a copy of1 protected health information about the individual1 or if an individual makes a request to a business associate to grant such access to1 or transmit such copy directly to1 a person or entity designated by the individual1 a business associate may provide the individual with such access or copy1 which may be in an electronic form1 or grant or transmit such access or copy to such person or entity designated by the individual2 and 4 #djjg4 ,,gao study on patient matching 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 review the policies and activities of the ,office of the ,national ,coordinator for ,health ,information ,technology and other relevant stakeholders1 which may include standards development organizations1 experts in the technical aspects of health information technology1 health information technology developers1 providers of health services1 health care suppliers1 health care payers1 health care quality organizations1 ,states1 health information technology policy experts1 and other appropriate entities1 to ensure appropriate patient matching to protect patient privacy and security with respect to electronic health records and the exchange of electronic health information2 and 7#b7 survey ongoing efforts related to the policies and activities described in paragraph 7#a7 and the effectiveness of such efforts occurring in the private sector4 7b7 ,areas of concentration ,in conducting the study under subsection 7a71 the ,comptroller ,general shall-- 7#a7 evaluate current methods used in certified electronic health records for patient matching based on performance related to factors such as-- 7,a7 the privacy of patient information2 7,b7 the security of patient information2 7,c7 improving matching rates2 7,d7 reducing matching errors2 and 7,e7 reducing duplicate records2 and 7#b7 determine whether the ,office of the ,national ,coordinator for ,health ,information ,technology could improve patient matching by taking steps including-- 7,a7 defining additional data elements to assist in patient data matching2 7,b7 agreeing on a required minimum set of elements that need to be collected and exchanged2 7,c7 requiring electronic health records to have the ability to make certain fields required and use specific standards2 and 7,d7 other options recommended by the relevant stakeholders consulted pursuant to subsection 7a74 7c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the appropriate committees of ,congress a report concerning the findings of the study conducted under subsection 7a74 #djjh4 ,,gao study on patient access to health information 7a7 ,study 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall build on prior ,government ,accountability ,office studies and other literature review and conduct a study to review patient access to their own protected health information1 including barriers to such patient access and complications or difficulties providers experience in providing access to patients4 ,in conducting such study1 the ,comptroller ,general shall consider the increase in adoption of health information technology and the increasing prevalence of protected health information that is maintained electronically4 7#b7 ,areas of concentration ,in conducting the review under paragraph 7#a71 the ,comptroller ,general shall consider-- 7,a7 instances when covered entities charge individuals1 including patients1 third parties1 and health care providers1 for record requests1 including records that are requested in an electronic format2 7,b7 examples of the amounts and types of fees charged to individuals for record requests1 including instances when the record is requested to be transmitted to a third party2 7,c7 the extent to which covered entities are unable to provide the access requested by individuals in the form and format requested by the individual1 including examples of such instances2 7,d7 instances in which third parties may request protected health information through patients' individual right of access1 including instances where such requests may be used to circumvent appropriate fees that may be charged to third parties2 7,e7 opportunities that permit covered entities to charge appropriate fees to third parties for patient records while providing patients with access to their protected health information at low or no cost2 7,f7 the ability of providers to distinguish between requests originating from an individual that require limitation to a cost-based fee and requests originating from third parties that may not be limited to cost-based fees2 and 7,g7 other circumstances that may inhibit the ability of providers to provide patients with access to their records1 and the ability of patients to gain access to their records4 7b7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general shall submit a report to ,congress on the findings of the study conducted under subsection 7a74 #djji4 ,improving ,medicare local coverage determinations 7a7 ,in general ,section #ahfb7l77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#e77 is amended by adding at the end the following new subparagraph3 7,d7 ,local coverage determinations ,the ,secretary shall require each ,medicare administrative contractor that develops a local coverage determination to make available on the ,internet website of such contractor and on the ,medicare ,internet website1 at least #de days before the effective date of such determination1 the following information3 7i7 ,such determination in its entirety4 7ii7 ,where and when the proposed determination was first made public4 7iii7 ,hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination4 7iv7 ,a summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence4 7v7 ,an explanation of the rationale that supports such determination4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is #ahj days after the date of enactment of this ,act4 #djaj4 ,medicare pharmaceutical and technology ombudsman ,section #ahjh of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#i7 is amended by adding at the end the following new subsection3 7d7 ,pharmaceutical and technology ombudsman 7#a7 ,in general ,not later than #ab months after the date of enactment of this paragraph1 the ,secretary shall provide for a pharmaceutical and technology ombudsman within the ,centers for ,medicare ,medicaid ,services who shall receive and respond to complaints1 grievances1 and requests that-- 7,a7 are from entities that manufacture pharmaceutical1 biotechnology1 medical device1 or diagnostic products that are covered or for which coverage is being sought under this title2 and 7,b7 are with respect to coverage1 coding1 or payment under this title for such products4 7#b7 ,application ,the second sentence of subsection 7c77#b7 shall apply to the ombudsman under subparagraph 7,a7 in the same manner as such sentence applies to the ,medicare ,beneficiary ,ombudsman under subsection 7c74 4 #djaa4 ,medicare site-of-service price transparency ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7t7 ,site-of-,service price transparency 7#a7 ,in general ,in order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title1 the ,secretary shall1 for #bjah and each year thereafter1 make available to the public via a searchable ,internet website1 with respect to an appropriate number of such items and services-- 7,a7 the estimated payment amount for the item or service under the outpatient department fee schedule under subsection 7t7 of section #ahcc and the ambulatory surgical center payment system under subsection 7i7 of such section2 and 7,b7 the estimated amount of beneficiary liability applicable to the item or service4 7#b7 ,calculation of estimated beneficiary liability ,for purposes of paragraph 7#a77;,b71 the estimated amount of beneficiary liability1 with respect to an item or service1 is the amount for such item or service for which an individual who does not have coverage under a ,medicare supplemental policy certified under section #ahhb or any other supplemental insurance coverage is responsible4 7#c7 ,implementation ,in carrying out this subsection1 the ,secretary-- 7,a7 shall include in the notice described in section #ahjd7;a7 a notification of the availability of the estimated amounts made available under paragraph 7#a72 and 7,b7 may utilize mechanisms in existence on the date of enactment of this subsection1 such as the portion of the ,internet website of the ,centers for ,medicare ,medicaid ,services on which information comparing physician performance is posted 7commonly referred to as the ,physician ,compare ,internet website71 to make available such estimated amounts under such paragraph4 7#d7 ,funding ,for purposes of implementing this subsection1 the ,secretary shall provide for the transfer1 from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 of #f1jjj1jjj for fiscal year #bjag1 to remain available until expended4 4 #djab4 ,telehealth services in ,medicare 7a7 ,provision of information by ,centers for ,medicare ,medicaid ,services ,not later than #a year after the date of enactment of this ,act1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall provide to the committees of jurisdiction of the ,house of ,representatives and the ,senate information on the following3 7#a7 ,the populations of ,medicare beneficiaries1 such as those who are dually eligible for the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 and the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 and those with chronic conditions1 whose care may be improved most in terms of quality and efficiency by the expansion1 in a manner that meets or exceeds the existing in-person standard of care under the ,medicare program under such title ,,xviii1 of telehealth services under section #ahcd7m77#d7 of such ,act 7#db ,u4,s4,c4 #aciem7m77#d774 7#b7 ,activities by the ,center for ,medicare and ,medicaid ,innovation which examine the use of telehealth services in models1 projects1 or initiatives funded through section #aaae;,a of such ,act 7#db ,u4,s4,c4 #acae;a74 7#c7 ,the types of high-volume services 7and related diagnoses7 under such title ,,xviii which might be suitable to be furnished using telehealth4 7#d7 ,barriers that might prevent the expansion of telehealth services under section #ahcd7m77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77 beyond such services that are in effect as of the date of enactment of this ,act4 7b7 ,provision of information by ,med,p,a,c ,not later than ,march #ae1 #bjah1 the ,medicare ,payment ,advisory ,commission established under section #ahje of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f7 shall1 using quantitative and qualitative research methods1 provide information to the committees of jurisdiction of the ,house of ,representatives and the ,senate that identifies-- 7#a7 the telehealth services for which payment can be made1 as of the date of enactment of this ,act1 under the fee-for-service program under parts ,a and ,b of title ,,xviii of such ,act2 7#b7 the telehealth services for which payment can be made1 as of such date1 under private health insurance plans2 and 7#c7 with respect to services identified under paragraph 7#b7 but not under paragraph 7#a71 ways in which payment for such services might be incorporated into such fee-for-service program 7including any recommendations for ways to accomplish this incorporation74 7c7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 eligible originating sites should be expanded beyond those originating sites described in section #ahcd7m77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c772 and 7#b7 any expansion of telehealth services under the ,medicare program under title ,,xviii of such ,act should-- 7,a7 recognize that telemedicine is the delivery of safe1 effective1 quality health care services1 by a health care provider1 using technology as the mode of care delivery2 7,b7 meet or exceed the conditions of coverage and payment with respect to the ,medicare program if the service was furnished in person1 including standards of care1 unless specifically addressed in subsequent legislation2 and 7,c7 involve clinically appropriate means to furnish such services4 ,v ,savings #ejja4 ,savings in the ,medicare ,improvement ,fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a771 as amended by section #gjd7;h7 of the ,comprehensive ,addiction and ,recovery ,act of #bjaf1 is amended by striking #adj1jjj1jjj and inserting #bgj1jjj1jjj4 #ejjb4 ,medicaid reimbursement to ,states for durable medical equipment ,section #aijc7;i77#bg7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#bg77 is amended by striking ,january #a1 #bjai and inserting ,january #a1 #bjah4 #ejjc4 ,penalties for violations of grants1 contracts1 and other agreements 7a7 ,in general ,section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is amended by adding at the end the following new subsections3 7o7 ,any person 7including an organization1 agency1 or other entity1 but excluding a program beneficiary1 as defined in subsection 7q77#d77 that1 with respect to a grant1 contract1 or other agreement for which the ,secretary provides funding-- 7#a7 knowingly presents or causes to be presented a specified claim 7as defined in subsection 7r77 under such grant1 contract1 or other agreement that the person knows or should know is false or fraudulent2 7#b7 knowingly makes1 uses1 or causes to be made or used any false statement1 omission1 or misrepresentation of a material fact in any application1 proposal1 bid1 progress report1 or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such ,secretary pursuant to such grant1 contract1 or other agreement2 7#c7 knowingly makes1 uses1 or causes to be made or used1 a false record or statement material to a false or fraudulent specified claim under such grant1 contract1 or other agreement2 7#d7 knowingly makes1 uses1 or causes to be made or used1 a false record or statement material to an obligation 7as defined in subsection 7s77 to pay or transmit funds or property to such ,secretary with respect to such grant1 contract1 or other agreement1 or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such ,secretary with respect to such grant1 contract1 or other agreement2 or 7#e7 fails to grant timely access1 upon reasonable request 7as defined by such ,secretary in regulations71 to the ,inspector ,general of the ,department1 for the purpose of audits1 investigations1 evaluations1 or other statutory functions of such ,inspector ,general in matters involving such grants1 contracts1 or other agreements2 shall be subject1 in addition to any other penalties that may be prescribed by law1 to a civil money penalty in cases under paragraph 7#a71 of not more than #aj1jjj for each specified claim2 in cases under paragraph 7#b71 not more than #ej1jjj for each false statement1 omission1 or misrepresentation of a material fact2 in cases under paragraph 7#c71 not more than #ej1jjj for each false record or statement2 in cases under paragraph 7#d71 not more than #ej1jjj for each false record or statement or #aj1jjj for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay2 or in cases under paragraph 7#e71 not more than #ae1jjj for each day of the failure described in such paragraph4 ,in addition1 in cases under paragraphs 7#a7 and 7#c71 such a person shall be subject to an assessment of not more than #c times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the ,united ,states or a specified ,state agency because of such specified claim1 and in cases under paragraphs 7#b7 and 7#d71 such a person shall be subject to an assessment of not more than #c times the total amount of the funds described in paragraph 7#b7 or 7#d71 respectively 7or1 in the case of an obligation to transmit property to the ,secretary described in paragraph 7#d71 of the value of the property described in such paragraph7 in lieu of damages sustained by the ,united ,states or a specified ,state agency because of such case4 ,in addition1 the ,secretary may make a determination in the same proceeding to exclude the person from participation in the ,federal health care programs 7as defined in section #aabh;,b7f77#a77 and to direct the appropriate ,state agency to exclude the person from participation in any ,state health care program4 7p7 ,the provisions of subsections 7c71 7d71 7g71 and 7h7 shall apply to a civil money penalty or assessment under subsection 7o7 in the same manner as such provisions apply to a penalty1 assessment1 or proceeding under subsection 7a74 ,in applying subsection 7d71 each reference to a claim under such subsection shall be treated as including a reference to a specified claim 7as defined in subsection 7r774 7q7 ,for purposes of this subsection and subsections 7o7 and 7p73 7#a7 ,the term ,department means the ,department of ,health and ,human ,services4 7#b7 ,the term material means having a natural tendency to influence1 or be capable of influencing1 the payment or receipt of money or property4 7#c7 ,the term other agreement includes a cooperative agreement1 scholarship1 fellowship1 loan1 subsidy1 payment for a specified use1 donation agreement1 award1 or subaward 7regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor74 7#d7 ,the term program beneficiary means1 in the case of a grant1 contract1 or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the ,secretary provides funding1 an individual who applies for1 or who receives1 such benefits or assistance from such grant1 contract1 or other agreement4 ,such term does not include1 with respect to such grant1 contract1 or other agreement1 an officer1 employee1 or agent of a person or entity that receives such grant or that enters into such contract or other agreement4 7#e7 ,the term recipient includes a subrecipient or subcontractor4 7#f7 ,the term specified ,state agency means an agency of a ,state government established or designated to administer or supervise the administration of a grant1 contract1 or other agreement funded in whole or in part by the ,secretary4 7r7 ,for purposes of this section1 the term specified claim means any application1 request1 or demand under a grant1 contract1 or other agreement for money or property1 whether or not the ,united ,states or a specified ,state agency has title to the money or property1 that is not a claim 7as defined in subsection 7i77#b77 and that-- 7#a7 is presented or caused to be presented to an officer1 employee1 or agent of the ,department or agency thereof1 or of any specified ,state agency2 or 7#b7 is made to a contractor1 grantee1 or any other recipient if the money or property is to be spent or used on the ,department's behalf or to advance a ,department program or interest1 and if the ,department-- 7,a7 provides or has provided any portion of the money or property requested or demanded2 or 7,b7 will reimburse such contractor1 grantee1 or other recipient for any portion of the money or property which is requested or demanded4 7s7 ,for purposes of subsection 7o71 the term obligation means an established duty1 whether or not fixed1 arising from an express or implied contractual1 grantor-grantee1 or licensor-licensee relationship1 for a fee-based or similar relationship1 from statute or regulation1 or from the retention of any overpayment4 4 7b7 ,conforming amendments ,section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 is amended-- 7#a7 in subsection 7e71 by inserting or specified claim after claim in the first sentence2 and 7#b7 in subsection 7f7-- 7,a7 in the matter preceding paragraph 7#a7-- 7i7 by inserting or specified claim 7as defined in subsection 7r77 after district where the claim2 and 7ii7 by inserting 7or1 with respect to a person described in subsection 7o71 the person7 after claimant2 and 7,b7 in the matter following paragraph 7#d71 by inserting 7or1 in the case of a penalty or assessment under subsection 7o71 by a specified ,state agency 7as defined in subsection 7q77#f771 after or a ,state agency4 #ejjd4 ,reducing overpayments of infusion drugs 7a7 ,treatment of infusion drugs furnished through durable medical equipment ,section #ahdb7o77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77 is amended-- 7#a7 in subparagraph 7,c71 by inserting 7and including a drug or biological described in subparagraph 7,d77i7 furnished on or after ,january #a1 #bjag7 after #bjje2 and 7#b7 in subparagraph 7,d7-- 7,a7 by striking infusion drugs and inserting infusion drugs or biologicals each place it appears2 and 7,b7 in clause 7i7-- 7i7 by striking #bjjd and inserting #bjjd1 and before ,january #a1 #bjag2 and 7ii7 by striking for such drug4 7b7 ,noninclusion of ,,dme infusion drugs under ,,dme competitive acquisition programs 7#a7 ,in general ,section #ahdg7;a77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77;,a77 is amended-- 7,a7 by striking and excluding and inserting 1 excluding2 and 7,b7 by inserting before the period at the end the following3 1 and excluding drugs and biologicals described in section #ahdb7o77#a77;,d74 7#b7 ,conforming amendment ,section #ahdb7o77#a77;,d77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77;,d77ii77 is amended by striking #bjjg and inserting #bjjg1 and before the date of the enactment of the #bast ,century ,cures ,act44 #ejje4 ,increasing oversight of termination of ,medicaid providers 7a7 ,increased oversight and reporting 7#a7 ,state reporting requirements ,section #aijb7kk7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77 is amended-- 7,a7 by redesignating paragraph 7#h7 as paragraph 7#i72 and 7,b7 by inserting after paragraph 7#g7 the following new paragraph3 7#h7 ,provider terminations 7,a7 ,in general ,beginning on ,july #a1 #bjah1 in the case of a notification under subsection 7a77#da7 with respect to a termination for a reason specified in section #dee4aja of title #db1 ,code of ,federal ,regulations 7as in effect on ,november #a1 #bjae7 or for any other reason specified by the ,secretary1 of the participation of a provider of services or any other person under the ,state plan 7or under a waiver of the plan71 the ,state1 not later than #cj days after the effective date of such termination1 submits to the ,secretary with respect to any such provider or person1 as appropriate-- 7i7 the name of such provider or person2 7ii7 the provider type of such provider or person2 7iii7 the specialty of such provider's or person's practice2 7iv7 the date of birth1 ,social ,security number1 national provider identifier 7if applicable71 ,federal taxpayer identification number1 and the ,state license or certification number of such provider or person 7if applicable72 7v7 the reason for the termination2 7vi7 a copy of the notice of termination sent to the provider or person2 7vii7 the date on which such termination is effective1 as specified in the notice2 and 7viii7 any other information required by the ,secretary4 7,b7 ,effective date defined ,for purposes of this paragraph1 the term effective date means1 with respect to a termination described in subparagraph 7,a71 the later of-- 7i7 the date on which such termination is effective1 as specified in the notice of such termination2 or 7ii7 the date on which all appeal rights applicable to such termination have been exhausted or the timeline for any such appeal has expired4 4 7#b7 ,contract requirement for managed care entities ,section #aicb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;d77 is amended by adding at the end the following new paragraph3 7#e7 ,contract requirement for managed care entities ,with respect to any contract with a managed care entity under section #aijc7m7 or #aije7t77#c7 7as applicable71 no later than ,july #a1 #bjah1 such contract shall include a provision that providers of services or persons terminated 7as described in section #aijb7kk77#h77 from participation under this title1 title ,,xviii1 or title ,,xxi shall be terminated from participating under this title as a provider in any network of such entity that serves individuals eligible to receive medical assistance under this title4 4 7#c7 ,termination ,notification ,database ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is amended by adding at the end the following new subsection3 7ll7 ,termination notification database ,in the case of a provider of services or any other person whose participation under this title or title ,,xxi is terminated 7as described in subsection 7kk77#h771 the ,secretary shall1 not later than #cj days after the date on which the ,secretary is notified of such termination under subsection 7a77#da7 7as applicable71 review such termination and1 if the ,secretary determines appropriate1 include such termination in any database or similar system developed pursuant to section #fdja7;b77#b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acie;cc note2 ,public ,law #aaa-adh74 4 7#d7 ,no ,federal funds for items and services furnished by terminated providers ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is amended-- 7,a7 in subsection 7i77#b7-- 7i7 in subparagraph 7,a71 by striking the comma at the end and inserting a semicolon2 7ii7 in subparagraph 7,b71 by striking or at the end2 and 7iii7 by adding at the end the following new subparagraph3 7,d7 beginning on ,july #a1 #bjah1 under the plan by any provider of services or person whose participation in the ,state plan is terminated 7as described in section #aijb7kk77#h77 after the date that is #fj days after the date on which such termination is included in the database or other system under section #aijb7ll72 or 2 and 7,b7 in subsection 7m71 by inserting after paragraph 7#b7 the following new paragraph3 7#c7 ,no payment shall be made under this title to a ,state with respect to expenditures incurred by the ,state for payment for services provided by a managed care entity 7as defined under section #aicb7;a77#a77 under the ,state plan under this title 7or under a waiver of the plan7 unless the ,state-- 7,a7 beginning on ,july #a1 #bjah1 has a contract with such entity that complies with the requirement specified in section #aicb7;d77#e72 and 7,b7 beginning on ,january #a1 #bjah1 complies with the requirement specified in section #aicb7;d77#f77;,a74 4 7#e7 ,development of uniform terminology for reasons for provider termination ,not later than ,july #a1 #bjag1 the ,secretary of ,health and ,human ,services shall1 in consultation with the heads of ,state agencies administering ,state ,medicaid plans 7or waivers of such plans71 issue regulations establishing uniform terminology to be used with respect to specifying reasons under subparagraph 7,a77v7 of paragraph 7#h7 of section #aijb7kk7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk771 as added by paragraph 7#a71 for the termination 7as described in such paragraph 7#h77 of the participation of certain providers in the ,medicaid program under title ,,xix of such ,act or the ,children's ,health ,insurance ,program under title ,,xxi of such ,act4 7#f7 ,conforming amendment ,section #aijb7;a77#da7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#da77 is amended by striking provide that whenever and inserting provide1 in accordance with subsection 7kk77#h7 7as applicable71 that whenever4 7b7 ,increasing availability of ,medicaid provider information 7#a7 ,,ffs provider enrollment ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is amended by inserting after paragraph 7#gg7 the following new paragraph3 7#gh7 provide that1 not later than ,january #a1 #bjag1 in the case of a ,state that pursuant to its ,state plan or waiver of the plan for medical assistance pays for medical assistance on a fee-for-service basis1 the ,state shall require each provider furnishing items and services to1 or ordering1 prescribing1 referring1 or certifying eligibility for1 services for individuals eligible to receive medical assistance under such plan to enroll with the ,state agency and provide to the ,state agency the provider's identifying information1 including the name1 specialty1 date of birth1 ,social ,security number1 national provider identifier 7if applicable71 ,federal taxpayer identification number1 and the ,state license or certification number of the provider 7if applicable72 4 7#b7 ,managed care provider enrollment ,section #aicb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;d771 as amended by subsection 7a77#b71 is amended by adding at the end the following new paragraph3 7#f7 ,enrollment of participating providers 7,a7 ,in general ,beginning not later than ,january #a1 #bjah1 a ,state shall require that1 in order to participate as a provider in the network of a managed care entity that provides services to1 or orders1 prescribes1 refers1 or certifies eligibility for services for1 individuals who are eligible for medical assistance under the ,state plan under this title 7or under a waiver of the plan7 and who are enrolled with the entity1 the provider is enrolled consistent with section #aijb7kk7 with the ,state agency administering the ,state plan under this title4 ,such enrollment shall include providing to the ,state agency the provider's identifying information1 including the name1 specialty1 date of birth1 ,social ,security number1 national provider identifier1 ,federal taxpayer identification number1 and the ,state license or certification number of the provider4 7,b7 ,rule of construction ,nothing in subparagraph 7,a7 shall be construed as requiring a provider described in such subparagraph to provide services to individuals who are not enrolled with a managed care entity under this title4 4 7c7 ,coordination with ,,chip 7#a7 ,in general ,section #bajg7;e77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77 is amended-- 7,a7 by redesignating subparagraphs 7,b71 7,c71 7,d71 7,e71 7,f71 7,g71 7,h71 7,i71 7,j71 7,k71 7,l71 7,m71 7,n71 and 7,o7 as subparagraphs 7,d71 7,e71 7,f71 7,g71 7,h71 7,i71 7,j71 7,k71 7,m71 7,n71 7,o71 7,p71 7,q71 and 7,r71 respectively2 7,b7 by inserting after subparagraph 7,a7 the following new subparagraphs3 7,b7 ,section #aijb7;a77#ci7 7relating to termination of participation of certain providers74 7,c7 ,section #aijb7;a77#gh7 7relating to enrollment of providers participating in ,state plans providing medical assistance on a fee-for-service basis74 2 7,c7 by inserting after subparagraph 7,k7 7as redesignated by subparagraph 7,a77 the following new subparagraph3 7,l7 ,section #aijc7m77#c7 7relating to limitation on payment with respect to managed care74 2 and 7,d7 in subparagraph 7,p7 7as redesignated by subparagraph 7,a771 by striking 7a77#b77;,c7 and 7h7 and inserting 7a77#b77;,c7 7relating to ,indian enrollment71 7d77#e7 7relating to contract requirement for managed care entities71 7d77#f7 7relating to enrollment of providers participating with a managed care entity71 and 7h7 7relating to special rules with respect to ,indian enrollees1 ,indian health care providers1 and ,indian managed care entities74 7#b7 ,excluding from ,medicaid providers excluded from ,,chip ,section #aijb7;a77#ci7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#ci77 is amended by striking title ,,xviii or any other ,state plan under this title and inserting title ,,xviii1 any other ,state plan under this title 7or waiver of the plan71 or any ,state child health plan under title ,,xxi 7or waiver of the plan7 and such termination is included by the ,secretary in any database or similar system developed pursuant to section #fdja7;b77#b7 of the ,patient ,protection and ,affordable ,care ,act4 7d7 ,rule of construction ,nothing in this section shall be construed as changing or limiting the appeal rights of providers or the process for appeals of ,states under the ,social ,security ,act4 7e7 ,,oig report ,not later than ,march #ca1 #bjbj1 the ,inspector ,general of the ,department of ,health and ,human ,services shall submit to ,congress a report on the implementation of the amendments made by this section4 ,such report shall include the following3 7#a7 ,an assessment of the extent to which providers who are included under subsection 7ll7 of section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 7as added by subsection 7a77#c77 in the database or similar system referred to in such subsection are terminated 7as described in paragraph 7#h7 of subsection 7kk7 of such section1 as added by subsection 7a77#a77 from participation in all ,state plans under title ,,xix of such ,act 7or waivers of such plans74 7#b7 ,information on the amount of ,federal financial participation paid to ,states under section #aijc of such ,act in violation of the limitation on such payment specified in subparagraph 7,d7 of subsection 7i77#b7 of such section and paragraph 7#c7 of subsection 7m7 of such section1 as added by subsection 7a77#d74 7#c7 ,an assessment of the extent to which contracts with managed care entities under title ,,xix of such ,act comply with the requirement specified in paragraph 7#e7 of section #aicb7;d7 of such ,act1 as added by subsection 7a77#b74 7#d7 ,an assessment of the extent to which providers have been enrolled under section #aijb7;a77#gh7 or #aicb7;d77#f77;,a7 of such ,act 7#db ,u4,s4,c4 #acif;a7a77#gh71 #acifu-#b7;d77#f77;,a77 with ,state agencies administering ,state plans under title ,,xix of such ,act 7or waivers of such plans74 #ejjf4 ,requiring publication of fee-for-service provider directory 7a7 ,in general ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is amended-- 7#a7 in paragraph 7#ha71 by striking and at the end2 7#b7 in paragraph 7#hb71 by striking the period at the end and inserting 2 and2 and 7#c7 by inserting after paragraph 7#hb7 the following new paragraph3 7#hc7 provide that1 not later than ,january #a1 #bjag1 in the case of a ,state plan 7or waiver of the plan7 that provides medical assistance on a fee-for-service basis or through a primary care case-management system described in section #aiae7;b77#a7 7other than a primary care case management entity 7as defined by the ,secretary771 the ,state shall publish 7and update on at least an annual basis7 on the public website of the ,state agency administering the ,state plan1 a directory of the physicians described in subsection 7mm7 and1 at ,state option1 other providers described in such subsection that-- 7,a7 includes-- 7i7 with respect to each such physician or provider-- 7,i7 the name of the physician or provider2 7,,ii7 the specialty of the physician or provider2 7,,iii7 the address at which the physician or provider provides services2 and 7,,iv7 the telephone number of the physician or provider2 and 7ii7 with respect to any such physician or provider participating in such a primary care case-management system1 information regarding-- 7,i7 whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title2 and 7,,ii7 the physician's or provider's cultural and linguistic capabilities1 including the languages spoken by the physician or provider or by the skilled medical interpreter providing interpretation services at the physician's or provider's office2 and 7,b7 may include1 at ,state option1 with respect to each such physician or provider-- 7i7 the ,internet website of such physician or provider2 or 7ii7 whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title4 4 7b7 ,directory physician or provider described ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 as amended by section #ejje7;a77#c71 is further amended by adding at the end the following new subsection3 7mm7 ,directory physician or provider described ,a physician or provider described in this subsection is-- 7#a7 in the case of a physician or provider of a provider type for which the ,state agency1 as a condition on receiving payment for items and services furnished by the physician or provider to individuals eligible to receive medical assistance under the ,state plan1 requires the enrollment of the physician or provider with the ,state agency1 a physician or a provider that-- 7,a7 is enrolled with the agency as of the date on which the directory is published or updated 7as applicable7 under subsection 7a77#hc72 and 7,b7 received payment under the ,state plan in the #ab-month period preceding such date2 and 7#b7 in the case of a physician or provider of a provider type for which the ,state agency does not require such enrollment1 a physician or provider that received payment under the ,state plan 7or a waiver of the plan7 in the #ab-month period preceding the date on which the directory is published or updated 7as applicable7 under subsection 7a77#hc74 4 7c7 ,rule of construction 7#a7 ,in general ,the amendment made by subsection 7a7 shall not be construed to apply in the case of a ,state 7as defined for purposes of title ,,xix of the ,social ,security ,act7 in which all the individuals enrolled in the ,state plan under such title 7or under a waiver of such plan71 other than individuals described in paragraph 7#b71 are enrolled with a medicaid managed care organization 7as defined in section #aijc7m77#a77;,a7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77#a77;,a7771 including prepaid inpatient health plans and prepaid ambulatory health plans 7as defined by the ,secretary of ,health and ,human ,services74 7#b7 ,individuals described ,an individual described in this paragraph is an individual who is an ,indian 7as defined in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc77 or an ,alaska ,native4 7d7 ,exception for ,state legislation ,in the case of a ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 which the ,secretary of ,health and ,human ,services determines requires ,state legislation in order for the respective plan to meet one or more additional requirements imposed by amendments made by this section1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session shall be considered to be a separate regular session of the ,state legislature4 #ejjg4 ,fairness in ,medicaid supplemental needs trusts 7a7 ,in general ,section #aiag7;d77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifp7d77#d77;,a77 is amended by inserting the individual1 after for the benefit of such individual by4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to trusts established on or after the date of the enactment of this ,act4 #ejjh4 ,eliminating ,federal financial participation with respect to expenditures under ,medicaid for agents used for cosmetic purposes or hair growth 7a7 ,in general ,section #aijc7;i77#ba7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#ba77 is amended by inserting section #aibg7;d77#b77;,c7 7relating to drugs when used for cosmetic purposes or hair growth71 except where medically necessary1 and after drugs described in4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to calendar quarters beginning on or after the date of the enactment of this ,act4 #ejji4 ,amendment to the ,prevention and ,public ,health ,fund ,section #djjb7;b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #cjju-#aa7;b77 is amended-- 7#a7 in paragraph 7#c71 by striking #a1bej1jjj1jjj and inserting #ijj1jjj1jjj2 7#b7 in paragraph 7#d71 by striking #a1ejj1jjj1jjj and inserting #a1jjj1jjj1jjj2 and 7#c7 by striking paragraph 7#e7 and inserting the following3 7#e7 for fiscal year #bjbb1 #a1ejj1jjj1jjj2 7#f7 for fiscal year #bjbc1 #a1jjj1jjj1jjj2 7#g7 for fiscal year #bjbd1 #a1gjj1jjj1jjj2 and 7#h7 for fiscal year #bjbe and each fiscal year thereafter1 #b1jjj1jjj1jjj4 4 #ejaj4 ,strategic ,petroleum ,reserve drawdown 7a7 ,drawdown and ,sale 7#a7 ,in general ,notwithstanding section #afa of the ,energy ,policy and ,conservation ,act 7#db ,u4,s4,c4 #fbda71 except as provided in subsections 7b7 and 7c71 the ,secretary of ,energy shall drawdown and sell from the ,strategic ,petroleum ,reserve-- 7,a7 #aj1jjj1jjj barrels of crude oil during fiscal year #bjag2 7,b7 #i1jjj1jjj barrels of crude oil during fiscal year #bjah2 and 7,c7 #f1jjj1jjj barrels of crude oil during fiscal year #bjai4 7#b7 ,deposit of amounts received from sale ,amounts received from a sale under paragraph 7#a7 shall be deposited in the general fund of the ,treasury during the fiscal year in which the sale occurs4 7b7 ,emergency ,protection ,the ,secretary shall not draw down and sell crude oil under this section in quantities that would limit the authority to sell petroleum products under section #afa7;h7 of the ,energy ,policy and ,conservation ,act 7#db ,u4,s4,c4 #fbda7;h77 in the full quantity authorized by that subsection4 7c7 ,strategic ,petroleum drawdown limitations ,subparagraphs 7,c7 and 7,d7 of section #afa7;h77#b7 of the ,energy ,policy and ,conservation ,act 7#db ,u4,s4,c4 #fbda7;h77#b77;,c7 and 7,d77 are both amended by striking #ejj1jjj1jjj and inserting #dej1jjj1jjj4 #ejaa4 ,rescission of portion of ,,aca territory funding ,of the unobligated amounts available under section #acbc7;c77#a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjdc7;c77#a771 #dfd1jjj1jjj is rescinded immediately upon the date of the enactment of this ,act4 #ejab4 ,medicare coverage of home infusion therapy 7a7 ,in general ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7s77#b7-- 7,a7 by striking and at the end of subparagraph 7,,ee72 7,b7 by inserting and at the end of subparagraph 7,,ff72 and 7,c7 by inserting at the end the following new subparagraph3 7,,gg7 home infusion therapy 7as defined in subsection 7iii77#a772 2 and 7#b7 by adding at the end the following new subsection3 7iii7 ,home ,infusion ,therapy 7#a7 ,the term home infusion therapy means the items and services described in paragraph 7#b7 furnished by a qualified home infusion therapy supplier 7as defined in paragraph 7#c77;,d77 which are furnished in the individual's home 7as defined in paragraph 7#c77;,b77 to an individual-- 7,a7 who is under the care of an applicable provider 7as defined in paragraph 7#c77;,a772 and 7,b7 with respect to whom a plan prescribing the type1 amount1 and duration of infusion therapy services that are to be furnished such individual has been established by a physician 7as defined in subsection 7r77#a77 and is periodically reviewed by a physician 7as so defined7 in coordination with the furnishing of home infusion drugs 7as defined in paragraph 7#c77;,c77 under part ,b4 7#b7 ,the items and services described in this paragraph are the following3 7,a7 ,professional services1 including nursing services1 furnished in accordance with the plan4 7,b7 ,training and education 7not otherwise paid for as durable medical equipment 7as defined in subsection 7n771 remote monitoring1 and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier4 7#c7 ,for purposes of this subsection3 7,a7 ,the term applicable provider means-- 7i7 a physician2 7ii7 a nurse practitioner2 and 7iii7 a physician assistant4 7,b7 ,the term home means a place of residence used as the home of an individual 7as defined for purposes of subsection 7n774 7,c7 ,the term home infusion drug means a parenteral drug or biological administered intravenously1 or subcutaneously for an administration period of #ae minutes or more1 in the home of an individual through a pump that is an item of durable medical equipment 7as defined in subsection 7n774 ,such term does not include the following3 7i7 ,insulin pump systems4 7ii7 ,a self-administered drug or biological on a self-administered drug exclusion list4 7,d7 7i7 ,the term qualified home infusion therapy supplier means a pharmacy1 physician1 or other provider of services or supplier licensed by the ,state in which the pharmacy1 physician1 or provider or services or supplier furnishes items or services and that-- 7,i7 furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs2 7,,ii7 ensures the safe and effective provision and administration of home infusion therapy on a #g-;day-a-week1 #bd-;hour-a-day basis2 7,,iii7 is accredited by an organization designated by the ,secretary pursuant to section #ahcd7u77#e72 and 7,,iv7 meets such other requirements as the ,secretary determines appropriate1 taking into account the standards of care for home infusion therapy established by ,medicare ,advantage plans under part ,c and in the private sector4 7ii7 ,a qualified home infusion therapy supplier may subcontract with a pharmacy1 physician1 provider of services1 or supplier to meet the requirements of this subparagraph4 4 7b7 ,payment and related requirements for home infusion therapy ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem71 as amended by section #djaa1 is further amended by adding at the end the following new subsection3 7u7 ,payment and related requirements for home infusion therapy 7#a7 ,payment 7,a7 ,single payment 7i7 ,in general ,subject to clause 7iii7 and subparagraphs 7,b7 and 7,c71 the ,secretary shall implement a payment system under which a single payment is made under this title to a qualified home infusion therapy supplier for items and services described in subparagraphs 7,a7 and 7,b7 of section #ahfa7;iii77#b77 furnished by a qualified home infusion therapy supplier 7as defined in section #ahfa7;iii77#c77;,d77 in coordination with the furnishing of home infusion drugs 7as defined in section #ahfa7;iii77#c77;,c77 under this part4 7ii7 ,unit of single payment ,a unit of single payment under the payment system implemented under this subparagraph is for each infusion drug administration calendar day in the individual's home4 ,the ,secretary shall1 as appropriate1 establish single payment amounts for types of infusion therapy1 including to take into account variation in utilization of nursing services by therapy type4 7iii7 ,limitation ,the single payment amount determined under this subparagraph after application of subparagraph 7,b7 and paragraph 7#c7 shall not exceed the amount determined under the fee schedule under section #ahdh for infusion therapy services furnished in a calendar day if furnished in a physician office setting1 except such single payment shall not reflect more than #e hours of infusion for a particular therapy in a calendar day4 7,b7 ,required adjustments ,the ,secretary shall adjust the single payment amount determined under subparagraph 7,a7 for home infusion therapy services under section #ahfa7;iii77#a7 to reflect other factors such as-- 7i7 a geographic wage index and other costs that may vary by region2 and 7ii7 patient acuity and complexity of drug administration4 7,c7 ,discretionary adjustments 7i7 ,in general ,subject to clause 7ii71 the ,secretary may adjust the single payment amount determined under subparagraph 7,a7 7after application of subparagraph 7,b77 to reflect outlier situations and other factors as the ,secretary determines appropriate4 7ii7 ,requirement of budget neutrality ,any adjustment under this subparagraph shall be made in a budget neutral manner4 7#b7 ,considerations ,in developing the payment system under this subsection1 the ,secretary may consider the costs of furnishing infusion therapy in the home1 consult with home infusion therapy suppliers1 consider payment amounts for similar items and services under this part and part ,a1 and consider payment amounts established by ,medicare ,advantage plans under part ,c and in the private insurance market for home infusion therapy 7including average per treatment day payment amounts by type of home infusion therapy74 7#c7 ,annual updates 7,a7 ,in general ,subject to subparagraph 7,b71 the ,secretary shall update the single payment amount under this subsection from year to year beginning in #bjbb by increasing the single payment amount from the prior year by the percentage increase in the ,consumer ,price ,index for all urban consumers 7,united ,states city average7 for the #ab-month period ending with ,june of the preceding year4 7,b7 ,adjustment ,for each year1 the ,secretary shall reduce the percentage increase described in subparagraph 7,a7 by the productivity adjustment described in section #ahhf7;b77#c77;,b77xi77,,ii74 ,the application of the preceding sentence may result in a percentage being less than #j4j for a year1 and may result in payment being less than such payment rates for the preceding year4 7#d7 ,authority to apply prior authorization ,the ,secretary may1 as determined appropriate by the ,secretary1 apply prior authorization for home infusion therapy services under section #ahfa7;iii77#a74 7#e7 ,accreditation of qualified home infusion therapy suppliers 7,a7 ,factors for designation of accreditation organizations ,the ,secretary shall consider the following factors in designating accreditation organizations under subparagraph 7,b7 and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph 7,c73 7i7 ,the ability of the organization to conduct timely reviews of accreditation applications4 7ii7 ,the ability of the organization to take into account the capacities of suppliers located in a rural area 7as defined in section #ahhf7;d77#b77;,d774 7iii7 ,whether the organization has established reasonable fees to be charged to suppliers applying for accreditation4 7iv7 ,such other factors as the ,secretary determines appropriate4 7,b7 ,designation ,not later than ,january #a1 #bjba1 the ,secretary shall designate organizations to accredit suppliers furnishing home infusion therapy4 ,the list of accreditation organizations so designated may be modified pursuant to subparagraph 7,c74 7,c7 ,review and modification of list of accreditation organizations 7i7 ,in general ,the ,secretary shall review the list of accreditation organizations designated under subparagraph 7,b7 taking into account the factors under subparagraph 7,a74 ,taking into account the results of such review1 the ,secretary may1 by regulation1 modify the list of accreditation organizations designated under subparagraph 7,b74 7ii7 ,special rule for accreditations done prior to removal from list of designated accreditation organizations ,in the case where the ,secretary removes an organization from the list of accreditation organizations designated under subparagraph 7,b71 any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph 7,b7 and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the ,secretary under subparagraph 7,b7 for the remaining period such accreditation is in effect4 7,d7 ,rule for accreditations made prior to designation ,in the case of a supplier that is accredited before ,january #a1 #bjba1 by an accreditation organization designated by the ,secretary under subparagraph 7,b7 as of ,january #a1 #bjai1 such supplier shall be considered to have been accredited by an organization designated by the ,secretary under such paragraph as of ,january #a1 #bjbc1 for the remaining period such accreditation is in effect4 7#f7 ,notification of infusion therapy options available prior to furnishing home infusion therapy ,prior to the furnishing of home infusion therapy to an individual1 the physician who establishes the plan described in section #ahfa7;iii77#a7 for the individual shall provide notification 7in a form1 manner1 and frequency determined appropriate by the ,secretary7 of the options available 7such as home1 physician's office1 hospital outpatient department7 for the furnishing of infusion therapy under this part4 4 7c7 ,conforming amendments 7#a7 ,payment reference ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and before 7,,aa72 and 7,b7 by inserting before the semicolon at the end the following3 1 and 7,,bb7 with respect to home infusion therapy1 the amount paid shall be an amount equal to #hj percent of the lesser of the actual charge for the services or the amount determined under section #ahcd7u74 7#b7 ,direct payment ,the first sentence of section #ahdb7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f77 is amended-- 7,a7 by striking and before 7,h72 and 7,b7 by inserting before the period at the end the following3 1 and 7,i7 in the case of home infusion therapy1 payment shall be made to the qualified home infusion therapy supplier4 7#c7 ,exclusion from home health services ,section #ahfa7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7m77 is amended1 in the first sentence1 by inserting the following before the period at the end3 and home infusion therapy 7as defined in subsection 7iii77i774 7d7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjba4 ,b ,helping ,families in ,mental ,health ,crisis #fjjj4 ,short title ,this division may be cited as the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf4 ,,vi ,strengthening ,leadership and ,accountability ,a ,leadership #fjja4 ,assistant ,secretary for ,mental ,health and ,substance ,use 7a7 ,assistant ,secretary ,section #eja7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa7c77 is amended to read as follows3 7c7 ,assistant secretary and deputy assistant secretary 7#a7 ,assistant ,secretary ,the ,administration shall be headed by an official to be known as the ,assistant ,secretary for ,mental ,health and ,substance ,use 7hereinafter in this title referred to as the ,assistant ,secretary7 who shall be appointed by the ,president1 by and with the advice and consent of the ,senate4 7#b7 ,deputy assistant secretary ,the ,assistant ,secretary1 with the approval of the ,secretary1 may appoint a ,deputy ,assistant ,secretary and may employ and prescribe the functions of such officers and employees1 including attorneys1 as are necessary to administer the activities to be carried out through the ,administration4 4 7b7 ,transfer of authorities ,the ,secretary of ,health and ,human ,services shall delegate to the ,assistant ,secretary for ,mental ,health and ,substance ,use all duties and authorities that-- 7#a7 as of the day before the date of enactment of this ,act1 were vested in the ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration2 and 7#b7 are not terminated by this ,act4 7c7 ,conforming amendments ,title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq471 as amended by the previous provisions of this section1 is further amended-- 7#a7 by striking ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration each place it appears and inserting ,assistant ,secretary for ,mental ,health and ,substance ,use2 and 7#b7 by striking ,administrator or ,administrator each place it appears 7including in any headings7 and inserting ,assistant ,secretary or ,assistant ,secretary1 respectively1 except where the term ,administrator appears-- 7,a7 in each of subsections 7e7 and 7f7 of section #eja of such ,act 7#db ,u4,s4,c4 #bij;aa71 including the headings of such subsections1 within the term ,associate ,administrator2 7,b7 in section #ejg7;b77#f7 of such ,act 7#db ,u4,s4,c4 #bij;bb7b77#f771 within the term ,administrator of the ,health ,resources and ,services ,administration2 7,c7 in section #ejg7;b77#f7 of such ,act 7#db ,u4,s4,c4 #bij;bb7b77#f771 within the term ,administrator of the ,centers for ,medicare ,medicaid ,services2 7,d7 in section #eai;,b7c77#a77;,b7 of such ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7c77#a77;,b771 within the term ,administrator of the ,national ,highway ,traffic ,safety ,administration2 or 7,e7 in each of sections #eai;,b7c77#a77;,b71 #ebj;,c7a71 and #ebj;,d7a7 of such ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7c77#a77;,b71 #bij;bb-#cd7;a71 #bij;bb-#ce7;a771 within the term ,administrator of the ,office of ,juvenile ,justice and ,delinquency ,prevention4 7d7 ,references ,after executing subsections 7a71 7b71 and 7c71 any reference in statute1 regulation1 or guidance to the ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration shall be construed to be a reference to the ,assistant ,secretary for ,mental ,health and ,substance ,use4 #fjjb4 ,strengthening the leadership of the ,substance ,abuse and ,mental ,health ,services ,administration ,section #eja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa71 as amended by section #fjja1 is further amended-- 7#a7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking ,agencies and inserting ,centers2 and 7,b7 in the matter preceding paragraph 7#a71 by striking entities and inserting ,centers2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by striking agencies each place the term appears and inserting ,centers2 and 7ii7 by striking such agency and inserting such ,center2 7,b7 in paragraph 7#b7-- 7i7 by striking agencies and inserting ,centers2 7ii7 by striking with respect to substance abuse and inserting with respect to substance use disorders2 and 7iii7 by striking and individuals who are substance abusers and inserting and individuals with substance use disorders2 7,c7 in paragraph 7#e71 by striking substance abuse and inserting substance use disorder2 7,d7 in paragraph 7#f7-- 7i7 by striking the ,centers for ,disease ,control and inserting the ,centers for ,disease ,control and ,prevention12 7ii7 by striking ,administration develop and inserting ,administration1 develop2 7iii7 by striking ,,hiv or tuberculosis among substance abusers and individuals with mental illness and inserting ,,hiv1 hepatitis1 tuberculosis1 and other communicable diseases among individuals with mental or substance use disorders12 and 7iv7 by striking illnesses at the end and inserting diseases or disorders2 7,e7 in paragraph 7#g71 by striking abuse utilizing anti-addiction medications1 including methadone and inserting use disorders1 including services that utilize drugs or devices approved or cleared by the ,food and ,drug ,administration for the treatment of substance use disorders2 7,f7 in paragraph 7#h7-- 7i7 by striking ,agency for ,health ,care ,policy ,research and inserting ,agency for ,healthcare ,research and ,quality2 and 7ii7 by striking treatment and prevention and inserting prevention and treatment2 7,g7 in paragraph 7#i7-- 7i7 by inserting and maintenance after development2 7ii7 by striking ,agency for ,health ,care ,policy ,research and inserting ,agency for ,healthcare ,research and ,quality2 and 7iii7 by striking treatment and prevention services and inserting prevention1 treatment1 and recovery support services and are appropriately incorporated into programs carried out by the ,administration2 7,h7 in paragraph 7#aj71 by striking abuse and inserting use disorder2 7,i7 by striking paragraph 7#aa7 and inserting the following3 7#aa7 work with relevant agencies of the ,department of ,health and ,human ,services on integrating mental health promotion and substance use disorder prevention with general health promotion and disease prevention and integrating mental and substance use disorders treatment services with physical health treatment services2 2 7,j7 in paragraph 7#ac7-- 7i7 in the matter preceding subparagraph 7,a71 by striking this title1 assure that and inserting this title or part ,b of title ,,xix1 or grant programs otherwise funded by the ,administration2 7ii7 in subparagraph 7,a7-- 7,i7 by inserting require that before all grants2 and 7,,ii7 by striking and at the end2 7iii7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 7iv7 by inserting after subparagraph 7,a7 the following3 7,b7 ensure that the director of each ,center of the ,administration consistently documents the application of criteria when awarding grants and the ongoing oversight of grantees after such grants are awarded2 2 7v7 in subparagraph 7,c71 as so redesignated-- 7,i7 by inserting require that before all grants2 and 7,,ii7 in clause 7ii71 by inserting and after the semicolon at the end2 and 7vi7 by adding at the end the following3 7,d7 inform a ,state when any funds are awarded through such a grant to any entity within such ,state2 2 7,k7 in paragraph 7#af71 by striking abuse and mental health information and inserting use disorder information1 including evidence-based and promising best practices for prevention1 treatment1 and recovery support services for individuals with mental and substance use disorders12 7,l7 in paragraph 7#ag7-- 7i7 by striking substance abuse and inserting substance use disorder2 and 7ii7 by striking and at the end2 7,m7 in paragraph 7#ah71 by striking the period and inserting a semicolon2 and 7,n7 by adding at the end the following3 7#ai7 consult with ,state1 local1 and tribal governments1 nongovernmental entities1 and individuals with mental illness1 particularly adults with a serious mental illness1 children with a serious emotional disturbance1 and the family members of such adults and children1 with respect to improving community-based and other mental health services2 7#bj7 collaborate with the ,secretary of ,defense and the ,secretary of ,veterans ,affairs to improve the provision of mental and substance use disorder services provided by the ,department of ,defense and the ,department of ,veterans ,affairs to members of the ,armed ,forces1 veterans1 and the family members of such members and veterans1 including through the provision of services using the telehealth capabilities of the ,department of ,defense and the ,department of ,veterans ,affairs2 7#ba7 collaborate with the heads of relevant ,federal agencies and departments1 ,states1 communities1 and nongovernmental experts to improve mental and substance use disorders services for chronically homeless individuals1 including by designing strategies to provide such services in supportive housing2 7#bb7 work with ,states and other stakeholders to develop and support activities to recruit and retain a workforce addressing mental and substance use disorders2 7#bc7 collaborate with the ,attorney ,general and representatives of the criminal justice system to improve mental and substance use disorders services for individuals who have been arrested or incarcerated2 7#bd7 after providing an opportunity for public input1 set standards for grant programs under this title for mental and substance use disorders services and prevention programs1 which standards may address-- 7,a7 the capacity of the grantee to implement the award2 7,b7 requirements for the description of the program implementation approach2 7,c7 the extent to which the grant plan submitted by the grantee as part of its application must explain how the grantee will reach the population of focus and provide a statement of need1 which may include information on how the grantee will increase access to services and a description of measurable objectives for improving outcomes2 7,d7 the extent to which the grantee must collect and report on required performance measures2 and 7,e7 the extent to which the grantee is proposing to use evidence-based practices2 and 7#be7 advance1 through existing programs1 the use of performance metrics1 including those based on the recommendations on performance metrics from the ,assistant ,secretary for ,planning and ,evaluation under section #fjba7;d7 of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf4 2 and 7#c7 in subsection 7m71 by adding at the end the following3 7#d7 ,emergency response ,amounts made available for carrying out this subsection shall remain available through the end of the fiscal year following the fiscal year for which such amounts are appropriated4 4 #fjjc4 ,chief ,medical ,officer ,section #eja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa71 as amended by sections #fjja and #fjjb1 is further amended-- 7#a7 by redesignating subsections 7g7 through 7j7 and subsections 7k7 through 7o7 as subsections 7h7 through 7k7 and subsections 7m7 through 7q71 respectively2 7#b7 in subsection 7e77#c77;,c71 by striking subsection 7k7 and inserting subsection 7m72 7#c7 in subsection 7f77#b77;,c77iii71 by striking subsection 7k7 and inserting subsection 7m72 and 7#d7 by inserting after subsection 7f7 the following3 7g7 ,chief medical officer 7#a7 ,in general ,the ,assistant ,secretary1 with the approval of the ,secretary1 shall appoint a ,chief ,medical ,officer to serve within the ,administration4 7#b7 ,eligible candidates ,the ,assistant ,secretary shall select the ,chief ,medical ,officer from among individuals who-- 7,a7 have a doctoral degree in medicine or osteopathic medicine2 7,b7 have experience in the provision of mental or substance use disorder services2 7,c7 have experience working with mental or substance use disorder programs2 7,d7 have an understanding of biological1 psychosocial1 and pharmaceutical treatments of mental or substance use disorders2 and 7,e7 are licensed to practice medicine in one or more ,states4 7#c7 ,duties ,the ,chief ,medical ,officer shall-- 7,a7 serve as a liaison between the ,administration and providers of mental and substance use disorders prevention1 treatment1 and recovery services2 7,b7 assist the ,assistant ,secretary in the evaluation1 organization1 integration1 and coordination of programs operated by the ,administration2 7,c7 promote evidence-based and promising best practices1 including culturally and linguistically appropriate practices1 as appropriate1 for the prevention and treatment of1 and recovery from1 mental and substance use disorders1 including serious mental illness and serious emotional disturbances2 7,d7 participate in regular strategic planning with the ,administration2 7,e7 coordinate with the ,assistant ,secretary for ,planning and ,evaluation to assess the use of performance metrics to evaluate activities within the ,administration related to mental and substance use disorders2 and 7,f7 coordinate with the ,assistant ,secretary to ensure mental and substance use disorders grant programs within the ,administration consistently utilize appropriate performance metrics and evaluation designs4 4 #fjjd4 ,improving the quality of behavioral health programs ,section #eje of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#d71 as amended by section #fjja7;c71 is amended-- 7#a7 by striking the section designation and heading and inserting the following3 #eje4 ,center for ,behavioral ,health ,statistics and ,quality 2 7#b7 by redesignating subsections 7a7 through 7d7 as subsections 7b7 through 7e71 respectively2 7#c7 before subsection 7b71 as redesignated by paragraph 7#b71 by inserting the following3 7a7 ,in general ,the ,assistant ,secretary shall maintain within the ,administration a ,center for ,behavioral ,health ,statistics and ,quality 7in this section referred to as the ,center74 ,the ,center shall be headed by a ,director 7in this section referred to as the ,director7 appointed by the ,secretary from among individuals with extensive experience and academic qualifications in research and analysis in behavioral health care or related fields4 2 7#d7 in subsection 7b71 as redesignated by paragraph 7#b7-- 7,a7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively2 7,b7 by striking ,the ,secretary1 acting and all that follows through year on-- and inserting ,the ,director shall-- 7#a7 coordinate the ,administration's integrated data strategy1 including by collecting data each year on-- 2 7,c7 in the subparagraph 7,b71 as redesignated by subparagraph 7,a71 by striking ,assistant ,secretary and inserting ,director2 and 7,d7 by adding at the end the following new paragraphs3 7#b7 provide statistical and analytical support for activities of the ,administration2 7#c7 recommend a core set of performance metrics to evaluate activities supported by the ,administration2 and 7#d7 coordinate with the ,assistant ,secretary1 the ,assistant ,secretary for ,planning and ,evaluation1 and the ,chief ,medical ,officer appointed under section #eja7;g71 as appropriate1 to improve the quality of services provided by programs of the ,administration and the evaluation of activities carried out by the ,administration4 4 7#e7 in subsection 7c71 as so redesignated-- 7,a7 by striking ,with respect to the activities and inserting ,mental health4--,with respect to the activities2 7,b7 by striking ,assistant ,secretary each place it appears and inserting ,director2 and 7,c7 by striking subsection 7a7 and inserting subsection 7b77#a72 7#f7 in subsection 7d71 as so redesignated-- 7,a7 by striking the subsection designation and all that follows through ,with respect to the activities and inserting the following3 7d7 ,substance abuse 7#a7 ,in general ,with respect to the activities 2 7,b7 in paragraph 7#a7-- 7i7 in the matter before subparagraph 7,a7-- 7,i7 by striking subsection 7a7 and inserting subsection 7b77#a72 and 7,,ii7 by striking ,assistant ,secretary each place it appears and inserting ,director2 and 7ii7 in subparagraph 7,b71 by inserting in coordination with the ,centers for ,disease ,control and ,prevention before the semicolon at the end2 and 7,c7 in paragraph 7#b71 by striking ,annual surveys and inserting ,annual surveys2 public availability of data4--,annual surveys2 and 7#g7 in subsection 7e71 as so redesignated-- 7,a7 by striking ,after consultation and inserting ,consultation4--,after consultation2 and 7,b7 by striking ,assistant ,secretary shall develop and inserting ,assistant ,secretary shall use existing standards and best practices to develop4 #fjje4 ,strategic plan ,section #eja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa71 as amended by sections #fjja through #fjjc1 is further amended by inserting after subsection 7k71 as redesignated by section #fjjc1 the following3 7l7 ,strategic plan 7#a7 ,in general ,not later than ,september #cj1 #bjah1 and every #d years thereafter1 the ,assistant ,secretary shall develop and carry out a strategic plan in accordance with this subsection for the planning and operation of activities carried out by the ,administration1 including evidence-based programs4 7#b7 ,coordination ,in developing and carrying out the strategic plan under this subsection1 the ,assistant ,secretary shall take into consideration the findings and recommendations of the ,assistant ,secretary for ,planning and ,evaluation under section #fjba7;d7 of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf and the report of the ,interdepartmental ,serious ,mental ,illness ,coordinating ,committee under section #fjca of such ,act4 7#c7 ,publication of plan ,not later than ,september #cj1 #bjah1 and every #d years thereafter1 the ,assistant ,secretary shall-- 7,a7 submit the strategic plan developed under paragraph 7#a7 to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate2 and 7,b7 post such plan on the ,internet website of the ,administration4 7#d7 ,contents ,the strategic plan developed under paragraph 7#a7 shall-- 7,a7 identify strategic priorities1 goals1 and measurable objectives for mental and substance use disorders activities and programs operated and supported by the ,administration1 including priorities to prevent or eliminate the burden of mental and substance use disorders2 7,b7 identify ways to improve the quality of services for individuals with mental and substance use disorders1 and to reduce homelessness1 arrest1 incarceration1 violence1 including self-directed violence1 and unnecessary hospitalization of individuals with a mental or substance use disorder1 including adults with a serious mental illness or children with a serious emotional disturbance2 7,c7 ensure that programs provide1 as appropriate1 access to effective and evidence-based prevention1 diagnosis1 intervention1 treatment1 and recovery services1 including culturally and linguistically appropriate services1 as appropriate1 for individuals with a mental or substance use disorder2 7,d7 identify opportunities to collaborate with the ,health ,resources and ,services ,administration to develop or improve-- 7i7 initiatives to encourage individuals to pursue careers 7especially in rural and underserved areas and with rural and underserved populations7 as psychiatrists1 including child and adolescent psychiatrists1 psychologists1 psychiatric nurse practitioners1 physician assistants1 clinical social workers1 certified peer support specialists1 licensed professional counselors1 or other licensed or certified mental health or substance use disorder professionals1 including such professionals specializing in the diagnosis1 evaluation1 or treatment of adults with a serious mental illness or children with a serious emotional disturbance2 and 7ii7 a strategy to improve the recruitment1 training1 and retention of a workforce for the treatment of individuals with mental or substance use disorders1 or co-occurring disorders2 7,e7 identify opportunities to improve collaboration with ,states1 local governments1 communities1 and ,indian tribes and tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act72 and 7,f7 specify a strategy to disseminate evidence-based and promising best practices related to prevention1 diagnosis1 early intervention1 treatment1 and recovery services related to mental illness1 particularly for adults with a serious mental illness and children with a serious emotional disturbance1 and for individuals with a substance use disorder4 4 #fjjf4 ,biennial report concerning activities and progress 7a7 ,in general ,section #eja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa71 as so amended1 is further amended by amending subsection 7m71 as redesignated by section #fjjc1 to read as follows3 7m7 ,biennial report concerning activities and progress ,not later than ,september #cj1 #bjbj1 and every #b years thereafter1 the ,assistant ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate1 and post on the ,internet website of the ,administration1 a report containing at a minimum-- 7#a7 a review of activities conducted or supported by the ,administration1 including progress toward strategic priorities1 goals1 and objectives identified in the strategic plan developed under subsection 7l72 7#b7 an assessment of programs and activities carried out by the ,assistant ,secretary1 including the extent to which programs and activities under this title and part ,b of title ,,xix meet identified goals and performance measures developed for the respective programs and activities2 7#c7 a description of the progress made in addressing gaps in mental and substance use disorders prevention1 treatment1 and recovery services and improving outcomes by the ,administration1 including with respect to serious mental illnesses1 serious emotional disturbances1 and co-occurring disorders2 7#d7 a description of the manner in which the ,administration coordinates and partners with other ,federal agencies and departments related to mental and substance use disorders1 including activities related to-- 7,a7 the implementation and dissemination of research findings into improved programs1 including with respect to how advances in serious mental illness and serious emotional disturbance research have been incorporated into programs2 7,b7 the recruitment1 training1 and retention of a mental and substance use disorders workforce2 7,c7 the integration of mental disorder services1 substance use disorder services1 and physical health services2 7,d7 homelessness2 and 7,e7 veterans2 7#e7 a description of the manner in which the ,administration promotes coordination by grantees under this title1 and part ,b of title ,,xix1 with ,state or local agencies2 and 7#f7 a description of the activities carried out under section #eja;,a7e71 with respect to mental and substance use disorders1 including-- 7,a7 the number and a description of grants awarded2 7,b7 the total amount of funding for grants awarded2 7,c7 a description of the activities supported through such grants1 including outcomes of programs supported2 and 7,d7 information on how the ,national ,mental ,health and ,substance ,use ,policy ,laboratory is consulting with the ,assistant ,secretary for ,planning and ,evaluation and collaborating with the ,center for ,substance ,abuse ,treatment1 the ,center for ,substance ,abuse ,prevention1 the ,center for ,behavioral ,health ,statistics and ,quality1 and the ,center for ,mental ,health ,services to carry out such activities2 and 7#g7 recommendations made by the ,assistant ,secretary for ,planning and ,evaluation under section #fjba of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf to improve programs within the ,administration1 and actions taken in response to such recommendations to improve programs within the ,administration4 ,the ,assistant ,secretary may meet reporting requirements established under this title by providing the contents of such reports as an addendum to the biennial report established under this subsection1 notwithstanding the timeline of other reporting requirements in this title4 ,nothing in this subsection shall be construed to alter the content requirements of such reports or authorize the ,assistant ,secretary to alter the timeline of any such reports to be less frequent than biennially1 unless as specified in this title4 4 7b7 ,conforming amendment ,section #ejh7p7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#a7p77 is amended by striking section #eja7k7 and inserting section #eja7m74 #fjjg4 ,authorities of centers for mental health services1 substance abuse prevention1 and substance abuse treatment 7a7 ,center for mental health services ,section #ebj7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ca7;b77 is amended-- 7#a7 by redesignating paragraphs 7#c7 through 7#ae7 as paragraphs 7#d7 through 7#af71 respectively2 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 collaborate with the ,director of the ,national ,institute of ,mental ,health and the ,chief ,medical ,officer1 appointed under section #eja7;g71 to ensure that1 as appropriate1 programs related to the prevention and treatment of mental illness and the promotion of mental health and recovery support are carried out in a manner that reflects the best available science and evidence-based practices1 including culturally and linguistically appropriate services1 as appropriate2 2 7#c7 in paragraph 7#e71 as so redesignated1 by inserting 1 including through programs that reduce risk and promote resiliency before the semicolon2 7#d7 in paragraph 7#f71 as so redesignated1 by inserting in collaboration with the ,director of the ,national ,institute of ,mental ,health1 before develop2 7#e7 in paragraph 7#h71 as so redesignated1 by inserting 1 increase meaningful participation of individuals with mental illness in programs and activities of the ,administration1 before and protect the legal2 7#f7 in paragraph 7#aj71 as so redesignated1 by striking professional and paraprofessional personnel pursuant to section #cjc and inserting health paraprofessional personnel and health professionals2 7#g7 in paragraph 7#aa71 as so redesignated1 by inserting and tele-mental health after rural mental health2 7#h7 in paragraph 7#ab71 as so redesignated1 by striking establish a clearinghouse for mental health information to assure the widespread dissemination of such information and inserting disseminate mental health information1 including evidence-based practices12 7#i7 in paragraph 7#ae71 as so redesignated1 by striking and at the end2 7#aj7 in paragraph 7#af71 as so redesignated1 by striking the period and inserting 2 and2 and 7#aa7 by adding at the end the following3 7#ag7 ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight of grantees after such grants are awarded4 4 7b7 ,director of the center for substance abuse prevention ,section #eae of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ba7 is amended-- 7#a7 in the section heading1 by striking office and inserting center2 7#b7 in subsection 7a7-- 7,a7 by striking an ,office and inserting a ,center2 and 7,b7 by striking ,the ,office and inserting ,the ,prevention ,center2 and 7#c7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by inserting through the reduction of risk and the promotion of resiliency before the semicolon2 7,b7 by redesignating paragraphs 7#c7 through 7#aa7 as paragraphs 7#d7 through 7#ab71 respectively2 7,c7 by inserting after paragraph 7#b7 the following3 7#c7 collaborate with the ,director of the ,national ,institute on ,drug ,abuse1 the ,director of the ,national ,institute on ,alcohol ,abuse and ,alcoholism1 and ,states to promote the study of substance abuse prevention and the dissemination and implementation of research findings that will improve the delivery and effectiveness of substance abuse prevention activities2 2 7,d7 in paragraph 7#d71 as so redesignated1 by striking literature on the adverse effects of cocaine free base 7known as crack7 and inserting educational information on the effects of drugs abused by individuals1 including drugs that are emerging as abused drugs2 7,e7 in paragraph 7#f71 as so redesignated-- 7i7 by striking substance abuse counselors and inserting health professionals who provide substance use and misuse prevention and treatment services2 and 7ii7 by striking drug abuse education1 prevention1 and inserting illicit drug use education and prevention2 7,f7 by amending paragraph 7#g71 as so redesignated1 to read as follows3 7#g7 in cooperation with the ,director of the ,centers for ,disease ,control and ,prevention1 develop and disseminate educational materials to increase awareness for individuals at greatest risk for substance use disorders to prevent the transmission of communicable diseases1 such as ,,hiv1 hepatitis1 tuberculosis1 and other communicable diseases2 2 7,g7 in paragraph 7#i71 as so redesignated-- 7i7 by striking to discourage and inserting that reduce the risk of2 and 7ii7 by inserting before the semicolon and promote resiliency2 7,h7 in paragraph 7#aa71 as so redesignated1 by striking and after the semicolon2 7,i7 in paragraph 7#ab71 as so redesignated1 by striking the period and inserting a semicolon2 and 7,j7 by adding at the end the following3 7#ac7 ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight of grantees after such grants are awarded2 and 7#ad7 assist and support ,states in preventing illicit drug use1 including emerging illicit drug use issues4 4 7c7 ,director of the center for substance abuse treatment ,section #ejg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking treatment of substance abuse and inserting treatment of substance use disorders2 and 7,b7 by striking abuse treatment systems and inserting use disorder treatment systems2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking abuse and inserting use disorder2 7,b7 in paragraph 7#c71 by striking abuse and inserting use disorder2 7,c7 in paragraph 7#d71 by striking individuals who abuse drugs and inserting individuals who illicitly use drugs2 7,d7 in paragraph 7#i71 by striking carried out by the ,director2 7,e7 by striking paragraph 7#aj72 7,f7 by redesignating paragraphs 7#aa7 through 7#ad7 as paragraphs 7#aj7 through 7#ac71 respectively2 7,g7 in paragraph 7#ab71 as so redesignated1 by striking 2 and and inserting a semicolon2 and 7,h7 by striking paragraph 7#ac71 as so redesignated1 and inserting the following3 7#ac7 ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight of grantees after such grants are awarded2 and 7#ad7 work with ,states1 providers1 and individuals in recovery1 and their families1 to promote the expansion of recovery support services and systems of care oriented toward recovery4 4 #fjjh4 ,advisory councils ,section #ejb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#a7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,e71 by striking and after the semicolon2 7,b7 by redesignating subparagraph 7,f7 as subparagraph 7,j72 and 7,c7 by inserting after subparagraph 7,e71 the following3 7,f7 the ,chief ,medical ,officer1 appointed under section #eja7;g72 7,g7 the ,director of the ,national ,institute of ,mental ,health for the advisory councils appointed under subsections 7a77#a77;,a7 and 7a77#a77;,d72 7,h7 the ,director of the ,national ,institute on ,drug ,abuse for the advisory councils appointed under subsections 7a77#a77;,a71 7a77#a77;,b71 and 7a77#a77;,c72 7,i7 the ,director of the ,national ,institute on ,alcohol ,abuse and ,alcoholism for the advisory councils appointed under subsections 7a77#a77;,a71 7a77#a77;,b71 and 7a77#a77;,c72 and 2 and 7#b7 in paragraph 7#c71 by adding at the end the following3 7,c7 ,not less than half of the members of the advisory council appointed under subsection 7a77#a77;,d7-- 7i7 shall-- 7,i7 have a medical degree2 7,,ii7 have a doctoral degree in psychology2 or 7,,iii7 have an advanced degree in nursing or social work from an accredited graduate school or be a certified physician assistant2 and 7ii7 shall specialize in the mental health field4 7,d7 ,not less than half of the members of the advisory councils appointed under subsections 7a77#a77;,b7 and 7a77#a77;,c7-- 7i7 shall-- 7,i7 have a medical degree2 7,,ii7 have a doctoral degree2 or 7,,iii7 have an advanced degree in nursing1 public health1 behavioral or social sciences1 or social work from an accredited graduate school or be a certified physician assistant2 and 7ii7 shall have experience in the provision of substance use disorder services or the development and implementation of programs to prevent substance misuse4 4 #fjji4 ,peer review ,section #ejd7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#c7;b77 is amended by adding at the end the following3 ,in the case of any such peer review group that is reviewing a grant1 cooperative agreement1 or contract related to mental illness treatment1 not less than half of the members of such peer review group shall be licensed and experienced professionals in the prevention1 diagnosis1 or treatment of1 or recovery from1 mental illness or co-occurring mental illness and substance use disorders and have a medical degree1 a doctoral degree in psychology1 or an advanced degree in nursing or social work from an accredited program1 and the ,secretary1 in consultation with the ,assistant ,secretary1 shall1 to the extent possible1 ensure such peer review groups include broad geographic representation1 including both urban and rural representatives44 ,b ,oversight and accountability #fjba4 ,improving oversight of mental and substance use disorders programs through the ,assistant ,secretary for ,planning and ,evaluation 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,planning and ,evaluation1 shall ensure efficient and effective planning and evaluation of mental and substance use disorders prevention and treatment programs and related activities4 7b7 ,evaluation strategy ,in carrying out subsection 7a71 the ,assistant ,secretary for ,planning and ,evaluation shall1 not later than #ahj days after the date of enactment of this ,act1 develop a strategy for conducting ongoing evaluations that identifies priority programs to be evaluated by the ,assistant ,secretary for ,planning and ,evaluation and priority programs to be evaluated by other relevant offices and agencies within the ,department of ,health and ,human ,services4 ,the strategy shall-- 7#a7 include a plan for evaluating programs related to mental and substance use disorders1 including co-occurring disorders1 across agencies1 as appropriate1 including programs related to-- 7,a7 prevention1 intervention1 treatment1 and recovery support services1 including such services for adults with a serious mental illness or children with a serious emotional disturbance2 7,b7 the reduction of homelessness and incarceration among individuals with a mental or substance use disorder2 and 7,c7 public health and health services2 and 7#b7 include a plan for assessing the use of performance metrics to evaluate activities carried out by entities receiving grants1 contracts1 or cooperative agreements related to mental and substance use disorders prevention and treatment services under title ,v or title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq42 #db ,u4,s4,c4 #cjjw et seq474 7c7 ,consultation ,in carrying out this section1 the ,assistant ,secretary for ,planning and ,evaluation shall consult1 as appropriate1 with the ,assistant ,secretary for ,mental ,health and ,substance ,use1 the ,chief ,medical ,officer of the ,substance ,abuse and ,mental ,health ,services ,administration appointed under section #eja7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa7g771 as amended by section #fjjc1 the ,behavioral ,health ,coordinating ,council of the ,department of ,health and ,human ,services1 other agencies within the ,department of ,health and ,human ,services1 and other relevant ,federal departments and agencies4 7d7 ,recommendations ,in carrying out this section1 the ,assistant ,secretary for ,planning and ,evaluation shall provide recommendations to the ,secretary of ,health and ,human ,services1 the ,assistant ,secretary for ,mental ,health and ,substance ,use1 and the ,congress on improving the quality of prevention and treatment programs and activities related to mental and substance use disorders1 including recommendations for the use of performance metrics4 ,the ,assistant ,secretary for ,mental ,health and ,substance ,use shall include such recommendations in the biennial report required by subsection #eja7m7 of the ,public ,health ,service ,act1 as redesignated by section #fjjc of this ,act4 #fjbb4 ,reporting for protection and advocacy organizations 7a7 ,public availability of reports ,section #aje7;a77#g7 of the ,protection and ,advocacy for ,individuals with ,mental ,illness ,act 7#db ,u4,s4,c4 #ajhje7;a77#g77 is amended by striking is located a report and inserting is located1 and make publicly available1 a report4 7b7 ,detailed accounting ,section #aad7;a7 of the ,protection and ,advocacy for ,individuals with ,mental ,illness ,act 7#db ,u4,s4,c4 #ajhbd7;a77 is amended-- 7#a7 in paragraph 7#c71 by striking and at the end2 7#b7 in paragraph 7#d71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#e7 using data from the existing required annual program progress reports submitted by each system funded under this title1 a detailed accounting for each such system of how funds are spent1 disaggregated according to whether the funds were received from the ,federal ,government1 the ,state government1 a local government1 or a private entity4 4 #fjbc4 ,,gao study 7a7 ,in general ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states1 in consultation with the ,secretary of ,health and ,human ,services and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall conduct an independent evaluation1 and submit a report1 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 on programs funded by allotments made under title ,i of the ,protection and ,advocacy for ,individuals with ,mental ,illness ,act 7#db ,u4,s4,c4 #ajhja et seq474 7b7 ,contents ,the report and evaluation required under subsection 7a7 shall include-- 7#a7 a review of the programs described in such subsection that are carried out by ,state agencies and such programs that are carried out by private1 nonprofit organizations2 and 7#b7 a review of the compliance of the programs described in subsection 7a7 with statutory and regulatory responsibilities1 such as-- 7,a7 responsibilities relating to family engagement2 7,b7 responsibilities relating to the grievance procedure for clients or prospective clients of the system to assure that individuals with mental illness have full access to the services of the system1 for individuals who have received or are receiving mental health services1 and for family members of such individuals with mental illness1 or representatives of such individuals or family members1 to assure that the eligible system is operating in compliance with the provisions of the ,protection and ,advocacy for ,individuals with ,mental ,illness ,act1 as required to be established by section #aje7;a77#i7 of such ,act 7#db ,u4,s4,c4 #ajhje7;a77#i772 7,c7 investigation of alleged abuse and neglect of persons with mental illness2 7,d7 availability of adequate medical and behavioral health treatment2 7,e7 denial of rights for persons with mental illness2 and 7,f7 compliance with the ,federal prohibition on lobbying4 ,c ,interdepartmental ,serious ,mental ,illness ,coordinating ,committee #fjca4 ,interdepartmental ,serious ,mental ,illness ,coordinating ,committee 7a7 ,establishment 7#a7 ,in general ,not later than #c months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 or the designee of the ,secretary1 shall establish a committee to be known as the ,interdepartmental ,serious ,mental ,illness ,coordinating ,committee 7in this section referred to as the ,committee74 7#b7 ,federal advisory committee act ,except as provided in this section1 the provisions of the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,committee4 7b7 ,meetings ,the ,committee shall meet not fewer than #b times each year4 7c7 ,responsibilities ,not later than #a year after the date of enactment of this ,act1 and #e years after such date of enactment1 the ,committee shall submit to ,congress and any other relevant ,federal department or agency a report including-- 7#a7 a summary of advances in serious mental illness and serious emotional disturbance research related to the prevention of1 diagnosis of1 intervention in1 and treatment and recovery of serious mental illnesses1 serious emotional disturbances1 and advances in access to services and support for adults with a serious mental illness or children with a serious emotional disturbance2 7#b7 an evaluation of the effect ,federal programs related to serious mental illness have on public health1 including public health outcomes such as-- 7,a7 rates of suicide1 suicide attempts1 incidence and prevalence of serious mental illnesses1 serious emotional disturbances1 and substance use disorders1 overdose1 overdose deaths1 emergency hospitalizations1 emergency room boarding1 preventable emergency room visits1 interaction with the criminal justice system1 homelessness1 and unemployment2 7,b7 increased rates of employment and enrollment in educational and vocational programs2 7,c7 quality of mental and substance use disorders treatment services2 or 7,d7 any other criteria as may be determined by the ,secretary2 and 7#c7 specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with a serious mental illness or children with a serious emotional disturbance4 7d7 ,committee extension ,upon the submission of the second report under subsection 7c71 the ,secretary shall submit a recommendation to ,congress on whether to extend the operation of the ,committee4 7e7 ,membership 7#a7 ,federal members ,the ,committee shall be composed of the following ,federal representatives1 or the designees of such representatives-- 7,a7 the ,secretary of ,health and ,human ,services1 who shall serve as the ,chair of the ,committee2 7,b7 the ,assistant ,secretary for ,mental ,health and ,substance ,use2 7,c7 the ,attorney ,general2 7,d7 the ,secretary of ,veterans ,affairs2 7,e7 the ,secretary of ,defense2 7,f7 the ,secretary of ,housing and ,urban ,development2 7,g7 the ,secretary of ,education2 7,h7 the ,secretary of ,labor2 7,i7 the ,administrator of the ,centers for ,medicare ,medicaid ,services2 and 7,j7 the ,commissioner of ,social ,security4 7#b7 ,non-,federal members ,the ,committee shall also include not less than #ad non-,federal public members appointed by the ,secretary of ,health and ,human ,services1 of which-- 7,a7 at least #b members shall be an individual who has received treatment for a diagnosis of a serious mental illness2 7,b7 at least #a member shall be a parent or legal guardian of an adult with a history of a serious mental illness or a child with a history of a serious emotional disturbance2 7,c7 at least #a member shall be a representative of a leading research1 advocacy1 or service organization for adults with a serious mental illness2 7,d7 at least #b members shall be-- 7i7 a licensed psychiatrist with experience in treating serious mental illnesses2 7ii7 a licensed psychologist with experience in treating serious mental illnesses or serious emotional disturbances2 7iii7 a licensed clinical social worker with experience treating serious mental illnesses or serious emotional disturbances2 or 7iv7 a licensed psychiatric nurse1 nurse practitioner1 or physician assistant with experience in treating serious mental illnesses or serious emotional disturbances2 7,e7 at least #a member shall be a licensed mental health professional with a specialty in treating children and adolescents with a serious emotional disturbance2 7,f7 at least #a member shall be a mental health professional who has research or clinical mental health experience in working with minorities2 7,g7 at least #a member shall be a mental health professional who has research or clinical mental health experience in working with medically underserved populations2 7,h7 at least #a member shall be a ,state certified mental health peer support specialist2 7,i7 at least #a member shall be a judge with experience in adjudicating cases related to criminal justice or serious mental illness2 7,j7 at least #a member shall be a law enforcement officer or corrections officer with extensive experience in interfacing with adults with a serious mental illness1 children with a serious emotional disturbance1 or individuals in a mental health crisis2 and 7,k7 at least #a member shall have experience providing services for homeless individuals and working with adults with a serious mental illness1 children with a serious emotional disturbance1 or individuals in a mental health crisis4 7#c7 ,terms ,a member of the ,committee appointed under subsection 7e77#b7 shall serve for a term of #c years1 and may be reappointed for #a or more additional #c-year terms4 ,any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term4 ,a member may serve after the expiration of the member's term until a successor has been appointed4 7f7 ,working groups ,in carrying out its functions1 the ,committee may establish working groups4 ,such working groups shall be composed of ,committee members1 or their designees1 and may hold such meetings as are necessary4 7g7 ,sunset ,the ,committee shall terminate on the date that is #f years after the date on which the ,committee is established under subsection 7a77#a74 ,,vii ,,ensuring ,,mental ,,and ,,substance ,,use ,,disorders ,,prevention1 ,,treatment1 ,,and ,,recovery ,,programs ,,keep ,,pace ,,with ,,science ,,and ,,technology #gjja4 ,encouraging innovation and evidence-based programs ,title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended by inserting after section #eja 7#db ,u4,s4,c4 #bij;aa7 the following3 #eja;,a4 ,national mental health and substance use policy laboratory 7a7 ,in general ,there shall be established within the ,administration a ,national ,mental ,health and ,substance ,use ,policy ,laboratory 7referred to in this section as the ,laboratory74 7b7 ,responsibilities ,the ,laboratory shall-- 7#a7 continue to carry out the authorities and activities that were in effect for the ,office of ,policy1 ,planning1 and ,innovation as such ,office existed prior to the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf2 7#b7 identify1 coordinate1 and facilitate the implementation of policy changes likely to have a significant effect on mental health1 mental illness1 recovery supports1 and the prevention and treatment of substance use disorder services2 7#c7 work with the ,center for ,behavioral ,health ,statistics and ,quality to collect1 as appropriate1 information from grantees under programs operated by the ,administration in order to evaluate and disseminate information on evidence-based practices1 including culturally and linguistically appropriate services1 as appropriate1 and service delivery models2 7#d7 provide leadership in identifying and coordinating policies and programs1 including evidence-based programs1 related to mental and substance use disorders2 7#e7 periodically review programs and activities operated by the ,administration relating to the diagnosis or prevention of1 treatment for1 and recovery from1 mental and substance use disorders to-- 7,a7 identify any such programs or activities that are duplicative2 7,b7 identify any such programs or activities that are not evidence-based1 effective1 or efficient2 and 7,c7 formulate recommendations for coordinating1 eliminating1 or improving programs or activities identified under subparagraph 7,a7 or 7,b7 and merging such programs or activities into other successful programs or activities2 and 7#f7 carry out other activities as deemed necessary to continue to encourage innovation and disseminate evidence-based programs and practices4 7c7 ,evidence-,based practices and service delivery models 7#a7 ,in general ,in carrying out subsection 7b77#c71 the ,laboratory-- 7,a7 may give preference to models that improve-- 7i7 the coordination between mental health and physical health providers2 7ii7 the coordination among such providers and the justice and corrections system2 and 7iii7 the cost effectiveness1 quality1 effectiveness1 and efficiency of health care services furnished to adults with a serious mental illness1 children with a serious emotional disturbance1 or individuals in a mental health crisis2 and 7,b7 may include clinical protocols and practices that address the needs of individuals with early serious mental illness4 7#b7 ,consultation ,in carrying out this section1 the ,laboratory shall consult with-- 7,a7 the ,chief ,medical ,officer appointed under section #eja7;g72 7,b7 representatives of the ,national ,institute of ,mental ,health1 the ,national ,institute on ,drug ,abuse1 and the ,national ,institute on ,alcohol ,abuse and ,alcoholism1 on an ongoing basis2 7,c7 other appropriate ,federal agencies2 7,d7 clinical and analytical experts with expertise in psychiatric medical care and clinical psychological care1 health care management1 education1 corrections health care1 and mental health court systems1 as appropriate2 and 7,e7 other individuals and agencies as determined appropriate by the ,assistant ,secretary4 7d7 ,deadline for beginning implementation ,the ,laboratory shall begin implementation of this section not later than ,january #a1 #bjah4 7e7 ,promoting innovation 7#a7 ,in general ,the ,assistant ,secretary1 in coordination with the ,laboratory1 may award grants to ,states1 local governments1 ,indian tribes or tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 educational institutions1 and nonprofit organizations to develop evidence-based interventions1 including culturally and linguistically appropriate services1 as appropriate1 for-- 7,a7 evaluating a model that has been scientifically demonstrated to show promise1 but would benefit from further applied development1 for-- 7i7 enhancing the prevention1 diagnosis1 intervention1 and treatment of1 and recovery from1 mental illness1 serious emotional disturbances1 substance use disorders1 and co-occurring illness or disorders2 or 7ii7 integrating or coordinating physical health services and mental and substance use disorders services2 and 7,b7 expanding1 replicating1 or scaling evidence-based programs across a wider area to enhance effective screening1 early diagnosis1 intervention1 and treatment with respect to mental illness1 serious mental illness1 serious emotional disturbances1 and substance use disorders1 primarily by-- 7i7 applying such evidence-based programs to the delivery of care1 including by training staff in effective evidence-based treatments2 or 7ii7 integrating such evidence-based programs into models of care across specialties and jurisdictions4 7#b7 ,consultation ,in awarding grants under this subsection1 the ,assistant ,secretary shall1 as appropriate1 consult with the ,chief ,medical ,officer1 appointed under section #eja7;g71 the advisory councils described in section #ejb1 the ,national ,institute of ,mental ,health1 the ,national ,institute on ,drug ,abuse1 and the ,national ,institute on ,alcohol ,abuse and ,alcoholism1 as appropriate4 7#c7 ,authorization of appropriations ,there are authorized to be appropriated-- 7,a7 to carry out paragraph 7#a77;,a71 #g1jjj1jjj for the period of fiscal years #bjah through #bjbj2 and 7,b7 to carry out paragraph 7#a77;,b71 #g1jjj1jjj for the period of fiscal years #bjah through #bjbj4 4 #gjjb4 ,promoting access to information on evidence-based programs and practices ,part ,d of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is amended by inserting after section #edc of such ,act 7#db ,u4,s4,c4 #bij;dd-#b7 the following3 #edc;,a4 ,promoting access to information on evidence-based programs and practices 7a7 ,in general ,the ,assistant ,secretary shall1 as appropriate1 improve access to reliable and valid information on evidence-based programs and practices1 including information on the strength of evidence associated with such programs and practices1 related to mental and substance use disorders for ,states1 local communities1 nonprofit entities1 and other stakeholders1 by posting on the ,internet website of the ,administration information on evidence-based programs and practices that have been reviewed by the ,assistant ,secretary in accordance with the requirements of this section4 7b7 ,applications 7#a7 ,application period ,in carrying out subsection 7a71 the ,assistant ,secretary may establish a period for the submission of applications for evidence-based programs and practices to be posted publicly in accordance with subsection 7a74 7#b7 ,notice ,in establishing the application period under paragraph 7#a71 the ,assistant ,secretary shall provide for the public notice of such application period in the ,federal ,register4 ,such notice may solicit applications for evidence-based programs and practices to address gaps in information identified by the ,assistant ,secretary1 the ,national ,mental ,health and ,substance ,use ,policy ,laboratory established under section #eja;,a1 or the ,assistant ,secretary for ,planning and ,evaluation1 including pursuant to the evaluation and recommendations under section #fjba of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf or priorities identified in the strategic plan under section #eja7l74 7c7 ,requirements ,the ,assistant ,secretary may establish minimum requirements for the applications submitted under subsection 7b71 including applications related to the submission of research and evaluation4 7d7 ,review and rating 7#a7 ,in general ,the ,assistant ,secretary shall review applications prior to public posting in accordance with subsection 7a71 and may prioritize the review of applications for evidence-based programs and practices that are related to topics included in the notice provided under subsection 7b77#b74 7#b7 ,system ,in carrying out paragraph 7#a71 the ,assistant ,secretary may utilize a rating and review system1 which may include information on the strength of evidence associated with the evidence-based programs and practices and a rating of the methodological rigor of the research supporting the applications4 7#c7 ,public access to metrics and rating ,the ,assistant ,secretary shall make the metrics used to evaluate applications under this section1 and any resulting ratings of such applications1 publicly available4 4 #gjjc4 ,priority mental health needs of regional and national significance ,section #ebj;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cb7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#d71 by inserting before the period 1 which may include technical assistance centers2 and 7,b7 in the flush sentence following paragraph 7#d7-- 7i7 by inserting 1 contracts1 before or cooperative agreements2 and 7ii7 by striking ,indian tribes and tribal organizations and inserting ,indian tribes or tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 health facilities1 or programs operated by or in accordance with a contract or grant with the ,indian ,health ,service1 or2 and 7#b7 by amending subsection 7f7 to read as follows3 7f7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #cid1eej1jjj for each of fiscal years #bjah through #bjbb4 4 #gjjd4 ,priority substance use disorder treatment needs of regional and national significance ,section #eji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking abuse and inserting use disorder2 7,b7 in paragraph 7#c71 by inserting before the period that permit ,states1 local governments1 communities1 and ,indian tribes and tribal organizations 7as the terms ,indian tribes and tribal organizations are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act7 to focus on emerging trends in substance abuse and co-occurrence of substance use disorders with mental illness or other conditions2 and 7,c7 in the flush sentence following paragraph 7#c7-- 7i7 by inserting 1 contracts1 before or cooperative agreements2 and 7ii7 by striking ,indian tribes and tribal organizations1 and inserting ,indian tribes or tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 health facilities1 or programs operated by or in accordance with a contract or grant with the ,indian ,health ,service1 or2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking abuse and inserting use disorder2 and 7,b7 in paragraph 7#b71 by striking abuse and inserting use disorder2 7#c7 in subsection 7e71 by striking abuse and inserting use disorder2 and 7#d7 in subsection 7f71 by striking #cjj1jjj1jjj and all that follows through the period and inserting #ccc1hjf1jjj for each of fiscal years #bjah through #bjbb44 #gjje4 ,priority substance use disorder prevention needs of regional and national significance ,section #eaf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#bb7 is amended-- 7#a7 in the section heading1 by striking abuse and inserting use disorder2 7#b7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking abuse and inserting use disorder2 7,b7 in paragraph 7#c71 by inserting before the period 1 including such programs that focus on emerging drug abuse issues2 and 7,c7 in the flush sentence following paragraph 7#c7-- 7i7 by inserting 1 contracts1 before or cooperative agreements2 and 7ii7 by striking ,indian tribes and tribal organizations1 and inserting ,indian tribes or tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 health facilities1 or programs operated by or in accordance with a contract or grant with the ,indian ,health ,service12 7#c7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by striking abuse and inserting use disorder2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking 2 and at the end and inserting 22 7ii7 in subparagraph 7,b7-- 7,i7 by striking abuse and inserting use disorder2 and 7,,ii7 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,c7 substance use disorder prevention among high-risk groups4 2 7#d7 in subsection 7e71 by striking abuse and inserting use disorder2 and 7#e7 in subsection 7f71 by striking #cjj1jjj1jjj and all that follows through the period and inserting #baa1adh1jjj for each of fiscal years #bjah through #bjbb44 ,,viii ,,supporting ,,state ,,prevention ,,activities ,,and ,,responses ,,to ,,mental ,,health ,,and ,,substance ,,use ,,disorder ,,needs #hjja4 ,community mental health services block grant 7a7 ,formula grants ,section #aiaa7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx7b77 is amended-- 7#a7 by redesignating paragraphs 7#a7 through 7#c7 as paragraphs 7#b7 through 7#d71 respectively2 and 7#b7 by inserting before paragraph 7#b7 7as so redesignated7 the following3 7#a7 providing community mental health services for adults with a serious mental illness and children with a serious emotional disturbance as defined in accordance with section #aiab7;c72 4 7b7 ,state plan ,section #aiab7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#a7;b77 is amended-- 7#a7 in paragraph 7#c71 by redesignating subparagraphs 7,a7 through 7,c7 as clauses 7i7 through 7iii71 respectively1 and realigning the margins accordingly2 7#b7 by redesignating paragraphs 7#a7 through 7#e7 as subparagraphs 7,a7 through 7,e71 respectively1 and realigning the margins accordingly2 7#c7 in the matter preceding subparagraph 7,a7 7as so redesignated71 by striking ,with respect to and all that follows through are as follows3 and inserting ,in accordance with subsection 7a71 a ,state shall submit to the ,secretary a plan every two years that1 at a minimum1 includes each of the following32 7#d7 by inserting before subparagraph 7,a7 7as so redesignated7 the following3 7#a7 ,system of care ,a description of the ,state's system of care that contains the following3 2 7#e7 by striking subparagraph 7,a7 7as so redesignated7 and inserting the following3 7,a7 ,comprehensive community-based health systems ,the plan shall-- 7i7 identify the single ,state agency to be responsible for the administration of the program under the grant1 including any third party who administers mental health services and is responsible for complying with the requirements of this part with respect to the grant2 7ii7 provide for an organized community-based system of care for individuals with mental illness1 and describe available services and resources in a comprehensive system of care1 including services for individuals with co-occurring disorders2 7iii7 include a description of the manner in which the ,state and local entities will coordinate services to maximize the efficiency1 effectiveness1 quality1 and cost-effectiveness of services and programs to produce the best possible outcomes 7including health services1 rehabilitation services1 employment services1 housing services1 educational services1 substance use disorder services1 legal services1 law enforcement services1 social services1 child welfare services1 medical and dental care services1 and other support services to be provided with ,federal1 ,state1 and local public and private resources7 with other agencies to enable individuals receiving services to function outside of inpatient or residential institutions1 to the maximum extent of their capabilities1 including services to be provided by local school systems under the ,individuals with ,disabilities ,education ,act2 7iv7 include a description of how the ,state promotes evidence-based practices1 including those evidence-based programs that address the needs of individuals with early serious mental illness regardless of the age of the individual at onset1 provide comprehensive individualized treatment1 or integrate mental and physical health services2 7v7 include a description of case management services2 7vi7 include a description of activities that seek to engage adults with a serious mental illness or children with a serious emotional disturbance and their caregivers where appropriate in making health care decisions1 including activities that enhance communication among individuals1 families1 caregivers1 and treatment providers2 and 7vii7 as appropriate to1 and reflective of1 the uses the ,state proposes for the block grant funds1 include-- 7,i7 a description of the activities intended to reduce hospitalizations and hospital stays using the block grant funds2 7,,ii7 a description of the activities intended to reduce incidents of suicide using the block grant funds2 7,,iii7 a description of how the ,state integrates mental health and primary care using the block grant funds1 which may include providing1 in the case of individuals with co-occurring mental and substance use disorders1 both mental and substance use disorders services in primary care settings or arrangements to provide primary and specialty care services in community-based mental and substance use disorders settings2 and 7,,iv7 a description of recovery and recovery support services for adults with a serious mental illness and children with a serious emotional disturbance4 2 7#f7 in subparagraph 7,b7 7as so redesignated7-- 7,a7 by striking ,the plan contains and inserting ,the plan shall contain2 and 7,b7 by striking presents quantitative targets to be achieved in the implementation of the system described in paragraph 7#a7 and inserting present quantitative targets and outcome measures for programs and services provided under this subpart2 7#g7 in subparagraph 7,c7 7as so redesignated7-- 7,a7 by striking serious emotional disturbance in the matter preceding clause 7i7 7as so redesignated7 and all that follows through substance abuse services in clause 7i7 7as so redesignated7 and inserting the following3 a serious emotional disturbance 7as defined pursuant to subsection 7c771 the plan shall provide for a system of integrated social services1 educational services1 child welfare services1 juvenile justice services1 law enforcement services1 and substance use disorder services2 7,b7 by striking ,education ,act72 and inserting ,education ,act742 and 7,c7 by striking clauses 7ii7 and 7iii7 7as so redesignated72 7#h7 in subparagraph 7,d7 7as so redesignated71 by striking plan describes and inserting plan shall describe2 7#i7 in subparagraph 7,e7 7as so redesignated7-- 7,a7 in the subparagraph heading by striking systems and inserting services2 7,b7 in the first sentence1 by striking plan describes and all that follows through and provides for and inserting plan shall describe the financial resources available1 the existing mental health workforce1 and the workforce trained in treating individuals with co-occurring mental and substance use disorders1 and shall provide for2 and 7,c7 in the second sentence-- 7i7 by striking further describes and inserting shall further describe2 and 7ii7 by striking involved4 and inserting involved1 and the manner in which the ,state intends to comply with each of the funding agreements in this subpart and subpart ,,iii42 7#aj7 by striking the flush matter at the end2 and 7#aa7 by adding at the end the following3 7#b7 ,goals and objectives ,the establishment of goals and objectives for the period of the plan1 including targets and milestones that are intended to be met1 and the activities that will be undertaken to achieve those targets4 4 7c7 ,early serious mental illness ,section #aibj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#i7 is amended by adding at the end the following3 7c7 ,early serious mental illness 7#a7 ,in general ,except as provided in paragraph 7#b71 a ,state shall expend not less than #aj percent of the amount the ,state receives for carrying out this section for each fiscal year to support evidence-based programs that address the needs of individuals with early serious mental illness1 including psychotic disorders1 regardless of the age of the individual at onset4 7#b7 ,state flexibility ,in lieu of expending #aj percent of the amount the ,state receives under this section for a fiscal year as required under paragraph 7#a71 a ,state may elect to expend not less than #bj percent of such amount by the end of such succeeding fiscal year4 4 7d7 ,additional provisions ,section #aiae7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#d7;b77 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking ,the ,secretary and inserting the following3 7,a7 ,in general ,the ,secretary 2 7,b7 by striking paragraph 7#a7 if and inserting paragraph 7#a7 in whole or in part if2 7,c7 by striking ,state justify the waiver4 and inserting ,state in the fiscal year involved or in the previous fiscal year justify the waiver2 and 7,d7 by adding at the end the following3 7,b7 ,date certain for action upon request ,the ,secretary shall approve or deny a request for a waiver under this paragraph not later than #abj days after the date on which the request is made4 7,c7 ,applicability of waiver ,a waiver provided by the ,secretary under this paragraph shall be applicable only to the fiscal year involved4 2 and 7#b7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 by inserting after the subparagraph designation the following3 ,in general4--2 7ii7 by striking ,in making a grant and inserting the following3 7i7 ,determination ,in making a grant 2 and 7iii7 by inserting at the end the following3 7ii7 ,alternative ,a ,state that has failed to comply with paragraph 7#a7 and would otherwise be subject to a reduction in the ,state's allotment under section #aiaa may1 upon request by the ,state1 in lieu of having the amount of the allotment under section #aiaa for the ,state reduced for the fiscal year of the grant1 agree to comply with a negotiated agreement that is approved by the ,secretary and carried out in accordance with guidelines issued by the ,secretary4 ,if a ,state fails to enter into or comply with a negotiated agreement1 the ,secretary may take action under this paragraph or the terms of the negotiated agreement4 2 and 7,b7 in subparagraph 7,b7-- 7i7 by inserting after the subparagraph designation the following3 ,submission of information to the ,secretary4--2 and 7ii7 by striking subparagraph 7,a7 and inserting subparagraph 7,a77i74 7e7 ,application for grant ,section #aiag7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#f7;a77 is amended-- 7#a7 in paragraph 7#a71 by striking #aida and inserting #aidb7;a72 and 7#b7 in paragraph 7#e71 by striking #aiae7;b77#c77;,b7 and inserting #aiae7;b74 7f7 ,funding ,section #aibj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#i7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking section #eje and inserting section #eje7;c72 and 7,b7 by striking #dej1jjj1jjj and all that follows through the period and inserting #ecb1ega1jjj for each of fiscal years #bjah through #bjbb42 and 7#b7 in subsection 7b77#b7 by striking sections #eje and and inserting sections #eje7;c7 and4 #hjjb4 ,substance abuse prevention and treatment block grant 7a7 ,formula grants ,section #aiba7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ba7;b77 is amended-- 7#a7 by inserting carrying out the plan developed in accordance with section #aicb7;b7 and for after for the purpose of2 and 7#b7 by striking abuse and inserting use disorders4 7b7 ,outreach to persons who inject drugs ,section #aibc7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bc7;b77 is amended-- 7#a7 in the subsection heading1 by striking regarding intravenous substance abuse and inserting to persons who inject drugs2 and 7#b7 by striking for intravenous drug abuse and inserting for persons who inject drugs4 7c7 ,requirements regarding tuberculosis and human immunodeficiency virus ,section #aibd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bd7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking substance abuse and inserting substance use disorders2 and 7,b7 in subparagraph 7,a71 by striking such abuse and inserting such disorders2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a77;,a71 by striking substance abuse and inserting substance use disorders2 7,b7 in paragraph 7#b71 by inserting and ,prevention after ,disease ,control2 7,c7 in paragraph 7#c7-- 7i7 in the paragraph heading1 by striking abuse and inserting use disorders2 and 7ii7 by striking substance abuse and inserting substance use disorders2 and 7,d7 in paragraph 7#f77;,b71 by striking substance abuse and inserting substance use disorders2 7#c7 by striking subsection 7d72 and 7#d7 by redesignating subsection 7e7 as subsection 7d74 7d7 ,group homes ,section #aibe of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#be7 is amended-- 7#a7 in the section heading1 by striking recovering substance abusers and inserting persons in recovery from substance use disorders2 and 7#b7 in subsection 7a71 in the matter preceding paragraph 7#a71 by striking recovering substance abusers and inserting persons in recovery from substance use disorders4 7e7 ,additional agreements ,section #aibh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bh7 is amended-- 7#a7 in subsection 7a71 by striking 7relative to fiscal year #aiib72 7#b7 by striking subsection 7b7 and inserting the following3 7b7 ,professional development ,a funding agreement for a grant under section #aiba is that the ,state involved will ensure that prevention1 treatment1 and recovery personnel operating in the ,state's substance use disorder prevention1 treatment1 and recovery systems have an opportunity to receive training1 on an ongoing basis1 concerning-- 7#a7 recent trends in substance use disorders in the ,state2 7#b7 improved methods and evidence-based practices for providing substance use disorder prevention and treatment services2 7#c7 performance-based accountability2 7#d7 data collection and reporting requirements2 and 7#e7 any other matters that would serve to further improve the delivery of substance use disorder prevention and treatment services within the ,state4 2 and 7#c7 in subsection 7d77#a71 by striking substance abuse and inserting substance use disorders4 7f7 ,repeal ,section #aibi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bi7 is repealed4 7g7 ,maintenance of effort ,section #aicj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#cj7 is amended-- 7#a7 in subsection 7c77#a71 by striking in the ,state justify the waiver and inserting exist in the ,state1 or any part of the ,state1 to justify the waiver2 and 7#b7 in subsection 7d71 by inserting at the end the following3 7#c7 ,alternative ,a ,state that has failed to comply with this section and would otherwise be subject to a reduction in the ,state's allotment under section #aiba1 may1 upon request by the ,state1 in lieu of having the ,state's allotment under section #aiba reduced1 agree to comply with a negotiated agreement that is approved by the ,secretary and carried out in accordance with guidelines issued by the ,secretary4 ,if a ,state fails to enter into or comply with a negotiated agreement1 the ,secretary may take action under this paragraph or the terms of the negotiated agreement4 4 7h7 ,restrictions on expenditures ,section #aica7;b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ca7;b77#a77 is amended by striking substance abuse and inserting substance use disorders4 7i7 ,application ,section #aicb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#cb7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking subsections 7c7 and 7d77#b7 and inserting subsection 7c72 and 7,b7 in paragraph 7#e71 by striking the information required in section #aibi1 the information required in section #aicj7;c77#b71 and2 7#b7 in subsection 7b7-- 7,a7 by striking paragraph 7#a7 and inserting the following3 7#a7 ,in general ,in order for a ,state to be in compliance with subsection 7a77#f71 the ,state shall submit to the ,secretary a plan that1 at a minimum1 includes the following3 7,a7 ,a description of the ,state's system of care that-- 7i7 identifies the single ,state agency responsible for the administration of the program1 including any third party who administers substance use disorder services and is responsible for complying with the requirements of the grant2 7ii7 provides information on the need for substance use disorder prevention and treatment services in the ,state1 including estimates on the number of individuals who need treatment1 who are pregnant women1 women with dependent children1 individuals with a co-occurring mental health and substance use disorder1 persons who inject drugs1 and persons who are experiencing homelessness2 7iii7 provides aggregate information on the number of individuals in treatment within the ,state1 including the number of such individuals who are pregnant women1 women with dependent children1 individuals with a co-occurring mental health and substance use disorder1 persons who inject drugs1 and persons who are experiencing homelessness2 7iv7 provides a description of the system that is available to provide services by modality1 including the provision of recovery support services2 7v7 provides a description of the ,state's comprehensive statewide prevention efforts1 including the number of individuals being served in the system1 target populations1 and priority needs1 and provides a description of the amount of funds from the prevention set-aside expended on primary prevention2 7vi7 provides a description of the financial resources available2 7vii7 describes the existing substance use disorders workforce and workforce trained in treating co-occurring substance use and mental disorders2 7viii7 includes a description of how the ,state promotes evidence-based practices2 and 7ix7 describes how the ,state integrates substance use disorder services and primary health care1 which in the case of those individuals with co-occurring mental health and substance use disorders may include providing both mental health and substance use disorder services in primary care settings or providing primary and specialty care services in community-based mental health and substance use disorder service settings4 7,b7 ,the establishment of goals and objectives for the period of the plan1 including targets and milestones that are intended to be met1 and the activities that will be undertaken to achieve those targets4 7,c7 ,a description of how the ,state will comply with each funding agreement for a grant under section #aiba that is applicable to the ,state1 including a description of the manner in which the ,state intends to expend grant funds4 2 and 7,b7 in paragraph 7#b7-- 7i7 in the paragraph heading1 by striking authority of ,secretary regarding modifications and inserting modifications2 7ii7 by striking ,as a condition and inserting the following3 7,a7 ,authority of ,secretary ,as a condition2 2 and 7iii7 by adding at the end the following3 7,b7 ,state request for modification ,if the ,state determines that a modification to such plan is necessary1 the ,state may request the ,secretary to approve the modification4 ,any such modification shall be in accordance with paragraph 7#a7 and section #aida4 2 and 7,c7 in paragraph 7#c71 by inserting1 1 including any modification under paragraph 7#b7 after subsection 7a77#f72 and 7#c7 in subsection 7e77#b71 by striking section #aibb7;c7 and inserting section #aibb7;b74 7j7 ,definitions ,section #aicd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#cd7 is amended-- 7#a7 in paragraph 7#c71 by striking substance abuse and inserting substance use disorders2 and 7#b7 in paragraph 7#g71 by striking substance abuse and inserting substance use disorders4 7k7 ,funding ,section #aice of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ce7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking section #eje and inserting section #eje7;d72 and 7,b7 by striking #b1jjj1jjj1jjj for fiscal year #bjja1 and such sums as may be necessary for each of the fiscal years #bjjb and #bjjc and inserting #a1heh1jgi1jjj for each of fiscal years #bjah through #bjbb42 and 7#b7 in subsection 7b77#a77;,b7 by striking sections #eje and and inserting sections #eje7;d7 and4 #hjjc4 ,additional provisions related to the block grants ,subpart ,,iii of part ,b of title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ea et seq47 is amended-- 7#a7 in section #aidc7;a77#c7 7#db ,u4,s4,c4 #cjjx-#ec7;a77#c771 by striking section #eje and inserting subsections 7c7 and 7d7 of section #eje2 7#b7 in section #aiec7;b7 7#db ,u4,s4,c4 #cjjx-#fc7;b771 by striking substance abuse and inserting substance use disorder2 and 7#c7 by adding at the end the following3 #aieg4 ,public health emergencies ,in the case of a public health emergency 7as determined under section #cai71 the ,secretary1 on a ,state by ,state basis1 may1 as the circumstances of the emergency reasonably require and for the period of the emergency1 grant an extension1 or waive application deadlines or compliance with any other requirement1 of a grant authorized under section #eba1 #aiaa1 or #aiba or an allotment authorized under ,public ,law #ii-cai 7#db ,u4,s4,c4 #ajhja et seq474 #aieh4 ,joint applications ,the ,secretary1 acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall permit a joint application to be submitted for grants under subpart ,i and subpart ,,ii upon the request of a ,state4 ,such application may be jointly reviewed and approved by the ,secretary with respect to such subparts1 consistent with the purposes and authorized activities of each such grant program4 ,a ,state submitting such a joint application shall otherwise meet the requirements with respect to each such subpart4 4 #hjjd4 ,study of distribution of funds under the substance abuse prevention and treatment block grant and the community mental health services block grant 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall through a grant or contract1 or through an agreement with a third party1 conduct a study on the formulas for distribution of funds under the substance abuse prevention and treatment block grant1 and the community mental health services block grant1 under part ,b of title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx et seq47 and recommend changes if necessary4 ,such study shall include-- 7#a7 an analysis of whether the distributions under such block grants accurately reflect the need for the services under the grants in the ,states2 7#b7 an examination of whether the indices used under the formulas for distribution of funds under such block grants are appropriate1 and if not1 alternatives recommended by the ,secretary2 7#c7 where recommendations are included under paragraph 7#b7 for the use of different indices1 a description of the variables and data sources that should be used to determine the indices2 7#d7 an evaluation of the variables and data sources that are being used for each of the indices involved1 and whether such variables and data sources accurately represent the need for services1 the cost of providing services1 and the ability of the ,states to pay for such services2 7#e7 the effect that the minimum allotment requirements for each such block grant have on each ,state's final allotment and the effect of such requirements1 if any1 on each ,state's formula-based allotment2 7#f7 recommendations for modifications to the minimum allotment provisions to ensure an appropriate distribution of funds2 and 7#g7 any other information that the ,secretary determines appropriate4 7b7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report containing the findings and recommendations of the study conducted under subsection 7a7 and the study conducted under section #ijjd7;g74 ,,ix ,,promoting ,,access ,,to ,,mental ,,health ,,and ,,substance ,,use ,,disorder ,,care ,a ,helping ,individuals and ,families #ijja4 ,grants for treatment and recovery for homeless individuals ,section #ejf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#e7 is amended-- 7#a7 in subsection 7a71 by striking substance abuse and inserting substance use disorder2 7#b7 in subsection 7b7-- 7,a7 in paragraphs 7#a7 and 7#c71 by striking substance abuse each place the term appears and inserting substance use disorder2 and 7,b7 in paragraph 7#d71 by striking substance abuse and inserting a substance use disorder2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by striking substance abuse disorder and inserting substance use disorder2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking substance abuse and inserting a substance use disorder2 and 7ii7 in subparagraph 7,b71 by striking substance abuse and inserting substance use disorder2 and 7#d7 in subsection 7e71 by striking 1 #ej1jjj1jjj for fiscal year #bjja1 and such sums as may be necessary for each of the fiscal years #bjjb and #bjjc and inserting #da1cjd1jjj for each of fiscal years #bjah through #bjbb4 #ijjb4 ,grants for jail diversion programs ,section #ebj;,g of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ch7 is amended-- 7#a7 by striking substance abuse each place such term appears and inserting substance use disorder2 7#b7 in subsection 7a7-- 7,a7 by striking ,indian tribes1 and tribal organizations and inserting and ,indian tribes and tribal organizations 7as the terms ,indian tribes and tribal organizations are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act72 and 7,b7 by inserting or a health facility or program operated by or in accordance with a contract or grant with the ,indian ,health ,service1 after entities12 7#c7 in subsection 7c77#b77;,a77i71 by striking the best known and inserting evidence-based2 7#d7 by redesignating subsections 7d7 through 7i7 as subsections 7e7 through 7j71 respectively2 7#e7 by inserting after subsection 7c7 the following3 7d7 ,special consideration regarding veterans ,in awarding grants under subsection 7a71 the ,secretary shall1 as appropriate1 give special consideration to entities proposing to use grant funding to support jail diversion services for veterans4 2 7#f7 in subsection 7e71 as so redesignated-- 7,a7 in paragraph 7#c71 by striking 2 and and inserting a semicolon2 7,b7 in paragraph 7#d71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7#e7 develop programs to divert individuals prior to booking or arrest4 2 and 7#g7 in subsection 7j71 as so redesignated1 by striking #aj1jjj1jjj for fiscal year #bjja1 and such sums as may be necessary for fiscal years #bjjb through #bjjc and inserting #d1bfi1jjj for each of fiscal years #bjah through #bjbb4 #ijjc4 ,promoting integration of primary and behavioral health care ,section #ebj,k of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#db7 is amended to read as follows3 #ebj,k4 ,integration incentive grants and cooperative agreements 7a7 ,definitions ,in this section3 7#a7 ,eligible entity ,the term eligible entity means a ,state1 or other appropriate ,state agency1 in collaboration with #a or more qualified community programs as described in section #aiac7;b77#a7 or #a or more community health centers as described in section #ccj4 7#b7 ,integrated care ,the term integrated care means collaborative models or practices offering mental and physical health services1 which may include practices that share the same space in the same facility4 7#c7 ,special population ,the term special population means-- 7,a7 adults with a mental illness who have co-occurring physical health conditions or chronic diseases2 7,b7 adults with a serious mental illness who have co-occurring physical health conditions or chronic diseases2 7,c7 children and adolescents with a serious emotional disturbance with co-occurring physical health conditions or chronic diseases2 or 7,d7 individuals with a substance use disorder4 7b7 ,grants and cooperative agreements 7#a7 ,in general ,the ,secretary may award grants and cooperative agreements to eligible entities to support the improvement of integrated care for primary care and behavioral health care in accordance with paragraph 7#b74 7#b7 ,purposes ,a grant or cooperative agreement awarded under this section shall be designed to-- 7,a7 promote full integration and collaboration in clinical practices between primary and behavioral health care2 7,b7 support the improvement of integrated care models for primary care and behavioral health care to improve the overall wellness and physical health status of adults with a serious mental illness or children with a serious emotional disturbance2 and 7,c7 promote integrated care services related to screening1 diagnosis1 prevention1 and treatment of mental and substance use disorders1 and co-occurring physical health conditions and chronic diseases4 7c7 ,applications 7#a7 ,in general ,an eligible entity seeking a grant or cooperative agreement under this section shall submit an application to the ,secretary at such time1 in such manner1 and accompanied by such information as the ,secretary may require1 including the contents described in paragraph 7#b74 7#b7 ,contents ,the contents described in this paragraph are-- 7,a7 a description of a plan to achieve fully collaborative agreements to provide services to special populations2 7,b7 a document that summarizes the policies1 if any1 that serve as barriers to the provision of integrated care1 and the specific steps1 if applicable1 that will be taken to address such barriers2 7,c7 a description of partnerships or other arrangements with local health care providers to provide services to special populations2 7,d7 an agreement and plan to report to the ,secretary performance measures necessary to evaluate patient outcomes and facilitate evaluations across participating projects2 and 7,e7 a plan for sustainability beyond the grant or cooperative agreement period under subsection 7e74 7d7 ,grant and cooperative agreement amounts 7#a7 ,target amount ,the target amount that an eligible entity may receive for a year through a grant or cooperative agreement under this section shall be #b1jjj1jjj4 7#b7 ,adjustment permitted ,the ,secretary1 taking into consideration the quality of the application and the number of eligible entities that received grants under this section prior to the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf1 may adjust the target amount that an eligible entity may receive for a year through a grant or cooperative agreement under this section4 7#c7 ,limitation ,an eligible entity receiving funding under this section may not allocate more than #aj percent of funds awarded under this section to administrative functions1 and the remaining amounts shall be allocated to health facilities that provide integrated care4 7e7 ,duration ,a grant or cooperative agreement under this section shall be for a period not to exceed #e years4 7f7 ,report on program outcomes ,an eligible entity receiving a grant or cooperative agreement under this section shall submit an annual report to the ,secretary that includes-- 7#a7 the progress made to reduce barriers to integrated care as described in the entity's application under subsection 7c72 and 7#b7 a description of functional outcomes of special populations1 including-- 7,a7 with respect to adults with a serious mental illness1 participation in supportive housing or independent living programs1 attendance in social and rehabilitative programs1 participation in job training opportunities1 satisfactory performance in work settings1 attendance at scheduled medical and mental health appointments1 and compliance with prescribed medication regimes2 7,b7 with respect to individuals with co-occurring mental illness and physical health conditions and chronic diseases1 attendance at scheduled medical and mental health appointments1 compliance with prescribed medication regimes1 and participation in learning opportunities related to improved health and lifestyle practices2 and 7,c7 with respect to children and adolescents with a serious emotional disturbance who have co-occurring physical health conditions and chronic diseases1 attendance at scheduled medical and mental health appointments1 compliance with prescribed medication regimes1 and participation in learning opportunities at school and extracurricular activities4 7g7 ,technical assistance for primary-,behavioral health care integration 7#a7 ,in general ,the ,secretary may provide appropriate information1 training1 and technical assistance to eligible entities that receive a grant or cooperative agreement under this section1 in order to help such entities meet the requirements of this section1 including assistance with-- 7,a7 development and selection of integrated care models2 7,b7 dissemination of evidence-based interventions in integrated care2 7,c7 establishment of organizational practices to support operational and administrative success2 and 7,d7 other activities1 as the ,secretary determines appropriate4 7#b7 ,additional dissemination of technical information ,the information and resources provided by the ,secretary under paragraph 7#a7 shall1 as appropriate1 be made available to ,states1 political subdivisions of ,states1 ,indian tribes or tribal organizations 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 outpatient mental health and addiction treatment centers1 community mental health centers that meet the criteria under section #aiac7;c71 certified community behavioral health clinics described in section #bbc of the ,protecting ,access to ,medicare ,act of #bjad1 primary care organizations such as ,federally qualified health centers or rural health clinics as defined in section #ahfa7;aa7 of the ,social ,security ,act1 other community-based organizations1 or other entities engaging in integrated care activities1 as the ,secretary determines appropriate4 7h7 ,authorization of ,appropriations ,to carry out this section1 there are authorized to be appropriated #ea1hgh1jjj for each of fiscal years #bjah through #bjbb4 4 #ijjd4 ,projects for assistance in transition from homelessness 7a7 ,formula grants to ,states ,section #eba of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#ba7 is amended by striking #aiia through #aiid and inserting #bjah through #bjbb4 7b7 ,purpose of grants ,section #ebb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#bb7 is amended-- 7#a7 in subsection 7a77#a77;,b71 by striking substance abuse and inserting a substance use disorder2 7#b7 in subsection 7b77#f71 by striking substance abuse and inserting substance use disorder2 7#c7 in subsection 7c71 by striking substance abuse and inserting a substance use disorder2 7#d7 in subsection 7e7-- 7,a7 in paragraph 7#a71 by striking substance abuse and inserting a substance use disorder2 and 7,b7 in paragraph 7#b71 by striking substance abuse and inserting substance use disorder2 7#e7 by striking subsection 7g7 and redesignating subsections 7h7 and 7i7 as 7g7 and 7h71 accordingly2 and 7#f7 in subsection 7g71 as redesignated by paragraph 7#e71 by striking substance abuse each place such term appears and inserting substance use disorder4 7c7 ,description of intended expenditures of grant ,section #ebg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#bg7 is amended by striking substance abuse each place such term appears and inserting substance use disorder4 7d7 ,technical assistance ,section #ecj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#cj7 is amended by striking through the ,national ,institute of ,mental ,health1 the ,national ,institute of ,alcohol ,abuse and ,alcoholism1 and the ,national ,institute on ,drug ,abuse and inserting acting through the ,assistant ,secretary4 7e7 ,definitions ,section #ecd7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#cd7d77 is amended to read as follows3 7#d7 ,substance use disorder services ,the term substance use disorder services has the meaning given the term substance abuse services in section #ccj7;h77#e77;,c74 4 7f7 ,funding ,section #ece7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#ce7;a77 is amended by striking #ge1jjj1jjj for each of the fiscal years #bjja through #bjjc and inserting #fd1fce1jjj for each of fiscal years #bjah through #bjbb4 7g7 ,study concerning formula 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,assistant ,secretary for ,mental ,health and ,substance ,use 7referred to in this section as the ,assistant ,secretary7 shall conduct a study concerning the formula used under section #ebd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;cc-#bd7 for making allotments to ,states under section #eba of such ,act 7#db ,u4,s4,c4 #bij;cc-#ba74 ,such study shall include an evaluation of quality indicators of need for purposes of revising the formula for determining the amount of each allotment for the fiscal years following the submission of the study4 7#b7 ,report ,in accordance with section #hjjd7;b71 the ,assistant ,secretary shall submit to the committees of ,congress described in such section a report concerning the results of the study conducted under paragraph 7#a74 #ijje4 ,national ,suicide ,prevention ,lifeline ,program ,subpart #c of part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq47 is amended by inserting after section #ebj;,e-#b 7#db ,u4,s4,c4 #bij;bb-#cf;b7 the following3 #ebj;,e-#c4 ,national suicide prevention lifeline program 7a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary1 shall maintain the ,national ,suicide ,prevention ,lifeline program 7referred to in this section as the program71 authorized under section #ebj;,a and in effect prior to the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf4 7b7 ,activities ,in maintaining the program1 the activities of the ,secretary shall include-- 7#a7 coordinating a network of crisis centers across the ,united ,states for providing suicide prevention and crisis intervention services to individuals seeking help at any time1 day or night2 7#b7 maintaining a suicide prevention hotline to link callers to local emergency1 mental health1 and social services resources2 and 7#c7 consulting with the ,secretary of ,veterans ,affairs to ensure that veterans calling the suicide prevention hotline have access to a specialized veterans' suicide prevention hotline4 7c7 ,authorization of ,appropriations ,to carry out this section1 there are authorized to be appropriated #g1aih1jjj for each of fiscal years #bjah through #bjbb4 4 #ijjf4 ,connecting individuals and families with care ,subpart #c of part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq471 as amended by section #ijje1 is further amended by inserting after section #ebj;,e-#c the following3 #ebj;,e-#d4 ,treatment referral routing service 7a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary1 shall maintain the ,national ,treatment ,referral ,routing ,service 7referred to in this section as the ,routing ,service7 to assist individuals and families in locating mental and substance use disorders treatment providers4 7b7 ,activities of the secretary ,to maintain the ,routing ,service1 the activities of the ,assistant ,secretary shall include administering-- 7#a7 a nationwide1 telephone number providing year-round access to information that is updated on a regular basis regarding local behavioral health providers and community-based organizations in a manner that is confidential1 without requiring individuals to identify themselves1 is in languages that include at least ,english and ,spanish1 and is at no cost to the individual using the ,routing ,service2 and 7#b7 an ,internet website to provide a searchable1 online treatment services locator of behavioral health treatment providers and community-based organizations1 which shall include information on the name1 location1 contact information1 and basic services provided by such providers and organizations4 7c7 ,removing practitioner contact information ,in the event that the ,internet website described in subsection 7b77#b7 contains information on any qualified practitioner that is certified to prescribe medication for opioid dependency under section #cjc7;g77#b77;,b7 of the ,controlled ,substances ,act1 the ,assistant ,secretary-- 7#a7 shall provide an opportunity to such practitioner to have the contact information of the practitioner removed from the website at the request of the practitioner2 and 7#b7 may evaluate other methods to periodically update the information displayed on such website4 7d7 ,rule of construction ,nothing in this section shall be construed to prevent the ,assistant ,secretary from using any unobligated amounts otherwise made available to the ,administration to maintain the ,routing ,service4 4 #ijjg4 ,strengthening community crisis response systems ,section #ebj;,f of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cg7 is amended to read as follows3 #ebj;,f4 ,strengthening community crisis response systems 7a7 ,in general ,the ,secretary shall award competitive grants to-- 7#a7 ,state and local governments and ,indian tribes and tribal organizations1 to enhance community-based crisis response systems2 or 7#b7 ,states to develop1 maintain1 or enhance a database of beds at inpatient psychiatric facilities1 crisis stabilization units1 and residential community mental health and residential substance use disorder treatment facilities1 for adults with a serious mental illness1 children with a serious emotional disturbance1 or individuals with a substance use disorder4 7b7 ,applications 7#a7 ,in general ,to receive a grant under subsection 7a71 an entity shall submit to the ,secretary an application1 at such time1 in such manner1 and containing such information as the ,secretary may require4 7#b7 ,community-based crisis response plan ,an application for a grant under subsection 7a77#a7 shall include a plan for-- 7,a7 promoting integration and coordination between local public and private entities engaged in crisis response1 including first responders1 emergency health care providers1 primary care providers1 law enforcement1 court systems1 health care payers1 social service providers1 and behavioral health providers2 7,b7 developing memoranda of understanding with public and private entities to implement crisis response services2 7,c7 addressing gaps in community resources for crisis intervention and prevention2 and 7,d7 developing models for minimizing hospital readmissions1 including through appropriate discharge planning4 7#c7 ,beds database plan ,an application for a grant under subsection 7a77#b7 shall include a plan for developing1 maintaining1 or enhancing a real-time1 ,internet-based bed database to collect1 aggregate1 and display information about beds in inpatient psychiatric facilities and crisis stabilization units1 and residential community mental health and residential substance use disorder treatment facilities to facilitate the identification and designation of facilities for the temporary treatment of individuals in mental or substance use disorder crisis4 7c7 ,database requirements ,a bed database described in this section is a database that-- 7#a7 includes information on inpatient psychiatric facilities1 crisis stabilization units1 and residential community mental health and residential substance use disorder facilities in the ,state involved1 including contact information for the facility or unit2 7#b7 provides real-time information about the number of beds available at each facility or unit and1 for each available bed1 the type of patient that may be admitted1 the level of security provided1 and any other information that may be necessary to allow for the proper identification of appropriate facilities for treatment of individuals in mental or substance use disorder crisis2 and 7#c7 enables searches of the database to identify available beds that are appropriate for the treatment of individuals in mental or substance use disorder crisis4 7d7 ,evaluation ,an entity receiving a grant under subsection 7a77#a7 shall submit to the ,secretary1 at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 a report1 including an evaluation of the effect of such grant on-- 7#a7 local crisis response services and measures for individuals receiving crisis planning and early intervention supports2 7#b7 individuals reporting improved functional outcomes2 and 7#c7 individuals receiving regular followup care following a crisis4 7e7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section1 #ab1ejj1jjj for the period of fiscal years #bjah through #bjbb4 4 #ijjh4 ,garrett ,lee ,smith ,memorial ,act reauthorization 7a7 ,suicide prevention technical assistance center ,section #ebj;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cd71 as amended by section #fjja1 is further amended-- 7#a7 in the section heading1 by striking ,youth interagency research1 training1 and technical assistance centers and inserting ,suicide prevention technical assistance center2 7#b7 in subsection 7a71 by striking acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use and all that follows through the period at the end of paragraph 7#b7 and inserting acting through the ,assistant ,secretary1 shall establish a research1 training1 and technical assistance resource center to provide appropriate information1 training1 and technical assistance to ,states1 political subdivisions of ,states1 federally recognized ,indian tribes1 tribal organizations1 institutions of higher education1 public organizations1 or private nonprofit organizations regarding the prevention of suicide among all ages1 particularly among groups that are at a high risk for suicide42 7#c7 by striking subsections 7b7 and 7c72 7#d7 by redesignating subsection 7d7 as subsection 7b72 7#e7 in subsection 7b71 as so redesignated-- 7,a7 in the subsection heading1 by striking ,additional center and inserting ,responsibilities of the ,center2 7,b7 in the matter preceding paragraph 7#a71 by striking ,the additional research and all that follows through nonprofit organizations for and inserting ,the center established under subsection 7a7 shall conduct activities for the purpose of2 7,c7 by striking youth suicide each place such term appears and inserting suicide2 7,d7 in paragraph 7#a7-- 7i7 by striking the development or continuation of and inserting developing and continuing2 and 7ii7 by inserting for all ages1 particularly among groups that are at a high risk for suicide before the semicolon at the end2 7,e7 in paragraph 7#b71 by inserting for all ages1 particularly among groups that are at a high risk for suicide before the semicolon at the end2 7,f7 in paragraph 7#c71 by inserting and tribal after statewide2 7,g7 in paragraph 7#e71 by inserting and prevention after intervention2 7,h7 in paragraph 7#h71 by striking in youth2 7,i7 in paragraph 7#i71 by striking and behavioral health and inserting health and substance use disorder2 and 7,j7 in paragraph 7#aj71 by inserting conducting before other2 and 7#f7 by striking subsection 7e7 and inserting the following3 7c7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated #e1ihh1jjj for each of fiscal years #bjah through #bjbb4 7d7 ,annual report ,not later than #b years after the date of enactment of this subsection1 the ,secretary shall submit to ,congress a report on the activities carried out by the center established under subsection 7a7 during the year involved1 including the potential effects of such activities1 and the ,states1 organizations1 and institutions that have worked with the center4 4 7b7 ,youth suicide early intervention and prevention strategies ,section #ebj;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf7 is amended-- 7#a7 in paragraph 7#a7 of subsection 7a7 and in subsection 7c71 by striking substance abuse each place such term appears and inserting substance use disorder2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 by striking ensure that each ,state is awarded only #a grant or cooperative agreement under this section and inserting ensure that a ,state does not receive more than #a grant or cooperative agreement under this section at any #a time2 and 7ii7 by striking been awarded and inserting received2 and 7,b7 by adding after paragraph 7#b7 the following3 7#c7 ,consideration ,in awarding grants under this section1 the ,secretary shall take into consideration the extent of the need of the applicant1 including the incidence and prevalence of suicide in the ,state and among the populations of focus1 including rates of suicide determined by the ,centers for ,disease ,control and ,prevention for the ,state or population of focus4 2 7#c7 in subsection 7g77#b71 by striking #b years after the date of enactment of this section1 and insert #b years after the date of enactment of ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf12 and 7#d7 by striking subsection 7m7 and inserting the following3 7m7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated #cj1jjj1jjj for each of fiscal years #bjah through #bjbb4 4 #ijji4 ,adult suicide prevention ,subpart #c of part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#ca et seq47 is amended by adding at the end the following3 #ebj,l4 ,adult suicide prevention 7a7 ,grants 7#a7 ,in general ,the ,assistant ,secretary shall award grants to eligible entities described in paragraph 7#b7 to implement suicide prevention and intervention programs1 for individuals who are #be years of age or older1 that are designed to raise awareness of suicide1 establish referral processes1 and improve care and outcomes for such individuals who are at risk of suicide4 7#b7 ,eligible entities ,to be eligible to receive a grant under this section1 an entity shall be a community-based primary care or behavioral health care setting1 an emergency department1 a ,state mental health agency 7or ,state health agency with mental or behavioral health functions71 public health agency1 a territory of the ,united ,states1 or an ,indian tribe or tribal organization 7as the terms ,indian tribe and tribal organization are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act74 7#c7 ,use of funds ,the grants awarded under paragraph 7#a7 shall be used to implement programs1 in accordance with such paragraph1 that include one or more of the following components3 7,a7 ,screening for suicide risk1 suicide intervention services1 and services for referral for treatment for individuals at risk for suicide4 7,b7 ,implementing evidence-based practices to provide treatment for individuals at risk for suicide1 including appropriate followup services4 7,c7 ,raising awareness and reducing stigma of suicide4 7b7 ,evaluations and technical assistance ,the ,assistant ,secretary shall-- 7#a7 evaluate the activities supported by grants awarded under subsection 7a71 and disseminate1 as appropriate1 the findings from the evaluation2 and 7#b7 provide appropriate information1 training1 and technical assistance1 as appropriate1 to eligible entities that receive a grant under this section1 in order to help such entities to meet the requirements of this section1 including assistance with selection and implementation of evidence-based interventions and frameworks to prevent suicide4 7c7 ,duration ,a grant under this section shall be for a period of not more than #e years4 7d7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #cj1jjj1jjj for the period of fiscal years #bjah through #bjbb4 4 #ijaj4 ,mental health awareness training grants ,section #ebj;,j of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#da7 is amended-- 7#a7 in the section heading1 by inserting mental health awareness before training2 and 7#b7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking illness and inserting health2 7,b7 in paragraph 7#a71 by inserting veterans1 law enforcement1 and other categories of individuals1 as determined by the ,secretary1 after emergency services personnel2 7,c7 in paragraph 7#e7-- 7i7 in the matter preceding subparagraph 7,a71 by striking to and inserting for evidence-based programs that provide training and education in accordance with paragraph 7#a7 on matters including2 and 7ii7 by striking subparagraphs 7,a7 through 7,c7 and inserting the following3 7,a7 recognizing the signs and symptoms of mental illness2 and 7,b7 7i7 resources available in the community for individuals with a mental illness and other relevant resources2 or 7ii7 safely de-escalating crisis situations involving individuals with a mental illness4 2 and 7,d7 in paragraph 7#g71 by striking 1 #be1jjj1jjj and all that follows through the period at the end and inserting #ad1fic1jjj for each of fiscal years #bjah through #bjbb44 #ijaa4 ,sense of ,congress on prioritizing ,american ,indians and ,alaska ,native youth within suicide prevention programs 7a7 ,findings ,the ,congress finds as follows3 7#a7 ,suicide is the eighth leading cause of death among ,american ,indians and ,alaska ,natives across all ages4 7#b7 ,among ,american ,indians and ,alaska ,natives who are #aj to #cd years of age1 suicide is the second leading cause of death4 7#c7 ,the suicide rate among ,american ,indian and ,alaska ,native adolescents and young adults ages #ae to #cd 7#ag4i per #ajj1jjj7 is approximately #a4c times higher than the national average for that age group 7#ac4c per #ajj1jjj74 7b7 ,sense of congress ,it is the sense of ,congress that the ,secretary of ,health and ,human ,services1 in carrying out suicide prevention and intervention programs1 should prioritize programs and activities for populations with disproportionately high rates of suicide1 such as ,american ,indians and ,alaska ,natives4 #ijab4 ,evidence-based practices for older adults ,section #ebj;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cb7;e77 is amended by adding at the end the following3 7#c7 ,geriatric mental disorders ,the ,secretary shall1 as appropriate1 provide technical assistance to grantees regarding evidence-based practices for the prevention and treatment of geriatric mental disorders and co-occurring mental health and substance use disorders among geriatric populations1 as well as disseminate information about such evidence-based practices to ,states and nongrantees throughout the ,united ,states4 4 #ijac4 ,national violent death reporting system ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 is encouraged to improve1 particularly through the inclusion of additional ,states1 the ,national ,violent ,death ,reporting ,system as authorized by title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq474 ,participation in the system by the ,states shall be voluntary4 #ijad4 ,assisted outpatient treatment ,section #bbd of the ,protecting ,access to ,medicare ,act of #bjad 7#db ,u4,s4,c4 #bij;aa note7 is amended-- 7#a7 in subsection 7e71 by striking and #bjah1 and inserting #bjah1 #bjai1 #bjbj1 #bjba1 and #bjbb12 and 7#b7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by striking #bjah and inserting #bjbb2 and 7,b7 in paragraph 7#b71 by striking is authorized to be appropriated to carry out this section #ae1jjj1jjj for each of fiscal years #bjae through #bjah and inserting are authorized to be appropriated to carry out this section #ae1jjj1jjj for each of fiscal years #bjae through #bjag1 #bj1jjj1jjj for fiscal year #bjah1 #ai1jjj1jjj for each of fiscal years #bjai and #bjbj1 and #ah1jjj1jjj for each of fiscal years #bjba and #bjbb4 #ijae4 ,assertive community treatment grant program ,part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb et seq471 as amended by section #ijji1 is further amended by adding at the end the following3 #ebj,m4 ,assertive community treatment grant program 7a7 ,in general ,the ,assistant ,secretary shall award grants to eligible entities-- 7#a7 to establish assertive community treatment programs for adults with a serious mental illness2 or 7#b7 to maintain or expand such programs4 7b7 ,eligible entities ,to be eligible to receive a grant under this section1 an entity shall be a ,state1 political subdivision of a ,state1 ,indian tribe or tribal organization 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 mental health system1 health care facility1 or any other entity the ,assistant ,secretary deems appropriate4 7c7 ,special consideration ,in selecting among applicants for a grant under this section1 the ,assistant ,secretary may give special consideration to the potential of the applicant's program to reduce hospitalization1 homelessness1 and involvement with the criminal justice system while improving the health and social outcomes of the patient4 7d7 ,additional activities ,the ,assistant ,secretary shall-- 7#a7 not later than the end of fiscal year #bjba1 submit a report to the appropriate congressional committees on the grant program under this section1 including an evaluation of-- 7,a7 any cost savings and public health outcomes such as mortality1 suicide1 substance use disorders1 hospitalization1 and use of services2 7,b7 rates of involvement with the criminal justice system of patients2 7,c7 rates of homelessness among patients2 and 7,d7 patient and family satisfaction with program participation2 and 7#b7 provide appropriate information1 training1 and technical assistance to grant recipients under this section to help such recipients to establish1 maintain1 or expand their assertive community treatment programs4 7e7 ,authorization of appropriations 7#a7 ,in general ,to carry out this section1 there is authorized to be appropriated #e1jjj1jjj for the period of fiscal years #bjah through #bjbb4 7#b7 ,use of certain funds ,of the funds appropriated to carry out this section in any fiscal year1 not more than #e percent shall be available to the ,assistant ,secretary for carrying out subsection 7d74 4 #ijaf4 ,sober truth on preventing underage drinking reauthorization ,section #eai;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#be;b7 is amended-- 7#a7 in subsection 7c77#c71 by striking fiscal year #bjjg and all that follows through the period at the end and inserting each of the fiscal years #bjah through #bjbb42 7#b7 in subsection 7d77#d71 by striking fiscal year #bjjg and all that follows through the period at the end and inserting each of the fiscal years #bjah through #bjbb42 7#c7 in subsection 7e77#a77;,i71 by striking fiscal year #bjjg and all that follows through the period at the end and inserting each of the fiscal years #bjah through #bjbb42 7#d7 in subsection 7f77#b71 by striking #f1jjj1jjj for fiscal year #bjjg and all that follows through the period at the end and inserting #c1jjj1jjj for each of the fiscal years #bjah through #bjbb2 and 7#e7 by adding at the end the following new subsection3 7g7 ,reducing underage drinking through screening and brief intervention 7#a7 ,grants to pediatric health care providers to reduce underage drinking ,the ,assistant ,secretary may make grants to eligible entities to increase implementation of practices for reducing the prevalence of alcohol use among individuals under the age of #ba1 including college students4 7#b7 ,purposes ,grants under this subsection shall be made to improve-- 7,a7 screening children and adolescents for alcohol use2 7,b7 offering brief interventions to children and adolescents to discourage such use2 7,c7 educating parents about the dangers of1 and methods of discouraging1 such use2 7,d7 diagnosing and treating alcohol use disorders2 and 7,e7 referring patients1 when necessary1 to other appropriate care4 7#c7 ,use of funds ,an entity receiving a grant under this subsection may use such funding for the purposes identified in paragraph 7#b7 by-- 7,a7 providing training to health care providers2 7,b7 disseminating best practices1 including culturally and linguistically appropriate best practices1 as appropriate1 and developing and distributing materials2 and 7,c7 supporting other activities1 as determined appropriate by the ,assistant ,secretary4 7#d7 ,application ,to be eligible to receive a grant under this subsection1 an entity shall submit an application to the ,assistant ,secretary at such time1 and in such manner1 and accompanied by such information as the ,assistant ,secretary may require4 ,each application shall include-- 7,a7 a description of the entity2 7,b7 a description of activities to be completed2 7,c7 a description of how the services specified in paragraphs 7#b7 and 7#c7 will be carried out and the qualifications for providing such services2 and 7,d7 a timeline for the completion of such activities4 7#e7 ,definitions ,for the purpose of this subsection3 7,a7 ,brief intervention ,the term brief intervention means1 after screening a patient1 providing the patient with brief advice and other brief motivational enhancement techniques designed to increase the insight of the patient regarding the patient's alcohol use1 and any realized or potential consequences of such use1 to effect the desired related behavioral change4 7,b7 ,children and adolescents ,the term children and adolescents means any person under #ba years of age4 7,c7 ,eligible entity ,the term eligible entity means an entity consisting of pediatric health care providers and that is qualified to support or provide the activities identified in paragraph 7#b74 7,d7 ,pediatric health care provider ,the term pediatric health care provider means a provider of primary health care to individuals under the age of #ba years4 7,e7 ,screening ,the term screening means using validated patient interview techniques to identify and assess the existence and extent of alcohol use in a patient4 4 #ijag4 ,center and program repeals ,part ,b of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb et seq47 is amended by striking section #ejf;,b 7#db ,u4,s4,c4 #bij;aa-#e;b71 the second section #ead 7#db ,u4,s4,c4 #bij;bb-#i7 relating to methamphetamine and amphetamine treatment initiatives1 and each of sections #ead;,a1 #eag1 #eai;,a1 #eai;,c1 #eai;,e1 #ebj;,b1 #ebj;,d1 and #ebj;,h 7#db ,u4,s4,c4 #bij;bb-#h1 #bij;bb-#bc1 #bij;bb-#be;a1 #bij;bb-#be;c1 #bij;bb-#be;e1 #bij;bb-#cc1 #bij;bb-#ce1 and #bij;bb-#ci74 ,b ,strengthening the ,health ,care ,workforce #ijba4 ,mental and behavioral health education and training grants ,section #gef of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid;e-#a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking of higher education2 and 7,b7 by striking paragraphs 7#a7 through 7#d7 and inserting the following3 7#a7 accredited institutions of higher education or accredited professional training programs that are establishing or expanding internships or other field placement programs in mental health in psychiatry1 psychology1 school psychology1 behavioral pediatrics1 psychiatric nursing 7which may include master's and doctoral level programs71 social work1 school social work1 substance use disorder prevention and treatment1 marriage and family therapy1 occupational therapy1 school counseling1 or professional counseling1 including such programs with a focus on child and adolescent mental health and transitional-age youth2 7#b7 accredited doctoral1 internship1 and post-doctoral residency programs of health service psychology 7including clinical psychology1 counseling1 and school psychology7 for the development and implementation of interdisciplinary training of psychology graduate students for providing behavioral health services1 including substance use disorder prevention and treatment services1 as well as the development of faculty in health service psychology2 7#c7 accredited master's and doctoral degree programs of social work for the development and implementation of interdisciplinary training of social work graduate students for providing behavioral health services1 including substance use disorder prevention and treatment services1 and the development of faculty in social work2 and 7#d7 ,state-licensed mental health nonprofit and for-profit organizations to enable such organizations to pay for programs for preservice or in-service training in a behavioral health-related paraprofessional field with preference for preservice or in-service training of paraprofessional child and adolescent mental health workers4 2 7#b7 in subsection 7b7-- 7,a7 by striking paragraph 7#e72 7,b7 by redesignating paragraphs 7#a7 through 7#d7 as paragraphs 7#b7 through 7#e71 respectively2 7,c7 by inserting before paragraph 7#b71 as so redesignated1 the following3 7#a7 an ability to recruit and place the students described in subsection 7a7 in areas with a high need and high demand population2 2 7,d7 in paragraph 7#c71 as so redesignated1 by striking subsection 7a7 and inserting paragraph 7#b71 especially individuals with mental disorder symptoms or diagnoses1 particularly children and adolescents1 and transitional-age youth2 7,e7 in paragraph 7#d71 as so redesignated1 by striking 2 and inserting 2 and2 and 7,f7 in paragraph 7#e71 as so redesignated1 by striking 2 and and inserting a period2 7#c7 in subsection 7c71 by striking authorized under subsection 7a77#a7 and inserting awarded under paragraphs 7#b7 and 7#c7 of subsection 7a72 7#d7 by amending subsection 7d7 to read as follows3 7d7 ,priority ,in selecting grant recipients under this section1 the ,secretary shall give priority to-- 7#a7 programs that have demonstrated the ability to train psychology1 psychiatry1 and social work professionals to work in integrated care settings for purposes of recipients under paragraphs 7#a71 7#b71 and 7#c7 of subsection 7a72 and 7#b7 programs for paraprofessionals that emphasize the role of the family and the lived experience of the consumer and family-paraprofessional partnerships for purposes of recipients under subsection 7a77#d74 2 and 7#e7 by striking subsection 7e7 and inserting the following3 7e7 ,report to ,congress ,not later than #d years after the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf1 the ,secretary shall include in the biennial report submitted to ,congress under section #eja7m7 an assessment on the effectiveness of the grants under this section in-- 7#a7 providing graduate students support for experiential training 7internship or field placement72 7#b7 recruiting students interested in behavioral health practice2 7#c7 recruiting students in accordance with subsection 7b77#a72 7#d7 developing and implementing interprofessional training and integration within primary care2 7#e7 developing and implementing accredited field placements and internships2 and 7#f7 collecting data on the number of students trained in behavioral health care and the number of available accredited internships and field placements4 7f7 ,authorization of appropriations ,for each of fiscal years #bjah through #bjbb1 there are authorized to be appropriated to carry out this section #ej1jjj1jjj1 to be allocated as follows3 7#a7 ,for grants described in subsection 7a77#a71 #ae1jjj1jjj4 7#b7 ,for grants described in subsection 7a77#b71 #ae1jjj1jjj4 7#c7 ,for grants described in subsection 7a77#c71 #aj1jjj1jjj4 7#d7 ,for grants described in subsection 7a77#d71 #aj1jjj1jjj4 4 #ijbb4 ,strengthening the mental and substance use disorders workforce ,part ,d of title ,,vii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid et seq47 is amended by adding at the end the following3 #gfj4 ,training demonstration program 7a7 ,in general ,the ,secretary shall establish a training demonstration program to award grants to eligible entities to support-- 7#a7 training for medical residents and fellows to practice psychiatry and addiction medicine in underserved1 community-based settings that integrate primary care with mental and substance use disorders prevention and treatment services2 7#b7 training for nurse practitioners1 physician assistants1 health service psychologists1 and social workers to provide mental and substance use disorders services in underserved community-based settings that integrate primary care and mental and substance use disorders services2 and 7#c7 establishing1 maintaining1 or improving academic units or programs that-- 7,a7 provide training for students or faculty1 including through clinical experiences and research1 to improve the ability to be able to recognize1 diagnose1 and treat mental and substance use disorders1 with a special focus on addiction2 or 7,b7 develop evidence-based practices or recommendations for the design of the units or programs described in subparagraph 7,a71 including curriculum content standards4 7b7 ,activities 7#a7 ,training for residents and fellows ,a recipient of a grant under subsection 7a77#a7-- 7,a7 shall use the grant funds-- 7i7 7,i7 to plan1 develop1 and operate a training program for medical psychiatry residents and fellows in addiction medicine practicing in eligible entities described in subsection 7c77#a72 or 7,,ii7 to train new psychiatric residents and fellows in addiction medicine to provide and expand access to integrated mental and substance use disorders services2 and 7ii7 to provide at least #a training track that is-- 7,i7 a virtual training track that includes an in-person rotation at a teaching health center or in a community-based setting1 followed by a virtual rotation in which the resident or fellow continues to support the care of patients at the teaching health center or in the community-based setting through the use of health information technology and1 as appropriate1 telehealth services2 7,,ii7 an in-person training track that includes a rotation1 during which the resident or fellow practices at a teaching health center or in a community-based setting2 or 7,,iii7 an in-person training track that includes a rotation during which the resident practices in a community-based setting that specializes in the treatment of infants1 children1 adolescents1 or pregnant or postpartum women2 and 7,b7 may use the grant funds to provide additional support for the administration of the program or to meet the costs of projects to establish1 maintain1 or improve faculty development1 or departments1 divisions1 or other units necessary to implement such training4 7#b7 ,training for other providers ,a recipient of a grant under subsection 7a77#b7-- 7,a7 shall use the grant funds to plan1 develop1 or operate a training program to provide mental and substance use disorders services in underserved1 community-based settings1 as appropriate1 that integrate primary care and mental and substance use disorders prevention and treatment services2 and 7,b7 may use the grant funds to provide additional support for the administration of the program or to meet the costs of projects to establish1 maintain1 or improve faculty development1 or departments1 divisions1 or other units necessary to implement such program4 7#c7 ,academic units or programs ,a recipient of a grant under subsection 7a77#c7 shall enter into a partnership with organizations such as an education accrediting organization 7such as the ,liaison ,committee on ,medical ,education1 the ,accreditation ,council for ,graduate ,medical ,education1 the ,commission on ,osteopathic ,college ,accreditation1 the ,accreditation ,commission for ,education in ,nursing1 the ,commission on ,collegiate ,nursing ,education1 the ,accreditation ,council for ,pharmacy ,education1 the ,council on ,social ,work ,education1 ,american ,psychological ,association ,commission on ,accreditation1 or the ,accreditation ,review ,commission on ,education for the ,physician ,assistant7 to carry out activities under subsection 7a77#c74 7c7 ,eligible entities 7#a7 ,training for residents and fellows ,to be eligible to receive a grant under subsection 7a77#a71 an entity shall-- 7,a7 be a consortium consisting of-- 7i7 at least one teaching health center2 and 7ii7 the sponsoring institution 7or parent institution of the sponsoring institution7 of-- 7,i7 a psychiatry residency program that is accredited by the ,accreditation ,council of ,graduate ,medical ,education 7or the parent institution of such a program72 or 7,,ii7 a fellowship in addiction medicine1 as determined appropriate by the ,secretary2 or 7,b7 be an entity described in subparagraph 7,a77ii7 that provides opportunities for residents or fellows to train in community-based settings that integrate primary care with mental and substance use disorders prevention and treatment services4 7#b7 ,training for other providers ,to be eligible to receive a grant under subsection 7a77#b71 an entity shall be-- 7,a7 a teaching health center 7as defined in section #gdi;,a7f772 7,b7 a ,federally qualified health center 7as defined in section #aije7l77#b77;,b7 of the ,social ,security ,act72 7,c7 a community mental health center 7as defined in section #ahfa7;ff77#c77;,b7 of the ,social ,security ,act72 7,d7 a rural health clinic 7as defined in section #ahfa7;aa7 of the ,social ,security ,act72 7,e7 a health center operated by the ,indian ,health ,service1 an ,indian tribe1 a tribal organization1 or an urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act72 or 7,f7 an entity with a demonstrated record of success in providing training for nurse practitioners1 physician assistants1 health service psychologists1 and social workers4 7#c7 ,academic units or programs ,to be eligible to receive a grant under subsection 7a77#c71 an entity shall be a school of medicine or osteopathic medicine1 a nursing school1 a physician assistant training program1 a school of pharmacy1 a school of social work1 an accredited public or nonprofit private hospital1 an accredited medical residency program1 or a public or private nonprofit entity which the ,secretary has determined is capable of carrying out such grant4 7d7 ,priority 7#a7 ,in general ,in awarding grants under subsection 7a77#a7 or 7a77#b71 the ,secretary shall give priority to eligible entities that-- 7,a7 demonstrate sufficient size1 scope1 and capacity to undertake the requisite training of an appropriate number of psychiatric residents1 fellows1 nurse practitioners1 physician assistants1 or social workers in addiction medicine per year to meet the needs of the area served2 7,b7 demonstrate experience in training providers to practice team-based care that integrates mental and substance use disorder prevention and treatment services with primary care in community-based settings2 7,c7 demonstrate experience in using health information technology and1 as appropriate1 telehealth to support-- 7i7 the delivery of mental and substance use disorders services at the eligible entities described in subsections 7c77#a7 and 7c77#b72 and 7ii7 community health centers in integrating primary care and mental and substance use disorders treatment2 or 7,d7 have the capacity to expand access to mental and substance use disorders services in areas with demonstrated need1 as determined by the ,secretary1 such as tribal1 rural1 or other underserved communities4 7#b7 ,academic units or programs ,in awarding grants under subsection 7a77#c71 the ,secretary shall give priority to eligible entities that-- 7,a7 have a record of training the greatest percentage of mental and substance use disorders providers who enter and remain in these fields or who enter and remain in settings with integrated primary care and mental and substance use disorder prevention and treatment services2 7,b7 have a record of training individuals who are from underrepresented minority groups1 including native populations1 or from a rural or disadvantaged background2 7,c7 provide training in the care of vulnerable populations such as infants1 children1 adolescents1 pregnant and postpartum women1 older adults1 homeless individuals1 victims of abuse or trauma1 individuals with disabilities1 and other groups as defined by the ,secretary2 7,d7 teach trainees the skills to provide interprofessional1 integrated care through collaboration among health professionals2 or 7,e7 provide training in cultural competency and health literacy4 7e7 ,duration ,grants awarded under this section shall be for a minimum of #e years4 7f7 ,study and report 7#a7 ,study 7,a7 ,in general ,the ,secretary1 acting through the ,administrator of the ,health ,resources and ,services ,administration1 shall conduct a study on the results of the demonstration program under this section4 7,b7 ,data submission ,not later than #ij days after the completion of the first year of the training program and each subsequent year that the program is in effect1 each recipient of a grant under subsection 7a7 shall submit to the ,secretary such data as the ,secretary may require for analysis for the report described in paragraph 7#b74 7#b7 ,report to congress ,not later than #a year after receipt of the data described in paragraph 7#a77;,b71 the ,secretary shall submit to ,congress a report that includes-- 7,a7 an analysis of the effect of the demonstration program under this section on the quality1 quantity1 and distribution of mental and substance use disorders services2 7,b7 an analysis of the effect of the demonstration program on the prevalence of untreated mental and substance use disorders in the surrounding communities of health centers participating in the demonstration2 and 7,c7 recommendations on whether the demonstration program should be expanded4 7g7 ,authorization of ,appropriations ,there are authorized to be appropriated to carry out this section #aj1jjj1jjj for each of fiscal years #bjah through #bjbb4 4 #ijbc4 ,clarification on current eligibility for loan repayment programs ,the ,administrator of the ,health ,resources and ,services ,administration shall clarify the eligibility pursuant to section #cch;,b7b77#a77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bedl-#a7;b77#a77;,b77 of child and adolescent psychiatrists for the ,national ,health ,service ,corps ,loan ,repayment ,program under subpart ,,iii of part ,d of title ,,iii of such ,act 7#db ,u4,s4,c4 #bedl et seq474 #ijbd4 ,minority fellowship program ,title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa et seq47 is amended by adding at the end the following3 ,k ,,minority ,,fellowship ,,program #eig4 ,fellowships 7a7 ,in general ,the ,secretary shall maintain a program1 to be known as the ,minority ,fellowship ,program1 under which the ,secretary shall award fellowships1 which may include stipends1 for the purposes of-- 7#a7 increasing the knowledge of mental and substance use disorders practitioners on issues related to prevention1 treatment1 and recovery support for individuals who are from racial and ethnic minority populations and who have a mental or substance use disorder2 7#b7 improving the quality of mental and substance use disorder prevention and treatment services delivered to racial and ethnic minority populations2 and 7#c7 increasing the number of culturally competent mental and substance use disorders professionals who teach1 administer services1 conduct research1 and provide direct mental or substance use disorder services to racial and ethnic minority populations4 7b7 ,training covered ,the fellowships awarded under subsection 7a7 shall be for postbaccalaureate training 7including for master's and doctoral degrees7 for mental and substance use disorder treatment professionals1 including in the fields of psychiatry1 nursing1 social work1 psychology1 marriage and family therapy1 mental health counseling1 and substance use disorder and addiction counseling4 7c7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #ab1ffi1jjj for each of fiscal years #bjah through #bjbb4 4 #ijbe4 ,liability protections for health professional volunteers at community health centers ,section #bbd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcc7 is amended by adding at the end the following3 7q7 7#a7 ,for purposes of this section1 a health professional volunteer at a deemed entity described in subsection 7g77#d7 shall1 in providing a health professional service eligible for funding under section #ccj to an individual1 be deemed to be an employee of the ,public ,health ,service for a calendar year that begins during a fiscal year for which a transfer was made under paragraph 7#d77;,c74 ,the preceding sentence is subject to the provisions of this subsection4 7#b7 ,in providing a health service to an individual1 a health care practitioner shall for purposes of this subsection be considered to be a health professional volunteer at an entity described in subsection 7g77#d7 if the following conditions are met3 7,a7 ,the service is provided to the individual at the facilities of an entity described in subsection 7g77#d71 or through offsite programs or events carried out by the entity4 7,b7 ,the entity is sponsoring the health care practitioner pursuant to paragraph 7#c77;,b74 7,c7 ,the health care practitioner does not receive any compensation for the service from the individual1 the entity described in subsection 7g77#d71 or any third-party payer 7including reimbursement under any insurance policy or health plan1 or under any ,federal or ,state health benefits program71 except that the health care practitioner may receive repayment from the entity described in subsection 7g77#d7 for reasonable expenses incurred by the health care practitioner in the provision of the service to the individual1 which may include travel expenses to or from the site of services4 7,d7 ,before the service is provided1 the health care practitioner or the entity described in subsection 7g77#d7 posts a clear and conspicuous notice at the site where the service is provided of the extent to which the legal liability of the health care practitioner is limited pursuant to this subsection4 7,e7 ,at the time the service is provided1 the health care practitioner is licensed or certified in accordance with applicable ,federal and ,state laws regarding the provision of the service4 7,f7 ,at the time the service is provided1 the entity described in subsection 7g77#d7 maintains relevant documentation certifying that the health care practitioner meets the requirements of this subsection4 7#c7 ,subsection 7g7 7other than paragraphs 7#c7 and 7#e77 and subsections 7h71 7i71 and 7l7 apply to a health care practitioner for purposes of this subsection to the same extent and in the same manner as such subsections apply to an officer1 governing board member1 employee1 or contractor of an entity described in subsection 7g77#d71 subject to paragraph 7#d71 and subject to the following3 7,a7 ,the first sentence of paragraph 7#a7 applies in lieu of the first sentence of subsection 7g77#a77;,a74 7,b7 ,with respect to an entity described in subsection 7g77#d71 a health care practitioner is not a health professional volunteer at such entity unless the entity sponsors the health care practitioner4 ,for purposes of this subsection1 the entity shall be considered to be sponsoring the health care practitioner if-- 7i7 with respect to the health care practitioner1 the entity submits to the ,secretary an application meeting the requirements of subsection 7g77#a77;,d72 and 7ii7 the ,secretary1 pursuant to subsection 7g77#a77;,e71 determines that the health care practitioner is deemed to be an employee of the ,public ,health ,service4 7,c7 ,in the case of a health care practitioner who is determined by the ,secretary pursuant to subsection 7g77#a77;,e7 to be a health professional volunteer at such entity1 this subsection applies to the health care practitioner 7with respect to services performed on behalf of the entity sponsoring the health care practitioner pursuant to subparagraph 7,b77 for any cause of action arising from an act or omission of the health care practitioner occurring on or after the date on which the ,secretary makes such determination4 7,d7 ,subsection 7g77#a77;,f7 applies to a health care practitioner for purposes of this subsection only to the extent that1 in providing health services to an individual1 each of the conditions specified in paragraph 7#b7 is met4 7#d7 7,a7 ,amounts in the fund established under subsection 7k77#b7 shall be available for transfer under subparagraph 7,c7 for purposes of carrying out this subsection4 7,b7 7i7 ,not later than ,may #a of each fiscal year1 the ,attorney ,general1 in consultation with the ,secretary1 shall submit to the ,congress a report providing an estimate of the amount of claims 7together with related fees and expenses of witnesses7 that1 by reason of the acts or omissions of health professional volunteers1 will be paid pursuant to this section during the calendar year that begins in the following fiscal year4 7ii7 ,subsection 7k77#a77;,b7 applies to the estimate under clause 7i7 regarding health professional volunteers to the same extent and in the same manner as such subsection applies to the estimate under such subsection regarding officers1 governing board members1 employees1 and contractors of entities described in subsection 7g77#d74 7iii7 ,the report shall include a summary of the data relied upon for the estimate in clause 7i71 including the number of claims filed and paid from the previous calendar year4 7,c7 ,not later than ,december #ca of each fiscal year1 the ,secretary shall transfer from the fund under subsection 7k77#b7 to the appropriate accounts in the ,treasury an amount equal to the estimate made under subparagraph 7,b7 for the calendar year beginning in such fiscal year1 subject to the extent of amounts in the fund4 7#e7 7,a7 ,this subsection shall take effect on ,october #a1 #bjag1 except as provided in subparagraph 7,b7 and paragraph 7#f74 7,b7 ,effective on the date of the enactment of this subsection-- 7i7 the ,secretary may issue regulations for carrying out this subsection1 and the ,secretary may accept and consider applications submitted pursuant to paragraph 7#c77;,b72 and 7ii7 reports under paragraph 7#d77;,b7 may be submitted to ,congress4 7#f7 ,beginning on ,october #a1 #bjbb1 this subsection shall cease to have any force or effect4 4 #ijbf4 ,reports 7a7 ,workforce development report 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,administrator of the ,health ,resources and ,services ,administration1 in consultation with the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall conduct a study and publicly post on the appropriate ,internet website of the ,department of ,health and ,human ,services a report on the adult and pediatric mental health and substance use disorder workforce in order to inform ,federal1 ,state1 and local efforts related to workforce enhancement4 7#b7 ,contents ,the report under this subsection shall contain-- 7,a7 national and ,state-level projections of the supply and demand of the mental health and substance use disorder health workforce1 disaggregated by profession2 7,b7 an assessment of the mental health and substance use disorder workforce capacity1 strengths1 and weaknesses as of the date of the report1 including the extent to which primary care providers are preventing1 screening1 or referring for mental and substance use disorder services2 7,c7 information on trends within the mental health and substance use disorder provider workforce1 including the number of individuals expected to enter the mental health workforce over the next #e years2 and 7,d7 any additional information determined by the ,administrator of the ,health ,resources and ,services ,administration1 in consultation with the ,assistant ,secretary for ,mental ,health and ,substance ,use1 to be relevant to the mental health and substance use disorder provider workforce4 7b7 ,peer-,support specialist programs 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on peer-support specialist programs in up to #aj ,states that receive funding from the ,substance ,abuse and ,mental ,health ,services ,administration4 7#b7 ,contents of study ,in conducting the study under paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall examine and identify best practices1 in the ,states selected pursuant to such paragraph1 related to training and credential requirements for peer-support specialist programs1 such as-- 7,a7 hours of formal work or volunteer experience related to mental and substance use disorders conducted through such programs2 7,b7 types of peer-support specialist exams required for such programs in the selected ,states2 7,c7 codes of ethics used by such programs in the selected ,states2 7,d7 required or recommended skill sets for such programs in the selected ,states2 and 7,e7 requirements for continuing education4 7#c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the study conducted under paragraph 7#a74 ,c ,mental ,health on ,campus ,improvement #ijca4 ,mental health and substance use disorder services on campus ,section #ebj;,e-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;b7 is amended-- 7#a7 in the section heading1 by striking and behavioral health and inserting health and substance use disorder2 7#b7 in subsection 7a7-- 7,a7 by striking ,services1 and inserting ,services and2 7,b7 by striking and behavioral health problems and inserting health or substance use disorders2 7,c7 by striking substance abuse and inserting substance use disorders2 and 7,d7 by adding after1 suicide attempts1 the following3 prevent mental and substance use disorders1 reduce stigma1 and improve the identification and treatment for students at risk12 7#c7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking for-- and inserting for one or more of the following32 and 7,b7 by striking paragraphs 7#a7 through 7#f7 and inserting the following3 7#a7 ,educating students1 families1 faculty1 and staff to increase awareness of mental and substance use disorders4 7#b7 ,the operation of hotlines4 7#c7 ,preparing informational material4 7#d7 ,providing outreach services to notify students about available mental and substance use disorder services4 7#e7 ,administering voluntary mental and substance use disorder screenings and assessments4 7#f7 ,supporting the training of students1 faculty1 and staff to respond effectively to students with mental and substance use disorders4 7#g7 ,creating a network infrastructure to link institutions of higher education with health care providers who treat mental and substance use disorders4 7#h7 ,providing mental and substance use disorders prevention and treatment services to students1 which may include recovery support services and programming and early intervention1 treatment1 and management1 including through the use of telehealth services4 7#i7 ,conducting research through a counseling or health center at the institution of higher education involved regarding improving the behavioral health of students through clinical services1 outreach1 prevention1 or academic success1 in a manner that is in compliance with all applicable personal privacy laws4 7#aj7 ,supporting student groups on campus1 including athletic teams1 that engage in activities to educate students1 including activities to reduce stigma surrounding mental and behavioral disorders1 and promote mental health4 7#aa7 ,employing appropriately trained staff4 7#ab7 ,developing and supporting evidence-based and emerging best practices1 including a focus on culturally and linguistically appropriate best practices4 2 7#d7 in subsection 7c77#e71 by striking substance abuse and inserting substance use disorder2 7#e7 in subsection 7d7-- 7,a7 in the matter preceding paragraph 7#a71 by striking ,an institution of higher education desiring a grant under this section and inserting ,to be eligible to receive a grant under this section1 an institution of higher education2 7,b7 by striking paragraph 7#a7 and inserting-- 7#a7 ,a description of the population to be targeted by the program carried out under the grant1 including veterans whenever possible and appropriate1 and of identified mental and substance use disorder needs of students at the institution of higher education4 2 7,c7 in paragraph 7#b71 by inserting 1 which may include1 as appropriate and in accordance with subsection 7b77#g71 a plan to seek input from relevant stakeholders in the community1 including appropriate public and private entities1 in order to carry out the program under the grant before the period at the end2 and 7,d7 by adding after paragraph 7#e7 the following new paragraphs3 7#f7 ,an outline of the objectives of the program carried out under the grant4 7#g7 ,for an institution of higher education proposing to use the grant for an activity described in paragraph 7#h7 or 7#i7 of subsection 7b71 a description of the policies and procedures of the institution of higher education that are related to applicable laws regarding access to1 and sharing of1 treatment records of students at any campus-based mental health center or partner organization1 including the policies and ,state laws governing when such records can be accessed and shared for non-treatment purposes and a description of the process used by the institution of higher education to notify students of these policies and procedures1 including the extent to which written consent is required4 7#h7 ,an assurance that grant funds will be used to supplement and not supplant any other ,federal1 ,state1 or local funds available to carry out activities of the type carried out under the grant4 2 7#f7 in subsection 7e77#a71 by striking and behavioral health problems and inserting health and substance use disorders2 7#g7 in subsection 7f77#b7-- 7,a7 by striking and behavioral health and inserting health and substance use disorder2 and 7,b7 by striking suicide and substance abuse and inserting suicide and substance use disorders2 7#h7 by redesignating subsection 7h7 as subsection 7i72 7#i7 by inserting after subsection 7g7 the following new subsection3 7h7 ,technical assistance ,the ,secretary may provide technical assistance to grantees in carrying out this section4 2 and 7#aj7 in subsection 7i71 as redesignated by paragraph 7#h71 by striking #e1jjj1jjj for fiscal year #bjje and all that follows through the period at the end and inserting #g1jjj1jjj for each of fiscal years #bjah through #bjbb44 #ijcb4 ,interagency ,working ,group on ,college ,mental ,health 7a7 ,purpose ,it is the purpose of this section to provide for the establishment of a ,college ,campus ,task ,force to discuss mental and behavioral health concerns on campuses of institutions of higher education4 7b7 ,establishment ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish a ,college ,campus ,task ,force 7referred to in this section as the ,task ,force7 to discuss mental and behavioral health concerns on campuses of institutions of higher education4 7c7 ,membership ,the ,task ,force shall be composed of a representative from each ,federal agency 7as appointed by the head of the agency7 that has jurisdiction over1 or is affected by1 mental health and education policies and projects1 including-- 7#a7 the ,department of ,education2 7#b7 the ,department of ,health and ,human ,services2 7#c7 the ,department of ,veterans ,affairs2 and 7#d7 such other ,federal agencies as the ,assistant ,secretary for ,mental ,health and ,substance ,use1 in consultation with the ,secretary1 determines to be appropriate4 7d7 ,duties ,the ,task ,force shall-- 7#a7 serve as a centralized mechanism to coordinate a national effort to-- 7,a7 discuss and evaluate evidence and knowledge on mental and behavioral health services available to1 and the prevalence of mental illness among1 the age population of students attending institutions of higher education in the ,united ,states2 7,b7 determine the range of effective1 feasible1 and comprehensive actions to improve mental and behavioral health on campuses of institutions of higher education2 7,c7 examine and better address the needs of the age population of students attending institutions of higher education dealing with mental illness2 7,d7 survey ,federal agencies to determine which policies are effective in encouraging1 and how best to facilitate outreach without duplicating1 efforts relating to mental and behavioral health promotion2 7,e7 establish specific goals within and across ,federal agencies for mental health promotion1 including determinations of accountability for reaching those goals2 7,f7 develop a strategy for allocating responsibilities and ensuring participation in mental and behavioral health promotion1 particularly in the case of competing agency priorities2 7,g7 coordinate plans to communicate research results relating to mental and behavioral health amongst the age population of students attending institutions of higher education to enable reporting and outreach activities to produce more useful and timely information2 7,h7 provide a description of evidence-based practices1 model programs1 effective guidelines1 and other strategies for promoting mental and behavioral health on campuses of institutions of higher education2 7,i7 make recommendations to improve ,federal efforts relating to mental and behavioral health promotion on campuses of institutions of higher education and to ensure ,federal efforts are consistent with available standards1 evidence1 and other programs in existence as of the date of enactment of this ,act2 7,j7 monitor ,federal progress in meeting specific mental and behavioral health promotion goals as they relate to settings of institutions of higher education2 and 7,k7 examine and disseminate best practices related to intracampus sharing of treatment records2 7#b7 consult with national organizations with expertise in mental and behavioral health1 especially those organizations working with the age population of students attending institutions of higher education2 and 7#c7 consult with and seek input from mental health professionals working on campuses of institutions of higher education as appropriate4 7e7 ,meetings 7#a7 ,in general ,the ,task ,force shall meet not fewer than three times each year4 7#b7 ,annual conference ,the ,secretary shall sponsor an annual conference on mental and behavioral health in settings of institutions of higher education to enhance coordination1 build partnerships1 and share best practices in mental and behavioral health promotion1 data collection1 analysis1 and services4 7f7 ,definition ,in this section1 the term institution of higher education has the meaning given such term in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja74 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #a1jjj1jjj for the period of fiscal years #bjah through #bjbb4 #ijcc4 ,improving mental health on college campuses ,part ,d of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;dd et seq47 is amended by adding at the end the following3 #edi4 ,mental and behavioral health outreach and education on college campuses 7a7 ,purpose ,it is the purpose of this section to increase access to1 and reduce the stigma associated with1 mental health services to ensure that students at institutions of higher education have the support necessary to successfully complete their studies4 7b7 ,national public education campaign ,the ,secretary1 acting through the ,assistant ,secretary and in collaboration with the ,director of the ,centers for ,disease ,control and ,prevention1 shall convene an interagency1 public-private sector working group to plan1 establish1 and begin coordinating and evaluating a targeted public education campaign that is designed to focus on mental and behavioral health on the campuses of institutions of higher education4 ,such campaign shall be designed to-- 7#a7 improve the general understanding of mental health and mental disorders2 7#b7 encourage help-seeking behaviors relating to the promotion of mental health1 prevention of mental disorders1 and treatment of such disorders2 7#c7 make the connection between mental and behavioral health and academic success2 and 7#d7 assist the general public in identifying the early warning signs and reducing the stigma of mental illness4 7c7 ,composition ,the working group convened under subsection 7b7 shall include-- 7#a7 mental health consumers1 including students and family members2 7#b7 representatives of institutions of higher education2 7#c7 representatives of national mental and behavioral health associations and associations of institutions of higher education2 7#d7 representatives of health promotion and prevention organizations at institutions of higher education2 7#e7 representatives of mental health providers1 including community mental health centers2 and 7#f7 representatives of private-sector and public-sector groups with experience in the development of effective public health education campaigns4 7d7 ,plan ,the working group under subsection 7b7 shall develop a plan that-- 7#a7 targets promotional and educational efforts to the age population of students at institutions of higher education and individuals who are employed in settings of institutions of higher education1 including through the use of roundtables2 7#b7 develops and proposes the implementation of research-based public health messages and activities2 7#c7 provides support for local efforts to reduce stigma by using the ,national ,health ,information ,center as a primary point of contact for information1 publications1 and service program referrals2 and 7#d7 develops and proposes the implementation of a social marketing campaign that is targeted at the population of students attending institutions of higher education and individuals who are employed in settings of institutions of higher education4 7e7 ,definition ,in this section1 the term institution of higher education has the meaning given such term in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja74 7f7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #a1jjj1jjj for the period of fiscal years #bjah through #bjbb4 4 ,x ,strengthening ,mental and ,substance ,use ,disorder ,care for ,children and ,adolescents #ajjja4 ,programs for children with a serious emotional disturbance 7a7 ,comprehensive community mental health services for children with a serious emotional disturbance ,section #efa7;a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ff7a77#a77 is amended by inserting 1 which may include efforts to identify and serve children at risk before the period4 7b7 ,requirements with respect to carrying out purpose of grants ,section #efb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ff-#a7;b77 is amended by striking will not provide an individual with access to the system if the individual is more than #ba years of age and inserting will provide an individual with access to the system through the age of #ba years4 7c7 ,additional provisions ,section #efd7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ff-#c7;f77 is amended by inserting 7and provide a copy to the ,state involved7 after to the ,secretary4 7d7 ,general provisions ,section #efe of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ff-#d7 is amended-- 7#a7 in subsection 7b77#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking receiving a grant under section #efa7;a7 and inserting 1 regardless of whether such public entity is receiving a grant under section #efa7;a72 and 7,b7 in subparagraph 7,b71 by striking pursuant to and inserting described in2 7#b7 in subsection 7d77#a71 by striking not more than #ba years of age and inserting through the age of #ba years2 and 7#c7 in subsection 7f77#a71 by striking #ajj1jjj1jjj for fiscal year #bjja1 and such sums as may be necessary for each of the fiscal years #bjjb and #bjjc and inserting #aai1jbf1jjj for each of fiscal years #bjah through #bjbb4 #ajjjb4 ,increasing access to pediatric mental health care ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,l of such ,act 7#db ,u4,s4,c4 #bed;c-#ah7 the following new section3 #ccj,m ,pediatric mental health care access grants 7a7 ,in general ,the ,secretary1 acting through the ,administrator of the ,health ,resources and ,services ,administration and in coordination with other relevant ,federal agencies1 shall award grants to ,states1 political subdivisions of ,states1 and ,indian tribes and tribal organizations 7for purposes of this section1 as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #dej;b77 to promote behavioral health integration in pediatric primary care by-- 7#a7 supporting the development of statewide or regional pediatric mental health care telehealth access programs2 and 7#b7 supporting the improvement of existing statewide or regional pediatric mental health care telehealth access programs4 7b7 ,program requirements 7#a7 ,in general ,a pediatric mental health care telehealth access program referred to in subsection 7a71 with respect to which a grant under such subsection may be used1 shall-- 7,a7 be a statewide or regional network of pediatric mental health teams that provide support to pediatric primary care sites as an integrated team2 7,b7 support and further develop organized ,state or regional networks of pediatric mental health teams to provide consultative support to pediatric primary care sites2 7,c7 conduct an assessment of critical behavioral consultation needs among pediatric providers and such providers' preferred mechanisms for receiving consultation1 training1 and technical assistance2 7,d7 develop an online database and communication mechanisms1 including telehealth1 to facilitate consultation support to pediatric practices2 7,e7 provide rapid statewide or regional clinical telephone or telehealth consultations when requested between the pediatric mental health teams and pediatric primary care providers2 7,f7 conduct training and provide technical assistance to pediatric primary care providers to support the early identification1 diagnosis1 treatment1 and referral of children with behavioral health conditions2 7,g7 provide information to pediatric providers about1 and assist pediatric providers in accessing1 pediatric mental health care providers1 including child and adolescent psychiatrists1 and licensed mental health professionals1 such as psychologists1 social workers1 or mental health counselors and in scheduling and conducting technical assistance2 7,h7 assist with referrals to specialty care and community or behavioral health resources2 and 7,i7 establish mechanisms for measuring and monitoring increased access to pediatric mental health care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to identify1 treat1 and refer children with mental health problems4 7#b7 ,pediatric mental health teams ,in this subsection1 the term pediatric mental health team means a team consisting of at least one case coordinator1 at least one child and adolescent psychiatrist1 and at least one licensed clinical mental health professional1 such as a psychologist1 social worker1 or mental health counselor4 ,such a team may be regionally based4 7c7 ,application ,a ,state1 political subdivision of a ,state1 ,indian tribe1 or tribal organization seeking a grant under this section shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require1 including a plan for the comprehensive evaluation of activities that are carried out with funds received under such grant4 7d7 ,evaluation ,a ,state1 political subdivision of a ,state1 ,indian tribe1 or tribal organization that receives a grant under this section shall prepare and submit an evaluation of activities that are carried out with funds received under such grant to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 including a process and outcome evaluation4 7e7 ,access to broadband ,in administering grants under this section1 the ,secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable1 high-speed ,internet for providers4 7f7 ,matching requirement ,the ,secretary may not award a grant under this section unless the ,state1 political subdivision of a ,state1 ,indian tribe1 or tribal organization involved agrees1 with respect to the costs to be incurred by the ,state1 political subdivision of a ,state1 ,indian tribe1 or tribal organization in carrying out the purpose described in this section1 to make available non-,federal contributions 7in cash or in kind7 toward such costs in an amount that is not less than #bj percent of ,federal funds provided in the grant4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated1 #i1jjj1jjj for the period of fiscal years #bjah through #bjbb4 4 #ajjjc4 ,substance use disorder treatment and early intervention services for children and adolescents ,the first section #ead of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#g71 relating to substance abuse treatment services for children and adolescents1 is amended-- 7#a7 in the section heading1 by striking abuse treatment and inserting use disorder treatment and early intervention2 7#b7 by striking subsection 7a7 and inserting the following3 7a7 ,in general ,the ,secretary shall award grants1 contracts1 or cooperative agreements to public and private nonprofit entities1 including ,indian tribes or tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 or health facilities or programs operated by or in accordance with a contract or grant with the ,indian ,health ,service1 for the purpose of-- 7#a7 providing early identification and services to meet the needs of children and adolescents who are at risk of substance use disorders2 7#b7 providing substance use disorder treatment services for children1 including children and adolescents with co-occurring mental illness and substance use disorders2 and 7#c7 providing assistance to pregnant women1 and parenting women1 with substance use disorders1 in obtaining treatment services1 linking mothers to community resources to support independent family lives1 and staying in recovery so that children are in safe1 stable home environments and receive appropriate health care services4 2 7#c7 in subsection 7b7-- 7,a7 by striking paragraph 7#a7 and inserting the following3 7#a7 apply evidence-based and cost-effective methods2 2 7,b7 in paragraph 7#b7-- 7i7 by striking treatment2 and 7ii7 by inserting substance abuse1 after child welfare12 7,c7 in paragraph 7#c71 by striking substance abuse disorders and inserting substance use disorders1 including children and adolescents with co-occurring mental illness and substance use disorders12 7,d7 in paragraph 7#e71 by striking treatment2 and inserting services2 and2 7,e7 in paragraph 7#f71 by striking substance abuse treatment2 and and inserting treatment42 and 7,f7 by striking paragraph 7#g72 and 7#d7 in subsection 7f71 by striking #dj1jjj1jjj and all that follows through the period and inserting #bi1fje1jjj for each of fiscal years #bjah through #bjbb44 #ajjjd4 ,children's recovery from trauma ,the first section #ehb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;hh-#a2 relating to grants to address the problems of persons who experience violence related stress7 is amended-- 7#a7 in subsection 7a71 by striking developing programs and all that follows through the period at the end and inserting the following3 developing and maintaining programs that provide for-- 7#a7 the continued operation of the ,national ,child ,traumatic ,stress ,initiative 7referred to in this section as the ,,nctsi71 which includes a cooperative agreement with a coordinating center1 that focuses on the mental1 behavioral1 and biological aspects of psychological trauma response1 prevention of the long-term consequences of child trauma1 and early intervention services and treatment to address the long-term consequences of child trauma2 and 7#b7 the development of knowledge with regard to evidence-based practices for identifying and treating mental1 behavioral1 and biological disorders of children and youth resulting from witnessing or experiencing a traumatic event4 2 7#b7 in subsection 7b7-- 7,a7 by striking subsection 7a7 related and inserting subsection 7a77#b7 7related2 7,b7 by striking treating disorders associated with psychological trauma and inserting treating mental1 behavioral1 and biological disorders associated with psychological trauma72 and 7,c7 by striking mental health agencies and programs that have established clinical and basic research and inserting universities1 hospitals1 mental health agencies1 and other programs that have established clinical expertise and research2 7#c7 by redesignating subsections 7c7 through 7g7 as subsections 7g7 through 7k71 respectively2 7#d7 by inserting after subsection 7b71 the following3 7c7 ,child outcome data ,the ,,nctsi coordinating center described in subsection 7a77#a7 shall collect1 analyze1 report1 and make publicly available1 as appropriate1 ,,nctsi-wide child treatment process and outcome data regarding the early identification and delivery of evidence-based treatment and services for children and families served by the ,,nctsi grantees4 7d7 ,training ,the ,,nctsi coordinating center shall facilitate the coordination of training initiatives in evidence-based and trauma-informed treatments1 interventions1 and practices offered to ,,nctsi grantees1 providers1 and partners4 7e7 ,dissemination and collaboration ,the ,,nctsi coordinating center shall1 as appropriate1 collaborate with-- 7#a7 the ,secretary1 in the dissemination of evidence-based and trauma-informed interventions1 treatments1 products1 and other resources to appropriate stakeholders2 and 7#b7 appropriate agencies that conduct or fund research within the ,department of ,health and ,human ,services1 for purposes of sharing ,,nctsi expertise1 evaluation data1 and other activities1 as appropriate4 7f7 ,review ,the ,secretary shall1 consistent with the peer-review process1 ensure that ,,nctsi applications are reviewed by appropriate experts in the field as part of a consensus-review process4 ,the ,secretary shall include review criteria related to expertise and experience in child trauma and evidence-based practices4 2 7#e7 in subsection 7g7 7as so redesignated71 by striking with respect to centers of excellence are distributed equitably among the regions of the country and inserting are distributed equitably among the regions of the ,united ,states2 7#f7 in subsection 7i7 7as so redesignated71 by striking recipient may not exceed #e years and inserting recipient shall not be less than #d years1 but shall not exceed #e years2 and 7#g7 in subsection 7j7 7as so redesignated71 by striking #ej1jjj1jjj and all that follows through #bjjf and inserting #df1hhg1jjj for each of fiscal years #bjah through #bjbb4 #ajjje4 ,screening and treatment for maternal depression ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cag,l 7#db ,u4,s4,c4 #bdg;b-#ac7 the following3 #cag,l-#a4 ,screening and treatment for maternal depression 7a7 ,grants ,the ,secretary shall make grants to ,states to establish1 improve1 or maintain programs for screening1 assessment1 and treatment services1 including culturally and linguistically appropriate services1 as appropriate1 for women who are pregnant1 or who have given birth within the preceding #ab months1 for maternal depression4 7b7 ,application ,to seek a grant under this section1 a ,state shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 ,at a minimum1 any such application shall include explanations of-- 7#a7 how a program1 or programs1 will increase the percentage of women screened and treated1 as appropriate1 for maternal depression in #a or more communities2 and 7#b7 how a program1 or programs1 if expanded1 would increase access to screening and treatment services for maternal depression4 7c7 ,priority ,in awarding grants under this section1 the ,secretary may give priority to ,states proposing to improve or enhance access to screening services for maternal depression in primary care settings4 7d7 ,use of funds ,the activities eligible for funding through a grant under subsection 7a7-- 7#a7 shall include-- 7,a7 providing appropriate training to health care providers2 and 7,b7 providing information to health care providers1 including information on maternal depression screening1 treatment1 and followup support services1 and linkages to community-based resources2 and 7#b7 may include-- 7,a7 enabling health care providers 7including obstetrician-gynecologists1 pediatricians1 psychiatrists1 mental health care providers1 and adult primary care clinicians7 to provide or receive real-time psychiatric consultation 7in-person or remotely7 to aid in the treatment of pregnant and parenting women2 7,b7 establishing linkages with and among community-based resources1 including mental health resources1 primary care resources1 and support groups2 and 7,c7 utilizing telehealth services for rural areas and medically underserved areas 7as defined in section #ccj;,i7a774 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjah through #bjbb4 4 #ajjjf4 ,infant and early childhood mental health promotion1 intervention1 and treatment ,part ,q of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;h et seq47 is amended by adding at the end the following3 #cii,z-#b4 ,infant and early childhood mental health promotion1 intervention1 and treatment 7a7 ,grants ,the ,secretary shall-- 7#a7 award grants to eligible entities to develop1 maintain1 or enhance infant and early childhood mental health promotion1 intervention1 and treatment programs1 including-- 7,a7 programs for infants and children at significant risk of developing1 showing early signs of1 or having been diagnosed with mental illness1 including a serious emotional disturbance2 and 7,b7 multigenerational therapy and other services that support the caregiving relationship2 and 7#b7 ensure that programs funded through grants under this section are evidence-informed or evidence-based models1 practices1 and methods that are1 as appropriate1 culturally and linguistically appropriate1 and can be replicated in other appropriate settings4 7b7 ,eligible children and entities ,in this section3 7#a7 ,eligible child ,the term eligible child means a child from birth to not more than #ab years of age who-- 7,a7 is at risk for1 shows early signs of1 or has been diagnosed with a mental illness1 including a serious emotional disturbance2 and 7,b7 may benefit from infant and early childhood intervention or treatment programs or specialized preschool or elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise but would benefit from further applied development4 7#b7 ,eligible entity ,the term eligible entity means a human services agency or nonprofit institution that-- 7,a7 employs licensed mental health professionals who have specialized training and experience in infant and early childhood mental health assessment1 diagnosis1 and treatment1 or is accredited or approved by the appropriate ,state agency1 as applicable1 to provide for children from infancy to #ab years of age mental health promotion1 intervention1 or treatment services2 and 7,b7 provides services or programs described in subsection 7a7 that are evidence-based or that have been scientifically demonstrated to show promise but would benefit from further applied development4 7c7 ,application ,an eligible entity seeking a grant under subsection 7a7 shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7d7 ,use of funds for early intervention and treatment programs ,an eligible entity may use amounts awarded under a grant under subsection 7a77#a7 to carry out the following3 7#a7 ,provide age-appropriate mental health promotion and early intervention services or mental illness treatment services1 which may include specialized programs1 for eligible children at significant risk of developing1 showing early signs of1 or having been diagnosed with a mental illness1 including a serious emotional disturbance4 ,such services may include social and behavioral services as well as multigenerational therapy and other services that support the caregiving relationship4 7#b7 ,provide training for health care professionals with expertise in infant and early childhood mental health care with respect to appropriate and relevant integration with other disciplines such as primary care clinicians1 early intervention specialists1 child welfare staff1 home visitors1 early care and education providers1 and others who work with young children and families4 7#c7 ,provide mental health consultation to personnel of early care and education programs 7including licensed or regulated center-based and home-based child care1 home visiting1 preschool special education1 and early intervention programs7 who work with children and families4 7#d7 ,provide training for mental health clinicians in infant and early childhood in promising and evidence-based practices and models for infant and early childhood mental health treatment and early intervention1 including with regard to practices for identifying and treating mental illness and behavioral disorders of infants and children resulting from exposure or repeated exposure to adverse childhood experiences or childhood trauma4 7#e7 ,provide age-appropriate assessment1 diagnostic1 and intervention services for eligible children1 including early mental health promotion1 intervention1 and treatment services4 7e7 ,matching funds ,the ,secretary may not award a grant under this section to an eligible entity unless the eligible entity agrees1 with respect to the costs to be incurred by the eligible entity in carrying out the activities described in subsection 7d71 to make available non-,federal contributions 7in cash or in kind7 toward such costs in an amount that is not less than #aj percent of the total amount of ,federal funds provided in the grant4 7f7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #bj1jjj1jjj for the period of fiscal years #bjah through #bjbb4 4 ,,xi ,compassionate communication on ,,hipaa #aajja4 ,sense of ,congress 7a7 ,findings ,congress finds the following3 7#a7 ,according to the ,national ,survey on ,drug ,use and ,health1 in #bjae1 there were approximately #i1hjj1jjj adults in the ,united ,states with serious mental illness4 7#b7 ,the ,substance ,abuse and ,mental ,health ,services ,administration defines the term serious mental illness as an illness affecting individuals #ah years of age or older as having1 at any time in the past year1 a diagnosable mental1 behavioral1 or emotional disorder that results in serious functional impairment and substantially interferes with or limits one or more major life activities4 7#c7 ,in reporting on the incidence of serious mental illness1 the ,substance ,abuse and ,mental ,health ,services ,administration includes major depression1 schizophrenia1 bipolar disorder1 and other mental disorders that cause serious impairment4 7#d7 ,adults with a serious mental illness are at a higher risk for chronic physical illnesses and premature death4 7#e7 ,according to the ,world ,health ,organization1 adults with a serious mental illness have lifespans that are #aj to #be years shorter than those without serious mental illness4 ,the vast majority of these deaths are due to chronic physical medical conditions1 such as cardiovascular1 respiratory1 and infectious diseases1 as well as diabetes and hypertension4 7#f7 ,according to the ,world ,health ,organization1 the majority of deaths of adults with a serious mental illness that are due to physical medical conditions are preventable4 7#g7 ,supported decision making can facilitate care decisions in areas where serious mental illness may impact the capacity of an individual to determine a course of treatment while still allowing the individual to make decisions independently4 7#h7 ,help should be provided to adults with a serious mental illness to address their acute or chronic physical illnesses1 make informed choices about treatment1 and understand and follow through with appropriate treatment4 7#i7 ,there is confusion in the health care community regarding permissible practices under the regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif 7commonly known as ,,hipaa74 ,this confusion may hinder appropriate communication of health care information or treatment preferences with appropriate caregivers4 7b7 ,sense of ,congress ,it is the sense of ,congress that clarification is needed regarding the privacy rule promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 regarding existing permitted uses and disclosures of health information by health care professionals to communicate with caregivers of adults with a serious mental illness to facilitate treatment4 #aajjb4 ,confidentiality of records ,not later than #a year after the date on which the ,secretary of ,health and ,human ,services 7in this title referred to as the ,secretary7 first finalizes regulations updating part #b of title #db1 ,code of ,federal ,regulations1 relating to confidentiality of alcohol and drug abuse patient records1 after the date of enactment of this ,act1 the ,secretary shall convene relevant stakeholders to determine the effect of such regulations on patient care1 health outcomes1 and patient privacy4 #aajjc4 ,clarification on permitted uses and disclosures of protected health information 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,office for ,civil ,rights1 shall ensure that health care providers1 professionals1 patients and their families1 and others involved in mental or substance use disorder treatment have adequate1 accessible1 and easily comprehensible resources relating to appropriate uses and disclosures of protected health information under the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 7b7 ,guidance 7#a7 ,issuance ,in carrying out subsection 7a71 not later than #a year after the date of enactment of this section1 the ,secretary shall issue guidance clarifying the circumstances under which1 consistent with regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 a health care provider or covered entity may use or disclose protected health information4 7#b7 ,circumstances addressed ,the guidance issued under this section shall address circumstances including those that-- 7,a7 require the consent of the patient2 7,b7 require providing the patient with an opportunity to object2 7,c7 are based on the exercise of professional judgment regarding whether the patient would object when the opportunity to object cannot practicably be provided because of the incapacity of the patient or an emergency treatment circumstance2 and 7,d7 are determined1 based on the exercise of professional judgment1 to be in the best interest of the patient when the patient is not present or otherwise incapacitated4 7#c7 ,communication with family members and caregivers ,in addressing the circumstances described in paragraph 7#b71 the guidance issued under this section shall clarify permitted uses or disclosures of protected health information for purposes of-- 7,a7 communicating with a family member of the patient1 caregiver of the patient1 or other individual1 to the extent that such family member1 caregiver1 or individual is involved in the care of the patient2 7,b7 in the case that the patient is an adult1 communicating with a family member of the patient1 caregiver of the patient1 or other individual involved in the care of the patient2 7,c7 in the case that the patient is a minor1 communicating with the parent or caregiver of the patient2 7,d7 involving the family members or caregivers of the patient1 or others involved in the patient's care or care plan1 including facilitating treatment and medication adherence2 7,e7 listening to the patient1 or receiving information with respect to the patient from the family or caregiver of the patient2 7,f7 communicating with family members of the patient1 caregivers of the patient1 law enforcement1 or others when the patient presents a serious and imminent threat of harm to self or others2 and 7,g7 communicating to law enforcement and family members or caregivers of the patient about the admission of the patient to receive care at1 or the release of a patient from1 a facility for an emergency psychiatric hold or involuntary treatment4 #aajjd4 ,development and dissemination of model training programs 7a7 ,initial programs and materials ,not later than #a year after the date of the enactment of this ,act1 the ,secretary1 in consultation with appropriate experts1 shall identify the following model programs and materials1 or 7in the case that no such programs or materials exist7 recognize private or public entities to develop and disseminate each of the following3 7#a7 ,model programs and materials for training health care providers 7including physicians1 emergency medical personnel1 psychiatrists1 including child and adolescent psychiatrists1 psychologists1 counselors1 therapists1 nurse practitioners1 physician assistants1 behavioral health facilities and clinics1 care managers1 and hospitals1 including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies7 regarding the permitted uses and disclosures1 consistent with the standards governing the privacy and security of individually identifiable health information promulgated by the ,secretary under part ,c of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 and regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 and such part ,c1 of the protected health information of patients seeking or undergoing mental or substance use disorder treatment4 7#b7 ,a model program and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations specified in paragraph 7#a74 7b7 ,periodic updates ,the ,secretary shall-- 7#a7 periodically review and update the model programs and materials identified or developed under subsection 7a72 and 7#b7 disseminate the updated model programs and materials to the individuals described in subsection 7a74 7c7 ,coordination ,the ,secretary shall carry out this section in coordination with the ,director of the ,office for ,civil ,rights within the ,department of ,health and ,human ,services1 the ,assistant ,secretary for ,mental ,health and ,substance ,use1 the ,administrator of the ,health ,resources and ,services ,administration1 and the heads of other relevant agencies within the ,department of ,health and ,human ,services4 7d7 ,input of certain entities ,in identifying1 reviewing1 or updating the model programs and materials under subsections 7a7 and 7b71 the ,secretary shall solicit the input of relevant national1 ,state1 and local associations2 medical societies2 licensing boards2 providers of mental and substance use disorder treatment2 organizations with expertise on domestic violence1 sexual assault1 elder abuse1 and child abuse2 and organizations representing patients and consumers and the families of patients and consumers4 7e7 ,funding ,there are authorized to be appropriated to carry out this section-- 7#a7 #d1jjj1jjj for fiscal year #bjah2 7#b7 #b1jjj1jjj for each of fiscal years #bjai and #bjbj2 and 7#c7 #a1jjj1jjj for each of fiscal years #bjba and #bjbb4 ,,xii ,medicaid ,mental ,health ,coverage #abjja4 ,rule of construction related to ,medicaid coverage of mental health services and primary care services furnished on the same day ,nothing in title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 shall be construed as prohibiting separate payment under the ,state plan under such title 7or under a waiver of the plan7 for the provision of a mental health service or primary care service under such plan1 with respect to an individual1 because such service is-- 7#a7 a primary care service furnished to the individual by a provider at a facility on the same day a mental health service is furnished to such individual by such provider 7or another provider7 at the facility2 or 7#b7 a mental health service furnished to the individual by a provider at a facility on the same day a primary care service is furnished to such individual by such provider 7or another provider7 at the facility4 #abjjb4 ,study and report related to ,medicaid managed care regulation 7a7 ,study ,the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall conduct a study on coverage under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 of services provided through a medicaid managed care organization 7as defined in section #aijc7m7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77 or a prepaid inpatient health plan 7as defined in section #dch4b of title #db1 ,code of ,federal ,regulations 7or any successor regulation77 with respect to individuals over the age of #ba and under the age of #fe for the treatment of a mental health disorder in institutions for mental diseases 7as defined in section #aije7;i7 of such ,act 7#db ,u4,s4,c4 #acif;d7i7774 ,such study shall include information on the following3 7#a7 ,the extent to which ,states1 including the ,district of ,columbia and each territory or possession of the ,united ,states1 are providing capitated payments to such organizations or plans for enrollees who are receiving services in institutions for mental diseases4 7#b7 ,the number of individuals receiving medical assistance under a ,state plan under such title ,,xix1 or a waiver of such plan1 who receive services in institutions for mental diseases through such organizations and plans4 7#c7 ,the range of and average number of months1 and the length of stay during such months1 that such individuals are receiving such services in such institutions4 7#d7 ,how such organizations or plans determine when to provide for the furnishing of such services through an institution for mental diseases in lieu of other benefits 7including the full range of community-based services7 under their contract with the ,state agency administering the ,state plan under such title ,,xix1 or a waiver of such plan1 to address psychiatric or substance use disorder treatment4 7#e7 ,the extent to which the provision of services within such institutions has affected the capitated payments for such organizations or plans4 7b7 ,report ,not later than #c years after the date of the enactment of this ,act1 the ,secretary shall submit to ,congress a report on the study conducted under subsection 7a74 #abjjc4 ,guidance on opportunities for innovation ,not later than #a year after the date of the enactment of this ,act1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall issue a ,state ,medicaid ,director letter regarding opportunities to design innovative service delivery systems1 including systems for providing community-based services1 for adults with a serious mental illness or children with a serious emotional disturbance who are receiving medical assistance under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq474 ,the letter shall include opportunities for demonstration projects under section #aaae of such ,act 7#db ,u4,s4,c4 #acae7 to improve care for such adults and children4 #abjjd4 ,study and report on ,medicaid emergency psychiatric demonstration project 7a7 ,collection of information ,the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall1 to the extent practical and data is available1 with respect to each ,state that has participated in the demonstration project established under section #bgjg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acif;a note71 collect from each such ,state information on the following3 7#a7 ,the number of institutions for mental diseases 7as defined in section #aije7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7i777 and beds in such institutions that received payment for the provision of services to individuals who receive medical assistance under a ,state plan under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or under a waiver of such plan7 through the demonstration project in each such ,state as compared to the total number of institutions for mental diseases and beds in the ,state4 7#b7 ,the extent to which there is a reduction in expenditures under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 or other spending on the full continuum of physical or mental health care for individuals who receive treatment in an institution for mental diseases under the demonstration project1 including outpatient1 inpatient1 emergency1 and ambulatory care1 that is attributable to such individuals receiving treatment in institutions for mental diseases under the demonstration project4 7#c7 ,the number of forensic psychiatric hospitals1 the number of beds in such hospitals1 and the number of forensic psychiatric beds in other hospitals in such ,state1 based on the most recent data available1 to the extent practical1 as determined by such ,administrator4 7#d7 ,the amount of any disproportionate share hospital payments under section #aibc of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 that institutions for mental diseases in the ,state received during the period beginning on ,july #a1 #bjab1 and ending on ,june #cj1 #bjae1 and the extent to which the demonstration project reduced the amount of such payments4 7#e7 ,the most recent data regarding all facilities or sites in the ,state in which any adults with a serious mental illness who are receiving medical assistance under a ,state plan under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or under a waiver of such plan7 are treated during the period referred to in paragraph 7#d71 to the extent practical1 as determined by the ,administrator1 including-- 7,a7 the types of such facilities or sites 7such as an institution for mental diseases1 a hospital emergency department1 or other inpatient hospital72 7,b7 the average length of stay in such a facility or site by such an individual1 disaggregated by facility type2 and 7,c7 the payment rate under the ,state plan 7or a waivers of such plan7 for services furnished to such an individual for that treatment1 disaggregated by facility type1 during the period in which the demonstration project is in operation4 7#f7 ,the extent to which the utilization of hospital emergency departments during the period in which the demonstration project was is in operation differed1 with respect to individuals who are receiving medical assistance under a ,state plan under the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 7or under a waiver of such plan71 between-- 7,a7 those individuals who received treatment in an institution for mental diseases under the demonstration project2 7,b7 those individuals who met the eligibility requirements for the demonstration project but who did not receive treatment in an institution for mental diseases under the demonstration project2 and 7,c7 those adults with a serious mental illness who did not meet such eligibility requirements and did not receive treatment for such illness in an institution for mental diseases4 7b7 ,report ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report that summarizes and analyzes the information collected under subsection 7a74 ,such report may be submitted as part of the report required under section #bgjg7;f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acif;a note7 or separately4 #abjje4 ,providing ,,epsdt services to children in ,i,m,ds 7a7 ,in general ,section #aije7;a77#af7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77#af77 is amended-- 7#a7 by striking effective ,january #a1 #aigc and inserting 7,a7 effective ,january #a1 #aigc2 and 7#b7 by inserting before the semicolon at the end the following3 1 and1 7,b7 for individuals receiving services described in subparagraph 7,a71 early and periodic screening1 diagnostic1 and treatment services 7as defined in subsection 7r771 whether or not such screening1 diagnostic1 and treatment services are furnished by the provider of the services described in such subparagraph4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply with respect to items and services furnished in calendar quarters beginning on or after ,january #a1 #bjai4 #abjjf4 ,electronic visit verification system required for personal care services and home health care services under ,medicaid 7a7 ,in general ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is amended by inserting after subsection 7k7 the following new subsection3 7l7 7#a7 ,subject to paragraphs 7#c7 and 7#d71 with respect to any amount expended for personal care services or home health care services requiring an in-home visit by a provider that are provided under a ,state plan under this title 7or under a waiver of the plan7 and furnished in a calendar quarter beginning on or after ,january #a1 #bjai 7or1 in the case of home health care services1 on or after ,january #a1 #bjbc71 unless a ,state requires the use of an electronic visit verification system for such services furnished in such quarter under the plan or such waiver1 the ,federal medical assistance percentage shall be reduced-- 7,a7 in the case of personal care services-- 7i7 for calendar quarters in #bjai and #bjbj1 by 4#be percentage points2 7ii7 for calendar quarters in #bjba1 by 4#e percentage points2 7iii7 for calendar quarters in #bjbb1 by 4#ge percentage points2 and 7iv7 for calendar quarters in #bjbc and each year thereafter1 by #a percentage point2 and 7,b7 in the case of home health care services-- 7i7 for calendar quarters in #bjbc and #bjbd1 by 4#be percentage points2 7ii7 for calendar quarters in #bjbe1 by 4#e percentage points2 7iii7 for calendar quarters in #bjbf1 by 4#ge percentage points2 and 7iv7 for calendar quarters in #bjbg and each year thereafter1 by #a percentage point4 7#b7 ,subject to paragraphs 7#c7 and 7#d71 in implementing the requirement for the use of an electronic visit verification system under paragraph 7#a71 a ,state shall-- 7,a7 consult with agencies and entities that provide personal care services1 home health care services1 or both under the ,state plan 7or under a waiver of the plan7 to ensure that such system-- 7i7 is minimally burdensome2 7ii7 takes into account existing best practices and electronic visit verification systems in use in the ,state2 and 7iii7 is conducted in accordance with the requirements of ,,hipaa privacy and security law 7as defined in section #cjji of the ,public ,health ,service ,act72 7,b7 take into account a stakeholder process that includes input from beneficiaries1 family caregivers1 individuals who furnish personal care services or home health care services1 and other stakeholders1 as determined by the ,state in accordance with guidance from the ,secretary2 and 7,c7 ensure that individuals who furnish personal care services1 home health care services1 or both under the ,state plan 7or under a waiver of the plan7 are provided the opportunity for training on the use of such system4 7#c7 ,paragraphs 7#a7 and 7#b7 shall not apply in the case of a ,state that1 as of the date of the enactment of this subsection1 requires the use of any system for the electronic verification of visits conducted as part of both personal care services and home health care services1 so long as the ,state continues to require the use of such system with respect to the electronic verification of such visits4 7#d7 7,a7 ,in the case of a ,state described in subparagraph 7,b71 the reduction under paragraph 7#a7 shall not apply-- 7i7 in the case of personal care services1 for calendar quarters in #bjai2 and 7ii7 in the case of home health care services1 for calendar quarters in #bjbc4 7,b7 ,for purposes of subparagraph 7,a71 a ,state described in this subparagraph is a ,state that demonstrates to the ,secretary that the ,state-- 7i7 has made a good faith effort to comply with the requirements of paragraphs 7#a7 and 7#b7 7including by taking steps to adopt the technology used for an electronic visit verification system72 and 7ii7 in implementing such a system1 has encountered unavoidable system delays4 7#e7 ,in this subsection3 7,a7 ,the term electronic visit verification system means1 with respect to personal care services or home health care services1 a system under which visits conducted as part of such services are electronically verified with respect to-- 7i7 the type of service performed2 7ii7 the individual receiving the service2 7iii7 the date of the service2 7iv7 the location of service delivery2 7v7 the individual providing the service2 and 7vi7 the time the service begins and ends4 7,b7 ,the term home health care services means services described in section #aije7;a77#g7 provided under a ,state plan under this title 7or under a waiver of the plan74 7,c7 ,the term personal care services means personal care services provided under a ,state plan under this title 7or under a waiver of the plan71 including services provided under section #aije7;a77#bd71 #aiae7;c71 #aiae7;i71 #aiae7;j71 or #aiae7k7 or under a wavier under section #aaae4 7#f7 7,a7 ,in the case in which a ,state requires personal care service and home health care service providers to utilize an electronic visit verification system operated by the ,state or a contractor on behalf of the ,state1 the ,secretary shall pay to the ,state1 for each quarter1 an amount equal to #ij per centum of so much of the sums expended during such quarter as are attributable to the design1 development1 or installation of such system1 and #ge per centum of so much of the sums for the operation and maintenance of such system4 7,b7 ,subparagraph 7,a7 shall not apply in the case in which a ,state requires personal care service and home health care service providers to utilize an electronic visit verification system that is not operated by the ,state or a contractor on behalf of the ,state4 4 7b7 ,collection and dissemination of best practices ,not later than ,january #a1 #bjah1 the ,secretary of ,health and ,human ,services shall1 with respect to electronic visit verification systems 7as defined in subsection 7l77#e7 of section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 as inserted by subsection 7a771 collect and disseminate best practices to ,state ,medicaid ,directors with respect to-- 7#a7 training individuals who furnish personal care services1 home health care services1 or both under the ,state plan under title ,,xix of such ,act 7or under a waiver of the plan7 on such systems and the operation of such systems and the prevention of fraud with respect to the provision of personal care services or home health care services 7as defined in such subsection 7l77#e772 and 7#b7 the provision of notice and educational materials to family caregivers and beneficiaries with respect to the use of such electronic visit verification systems and other means to prevent such fraud4 7c7 ,rules of construction 7#a7 ,no employer-employee relationship established ,nothing in the amendment made by this section may be construed as establishing an employer-employee relationship between the agency or entity that provides for personal care services or home health care services and the individuals who1 under a contract with such an agency or entity1 furnish such services for purposes of part #eeb of title #bi1 ,code of ,federal ,regulations 7or any successor regulations74 7#b7 ,no particular or uniform electronic visit verification system required ,nothing in the amendment made by this section shall be construed to require the use of a particular or uniform electronic visit verification system 7as defined in subsection 7l77#e7 of section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 as inserted by subsection 7a77 by all agencies or entities that provide personal care services or home health care under a ,state plan under title ,,xix of the ,social ,security ,act 7or under a waiver of the plan7 7#db ,u4,s4,c4 #acif et seq474 7#c7 ,no limits on provision of care ,nothing in the amendment made by this section may be construed to limit1 with respect to personal care services or home health care services provided under a ,state plan under title ,,xix of the ,social ,security ,act 7or under a waiver of the plan7 7#db ,u4,s4,c4 #acif et seq471 provider selection1 constrain beneficiaries' selection of a caregiver1 or impede the manner in which care is delivered4 7#d7 ,no prohibition on ,state quality measures requirements ,nothing in the amendment made by this section shall be construed as prohibiting a ,state1 in implementing an electronic visit verification system 7as defined in subsection 7l77#e7 of section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b71 as inserted by subsection 7a771 from establishing requirements related to quality measures for such system4 ,,xiii ,mental ,health ,parity #acjja4 ,enhanced compliance with mental health and substance use disorder coverage requirements 7a7 ,compliance program guidance document ,section #bgbf7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7;a77 is amended by adding at the end the following3 7#f7 ,compliance program guidance document 7,a7 ,in general ,not later than #ab months after the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 the ,inspector ,general of the ,department of ,labor1 and the ,inspector ,general of the ,department of the ,treasury1 shall issue a compliance program guidance document to help improve compliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 and section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable4 ,in carrying out this paragraph1 the ,secretaries may take into consideration the #bjaf publication of the ,department of ,health and ,human ,services and the ,department of ,labor1 entitled ,warning ,signs - ,plan or ,policy ,non-,quantitative ,treatment ,limitations 7,n,q,t,ls7 that ,require ,additional ,analysis to ,determine ,mental ,health ,parity ,compliance4 7,b7 ,examples illustrating compliance and noncompliance 7i7 ,in general ,the compliance program guidance document required under this paragraph shall provide illustrative1 de-identified examples 7that do not disclose any protected health information or individually identifiable information7 of previous findings of compliance and noncompliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 based on investigations of violations of such sections1 including-- 7,i7 examples illustrating requirements for information disclosures and nonquantitative treatment limitations2 and 7,,ii7 descriptions of the violations uncovered during the course of such investigations4 7ii7 ,nonquantitative treatment limitations ,to the extent that any example described in clause 7i7 involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations1 the example shall provide sufficient detail to fully explain such finding1 including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits4 7iii7 ,access to additional information regarding compliance ,in developing and issuing the compliance program guidance document required under this paragraph1 the ,secretaries specified in subparagraph 7,a7-- 7,i7 shall enter into interagency agreements with the ,inspector ,general of the ,department of ,health and ,human ,services1 the ,inspector ,general of the ,department of ,labor1 and the ,inspector ,general of the ,department of the ,treasury to share findings of compliance and noncompliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable2 and 7,,ii7 shall seek to enter into an agreement with a ,state to share information on findings of compliance and noncompliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable4 7,c7 ,recommendations ,the compliance program guidance document shall include recommendations to advance compliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 and encourage the development and use of internal controls to monitor adherence to applicable statutes1 regulations1 and program requirements4 ,such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits1 which may fail to comply with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 in relation to nonquantitative treatment limitations on medical and surgical benefits4 7,d7 ,updating the compliance program guidance document ,the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 the ,inspector ,general of the ,department of ,labor1 and the ,inspector ,general of the ,department of the ,treasury1 shall update the compliance program guidance document every #b years to include illustrative1 de-identified examples 7that do not disclose any protected health information or individually identifiable information7 of previous findings of compliance and noncompliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable4 4 7b7 ,additional guidance ,section #bgbf7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7;a771 as amended by subsection 7a71 is further amended by adding at the end the following3 7#g7 ,additional guidance 7,a7 ,in general ,not later than #ab months after the date of enactment of the ,helping ,families in ,mental ,health ,crisis ,reform ,act of #bjaf1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable4 7,b7 ,disclosure 7i7 ,guidance for plans and issuers ,the guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 7and any regulations promulgated pursuant to such sections1 as applicable74 7ii7 ,documents for participants1 beneficiaries1 contracting providers1 or authorized representatives ,the guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use to provide any participant1 beneficiary1 contracting provider1 or authorized representative1 as applicable1 with documents containing information that the health plans or issuers are required to disclose to participants1 beneficiaries1 contracting providers1 or authorized representatives to ensure compliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 compliance with any regulation issued pursuant to such respective section1 or compliance with any other applicable law or regulation4 ,such guidance shall include information that is comparative in nature with respect to-- 7,i7 nonquantitative treatment limitations for both medical and surgical benefits and mental health and substance use disorder benefits2 7,,ii7 the processes1 strategies1 evidentiary standards1 and other factors used to apply the limitations described in subclause 7,i72 and 7,,iii7 the application of the limitations described in subclause 7,i7 to ensure that such limitations are applied in parity with respect to both medical and surgical benefits and mental health and substance use disorder benefits4 7,c7 ,nonquantitative treatment limitations ,the guidance issued under this paragraph shall include clarifying information and illustrative examples of methods1 processes1 strategies1 evidentiary standards1 and other factors that group health plans and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable1 7and any regulations promulgated pursuant to such respective section71 including-- 7i7 examples of methods of determining appropriate types of nonquantitative treatment limitations with respect to both medical and surgical benefits and mental health and substance use disorder benefits1 including nonquantitative treatment limitations pertaining to-- 7,i7 medical management standards based on medical necessity or appropriateness1 or whether a treatment is experimental or investigative2 7,,ii7 limitations with respect to prescription drug formulary design2 and 7,,iii7 use of fail-first or step therapy protocols2 7ii7 examples of methods of determining-- 7,i7 network admission standards 7such as credentialing72 and 7,,ii7 factors used in provider reimbursement methodologies 7such as service type1 geographic market1 demand for services1 and provider supply1 practice size1 training1 experience1 and licensure7 as such factors apply to network adequacy2 7iii7 examples of sources of information that may serve as evidentiary standards for the purposes of making determinations regarding the development and application of nonquantitative treatment limitations2 7iv7 examples of specific factors1 and the evidentiary standards used to evaluate such factors1 used by such plans or issuers in performing a nonquantitative treatment limitation analysis2 7v7 examples of how specific evidentiary standards may be used to determine whether treatments are considered experimental or investigative2 7vi7 examples of how specific evidentiary standards may be applied to each service category or classification of benefits2 7vii7 examples of methods of reaching appropriate coverage determinations for new mental health or substance use disorder treatments1 such as evidence-based early intervention programs for individuals with a serious mental illness and types of medical management techniques2 7viii7 examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship between the covered mental health or substance use disorder benefit and a traditional covered medical and surgical benefit1 such as residential treatment or hospitalizations involving voluntary or involuntary commitment2 and 7ix7 additional illustrative examples of methods1 processes1 strategies1 evidentiary standards1 and other factors for which the ,secretary determines that additional guidance is necessary to improve compliance with this section1 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihab of the ,internal ,revenue ,code of #aihf1 as applicable4 7,d7 ,public comment ,prior to issuing any final guidance under this paragraph1 the ,secretary shall provide a public comment period of not less than #fj days during which any member of the public may provide comments on a draft of the guidance4 4 7c7 ,availability of plan information 7#a7 ,solicitation of public feedback ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall solicit feedback from the public on how the disclosure request process for documents containing information that health plans or health insurance issuers are required under ,federal or ,state law to disclose to participants1 beneficiaries1 contracting providers1 or authorized representatives to ensure compliance with existing mental health parity and addiction equity requirements can be improved while continuing to ensure consumers' rights to access all information required by ,federal or ,state law to be disclosed4 7#b7 ,public availability ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall make such feedback publicly available4 7#c7 ,,naic ,the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall share feedback obtained pursuant to paragraph 7#a7 directly with the ,national ,association of ,insurance ,commissioners to the extent such feedback includes recommendations for the development of simplified information disclosure tools to provide consistent information for consumers4 ,such feedback may be taken into consideration by the ,national ,association of ,insurance ,commissioners and other appropriate entities for the voluntary development and voluntary use of common templates and other sample standardized forms to improve consumer access to plan information4 7d7 ,improving compliance 7#a7 ,in general ,in the case that the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 or the ,secretary of the ,treasury determines that a group health plan or health insurance issuer offering group or individual health insurance coverage has violated1 at least #e times1 section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;a71 or section #ihab of the ,internal ,revenue ,code of #aihf1 respectively1 the appropriate ,secretary shall audit plan documents for such health plan or issuer in the plan year following the ,secretary's determination in order to help improve compliance with such section4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to limit the authority1 as in effect on the day before the date of enactment of this ,act1 of the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 or the ,secretary of the ,treasury to audit documents of health plans or health insurance issuers4 #acjjb4 ,action plan for enhanced enforcement of mental health and substance use disorder coverage 7a7 ,public meeting 7#a7 ,in general ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a public meeting of stakeholders described in paragraph 7#b7 to produce an action plan for improved ,federal and ,state coordination related to the enforcement of section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;a71 and section #ihab of the ,internal ,revenue ,code of #aihf1 and any comparable provisions of ,state law 7in this section such sections and provisions are collectively referred to as mental health parity and addiction equity requirements74 7#b7 ,stakeholders ,the stakeholders described in this paragraph shall include each of the following3 7,a7 ,the ,federal ,government1 including representatives from-- 7i7 the ,department of ,health and ,human ,services2 7ii7 the ,department of the ,treasury2 7iii7 the ,department of ,labor2 and 7iv7 the ,department of ,justice4 7,b7 ,state governments1 including-- 7i7 ,state health insurance commissioners2 7ii7 appropriate ,state agencies1 including agencies on public health or mental health2 and 7iii7 ,state attorneys general or other representatives of ,state entities involved in the enforcement of mental health parity and addiction equity requirements4 7,c7 ,representatives from key stakeholder groups1 including-- 7i7 the ,national ,association of ,insurance ,commissioners2 7ii7 health insurance issuers2 7iii7 providers of mental health and substance use disorder treatment2 7iv7 employers2 and 7v7 patients or their advocates4 7b7 ,action plan ,not later than #f months after the conclusion of the public meeting under subsection 7a71 the ,secretary of ,health and ,human ,services shall finalize the action plan described in such subsection and make it plainly available on the ,internet website of the ,department of ,health and ,human ,services4 7c7 ,content ,the action plan under this section shall-- 7#a7 take into consideration the recommendations of the ,mental ,health and ,substance ,use ,disorder ,parity ,task ,force in its final report issued in ,october of #bjaf1 and any subsequent ,federal and ,state actions in relation to such recommendations2 7#b7 reflect the input of the stakeholders participating in the public meeting under subsection 7a72 7#c7 identify specific strategic objectives regarding how the various ,federal and ,state agencies charged with enforcement of mental health parity and addiction equity requirements will collaborate to improve enforcement of such requirements2 7#d7 provide a timeline for implementing the action plan2 and 7#e7 provide specific examples of how such objectives may be met1 which may include-- 7,a7 providing common educational information and documents1 such as the ,consumer ,guide to ,disclosure ,rights1 to patients about their rights under mental health parity and addiction equity requirements2 7,b7 facilitating the centralized collection of1 monitoring of1 and response to patient complaints or inquiries relating to mental health parity and addiction equity requirements1 which may be through the development and administration of-- 7i7 a single1 toll-free telephone number2 and 7ii7 a new parity website-- 7,i7 to help consumers find the appropriate ,federal or ,state agency to assist with their parity complaints1 appeals1 and other actions2 and 7,,ii7 that takes into consideration1 but is not duplicative of1 the parity beta site being tested1 and released for public comment1 by the ,department of ,health and ,human ,services as of the date of the enactment of this ,act2 7,c7 ,federal and ,state law enforcement agencies entering into memoranda of understanding to better coordinate enforcement responsibilities and information sharing-- 7i7 including whether such agencies should make the results of enforcement actions related to mental health parity and addiction equity requirements publicly available2 and 7ii7 which may include ,state ,policy ,academies on ,parity ,implementation for ,state ,officials and other forums to bring together national experts to provide technical assistance to teams of ,state officials on strategies to advance compliance with mental health parity and addiction equity requirements in both the commercial market1 and in the ,medicaid program under title ,,xix of the ,social ,security ,act and the ,state ,children's ,health ,insurance ,program under title ,,xxi of such ,act2 and 7,d7 recommendations to the ,congress regarding the need for additional legal authority to improve enforcement of mental health parity and addiction equity requirements1 including the need for additional legal authority to ensure that nonquantitative treatment limitations are applied1 and the extent and frequency of the applications of such limitations1 both to medical and surgical benefits and to mental health and substance use disorder benefits in a comparable manner4 #acjjc4 ,report on investigations regarding parity in mental health and substance use disorder benefits 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 and annually thereafter for the subsequent #e years1 the ,assistant ,secretary of ,labor of the ,employee ,benefits ,security ,administration1 in collaboration with the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,secretary of the ,treasury1 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report summarizing the results of all closed ,federal investigations completed during the preceding #ab-month period with findings of any serious violation regarding compliance with mental health and substance use disorder coverage requirements under section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;a71 and section #ihab of the ,internal ,revenue ,code of #aihf4 7b7 ,contents ,subject to subsection 7c71 a report under subsection 7a7 shall1 with respect to investigations described in such subsection1 include each of the following3 7#a7 ,the number of closed ,federal investigations conducted during the covered reporting period4 7#b7 ,each benefit classification examined by any such investigation conducted during the covered reporting period4 7#c7 ,each subject matter1 including compliance with requirements for quantitative and nonquantitative treatment limitations1 of any such investigation conducted during the covered reporting period4 7#d7 ,a summary of the basis of the final decision rendered for each closed investigation conducted during the covered reporting period that resulted in a finding of a serious violation4 7c7 ,limitation ,any individually identifiable information shall be excluded from reports under subsection 7a7 consistent with protections under the health privacy and security rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 #acjjd4 ,,gao study on parity in mental health and substance use disorder benefits ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states1 in consultation with the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report detailing the extent to which group health plans or health insurance issuers offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits1 medicaid managed care organizations with a contract under section #aijc7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m771 and health plans provided under the ,state ,children's ,health ,insurance ,program under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq47 comply with section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;a71 and section #ihab of the ,internal ,revenue ,code of #aihf1 including-- 7#a7 how nonquantitative treatment limitations1 including medical necessity criteria1 of such plans or issuers comply with such sections2 7#b7 how the responsible ,federal departments and agencies ensure that such plans or issuers comply with such sections1 including an assessment of how the ,secretary of ,health and ,human ,services has used its authority to conduct audits of such plans to ensure compliance2 7#c7 a review of how the various ,federal and ,state agencies responsible for enforcing mental health parity requirements have improved enforcement of such requirements in accordance with the objectives and timeline described in the action plan under section #acjjb2 and 7#d7 recommendations for how additional enforcement1 education1 and coordination activities by responsible ,federal and ,state departments and agencies could better ensure compliance with such sections1 including recommendations regarding the need for additional legal authority4 #acjje4 ,information and awareness on eating disorders 7a7 ,information ,the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,office on ,women's ,health1 may-- 7#a7 update information1 related fact sheets1 and resource lists related to eating disorders that are available on the public ,internet website of the ,national ,women's ,health ,information ,center sponsored by the ,office on ,women's ,health1 to include-- 7,a7 updated findings and current research related to eating disorders1 as appropriate2 and 7,b7 information about eating disorders1 including information related to males and females2 7#b7 incorporate1 as appropriate1 and in coordination with the ,secretary of ,education1 information from publicly available resources into appropriate obesity prevention programs developed by the ,office on ,women's ,health2 and 7#c7 make publicly available 7through a public ,internet website or other method7 information1 related fact sheets1 and resource lists1 as updated under paragraph 7#a71 and the information incorporated into appropriate obesity prevention programs under paragraph 7#b74 7b7 ,awareness ,the ,secretary of ,health and ,human ,services may advance public awareness on-- 7#a7 the types of eating disorders2 7#b7 the seriousness of eating disorders1 including prevalence1 comorbidities1 and physical and mental health consequences2 7#c7 methods to identify1 intervene1 refer for treatment1 and prevent behaviors that may lead to the development of eating disorders2 7#d7 discrimination and bullying based on body size2 7#e7 the effects of media on self-esteem and body image2 and 7#f7 the signs and symptoms of eating disorders4 #acjjf4 ,education and training on eating disorders ,the ,secretary of ,health and ,human ,services may facilitate the identification of model programs and materials for educating and training health professionals in effective strategies to-- 7#a7 identify individuals with eating disorders2 7#b7 provide early intervention services for individuals with eating disorders2 7#c7 refer patients with eating disorders for appropriate treatment2 7#d7 prevent the development of eating disorders2 and 7#e7 provide appropriate treatment services for individuals with eating disorders4 #acjjg4 ,clarification of existing parity rules ,if a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage for eating disorder benefits1 including residential treatment1 such group health plan or health insurance issuer shall provide such benefits consistent with the requirements of section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf71 section #gab of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;a71 and section #ihab of the ,internal ,revenue ,code of #aihf4 ,,xiv ,mental health and safe communities ,a ,mental health and safe communities #adjja4 ,law enforcement grants for crisis intervention teams1 mental health purposes 7a7 ,edward ,byrne ,memorial ,justice ,assistance ,grant ,program ,section #eja7;a77#a7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgea7;a77#a77 is amended by adding at the end the following3 7,h7 ,mental health programs and related law enforcement and corrections programs1 including behavioral programs and crisis intervention teams4 4 7b7 ,community ,oriented ,policing ,services ,program ,section #agja7;b7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgif;dd7b77 is amended-- 7#a7 in paragraph 7#ag71 by striking and at the end2 7#b7 by redesignating paragraph 7#ah7 as paragraph 7#bb72 7#c7 by inserting after paragraph 7#ag7 the following3 7#ah7 to provide specialized training to law enforcement officers to-- 7,a7 recognize individuals who have a mental illness2 and 7,b7 properly interact with individuals who have a mental illness1 including strategies for verbal de-escalation of crises2 7#ai7 to establish collaborative programs that enhance the ability of law enforcement agencies to address the mental health1 behavioral1 and substance abuse problems of individuals encountered by law enforcement officers in the line of duty2 7#bj7 to provide specialized training to corrections officers to recognize individuals who have a mental illness2 7#ba7 to enhance the ability of corrections officers to address the mental health of individuals under the care and custody of jails and prisons1 including specialized training and strategies for verbal de-escalation of crises2 and 2 and 7#d7 in paragraph 7#bb71 as redesignated1 by striking through 7#ag7 and inserting through 7#ba74 7c7 ,modifications to the staffing for adequate fire and emergency response grants ,section #cd7;a77#a77;,b7 of the ,federal ,fire ,prevention and ,control ,act of #aigd 7#ae ,u4,s4,c4 #bbbi;a7a77#a77;,b77 is amended by inserting before the period at the end the following3 and to provide specialized training to paramedics1 emergency medical services workers1 and other first responders to recognize individuals who have mental illness and how to properly intervene with individuals with mental illness1 including strategies for verbal de-escalation of crises4 #adjjb4 ,assisted outpatient treatment programs 7a7 ,in general ,section #bbja of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgif;ii7 is amended in paragraph 7#b77;,b71 by inserting before the semicolon the following3 1 or court-ordered assisted outpatient treatment when the court has determined such treatment to be necessary4 7b7 ,definitions ,section #bbjb of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgif;ii--#a7 is amended-- 7#a7 in paragraph 7#a71 by striking and at the end2 7#b7 in paragraph 7#b71 by striking the period at the end and inserting a semicolon2 and 7#c7 by adding at the end the following3 7#c7 the term court-ordered assisted outpatient treatment means a program through which a court may order a treatment plan for an eligible patient that-- 7,a7 requires such patient to obtain outpatient mental health treatment while the patient is not currently residing in a correctional facility or inpatient treatment facility2 and 7,b7 is designed to improve access and adherence by such patient to intensive behavioral health services in order to-- 7i7 avert relapse1 repeated hospitalizations1 arrest1 incarceration1 suicide1 property destruction1 and violent behavior2 and 7ii7 provide such patient with the opportunity to live in a less restrictive alternative to incarceration or involuntary hospitalization2 and 7#d7 the term eligible patient means an adult1 mentally ill person who1 as determined by a court-- 7,a7 has a history of violence1 incarceration1 or medically unnecessary hospitalizations2 7,b7 without supervision and treatment1 may be a danger to self or others in the community2 7,c7 is substantially unlikely to voluntarily participate in treatment2 7,d7 may be unable1 for reasons other than indigence1 to provide for any of his or her basic needs1 such as food1 clothing1 shelter1 health1 or safety2 7,e7 has a history of mental illness or a condition that is likely to substantially deteriorate if the person is not provided with timely treatment2 or 7,f7 due to mental illness1 lacks capacity to fully understand or lacks judgment to make informed decisions regarding his or her need for treatment1 care1 or supervision4 4 #adjjc4 ,federal drug and mental health courts 7a7 ,definitions ,in this section-- 7#a7 the term eligible offender means a person who-- 7,a7 7i7 previously or currently has been diagnosed by a qualified mental health professional as having a mental illness1 mental retardation1 or co-occurring mental illness and substance abuse disorders2 or 7ii7 manifests obvious signs of mental illness1 mental retardation1 or co-occurring mental illness and substance abuse disorders during arrest or confinement or before any court2 7,b7 comes into contact with the criminal justice system or is arrested or charged with an offense that is not-- 7i7 a crime of violence1 as defined under applicable ,state law or in section #caef of title #ah1 ,united ,states ,code2 or 7ii7 a serious drug offense1 as defined in section #ibd7;e77#b77;,a7 of title #ah1 ,united ,states ,code2 and 7,c7 is determined by a judge to be eligible2 and 7#b7 the term mental illness means a diagnosable mental1 behavioral1 or emotional disorder-- 7,a7 of sufficient duration to meet diagnostic criteria within the most recent edition of the ,diagnostic and ,statistical ,manual of ,mental ,disorders published by the ,american ,psychiatric ,association2 and 7,b7 that has resulted in functional impairment that substantially interferes with or limits #a or more major life activities4 7b7 ,establishment of program ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general shall establish a pilot program to determine the effectiveness of diverting eligible offenders from ,federal prosecution1 ,federal probation1 or a ,bureau of ,prisons facility1 and placing such eligible offenders in drug or mental health courts4 7c7 ,program specifications ,the pilot program established under subsection 7b7 shall involve-- 7#a7 continuing judicial supervision1 including periodic review1 of program participants who have a substance abuse problem or mental illness2 and 7#b7 the integrated administration of services and sanctions1 which shall include-- 7,a7 mandatory periodic testing1 as appropriate1 for the use of controlled substances or other addictive substances during any period of supervised release or probation for each program participant2 7,b7 substance abuse treatment for each program participant who requires such services2 7,c7 diversion1 probation1 or other supervised release with the possibility of prosecution1 confinement1 or incarceration based on noncompliance with program requirements or failure to show satisfactory progress toward completing program requirements2 7,d7 programmatic offender management1 including case management1 and aftercare services1 such as relapse prevention1 health care1 education1 vocational training1 job placement1 housing placement1 and child care or other family support services for each program participant who requires such services2 7,e7 outpatient or inpatient mental health treatment1 as ordered by the court1 that carries with it the possibility of dismissal of charges or reduced sentencing upon successful completion of such treatment2 7,f7 centralized case management1 including-- 7i7 the consolidation of all cases1 including violations of probations1 of the program participant2 and 7ii7 coordination of all mental health treatment plans and social services1 including life skills and vocational training1 housing and job placement1 education1 health care1 and relapse prevention for each program participant who requires such services2 and 7,g7 continuing supervision of treatment plan compliance by the program participant for a term not to exceed the maximum allowable sentence or probation period for the charged or relevant offense and1 to the extent practicable1 continuity of psychiatric care at the end of the supervised period4 7d7 ,implementation2 duration ,the pilot program established under subsection 7b7 shall be conducted-- 7#a7 in not less than #a ,united ,states judicial district1 designated by the ,attorney ,general in consultation with the ,director of the ,administrative ,office of the ,united ,states ,courts1 as appropriate for the pilot program2 and 7#b7 during fiscal year #bjag through fiscal year #bjba4 7e7 ,criteria for designation ,before making a designation under subsection 7d77#a71 the ,attorney ,general shall-- 7#a7 obtain the approval1 in writing1 of the ,united ,states ,attorney for the ,united ,states judicial district being designated2 7#b7 obtain the approval1 in writing1 of the chief judge for the ,united ,states judicial district being designated2 and 7#c7 determine that the ,united ,states judicial district being designated has adequate behavioral health systems for treatment1 including substance abuse and mental health treatment4 7f7 ,assistance from other ,federal entities ,the ,administrative ,office of the ,united ,states ,courts and the ,united ,states ,probation ,offices shall provide such assistance and carry out such functions as the ,attorney ,general may request in monitoring1 supervising1 providing services to1 and evaluating eligible offenders placed in a drug or mental health court under this section4 7g7 ,reports ,the ,attorney ,general1 in consultation with the ,director of the ,administrative ,office of the ,united ,states ,courts1 shall monitor the drug and mental health courts under this section1 and shall submit a report to ,congress on the outcomes of the program at the end of the period described in subsection 7d77#b74 #adjjd4 ,mental health in the judicial system ,part ,v of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgif;ii et seq47 is amended by inserting at the end the following3 #bbji4 ,mental health responses in the judicial system 7a7 ,pretrial screening and supervision 7#a7 ,in general ,the ,attorney ,general may award grants to ,states1 units of local government1 territories1 ,indian ,tribes1 nonprofit agencies1 or any combination thereof1 to develop1 implement1 or expand pretrial services programs to improve the identification and outcomes of individuals with mental illness4 7#b7 ,allowable uses ,grants awarded under this subsection may be may be used for-- 7,a7 behavioral health needs and risk screening of defendants1 including verification of interview information1 mental health evaluation1 and criminal history screening2 7,b7 assessment of risk of pretrial misconduct through objective1 statistically validated means1 and presentation to the court of recommendations based on such assessment1 including services that will reduce the risk of pre-trial misconduct2 7,c7 followup review of defendants unable to meet the conditions of pretrial release2 7,d7 evaluation of process and results of pre-trial service programs2 7,e7 supervision of defendants who are on pretrial release1 including reminders to defendants of scheduled court dates2 7,f7 reporting on process and results of pretrial services programs to relevant public and private mental health stakeholders2 and 7,g7 data collection and analysis necessary to make available information required for assessment of risk4 7b7 ,behavioral health assessments and intervention 7#a7 ,in general ,the ,attorney ,general may award grants to ,states1 units of local government1 territories1 ,indian ,tribes1 nonprofit agencies1 or any combination thereof1 to develop1 implement1 or expand a behavioral health screening and assessment program framework for ,state or local criminal justice systems4 7#b7 ,allowable uses ,grants awarded under this subsection may be used for-- 7,a7 promotion of the use of validated assessment tools to gauge the criminogenic risk1 substance abuse needs1 and mental health needs of individuals2 7,b7 initiatives to match the risk factors and needs of individuals to programs and practices associated with research-based1 positive outcomes2 7,c7 implementing methods for identifying and treating individuals who are most likely to benefit from coordinated supervision and treatment strategies1 and identifying individuals who can do well with fewer interventions2 and 7,d7 collaborative decision-making among the heads of criminal justice agencies1 mental health systems1 judicial systems1 substance abuse systems1 and other relevant systems or agencies for determining how treatment and intensive supervision services should be allocated in order to maximize benefits1 and developing and utilizing capacity accordingly4 7c7 ,use of grant funds ,a ,state1 unit of local government1 territory1 ,indian ,tribe1 or nonprofit agency that receives a grant under this section shall1 in accordance with subsection 7b77#b71 use grant funds for the expenses of a treatment program1 including-- 7#a7 salaries1 personnel costs1 equipment costs1 and other costs directly related to the operation of the program1 including costs relating to enforcement2 7#b7 payments for treatment providers that are approved by the ,state or ,indian ,tribe and licensed1 if necessary1 to provide needed treatment to program participants1 including aftercare supervision1 vocational training1 education1 and job placement2 and 7#c7 payments to public and nonprofit private entities that are approved by the ,state or ,indian ,tribe and licensed1 if necessary1 to provide alcohol and drug addiction treatment to offenders participating in the program4 7d7 ,supplement of non-,federal funds 7#a7 ,in general ,grants awarded under this section shall be used to supplement1 and not supplant1 non-,federal funds that would otherwise be available for programs described in this section4 7#b7 ,federal share ,the ,federal share of a grant made under this section may not exceed #ej percent of the total costs of the program described in an application under subsection 7e74 7e7 ,applications ,to request a grant under this section1 a ,state1 unit of local government1 territory1 ,indian ,tribe1 or nonprofit agency shall submit an application to the ,attorney ,general in such form and containing such information as the ,attorney ,general may reasonably require4 7f7 ,geographic distribution ,the ,attorney ,general shall ensure that1 to the extent practicable1 the distribution of grants under this section is equitable and includes-- 7#a7 each ,state2 and 7#b7 a unit of local government1 territory1 ,indian ,tribe1 or nonprofit agency-- 7,a7 in each ,state2 and 7,b7 in rural1 suburban1 ,tribal1 and urban jurisdictions4 7g7 ,reports and evaluations ,for each fiscal year1 each grantee under this section during that fiscal year shall submit to the ,attorney ,general a report on the effectiveness of activities carried out using such grant4 ,each report shall include an evaluation in such form and containing such information as the ,attorney ,general may reasonably require4 ,the ,attorney ,general shall specify the dates on which such reports shall be submitted4 7h7 ,accountability ,grants awarded under this section shall be subject to the following accountability provisions3 7#a7 ,audit requirement 7,a7 ,definition ,in this paragraph1 the term unresolved audit finding means a finding in the final audit report of the ,inspector ,general of the ,department of ,justice under subparagraph 7,c7 that the audited grantee has used grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within #a year after the date on which final audit report is issued4 7,b7 ,audits ,beginning in the first fiscal year beginning after the date of enactment of this section1 and in each fiscal year thereafter1 the ,inspector ,general of the ,department of ,justice shall conduct audits of grantees under this section to prevent waste1 fraud1 and abuse of funds by grantees4 ,the ,inspector ,general shall determine the appropriate number of grantees to be audited each year4 7,c7 ,final audit report ,the ,inspector ,general of the ,department of ,justice shall submit to the ,attorney ,general a final report on each audit conducted under subparagraph 7,b74 7,d7 ,mandatory exclusion ,grantees under this section about which there is an unresolved audit finding shall not be eligible to receive a grant under this section during the #b fiscal years beginning after the end of the #a-year period described in subparagraph 7,a74 7,e7 ,priority ,in making grants under this section1 the ,attorney ,general shall give priority to applicants that did not have an unresolved audit finding during the #c fiscal years before submitting an application for a grant under this section4 7,f7 ,reimbursement ,if an entity receives a grant under this section during the #b-;fiscal-year period during which the entity is prohibited from receiving grants under subparagraph 7,d71 the ,attorney ,general shall-- 7i7 deposit an amount equal to the amount of the grant that was improperly awarded to the grantee into the ,general ,fund of the ,treasury2 and 7ii7 seek to recoup the costs of the repayment under clause 7i7 from the grantee that was erroneously awarded grant funds4 7#b7 ,nonprofit agency requirements 7,a7 ,definition ,for purposes of this paragraph and the grant program under this section1 the term nonprofit agency means an organization that is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;c77#c77 and is exempt from taxation under section #eja7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;a774 7,b7 ,prohibition ,the ,attorney ,general may not award a grant under this section to a nonprofit agency that holds money in an offshore account for the purpose of avoiding paying the tax described in section #eaa7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eaa7;a774 7,c7 ,disclosure ,each nonprofit agency that is awarded a grant under this section and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers1 directors1 trustees1 and key employees1 shall disclose to the ,attorney ,general1 in the application for the grant1 the process for determining such compensation1 including the independent persons involved in reviewing and approving such compensation1 the comparability data used1 and contemporaneous substantiation of the deliberation and decision4 ,upon request1 the ,attorney ,general shall make the information disclosed under this subparagraph available for public inspection4 7#c7 ,conference expenditures 7,a7 ,limitation ,not more than #bj1jjj of the amounts made available to the ,department of ,justice to carry out this section may be used by the ,attorney ,general1 or by any individual or entity awarded a grant under this section to host1 or make any expenditures relating to1 a conference unless the ,deputy ,attorney ,general provides prior written authorization that the funds may be expended to host the conference or make such expenditure4 7,b7 ,written approval ,written approval under subparagraph 7,a7 shall include a written estimate of all costs associated with the conference1 including the cost of all food1 beverages1 audio-visual equipment1 honoraria for speakers1 and entertainment4 7,c7 ,report ,the ,deputy ,attorney ,general shall submit an annual report to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives on all conference expenditures approved under this paragraph4 7#d7 ,annual certification ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 the ,attorney ,general shall submit to the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,house of ,representatives an annual certification-- 7,a7 indicating whether-- 7i7 all final audit reports issued by the ,office of the ,inspector ,general under paragraph 7#a7 have been completed and reviewed by the appropriate ,assistant ,attorney ,general or ,director2 7ii7 all mandatory exclusions required under paragraph 7#a77;,d7 have been issued2 and 7iii7 any reimbursements required under paragraph 7#a77;,f7 have been made2 and 7,b7 that includes a list of any grantees excluded under paragraph 7#a77;,d7 from the previous year4 7i7 ,preventing duplicative grants 7#a7 ,in general ,before the ,attorney ,general awards a grant to an applicant under this section1 the ,attorney ,general shall compare the possible grant with any other grants awarded to the applicant under this ,act to determine whether the grants are for the same purpose4 7#b7 ,report ,if the ,attorney ,general awards multiple grants to the same applicant for the same purpose1 the ,attorney ,general shall submit to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives a report that includes-- 7,a7 a list of all duplicate grants awarded1 including the total dollar amount of any such grants awarded2 and 7,b7 the reason the ,attorney ,general awarded the duplicate grants4 4 #adjje4 ,forensic assertive community treatment initiatives ,section #biia of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7 is amended by-- 7#a7 redesignating subsection 7j7 as subsection 7o72 and 7#b7 inserting after subsection 7i7 the following3 7j7 ,forensic ,assertive ,community ,treatment 7,,fact7 ,initiative ,program 7#a7 ,in general ,the ,attorney ,general may make grants to ,states1 units of local government1 territories1 ,indian ,tribes1 nonprofit agencies1 or any combination thereof1 to develop1 implement1 or expand ,assertive ,community ,treatment initiatives to develop forensic assertive community treatment 7referred to in this subsection as ,,fact7 programs that provide high intensity services in the community for individuals with mental illness with involvement in the criminal justice system to prevent future incarcerations4 7#b7 ,allowable uses ,grant funds awarded under this subsection may be used for-- 7,a7 multidisciplinary team initiatives for individuals with mental illnesses with criminal justice involvement that address criminal justice involvement as part of treatment protocols2 7,b7 ,,fact programs that involve mental health professionals1 criminal justice agencies1 chemical dependency specialists1 nurses1 psychiatrists1 vocational specialists1 forensic peer specialists1 forensic specialists1 and dedicated administrative support staff who work together to provide recovery oriented1 #bd_/g wraparound services2 7,c7 services such as integrated evidence-based practices for the treatment of co-occurring mental health and substance-related disorders1 assertive outreach and engagement1 community-based service provision at participants' residence or in the community1 psychiatric rehabilitation1 recovery oriented services1 services to address criminogenic risk factors1 and community tenure2 7,d7 payments for treatment providers that are approved by the ,state or ,indian ,tribe and licensed1 if necessary1 to provide needed treatment to eligible offenders participating in the program1 including behavioral health services and aftercare supervision2 and 7,e7 training for all ,,fact teams to promote high-fidelity practice principles and technical assistance to support effective and continuing integration with criminal justice agency partners4 7#c7 ,supplement and not supplant ,grants made under this subsection shall be used to supplement1 and not supplant1 non-,federal funds that would otherwise be available for programs described in this subsection4 7#d7 ,applications ,to request a grant under this subsection1 a ,state1 unit of local government1 territory1 ,indian ,tribe1 or nonprofit agency shall submit an application to the ,attorney ,general in such form and containing such information as the ,attorney ,general may reasonably require4 4 #adjjf4 ,assistance for individuals transitioning out of systems ,section #bigf7;f7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgigw7f77 is amended-- 7#a7 in paragraph 7#e71 by striking and at the end2 7#b7 in paragraph 7#f71 by striking the period at the end and inserting a semicolon2 and 7#c7 by adding at the end the following3 7#g7 provide mental health treatment and transitional services for those with mental illnesses or with co-occurring disorders1 including housing placement or assistance2 and 4 #adjjg4 ,co-occurring substance abuse and mental health challenges in drug courts ,part ,,ee of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgigu et seq47 is amended-- 7#a7 in section #biea7;a77#a7 7#db ,u4,s4,c4 #cgigu7a77#a771 by inserting 1 including co-occurring substance abuse and mental health problems1 after problems2 and 7#b7 in section #biei7;a7 7#db ,u4,s4,c4 #cgigu-#h7;a771 by inserting 1 including training for drug court personnel and officials on identifying and addressing co-occurring substance abuse and mental health problems after part4 #adjjh4 ,mental health training for ,federal uniformed services 7a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,defense1 the ,secretary of ,homeland ,security1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,commerce shall provide the following to each of the uniformed services 7as that term is defined in section #aja of title #aj1 ,united ,states ,code7 under their direction3 7#a7 ,training programs ,programs that offer specialized and comprehensive training in procedures to identify and respond appropriately to incidents in which the unique needs of individuals with mental illnesses are involved4 7#b7 ,improved technology ,computerized information systems or technological improvements to provide timely information to ,federal law enforcement personnel1 other branches of the uniformed services1 and criminal justice system personnel to improve the ,federal response to mentally ill individuals4 7#c7 ,cooperative programs ,the establishment and expansion of cooperative efforts to promote public safety through the use of effective intervention with respect to mentally ill individuals encountered by members of the uniformed services4 #adjji4 ,advancing mental health as part of offender reentry 7a7 ,reentry demonstration projects ,section #bigf7;f7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgigw7f771 as amended by section #adjjf1 is amended-- 7#a7 in paragraph 7#c77;,c71 by inserting mental health services1 before drug treatment2 and 7#b7 by adding at the end the following3 7#h7 target offenders with histories of homelessness1 substance abuse1 or mental illness1 including a prerelease assessment of the housing status of the offender and behavioral health needs of the offender with clear coordination with mental health1 substance abuse1 and homelessness services systems to achieve stable and permanent housing outcomes with appropriate support service4 4 7b7 ,mentoring grants ,section #baa7;b77#b7 of the ,second ,chance ,act of #bjjg 7#db ,u4,s4,c4 #ageca7;b77#b77 is amended by inserting 1 including mental health care after community4 #adjaj4 ,school mental health crisis intervention teams ,section #bgja7;b7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;a7b77 is amended-- 7#a7 by redesignating paragraphs 7#d7 and 7#e7 as paragraphs 7#e7 and 7#f71 respectively2 and 7#b7 by inserting after paragraph 7#c7 the following3 7#d7 ,the development and operation of crisis intervention teams that may include coordination with law enforcement agencies and specialized training for school officials in responding to mental health crises4 4 #adjaa4 ,active-shooter training for law enforcement ,the ,attorney ,general1 as part of the ,preventing ,violence ,against ,law ,enforcement and ,ensuring ,officer ,resilience and ,survivability ,initiative 7,,valor7 of the ,department of ,justice1 may provide safety training and technical assistance to local law enforcement agencies1 including active-shooter response training4 #adjab4 ,co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs ,section #aija7;a7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgif;ff7a77 is amended-- 7#a7 in paragraph 7#a71 by striking and at the end2 7#b7 in paragraph 7#b71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#c7 developing and implementing specialized residential substance abuse treatment programs that identify and provide appropriate treatment to inmates with co-occurring mental health and substance abuse disorders or challenges4 4 #adjac4 ,mental health and drug treatment alternatives to incarceration programs ,title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgaa et seq47 is amended by striking part ,,cc and inserting the following3 ,,cc ,mental health and drug treatment alternatives to incarceration programs #bija4 ,mental health and drug treatment alternatives to incarceration programs 7a7 ,definitions ,in this section-- 7#a7 the term eligible entity means a ,state1 unit of local government1 ,indian tribe1 or nonprofit organization2 and 7#b7 the term eligible participant means an individual who-- 7,a7 comes into contact with the criminal justice system or is arrested or charged with an offense that is not-- 7i7 a crime of violence1 as defined under applicable ,state law or in section #caef of title #ah1 ,united ,states ,code2 or 7ii7 a serious drug offense1 as defined in section #ibd7;e77#b77;,a7 of title #ah1 ,united ,states ,code2 7,b7 has a history of1 or a current-- 7i7 substance use disorder2 7ii7 mental illness2 or 7iii7 co-occurring mental illness and substance use disorder2 and 7,c7 has been approved for participation in a program funded under this section by the relevant law enforcement agency1 prosecuting attorney1 defense attorney1 probation official1 corrections official1 judge1 representative of a mental health agency1 or representative of a substance abuse agency1 as required by law4 7b7 ,program authorized ,the ,attorney ,general may make grants to eligible entities to develop1 implement1 or expand a treatment alternative to incarceration program for eligible participants1 including-- 7#a7 pre-booking treatment alternative to incarceration programs1 including-- 7,a7 law enforcement training on substance use disorders1 mental illness1 and co-occurring mental illness and substance use disorders2 7,b7 receiving centers as alternatives to incarceration of eligible participants2 7,c7 specialized response units for calls related to substance use disorders1 mental illness1 or co-occurring mental illness and substance use disorders2 and 7,d7 other arrest and pre-booking treatment alternatives to incarceration models2 or 7#b7 post-booking treatment alternative to incarceration programs1 including-- 7,a7 specialized clinical case management2 7,b7 pre-trial services related to substances use disorders1 mental illness1 and co-occurring mental illness and substance use disorders2 7,c7 prosecutor and defender based programs2 7,d7 specialized probation2 7,e7 treatment and rehabilitation programs2 and 7,f7 problem-solving courts1 including mental health courts1 drug courts1 co-occurring mental health and substance abuse courts1 ,,dwi courts1 and veterans treatment courts4 7c7 ,application 7#a7 ,in general ,an eligible entity desiring a grant under this section shall submit an application to the ,attorney ,general-- 7,a7 that meets the criteria under paragraph 7#b72 and 7,b7 at such time1 in such manner1 and accompanied by such information as the ,attorney ,general may require4 7#b7 ,criteria ,an eligible entity1 in submitting an application under paragraph 7#a71 shall-- 7,a7 provide extensive evidence of collaboration with ,state and local government agencies overseeing health1 community corrections1 courts1 prosecution1 substance abuse1 mental health1 victims services1 and employment services1 and with local law enforcement agencies2 7,b7 demonstrate consultation with the ,single ,state ,authority for ,substance ,abuse of the ,state 7as that term is defined in section #bja7;e7 of the ,second ,chance ,act of #bjjg72 7,c7 demonstrate that evidence-based treatment practices will be utilized2 and 7,d7 demonstrate that evidence-based screening and assessment tools will be used to place participants in the treatment alternative to incarceration program4 7d7 ,requirements ,each eligible entity awarded a grant for a treatment alternative to incarceration program under this section shall-- 7#a7 determine the terms and conditions of participation in the program by eligible participants1 taking into consideration the collateral consequences of an arrest1 prosecution or criminal conviction2 7#b7 ensure that each substance abuse and mental health treatment component is licensed and qualified by the relevant jurisdiction2 7#c7 for programs described in subsection 7b77#b71 organize an enforcement unit comprised of appropriately trained law enforcement professionals under the supervision of the ,state1 ,tribal1 or local criminal justice agency involved1 the duties of which shall include-- 7,a7 the verification of addresses and other contact information of each eligible participant who participates or desires to participate in the program2 and 7,b7 if necessary1 the location1 apprehension1 arrest1 and return to custody of an eligible participant in the program who has absconded from the facility of a treatment provider or has otherwise significantly violated the terms and conditions of the program1 consistent with ,federal and ,state confidentiality requirements2 7#d7 notify the relevant criminal justice entity if any eligible participant in the program absconds from the facility of the treatment provider or otherwise violates the terms and conditions of the program1 consistent with ,federal and ,state confidentiality requirements2 7#e7 submit periodic reports on the progress of treatment or other measured outcomes from participation in the program of each eligible participant in the program to the relevant ,state1 ,tribal1 or local criminal justice agency1 including mental health courts1 drug courts1 co-occurring mental health and substance abuse courts1 ,,dwi courts1 and veterans treatment courts2 7#f7 describe the evidence-based methodology and outcome measurements that will be used to evaluate the program1 and specifically explain how such measurements will provide valid measures of the impact of the program2 and 7#g7 describe how the program could be broadly replicated if demonstrated to be effective4 7e7 ,use of funds ,an eligible entity shall use a grant received under this section for expenses of a treatment alternative to incarceration program1 including-- 7#a7 salaries1 personnel costs1 equipment costs1 and other costs directly related to the operation of the program1 including the enforcement unit2 7#b7 payments for treatment providers that are approved by the relevant ,state or ,tribal jurisdiction and licensed1 if necessary1 to provide needed treatment to eligible offenders participating in the program1 including aftercare supervision1 vocational training1 education1 and job placement2 and 7#c7 payments to public and nonprofit private entities that are approved by the ,state or ,tribal jurisdiction and licensed1 if necessary1 to provide alcohol and drug addiction treatment to eligible offenders participating in the program4 7f7 ,supplement not supplant ,an eligible entity shall use ,federal funds received under this section only to supplement the funds that would1 in the absence of those ,federal funds1 be made available from other ,federal and non-,federal sources for the activities described in this section1 and not to supplant those funds4 ,the ,federal share of a grant made under this section may not exceed #ej percent of the total costs of the program described in an application under subsection 7d74 7g7 ,geographic distribution ,the ,attorney ,general shall ensure that1 to the extent practicable1 the geographical distribution of grants under this section is equitable and includes a grant to an eligible entity in-- 7#a7 each ,state2 7#b7 rural1 suburban1 and urban areas2 and 7#c7 ,tribal jurisdictions4 7h7 ,reports and evaluations ,each fiscal year1 each recipient of a grant under this section during that fiscal year shall submit to the ,attorney ,general a report on the outcomes of activities carried out using that grant in such form1 containing such information1 and on such dates as the ,attorney ,general shall specify4 7i7 ,accountability ,all grants awarded by the ,attorney ,general under this section shall be subject to the following accountability provisions3 7#a7 ,audit requirement 7,a7 ,definition ,in this paragraph1 the term unresolved audit finding means a finding in the final audit report of the ,inspector ,general of the ,department of ,justice that the audited grantee has utilized grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within #ab months from the date on which the final audit report is issued4 7,b7 ,audits ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 and in each fiscal year thereafter1 the ,inspector ,general of the ,department of ,justice shall conduct audits of recipients of grants under this section to prevent waste1 fraud1 and abuse of funds by grantees4 ,the ,inspector ,general shall determine the appropriate number of grantees to be audited each year4 7,c7 ,mandatory exclusion ,a recipient of grant funds under this section that is found to have an unresolved audit finding shall not be eligible to receive grant funds under this section during the first #b fiscal years beginning after the end of the #ab-month period described in subparagraph 7,a74 7,d7 ,priority ,in awarding grants under this section1 the ,attorney ,general shall give priority to eligible applicants that did not have an unresolved audit finding during the #c fiscal years before submitting an application for a grant under this section4 7,e7 ,reimbursement ,if an entity is awarded grant funds under this section during the #b-;fiscal-year period during which the entity is barred from receiving grants under subparagraph 7,c71 the ,attorney ,general shall-- 7i7 deposit an amount equal to the amount of the grant funds that were improperly awarded to the grantee into the ,general ,fund of the ,treasury2 and 7ii7 seek to recoup the costs of the repayment to the fund from the grant recipient that was erroneously awarded grant funds4 7#b7 ,nonprofit organization requirements 7,a7 ,definition ,for purposes of this paragraph and the grant programs under this part1 the term nonprofit organization means an organization that is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf and is exempt from taxation under section #eja7;a7 of such ,code4 7,b7 ,prohibition ,the ,attorney ,general may not award a grant under this part to a nonprofit organization that holds money in offshore accounts for the purpose of avoiding paying the tax described in section #eaa7;a7 of the ,internal ,revenue ,code of #aihf4 7,c7 ,disclosure ,each nonprofit organization that is awarded a grant under this section and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers1 directors1 trustees1 and key employees1 shall disclose to the ,attorney ,general1 in the application for the grant1 the process for determining such compensation1 including the independent persons involved in reviewing and approving such compensation1 the comparability data used1 and contemporaneous substantiation of the deliberation and decision4 ,upon request1 the ,attorney ,general shall make the information disclosed under this subparagraph available for public inspection4 7#c7 ,conference expenditures 7,a7 ,limitation ,no amounts made available to the ,department of ,justice under this section may be used by the ,attorney ,general1 or by any individual or entity awarded discretionary funds through a cooperative agreement under this section1 to host or support any expenditure for conferences that uses more than #bj1jjj in funds made available by the ,department of ,justice1 unless the head of the relevant agency or department1 provides prior written authorization that the funds may be expended to host the conference4 7,b7 ,written approval ,written approval under subparagraph 7,a7 shall include a written estimate of all costs associated with the conference1 including the cost of all food1 beverages1 audio-visual equipment1 honoraria for speakers1 and entertainment4 7,c7 ,report ,the ,deputy ,attorney ,general shall submit an annual report to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives on all conference expenditures approved under this paragraph4 7#d7 ,annual certification ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 the ,attorney ,general shall submit1 to the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,house of ,representatives1 an annual certification-- 7,a7 indicating whether-- 7i7 all audits issued by the ,office of the ,inspector ,general under paragraph 7#a7 have been completed and reviewed by the appropriate ,assistant ,attorney ,general or ,director2 7ii7 all mandatory exclusions required under paragraph 7#a77;,c7 have been issued2 and 7iii7 all reimbursements required under paragraph 7#a77;,e7 have been made2 and 7,b7 that includes a list of any grant recipients excluded under paragraph 7#a7 from the previous year4 7#e7 ,preventing duplicative grants 7,a7 ,in general ,before the ,attorney ,general awards a grant to an applicant under this section1 the ,attorney ,general shall compare potential grant awards with other grants awarded under this ,act to determine if duplicate grant awards are awarded for the same purpose4 7,b7 ,report ,if the ,attorney ,general awards duplicate grants to the same applicant for the same purpose the ,attorney ,general shall submit to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives a report that includes-- 7i7 a list of all duplicate grants awarded1 including the total dollar amount of any duplicate grants awarded2 and 7ii7 the reason the ,attorney ,general awarded the duplicate grants4 4 #adjad4 ,national criminal justice and mental health training and technical assistance ,part ,,hh of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa et seq47 is amended by adding at the end the following3 #biib4 ,national criminal justice and mental health training and technical assistance 7a7 ,authority ,the ,attorney ,general may make grants to eligible organizations to provide for the establishment of a ,national ,criminal ,justice and ,mental ,health ,training and ,technical ,assistance ,center4 7b7 ,eligible organization ,for purposes of subsection 7a71 the term eligible organization means a national nonprofit organization that provides technical assistance and training to1 and has special expertise and broad1 national-level experience in1 mental health1 crisis intervention1 criminal justice systems1 law enforcement1 translating evidence into practice1 training1 and research1 and education and support of people with mental illness and the families of such individuals4 7c7 ,use of funds ,any organization that receives a grant under subsection 7a7 shall collaborate with other grant recipients to establish and operate a ,national ,criminal ,justice and ,mental ,health ,training and ,technical ,assistance ,center to-- 7#a7 provide law enforcement officer training regarding mental health and working with individuals with mental illnesses1 with an emphasis on de-escalation of encounters between law enforcement officers and those with mental disorders or in crisis1 which shall include support the development of in-person and technical information exchanges between systems and the individuals working in those systems in support of the concepts identified in the training2 7#b7 provide education1 training1 and technical assistance for ,states1 ,indian tribes1 territories1 units of local government1 service providers1 nonprofit organizations1 probation or parole officers1 prosecutors1 defense attorneys1 emergency response providers1 and corrections institutions to advance practice and knowledge relating to mental health crisis and approaches to mental health and criminal justice across systems2 7#c7 provide training and best practices to mental health providers and criminal justice agencies relating to diversion initiatives1 jail and prison strategies1 reentry of individuals with mental illnesses into the community1 and dispatch protocols and triage capabilities1 including the establishment of learning sites2 7#d7 develop suicide prevention and crisis intervention training and technical assistance for criminal justice agencies2 7#e7 develop a receiving center system and pilot strategy that provides1 for a jurisdiction1 a single point of entry into the mental health and substance abuse system for assessments and appropriate placement of individuals experiencing a crisis2 7#f7 collect data and best practices in mental health and criminal health and criminal justice initiatives and policies from grantees under this part1 other recipients of grants under this section1 ,federal1 ,state1 and local agencies involved in the provision of mental health services1 and nongovernmental organizations involved in the provision of mental health services2 7#g7 develop and disseminate to mental health providers and criminal justice agencies evaluation tools1 mechanisms1 and measures to better assess and document performance measures and outcomes relating to the provision of mental health services2 7#h7 disseminate information to ,states1 units of local government1 criminal justice agencies1 law enforcement agencies1 and other relevant entities about best practices1 policy standards1 and research findings relating to the provision of mental health services2 and 7#i7 provide education and support to individuals with mental illness involved with1 or at risk of involvement with1 the criminal justice system1 including the families of such individuals4 7d7 ,accountability ,grants awarded under this section shall be subject to the following accountability provisions3 7#a7 ,audit requirement 7,a7 ,definition ,in this paragraph1 the term unresolved audit finding means a finding in the final audit report of the ,inspector ,general of the ,department of ,justice under subparagraph 7,c7 that the audited grantee has used grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within #a year after the date on which the final audit report is issued4 7,b7 ,audits ,beginning in the first fiscal year beginning after the date of enactment of this section1 and in each fiscal year thereafter1 the ,inspector ,general of the ,department of ,justice shall conduct audits of grantees under this section to prevent waste1 fraud1 and abuse of funds by grantees4 ,the ,inspector ,general shall determine the appropriate number of grantees to be audited each year4 7,c7 ,final audit report ,the ,inspector ,general of the ,department of ,justice shall submit to the ,attorney ,general a final report on each audit conducted under subparagraph 7,b74 7,d7 ,mandatory exclusion ,grantees under this section about which there is an unresolved audit finding shall not be eligible to receive a grant under this section during the #b fiscal years beginning after the end of the #a-year period described in subparagraph 7,a74 7,e7 ,priority ,in making grants under this section1 the ,attorney ,general shall give priority to applicants that did not have an unresolved audit finding during the #c fiscal years before submitting an application for a grant under this section4 7,f7 ,reimbursement ,if an entity receives a grant under this section during the #b-;fiscal-year period during which the entity is prohibited from receiving grants under subparagraph 7,d71 the ,attorney ,general shall-- 7i7 deposit an amount equal to the amount of the grant that was improperly awarded to the grantee into the ,general ,fund of the ,treasury2 and 7ii7 seek to recoup the costs of the repayment under clause 7i7 from the grantee that was erroneously awarded grant funds4 7#b7 ,nonprofit agency requirements 7,a7 ,definition ,for purposes of this paragraph and the grant program under this section1 the term nonprofit agency means an organization that is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;c77#c77 and is exempt from taxation under section #eja7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;a774 7,b7 ,prohibition ,the ,attorney ,general may not award a grant under this section to a nonprofit agency that holds money in an offshore account for the purpose of avoiding paying the tax described in section #eaa7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eaa7;a774 7,c7 ,disclosure ,each nonprofit agency that is awarded a grant under this section and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers1 directors1 trustees1 and key employees1 shall disclose to the ,attorney ,general1 in the application for the grant1 the process for determining such compensation1 including the independent persons involved in reviewing and approving such compensation1 the comparability data used1 and contemporaneous substantiation of the deliberation and decision4 ,upon request1 the ,attorney ,general shall make the information disclosed under this subparagraph available for public inspection4 7#c7 ,conference expenditures 7,a7 ,limitation ,no amounts made available to the ,department of ,justice under this section may be used by the ,attorney ,general1 or by any individual or entity awarded discretionary funds through a cooperative agreement under this section1 to host or support any expenditure for conferences that uses more than #bj1jjj in funds made available by the ,department of ,justice1 unless the head of the relevant agency or department1 provides prior written authorization that the funds may be expended to host the conference4 7,b7 ,written approval ,written approval under subparagraph 7,a7 shall include a written estimate of all costs associated with the conference1 including the cost of all food1 beverages1 audio-visual equipment1 honoraria for speakers1 and entertainment4 7,c7 ,report ,the ,deputy ,attorney ,general shall submit an annual report to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives on all conference expenditures approved under this paragraph4 7#d7 ,annual certification ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 the ,attorney ,general shall submit to the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,house of ,representatives an annual certification-- 7,a7 indicating whether-- 7i7 all final audit reports issued by the ,office of the ,inspector ,general under paragraph 7#a7 have been completed and reviewed by the appropriate ,assistant ,attorney ,general or ,director2 7ii7 all mandatory exclusions required under paragraph 7#a77;,d7 have been issued2 and 7iii7 any reimbursements required under paragraph 7#a77;,f7 have been made2 and 7,b7 that includes a list of any grantees excluded under paragraph 7#a77;,d7 from the previous year4 7#e7 ,preventing duplicative grants 7,a7 ,in general ,before the ,attorney ,general awards a grant to an applicant under this section1 the ,attorney ,general shall compare potential grant awards with other grants awarded under this ,act to determine if duplicate grant awards are awarded for the same purpose4 7,b7 ,report ,if the ,attorney ,general awards duplicate grants to the same applicant for the same purpose the ,attorney ,general shall submit to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives a report that includes-- 7i7 a list of all duplicate grants awarded1 including the total dollar amount of any duplicate grants awarded2 and 7ii7 the reason the ,attorney ,general awarded the duplicate grants4 4 #adjae4 ,improving ,department of ,justice data collection on mental illness involved in crime 7a7 ,in general ,notwithstanding any other provision of law1 on or after the date that is #ij days after the date on which the ,attorney ,general promulgates regulations under subsection 7b71 any data prepared by1 or submitted to1 the ,attorney ,general or the ,director of the ,federal ,bureau of ,investigation with respect to the incidences of homicides1 law enforcement officers killed1 seriously injured1 and assaulted1 or individuals killed or seriously injured by law enforcement officers shall include data with respect to the involvement of mental illness in such incidences1 if any4 7b7 ,regulations ,not later than #ij days after the date of the enactment of this ,act1 the ,attorney ,general shall promulgate or revise regulations as necessary to carry out subsection 7a74 #adjaf4 ,reports on the number of mentally ill offenders in prison 7a7 ,report on the ,cost of ,treating the ,mentally ,ill in the ,criminal ,justice ,system ,not later than #ab months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report detailing the cost of imprisonment for individuals who have serious mental illness by the ,federal ,government or a ,state or unit of local government1 which shall include-- 7#a7 the number and type of crimes committed by individuals with serious mental illness each year2 and 7#b7 detail strategies or ideas for preventing crimes by those individuals with serious mental illness from occurring4 7b7 ,definition ,for purposes of this section1 the ,attorney ,general1 in consultation with the ,assistant ,secretary of ,mental ,health and ,substance ,use ,disorders1 shall define serious mental illness based on the ,health ,care ,reform for ,americans with ,severe ,mental ,illnesses3 ,report of the ,national ,advisory ,mental ,health ,council1 ,american ,journal of ,psychiatry #aiic2 #aej3addg-adfe4 #adjag4 ,codification of due process for determinations by secretary of veterans affairs of mental capacity of beneficiaries 7a7 ,in general ,chapter #ee of title #ch1 ,united ,states ,code1 is amended by inserting after section #eeja the following new section3 #eeja;,a4 ,beneficiaries' rights in mental competence determinations ,the ,secretary may not make an adverse determination concerning the mental capacity of a beneficiary to manage monetary benefits paid to or for the beneficiary by the ,secretary under this title unless such beneficiary has been provided all of the following1 subject to the procedures and timelines prescribed by the ,secretary for determinations of incompetency3 7#a7 ,notice of the proposed adverse determination and the supporting evidence4 7#b7 ,an opportunity to request a hearing4 7#c7 ,an opportunity to present evidence1 including an opinion from a medical professional or other person1 on the capacity of the beneficiary to manage monetary benefits paid to or for the beneficiary by the ,secretary under this title4 7#d7 ,an opportunity to be represented at no expense to the ,government 7including by counsel7 at any such hearing and to bring a medical professional or other person to provide relevant testimony at any such hearing4 4 7b7 ,clerical amendment ,the table of sections at the beginning of such chapter #ee is amended by inserting after the item relating to section #eeja the following new item3 #eeja;,a4 ,beneficiaries' rights in mental competence determinations 4 7c7 ,effective date ,section #eeja;,a of title #ch1 ,united ,states ,code1 as added by subsection 7a71 shall apply to determinations made by the ,secretary of ,veterans ,affairs on or after the date of the enactment of this ,act4 #adjah4 ,reauthorization of appropriations ,subsection 7o7 of section #biia of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa71 as redesignated by section #adjjf1 is amended-- 7#a7 in paragraph 7#a77;,c71 by striking #bjji through #bjad and inserting #bjag through #bjba2 and 7#b7 by adding at the end the following3 7#c7 ,limitation ,not more than #bj percent of the funds authorized to be appropriated under this section may be used for purposes described in subsection 7i7 7relating to veterans74 4 ,b ,comprehensive ,justice and ,mental ,health #adjba4 ,sequential intercept model ,section #biia of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa71 as amended by section #adjje1 is amended by inserting after subsection 7j71 the following3 7k7 ,sequential intercept grants 7#a7 ,definition ,in this subsection1 the term eligible entity means a ,state1 unit of local government1 ,indian tribe1 or tribal organization4 7#b7 ,authorization ,the ,attorney ,general may make grants under this subsection to an eligible entity for sequential intercept mapping and implementation in accordance with paragraph 7#c74 7#c7 ,sequential intercept mapping2 implementation ,an eligible entity that receives a grant under this subsection may use funds for-- 7,a7 sequential intercept mapping1 which-- 7i7 shall consist of-- 7,i7 convening mental health and criminal justice stakeholders to-- 7aa7 develop a shared understanding of the flow of justice-involved individuals with mental illnesses through the criminal justice system2 and 7bb7 identify opportunities for improved collaborative responses to the risks and needs of individuals described in item 7aa72 and 7,,ii7 developing strategies to address gaps in services and bring innovative and effective programs to scale along multiple intercepts1 including-- 7aa7 emergency and crisis services2 7bb7 specialized police-based responses2 7cc7 court hearings and disposition alternatives2 7dd7 reentry from jails and prisons2 and 7ee7 community supervision1 treatment and support services2 and 7ii7 may serve as a starting point for the development of strategic plans to achieve positive public health and safety outcomes2 and 7,b7 implementation1 which shall-- 7i7 be derived from the strategic plans described in subparagraph 7,a77ii72 and 7ii7 consist of-- 7,i7 hiring and training personnel2 7,,ii7 identifying the eligible entity's target population2 7,,iii7 providing services and supports to reduce unnecessary penetration into the criminal justice system2 7,,iv7 reducing recidivism2 7,v7 evaluating the impact of the eligible entity's approach2 and 7,,vi7 planning for the sustainability of effective interventions4 4 #adjbb4 ,prison and jails ,section #biia of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7 is amended by inserting after subsection 7k71 as added by section #adjba1 the following3 7l7 ,correctional facilities 7#a7 ,definitions 7,a7 ,correctional facility ,the term correctional facility means a jail1 prison1 or other detention facility used to house people who have been arrested1 detained1 held1 or convicted by a criminal justice agency or a court4 7,b7 ,eligible inmate ,the term eligible inmate means an individual who-- 7i7 is being held1 detained1 or incarcerated in a correctional facility2 and 7ii7 manifests obvious signs of a mental illness or has been diagnosed by a qualified mental health professional as having a mental illness4 7#b7 ,correctional facility grants ,the ,attorney ,general may award grants to applicants to enhance the capabilities of a correctional facility-- 7,a7 to identify and screen for eligible inmates2 7,b7 to plan and provide-- 7i7 initial and periodic assessments of the clinical1 medical1 and social needs of inmates2 and 7ii7 appropriate treatment and services that address the mental health and substance abuse needs of inmates2 7,c7 to develop1 implement1 and enhance-- 7i7 post-release transition plans for eligible inmates that1 in a comprehensive manner1 coordinate health1 housing1 medical1 employment1 and other appropriate services and public benefits2 7ii7 the availability of mental health care services and substance abuse treatment services2 and 7iii7 alternatives to solitary confinement and segregated housing and mental health screening and treatment for inmates placed in solitary confinement or segregated housing2 and 7,d7 to train each employee of the correctional facility to identify and appropriately respond to incidents involving inmates with mental health or co-occurring mental health and substance abuse disorders4 4 #adjbc4 ,allowable uses ,section #biia7;b77#e77;,i7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7b77#e77;,i77 is amended by adding at the end the following3 7v7 ,teams addressing frequent users of crisis services ,multidisciplinary teams that-- 7,i7 coordinate1 implement1 and administer community-based crisis responses and long-term plans for frequent users of crisis services2 7,,ii7 provide training on how to respond appropriately to the unique issues involving frequent users of crisis services for public service personnel1 including criminal justice1 mental health1 substance abuse1 emergency room1 healthcare1 law enforcement1 corrections1 and housing personnel2 7,,iii7 develop or support alternatives to hospital and jail admissions for frequent users of crisis services that provide treatment1 stabilization1 and other appropriate supports in the least restrictive1 yet appropriate1 environment2 and 7,,iv7 develop protocols and systems among law enforcement1 mental health1 substance abuse1 housing1 corrections1 and emergency medical service operations to provide coordinated assistance to frequent users of crisis services4 4 #adjbd4 ,law enforcement training ,section #biia7;h7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7h77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following3 7,f7 ,academy training ,to provide support for academy curricula1 law enforcement officer orientation programs1 continuing education training1 and other programs that teach law enforcement personnel how to identify and respond to incidents involving persons with mental health disorders or co-occurring mental health and substance abuse disorders4 2 and 7#b7 by adding at the end the following3 7#d7 ,priority consideration ,the ,attorney ,general1 in awarding grants under this subsection1 shall give priority to programs that law enforcement personnel and members of the mental health and substance abuse professions develop and administer cooperatively4 4 #adjbe4 ,federal law enforcement training ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general shall provide direction and guidance for the following3 7#a7 ,training programs ,programs that offer specialized and comprehensive training1 in procedures to identify and appropriately respond to incidents in which the unique needs of individuals who have a mental illness are involved1 to first responders and tactical units of-- 7,a7 ,federal law enforcement agencies2 and 7,b7 other ,federal criminal justice agencies such as the ,bureau of ,prisons1 the ,administrative ,office of the ,united ,states ,courts1 and other agencies that the ,attorney ,general determines appropriate4 7#b7 ,improved technology ,the establishment of1 or improvement of existing1 computerized information systems to provide timely information to employees of ,federal law enforcement agencies1 and ,federal criminal justice agencies to improve the response of such employees to situations involving individuals who have a mental illness4 #adjbf4 ,,gao report ,no later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states1 in coordination with the ,attorney ,general1 shall submit to ,congress a report on-- 7#a7 the practices that ,federal first responders1 tactical units1 and corrections officers are trained to use in responding to individuals with mental illness2 7#b7 procedures to identify and appropriately respond to incidents in which the unique needs of individuals who have a mental illness are involved1 to ,federal first responders and tactical units2 7#c7 the application of evidence-based practices in criminal justice settings to better address individuals with mental illnesses2 and 7#d7 recommendations on how the ,department of ,justice can expand and improve information sharing and dissemination of best practices4 #adjbg4 ,evidence based practices ,section #biia7;c7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7c77 is amended-- 7#a7 in paragraph 7#c71 by striking or at the end2 7#b7 by redesignating paragraph 7#d7 as paragraph 7#f72 and 7#c7 by inserting after paragraph 7#c71 the following3 7#d7 propose interventions that have been shown by empirical evidence to reduce recidivism2 7#e7 when appropriate1 use validated assessment tools to target preliminarily qualified offenders with a moderate or high risk of recidivism and a need for treatment and services2 or 4 #adjbh4 ,transparency1 program accountability1 and enhancement of local authority 7a7 ,in general ,section #biia7;a7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7a77 is amended-- 7#a7 in paragraph 7#g7-- 7,a7 in the heading1 by striking ,mental illness and inserting ,mental illness2 mental health disorder2 and 7,b7 by striking term mental illness means and inserting terms mental illness and mental health disorder mean2 and 7#b7 by striking paragraph 7#i7 and inserting the following3 7#i7 ,preliminarily qualified offender 7,a7 ,in general ,the term preliminarily qualified offender means an adult or juvenile accused of an offense who-- 7i7 7,i7 previously or currently has been diagnosed by a qualified mental health professional as having a mental illness or co-occurring mental illness and substance abuse disorders2 7,,ii7 manifests obvious signs of mental illness or co-occurring mental illness and substance abuse disorders during arrest or confinement or before any court2 or 7,,iii7 in the case of a veterans treatment court provided under subsection 7i71 has been diagnosed with1 or manifests obvious signs of1 mental illness or a substance abuse disorder or co-occurring mental illness and substance abuse disorder2 7ii7 has been unanimously approved for participation in a program funded under this section by1 when appropriate-- 7,i7 the relevant-- 7aa7 prosecuting attorney2 7bb7 defense attorney2 7cc7 probation or corrections official2 and 7dd7 judge2 and 7,,ii7 a representative from the relevant mental health agency described in subsection 7b77#e77;,b77i72 7iii7 has been determined1 by each person described in clause 7ii7 who is involved in approving the adult or juvenile for participation in a program funded under this section1 to not pose a risk of violence to any person in the program1 or the public1 if selected to participate in the program2 and 7iv7 has not been charged with or convicted of-- 7,i7 any sex offense 7as defined in section #aaa of the ,sex ,offender ,registration and ,notification ,act 7#db ,u4,s4,c4 #afiaa77 or any offense relating to the sexual exploitation of children2 or 7,,ii7 murder or assault with intent to commit murder4 7,b7 ,determination ,in determining whether to designate a defendant as a preliminarily qualified offender1 the relevant prosecuting attorney1 defense attorney1 probation or corrections official1 judge1 and mental health or substance abuse agency representative shall take into account-- 7i7 whether the participation of the defendant in the program would pose a substantial risk of violence to the community2 7ii7 the criminal history of the defendant and the nature and severity of the offense for which the defendant is charged2 7iii7 the views of any relevant victims to the offense2 7iv7 the extent to which the defendant would benefit from participation in the program2 7v7 the extent to which the community would realize cost savings because of the defendant's participation in the program2 and 7vi7 whether the defendant satisfies the eligibility criteria for program participation unanimously established by the relevant prosecuting attorney1 defense attorney1 probation or corrections official1 judge and mental health or substance abuse agency representative4 4 7b7 ,technical and conforming amendment ,section #bibg7b7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgigs-#f7b77 is amended by striking has the meaning given that term in section #biia7;a74 and inserting 8means an offense that-- 7,a7 does not have as an element the use1 attempted use1 or threatened use of physical force against the person or property of another2 or 7,b7 is not a felony that by its nature involves a substantial risk that physical force against the person or property of another may be used in the course of committing the offense4 4 #adjbi4 ,grant accountability ,section #biia of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7 is amended by inserting after subsection 7l71 as added by section #adjbb1 the following3 7m7 ,accountability ,all grants awarded by the ,attorney ,general under this section shall be subject to the following accountability provisions3 7#a7 ,audit requirement 7,a7 ,definition ,in this paragraph1 the term unresolved audit finding means a finding in the final audit report of the ,inspector ,general of the ,department of ,justice that the audited grantee has utilized grant funds for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved within #ab months from the date when the final audit report is issued4 7,b7 ,audits ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 and in each fiscal year thereafter1 the ,inspector ,general of the ,department of ,justice shall conduct audits of recipients of grants under this section to prevent waste1 fraud1 and abuse of funds by grantees4 ,the ,inspector ,general shall determine the appropriate number of grantees to be audited each year4 7,c7 ,mandatory exclusion ,a recipient of grant funds under this section that is found to have an unresolved audit finding shall not be eligible to receive grant funds under this section during the first #b fiscal years beginning after the end of the #ab-month period described in subparagraph 7,a74 7,d7 ,priority ,in awarding grants under this section1 the ,attorney ,general shall give priority to eligible applicants that did not have an unresolved audit finding during the #c fiscal years before submitting an application for a grant under this section4 7,e7 ,reimbursement ,if an entity is awarded grant funds under this section during the #b-;fiscal-year period during which the entity is barred from receiving grants under subparagraph 7,c71 the ,attorney ,general shall-- 7i7 deposit an amount equal to the amount of the grant funds that were improperly awarded to the grantee into the ,general ,fund of the ,treasury2 and 7ii7 seek to recoup the costs of the repayment to the fund from the grant recipient that was erroneously awarded grant funds4 7#b7 ,nonprofit organization requirements 7,a7 ,definition ,for purposes of this paragraph and the grant programs under this part1 the term nonprofit organization means an organization that is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf and is exempt from taxation under section #eja7;a7 of such ,code4 7,b7 ,prohibition ,the ,attorney ,general may not award a grant under this part to a nonprofit organization that holds money in offshore accounts for the purpose of avoiding paying the tax described in section #eaa7;a7 of the ,internal ,revenue ,code of #aihf4 7,c7 ,disclosure ,each nonprofit organization that is awarded a grant under this section and uses the procedures prescribed in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers1 directors1 trustees1 and key employees1 shall disclose to the ,attorney ,general1 in the application for the grant1 the process for determining such compensation1 including the independent persons involved in reviewing and approving such compensation1 the comparability data used1 and contemporaneous substantiation of the deliberation and decision4 ,upon request1 the ,attorney ,general shall make the information disclosed under this subparagraph available for public inspection4 7#c7 ,conference expenditures 7,a7 ,limitation ,no amounts made available to the ,department of ,justice under this section may be used by the ,attorney ,general1 or by any individual or entity awarded discretionary funds through a cooperative agreement under this section1 to host or support any expenditure for conferences that uses more than #bj1jjj in funds made available by the ,department of ,justice1 unless the head of the relevant agency or department1 provides prior written authorization that the funds may be expended to host the conference4 7,b7 ,written approval ,written approval under subparagraph 7,a7 shall include a written estimate of all costs associated with the conference1 including the cost of all food1 beverages1 audio-visual equipment1 honoraria for speakers1 and entertainment4 7,c7 ,report ,the ,deputy ,attorney ,general shall submit an annual report to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives on all conference expenditures approved under this paragraph4 7#d7 ,annual certification ,beginning in the first fiscal year beginning after the date of enactment of this subsection1 the ,attorney ,general shall submit1 to the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary and the ,committee on ,appropriations of the ,house of ,representatives1 an annual certification-- 7,a7 indicating whether-- 7i7 all audits issued by the ,office of the ,inspector ,general under paragraph 7#a7 have been completed and reviewed by the appropriate ,assistant ,attorney ,general or ,director2 7ii7 all mandatory exclusions required under paragraph 7#a77;,c7 have been issued2 and 7iii7 all reimbursements required under paragraph 7#a77;,e7 have been made2 and 7,b7 that includes a list of any grant recipients excluded under paragraph 7#a7 from the previous year4 7n7 ,preventing duplicative grants 7#a7 ,in general ,before the ,attorney ,general awards a grant to an applicant under this section1 the ,attorney ,general shall compare potential grant awards with other grants awarded under this ,act to determine if duplicate grant awards are awarded for the same purpose4 7#b7 ,report ,if the ,attorney ,general awards duplicate grants to the same applicant for the same purpose the ,attorney ,general shall submit to the ,committee on the ,judiciary of the ,senate and the ,committee on the ,judiciary of the ,house of ,representatives a report that includes-- 7,a7 a list of all duplicate grants awarded1 including the total dollar amount of any duplicate grants awarded2 and 7,b7 the reason the ,attorney ,general awarded the duplicate grants4 4 ,c ,increasing ,choice1 ,access1 and ,quality in ,health ,care for ,americans #aejjj4 ,short title ,this division may be cited as the ,increasing ,choice1 ,access1 and ,quality in ,health ,care for ,americans ,act4 ,,xv ,provisions ,relating to ,medicare ,part ,a #aejja4 ,development of ,medicare ,,hcpcs version of ,,ms-,,drg codes for similar hospital services ,section #ahhf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 is amended by adding at the end the following new subsection3 7t7 ,relating similar inpatient and outpatient hospital services 7#a7 ,development of ,,hcpcs version of ,,ms-,,drg codes ,not later than ,january #a1 #bjah1 the ,secretary shall develop ,,hcpcs versions for ,,ms-,d,r,gs that are similar to the ,,icd-#aj-,,pcs for such ,,ms-,d,r,gs such that1 to the extent possible1 the ,,ms-,,drg assignment shall be similar for a claim coded with the ,,hcpcs version as an identical claim coded with a ,,icd-#aj-,,pcs code4 7#b7 ,coverage of surgical ,,ms-,d,r,gs ,in carrying out paragraph 7#a71 the ,secretary shall develop ,,hcpcs versions of ,,ms-,,drg codes for not fewer than #aj surgical ,,ms-,d,r,gs4 7#c7 ,publication and dissemination of the ,,hcpcs versions of ,,ms-,d,r,gs 7,a7 ,in general ,the ,secretary shall develop a ,,hcpcs ,,ms-,,drg definitions manual and software that is similar to the definitions manual and software for ,,icd-#aj-,,pcs codes for such ,,ms-,d,r,gs4 ,the ,secretary shall post the ,,hcpcs ,,ms-,,drg definitions manual and software on the ,internet website of the ,centers for ,medicare ,medicaid ,services4 ,the ,,hcpcs ,,ms-,,drg definitions manual and software shall be in the public domain and available for use and redistribution without charge4 7,b7 ,use of previous analysis done by ,med,p,a,c ,in developing the ,,hcpcs ,,ms-,,drg definitions manual and software under subparagraph 7,a71 the ,secretary shall consult with the ,medicare ,payment ,advisory ,commission and shall consider the analysis done by such ,commission in translating outpatient surgical claims into inpatient surgical ,,ms-,d,r,gs in preparing chapter #g 7relating to hospital short-stay policy issues7 of its ,medicare and the ,health ,care ,delivery ,system report submitted to ,congress in ,june #bjae4 7#d7 ,definition and reference ,in this subsection3 7,a7 ,,hcpcs ,the term ,,hcpcs means1 with respect to hospital items and services1 the code under the ,healthcare ,common ,procedure ,coding ,system 7,,hcpcs7 7or a successor code7 for such items and services4 7,b7 ,,icd-#aj-,,pcs ,the term ,,icd-#aj-,,pcs means the ,international ,classification of ,diseases1 #ajth ,revision1 ,procedure ,coding ,system1 and includes any subsequent revision of such ,international ,classification of ,diseases1 ,procedure ,coding ,system4 4 #aejjb4 ,establishing beneficiary equity in the ,medicare hospital readmission program 7a7 ,transitional adjustment for dual eligible population ,section #ahhf7q77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#c77 is amended-- 7#a7 in subparagraph 7,a71 by inserting subject to subparagraph 7,d71 after purposes of paragraph 7#a712 and 7#b7 by adding at the end the following new subparagraph3 7,d7 ,transitional adjustment for dual eligibles 7i7 ,in general ,in determining a hospital's adjustment factor under this paragraph for purposes of making payments for discharges occurring during and after fiscal year #bjai1 and before the application of clause 7i7 of subparagraph 7,e71 the ,secretary shall assign hospitals to groups 7as defined by the ,secretary under clause 7ii77 and apply the applicable provisions of this subsection using a methodology in a manner that allows for separate comparison of hospitals within each such group1 as determined by the ,secretary4 7ii7 ,defining groups ,for purposes of this subparagraph1 the ,secretary shall define groups of hospitals1 based on their overall proportion1 of the inpatients who are entitled to1 or enrolled for1 benefits under part ,a1 and who are full-benefit dual eligible individuals 7as defined in section #aice7;c77#f774 ,in defining groups1 the ,secretary shall consult the ,medicare ,payment ,advisory ,commission and may consider the analysis done by such ,commission in preparing the portion of its report submitted to ,congress in ,june #bjac relating to readmissions4 7iii7 ,minimizing reporting burden on hospitals ,in carrying out this subparagraph1 the ,secretary shall not impose any additional reporting requirements on hospitals4 7iv7 ,budget neutral design methodology ,the ,secretary shall design the methodology to implement this subparagraph so that the estimated total amount of reductions in payments under this subsection equals the estimated total amount of reductions in payments that would otherwise occur under this subsection if this subparagraph did not apply4 4 7b7 ,changes in risk adjustment ,section #ahhf7q77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#c771 as amended by subsection 7a71 is further amended by adding at the end the following new subparagraph3 7,e7 ,changes in risk adjustment 7i7 ,consideration of recommendations in ,,impact reports ,the ,secretary may take into account the studies conducted and the recommendations made by the ,secretary under section #b7;d77#a7 of the ,,impact ,act of #bjad 7,public ,law #aac-ahe2 #db ,u4,s4,c4 #acielll note7 with respect to the application under this subsection of risk adjustment methodologies4 ,nothing in this clause shall be construed as precluding consideration of the use of groupings of hospitals4 7ii7 ,consideration of exclusion of patient cases based on ,v or other appropriate codes ,in promulgating regulations to carry out this subsection with respect to discharges occurring after fiscal year #bjah1 the ,secretary may consider the use of ,v or other ,,icd-related codes for removal of a readmission4 ,the ,secretary may consider modifying measures under this subsection to incorporate ,v or other ,,icd-related codes at the same time as other changes are being made under this subparagraph4 7iii7 ,removal of certain readmissions ,in promulgating regulations to carry out this subsection1 with respect to discharges occurring after fiscal year #bjah1 the ,secretary may consider removal as a readmission of an admission that is classified within one or more of the following3 transplants1 end-stage renal disease1 burns1 trauma1 psychosis1 or substance abuse4 ,the ,secretary may consider modifying measures under this subsection to remove readmissions at the same time as other changes are being made under this subparagraph4 4 7c7 ,med,p,a,c study on readmissions program ,the ,medicare ,payment ,advisory ,commission shall conduct a study to review overall hospital readmissions described in section #ahhf7q77#e77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7q77#e77;,e77 and whether such readmissions are related to any changes in outpatient and emergency services furnished4 ,the ,commission shall submit to ,congress a report on such study in its report to ,congress in ,june #bjah4 #aejjc4 ,five-year extension of the rural community hospital demonstration program 7a7 ,extension ,section #daj;,a of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7,public ,law #ajh-agc2 #db ,u4,s4,c4 #acieww note7 is amended-- 7#a7 in subsection 7a77#e71 by striking #e-year extension period and inserting #aj-year extension period2 and 7#b7 in subsection 7g7-- 7,a7 in the subsection heading1 by striking ,five-,year and inserting ,ten-,year2 7,b7 in paragraph 7#a71 by striking additional #e-year and inserting additional #aj-year2 7,c7 by striking #e-year extension period and inserting #aj-year extension period each place it appears2 7,d7 in paragraph 7#d77;,b7-- 7i7 in the matter preceding clause 7i71 by inserting each #e-year period in after hospital during2 and 7ii7 in clause 7i71 by inserting each applicable #e-year period in after the first day of2 and 7,e7 by adding at the end the following new paragraphs3 7#e7 ,other hospitals in demonstration program ,during the second #e years of the #aj-year extension period1 the ,secretary shall apply the provisions of paragraph 7#d7 to rural community hospitals that are not described in paragraph 7#d7 but are participating in the demonstration program under this section as of ,december #cj1 #bjad1 in a similar manner as such provisions apply to rural community hospitals described in paragraph 7#d74 7#f7 ,expansion of demonstration program to rural areas in any ,state 7,a7 ,in general ,the ,secretary shall1 notwithstanding subsection 7a77#b7 or paragraph 7#b7 of this subsection1 not later than #abj days after the date of the enactment of this paragraph1 issue a solicitation for applications to select up to the maximum number of additional rural community hospitals located in any ,state to participate in the demonstration program under this section for the second #e years of the #aj-year extension period without exceeding the limitation under paragraph 7#c7 of this subsection4 7,b7 ,priority ,in determining which rural community hospitals that submitted an application pursuant to the solicitation under subparagraph 7,a7 to select for participation in the demonstration program1 the ,secretary-- 7i7 shall give priority to rural community hospitals located in one of the #bj ,states with the lowest population densities 7as determined by the ,secretary using the #bjae ,statistical ,abstract of the ,united ,states72 and 7ii7 may consider-- 7,i7 closures of hospitals located in rural areas in the ,state in which the rural community hospital is located during the #e-year period immediately preceding the date of the enactment of this paragraph2 and 7,,ii7 the population density of the ,state in which the rural community hospital is located4 4 7b7 ,change in timing for report ,subsection 7e7 of such section #daj;,a is amended-- 7#a7 by striking ,not later than #f months after the completion of the demonstration program under this section and inserting ,not later than ,august #a1 #bjah2 and 7#b7 by striking such program and inserting the demonstration program under this section4 #aejjd4 ,regulatory relief for ,l,t,c,hs 7a7 ,technical change to the ,medicare long-,term care hospital moratorium exception 7#a7 ,in general ,section #aad7;d77#g7 of the ,medicare1 ,medicaid1 and ,,schip ,extension ,act of #bjjg 7#db ,u4,s4,c4 #acieww note71 as amended by sections #cajf7;b7 and #ajcab7;b7 of ,public ,law #aaa-adh1 section #abjf7;b77#b7 of the ,pathway for ,,sgr ,reform ,act of #bjac 7division ,b of ,public ,law #aac-fg71 and section #aab of the ,protecting ,access to ,medicare ,act of #bjad 7,public ,law #aac-ic71 is amended by striking ,the moratorium under paragraph 7#a77;,a7 and inserting ,any moratorium under paragraph 7#a74 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as if included in the enactment of section #aab of the ,protecting ,access to ,medicare ,act of #bjad4 7b7 ,modification to ,medicare long-,term care hospital high cost outlier payments ,section #ahhf7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77 is amended by adding at the end the following new paragraph3 7#g7 ,treatment of high cost outlier payments 7,a7 ,adjustment to the standard ,federal payment rate for estimated high cost outlier payments ,under the system described in paragraph 7#a71 for fiscal years beginning on or after ,october #a1 #bjag1 the ,secretary shall reduce the standard ,federal payment rate as if the estimated aggregate amount of high cost outlier payments for standard ,federal payment rate discharges for each such fiscal year would be equal to #h percent of estimated aggregate payments for standard ,federal payment rate discharges for each such fiscal year4 7,b7 ,limitation on high cost outlier payment amounts ,notwithstanding subparagraph 7,a71 the ,secretary shall set the fixed loss amount for high cost outlier payments such that the estimated aggregate amount of high cost outlier payments made for standard ,federal payment rate discharges for fiscal years beginning on or after ,october #a1 #bjag1 shall be equal to #ii4fhge percent of #h percent of estimated aggregate payments for standard ,federal payment rate discharges for each such fiscal year4 7,c7 ,waiver of budget neutrality ,any reduction in payments resulting from the application of subparagraph 7,b7 shall not be taken into account in applying any budget neutrality provision under such system4 7,d7 ,no effect on site neutral high cost outlier payment rate ,this paragraph shall not apply with respect to the computation of the applicable site neutral payment rate under paragraph 7#f74 4 #aejje4 ,savings from ,,ipps ,,macra pay-for through not applying documentation and coding adjustments ,section #g7;b77#a77;,b7 of the ,,tma1 ,abstinence ,education1 and ,,qi ,programs ,extension ,act of #bjjg 7,public ,law #aaj-ij71 as amended by section #fca7;b7 of the ,american ,taxpayer ,relief ,act of #bjab 7,public ,law #aab-bdj7 and section #dad7a77;,b77iii7 of the ,medicare ,access and ,,chip ,reauthorization ,act of #bjae 7,public ,law #aad-aj71 is amended in clause 7iii7 by striking an increase of #j4e percentage points for discharges occurring during each of fiscal years #bjah through #bjbc and inserting an increase of #j4dehh percentage points for discharges occurring during fiscal year #bjah and #j4e percentage points for discharges occurring during each of fiscal years #bjai through #bjbc4 #aejjf4 ,extension of certain ,,ltch ,medicare payment rules 7a7 #be-,percent patient threshold payment adjustment ,section #aad7;c77#a77;,a7 of the ,medicare1 ,medicaid1 and ,,schip ,extension ,act of #bjjg 7#db ,u4,s4,c4 #acieww note71 as amended by section #dcjb7;a7 of division ,b of the ,american ,recovery and ,reinvestment ,act 7,public ,law #aaa-e71 sections #cajf7;a7 and #ajcab7;a7 of ,public ,law #aaa-adh1 and section #abjf7;b77#a77;,b7 of the ,pathway for ,,sgr ,reform ,act of #bjac 7division ,b of ,public ,law #aac-fg71 is amended by striking for a #i-year period and inserting through ,june #cj1 #bjaf1 and for discharges occurring on or after ,october #a1 #bjaf1 and before ,october #a1 #bjag4 7b7 ,payment for hospitals-,within-,hospitals ,section #aad7;c77#b7 of the ,medicare1 ,medicaid1 and ,,schip ,extension ,act of #bjjg 7#db ,u4,s4,c4 #acieww note71 as amended by section #dcjb7;a7 of division ,b of the ,american ,recovery and ,reinvestment ,act 7,public ,law #aaa-e71 sections #cajf7;a7 and #ajcab7;a7 of ,public ,law #aaa-adh1 and section #abjf7;b77#a77;,a7 of the ,pathway for ,,sgr ,reform ,act of #bjac 7division ,b of ,public ,law #aac-fg71 is amended-- 7#a7 in subparagraph 7,a71 by inserting or any similar provision1 after ,regulations12 7#b7 in subparagraph 7,b7-- 7,a7 in clause 7i71 by inserting or any similar provision1 after ,regulations12 and 7,b7 in clause 7ii71 by inserting 1 or any similar provision1 after ,regulations2 and 7#c7 in subparagraph 7,c71 by striking for a #i-year period and inserting through ,june #cj1 #bjaf1 and for discharges occurring on or after ,october #a1 #bjaf1 and before ,october #a1 #bjag4 #aejjg4 ,application of rules on the calculation of hospital length of stay to all ,l,t,c,hs 7a7 ,in general ,section #abjf7;a77#c7 of the ,pathway for ,,sgr ,reform ,act of #bjac 7division ,b of ,public ,law #aac-fg2 #db ,u4,s4,c4 #acieww note7 is amended-- 7#a7 by striking subparagraph 7,b72 7#b7 by striking site neutral basis4-- and all that follows through ,for discharges occurring and inserting site neutral basis4--,for discharges occurring2 7#c7 by striking subject to subparagraph 7,b712 and 7#d7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and moving each of such subparagraphs 7as so redesignated7 #b ems to the left4 7b7 ,effective date ,the amendments made by subsection 7a7 shall be effective as if included in the enactment of section #abjf7;a77#c7 of the ,pathway for ,,sgr ,reform ,act of #bjac 7division ,b of ,public ,law #aac-fg2 #db ,u4,s4,c4 #acieww note74 #aejjh4 ,change in ,medicare classification for certain hospitals 7a7 ,in general ,subsection 7d77#a77;,b77iv7 of section #ahhf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 is amended-- 7#a7 in subclause 7,i71 by striking or at the end2 7#b7 in subclause 7,,ii7-- 7,a7 by striking 1 or at the end and inserting a semicolon2 7,b7 by redesignating such subclause as clause 7vi7 and by moving it to immediately follow clause 7v72 and 7,c7 in clause 7v71 by striking the semicolon at the end and inserting 1 or2 and 7#c7 by striking 7iv77,i7 a hospital and inserting 7iv7 a hospital4 7b7 ,conforming payment references ,the second sentence of subsection 7d77#a77;,b7 of such section is amended-- 7#a7 by inserting 7as in effect as of such date7 after clause 7iv72 and 7#b7 by inserting 7or1 in the case of a hospital described in clause 7iv77,,ii71 as so in effect1 shall be classified under clause 7vi7 on and after the effective date of such clause 7vi7 and for cost reporting periods beginning on or after ,january #a1 #bjae1 shall not be subject to subsection 7m7 as of the date of such classification7 after so classified4 7c7 ,application 7#a7 ,in general ,for cost reporting periods beginning on or after ,january #a1 #bjae1 in the case of an applicable hospital 7as defined in paragraph 7#c771 the following shall apply3 7,a7 ,payment for inpatient operating costs shall be made on a reasonable cost basis in the manner provided in section #dab4ebf7;c77#c7 of title #db1 ,code of ,federal ,regulations 7as in effect on ,january #a1 #bjae7 and in any subsequent modifications4 7,b7 ,payment for capital costs shall be made in the manner provided by section #dab4ebf7;c77#d7 of title #db1 ,code of ,federal ,regulations 7as in effect on such date74 7,c7 ,claims for payment for ,medicare beneficiaries who are discharged on or after ,january #a1 #bjag1 shall be processed as claims which are paid on a reasonable cost basis as described in section #dab4ebf7;c7 of title #db1 ,code of ,federal ,regulations 7as in effect on such date74 7#b7 ,applicable hospital defined ,in this subsection1 the term applicable hospital means a hospital that is classified under clause 7iv77,,ii7 of section #ahhf7;d77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#a77;,b77 on the day before the date of the enactment of this ,act and which is classified under clause 7vi7 of such section1 as redesignated and moved by subsection 7a71 on or after such date of enactment4 7d7 ,conforming technical amendments 7#a7 ,section #ahii;,b7a77#b77;,a77iv7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acielll7a77#b77;,a77iv77 is amended by striking #ahhf7;d77#a77;,b77iv77,,ii7 and inserting #ahhf7;d77#a77;,b77vi74 7#b7 ,section #ahhf7m77#e77;,f7 of such ,act 7#db ,u4,s4,c4 #acieww7m77#e77;,f77 is amended in each of clauses 7i7 and 7ii7 by striking 7d77#a77;,b77iv77,,ii7 and inserting 7d77#a77;,b77vi74 #aejji4 ,temporary exception to the application of the ,medicare ,,ltch site neutral provisions for certain spinal cord specialty hospitals 7a7 ,exception ,section #ahhf7m77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77#f77 is amended-- 7#a7 in subparagraph 7,a77i71 by striking and 7,e7 and inserting 1 7,e71 and 7,f72 and 7#b7 by adding at the end the following new subparagraph3 7,f7 ,temporary exception for certain spinal cord specialty hospitals ,for discharges in cost reporting periods beginning during fiscal years #bjah and #bjai1 subparagraph 7,a77i7 shall not apply 7and payment shall be made to a long-term care hospital without regard to this paragraph7 if such discharge is from a long-term care hospital that meets each of the following requirements3 7i7 ,not-for-profit ,the long-term care hospital was a not-for-profit long-term care hospital on ,june #a1 #bjad1 as determined by cost report data4 7ii7 ,primarily providing treatment for catastrophic spinal cord or acquired brain injuries or other paralyzing neuromuscular conditions ,of the discharges in calendar year #bjac from the long-term care hospital for which payment was made under this section1 at least #ej percent were classified under ,,ms-,,ltch-,d,r,gs #bh1 #bi1 #eb1 #eg1 #eea1 #egc1 and #ifc4 7iii7 ,significant out-of-,state admissions 7,i7 ,in general ,the long-term care hospital discharged inpatients 7including both individuals entitled to1 or enrolled for1 benefits under this title and individuals not so entitled or enrolled7 during fiscal year #bjad who had been admitted from at least #bj of the #ej ,states1 determined by the ,states of residency of such inpatients and based on such data submitted by the hospital to the ,secretary as the ,secretary may require4 7,,ii7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement subclause 7,i7 by program instruction or otherwise4 7,,iii7 ,non-application of ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to data collected under this clause4 4 7b7 ,study and report on the status and viability of certain spinal cord specialty long-,term care hospitals 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on long-term care hospitals described in section #ahhf7m77#f77;,f7 of the ,social ,security ,act1 as added by subsection 7a74 ,such report shall include an analysis of the following3 7,a7 ,the impact on such hospitals of the classification and facility licensure by ,state agencies of such hospitals4 7,b7 ,the ,medicare payment rates for such hospitals4 7,c7 ,data on the number and health care needs of ,medicare beneficiaries who have been diagnosed with catastrophic spinal cord or acquired brain injuries or other paralyzing neuromuscular conditions 7as described within the discharge classifications specified in clause 7ii7 of such section7 who are receiving services from such hospitals4 7#b7 ,report ,not later than ,october #a1 #bjah1 the ,comptroller ,general shall submit to ,congress a report on the study conducted under paragraph 7#a71 including recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 #aejaj4 ,temporary extension to the application of the ,medicare ,,ltch site neutral provisions for certain discharges with severe wounds 7a7 ,in general ,section #ahhf7m77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7m77#f771 as amended by section #aejji1 is further amended-- 7#a7 in subparagraph 7,a77i7 by striking and 7,f7 and inserting 7,f71 and 7,g72 7#b7 in subparagraph 7,e77i77,i77aa71 by striking the amendment made and all that follows before the semicolon and inserting the last sentence of subsection 7d77#a77;,b72 and 7#c7 by adding at the end the following new subparagraph3 7,g7 ,additional temporary exception for certain severe wound discharges from certain long-term care hospitals 7i7 ,in general ,for a discharge occurring in a cost reporting period beginning during fiscal year #bjah1 subparagraph 7,a77i7 shall not apply 7and payment shall be made to a long-term care hospital without regard to this paragraph7 if such discharge-- 7,i7 is from a long-term care hospital identified by the last sentence of subsection 7d77#a77;,b72 7,,ii7 is classified under ,,ms-,,ltch-,,drg #fjb1 #fjc1 #eci1 or #edj2 and 7,,iii7 is with respect to an individual treated by a long-term care hospital for a severe wound4 7ii7 ,severe wound defined ,in this subparagraph1 the term severe wound means a wound which is a stage #c wound1 stage #d wound1 unstageable wound1 non-healing surgical wound1 or fistula as identified in the claim from the long-term care hospital4 7iii7 ,wound defined ,in this subparagraph1 the term wound means an injury involving division of tissue or rupture of the integument or mucous membrane with exposure to the external environment4 4 7c7 ,study and report to ,congress 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall1 in consultation with relevant stakeholders1 conduct a study on the treatment needs of individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled under part ,b of such title who require specialized wound care1 and the cost1 for such individuals and the ,medicare program under such title1 of treating severe wounds in rural and urban areas4 ,such study shall include an assessment of-- 7,a7 access of such individuals to appropriate levels of care for such cases2 7,b7 the potential impact that section #ahhf7m77#f77;,a77i7 of such ,act 7#db ,u4,s4,c4 #acieww7m77#f77;,a77i77 will have on the access1 quality1 and cost of care for such individuals2 and 7,c7 how to appropriately pay for such care under the ,medicare program under such title4 7#b7 ,report ,not later than ,october #a1 #bjbj1 the ,comptroller ,general shall submit to ,congress a report on the study conducted under paragraph 7#a71 including recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 ,,xvi ,provisions ,relating to ,medicare ,part ,b #afjja4 ,continuing ,medicare payment under ,,hopd prospective payment system for services furnished by mid-build off-campus outpatient departments of providers 7a7 ,in general ,section #ahcc7t77#ba7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ba77 is amended-- 7#a7 in subparagraph 7,b7-- 7,a7 in clause 7i71 by striking clause 7ii7 and inserting the subsequent provisions of this subparagraph2 and 7,b7 by adding at the end the following new clauses3 7iii7 ,deemed treatment for #bjag ,for purposes of applying clause 7ii7 with respect to applicable items and services furnished during #bjag1 a department of a provider 7as so defined7 not described in such clause is deemed to be billing under this subsection with respect to covered ,,opd services furnished prior to ,november #b1 #bjae1 if the ,secretary received from the provider prior to ,december #b1 #bjae1 an attestation 7pursuant to section #dac4fe7;b77#c7 of title #db of the ,code of ,federal ,regulations7 that such department was a department of a provider 7as so defined74 7iv7 ,alternative exception beginning with #bjah ,for purposes of paragraph 7#a77;,b77v7 and this paragraph with respect to applicable items and services furnished during #bjah or a subsequent year1 the term off-campus outpatient department of a provider also shall not include a department of a provider 7as so defined7 that is not described in clause 7ii7 if-- 7,i7 the ,secretary receives from the provider an attestation 7pursuant to such section #dac4fe7;b77#c77 not later than ,december #ca1 #bjaf 7or1 if later1 #fj days after the date of the enactment of this clause71 that such department met the requirements of a department of a provider specified in section #dac4fe of title #db of the ,code of ,federal ,regulations2 7,,ii7 the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under section #ahff7;j72 and 7,,iii7 the department met the mid-build requirement of clause 7v7 and the ,secretary receives1 not later than #fj days after the date of the enactment of this clause1 from the chief executive officer or chief operating officer of the provider a written certification that the department met such requirement4 7v7 ,mid-build requirement described ,the mid-build requirement of this clause is1 with respect to a department of a provider1 that before ,november #b1 #bjae1 the provider had a binding written agreement with an outside unrelated party for the actual construction of such department4 7vii7 ,audit ,not later than ,december #ca1 #bjah1 the ,secretary shall audit the compliance with requirements of clause 7iv7 with respect to each department of a provider to which such clause applies4 ,if the ,secretary finds as a result of an audit under this clause that the applicable requirements were not met with respect to such department1 the department shall not be excluded from the term off-campus outpatient department of a provider under such clause4 7viii7 ,implementation ,for purposes of implementing clauses 7iii7 through 7vii73 7,i7 ,notwithstanding any other provision of law1 the ,secretary may implement such clauses by program instruction or otherwise4 7,,ii7 ,subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code1 shall not apply4 7,,iii7 ,for purposes of carrying out this subparagraph with respect to clauses 7iii7 and 7iv7 7and clause 7vii7 insofar as it relates to clause 7iv771 #aj1jjj1jjj shall be available from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda1 to remain available until ,december #ca1 #bjah4 2 and 7#b7 in subparagraph 7,e71 by adding at the end the following new clause3 7iv7 ,the determination of an audit under subparagraph 7,b77vii74 4 7b7 ,effective date ,the amendments made by this section shall be effective as if included in the enactment of section #fjc of the ,bipartisan ,budget ,act of #bjae 7,public ,law #aad-gd74 #afjjb4 ,treatment of cancer hospitals in off-campus outpatient department of a provider policy 7a7 ,in general ,section #ahcc7t77#ba77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ba77;,b771 as amended by section #afjja7;a71 is amended-- 7#a7 by inserting after clause 7v7 the following new clause3 7vi7 ,exclusion for certain cancer hospitals ,for purposes of paragraph 7#a77;,b77v7 and this paragraph with respect to applicable items and services furnished during #bjag or a subsequent year1 the term off-campus outpatient department of a provider also shall not include a department of a provider 7as so defined7 that is not described in clause 7ii7 if the provider is a hospital described in section #ahhf7;d77#a77;,b77v7 and-- 7,i7 in the case of a department that met the requirements of section #dac4fe of title #db of the ,code of ,federal ,regulations after ,november #a1 #bjae1 and before the date of the enactment of this clause1 the ,secretary receives from the provider an attestation that such department met such requirements not later than #fj days after such date of enactment2 or 7,,ii7 in the case of a department that meets such requirements after such date of enactment1 the ,secretary receives from the provider an attestation that such department meets such requirements not later than #fj days after the date such requirements are first met with respect to such department4 2 7#b7 in clause 7vii71 by inserting after the first sentence the following3 ,not later than #b years after the date the ,secretary receives an attestation under clause 7vi7 relating to compliance of a department of a provider with requirements referred to in such clause1 the ,secretary shall audit the compliance with such requirements with respect to the department42 and 7#c7 in clause 7viii77,,iii71 by adding at the end the following3 ,for purposes of carrying out this subparagraph with respect to clause 7vi7 7and clause 7vii7 insofar as it relates to such clause71 #b1jjj1jjj shall be available from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda1 to remain available until expended44 7b7 ,offsetting savings ,section #ahcc7t77#ah7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ah77 is amended-- 7#a7 in subparagraph 7,b71 by inserting 1 subject to subparagraph 7,c71 after shall2 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,target ,,pcr adjustment ,in applying section #dai4dc7;i7 of title #db of the ,code of ,federal ,regulations to implement the appropriate adjustment under this paragraph for services furnished on or after ,january #a1 #bjah1 the ,secretary shall use a target ,,pcr that is #a4j percentage points less than the target ,,pcr that would otherwise apply4 ,in addition to the percentage point reduction under the previous sentence1 the ,secretary may consider making an additional percentage point reduction to such target ,,pcr that takes into account payment rates for applicable items and services described in paragraph 7#ba77;,c7 other than for services furnished by hospitals described in section #ahhf7;d77#a77;,b77v74 ,in making any budget neutrality adjustments under this subsection for #bjah or a subsequent year1 the ,secretary shall not take into account the reduced expenditures that result from the application of this subparagraph4 4 7c7 ,effective date ,the amendments made by this section shall be effective as if included in the enactment of section #fjc of the ,bipartisan ,budget ,act of #bjae 7,public ,law #aad-gd74 #afjjc4 ,treatment of eligible professionals in ambulatory surgical centers for meaningful use and ,,mips ,section #ahdh7;a77#g77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;a77#g77;,d77 is amended-- 7#a7 by striking hospital-based eligible professionals and all that follows through ,no payment and inserting the following3 hospital-based and ambulatory surgical center-based eligible professionals4-- 7i7 ,hospital-based ,no payment 2 and 7#b7 by adding at the end the following new clauses3 7ii7 ,ambulatory surgical center-based ,subject to clause 7iv71 no payment adjustment may be made under subparagraph 7,a7 for #bjag and #bjah in the case of an eligible professional with respect to whom substantially all of the covered professional services furnished by such professional are furnished in an ambulatory surgical center4 7iii7 ,determination ,the determination of whether an eligible professional is an eligible professional described in clause 7ii7 may be made on the basis of-- 7,i7 the site of service 7as defined by the ,secretary72 or 7,,ii7 an attestation submitted by the eligible professional4 ,determinations made under subclauses 7,i7 and 7,,ii7 shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services4 7iv7 ,sunset ,clause 7ii7 shall no longer apply as of the first year that begins more than #c years after the date on which the ,secretary determines1 through notice and comment rulemaking1 that certified ,,ehr technology applicable to the ambulatory surgical center setting is available4 4 #afjjd4 ,continuing ,access to ,hospitals ,act of #bjaf 7a7 ,extension of enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through #bjaf ,section #a of ,public ,law #aac-aih1 as amended by section #a of ,public ,law #aad-aab1 is amended-- 7#a7 in the heading1 by striking #bjad and #bjae and inserting #bjaf2 and 7#b7 by striking and #bjae and inserting 1 #bjae1 and #bjaf4 7b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,medicare ,payment ,advisory ,commission 7established under section #ahje of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#f77 shall submit to ,congress a report analyzing the effect of the extension of the enforcement instruction under section #a of ,public ,law #aac-aih1 as amended by section #a of ,public ,law #aad-aab and subsection 7a7 of this section1 on the access to health care by ,medicare beneficiaries1 on the economic impact and the impact upon hospital staffing needs1 and on the quality of health care furnished to such beneficiaries4 #afjje4 ,delay of implementation of ,medicare fee schedule adjustments for wheelchair accessories and seating systems when used in conjunction with complex rehabilitation technology 7,,crt7 wheelchairs ,section #b7;a7 of the ,patient ,access and ,medicare ,protection ,act 7#db ,u4,s4,c4 #acje note7 is amended by striking ,january #a1 #bjag and inserting ,july #a1 #bjag4 #afjjf4 ,allowing physical therapists to utilize locum tenens arrangements under ,medicare 7a7 ,in general ,the first sentence of section #ahdb7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f771 as amended by section #ejab1 is further amended-- 7#a7 by striking and before 7,i72 and 7#b7 by inserting before the period at the end the following3 1 and 7,j7 in the case of outpatient physical therapy services furnished by physical therapists in a health professional shortage area 7as defined in section #ccb7;a77#a77;,a7 of the ,public ,health ,service ,act71 a medically underserved area 7as designated pursuant to section #ccj7;b77#c77;,a7 of such ,act71 or a rural area 7as defined in section #ahhf7;d77#b77;,d771 subparagraph 7,d7 of this sentence shall apply to such services and therapists in the same manner as such subparagraph applies to physicians' services furnished by physicians4 7b7 ,effective date2 implementation 7#a7 ,effective date ,the amendments made by subsection 7a7 shall apply to services furnished beginning not later than six months after the date of the enactment of this ,act4 7#b7 ,implementation ,the ,secretary of ,health and ,human ,services may implement subparagraph 7,j7 of section #ahdb7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f771 as added by subsection 7a77#b71 by program instruction or otherwise4 #afjjg4 ,extension of the transition to new payment rates for durable medical equipment under the ,medicare program 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall extend the transition period described in clause 7i7 of section #dad4baj7;g77#i7 of title #db1 ,code of ,federal ,regulations1 from ,june #cj1 #bjaf1 to ,december #ca1 #bjaf 7with the full implementation described in clause 7ii7 of such section applying to items and services furnished with dates of service on or after ,january #a1 #bjag74 7b7 ,study and report 7#a7 ,study 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall conduct a study that examines the impact of applicable payment adjustments upon-- 7i7 the number of suppliers of durable medical equipment that1 on a date that is not before ,january #a1 #bjaf1 and not later than ,december #ca1 #bjaf1 ceased to conduct business as such suppliers2 and 7ii7 the availability of durable medical equipment1 during the period beginning on ,january #a1 #bjaf1 and ending on ,december #ca1 #bjaf1 to individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or enrolled under part ,b of such title4 7,b7 ,definitions ,for purposes of this subsection1 the following definitions apply3 7i7 ,supplier2 durable medical equipment ,the terms supplier and durable medical equipment have the meanings given such terms by section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex74 7ii7 ,applicable payment adjustment ,the term applicable payment adjustment means a payment adjustment described in section #dad4baj7;g7 of title #db1 ,code of ,federal ,regulations1 that is phased in by paragraph 7#i77;i7 of such section4 ,for purposes of the preceding sentence1 a payment adjustment that is phased in pursuant to the extension under subsection 7a7 shall be considered a payment adjustment that is phased in by such paragraph 7#i77;i74 7#b7 ,report ,the ,secretary of ,health and ,human ,services shall1 not later than ,january #ab1 #bjag1 submit to the ,committees on ,ways and ,means and on ,energy and ,commerce of the ,house of ,representatives1 and to the ,committee on ,finance of the ,senate1 a report on the findings of the study conducted under paragraph 7#a74 #afjjh4 ,requirements in determining adjustments using information from competitive bidding programs 7a7 ,in general ,section #ahcd7;a77#a77;,g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77#a77;,g77 is amended by adding at the end the following new sentence3 ,in the case of items and services furnished on or after ,january #a1 #bjai1 in making any adjustments under clause 7ii7 or 7iii7 of subparagraph 7,f71 under subsection 7h77#a77;,h77ii71 or under section #ahdb7s77#c77;,b71 the ,secretary shall-- 7i7 solicit and take into account stakeholder input2 and 7ii7 take into account the highest amount bid by a winning supplier in a competitive acquisition area and a comparison of each of the following with respect to non-competitive acquisition areas and competitive acquisition areas3 7,i7 ,the average travel distance and cost associated with furnishing items and services in the area4 7,,ii7 ,the average volume of items and services furnished by suppliers in the area4 7,,iii7 ,the number of suppliers in the area4 4 7b7 ,conforming amendments 7#a7 ,section #ahcd7;h77#a77;,h77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h77ii77 is amended by striking the ,secretary and inserting subject to subsection 7a77#a77;,g71 the ,secretary4 7#b7 ,section #ahdb7s77#c77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7s77#c77;,b77 is amended by striking the ,secretary and inserting subject to section #ahcd7;a77#a77;,g71 the ,secretary4 ,,xvii ,other ,medicare ,provisions #agjja4 ,delay in authority to terminate contracts for ,medicare ,advantage plans failing to achieve minimum quality ratings 7a7 ,findings ,consistent with the studies provided under the ,,impact ,act of #bjad 7,public ,law #aac-ahe71 it is the intent of ,congress-- 7#a7 to continue to study and request input on the effects of socioeconomic status and dual-eligible populations on the ,medicare ,advantage ,,stars rating system before reforming such system with the input of stakeholders2 and 7#b7 pending the results of such studies and input1 to provide for a temporary delay in authority of the ,centers for ,medicare ,medicaid ,services 7,,cms7 to terminate ,medicare ,advantage plan contracts solely on the basis of performance of plans under the ,,stars rating system4 7b7 ,delay in ,,ma contract termination authority for plans failing ,to achieve minimum quality ratings ,section #aheg7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;h77 is amended by adding at the end the following new paragraph3 7#c7 ,delay in contract termination authority for plans failing to achieve minimum quality rating ,during the period beginning on the date of the enactment of this paragraph and through the end of plan year #bjah1 the ,secretary may not terminate a contract under this section with respect to the offering of an ,,ma plan by a ,medicare ,advantage organization solely because the ,,ma plan has failed to achieve a minimum quality rating under the #e-star rating system under section #ahec7o77#d74 4 #agjjb4 ,requirement for enrollment data reporting for ,medicare ,section #ahgd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciekk7 is amended by adding at the end the following new subsection3 7g7 ,requirement for enrollment data reporting 7#a7 ,in general ,each year 7beginning with #bjaf71 the ,secretary shall submit to the ,committees on ,ways and ,means and ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,finance of the ,senate a report on ,medicare enrollment data 7and1 in the case of part ,a1 on data on individuals receiving benefits under such part7 as of a date in such year specified by the ,secretary4 ,such data shall be presented-- 7,a7 by ,congressional district and ,state2 and 7,b7 in a manner that provides for such data based on-- 7i7 fee-for-service enrollment 7as defined in paragraph 7#b772 7ii7 enrollment under part ,c 7including separate for aggregate enrollment in ,,ma-,,pd plans and aggregate enrollment in ,,ma plans that are not ,,ma-,,pd plans72 and 7iii7 enrollment under part ,d4 7#b7 ,fee-for-service enrollment defined ,for purpose of paragraph 7#a77;,b77i71 the term fee-for-service enrollment means aggregate enrollment 7including receipt of benefits other than through enrollment7 under-- 7,a7 part ,a only2 7,b7 part ,b only2 and 7,c7 both part ,a and part ,b4 4 #agjjc4 ,updating the ,welcome to ,medicare package 7a7 ,in general ,not later than #ab months after the last day of the period for the request of information described in subsection 7b71 the ,secretary of ,health and ,human ,services shall1 taking into consideration information collected pursuant to subsection 7b71 update the information included in the ,welcome to ,medicare package to include information1 presented in a clear and simple manner1 about options for receiving benefits under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 including through the original medicare fee-for-service program under parts ,a and ,b of such title 7#db ,u4,s4,c4 #acie;c et seq41 #db ,u4,s4,c4 #acie;j et seq471 ,medicare ,advantage plans under part ,c of such title 7#db ,u4,s4,c4 #aciew-#ba et seq471 and prescription drug plans under part ,d of such title 7#db ,u4,s4,c4 #aciew-#aja et seq4774 ,the ,secretary shall make subsequent updates to the information included in the ,welcome to ,medicare package as appropriate4 7b7 ,request for information ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall request information1 including recommendations1 from stakeholders 7including patient advocates1 issuers1 and employers7 on information included in the ,welcome to ,medicare package1 including pertinent data and information regarding enrollment and coverage for ,medicare eligible individuals4 #agjjd4 ,no payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area 7a7 ,medicare ,section #ahff7;j77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77#g77 is amended-- 7#a7 in the paragraph heading1 by inserting 2 ,nonpayment before the period2 and 7#b7 by adding at the end the following new subparagraph3 7,c7 ,nonpayment 7i7 ,in general ,no payment may be made under this title or under a program described in subparagraph 7,a7 with respect to an item or service described in clause 7ii7 furnished on or after ,october #a1 #bjag4 7ii7 ,item or service described ,an item or service described in this clause is an item or service furnished-- 7,i7 within a geographic area with respect to which a temporary moratorium imposed under subparagraph 7,a7 is in effect2 and 7,,ii7 by a provider of services or supplier that meets the requirements of clause 7iii74 7iii7 ,requirements ,for purposes of clause 7ii71 the requirements of this clause are that a provider of services or supplier-- 7,i7 enrolls under this title on or after the effective date of such temporary moratorium2 and 7,,ii7 is within a category of providers of services and suppliers 7as described in subparagraph 7,a77 subject to such temporary moratorium4 7iv7 ,prohibition on charges for specified items or services ,in no case shall a provider of services or supplier described in clause 7ii77,,ii7 charge an individual or other person for an item or service described in clause 7ii7 furnished on or after ,october #a1 #bjag1 to an individual entitled to benefits under part ,a or enrolled under part ,b or an individual under a program specified in subparagraph 7,a74 4 7b7 ,conforming amendments 7#a7 ,medicaid 7,a7 ,in general ,section #aijc7;i77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#b771 as amended by section #ejje7;a77#d71 is further amended-- 7i7 in subparagraph 7,c71 by striking or at the end2 and 7ii7 by adding at the end the following new subparagraph3 7,e7 with respect to any amount expended for such an item or service furnished during calendar quarters beginning on or after ,october #a1 #bjag1 subject to section #aijb7kk77#d77;,a77ii77,,ii71 within a geographic area that is subject to a moratorium imposed under section #ahff7;j77#g7 by a provider or supplier that meets the requirements specified in subparagraph 7,c77iii7 of such section1 during the period of such moratorium2 or 4 7,b7 ,exception with respect to access ,section #aijb7kk77#d77;,a77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#d77;,a77ii77 is amended to read as follows3 7ii7 ,exceptions 7,i7 ,compliance with moratorium ,a ,state shall not be required to comply with a temporary moratorium described in clause 7i7 if the ,state determines that the imposition of such temporary moratorium would adversely impact beneficiaries' access to medical assistance4 7,,ii7 ,,ffp available ,notwithstanding section #aijc7;i77#b77;,e71 payment may be made to a ,state under this title with respect to amounts expended for items and services described in such section if the ,secretary1 in consultation with the ,state agency administering the ,state plan under this title 7or a waiver of the plan71 determines that denying payment to the ,state pursuant to such section would adversely impact beneficiaries' access to medical assistance4 4 7,c7 ,state plan requirement with respect to limitation on charges to beneficiaries ,section #aijb7kk77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#d77;,a77 is amended by adding at the end the following new clause3 7iii7 ,limitation on charges to beneficiaries ,with respect to any amount expended for items or services furnished during calendar quarters beginning on or after ,october #a1 #bjag1 the ,state prohibits1 during the period of a temporary moratorium described in clause 7i71 a provider meeting the requirements specified in subparagraph 7,c77iii7 of section #ahff7;j77#g7 from charging an individual or other person eligible to receive medical assistance under the ,state plan under this title 7or a waiver of the plan7 for an item or service described in section #aijc7;i77#b77;,e7 furnished to such an individual4 4 7#b7 ,correcting amendments to related provisions 7,a7 ,section #ahff7;j7 ,section #ahff7;j7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77 is amended-- 7i7 in paragraph 7#a77;,a7-- 7,i7 by striking paragraph 7#d7 and inserting paragraph 7#e72 7,,ii7 by striking moratoria in accordance with paragraph 7#e7 and inserting moratoria in accordance with paragraph 7#g72 and 7,,iii7 by striking paragraph 7#f7 and inserting paragraph 7#i72 and 7ii7 by redesignating the second paragraph 7#h7 7redesignated by section #acjd7a7 of ,public ,law #aaa-aeb7 as paragraph 7#i74 7,b7 ,section #aijb7kk7 ,section #aijb7kk7 of such ,act 7#db ,u4,s4,c4 #acif;a7kk77 is amended-- 7i7 in paragraph 7#a71 by striking section #ahhf7;j77#b7 and inserting section #ahff7;j77#b72 7ii7 in paragraph 7#b71 by striking section #ahhf7;j77#c7 and inserting section #ahff7;j77#c72 7iii7 in paragraph 7#c71 by striking section #ahhf7;j77#d7 and inserting section #ahff7;j77#e72 and 7iv7 in paragraph 7#d77;,a71 by striking section #ahhf7;j77#f7 and inserting section #ahff7;j77#g74 #agjje4 ,preservation of ,medicare beneficiary choice under ,medicare ,advantage ,section #ahea7;e77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;e77#b77 is amended-- 7#a7 in subparagraph 7,c7-- 7,a7 in the heading1 by inserting from #bjaa through #bjah after #de-;day period2 and 7,b7 by inserting and ending with #bjah after beginning with #bjaa2 and 7#b7 by adding at the end the following new subparagraph3 7,g7 ,continuous open enrollment and disenrollment for first #c months in #bjaf and subsequent years 7i7 ,in general ,subject to clause 7ii7 and subparagraph 7,d7-- 7,i7 in the case of an ,,ma eligible individual who is enrolled in an ,,ma plan1 at any time during the first #c months of a year 7beginning with #bjai72 or 7,,ii7 in the case of an individual who first becomes an ,,ma eligible individual during a year 7beginning with #bjai7 and enrolls in an ,,ma plan1 during the first #c months during such year in which the individual is an ,,ma eligible individual2 such ,,ma eligible individual may change the election under subsection 7a77#a74 7ii7 ,limitation of one change during open enrollment period each year ,an individual may change the election pursuant to clause 7i7 only once during the applicable #c-month period described in such clause in each year4 ,the limitation under this clause shall not apply to changes in elections effected during an annual1 coordinated election period under paragraph 7#c7 or during a special enrollment period under paragraph 7#d74 7iii7 ,limited application to part ,d ,clauses 7i7 and 7ii7 of this subparagraph shall only apply with respect to changes in enrollment in a prescription drug plan under part ,d in the case of an individual who1 previous to such change in enrollment1 is enrolled in a ,medicare ,advantage plan4 7iv7 ,limitations on marketing ,pursuant to subsection 7j71 no unsolicited marketing or marketing materials may be sent to an individual described in clause 7i7 during the continuous open enrollment and disenrollment period established for the individual under such clause1 notwithstanding marketing guidelines established by the ,centers for ,medicare ,medicaid ,services4 4 #agjjf4 ,allowing end-stage renal disease beneficiaries to choose a ,medicare ,advantage plan 7a7 ,removing prohibition 7#a7 ,in general ,section #ahea7;a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;a77#c77 is amended-- 7,a7 by striking subparagraph 7,b72 and 7,b7 by striking eligible individual and all that follows through ,in this title1 subject to subparagraph 7,b71 and inserting eligible individual4--,in this title14 7#b7 ,conforming amendments 7,a7 ,section #aheb7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;b77#a77 is amended-- 7i7 by striking subparagraph 7,b72 and 7ii7 by striking ,beneficiaries and all that follows through ,a ,medicare,choice organization and inserting ,beneficiaries4--,a ,medicare ,advantage organization4 7,b7 ,section #ahei7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bh7;b77#f77 is amended1 in the last sentence1 by striking may waive and all that follows through subparagraph and4 7#c7 ,effective date ,the amendments made by this subsection shall apply with respect to plan years beginning on or after ,january #a1 #bjba4 7b7 ,excluding costs for kidney acquisitions from ,,ma benchmark ,section #ahec of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7 is amended-- 7#a7 in subsection 7k7-- 7,a7 in paragraph 7#a7-- 7i7 in the matter preceding subparagraph 7,a71 by striking paragraphs 7#b7 and 7#d7 and inserting paragraphs 7#b71 7#d71 and 7#e72 and 7ii7 in subparagraph 7,b77i71 by striking paragraphs 7#b7 and 7#d7 and inserting paragraphs 7#b71 7#d71 and 7#e72 and 7,b7 by adding at the end the following new paragraph3 7#e7 ,exclusion of costs for kidney acquisitions from capitation rates ,after determining the applicable amount for an area for a year under paragraph 7#a7 7beginning with #bjba71 the ,secretary shall adjust such applicable amount to exclude from such applicable amount the ,secretary's estimate of the standardized costs for payments for organ acquisitions for kidney transplants covered under this title 7including expenses covered under section #ahha7;d77 in the area for the year4 2 and 7#b7 in subsection 7n77#b7-- 7,a7 in subparagraph 7,a77i71 by inserting and1 for #bjba and subsequent years1 the exclusion of payments for organ acquisitions for kidney transplants from the capitation rate as described in subsection 7k77#e7 before the semicolon at the end2 7,b7 in subparagraph 7,e71 in the matter preceding clause 7i71 by striking subparagraph 7,f7 and inserting subparagraphs 7,f7 and 7,g72 and 7,c7 by adding at the end the following new subparagraph3 7,g7 ,application of kidney acquisitions adjustment ,the base payment amount specified in subparagraph 7,e7 for a year 7beginning with #bjba7 shall be adjusted in the same manner under paragraph 7#e7 of subsection 7k7 as the applicable amount is adjusted under such subsection4 4 7c7 ,,ffs coverage of kidney acquisitions 7#a7 ,in general ,section #aheb7;a77#a77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#a77;,b77i77 is amended by inserting or coverage for organ acquisitions for kidney transplants1 including as covered under section #ahha7;d7 after hospice care4 7#b7 ,conforming amendment ,section #ahea7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;i77 is amended by adding at the end the following new paragraph3 7#c7 ,,ffs payment for expenses for kidney acquisitions ,paragraphs 7#a7 and 7#b7 shall not apply with respect to expenses for organ acquisitions for kidney transplants described in section #aheb7;a77#a77;,b77i74 4 7#c7 ,effective date ,the amendments made by this subsection shall apply with respect to plan years beginning on or after ,january #a1 #bjba4 7d7 ,evaluation of quality 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall conduct an evaluation of whether the #e-star rating system based on the data collected under section #aheb7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;e77 should include a quality measure specifically related to care for enrollees in ,medicare ,advantage plans under part ,c of title ,,xviii of such ,act determined to have end-stage renal disease4 7#b7 ,public availability ,not later than ,april #a1 #bjbj1 the ,secretary shall post on the ,internet website of the ,centers for ,medicare ,medicaid ,services the results of the evaluation under paragraph 7#a74 7e7 ,report ,not later than ,december #ca1 #bjbc1 the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall submit to ,congress a report on the impact of the provisions of1 and amendments made by1 this section with respect to the following3 7#a7 ,spending under-- 7,a7 the original ,medicare fee-for-service program under parts ,a and ,b of title ,,xviii of the ,social ,security ,act2 and 7,b7 the ,medicare ,advantage program under part ,c of such title4 7#b7 ,the number of enrollees determined to have end-stage renal disease-- 7,a7 in the original ,medicare fee-for-service program2 and 7,b7 in the ,medicare ,advantage program4 7#c7 ,the sufficiency of the amount of data under the original ,medicare fee-for-service program for individuals determined to have end-stage renal disease for purposes of determining payment rates for end-stage renal disease under the ,medicare ,advantage program4 7f7 ,improvements to risk adjustment under medicare advantage 7#a7 ,in general ,section #ahec7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7;a77#a77 is amended-- 7,a7 in subparagraph 7,c77i71 by striking ,the ,secretary and inserting ,subject to subparagraph 7,i71 the ,secretary2 and 7,b7 by adding at the end the following new subparagraph3 7,i7 ,improvements to risk adjustment for #bjai and subsequent years 7i7 ,in general ,in order to determine the appropriate adjustment for health status under subparagraph 7,c77i71 the following shall apply3 7,i7 ,taking into account total number of diseases or conditions ,the ,secretary shall take into account the total number of diseases or conditions of an individual enrolled in an ,,ma plan4 ,the ,secretary shall make an additional adjustment under such subparagraph as the number of diseases or conditions of an individual increases4 7,,ii7 ,using at least #b years of diagnostic data ,the ,secretary may use at least #b years of diagnosis data4 7,,iii7 ,providing separate adjustments for dual eligible individuals ,with respect to individuals who are dually eligible for benefits under this title and title ,,xix1 the ,secretary shall make separate adjustments for each of the following3 7aa7 ,full-benefit dual eligible individuals 7as defined in section #aice7;c77#f774 7bb7 ,such individuals not described in item 7aa74 7,,iv7 ,evaluation of mental health and substance use disorders ,the ,secretary shall evaluate the impact of including additional diagnosis codes related to mental health and substance use disorders in the risk adjustment model4 7,v7 ,evaluation of chronic kidney disease ,the ,secretary shall evaluate the impact of including the severity of chronic kidney disease in the risk adjustment model4 7,,vi7 ,evaluation of payment rates for end-stage renal disease ,the ,secretary shall evaluate whether other factors 7in addition to those described in subparagraph 7,h77 should be taken into consideration when computing payment rates under such subparagraph4 7ii7 ,phased-in implementation ,the ,secretary shall phase-in any changes to risk adjustment payment amounts under subparagraph 7,c77i7 under this subparagraph over a #c-year period1 beginning with #bjai1 with such changes being fully implemented for #bjbb and subsequent years4 7iii7 ,opportunity for review and public comment ,the ,secretary shall provide an opportunity for review of the proposed changes to such risk adjustment payment amounts under this subparagraph and a public comment period of not less than #fj days before implementing such changes4 4 7#b7 ,studies and reports 7,a7 ,reports on the risk adjustment system 7i7 ,medpac evaluation and report 7,i7 ,evaluation ,the ,medicare ,payment ,advisory ,commission shall conduct an evaluation of the impact of the provisions of1 and amendments made by1 this section on risk scores for enrollees in ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act and payments to ,medicare ,advantage plans under such part1 including the impact of such provisions and amendments on the overall accuracy of risk scores under the ,medicare ,advantage program4 7,,ii7 ,report ,not later than ,july #a1 #bjbj1 the ,medicare ,payment ,advisory ,commission shall submit to ,congress a report on the evaluation under subclause 7,i71 together with recommendations for such legislation and administrative action as the ,commission determines appropriate4 7ii7 ,reports by secretary of health and human services ,not later than ,december #ca1 #bjah1 and every #c years thereafter1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report on the risk adjustment model and the ,,esrd risk adjustment model under the ,medicare ,advantage program under part ,c of title ,,xviii of the ,social ,security ,act1 including any revisions to either such model since the previous report4 ,such report shall include information on how such revisions impact the predictive ratios under either such model for groups of enrollees in ,medicare ,advantage plans1 including very high and very low cost enrollees1 and groups defined by the number of chronic conditions of enrollees4 7,b7 ,study and report on functional status 7i7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subparagraph referred to as the ,comptroller ,general7 shall conduct a study on how to most accurately measure the functional status of enrollees in ,medicare ,advantage plans and whether the use of such functional status would improve the accuracy of risk adjustment payments under the ,medicare ,advantage program under part ,c of title ,,xviii of the ,social ,security ,act4 ,such study shall include an analysis of the challenges in collecting and reporting functional status information for ,medicare ,advantage plans under such part1 providers of services and suppliers under the ,medicare program1 and the ,centers for ,medicare ,medicaid ,services4 7ii7 ,report ,not later than ,june #cj1 #bjah1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study under clause 7i71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 #agjjg4 ,improvements to the assignment of beneficiaries under the ,medicare ,shared ,savings ,program ,section #ahii7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7c77 is amended-- 7#a7 by striking utilization of primary and inserting utilization of-- 7#a7 in the case of performance years beginning on or after ,april #a1 #bjab1 primary 2 7#b7 in paragraph 7#a71 as added by paragraph 7#a7 of this section1 by striking the period at the end and inserting 2 and2 7#c7 by adding at the end the following new paragraph3 7#b7 in the case of performance years beginning on or after ,january #a1 #bjai1 services provided under this title by a ,federally qualified health center or rural health clinic 7as those terms are defined in section #ahfa7;aa771 as may be determined by the ,secretary4 4 ,,xviii ,other ,provisions #ahjja4 ,exception from group health plan requirements for qualified small employer health reimbursement arrangements 7a7 ,amendments to the ,internal ,revenue ,code of #aihf and the ,patient ,protection and ,affordable ,care ,act 7#a7 ,in general ,section #ihca of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subsection3 7d7 ,exception for qualified small employer health reimbursement arrangements 7#a7 ,in general ,for purposes of this title 7except as provided in section #dihj;,i7f77#d7 and notwithstanding any other provision of this title71 the term group health plan shall not include any qualified small employer health reimbursement arrangement4 7#b7 ,qualified small employer health reimbursement arrangement ,for purposes of this subsection-- 7,a7 ,in general ,the term qualified small employer health reimbursement arrangement means an arrangement which-- 7i7 is described in subparagraph 7,b71 and 7ii7 is provided on the same terms to all eligible employees of the eligible employer4 7,b7 ,arrangement described ,an arrangement is described in this subparagraph if-- 7i7 such arrangement is funded solely by an eligible employer and no salary reduction contributions may be made under such arrangement1 7ii7 such arrangement provides1 after the employee provides proof of coverage1 for the payment of1 or reimbursement of1 an eligible employee for expenses for medical care 7as defined in section #bac7;d77 incurred by the eligible employee or the eligible employee's family members 7as determined under the terms of the arrangement71 and 7iii7 the amount of payments and reimbursements described in clause 7ii7 for any year do not exceed #d1iej 7#aj1jjj in the case of an arrangement that also provides for payments or reimbursements for family members of the employee74 7,c7 ,certain variation permitted ,for purposes of subparagraph 7,a77ii71 an arrangement shall not fail to be treated as provided on the same terms to each eligible employee merely because the employee's permitted benefit under such arrangement varies in accordance with the variation in the price of an insurance policy in the relevant individual health insurance market based on-- 7i7 the age of the eligible employee 7and1 in the case of an arrangement which covers medical expenses of the eligible employee's family members1 the age of such family members71 or 7ii7 the number of family members of the eligible employee the medical expenses of which are covered under such arrangement4 ,the variation permitted under the preceding sentence shall be determined by reference to the same insurance policy with respect to all eligible employees4 7,d7 ,rules relating to maximum dollar limitation 7i7 ,amount prorated in certain cases ,in the case of an individual who is not covered by an arrangement for the entire year1 the limitation under subparagraph 7,b77iii7 for such year shall be an amount which bears the same ratio to the amount which would 7but for this clause7 be in effect for such individual for such year under subparagraph 7,b77iii7 as the number of months for which such individual is covered by the arrangement for such year bears to #ab4 7ii7 ,inflation adjustment ,in the case of any year beginning after #bjaf1 each of the dollar amounts in subparagraph 7,b77iii7 shall be increased by an amount equal to-- 7,i7 such dollar amount1 multiplied by 7,,ii7 the cost-of-living adjustment determined under section #a7;f77#c7 for the calendar year in which the taxable year begins1 determined by substituting calendar year #bjae for calendar year #aiib in subparagraph 7,b7 thereof4 ,if any dollar amount increased under the preceding sentence is not a multiple of #ej1 such dollar amount shall be rounded to the next lowest multiple of #ej4 7#c7 ,other definitions ,for purposes of this subsection-- 7,a7 ,eligible employee ,the term eligible employee means any employee of an eligible employer1 except that the terms of the arrangement may exclude from consideration employees described in any clause of section #aje7;h77#c77;,b7 7applied by substituting #ij days for #c years in clause 7i7 thereof74 7,b7 ,eligible employer ,the term eligible employer means an employer that-- 7i7 is not an applicable large employer as defined in section #dihj;,h7c77#b71 and 7ii7 does not offer a group health plan to any of its employees4 7,c7 ,permitted benefit ,the term permitted benefit means1 with respect to any eligible employee1 the maximum dollar amount of payments and reimbursements which may be made under the terms of the qualified small employer health reimbursement arrangement for the year with respect to such employee4 7#d7 ,notice 7,a7 ,in general ,an employer funding a qualified small employer health reimbursement arrangement for any year shall1 not later than #ij days before the beginning of such year 7or1 in the case of an employee who is not eligible to participate in the arrangement as of the beginning of such year1 the date on which such employee is first so eligible71 provide a written notice to each eligible employee which includes the information described in subparagraph 7,b74 7,b7 ,contents of notice ,the notice required under subparagraph 7,a7 shall include each of the following3 7i7 ,a statement of the amount which would be such eligible employee's permitted benefit under the arrangement for the year4 7ii7 ,a statement that the eligible employee should provide the information described in clause 7i7 to any health insurance exchange to which the employee applies for advance payment of the premium assistance tax credit4 7iii7 ,a statement that if the employee is not covered under minimum essential coverage for any month the employee may be subject to tax under section #ejjj;,a for such month and reimbursements under the arrangement may be includible in gross income4 4 7#b7 ,limitation on exclusion from gross income ,section #ajf of such ,code is amended by adding at the end the following3 7g7 ,qualified small employer health reimbursement arrangement ,for purposes of this section and section #aje1 payments or reimbursements from a qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77 of an individual for medical care 7as defined in section #bac7;d77 shall not be treated as paid or reimbursed under employer-provided coverage for medical expenses under an accident or health plan if for the month in which such medical care is provided the individual does not have minimum essential coverage 7within the meaning of section #ejjj;,a7f774 4 7#c7 ,coordination with health insurance premium credit ,section #cf;,b7c7 of such ,code is amended by adding at the end the following new paragraph3 7#d7 ,special rules for qualified small employer health reimbursement arrangements 7,a7 ,in general ,the term coverage month shall not include any month with respect to an employee 7or any spouse or dependent of such employee7 if for such month the employee is provided a qualified small employer health reimbursement arrangement which constitutes affordable coverage4 7,b7 ,denial of double benefit ,in the case of any employee who is provided a qualified small employer health reimbursement arrangement for any coverage month 7determined without regard to subparagraph 7,a771 the credit otherwise allowable under subsection 7a7 to the taxpayer for such month shall be reduced 7but not below zero7 by the amount described in subparagraph 7,c77i77,,ii7 for such month4 7,c7 ,affordable coverage ,for purposes of subparagraph 7,a71 a qualified small employer health reimbursement arrangement shall be treated as constituting affordable coverage for a month if-- 7i7 the excess of-- 7,i7 the amount that would be paid by the employee as the premium for such month for self-only coverage under the second lowest cost silver plan offered in the relevant individual health insurance market1 over 7,,ii7 #aab of the employee's permitted benefit 7as defined in section #ihca7;d77#c77;,c77 under such arrangement1 does not exceed-- 7ii7 #aab of #i4e percent of the employee's household income4 7,d7 ,qualified small employer health reimbursement arrangement ,for purposes of this paragraph1 the term qualified small employer health reimbursement arrangement has the meaning given such term by section #ihca7;d77#b74 7,e7 ,coverage for less than entire year ,in the case of an employee who is provided a qualified small employer health reimbursement arrangement for less than an entire year1 subparagraph 7,c77i77,,ii7 shall be applied by substituting the number of months during the year for which such arrangement was provided for #ab4 7,f7 ,indexing ,in the case of plan years beginning in any calendar year after #bjad1 the ,secretary shall adjust the #i4e percent amount under subparagraph 7,c77ii7 in the same manner as the percentages are adjusted under subsection 7b77#c77;,a77ii74 4 7#d7 ,application of excise tax on high cost employer-sponsored health coverage 7,a7 ,in general ,section #dihj;,i7f77#d7 of such ,code is amended by adding at the end the following3 ,section #ihca7;d77#a7 shall not apply for purposes of this section44 7,b7 ,determination of cost of coverage ,section #dihj;,i7d77#b7 of such ,code is amended by redesignating subparagraph 7,d7 as subparagraph 7,e7 and by inserting after subparagraph 7,c7 the following new subparagraph3 7,d7 ,qualified small employer health reimbursement arrangements ,in the case of applicable employer-sponsored coverage consisting of coverage under any qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b771 the cost of coverage shall be equal to the amount described in section #fjea7;a77#ae74 4 7#e7 ,enforcement of notice requirement ,section #ffeb of such ,code is amended by adding at the end the following new subsection3 7o7 ,failure to provide notices with respect to qualified small employer health reimbursement arrangements ,in the case of each failure to provide a written notice as required by section #ihca7;d77#d71 unless it is shown that such failure is due to reasonable cause and not willful neglect1 there shall be paid1 on notice and demand of the ,secretary and in the same manner as tax1 by the person failing to provide such written notice1 an amount equal to #ej per employee per incident of failure to provide such notice1 but the total amount imposed on such person for all such failures during any calendar year shall not exceed #b1ejj4 4 7#f7 ,reporting 7,a7 ,w-#b reporting ,section #fjea7;a7 of such ,code is amended by striking and at the end of paragraph 7#ac71 by striking the period at the end of paragraph 7#ad7 and inserting 1 and1 and by inserting after paragraph 7#ad7 the following new paragraph3 7#ae7 the total amount of permitted benefit 7as defined in section #ihca7;d77#c77;,c77 for the year under a qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b77 with respect to the employee4 4 7,b7 ,information required to be provided by exchange subsidy applicants ,section #adaa7;b77#c7 of the ,patient ,protection and ,affordable ,care ,act is amended by redesignating subparagraph 7,b7 as subparagraph 7,c7 and by inserting after subparagraph 7,a7 the following new subparagraph3 7,b7 ,certain individual health insurance policies obtained through small employers ,the amount of the enrollee's permitted benefit 7as defined in section #ihca7;d77#c77;,c7 of the ,internal ,revenue ,code of #aihf7 under a qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b7 of such ,code74 4 7#g7 ,effective dates 7,a7 ,in general ,except as otherwise provided in this paragraph1 the amendments made by this subsection shall apply to years beginning after ,december #ca1 #bjaf4 7,b7 ,transition relief ,the relief under ,treasury ,notice #bjae-ag shall be treated as applying to any plan year beginning on or before ,december #ca1 #bjaf4 7,c7 ,coordination with health insurance premium credit ,the amendments made by paragraph 7#c7 shall apply to taxable years beginning after ,december #ca1 #bjaf4 7,d7 ,employee notice 7i7 ,in general ,the amendments made by paragraph 7#e7 shall apply to notices with respect to years beginning after ,december #ca1 #bjaf4 7ii7 ,transition relief ,for purposes of section #ffeb7o7 of the ,internal ,revenue ,code of #aihf 7as added by this ,act71 a person shall not be treated as failing to provide a written notice as required by section #ihca7;d77#d7 of such ,code if such notice is so provided not later than #ij days after the date of the enactment of this ,act4 7,e7 ,w-#b reporting ,the amendments made by paragraph 7#f77;,a7 shall apply to calendar years beginning after ,december #ca1 #bjaf4 7,f7 ,information provided by exchange subsidy applicants 7i7 ,in general ,the amendments made by paragraph 7#f77;,b7 shall apply to applications for enrollment made after ,december #ca1 #bjaf4 7ii7 ,verification ,verification under section #adaa of the ,patient ,protection and ,affordable ,care ,act of information provided under section #adaa7;b77#c77;,b7 of such ,act shall apply with respect to months beginning after ,october #bjaf4 7iii7 ,transitional relief ,in the case of an application for enrollment under section #adaa7;b7 of the ,patient ,protection and ,affordable ,care ,act made before ,april #a1 #bjag1 the requirement of section #adaa7;b77#c77;,b7 of such ,act shall be treated as met if the information described therein is provided not later than #cj days after the date on which the applicant receives the notice described in section #ihca7;d77#d7 of the ,internal ,revenue ,code of #aihf4 7#h7 ,substantiation requirements ,the ,secretary of the ,treasury 7or his designee7 may issue substantiation requirements as necessary to carry out this subsection4 7b7 ,amendments to the ,employee ,retirement ,income ,security ,act of #aigd 7#a7 ,in general ,section #gcc7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaia;b7a77#a77 is amended by adding at the end the following3 ,such term shall not include any qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b7 of the ,internal ,revenue ,code of #aihf744 7#b7 ,exception from continuation coverage requirements1 etc ,section #fjg7a7 of such ,act 7#bi ,u4,s4,c4 #aafg7a77 is amended by adding at the end the following3 ,such term shall not include any qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b7 of the ,internal ,revenue ,code of #aihf744 7#c7 ,effective date ,the amendments made by this subsection shall apply to plan years beginning after ,december #ca1 #bjaf4 7c7 ,amendments to the ,public ,health ,service ,act 7#a7 ,in general ,section #bgia7;a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;a77#a77 is amended by adding at the end the following3 ,except for purposes of part ,c of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq471 such term shall not include any qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b7 of the ,internal ,revenue ,code of #aihf744 7#b7 ,exception from continuation coverage requirements ,section #bbjh7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;bb-#h7a77 is amended by adding at the end the following3 ,such term shall not include any qualified small employer health reimbursement arrangement 7as defined in section #ihca7;d77#b7 of the ,internal ,revenue ,code of #aihf744 7#c7 ,effective date ,the amendments made by this subsection shall apply to plan years beginning after ,december #ca1 #bjaf4 ,clerk4