,,ii #aaith ,,congress #ast ,session ,s4 #hia ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #f1 #bjbe,mr4 ,wyden 7for himself and ,mr4 ,sanders7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to extend expiring health provisions and improve health care delivery4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,bipartisan ,health ,care ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,medicaid,sec4 #aja4 ,streamlined enrollment process for eligible out-of-state providers under ,medicaid and ,,chip4,sec4 #ajb4 ,making certain adjustments to coverage of home or community-based services under ,medicaid4,sec4 #ajc4 ,removing certain age restrictions on ,medicaid eligibility for working adults with disabilities4,sec4 #ajd4 ,medicaid ,state plan requirement for determining residency and coverage for military families4,sec4 #aje4 ,ensuring the reliability of address information provided under the ,medicaid program4,sec4 #ajf4 ,codifying certain ,medicaid provider screening requirements related to deceased providers4,sec4 #ajg4 ,modifying certain ,state requirements for ensuring deceased individuals do not remain enrolled4,sec4 #ajh4 ,one-year delay of ,medicaid and ,,chip requirements for health screenings1 referrals1 and case management services for eligible juveniles in public institutions2 ,state interim work plans4,sec4 #aji4 ,state studies and ,,hhs report on costs of providing maternity1 labor1 and delivery services4,sec4 #aaj4 ,modifying certain disproportionate share hospital allotments4,sec4 #aaa4 ,modifying certain limitations on disproportionate share hospital payment adjustments under the ,medicaid program4,sec4 #aab4 ,ensuring accurate payments to pharmacies under ,medicaid4,sec4 #aac4 ,preventing the use of abusive spread pricing in ,medicaid4,,title ,,ii--,medicare,sec4 #bja4 ,extension of increased inpatient hospital payment adjustment for certain low-volume hospitals4,sec4 #bjb4 ,extension of the ,medicare-dependent hospital 7,,mdh7 program4,sec4 #bjc4 ,extension of add-on payments for ambulance services4,sec4 #bjd4 ,extending incentive payments for participation in eligible alternative payment models4,sec4 #bje4 ,temporary payment increase under the ,medicare physician fee schedule to account for exceptional circumstances4,sec4 #bjf4 ,extension of funding for quality measure endorsement1 input1 and selection4,sec4 #bjg4 ,extension of funding outreach and assistance for low-income programs4,sec4 #bjh4 ,extension of the work geographic index floor4,sec4 #bji4 ,extension of certain telehealth flexibilities4,sec4 #baj4 ,requiring modifier for use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care4,sec4 #baa4 ,extending acute hospital care at home waiver flexibilities4,sec4 #bab4 ,enhancing certain program integrity requirements for ,,dme under ,medicare4,sec4 #bac4 ,guidance on furnishing services via telehealth to individuals with limited ,english proficiency4,sec4 #bad4 ,in-home cardiopulmonary rehabilitation flexibilities4,sec4 #bae4 ,inclusion of virtual diabetes prevention program suppliers in ,,mdpp ,expanded ,model4,sec4 #baf4 ,medication-induced movement disorder outreach and education4,sec4 #bag4 ,report on wearable medical devices4,sec4 #bah4 ,extension of temporary inclusion of authorized oral antiviral drugs as covered part ,d drugs4,sec4 #bai4 ,extension of adjustment to calculation of hospice cap amount4,sec4 #bbj4 ,multiyear contracting authority for ,med,p,a,c and ,,macpac4,sec4 #bba4 ,contracting parity for ,med,p,a,c and ,,macpac4,sec4 #bbb4 ,adjustments to ,medicare part ,d cost-sharing reductions for low-income individuals4,sec4 #bbc4 ,requiring ,enhanced and ,accurate ,lists of 7,,real7 ,health ,providers ,act4,sec4 #bbd4 ,medicare coverage of multi-cancer early detection screening tests4,sec4 #bbe4 ,medicare coverage of external infusion pumps and non-self-administrable home infusion drugs4,sec4 #bbf4 ,assuring pharmacy access and choice for ,medicare beneficiaries4,sec4 #bbg4 ,modernizing and ,ensuring ,,pbm ,accountability4,sec4 #bbh4 ,requiring a separate identification number and an attestation for each off-campus outpatient department of a provider4,sec4 #bbi4 ,medicare sequestration4,sec4 #bcj4 ,medicare improvement fund4,,title ,,iii--,human ,services,sec4 #cja4 ,sexual risk avoidance education extension4,sec4 #cjb4 ,personal responsibility education extension4,sec4 #cjc4 ,extension of funding for family-to-family health information centers4,,title ,,iv--,public health extenders,subtitle ,a--,extensions,sec4 #dja4 ,extension for community health centers1 ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs4,sec4 #djb4 ,extension of special diabetes programs4,subtitle ,b--,world ,trade ,center ,health ,program,sec4 #daa4 #i_/aa responder and survivor health funding corrections4,,title ,v--,,support ,act ,reauthorization,sec4 #eja4 ,short title4,subtitle ,a--,prevention,sec4 #eaa4 ,prenatal and postnatal health4,sec4 #eab4 ,monitoring and education regarding infections associated with illicit drug use and other risk factors4,sec4 #eac4 ,preventing overdoses of controlled substances4,sec4 #ead4 ,support for individuals and families impacted by fetal alcohol spectrum disorder4,sec4 #eae4 ,promoting ,state choice in ,,pdmp systems4,sec4 #eaf4 ,first responder training program4,sec4 #eag4 ,donald ,j4 ,cohen ,national ,child ,traumatic ,stress ,initiative4,sec4 #eah4 ,protecting suicide prevention lifeline from cybersecurity incidents4,sec4 #eai4 ,bruce's law4,sec4 #ebj4 ,guidance on at-home drug disposal systems4,sec4 #eba4 ,assessment of opioid drugs and actions4,sec4 #ebb4 ,grant program for ,state and ,tribal response to opioid use disorders4,subtitle ,b--,treatment,sec4 #eca4 ,residential treatment program for pregnant and postpartum women4,sec4 #ecb4 ,improving access to addiction medicine providers4,sec4 #ecc4 ,mental and behavioral health education and training grants4,sec4 #ecd4 ,loan repayment program for substance use disorder treatment workforce4,sec4 #ece4 ,development and dissemination of model training programs for substance use disorder patient records4,sec4 #ecf4 ,task force on best practices for trauma-informed identification1 referral1 and support4,sec4 #ecg4 ,grants to enhance access to substance use disorder treatment4,sec4 #ech4 ,state guidance related to individuals with serious mental illness and children with serious emotional disturbance4,sec4 #eci4 ,reviewing the scheduling of approved products containing a combination of buprenorphine and naloxone4,subtitle ,c--,recovery,sec4 #eda4 ,building communities of recovery4,sec4 #edb4 ,peer support technical assistance center4,sec4 #edc4 ,comprehensive opioid recovery centers4,sec4 #edd4 ,youth prevention and recovery4,sec4 #ede4 ,,career ,act4,sec4 #edf4 ,addressing economic and workforce impacts of the opioid crisis4,subtitle ,d--,miscellaneous matters,sec4 #eea4 ,delivery of a controlled substance by a pharmacy to a prescribing practitioner4,sec4 #eeb4 ,technical correction on controlled substances dispensing4,sec4 #eec4 ,required training for prescribers of controlled substances4,sec4 #eed4 ,extension of temporary order for fentanyl-related substances4,,title ,,vi--,pandemic and ,all-,hazards ,preparedness and ,response,sec4 #fja4 ,short title4,subtitle ,a--,state and local readiness and response,sec4 #faa4 ,temporary reassignment of ,state and local personnel during a public health emergency4,sec4 #fab4 ,public ,health ,emergency ,preparedness program4,sec4 #fac4 ,hospital ,preparedness ,program4,sec4 #fad4 ,facilities and capacities of the ,centers for ,disease ,control and ,prevention to combat public health security threats4,sec4 #fae4 ,pilot program to support ,state medical stockpiles4,sec4 #faf4 ,enhancing domestic wastewater surveillance for pathogen detection4,sec4 #fag4 ,reauthorization of ,mosquito ,abatement for ,safety and ,health program4,subtitle ,b--,federal planning and coordination,sec4 #fba4 ,all-,hazards ,emergency ,preparedness and ,response4,sec4 #fbb4 ,national ,health ,security ,strategy4,sec4 #fbc4 ,improving development and distribution of diagnostic tests4,sec4 #fbd4 ,combating antimicrobial resistance4,sec4 #fbe4 ,strategic ,national ,stockpile and material threats4,sec4 #fbf4 ,medical countermeasures for viral threats with pandemic potential4,sec4 #fbg4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise4,sec4 #fbh4 ,fellowship and training programs4,sec4 #fbi4 ,regional biocontainment research laboratories4,sec4 #fbi;,a4 ,limitation related to countries of concern conducting certain research4,subtitle ,c--,addressing the needs of all individuals,sec4 #fca4 ,improving access to certain programs4,sec4 #fcb4 ,supporting at-risk individuals during emergency responses4,sec4 #fcc4 ,national advisory committees4,sec4 #fcd4 ,national ,academies study on prizes4,subtitle ,d--,additional reauthorizations,sec4 #fda4 ,medical countermeasure priority review voucher4,sec4 #fdb4 ,epidemic ,intelligence ,service4,sec4 #fdc4 ,monitoring and distribution of certain medical countermeasures4,sec4 #fdd4 ,regional health care emergency preparedness and response systems4,sec4 #fde4 ,emergency system for advance registration of volunteer health professionals4,sec4 #fdf4 ,ensuring collaboration and coordination in medical countermeasure development4,sec4 #fdg4 ,military and civilian partnership for trauma readiness4,sec4 #fdh4 ,national ,disaster ,medical ,system4,sec4 #fdi4 ,volunteer ,medical ,reserve ,corps4,sec4 #fdi;,a4 ,epidemiology-laboratory capacity4,,title ,,vii--,public ,health ,programs,sec4 #gja4 ,action for dental health4,sec4 #gjb4 ,,preemie4,sec4 #gjc4 ,preventing maternal deaths4,sec4 #gjd4 ,sickle cell disease prevention and treatment4,sec4 #gje4 ,traumatic brain injuries4,sec4 #gjf4 ,lifespan respite care4,sec4 #gjg4 ,dr4 ,lorna ,breen health care provider protection4,sec4 #gjh4 ,,screens for ,cancer4,sec4 #gji4 ,de,ondra ,dixon ,,include ,project4,sec4 #gaj4 ,,improve ,initiative4,sec4 #gaa4 ,organ ,procurement and ,transplantation ,network4,sec4 #gab4 ,honor ,our ,living ,donors4,sec4 #gac4 ,program for pediatric studies of drugs4,,title ,,viii--,food and ,drug ,administration,subtitle ,a--,give ,kids a ,chance ,sec4 #hja4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs4,sec4 #hjb4 ,ensuring completion of pediatric study requirements4,sec4 #hjc4 ,,fda report on ,,prea enforcement4,sec4 #hjd4 ,extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases4,sec4 #hje4 ,limitations on exclusive approval or licensure of orphan drugs4,subtitle ,b--,united ,states-,abraham ,accords ,cooperation and ,security,sec4 #haa4 ,establishment of ,abraham ,accords ,office within ,food and ,drug ,administration4,,title ,,ix--,lowering prescription drug costs,sec4 #ija4 ,oversight of pharmacy benefit management services4,sec4 #ijb4 ,full rebate pass through to plan2 exception for innocent plan fiduciaries4,sec4 #ijc4 ,increasing transparency in generic drug applications4,sec4 #ijd4 ,title #ce amendments4,,title ,x--,miscellaneous,sec4 #ajja4 ,extension of safe harbor for absence of deductible for telehealth4 ,i ,medicaid #aja4 ,streamlined enrollment process for eligible out-of-state providers under ,medicaid and ,,chip 7a7 ,in general ,section #aijb7kk7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77 is amended by adding at the end the following new paragraph3 7#aj7 ,streamlined enrollment process for eligible out-of-state providers 7,a7 ,in general ,the ,state-- 7i7 adopts and implements a process to allow an eligible out-of-,state provider to enroll under the ,state plan 7or a waiver of such plan7 to furnish items and services to1 or order1 prescribe1 refer1 or certify eligibility for items and services for1 qualifying individuals without the imposition of screening or enrollment requirements by such ,state that exceed the minimum necessary for such ,state to provide payment to an eligible out-of-,state provider under such ,state plan 7or a waiver of such plan71 such as the provider's name and ,national ,provider ,identifier 7and such other information specified by the ,secretary72 and 7ii7 provides that an eligible out-of-,state provider that enrolls as a participating provider in the ,state plan 7or a waiver of such plan7 through such process shall be so enrolled for a #e-year period1 unless the provider is terminated or excluded from participation during such period4 7,b7 ,definitions ,in this paragraph3 7i7 ,eligible out-of-state provider ,the term eligible out-of-,state provider means1 with respect to a ,state1 a provider-- 7,i7 that is located in any other ,state2 7,,ii7 that-- 7aa7 was determined by the ,secretary to have a limited risk of fraud1 waste1 and abuse for purposes of determining the level of screening to be conducted under section #ahff7;j77#b71 has been so screened under such section #ahff7;j77#b71 and is enrolled in the ,medicare program under title ,,xviii2 or 7bb7 was determined by the ,state agency administering or supervising the administration of the ,state plan 7or a waiver of such plan7 of such other ,state to have a limited risk of fraud1 waste1 and abuse for purposes of determining the level of screening to be conducted under paragraph 7#a7 of this subsection1 has been so screened under such paragraph 7#a71 and is enrolled under such ,state plan 7or a waiver of such plan72 and 7,,iii7 that has not been-- 7aa7 excluded from participation in any ,federal health care program pursuant to section #aabh or #aabh;,a2 7bb7 excluded from participation in the ,state plan 7or a waiver of such plan7 pursuant to part #ajjb of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 or ,state law2 or 7cc7 terminated from participating in a ,federal health care program or the ,state plan 7or a waiver of such plan7 for a reason described in paragraph 7#h77;,a74 7ii7 ,qualifying individual ,the term qualifying individual means an individual under #ba years of age who is enrolled under the ,state plan 7or waiver of such plan74 7iii7 ,state ,the term ,state means #a of the #ej ,states or the ,district of ,columbia4 4 7b7 ,conforming amendments 7#a7 ,section #aijb7;a77#gg7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#gg77 is amended by inserting enrollment1 after screening14 7#b7 ,the subsection heading for section #aijb7kk7 of such ,act 7#db ,u4,s4,c4 #acif;a7kk77 is amended by inserting enrollment1 after screening14 7#c7 ,section #bajg7;e77#a77;,g7 of such ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77;,g77 is amended by inserting enrollment1 after screening14 7c7 ,effective date ,the amendments made by this section shall take effect on the date that is #c years after the date of enactment of this ,act4 #ajb4 ,making certain adjustments to coverage of home or community-based services under ,medicaid 7a7 ,increasing transparency of ,,hcbs coverage under ,medicaid 7#a7 ,in general ,section #aiae7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifn7c77 is amended-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,e7-- 7,i7 by inserting 1 not less frequently than before annually2 and 7,,ii7 by inserting 7including1 with respect to such information provided on or after ,july #i1 #bjbg1 the information specified in paragraph 7#aa77 before the period at the end2 and 7ii7 by adding at the end the following flush sentence3 ,the ,secretary shall make all information provided under subparagraph 7,e7 on or after the date of the enactment of this sentence publicly available on the website of the ,centers for ,medicare ,medicaid ,services4 2 and 7,b7 by adding at the end the following new paragraph3 7#aa7 ,for purposes of paragraph 7#b77;,e71 the information specified in this paragraph is the following3 7,a7 ,in the case of a ,state that limits the number of individuals who may be provided home or community-based services under a waiver granted under this subsection and maintains a list of individuals waiting to enroll in such waiver1 a description of how the ,state maintains such list1 including-- 7i7 information on whether the ,state screens individuals on such list to determine whether such individuals are eligible to receive such services under such waiver2 7ii7 information on whether 7and1 if applicable1 how often7 the ,state periodically re-screens individuals on such list for eligibility2 7iii7 the number of people on such list of individuals waiting to enroll in such waiver2 and 7iv7 the average amount of time that individuals newly enrolled in such waiver within the past #ab months were on such list of individuals waiting to enroll in such waiver4 7,b7 ,with respect to homemaker services1 home health aide services1 personal care services1 and habilitation services furnished under waivers under this subsection1 by each such service type-- 7i7 for individuals newly receiving such services within the past #ab months1 the average amount of time 7which may be determined using statistically valid random sampling of such individuals7 from when such services are initially approved for such an individual to when such individual begins receiving such services2 and 7ii7 the percentage of authorized hours 7which may be determined using statistically valid random sampling of individuals authorized to receive such services7 that are provided within the past #ab months4 4 7#b7 ,conforming amendments ,section #aiae of the ,social ,security ,act 7#db ,u4,s4,c4 #acifn7 is amended-- 7,a7 in subsection 7i7 by adding at the end the following new paragraph3 7#h7 ,reporting requirement ,with respect to homemaker services1 home health aide services1 personal care services1 and habilitation services provided under this subsection on or after ,july #i1 #bjbg1 the ,state1 not less frequently than annually1 shall provide to the ,secretary the same information regarding such services as the ,state is required to provide under subsection 7c77#aa77;,b74 2 7,b7 in subsection 7j77#b77;,e71 by inserting after the second sentence the following3 ,with respect to any homemaker services1 home health aide services1 personal care services1 and habilitation services provided under this subsection on or after ,july #i1 #bjbg1 the ,state1 not less frequently than annually1 shall provide to the ,secretary the same information regarding such services as the ,state is required to provide under subsection 7c77#aa77;,b742 and 7,c7 in subsection 7k77#c77;,e7-- 7i7 by striking and after the cost of such services and supports12 and 7ii7 by inserting before the period1 the following3 1 and with respect to homemaker services1 home health aide services1 personal care services1 and habilitation services provided under this subsection on or after ,july #i1 #bjbg1 not less frequently than annually1 the same information regarding such services as the ,state is required to provide under subsection 7c77#aa77;,b74 7b7 ,demonstration program ,to expand ,,hcbs coverage under section #aiae7;c7 waivers ,section #aiae7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifn7c771 as amended by subsection 7a71 is further amended-- 7#a7 in paragraph 7#b77;,e71 by inserting 1 and the information specified in paragraph 7#ab77;,c77v71 when applicable after paragraph 7#aa72 and 7#b7 by adding at the end the following new paragraph3 7#ab7 ,demonstration program to expand coverage for home or community-based services 7,a7 ,in general 7i7 ,approval ,not later than #bd months after the date on which the planning grants under subparagraph 7,b7 are awarded1 notwithstanding paragraph 7#a71 the ,secretary may approve a waiver that is standalone from any other waiver approved under this subsection for not more than #e ,states1 selected in accordance with clause 7ii71 to include as medical assistance under the ,state plan of such ,state1 for the #c-year period beginning on the date of such approval1 payment for part or all of the cost of home or community-based services 7other than room and board 7as described in paragraph 7#a777 approved by the ,secretary which are provided pursuant to a written plan of care to individuals described in subparagraph 7,c77iii74 7ii7 ,selection criteria ,in selecting ,states for purposes of clause 7i71 the ,secretary shall-- 7,i7 only select ,states that received a planning grant under subparagraph 7,b72 7,,ii7 only select ,states that meet the requirements specified in subparagraph 7,c7 and such other requirements as the ,secretary may determine appropriate2 7,,iii7 select ,states in a manner that ensures geographic diversity2 7,,iv7 give preference to ,states with a higher percentage 7relative to other ,states that apply to be selected for purposes of clause 7i77 of the total ,state population residing in rural areas 7as determined by the ,secretary72 7,v7 give preference to ,states that have demonstrated more progress in rebalancing long-term services and supports systems under this title1 as determined based on the relative share of individuals who use home or community-based services 7as defined by the ,secretary7 under this title as a percentage of total individuals who use long-term services and supports 7as defined by the ,secretary7 under this title 7in the most recent year for which such data is available72 and 7,,vi7 give preference to ,states that pursue a waiver under this paragraph that incorporates the provision of mental health services for adults with serious mental illness1 children with serious emotional disturbances1 or individuals with substance use disorder4 7,b7 ,planning grants 7i7 ,in general 7,i7 ,approval ,not later than #ah months after the date of the enactment of this paragraph1 the ,secretary shall award planning grants of not more than #e1jjj1jjj each to not more than #aj ,states for purposes of preparing to submit a request for a waiver under this subsection 7including for costs to implement the waiver or other activities to expand the provision of home or community-based services under this section7 to provide home or community-based services to individuals described in subparagraph 7,c77iii74 7,,ii7 ,selection criteria ,in awarding planning grants under subclause 7,i71 the ,secretary shall use the selection criteria specified in subclauses 7,,iii7 through 7,,vi7 of subparagraph 7,a77ii74 7ii7 ,consultation ,a ,state that is awarded a planning grant under clause 7i7 shall1 in preparing to submit a request for a waiver described in such clause1 consult with-- 7,i7 individuals in need of 7and not receiving7 home or community-based services1 individuals receiving home or community-based services1 and the caregivers of such individuals2 7,,ii7 providers furnishing home or community-based services2 and 7,,iii7 such other stakeholders1 as the ,secretary may specify4 7,c7 ,state requirements ,in addition to the requirements specified under this subsection 7except for the requirements described in subparagraphs 7,c7 and 7,d7 of paragraph 7#b7 and any other requirement the ,secretary determines to be inapplicable in the context of a waiver relation to individuals who do not require the level of care described in paragraph 7#a771 the requirements specified in this paragraph are1 with respect to a ,state1 the following3 7i7 ,as of the date that such ,state requests a waiver under this subsection to provide home or community-based services to individuals described in clause 7iii71 all other waivers 7if any7 granted under this subsection to such ,state meet the requirements of this subsection4 7ii7 ,the ,state demonstrates to the ,secretary that approval of a waiver under this subsection with respect to individuals described in clause 7iii7 will not result in a material increase of the average amount of time that individuals with respect to whom a determination described in paragraph 7#a7 has been made will need to wait to receive home or community-based services under any waiver granted under this subsection1 as determined by the ,secretary4 7iii7 ,the ,state establishes needs-based criteria1 subject to the approval of the ,secretary1 to identify individuals for whom a determination described in paragraph 7#a7 is not applicable1 who will be eligible for home or community-based services under a waiver approved under this paragraph1 and specifies the home or community-based services such individuals so eligible will receive4 7iv7 ,the ,state established needs-based criteria for determining whether an individual described in clause 7iii7 requires the level of care provided in a hospital1 nursing facility1 or an intermediate care facility for individuals with developmental disabilities under the ,state plan or under any waiver of such plan that are more stringent than the needs-based criteria established under clause 7iii7 for determining eligibility for home or community-based services4 7v7 ,the ,state attests that the ,state's average per capita expenditure for medical assistance under the ,state plan 7or waiver of such plan7 provided with respect to such individuals enrolled in a waiver under this paragraph will not exceed the ,state's average per capita expenditures for medical assistance for individuals receiving institutional care under the ,state plan 7or waiver of such plan7 for the duration that the waiver under this paragraph is in effect4 7vi7 ,the ,state provides to the ,secretary data 7in such form and manner as the ,secretary may specify7 regarding the number of individuals described in clause 7i7 with respect to a ,state seeking approval of a waiver under this subsection1 to whom the ,state will make such services available under such waiver4 7vii7 ,the ,state agrees to provide to the ,secretary1 not less frequently than annually1 data for purposes of paragraph 7#b77;,e7 7in such form and manner as the ,secretary may specify7 regarding1 with respect to each preceding year in which a waiver under this subsection to provide home and community-based services to individuals described in clause 7iii7 was in effect-- 7,i7 the cost 7as such term is defined by the ,secretary7 of such services furnished to individuals described in clause 7iii71 broken down by type of service2 7,,ii7 with respect to each type of home and community-based service provided under the waiver1 the length of time that such individuals have received such service2 7,,iii7 a comparison between the data described in subclause 7,i7 and any comparable data available with respect to individuals with respect to whom a determination described in paragraph 7#a7 has been made and with respect to individuals receiving institutional care under this title2 and 7,,iv7 the number of individuals who have received home and community-based services under the waiver during the preceding year4 4 7c7 ,non-,application of the ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the 8,paperwork ,reduction ,act of #aiie071 shall not apply to the implementation of the amendments made by subsections 7a7 and 7b74 7d7 ,,cms guidance to ,states on interim coverage under section #aiae home and community-,based services authorities ,not later than ,january #a1 #bjbg1 the ,secretary of ,health and ,human ,services shall issue guidance to the ,states to clarify how a ,state may provide1 with respect to an individual who is eligible for home and community-based services under section #aiae of the ,social ,security ,act 7#db ,u4,s4,c4 #acifn71 coverage of such services pursuant to a provisional written plan of care1 pending finalization1 with respect to such individual4 7e7 ,funding 7#a7 ,in general ,there are appropriated1 out of any funds in the ,treasury not otherwise obligated1 #ga1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to the ,secretary of ,health and ,human ,services for purposes of carrying out subsection 7d7 and the amendments made by subsection 7b74 7#b7 ,reservation for planning grants ,of the amount appropriated under paragraph 7#a71 the ,secretary of ,health and ,human ,services shall reserve #ej1jjj1jjj of such amount to award planning grants under the demonstration program established by the amendments made by subsection 7b74 #ajc4 ,removing certain age restrictions on ,medicaid eligibility for working adults with disabilities 7a7 ,modification of optional buy-,in groups 7#a7 ,in general ,section #aijb7;a77#aj77;,a77ii77,,xv7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77ii77,,xv77 is amended by striking but less than #fe14 7#b7 ,definition modification ,section #aije7v77#a77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7v77#a77;,a77 is amended by striking 1 but less than #fe14 7b7 ,application to certain ,states ,a ,state that1 as of the date of enactment of this ,act1 provides for making medical assistance available to individuals described in subclause 7,,xv7 or 7,,xvi7 of section #aijb7;a77#aj77;,a77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77ii77 shall not be regarded as failing to comply with the requirements of either such subclause 7as amended by subsection 7a77#a77 or with section #aije7v77#a77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7v77#a77;,a77 7as amended by subsection 7a77#b77 before ,january #a1 #bjbg4 #ajd4 ,medicaid ,state plan requirement for determining residency and coverage for military families 7a7 ,in general ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#hf71 by striking and at the end2 7,b7 in paragraph 7#hg71 by striking the period at the end and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hg71 the following new paragraph3 7#hh7 beginning ,january #a1 #bjbh1 provide1 with respect to an active duty relocated individual 7as defined in subsection 7uu77#a77-- 7,a7 that1 for purposes of determining eligibility for medical assistance under the ,state plan 7or waiver of such plan71 such active duty relocated individual is treated as a resident of the ,state unless such individual voluntarily elects not to be so treated for such purposes2 7,b7 that if1 at the time of relocation 7as described in subsection 7uu77#a771 such active duty relocated individual is on a home and community-based services waiting list 7as defined in subsection 7uu77#b771 such individual remains on such list until-- 7i7 the ,state completes an assessment and renders a decision with respect to the eligibility of such individual to receive the relevant home and community-based services at the time a slot for such services becomes available and1 in the case such decision is a denial of such eligibility1 such individual has exhausted the individual's opportunity for a fair hearing2 or 7ii7 such individual elects to be removed from such list2 and 7,c7 payment for medical assistance furnished under the ,state plan 7or a waiver of the plan7 on behalf of such active duty relocated individual in the military service relocation ,state 7as referred to in subsection 7uu77#a77;,b77i771 to the extent that such assistance is available in such military service relocation ,state in accordance with such guidance as the ,secretary may issue to ensure access to such assistance4 2 and 7#b7 by adding at the end the following new subsection3 7uu7 ,active duty relocated individual2 home and community-,based services waiting list ,for purposes of subsection 7a77#hh7 and this subsection3 7#a7 ,active duty relocated individual ,the term active duty relocated individual means an individual-- 7,a7 who-- 7i7 is enrolled under the ,state plan 7or waiver of such plan72 or 7ii7 with respect to an individual described in subparagraph 7,c77ii71 would be so enrolled pursuant to subsection 7a77#aj77;,a77ii77,,vi7 if such individual began receiving home and community-based services2 7,b7 who-- 7i7 is a member of the ,armed ,forces engaged in active duty service and is relocated to another ,state 7in this subsection referred to as the military service relocation ,state7 by reason of such service2 7ii7 would be described in clause 7i7 except that the individual stopped being engaged in active duty service 7including by reason of retirement from such service7 and the last day on which the individual was engaged in active duty service occurred not more than #ab months ago2 or 7iii7 is a dependent 7as defined by the ,secretary7 of a member described in clause 7i7 or 7ii7 who relocates to the military service relocation ,state with such member2 and 7,c7 who-- 7i7 was receiving home and community-based services 7as defined in section #ihag7;a77#b77;,b7 of the ,american ,rescue ,plan ,act of #bjba7 at the time of such relocation2 or 7ii7 if the ,state maintains a home and community-based services waiting list1 was on such home and community-based services waiting list at the time of such relocation4 7#b7 ,home and community-based services waiting list ,the term home and community-based services waiting list means1 in the case of a ,state that has a limit on the number of individuals who may receive home and community-based services under section #aaae7;a71 section #aiae7;c71 or section #aiae7;j71 a list maintained by such ,state of individuals who are requesting to receive such services under #a or more such sections but for whom the ,state has not yet completed an assessment and rendered a decision with respect to the eligibility of such individuals to receive the relevant home and community-based services at the time a slot for such services becomes available due to such limit4 4 7b7 ,implementation funding ,there are appropriated1 out of any funds in the ,treasury not otherwise obligated1 #a1jjj1jjj for each of fiscal years #bjbe through #bjbi1 to remain available until expended1 to the ,secretary of ,health and ,human ,services for purposes of implementing the amendments made by subsection 7a74 #aje4 ,ensuring the reliability of address information provided under the ,medicaid program 7a7 ,in general ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a771 as previously amended by this title1 is amended-- 7#a7 in paragraph 7#hg71 by striking and at the end2 7#b7 in paragraph 7#hh71 by striking the period at the end and inserting 2 and2 and 7#c7 by inserting after paragraph 7#hh7 the following new paragraph3 7#hi7 beginning ,january #a1 #bjbf1 provide for a process to regularly obtain address information for individuals enrolled under such plan 7or a waiver of such plan7 from reliable data sources 7as described in section #dce4iai7;f77#a77;iii7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation77 and act on any changes to such an address based on such information in accordance with such section 7or successor regulation71 except that this paragraph shall only apply in the case of the #ej ,states and the ,district of ,columbia4 4 7b7 ,application to ,,chip ,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,h7 through 7,u7 as subparagraphs 7,i7 through 7,v71 respectively2 and 7#b7 by inserting after subparagraph 7,g7 the following new subparagraph3 7,h7 ,section #aijb7;a77#hi7 7relating to regularly obtaining address information for enrollees74 4 7c7 ,ensuring transmission of address information from managed care organizations ,section #aicb of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7 is amended by adding at the end the following new subsection3 7j7 ,transmission of address information ,beginning ,january #a1 #bjbf1 each contract under a ,state plan with a managed care entity under section #aijc7m7 shall provide that the entity transmits to the ,state any address information for an individual enrolled with the entity that is provided to such entity directly from1 or verified by such entity directly with1 such individual4 4 #ajf4 ,codifying certain ,medicaid provider screening requirements related to deceased providers ,section #aijb7kk77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#a77 is amended-- 7#a7 by striking ,the ,state and inserting3 7,a7 ,in general ,the ,state 2 and 7#b7 by adding at the end the following new subparagraph3 7,b7 ,additional provider screening ,beginning ,january #a1 #bjbg1 as part of the enrollment 7or reenrollment or revalidation of enrollment7 of a provider or supplier under this title1 and not less frequently than quarterly during the period that such provider or supplier is so enrolled1 the ,state conducts a check of the ,death ,master ,file 7as such term is defined in section #bjc7;d7 of the ,bipartisan ,budget ,act of #bjac7 to determine whether such provider or supplier is deceased4 4 #ajg4 ,modifying certain ,state requirements for ensuring deceased individuals do not remain enrolled ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 as previously amended by this title1 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#hh71 by striking 2 and and inserting a semicolon2 7,b7 in paragraph 7#hi71 by striking the period at the end and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hi7 the following new paragraph3 7#ij7 provide that the ,state shall comply with the eligibility verification requirements under subsection 7vv71 except that this paragraph shall apply only in the case of the #ej ,states and the ,district of ,columbia4 2 and 7#b7 by adding at the end the following new subsection3 7vv7 ,verification of certain eligibility criteria 7#a7 ,in general ,for purposes of subsection 7a77#ij71 the eligibility verification requirements1 beginning ,january #a1 #bjbf1 are as follows3 7,a7 ,quarterly screening to verify enrollee status ,the ,state shall1 not less frequently than quarterly1 review the ,death ,master ,file 7as such term is defined in section #bjc7;d7 of the ,bipartisan ,budget ,act of #bjac7 to determine whether any individuals enrolled for medical assistance under the ,state plan 7or waiver of such plan7 are deceased4 7,b7 ,disenrollment under ,state plan ,if the ,state determines1 based on information obtained from the ,death ,master ,file1 that an individual enrolled for medical assistance under the ,state plan 7or waiver of such plan7 is deceased1 the ,state shall-- 7i7 treat such information as factual information confirming the death of a beneficiary for purposes of section #dca4bac7;a7 of title #db1 ,code of ,federal ,regulations 7or any successor regulation72 7ii7 disenroll such individual from the ,state plan 7or waiver of such plan72 and 7iii7 discontinue any payments for medical assistance under this title made on behalf of such individual 7other than payments for any items or services furnished to such individual prior to the death of such individual74 7,c7 ,reinstatement of coverage in the event of error ,if a ,state determines that an individual was misidentified as deceased based on information obtained from the ,death ,master ,file1 and was erroneously disenrolled from medical assistance under the ,state plan 7or waiver of such plan7 based on such misidentification1 the ,state shall immediately reenroll such individual under the ,state plan 7or waiver of such plan71 retroactive to the date of such disenrollment4 7#b7 ,rule of construction ,nothing under this subsection shall be construed to preclude the ability of a ,state to use other electronic data sources to timely identify potentially deceased beneficiaries1 so long as the ,state is also in compliance with the requirements of this subsection 7and all other requirements under this title relating to ,medicaid eligibility determination and redetermination74 4 #ajh4 ,one-year delay of ,medicaid and ,,chip requirements for health screenings1 referrals1 and case management services for eligible juveniles in public institutions2 ,state interim work plans 7a7 ,in general ,section #eaba7;d7 of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is amended-- 7#a7 by striking ,the amendments made by this section and inserting the following3 7#a7 ,in general ,subject to paragraph 7#b71 the amendments made by this section 2 and 7#b7 by adding at the end the following new paragraph3 7#b7 ,delay of date by which ,states must comply with certain juvenile justice-related requirements ,a ,state shall not be regarded as failing to comply with the requirements of section #aijb7;a77#hd77;,d7 or #bajb7;d77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#hd77;,d71 #acig;bb7d77#b77 before ,january #a1 #bjbf4 4 7b7 ,clarifying nonapplication of requirements to individuals in ,federal custody 7#a7 ,medicaid 7,a7 ,subparagraph 7,d7 of section #aijb7;a77#hd7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#hd771 as added by section #eaba of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 is amended by striking an individual who is an eligible juvenile and inserting an individual 7other than an individual who is in ,federal custody1 including as an inmate in a ,federal prison7 who is an eligible juvenile4 7,b7 ,section #eabb7;a7 of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is amended-- 7i7 by striking paragraph 7#ca7 each place it appears and inserting the last numbered paragraph2 and 7ii7 in paragraph 7#a71 by striking an individual who is an eligible juvenile and inserting an individual 7other than an individual who is in ,federal custody1 including as an inmate in a ,federal prison7 who is an eligible juvenile4 7#b7 ,,chip 7,a7 ,subsection 7d77#b7 of section #bajb of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb71 as added by section #eaba of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 is amended by striking a targeted low-income child who and inserting a targeted low income child 7other than a child who is in ,federal custody1 including as an inmate in a ,federal prison7 who4 7,b7 ,section #eabb7;b77#b7 of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is amended by striking a child who is and inserting a child 7other than a child who is in ,federal custody1 including as an inmate in a ,federal prison7 who is4 7#c7 ,effective date ,the amendments made by this subsection shall take effect as if enacted on ,december #bi1 #bjbb4 7c7 ,interim work plan ,not later than ,june #cj1 #bjbe1 each ,state 7as such term is defined in section #aaja7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acja7;a77#a77 for purposes of titles ,,xix and ,,xxi of such ,act7 shall submit to the ,secretary of ,health and ,human ,services an interim work plan1 in such form and containing such information as the ,secretary may specify1 describing the ,state's progress towards implementing1 and its plans to come into compliance with1 the requirements imposed by the amendments made by section #eaba of subtitle ,c of title ,v of division ,,ff of the ,consolidated ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 consistent with the guidance issued by the ,centers for ,medicare ,medicaid ,services in ,state ,health ,official ,letter #bd-jjd on ,july #bc1 #bjbd4 #aji4 ,state studies and ,,hhs report on costs of providing maternity1 labor1 and delivery services 7a7 ,state study 7#a7 ,in general ,not later than #bd months after the date of enactment of this ,act1 and every #e years thereafter1 each ,state 7as such term is defined in section #aaja7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acja7;a77#a77 for purposes of titles ,,xix and ,,xxi of such ,act7 shall conduct a study on the costs of providing maternity1 labor1 and delivery services in applicable hospitals 7as defined in paragraph 7#c77 and submit the results of such study to the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary74 7#b7 ,content of study ,a ,state study required under paragraph 7#a7 shall include the following information 7to the extent practicable7 with respect to maternity1 labor1 and delivery services furnished by applicable hospitals located in the ,state3 7,a7 ,an estimate of the cost of providing maternity1 labor1 and delivery services at applicable hospitals1 based on the expenditures a representative sample of such hospitals incurred for providing such services during the #b most recent years for which data is available4 7,b7 ,an estimate of the cost of providing maternity1 labor1 and delivery services at applicable hospitals that ceased providing labor and delivery services within the past #e years1 based on the expenditures a representative sample of such hospitals incurred for providing such services during the #b most recent years for which data is available4 7,c7 ,to the extent data allows1 an analysis of the extent to which geographic location1 community demographics1 and local economic factors 7as defined by the ,secretary7 affect the cost of providing maternity1 labor1 and delivery services at applicable hospitals1 including the cost of services that support the provision of maternity1 labor1 and delivery services4 7,d7 ,the amounts applicable hospitals are paid for maternity1 labor1 and delivery services1 by geographic location and hospital size1 under-- 7i7 ,medicare2 7ii7 the ,state ,medicaid program1 including payment amounts for such services under fee-for-service payment arrangements and under managed care 7as applicable72 7iii7 the ,state ,,chip plan1 including payment amounts for such services under fee-for-service payment arrangements and under managed care 7as applicable72 and 7iv7 private health insurance4 7,e7 ,a comparative payment rate analysis-- 7i7 comparing payment rates for maternity1 labor1 and delivery services 7inclusive of all payments received by applicable hospitals for furnishing maternity1 labor1 and delivery services7 under the ,state ,medicaid fee-for-service program to such payment rates for such services under ,medicare 7as described in section #ddg4bjc7;b77#c7 of title #db1 ,code of ,federal ,regulations71 other ,federally-funded or ,state-funded programs 7including1 to the extent data is available1 ,medicaid managed care rates71 and to the payment rates for such services1 to the extent data is available1 of private health insurers within geographic areas of the ,state2 and 7ii7 analyzing different payment methods for such services1 such as the use of bundled payments1 quality incentives1 and low-volume adjustments4 7,f7 ,an evaluation1 using such methodology and parameters established by the ,secretary1 of whether each hospital located in the ,state that furnishes maternity1 labor1 and delivery services is expected to experience in the next #c years significant changes in particular expenditures or types of reimbursement for maternity1 labor1 and delivery services4 7#c7 ,applicable hospital defined ,for purposes of this subsection1 the term applicable hospital means any hospital located in a ,state that meets either of the following criteria3 7,a7 ,the hospital provides labor and delivery services and more than #ej percent of the hospital's births 7in the most recent year for which such data is available7 are financed by the ,medicaid program or ,,chip4 7,b7 ,the hospital-- 7i7 is located in a rural area 7as defined by the ,federal ,office of ,rural ,health ,policy for the purpose of rural health grant programs administered by such ,office72 7ii7 based on the most recent #b years of data available 7as determined by the ,secretary71 furnished services for less than an average of #cjj births per year2 and 7iii7 provides labor and delivery services4 7#d7 ,assistance to small hospitals in compiling cost information ,there are appropriated to the ,secretary for fiscal year #bjbe1 #aj1jjj1jjj for the purpose of providing grants and technical assistance to a hospital described in paragraph 7#c77;,b7 to enable such hospital to compile detailed information for use in the ,state studies required under paragraph 7#a71 to remain available until expended4 7#e7 ,,hhs report on ,state studies ,for each year in which a ,state is required to conduct a study under paragraph 7#a71 the ,secretary shall issue1 not later than #ab months after the date on which the ,state submits to the ,secretary the data described in such paragraph1 a publicly available report that compiles and details the results of such study and includes the information described in paragraph 7#b74 7b7 ,,hhs report on national data collection findings ,not later than #c years after the date of enactment of this ,act1 the ,secretary shall submit to ,congress1 and make publicly available1 a report analyzing the first studies conducted by ,states under subsection 7a77#a71 including recommendations for improving data collection on the cost of providing maternity1 labor1 and delivery services4 7c7 ,implementation funding ,in addition to the amount appropriated under subsection 7a77#d71 there are appropriated1 out of any funds in the ,treasury not otherwise obligated1 #c1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to the ,secretary of ,health and ,human ,services for purposes of implementing this section4 #aaj4 ,modifying certain disproportionate share hospital allotments 7a7 ,extending ,tennessee ,,dsh allotments ,section #aibc7;f77#f77;,a77vi7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;f77#f77;,a77vi77 is amended-- 7#a7 in the heading1 by striking #bjbe and inserting #bjbf and for the #ast quarter of fiscal year #bjbg2 7#b7 by striking fiscal year #bjbe and inserting fiscal year #bjbf2 and 7#c7 by inserting 1 and the ,,dsh allotment for ,tennessee for the #ast quarter of fiscal year #bjbg1 shall be #ac1bge1jjj before the period4 7b7 ,eliminating and delaying ,,dsh allotment reductions ,section #aibc7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;f77 is amended-- 7#a7 in paragraph 7#g77;,a7-- 7,a7 in clause 7i71 in the matter preceding subclause 7,i71 by striking ,april #a1 #bjbe1 and all that follows through #bjbg and inserting ,january #a1 #bjbg1 and ending ,september #cj1 #bjbg1 and for fiscal year #bjbh2 and 7,b7 in clause 7ii71 by striking ,april #a1 #bjbe1 and all that follows through #bjbg and inserting ,january #a1 #bjbg1 and ending ,september #cj1 #bjbg1 and for fiscal year #bjbh2 and 7#b7 in paragraph 7#h71 by striking #bjbg and inserting #bjbh4 #aaa4 ,modifying certain limitations on disproportionate share hospital payment adjustments under the ,medicaid program 7a7 ,in general ,section #aibc7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;g77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking 7other than a hospital described in paragraph 7#b77;,b772 7ii7 in clause 7i71 by inserting with respect to such hospital and year after described in subparagraph 7,b72 and 7iii7 in clause 7ii7-- 7,i7 in subclause 7,i71 by striking and at the end2 7,,ii7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7,,iii7 by adding at the end the following new subclause3 7,,iii7 payments made under title ,,xviii or by an applicable plan 7as defined in section #ahfb7;b77#h77;,f77 for such services4 2 and 7,b7 in subparagraph 7,b7-- 7i7 in the matter preceding clause 7i71 by striking in this clause are and inserting in this subparagraph are1 with respect to a hospital and a year12 and 7ii7 by adding at the end the following new clause3 7iii7 ,individuals who are eligible for medical assistance under the ,state plan or under a waiver of such plan and for whom the ,state plan or waiver is a payor for such services after application of benefits under title ,,xviii or under an applicable plan 7as defined in section #ahfb7;b77#h77;,f771 but only if the hospital has in the aggregate incurred costs exceeding payments under such ,state plan1 waiver1 title ,,xviii1 or applicable plan for such services furnished to such individuals during such year4 2 7#b7 by striking paragraph 7#b72 7#c7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7#d7 in paragraph 7#b71 as so redesignated1 by striking ,notwithstanding paragraph 7#b7 of this subsection 7as in effect on ,october #a1 #bjba71 paragraph 7#b7 and inserting ,paragraph 7#b74 7b7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b71 the amendments made by this section shall apply to payment adjustments made under section #aibc of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 for ,medicaid ,state plan rate years beginning on or after the date of enactment of this ,act4 7#b7 ,state option to distribute unspent ,,dsh allotments from prior years up to modified cap 7,a7 ,in general ,if1 for any ,medicaid ,state plan rate year that begins on or after ,october #a1 #bjba1 and before the date of enactment of this ,act1 a ,state did not spend the full amount of its ,federal fiscal year allotment under section #aibc of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 applicable to that ,state plan rate year1 the ,state may use the unspent portion of such allotment to increase the amount of any payment adjustment made to a hospital for such rate year1 provided that-- 7i7 such payment adjustment 7as so increased7 is consistent with subsection 7g7 of such section 7as amended by this section72 and 7ii7 the total amount of all payment adjustments for the ,state plan rate year 7as so increased7 does not exceed the disproportionate share hospital allotment for the ,state and applicable ,federal fiscal year under subsection 7f7 of such section4 7,b7 ,no recoupment of payments already made to hospitals ,a ,state shall not recoup any payment adjustment made by the ,state to a hospital for a ,medicaid ,state plan rate year described in subparagraph 7,a7 if such payment adjustment is consistent with section #aibc7;g7 of such ,act 7#db ,u4,s4,c4 #acifr-#d7;g77 as in effect on ,october #a1 #bjba4 7,c7 ,authority to permit retroactive modification of ,state plan amendments to allow for increases 7i7 ,in general ,subject to paragraph 7#b71 solely for the purpose of allowing a ,state to increase the amount of a payment adjustment to a hospital for a ,medicaid ,state plan rate year described in subparagraph 7,a7 pursuant to this paragraph1 a ,state may retroactively modify a provision of the ,medicaid ,state plan1 a waiver of such plan1 or a ,state plan amendment that relates to such rate year and the ,secretary may approve such modification4 7ii7 ,deadline ,a ,state may not submit a request for approval of a retroactive modification to a provision of the ,medicaid ,state plan1 a waiver of such plan1 or a ,state plan amendment for a ,medicaid ,state plan rate year after the date by which the ,state is required to submit the independent certified audit for that ,state plan rate year as required under section #aibc7;j77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;j77#b774 7,d7 ,reporting ,if a ,state increases a payment adjustment made to a hospital for a ,medicaid ,state plan rate year pursuant to this paragraph1 the ,state shall include information on such increased payment adjustment as part of the next annual report submitted by the ,state under section #aibc7;j77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;j77#a774 #aab4 ,ensuring accurate payments to pharmacies under ,medicaid 7a7 ,in general ,section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is amended-- 7#a7 in paragraph 7#a77;,a7-- 7,a7 by redesignating clause 7ii7 as clause 7iii72 and 7,b7 by striking and after the semicolon at the end of clause 7i7 and all that precedes it through 7#a7 and inserting the following3 7#a7 ,determining pharmacy actual acquisition costs ,the ,secretary shall conduct a survey of retail community pharmacy drug prices and applicable non-retail pharmacy drug prices to determine national average drug acquisition cost benchmarks 7as such term is defined by the ,secretary7 as follows3 7,a7 ,use of vendor ,the ,secretary may contract services for-- 7i7 with respect to retail community pharmacies1 the determination of retail survey prices of the national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 7ii7 with respect to applicable non-retail pharmacies-- 7,i7 the determination of survey prices1 separate from the survey prices described in clause 7i71 of the non-retail national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 and 7,,ii7 at the discretion of the ,secretary1 for each type of applicable non-retail pharmacy1 the determination of survey prices1 separate from the survey prices described in clause 7i7 or subclause 7,i7 of this clause1 of the national average drug acquisition cost for such type of pharmacy for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts1 rebates1 and other price concessions 7to the extent any information with respect to such discounts1 rebates1 and other price concessions is available7 based on a monthly survey of such pharmacies2 and 2 7#b7 in subparagraph 7,b7 of paragraph 7#a71 by striking subparagraph 7,a77ii7 and inserting subparagraph 7,a77iii72 7#c7 in subparagraph 7,d7 of paragraph 7#a71 by striking clauses 7ii7 and 7iii7 and inserting the following3 7ii7 ,the vendor must update the ,secretary no less often than monthly on the survey prices for covered outpatient drugs4 7iii7 ,the vendor must differentiate1 in collecting and reporting survey data1 for all cost information collected1 whether a pharmacy is a retail community pharmacy or an applicable non-retail pharmacy1 including whether such pharmacy is an affiliate 7as defined in subsection 7k77#ad771 and1 in the case of an applicable non-retail pharmacy1 which type of applicable non-retail pharmacy it is using the relevant pharmacy type indicators included in the guidance required by subsection 7d77#b7 of section #aab of the ,bipartisan ,health ,care ,act4 2 7#d7 by adding at the end of paragraph 7#a7 the following3 7,f7 ,survey reporting ,in order to meet the requirement of section #aijb7;a77#ed71 a ,state shall require that any retail community pharmacy or applicable non-retail pharmacy in the ,state that receives any payment1 reimbursement1 administrative fee1 discount1 rebate1 or other price concession related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title1 regardless of whether such payment1 reimbursement1 administrative fee1 discount1 rebate1 or other price concession is received from the ,state or a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d77 directly or from a pharmacy benefit manager or another entity that has a contract with the ,state or a managed care entity or other specified entity 7as so defined71 shall respond to surveys conducted under this paragraph4 7,g7 ,survey information ,information on national drug acquisition prices obtained under this paragraph shall be made publicly available in a form and manner to be determined by the ,secretary and shall include at least the following3 7i7 ,the monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph 7,f74 7ii7 ,the sampling methodology and number of pharmacies sampled monthly4 7iii7 ,information on price concessions to pharmacies1 including discounts1 rebates1 and other price concessions1 to the extent that such information may be publicly released and has been collected by the ,secretary as part of the survey4 7,h7 ,penalties 7i7 ,in general ,subject to clauses 7ii71 7iii71 and 7iv71 the ,secretary shall enforce the provisions of this paragraph with respect to a pharmacy through the establishment of civil money penalties applicable to a retail community pharmacy or an applicable non-retail pharmacy4 7ii7 ,basis for penalties ,the ,secretary shall impose a civil money penalty established under this subparagraph on a retail community pharmacy or applicable non-retail pharmacy if-- 7,i7 the retail pharmacy or applicable non-retail pharmacy refuses or otherwise fails to respond to a request for information about prices in connection with a survey under this subsection2 7,,ii7 knowingly provides false information in response to such a survey2 or 7,,iii7 otherwise fails to comply with the requirements established under this paragraph4 7iii7 ,parameters for penalties 7,i7 ,in general ,a civil money penalty established under this subparagraph may be assessed with respect to each violation1 and with respect to each non-compliant retail community pharmacy 7including a pharmacy that is part of a chain7 or non-compliant applicable non-retail pharmacy 7including a pharmacy that is part of a chain71 in an amount not to exceed #ajj1jjj for each such violation4 7,,ii7 ,considerations ,in determining the amount of a civil money penalty imposed under this subparagraph1 the ,secretary may consider the size1 business structure1 and type of pharmacy involved1 as well as the type of violation and other relevant factors1 as determined appropriate by the ,secretary4 7iv7 ,rule of application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a civil money penalty or proceeding under section #aabh;,a7a74 7,i7 ,limitation on use of applicable non-retail pharmacy pricing information ,no ,state shall use pricing information reported by applicable non-retail pharmacies under subparagraph 7,a77ii7 to develop or inform payment methodologies for retail community pharmacies4 2 7#e7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by inserting 1 including payment rates and methodologies for determining ingredient cost reimbursement under managed care entities or other specified entities 7as such terms are defined in section #aijc7m77#i77;,d771 after under this title2 and 7,b7 in subparagraph 7,b71 by inserting and the basis for such dispensing fees before the semicolon2 7#f7 by redesignating paragraph 7#d7 as paragraph 7#e72 7#g7 by inserting after paragraph 7#c7 the following new paragraph3 7#d7 ,oversight 7,a7 ,in general ,the ,inspector ,general of the ,department of ,health and ,human ,services shall conduct periodic studies of the survey data reported under this subsection1 as appropriate1 including with respect to substantial variations in acquisition costs or other applicable costs1 as well as with respect to how internal transfer prices and related party transactions may influence the costs reported by pharmacies that are affiliates 7as defined in subsection 7k77#ad77 or are owned by1 controlled by1 or related under a common ownership structure with a wholesaler1 distributor1 or other entity that acquires covered outpatient drugs relative to costs reported by pharmacies not affiliated with such entities4 ,the ,inspector ,general shall provide periodic updates to ,congress on the results of such studies1 as appropriate1 in a manner that does not disclose trade secrets or other proprietary information4 7,b7 ,appropriation ,there is appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services1 out of any money in the ,treasury not otherwise appropriated1 #e1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this paragraph4 2 and 7#h7 in paragraph 7#e71 as so redesignated-- 7,a7 by inserting 1 and #i1jjj1jjj for fiscal year #bjbe and each fiscal year thereafter1 after #bjaj2 and 7,b7 by inserting ,funds appropriated under this paragraph for fiscal year #bjbe and any subsequent fiscal year shall remain available until expended4 after the period4 7b7 ,definitions ,section #aibg7k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking ,in the section and inserting ,in this section2 and 7#b7 by adding at the end the following new paragraphs3 7#ab7 ,applicable non-retail pharmacy ,the term applicable non-retail pharmacy means a pharmacy that is licensed as a pharmacy by the ,state and that is not a retail community pharmacy1 including a pharmacy that dispenses prescription medications to patients primarily through mail and specialty pharmacies4 ,such term does not include nursing home pharmacies1 long-term care facility pharmacies1 hospital pharmacies1 clinics1 charitable or not-for-profit pharmacies1 government pharmacies1 or low dispensing pharmacies 7as defined by the ,secretary74 7#ac7 ,affiliate ,the term affiliate means any entity that is owned by1 controlled by1 or related under a common ownership structure with a pharmacy benefit manager or a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d774 4 7c7 ,effective date 7#a7 ,in general ,subject to paragraph 7#b71 the amendments made by this section shall take effect on the first day of the first quarter that begins on or after the date that is #f months after the date of enactment of this ,act4 7#b7 ,delayed application to applicable non-retail pharmacies ,the pharmacy survey requirements established by the amendments to section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made by this section shall apply to retail community pharmacies beginning on the effective date described in paragraph 7#a71 but shall not apply to applicable non-retail pharmacies until the first day of the first quarter that begins on or after the date that is #ah months after the date of enactment of this ,act4 7d7 ,identification of applicable non-,retail pharmacies 7#a7 ,in general ,not later than ,january #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall1 in consultation with stakeholders as appropriate1 publish guidance specifying pharmacies that meet the definition of applicable non-retail pharmacies 7as such term is defined in subsection 7k77#ab7 of section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 as added by subsection 7b771 and that will be subject to the survey requirements under subsection 7f77#a7 of such section1 as amended by subsection 7a74 7#b7 ,inclusion of pharmacy type indicators ,the guidance published under paragraph 7#a7 shall include pharmacy type indicators to distinguish between different types of applicable non-retail pharmacies1 such as pharmacies that dispense prescriptions primarily through the mail and pharmacies that dispense prescriptions that require special handling or distribution4 ,an applicable non-retail pharmacy may be identified through multiple pharmacy type indicators4 7e7 ,implementation 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 7#b7 ,nonapplication of ,administrative ,procedure ,act ,implementation of the amendments made by this section shall be exempt from the requirements of section #eec of title #e1 ,united ,states ,code4 7f7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary of ,health and ,human ,services under section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f771 as amended by this section4 #aac4 ,preventing the use of abusive spread pricing in ,medicaid 7a7 ,in general ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7#a7 in subsection 7e71 by adding at the end the following new paragraph3 7#f7 ,transparent prescription drug pass-through pricing required 7,a7 ,in general ,a contract between the ,state and a pharmacy benefit manager 7referred to in this paragraph as a ,,pbm71 or a contract between the ,state and a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d7 and collectively referred to in this paragraph as the entity7 that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity1 shall require that payment for such drugs and related administrative services 7as applicable71 including payments made by a ,,pbm on behalf of the ,state or entity1 is based on a transparent prescription drug pass-through pricing model under which-- 7i7 any payment made by the entity or the ,,pbm 7as applicable7 for such a drug-- 7,i7 is limited to-- 7aa7 ingredient cost2 and 7bb7 a professional dispensing fee that is not less than the professional dispensing fee that the ,state would pay if the ,state were making the payment directly in accordance with the ,state plan2 7,,ii7 is passed through in its entirety 7except as reduced under ,federal or ,state laws and regulations in response to instances of waste1 fraud1 or abuse7 by the entity or ,,pbm to the pharmacy or provider that dispenses the drug2 and 7,,iii7 is made in a manner that is consistent with sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 and #ddg4eah of title #db1 ,code of ,federal ,regulations 7or any successor regulation7 as if such requirements applied directly to the entity or the ,,pbm1 except that any payment by the entity or the ,,pbm for the ingredient cost of such drug purchased by a covered entity 7as defined in subsection 7a77#e77;,b77 may exceed the actual acquisition cost 7as defined in #ddg4ejb of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 for such drug if-- 7aa7 such drug was subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act2 7bb7 such payment for the ingredient cost of such drug does not exceed the maximum payment that would have been made by the entity or the ,,pbm for the ingredient cost of such drug if such drug had not been purchased by such covered entity2 and 7cc7 such covered entity reports to the ,secretary 7in a form and manner specified by the ,secretary71 on an annual basis and with respect to payments for the ingredient costs of such drugs so purchased by such covered entity that are in excess of the actual acquisition costs for such drugs1 the aggregate amount of such excess2 7ii7 payment to the entity or the ,,pbm 7as applicable7 for administrative services performed by the entity or ,,pbm is limited to an administrative fee that reflects the fair market value 7as defined by the ,secretary7 of such services2 7iii7 the entity or the ,,pbm 7as applicable7 makes available to the ,state1 and the ,secretary upon request in a form and manner specified by the ,secretary1 all costs and payments related to covered outpatient drugs and accompanying administrative services 7as described in clause 7ii77 incurred1 received1 or made by the entity or the ,,pbm1 broken down 7as specified by the ,secretary71 to the extent such costs and payments are attributable to an individual covered outpatient drug1 by each such drug1 including any ingredient costs1 professional dispensing fees1 administrative fees 7as described in clause 7ii771 post-sale and post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees1 and any and all other remuneration1 as defined by the ,secretary2 and 7iv7 any form of spread pricing whereby any amount charged or claimed by the entity or the ,,pbm 7as applicable7 that exceeds the amount paid to the pharmacies or providers on behalf of the ,state or entity1 including any post-sale or post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees or assessments1 as defined by the ,secretary1 7after allowing for an administrative fee as described in clause 7ii77 is not allowable for purposes of claiming ,federal matching payments under this title4 7,b7 ,publication of information ,the ,secretary shall publish1 not less frequently than on an annual basis and in a manner that does not disclose the identity of a particular covered entity or organization1 information received by the ,secretary pursuant to subparagraph 7,a77iii77,,iii7 that is broken out by ,state and by each of the following categories of covered entity within each such ,state3 7i7 ,covered entities described in subparagraph 7,a7 of section #cdj;,b7a77#d7 of the ,public ,health ,service ,act4 7ii7 ,covered entities described in subparagraphs 7,b7 through 7,k7 of such section4 7iii7 ,covered entities described in subparagraph 7,l7 of such section4 7iv7 ,covered entities described in subparagraph 7,m7 of such section4 7v7 ,covered entities described in subparagraph 7,n7 of such section4 7vi7 ,covered entities described in subparagraph 7,o7 of such section4 2 and 7#b7 in subsection 7k71 as previously amended by this title1 by adding at the end the following new paragraph3 7#ad7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,state1 managed care entity 7as defined in section #aijc7m77#i77;,d771 or other specified entity 7as so defined71 or manages the prescription drug benefits provided by a ,state1 managed care entity1 or other specified entity1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the managing of appeals or grievances related to the prescription drug benefits1 contracting with pharmacies1 controlling the cost of covered outpatient drugs1 or the provision of services related thereto4 ,such term includes any person or entity that acts as a price negotiator 7with regard to payment amounts to pharmacies and providers for a covered outpatient drug or the net cost of the drug7 or group purchaser on behalf of a ,state1 managed care entity1 or other specified entity or that carries out #a or more of the other activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7b7 ,conforming amendments ,section #aijc7m7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended-- 7#a7 in paragraph 7#b77;,a77xiii7-- 7,a7 by striking and 7,,iii7 and inserting 7,,iii72 7,b7 by inserting before the period at the end the following3 1 and 7,,iv7 if the contract includes provisions making the entity responsible for coverage of covered outpatient drugs1 the entity shall comply with the requirements of section #aibg7;e77#f72 and 7,c7 by moving the margin #b ems to the left2 and 7#b7 by adding at the end the following new paragraph3 7#aj7 ,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 an other specified entity 7as defined in paragraph 7#i77;,d77iii77 unless such services are provided in accordance with a contract between the ,state and such entity which satisfies the requirements of paragraph 7#b77;,a77xiii74 4 7c7 ,effective date ,the amendments made by this section shall apply to contracts between ,states and managed care entities1 other specified entities1 or pharmacy benefit managers that have an effective date beginning on or after the date that is #ah months after the date of enactment of this ,act4 7d7 ,implementation 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 7#b7 ,nonapplication of administrative procedure act ,implementation of the amendments made by this section shall be exempt from the requirements of section #eec of title #e1 ,united ,states ,code4 7e7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary of ,health and ,human ,services under section #aibg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e771 as amended by this section4 ,,ii ,medicare #bja4 ,extension of increased inpatient hospital payment adjustment for certain low-volume hospitals 7a7 ,in general ,section #ahhf7;d77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#ab77 is amended-- 7#a7 in subparagraph 7,b71 in the matter preceding clause 7i71 by striking fiscal year #bjbe beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and in fiscal year #bjbf and inserting fiscal year #bjbf beginning on ,january #a1 #bjbf1 and ending on ,september #cj1 #bjbf1 and in fiscal year #bjbg2 7#b7 in subparagraph 7,c77i7-- 7,a7 in the matter preceding subclause 7,i71 by striking through #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through #bjbe and the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe2 7,b7 in subclause 7,,iii71 by striking through #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through #bjbe and the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe2 and 7,c7 in subclause 7,,iv71 by striking fiscal year #bjbe beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and fiscal year #bjbf and inserting fiscal year #bjbf beginning on ,january #a1 #bjbf1 and ending on ,september #cj1 #bjbf1 and fiscal year #bjbg2 and 7#c7 in subparagraph 7,d7-- 7,a7 in the matter preceding clause 7i71 by striking through #bjbd or during the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through #bjbe or during the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe2 and 7,b7 in clause 7ii71 by striking through #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through #bjbe and the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe4 7b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 #bjb4 ,extension of the ,medicare-dependent hospital 7,,mdh7 program 7a7 ,in general ,section #ahhf7;d77#e77;,g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,g77 is amended-- 7#a7 in clause 7i71 by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbf2 and 7#b7 in clause 7ii77,,ii71 by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbf4 7b7 ,conforming amendments 7#a7 ,in general ,section #ahhf7;b77#c77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,d77 is amended-- 7,a7 in the matter preceding clause 7i71 by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbf2 and 7,b7 in clause 7iv71 by striking through fiscal year #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through fiscal year #bjbe and the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe4 7#b7 ,permitting hospitals to decline reclassification ,section #aceja7;e77#b7 of the ,omnibus ,budget ,reconciliation ,act of #aiic 7#db ,u4,s4,c4 #acieww note7 is amended by striking through fiscal year #bjbd1 or the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe and inserting through fiscal year #bjbe1 or the portion of fiscal year #bjbf beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe4 #bjc4 ,extension of add-on payments for ambulance services ,section #ahcd7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7l77 is amended-- 7#a7 in paragraph 7#ab77;,a71 by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbg2 and 7#b7 in paragraph 7#ac71 by striking ,april #a1 #bjbe each place it appears and inserting ,january #a1 #bjbg in each such place4 #bjd4 ,extending incentive payments for participation in eligible alternative payment models 7a7 ,in general ,section #ahcc7z7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7z77 is amended-- 7#a7 in paragraph 7#a77;,a7-- 7,a7 by striking with #bjbf and inserting with #bjbg2 and 7,b7 by inserting 1 or1 with respect to #bjbg1 #c4ec percent after #a4hh percent2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjbf and inserting #bjbg2 and 7ii7 in the matter preceding clause 7i71 by striking #bjbf and inserting #bjbg2 7,b7 in subparagraph 7,c7-- 7i7 in the heading1 by striking #bjbg and inserting #bjbh2 and 7ii7 in the matter preceding clause 7i71 by striking #bjbg and inserting #bjbh2 and 7,c7 in subparagraph 7,d71 by striking and #bjbf and inserting #bjbf1 and #bjbg2 and 7#c7 in paragraph 7#d77;,b71 by inserting or1 with respect to #bjbg1 #c4ec percent after #a4hh percent4 7b7 ,conforming amendments ,section #ahdh7q77#a77;,c77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#a77;,c77iii77 is amended-- 7#a7 in subclause 7,,ii71 by striking #bjbf and inserting #bjbg2 and 7#b7 in subclause 7,,iii71 by striking #bjbg and inserting #bjbh4 #bje4 ,temporary payment increase under the ,medicare physician fee schedule to account for exceptional circumstances 7a7 ,in general ,section #ahdh7t77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7t77#a77 is amended-- 7#a7 in subparagraph 7,d71 by striking and at the end2 7#b7 in subparagraph 7,e71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,f7 such services furnished on or after ,march #ae1 #bjbe1 and before ,january #a1 #bjbf1 by #c4ecge percent4 4 7b7 ,conforming amendment ,section #ahdh7;c77#b77;,b77iv77,v7 is amended by striking or #bjbd and inserting #bjbd1 or #bjbe4 #bjf4 ,extension of funding for quality measure endorsement1 input1 and selection ,section #ahij7;d77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa7d77#b77 is amended-- 7#a7 in the first sentence-- 7,a7 by striking #aa1jcj1jjj and inserting #ad1jjj1jjj2 and 7,b7 by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbe2 and 7#b7 in the third sentence1 by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbe4 #bjg4 ,extension of funding outreach and assistance for low-income programs 7a7 ,state health insurance assistance programs ,subsection 7a77#a77;,b7 of section #aai of the ,medicare ,improvements for ,patients and ,providers ,act of #bjjh 7#db ,u4,s4,c4 #acie;b-#c note7 is amended-- 7#a7 in clause 7xiii71 by striking and at the end2 7#b7 in clause 7xiv71 by striking the period and inserting 2 and2 and 7#c7 by inserting after clause 7xiv7 the following new clause3 7xv7 for the period beginning on ,april #a1 #bjbe1 and ending on ,december #ca1 #bjbf1 #bf1bej1jjj4 4 7b7 ,area agencies on aging ,subsection 7b77#a77;,b7 of such section #aai is amended-- 7#a7 in clause 7xiii71 by striking and at the end2 7#b7 in clause 7xiv71 by striking the period and inserting 2 and2 and 7#c7 by inserting after clause 7xiv7 the following new clause3 7xv7 for the period beginning on ,april #a1 #bjbe1 and ending on ,december #ca1 #bjbf1 #bf1bej1jjj4 4 7c7 ,aging and disability resource centers ,subsection 7c77#a77;,b7 of such section #aai is amended-- 7#a7 in clause 7xiii71 by striking and at the end2 7#b7 in clause 7xiv71 by striking the period and inserting 2 and2 and 7#c7 by inserting after clause 7xiv7 the following new clause3 7xv7 for the period beginning on ,april #a1 #bjbe1 and ending on ,december #ca1 #bjbf1 #g1gej1jjj4 4 7d7 ,coordination of efforts ,to inform older ,americans about benefits available under ,federal and ,state programs ,subsection 7d77#b7 of such section #aai is amended-- 7#a7 in clause 7xiii71 by striking and at the end2 7#b7 in clause 7xiv71 by striking the period and inserting 2 and2 and 7#c7 by inserting after clause 7xiv7 the following new clause3 7xv7 for the period beginning on ,april #a1 #bjbe1 and ending on ,december #ca1 #bjbf1 #bf1bej1jjj4 4 #bjh4 ,extension of the work geographic index floor ,section #ahdh7;e77#a77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;e77#a77;,e77 is amended by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbf4 #bji4 ,extension of certain telehealth flexibilities 7a7 ,removing geographic requirements and expanding originating sites for telehealth services ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#b77;,b77iii71 by striking ending ,march #ca1 #bjbe and inserting ending ,december #ca1 #bjbf2 and 7#b7 in paragraph 7#d77;,c77iii71 by striking ending on ,march #ca1 #bjbe and inserting ending on ,december #ca1 #bjbf4 7b7 ,expanding practitioners eligible ,to furnish telehealth services ,section #ahcd7m77#d77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,e77 is amended by striking ending on ,march #ca1 #bjbe and inserting ending on ,december #ca1 #bjbf4 7c7 ,extending telehealth services for federally qualified health centers and rural health clinics ,section #ahcd7m77#h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h77 is amended-- 7#a7 in subparagraph 7,a71 by striking ending on ,march #ca1 #bjbe and inserting ending on ,december #ca1 #bjbf2 7#b7 in subparagraph 7,b7-- 7,a7 in the subparagraph heading1 by inserting before ,april #a1 #bjbe after rule2 7,b7 in clause 7i71 by striking during the periods for which subparagraph 7,a7 applies and inserting before ,april #a1 #bjbe2 and 7,c7 in clause 7ii71 by inserting furnished to an eligible telehealth individual before ,april #a1 #bjbe after telehealth services2 and 7#c7 by adding at the end the following new subparagraph3 7,c7 ,payment rule for portion of #bjbe and #bjbf 7i7 ,in general ,a telehealth service furnished to an eligible telehealth individual by a ,federally qualified health center or rural health clinic on or after ,april #a1 #bjbe1 and before ,january #a1 #bjbg1 shall be paid as a ,federally qualified health center service or rural health clinic service 7as applicable7 under the prospective payment system established under section #ahcd7o7 or the methodology for all-inclusive rates established under section #ahcc7;a77#c71 respectively4 7ii7 ,treatment of costs ,costs associated with the furnishing of telehealth services by a ,federally qualified health center or rural health clinic on or after ,april #a1 #bjbe1 and before ,january #a1 #bjbg1 shall be considered allowable costs for purposes of the prospective payment system established under section #ahcd7o7 and the methodology for all-inclusive rates established under section #ahcc7;a77#c71 as applicable4 7iii7 ,requiring modifiers ,not later than ,july #a1 #bjbe1 the ,secretary shall establish requirements to include #a or more codes or modifiers1 as determined appropriate by the ,secretary1 in the case of claims for telehealth services furnished to an eligible telehealth individual by a ,federally qualified health center or rural health clinic4 4 7d7 ,delaying the in-,person requirements under ,medicare for mental health services furnished through telehealth and telecommunications technology 7#a7 ,delay in requirements for mental health services furnished through telehealth ,section #ahcd7m77#g77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#g77;,b77i77 is amended1 in the matter preceding subclause 7,i71 by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbg4 7#b7 ,mental health visits furnished by rural health clinics ,section #ahcd7y77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7y77#b77 is amended by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbg4 7#c7 ,mental health visits furnished by ,federally qualified health centers ,section #ahcd7o77#d77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77#d77;,b77 is amended by striking ,april #a1 #bjbe and inserting ,january #a1 #bjbg4 7e7 ,allowing for the furnishing of audio-,only telehealth services ,section #ahcd7m77#i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#i77 is amended by striking ending on ,march #ca1 #bjbe and inserting ending on ,december #ca1 #bjbf4 7f7 ,extending use of telehealth ,to conduct face-to-,face encounter prior to recertification of eligibility for hospice care ,section #ahad7;a77#g77;,d77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 is amended-- 7#a7 by striking ending on ,march #ca1 #bjbe and inserting ending on ,december #ca1 #bjbf2 and 7#b7 by inserting 1 except that this subclause shall not apply in the case of such an encounter with an individual occurring on or after ,april #a1 #bjbe1 if such individual is located in an area that is subject to a moratorium on the enrollment of hospice programs under this title pursuant to section #ahff7;j77#g71 if such individual is receiving hospice care from a provider that is subject to enhanced oversight under this title pursuant to section #ahff7;j77#c71 or if such encounter is performed by a hospice physician or nurse practitioner who is not enrolled under section #ahff7;j7 and is not an opt-out physician or practitioner 7as defined in section #ahjb7;b77#f77;,d77 before the semicolon4 7g7 ,requiring modifiers for telehealth services in certain instances ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended by adding at the end the following new paragraph3 7#aj7 ,required use of modifiers in certain instances ,not later than ,january #a1 #bjbf1 the ,secretary shall establish requirements to include #a or more codes or modifiers1 as determined appropriate by the ,secretary1 in the case of-- 7,a7 claims for telehealth services under this subsection that are furnished through a telehealth virtual platform-- 7i7 by a physician or practitioner that contracts with an entity that owns such virtual platform2 or 7ii7 for which a physician or practitioner has a payment arrangement with an entity for use of such virtual platform2 and 7,b7 claims for telehealth services under this subsection that are furnished incident to a physician's or practitioner's professional service4 4 7h7 ,program instruction authority ,the ,secretary of ,health and ,human ,services may implement the amendments made by this section through program instruction or otherwise4 #baj4 ,requiring modifier for use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care ,section #ahad7;a77#g77;,d77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii771 as amended by section #bji7;f71 is further amended by inserting 1 but only if1 in the case of such an encounter occurring on or after ,january #a1 #bjbf1 any hospice claim includes #a or more modifiers or codes 7as specified by the ,secretary7 to indicate that such encounter was conducted via telehealth after as determined appropriate by the ,secretary4 #baa4 ,extending acute hospital care at home waiver flexibilities ,section #ahff;,g of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc-#g7 is amended-- 7#a7 in the section heading1 by inserting the ,thomas ,r4 ,carper1 ,tim ,scott1 ,brad ,r4 ,wenstrup1 ,d4,p4,m41 and ,earl ,blumenauer after ,extension of2 7#b7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbi2 and 7ii7 by striking in the ,acute ,hospital ,care at ,home initiative of the ,secretary and inserting in the ,thomas ,r4 ,carper1 ,tim ,scott1 ,brad ,r4 ,wenstrup1 ,d4,p4,m41 and ,earl ,blumenauer ,acute ,hospital ,care at ,home initiative of the ,secretary 7in this section referred to as the ,acute ,hospital ,care at ,home initiative72 7,b7 in paragraph 7#b71 by striking of the ,secretary2 and 7,c7 in paragraph 7#c77;,e71 by adding at the end the following new flush sentence3 ,the ,secretary may require that such data and information be submitted through a hospital's cost report1 through such survey instruments as the ,secretary may develop1 through medical record information1 or through such other means as the ,secretary determines appropriate4 2 7#c7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking ,study and inserting ,initial study2 7,b7 in paragraph 7#a77;,a71 by striking of the ,secretary2 and 7,c7 in paragraph 7#c71 by inserting or subsection 7c7 before the period at the end2 7#d7 by redesignating subsections 7c7 and 7d7 as subsections 7d7 and 7e71 respectively2 and 7#e7 by inserting after subsection 7b7 the following new subsection3 7c7 ,subsequent study and report 7#a7 ,in general ,not later than ,september #cj1 #bjbh1 the ,secretary shall conduct a study to-- 7,a7 analyze1 to the extent practicable1 the criteria established by hospitals under the ,acute ,hospital ,care at ,home initiative to determine which individuals may be furnished services under such initiative2 and 7,b7 analyze and compare 7both within and between hospitals participating in the initiative1 and relative to comparable hospitals that do not participate in the initiative1 for relevant parameters such as diagnosis-related groups7-- 7i7 quality of care furnished to individuals with similar conditions and characteristics in the inpatient setting and through the ,acute ,hospital ,care at ,home initiative1 including health outcomes1 hospital readmission rates 7including readmissions both within and beyond #cj days post-discharge71 hospital mortality rates1 length of stay1 infection rates1 composition of care team 7including the types of labor used1 such as contracted labor71 the ratio of nursing staff1 transfers from the hospital to the home1 transfers from the home to the hospital 7including the timing1 frequency1 and causes of such transfers71 transfers and discharges to post-acute care settings 7including the timing1 frequency1 and causes of such transfers and discharges71 and patient and caregiver experience of care2 7ii7 clinical conditions treated and diagnosis-related groups of discharges from inpatient settings relative to discharges from the ,acute ,hospital ,care at ,home initiative2 7iii7 costs incurred by the hospital for furnishing care in inpatient settings relative to costs incurred by the hospital for furnishing care through the ,acute ,hospital ,care at ,home initiative1 including costs relating to staffing1 equipment1 food1 prescriptions1 and other services1 as determined by the ,secretary2 7iv7 the quantity1 mix1 and intensity of services 7such as in-person visits and virtual contacts with patients and the intensity of such services7 furnished in inpatient settings relative to the ,acute ,hospital ,care at ,home initiative1 and1 to the extent practicable1 the nature and extent of family or caregiver involvement2 7v7 socioeconomic information on individuals treated in comparable inpatient settings relative to the initiative1 including racial and ethnic data1 income1 housing1 geographic proximity to the brick-and-mortar facility and whether such individuals are dually eligible for benefits under this title and title ,,xix2 and 7vi7 the quality of care1 outcomes1 costs1 quantity and intensity of services1 and other relevant metrics between individuals who entered into the ,acute ,hospital ,care at ,home initiative directly from an emergency department compared with individuals who entered into the ,acute ,hospital ,care at ,home initiative directly from an existing inpatient stay in a hospital4 7#b7 ,selection bias ,in conducting the study under paragraph 7#a71 the ,secretary shall1 to the extent practicable1 analyze and compare individuals who participate and do not participate in the initiative controlling for selection bias or other factors that may impact the reliability of data4 7#c7 ,report ,not later than ,september #cj1 #bjbh1 the ,secretary of ,health and ,human ,services shall post on a website of the ,centers for ,medicare ,medicaid ,services a report on the study conducted under paragraph 7#a74 7#d7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account for fiscal year #bjbf1 out of any amounts in the ,treasury not otherwise appropriated1 #f1jjj1jjj1 respectively1 to remain available until expended1 for purposes of carrying out this section4 4 #bab4 ,enhancing certain program integrity requirements for ,,dme under ,medicare 7a7 ,durable medical equipment 7#a7 ,in general ,section #ahcd7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is amended by adding at the end the following new paragraph3 7#bc7 ,master ,list inclusion and claim review for certain items 7,a7 ,master ,list inclusion ,beginning ,january #a1 #bjbh1 for purposes of the ,master ,list described in section #dad4bcd7;b7 of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 an item for which payment may be made under this subsection shall be treated as having aberrant billing patterns 7as such term is used for purposes of such section7 if the ,secretary determines that1 without explanatory contributing factors 7such as furnishing emergent care services71 a substantial number of claims for such items under this subsection are for such items ordered by a physician or practitioner who has not previously 7during a period of not less than #bd months1 as established by the ,secretary7 furnished to the individual involved any item or service for which payment may be made under this title4 7,b7 ,claim review ,with respect to items furnished on or after ,january #a1 #bjbh1 that are included on the ,master ,list pursuant to subparagraph 7,a71 if such an item is not subject to a determination of coverage in advance pursuant to paragraph 7#ae77;,c71 the ,secretary may conduct prepayment review of claims for payment for such item4 4 7#b7 ,conforming amendment for prosthetic devices1 orthotics1 and prosthetics ,section #ahcd7;h77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#c77 is amended by inserting 1 and paragraph 7#bc7 of subsection 7a7 shall apply to prosthetic devices1 orthotics1 and prosthetics in the same manner as such provision applies to items for which payment may be made under such subsection before the period at the end4 7b7 ,report on identifying clinical diagnostic laboratory tests at high risk for fraud and effective mitigation measures ,not later than ,january #a1 #bjbf1 the ,inspector ,general of the ,department of ,health and ,human ,services shall submit to ,congress a report assessing fraud risks relating to claims for clinical diagnostic laboratory tests for which payment may be made under section #ahcd;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7 and effective tools for reducing such fraudulent claims4 ,the report may include information regarding-- 7#a7 which1 if any1 clinical diagnostic laboratory tests are identified as being at high risk of fraudulent claims1 and an analysis of the factors that contribute to such risk2 7#b7 with respect to a clinical diagnostic laboratory test identified under paragraph 7#a7 as being at high risk of fraudulent claims-- 7,a7 the amount payable under such section #ahcd;,a with respect to such test2 7,b7 the number of such tests furnished to individuals enrolled under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq472 7,c7 whether an order for such a test was more likely to come from a provider with whom the individual involved did not have a prior relationship1 as determined on the basis of prior payment experience2 and 7,d7 the frequency with which a claim for payment under such section #ahcd;,a included the payment modifier identified by code #ei or #ia2 and 7#c7 suggested strategies for reducing the number of fraudulent claims made with respect to tests so identified as being at high risk1 including-- 7,a7 an analysis of whether the ,centers for ,medicare ,medicaid ,services can detect aberrant billing patterns with respect to such tests in a timely manner2 7,b7 any strategies for identifying and monitoring the providers who are outliers with respect to the number of such tests that such providers order2 and 7,c7 targeted education efforts to mitigate improper billing for such tests2 and 7#d7 such other information as the ,inspector ,general determines appropriate4 #bac4 ,guidance on furnishing services via telehealth to individuals with limited ,english proficiency 7a7 ,in general ,not later than #a year after the date of the enactment of this section1 the ,secretary of ,health and ,human ,services1 in consultation with #a or more entities from each of the categories described in paragraphs 7#a7 through 7#g7 of subsection 7b71 shall issue and disseminate1 or update and revise as applicable1 guidance for the entities described in such subsection on the following3 7#a7 ,best practices on facilitating and integrating use of interpreters during a telemedicine appointment4 7#b7 ,best practices on providing accessible instructions on how to access telecommunications systems 7as such term is used for purposes of section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 for individuals with limited ,english proficiency4 7#c7 ,best practices on improving access to digital patient portals for individuals with limited ,english proficiency4 7#d7 ,best practices on integrating the use of video platforms that enable multi-person video calls furnished via a telecommunications system for purposes of providing interpretation during a telemedicine appointment for an individual with limited ,english proficiency4 7#e7 ,best practices for providing patient materials1 communications1 and instructions in multiple languages1 including text message appointment reminders and prescription information4 7b7 ,entities described ,for purposes of subsection 7a71 an entity described in this subsection is an entity in #a or more of the following categories3 7#a7 ,health information technology service providers1 including-- 7,a7 electronic medical record companies2 7,b7 remote patient monitoring companies2 and 7,c7 telehealth or mobile health vendors and companies4 7#b7 ,health care providers1 including-- 7,a7 physicians2 and 7,b7 hospitals4 7#c7 ,health insurers4 7#d7 ,language service companies4 7#e7 ,interpreter or translator professional associations4 7#f7 ,health and language services quality certification organizations4 7#g7 ,patient and consumer advocates1 including such advocates that work with individuals with limited ,english proficiency4 #bad4 ,in-home cardiopulmonary rehabilitation flexibilities 7a7 ,in general ,section #ahfa7;eee77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7eee77#b77 is amended-- 7#a7 in subparagraph 7,a77ii71 by inserting 7including1 with respect to items and services furnished through audio and video real-time communications technology 7excluding audio-only7 on or after ,april #a1 #bjbe1 and before ,january #a1 #bjbg1 in the home of an individual who is an outpatient of the hospital7 after outpatient basis2 and 7#b7 in subparagraph 7,b71 by inserting 7including1 with respect to items and services furnished through audio and video real-time communications technology on or after ,april #a1 #bjbe1 and before ,january #a1 #bjbg1 the virtual presence of such physician1 physician assistant1 nurse practitioner1 or clinical nurse specialist7 after under the program4 7b7 ,program instruction authority ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 #bae4 ,inclusion of virtual diabetes prevention program suppliers in ,,mdpp ,expanded ,model 7a7 ,in general ,not later than ,january #a1 #bjbf1 the ,secretary shall revise the regulations under parts #daj and #dbd of title #db1 ,code of ,federal ,regulations1 to provide that1 for the period beginning ,january #a1 #bjbf1 and ending ,december #ca1 #bjcj-- 7#a7 an entity may participate in the ,,mdpp by offering only online ,,mdpp services via synchronous or asynchronous technology or telecommunications if such entity meets the conditions for enrollment as an ,,mdpp supplier 7as specified in section #dbd4bje7;b7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation772 7#b7 if an entity participates in the ,,mdpp in the manner described in paragraph 7#a7-- 7,a7 the administrative location of such entity shall be the address of the entity on file under the ,diabetes ,prevention ,recognition ,program2 and 7,b7 in the case of online ,,mdpp services furnished by such entity to an ,,mdpp beneficiary who was not located in the same ,state as the entity at the time such services were furnished1 the entity shall not be prohibited from submitting a claim for payment for such services solely by reason of the location of such beneficiary at such time2 and 7#c7 no limit is applied on the number of times an individual may enroll in the ,,mdpp4 7b7 ,definitions ,in this section3 7#a7 ,,mdpp ,the term ,,mdpp means the ,medicare ,diabetes ,prevention ,program conducted under section #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a71 as described in the final rule published in the ,federal ,register entitled ,medicare and ,medicaid ,programs2 ,,cy #bjbd ,payment ,policies ,under the ,physician ,fee ,schedule and ,other ,changes to ,part ,b ,payment and ,coverage ,policies2 ,medicare ,shared ,savings ,program ,requirements2 ,medicare ,advantage2 ,medicare and ,medicaid ,provider and ,supplier ,enrollment ,policies2 and ,basic ,health ,program 7#hh ,fed4 ,reg4 #ghhah 7,november #af1 #bjbc77 7or a successor regulation74 7#b7 ,regulatory terms ,the terms ,diabetes ,prevention ,recognition ,program1 full ,,cdc ,,dprp recognition1 ,,mdpp beneficiary1 ,,mdpp services1 and ,,mdpp supplier have the meanings given each such term in section #daj4gi7;b7 of title #db1 ,code of ,federal ,regulations4 7#c7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 #baf4 ,medication-induced movement disorder outreach and education ,not later than ,january #a1 #bjbf1 the ,secretary shall use existing communications mechanisms to provide education and outreach to physicians and appropriate non-physician practitioners participating under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 with respect to periodic screening for medication-induced movement disorders that are associated with the treatment of mental health disorders in at-risk patients1 as well as resources related to clinical guidelines and best practices for furnishing such screening services through telehealth4 ,such education and outreach shall include information on how to account for such screening services in evaluation and management code selection4 ,the ,secretary shall1 to the extent practicable1 seek input from relevant stakeholders to inform such education and outreach4 ,such education and outreach may also address other relevant screening services furnished through telehealth1 as the ,secretary determines appropriate4 #bag4 ,report on wearable medical devices ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a technology assessment of1 and submit to ,congress a report on1 the capabilities and limitations of wearable medical devices used to support clinical decision-making4 ,such report shall include a description of-- 7#a7 the potential for such devices to accurately prescribe treatments2 7#b7 an examination of the benefits and challenges of artificial intelligence to augment such capabilities2 and 7#c7 policy options to enhance the benefits and mitigate potential challenges of developing or using such devices4 #bah4 ,extension of temporary inclusion of authorized oral antiviral drugs as covered part ,d drugs ,section #ahfj;,d-#b7;e77#a77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77#a77;,c77 is amended by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbe4 #bai4 ,extension of adjustment to calculation of hospice cap amount ,section #ahad7;i77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7i77#b77;,b77 is amended-- 7#a7 in clause 7ii71 by striking #bjcc and inserting #bjcd2 and 7#b7 in clause 7iii71 by striking #bjcc and inserting #bjcd4 #bbj4 ,multiyear contracting authority for ,med,p,a,c and ,,macpac ,section #cijd of title #da1 ,united ,states ,code1 is amended by adding at the end the following new subsections3 7i7 ,the ,medicare ,payment ,advisory ,commission ,the ,medicare ,payment ,advisory ,commission may use available funds to enter into contracts for the procurement of severable services for a period that begins in one fiscal year and ends in the next fiscal year and may enter into multiyear contracts for the acquisition of property and services to the same extent as executive agencies under the authority of sections #cijb and #cijc of this title4 7j7 ,the ,medicaid and ,,chip ,payment and ,access ,commission ,the ,medicaid and ,,chip ,payment and ,access ,commission may use available funds to enter into contracts for the procurement of severable services for a period that begins in one fiscal year and ends in the next fiscal year and may enter into multiyear contracts for the acquisition of property and services to the same extent as executive agencies under the authority of sections #cijb and #cijc of this title4 4 #bba4 ,contracting parity for ,med,p,a,c and ,,macpac ,in fiscal year #bjbe and thereafter1 for all contracts for goods and services to which the ,medicare and ,payment ,advisory ,commission or the ,medicaid and ,,chip ,payment and ,access ,commission is a party1 the following ,federal ,acquisition ,regulation 7,,far7 clauses will apply3 ,,far #eb4bcb-ci and ,,far #eb4bcc-d 7or a successor clause74 #bbb4 ,adjustments to ,medicare part ,d cost-sharing reductions for low-income individuals ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is amended-- 7#a7 in paragraph 7#a77;,d77ii71 by striking that does not exceed #a for and all that follows through the period at the end and inserting that does not exceed-- 7,i7 for a plan year before #bjbg-- 7aa7 for a generic drug or a preferred drug that is a multiple source drug 7as defined in section #aibg7k77#g77;,a77i771 #a or1 if less1 the copayment amount applicable to an individual under clause 7iii72 and 7bb7 for any other drug1 #c or1 if less1 the copayment amount applicable to an individual under clause 7iii72 and 7,,ii7 for plan year #bjbg and each subsequent plan year-- 7aa7 for a generic drug1 #j2 7bb7 for a preferred drug that is a multiple source drug 7as defined in section #aibg7k77#g77;,a77i771 the dollar amount applied under this clause for such a drug for the preceding plan year1 increased by the annual percentage increase in the consumer price index 7all items2 ,u4,s4 city average7 as of ,september of such preceding year1 or1 if less1 the copayment amount applicable to an individual under clause 7iii72 and 7cc7 for a drug not described in either item 7aa7 or 7bb71 the dollar amount applied under this clause for such a drug for the preceding plan year1 increased in the manner specified in item 7bb71 or1 if less1 the copayment amount applicable to an individual under clause 7iii74 ,any amount established under item 7bb7 or 7cc7 of subclause 7,,ii71 that is based on an increase of #a or #c1 that is not a multiple of #e cents or #aj cents1 respectively1 shall be rounded to the nearest multiple of #e cents or #aj cents1 respectively4 2 and 7#b7 in paragraph 7#d77;,a77ii71 by inserting 7before #bjbg7 after a subsequent year4 #bbc4 ,requiring ,enhanced and ,accurate ,lists of 7,,real7 ,health ,providers ,act 7a7 ,in general ,section #aheb7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;c77 is amended-- 7#a7 in paragraph 7#a77;,c7-- 7,a7 by striking plan1 and any and inserting plan1 any2 and 7,b7 by inserting the following before the period at the end3 1 and1 in the case of a specified ,,ma plan 7as defined in paragraph 7#c77;,c771 for plan year #bjbg and subsequent plan years1 the information described in paragraph 7#c77;,b72 and 7#b7 by adding at the end the following new paragraph3 7#c7 ,provider directory accuracy 7,a7 ,in general ,for plan year #bjbg and subsequent plan years1 each ,,ma organization offering a specified ,,ma plan 7as defined in subparagraph 7,c77 shall1 for each such plan offered by the organization-- 7i7 maintain1 on a publicly available internet website1 an accurate provider directory that includes the information described in subparagraph 7,b72 7ii7 not less frequently than once every #ij days 7or1 in the case of a hospital or any other facility determined appropriate by the ,secretary1 at a lesser frequency specified by the ,secretary but in no case less frequently than once every #ab months71 verify the provider directory information of each provider listed in such directory and1 if applicable1 update such provider directory information2 7iii7 if the organization is unable to verify such information with respect to a provider1 include in such directory an indication that the information of such provider may not be up-to-date2 and 7iv7 remove a provider from such directory within #e business days if the organization determines that the provider is no longer a provider participating in the network of such plan4 7,b7 ,provider directory information ,the information described in this subparagraph is information enrollees may need to access covered benefits from a provider with which such organization offering such plan has an agreement for furnishing items and services covered under such plan such as name1 specialty1 contact information1 primary office or facility address1 whether the provider is accepting new patients1 accommodations for people with disabilities1 cultural and linguistic capabilities1 and telehealth capabilities4 7,c7 ,specified ,,ma plan ,in this paragraph1 the term specified ,,ma plan means-- 7i7 a network-based plan 7as defined in subsection 7d77#e77;,c772 or 7ii7 a ,medicare ,advantage private fee-for-service plan 7as defined in section #ahei7;b77#b77 that meets the access standards under subsection 7d77#d71 in whole or in part1 through entering into contracts or agreements as provided for under subparagraph 7,b7 of such subsection4 4 7b7 ,accountability for provider directory accuracy 7#a7 ,cost ,sharing for ,services ,furnished ,based on ,reliance on ,incorrect ,provider directory ,information ,section #aheb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is amended-- 7,a7 in paragraph 7#a77;,c7-- 7i7 in clause 7ii71 by striking or at the end2 7ii7 in clause 7iii71 by striking the semicolon at the end and inserting 1 or2 and 7iii7 by adding at the end the following new clause3 7iv7 the services are furnished by a provider that is not participating in the network of a specified ,,ma plan 7as defined in subsection 7c77#c77;,c77 but is listed in the provider directory of such plan on the date on which the appointment is made1 as described in paragraph 7#g77;,a72 2 and 7,b7 by adding at the end the following new paragraph3 7#g7 ,cost sharing for services furnished based on reliance on incorrect provider directory information 7,a7 ,in general ,for plan year #bjbg and subsequent plan years1 if an enrollee is furnished an item or service by a provider that is not participating in the network of a specified ,,ma plan 7as defined in subsection 7c77#c77;,c77 but is listed in the provider directory of such plan 7as required to be provided to an enrollee pursuant to subsection 7c77#a77;,c77 on the date on which the appointment is made1 and if such item or service would otherwise be covered under such plan if furnished by a provider that is participating in the network of such plan1 the ,,ma organization offering such plan shall ensure that the enrollee is only responsible for the lesser of-- 7i7 the amount of cost sharing that would apply if such provider had been participating in the network of such plan2 or 7ii7 the amount of cost sharing that would otherwise apply 7without regard to this subparagraph74 7,b7 ,notification requirement ,for plan year #bjbg and subsequent plan years1 each ,,ma organization that offers a specified ,,ma plan shall-- 7i7 notify enrollees of their cost-sharing protections under this paragraph and make such notifications1 to the extent practicable1 by not later than the first day of an annual1 coordinated election period under section #ahea7;e77#c7 with respect to a year2 7ii7 include information regarding such cost-sharing protections in the provider directory of each specified ,,ma plan offered by the ,,ma organization42 and 7iii7 notify enrollees of their cost-sharing protections under this paragraph in an explanation of benefits4 4 7#b7 ,required provider directory accuracy analysis and reports 7,a7 ,in general ,section #aheg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is amended by adding at the end the following new paragraph3 7#f7 ,provider directory accuracy analysis and reports 7,a7 ,in general ,beginning with plan years beginning on or after ,january #a1 #bjbg1 subject to subparagraph 7,c71 a contract under this section with an ,,ma organization shall require the organization1 for each specified ,,ma plan 7as defined in section #aheb7;c77#c77;,c77 offered by the organization to annually do the following3 7i7 ,conduct an analysis estimating the accuracy of the provider directory information of such plan using a random sample of providers included in such provider directory as follows3 7,i7 ,such a random sample shall include a random sample of each specialty of providers with a high inaccuracy rate of provider directory information relative to other specialties of providers1 as determined by the ,secretary4 7,,ii7 ,for purposes of subclause 7,i71 one type of specialty may be providers specializing in mental health or substance use disorder treatment4 7ii7 ,submit to the ,secretary a report containing the results of the analysis conducted under clause 7i71 including an accuracy score for such provider directory information 7as determined using a plan verification method specified by the ,secretary under subparagraph 7,b77i774 7,b7 ,determination of accuracy score 7i7 ,in general ,the ,secretary shall specify plan verification methods1 such as using telephonic verification or other approaches using data sources maintained by an ,,ma organization or using publicly available data sets1 that ,,ma organizations may use for estimating accuracy scores of the provider directory information of specified ,,ma plans offered by such organizations4 7ii7 ,accuracy score methodology ,with respect to each such method specified by the ,secretary as described in clause 7i71 the ,secretary shall specify a methodology for ,,ma organizations to use in estimating such accuracy scores4 ,each such methodology shall take into account the administrative burden on plans and providers and the relative importance of certain provider directory information on enrollee ability to access care4 7,c7 ,exception ,the ,secretary may waive the requirements of this paragraph in the case of a specified ,,ma plan with low enrollment 7as defined by the ,secretary74 7,d7 ,transparency ,beginning with plan years beginning on or after ,january #a1 #bjbh1 the ,secretary shall post accuracy scores 7as reported under subparagraph 7,a77ii771 in a machine readable file1 on the internet website of the ,centers for ,medicare ,medicaid ,services4 4 7,b7 ,provision of information to beneficiaries ,section #ahea7;d77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;d77#d77 is amended by adding at the end the following new subparagraph3 7,f7 ,provider ,directory ,beginning with plan years beginning on or after ,january #a1 #bjbh1 the accuracy score of the plan's provider directory 7as reported under section #aheg7;e77#f77;,a77ii77 listed prominently on the plan's provider directory4 4 7,c7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #d1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out the amendments made by this paragraph4 7#c7 ,,gao study and report 7,a7 ,analysis ,the ,comptroller ,general of the ,united ,states 7in this paragraph referred to as the ,comptroller ,general7 shall conduct a study of the implementation of the amendments made by paragraphs 7#a7 and 7#b74 ,to the extent data are available and reliable1 such study shall include an analysis of-- 7i7 the use of cost-sharing protections required under section #aheb7;d77#g77;,a7 of the ,social ,security ,act1 as added by paragraph 7#a72 7ii7 the trends in provider directory information accuracy scores under section #aheg7;e77#f77;,a77ii7 of the ,social ,security ,act 7as added by paragraph 7#b77;,a771 both overall and among providers specializing in mental health or substance use disorder treatment2 7iii7 provider response rates by plan verification methods2 7iv7 administrative costs to providers and ,medicare ,advantage organizations2 and 7v7 other items determined appropriate by the ,comptroller ,general4 7,b7 ,report ,not later than ,january #ae1 #bjcb1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under subparagraph 7,a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7c7 ,guidance on maintaining accurate provider directories 7#a7 ,stakeholder meeting 7,a7 ,in general ,not later than #c 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 hold a public meeting to receive input on approaches for maintaining accurate provider directories for ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq471 including input on approaches for reducing administrative burden1 such as data standardization1 and best practices to maintain accurate provider directory information4 7,b7 ,participants ,participants of the meeting under subparagraph 7,a7 shall include representatives from the ,centers for ,medicare ,medicaid ,services and the ,assistant ,secretary for ,technology ,policy and ,office of the ,national ,coordinator for ,health ,information ,technology4 ,such meeting shall be open to the public4 ,to the extent practicable1 the ,secretary shall include health care providers1 companies that specialize in relevant technologies1 health insurers1 and patient advocates4 7#b7 ,guidance to ,medicare ,advantage organizations ,not later than #ab months after the date of enactment of this ,act1 the ,secretary shall issue guidance to ,medicare ,advantage organizations offering ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq47 on maintaining accurate provider directories for such plans1 taking into consideration input received during the stakeholder meeting under paragraph 7#a74 ,such guidance may include the following1 as determined appropriate by the ,secretary3 7,a7 ,best practices for ,medicare ,advantage organizations on how to work with providers to maintain the accuracy of provider directories and reduce provider and ,medicare ,advantage organization burden with respect to maintaining the accuracy of provider directories4 7,b7 ,information on data sets and data sources with information that could be used by ,medicare ,advantage organizations to maintain accurate provider directories4 7,c7 ,approaches for utilizing data sources maintained by ,medicare ,advantage organizations and publicly available data sets to maintain accurate provider directories4 7,d7 ,information to be included in provider directories that may be useful for ,medicare beneficiaries to assess plan networks when selecting a plan and accessing providers participating in plan networks during the plan year4 7#c7 ,guidance to part ,b providers ,not later than #ab months after the date of enactment of this ,act1 the ,secretary shall issue guidance to providers of services and suppliers who furnish items or services for which benefits are available under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 on when to update the ,national ,plan and ,provider ,enumeration ,system for information changes4 #bbd4 ,medicare coverage of multi-cancer early detection screening tests 7a7 ,coverage ,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 the semicolon at the end of subparagraph 7,,jj7 and inserting 2 and2 and 7,b7 by adding at the end the following new subparagraph3 7,,kk7 multi-cancer early detection screening tests 7as defined in subsection 7nnn772 2 and 7#b7 by adding at the end the following new subsection3 7nnn7 ,multi-,cancer early detection screening tests 7#a7 ,in general ,the term multi-cancer early detection screening test means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after ,january #a1 #bjbi1 that-- 7,a7 is cleared under section #eaj7k71 classified under section #eac7;f77#b71 or approved under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 is-- 7i7 a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids2 or 7ii7 a test based on samples of biological material that provide results comparable to those obtained with a test described in clause 7i71 as determined by the ,secretary2 and 7,c7 the ,secretary determines is-- 7i7 reasonable and necessary for the prevention or early detection of an illness or disability2 and 7ii7 appropriate for individuals entitled to benefits under part ,a or enrolled under part ,b4 7#b7 ,,ncd process ,in making determinations under paragraph 7#a77;,c7 regarding the coverage of a new test1 the ,secretary shall use the process for making national coverage determinations 7as defined in section #ahfi7;f77#a77;,b77 under this title4 4 7b7 ,payment and standards for multi-,cancer early detection screening tests 7#a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7aa7 ,payment and standards for multi-,cancer early detection screening tests 7#a7 ,payment amount ,the payment amount for a multi-cancer early detection screening test 7as defined in section #ahfa7nnn77 is-- 7,a7 with respect to such a test furnished before ,january #a1 #bjca1 equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening ,,dna test covered pursuant to section #ahfa7pp77#a77;,d72 and 7,b7 with respect to such a test furnished on or after ,january #a1 #bjca1 equal to the lesser of-- 7i7 the amount described in subparagraph 7,a72 or 7ii7 the payment amount determined for such test under section #ahcd;,a4 7#b7 ,limitations 7,a7 ,in general ,no payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if-- 7i7 such individual-- 7,i7 is under #ej years of age2 or 7,,ii7 as of ,january #a of such year1 has attained the age specified in subparagraph 7,b7 for such year2 or 7ii7 such a test was furnished to the individual during the previous #aa months4 7,b7 ,age specified ,for purposes of subparagraph 7,a77i77,,ii71 the age specified in this subparagraph is-- 7i7 for #bjbi1 #fe years of age2 and 7ii7 for a succeeding year1 the age specified in this subparagraph for the preceding year1 increased by #a year4 7,c7 ,standards following ,,uspstf rating of ,a or ,b ,in the case of a multi-cancer early detection screening test that is recommended with a grade of ,a or ,b by the ,united ,states ,preventive ,services ,task ,force1 beginning on the date on which coverage for such test is provided pursuant to section #ahfa7;ddd77#a71 the preceding provisions of this paragraph shall not apply4 4 7#b7 ,conforming amendments 7,a7 ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7i7 in subsection 7a7-- 7,i7 in paragraph 7#a77;,d77i77,i71 by striking section #ahcd7;d77#a7 and inserting subsection 7d77#a7 or 7aa7 of section #ahcd2 and 7,,ii7 in paragraph 7#b77;,d77i77,i71 by striking section #ahcd7;d77#a7 and inserting subsection 7d77#a7 or 7aa7 of section #ahcd2 and 7ii7 in subsection 7h77#a77;,a71 by striking section #ahcd7;d77#a7 and inserting subsections 7d77#a7 and 7aa7 of section #ahcd4 7,b7 ,section #ahfb7;a77#a77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a77 is amended-- 7i7 by striking or additional preventive services and inserting 1 additional preventive services2 and 7ii7 by inserting 1 or multi-cancer early detection screening tests 7as defined in section #ahfa7nnn77 after 7as described in section #ahfa7;ddd77#a774 7c7 ,rule of construction relating to other cancer screening tests ,nothing in this section1 including the amendments made by this section1 shall be construed-- 7#a7 in the case of an individual who undergoes a multi-cancer early detection screening test1 to affect coverage under part ,b of title ,,xviii of the ,social ,security ,act for other cancer screening tests covered under such title1 such as screening tests for breast1 cervical1 colorectal1 lung1 or prostate cancer2 or 7#b7 in the case of an individual who undergoes another cancer screening test1 to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test4 #bbe4 ,medicare coverage of external infusion pumps and non-self-administrable home infusion drugs 7a7 ,in general ,section #ahfa7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7n77 is amended by adding at the end the following new sentence3 ,beginning with the first calendar quarter beginning on or after the date that is #a year after the date of the enactment of this sentence1 an external infusion pump and associated home infusion drug 7as defined in subsection 7iii77#c77;,c77 or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section #dad4bjb of title #db1 ,code of ,federal ,regulations 7or any successor to such regulation7 shall be treated as meeting such requirement if each of the following criteria is satisfied3 7#a7 ,the prescribing information approved by the ,food and ,drug ,administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional4 7#b7 ,a qualified home infusion therapy supplier 7as defined in subsection 7iii77#c77;,d77 administers or supervises the administration of the drug or biological in a safe and effective manner in the patient's home 7as defined in subsection 7iii77#c77;,b774 7#c7 ,the prescribing information described in paragraph 7#a7 instructs that the drug should be infused at least #ab times per year-- 7,a7 intravenously or subcutaneously2 or 7,b7 at infusion rates that the ,secretary determines would require the use of an external infusion pump4 4 7b7 ,cost sharing notification ,the ,secretary of ,health and ,human ,services shall ensure that patients are notified of the cost sharing for electing home infusion therapy compared to other applicable settings of care for the furnishing of infusion drugs under the ,medicare program4 #bbf4 ,assuring pharmacy access and choice for ,medicare beneficiaries 7a7 ,in general ,section #ahfj;,d-#d7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#a77 is amended by striking subparagraph 7,a7 and inserting the following3 7,a7 ,in general 7i7 ,participation of any willing pharmacy ,a ,,pdp sponsor offering a prescription drug plan shall permit any pharmacy that meets the standard contract terms and conditions under such plan to participate as a network pharmacy of such plan4 7ii7 ,contract terms and conditions 7,i7 ,in general ,notwithstanding any other provision of law1 for plan years beginning on or after ,january #a1 #bjbh1 in accordance with clause 7i71 contract terms and conditions offered by such ,,pdp sponsor shall be reasonable and relevant according to standards established by the ,secretary under subclause 7,,ii74 7,,ii7 ,standards ,not later than the first ,monday in ,april of #bjbg1 the ,secretary shall establish standards for reasonable and relevant contract terms and conditions for purposes of this clause4 7,,iii7 ,request for information ,not later than ,april #a1 #bjbf1 for purposes of establishing the standards under subclause 7,,ii71 the ,secretary shall issue a request for information to seek input on trends in prescription drug plan and network pharmacy contract terms and conditions1 current prescription drug plan and network pharmacy contracting practices1 whether pharmacy reimbursement and dispensing fees paid by ,,pdp sponsors to network pharmacies sufficiently cover the ingredient and operational costs of such pharmacies1 the use and application of pharmacy quality measures by ,,pdp sponsors for network pharmacies1 ,,pdp sponsor restrictions or limitations on the dispensing of covered part ,d drugs by network pharmacies 7or any subsets of such pharmacies71 ,,pdp sponsor auditing practices for network pharmacies1 areas in current regulations or program guidance related to contracting between prescription drug plans and network pharmacies requiring clarification or additional specificity1 factors for consideration in determining the reasonableness and relevance of contract terms and conditions between prescription drug plans and network pharmacies1 and other issues as determined appropriate by the ,secretary4 4 7b7 ,essential retail pharmacies ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is amended by adding at the end the following new subsection3 7e7 ,essential retail pharmacies 7#a7 ,in general ,with respect to plan years beginning on or after ,january #a1 #bjbh1 the ,secretary shall publish reports1 at least once every #b years until #bjcd1 and periodically thereafter1 that provide information1 to the extent feasible1 on-- 7,a7 trends in ingredient cost reimbursement1 dispensing fees1 incentive payments and other fees paid by ,,pdp sponsors offering prescription drug plans and ,,ma organizations offering ,,ma-,,pd plans under this part to essential retail pharmacies 7as defined in paragraph 7#b77 with respect to the dispensing of covered part ,d drugs1 including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies2 7,b7 trends in amounts paid to ,,pdp sponsors offering prescription drug plans and ,,ma organizations offering ,,ma-,,pd plans under this part by essential retail pharmacies with respect to the dispensing of covered part ,d drugs1 including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies2 7,c7 trends in essential retail pharmacy participation in pharmacy networks and preferred pharmacy networks for prescription drug plans offered by ,,pdp sponsors and ,,ma-,,pd plans offered by ,,ma organizations under this part1 including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies2 7,d7 trends in the number of essential retail pharmacies1 including variation in such trends by geographic region or other factors2 7,e7 a comparison of cost-sharing for covered part ,d drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by ,,pdp sponsors and ,,ma-,,pd plans offered by ,,ma organizations under this part and cost-sharing for covered part ,d drugs dispensed by other network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies2 7,f7 a comparison of the volume of covered part ,d drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by ,,pdp sponsors and ,,ma-,,pd plans offered by ,,ma organizations under this part and such volume of dispensing by network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies1 including information on any patterns or trends in such comparison specific to certain types of covered part ,d drugs1 such as generic drugs or drugs specified as specialty drugs by a ,,pdp sponsor under a prescription drug plan or an ,,ma organization under an ,,ma-,,pd plan2 and 7,g7 a comparison of the information described in subparagraphs 7,a7 through 7,f7 between essential retail pharmacies that are network pharmacies for prescription drug plans offered by ,,pdp sponsors under this part and essential retail pharmacies that are network pharmacies for ,,ma-,,pd plans offered by ,,ma organizations under this part4 7#b7 ,definition of essential retail pharmacy ,in this subsection1 the term essential retail pharmacy means1 with respect to a plan year1 a retail pharmacy that-- 7,a7 is not a pharmacy that is an affiliate as defined in paragraph 7#d72 and 7,b7 is located in-- 7i7 a medically underserved area 7as designated pursuant to section #ccj7;b77#c77;,a7 of the ,public ,health ,service ,act72 7ii7 a rural area in which there is no other retail pharmacy within #aj miles1 as determined by the ,secretary2 7iii7 a suburban area in which there is no other retail pharmacy within #b miles1 as determined by the ,secretary2 or 7iv7 an urban area in which there is no other retail pharmacy within #a mile1 as determined by the ,secretary4 7#c7 ,list of essential retail pharmacies 7,a7 ,publication of list of essential retail pharmacies ,for each plan year 7beginning with plan year #bjbh71 the ,secretary shall publish1 on a publicly available internet website of the ,centers for ,medicare ,medicaid ,services1 a list of pharmacies that meet the criteria described in subparagraphs 7,a7 and 7,b7 of paragraph 7#b7 to be considered an essential retail pharmacy4 7,b7 ,required submissions from pdp sponsors ,for each plan year 7beginning with plan year #bjbh71 each ,,pdp sponsor offering a prescription drug plan and each ,,ma organization offering an ,,ma-,,pd plan shall submit to the ,secretary1 for the purposes of determining retail pharmacies that meet the criterion specified in subparagraph 7,a7 of paragraph 7#b71 a list of retail pharmacies that are affiliates of such sponsor or organization1 or are affiliates of a pharmacy benefit manager acting on behalf of such sponsor or organization1 at a time1 and in a form and manner1 specified by the ,secretary4 7,c7 ,reporting by pdp sponsors and ma organizations ,for each plan year beginning with plan year #bjbg1 each ,,pdp sponsor offering a prescription drug plan and each ,,ma organization offering an ,,ma-,,pd plan under this part shall submit to the ,secretary information on incentive payments and other fees paid by such sponsor or organization to pharmacies1 insofar as any such payments or fees are not otherwise reported1 at a time1 and in a form and manner1 specified by the ,secretary4 7,d7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 7,e7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the implementation of this paragraph4 7#d7 ,definition of affiliate2 pharmacy benefit manager ,in this subsection1 the terms affiliate and pharmacy benefit manager have the meaning given those terms in section #ahfj;,d-#ab7;h77#g74 4 7c7 ,enforcement 7#a7 ,in general ,section #ahfj;,d-#d7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#a77 is amended by adding at the end the following new subparagraph3 7,f7 ,enforcement of standards for reasonable and relevant contract terms and conditions 7i7 ,allegation submission process 7,i7 ,in general ,not later than ,january #a1 #bjbh1 the ,secretary shall establish a process through which a pharmacy may submit to the ,secretary an allegation of a violation by a ,,pdp sponsor offering a prescription drug plan of the standards for reasonable and relevant contract terms and conditions under subparagraph 7,a77ii71 or of subclause 7,,viii7 of this clause4 7,,ii7 ,frequency of submission 7aa7 ,in general ,except as provided in item 7bb71 the allegation submission process under this clause shall allow pharmacies to submit any allegations of violations described in subclause 7,i7 not more frequently than once per plan year per contract between a pharmacy and a ,,pdp sponsor4 7bb7 ,allegations relating to contract modifications ,in the case where a contract between a pharmacy and a ,,pdp sponsor is modified following the submission of allegations by a pharmacy with respect to such contract and plan year1 the allegation submission process under this clause shall allow such pharmacy to submit an additional allegation related to those modifications with respect to such contract and plan year4 7,,iii7 ,access to relevant documents and materials ,a ,,pdp sponsor subject to an allegation under this clause-- 7aa7 shall provide documents or materials1 as specified by the ,secretary1 including contract offers made by such sponsor to such pharmacy or correspondence related to such offers1 to the ,secretary at a time1 and in a form and manner1 specified by the ,secretary2 and 7bb7 shall not prohibit or otherwise limit the ability of a pharmacy to submit such documents or materials to the ,secretary for the purpose of submitting an allegation or providing evidence for such an allegation under this clause4 7,,iv7 ,standardized template ,the ,secretary shall establish a standardized template for pharmacies to use for the submission of allegations described in subclause 7,i74 ,such template shall require that the submission include a certification by the pharmacy that the information included is accurate1 complete1 and true to the best of the knowledge1 information1 and belief of such pharmacy4 7,v7 ,preventing frivolous allegations ,in the case where the ,secretary determines that a pharmacy has submitted frivolous allegations under this clause on a routine basis1 the ,secretary may temporarily prohibit such pharmacy from using the allegation submission process under this clause1 as determined appropriate by the ,secretary4 7,,vi7 ,exemption from freedom of information act ,allegations submitted under this clause shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code4 7,,vii7 ,rule of construction ,nothing in this clause shall be construed as limiting the ability of a pharmacy to pursue other legal actions or remedies1 consistent with applicable ,federal or ,state law1 with respect to a potential violation of a requirement described in this subparagraph4 7,,viii7 ,anti-retaliation and anti-coercion ,consistent with applicable ,federal or ,state law1 a ,,pdp sponsor shall not-- 7aa7 retaliate against a pharmacy for submitting any allegations under this clause2 or 7bb7 coerce1 intimidate1 threaten1 or interfere with the ability of a pharmacy to submit any such allegations4 7ii7 ,investigation ,the ,secretary shall investigate1 as determined appropriate by the ,secretary1 allegations submitted pursuant to clause 7i74 7iii7 ,enforcement 7,i7 ,in general ,in the case where the ,secretary determines that a ,,pdp sponsor offering a prescription drug plan has violated the standards for reasonable and relevant contract terms and conditions under subparagraph 7,a77ii71 the ,secretary may use authorities under sections #aheg7;g7 and #ahfj;,d-#ab7;b77#c77;,e7 to impose civil monetary penalties or other intermediate sanctions4 7,,ii7 ,application of civil monetary penalties ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 4 7#b7 ,conforming amendment ,section #aheg7;g77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77 is amended-- 7,a7 in subparagraph 7,j71 by striking or after the semicolon2 7,b7 by redesignating subparagraph 7,k7 as subparagraph 7,l72 7,c7 by inserting after subparagraph 7,j71 the following new subparagraph3 7,k7 fails to comply with the standards for reasonable and relevant contract terms and conditions under subparagraph 7,a77ii7 of section #ahfj;,d-#d7;b77#a72 or 2 7,d7 in subparagraph 7,l71 as redesignated by subparagraph 7,b71 by striking through 7,j7 and inserting through 7,k72 and 7,e7 in the flush matter following subparagraph 7,l71 as so redesignated1 by striking subparagraphs 7,a7 through 7,k7 and inserting subparagraphs 7,a7 through 7,l74 7d7 ,accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms and conditions 7#a7 ,in general ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is amended by adding at the end the following new paragraph3 7#i7 ,accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms and conditions ,for plan years beginning on or after ,january #a1 #bjbh1 each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the ,,pdp sponsor under which the pharmacy benefit manager agrees to reimburse the ,,pdp sponsor for any amounts paid by such sponsor under section #ahfj;,d-#d7;b77#a77;,f77iii77,i7 to the ,secretary as a result of a violation described in such section if such violation is related to a responsibility delegated to the pharmacy benefit manager by such ,,pdp sponsor4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is amended by adding at the end the following new subparagraph3 7,f7 ,accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms ,for plan years beginning on or after ,january #a1 #bjbh1 section #ahfj;,d-#ab7;b77#i74 4 7e7 ,biennial report on enforcement and oversight of pharmacy access requirements ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by subsection 7b71 is amended by adding at the end the following new subsection3 7f7 ,biennial report on enforcement and oversight of pharmacy access requirements 7#a7 ,in general ,not later than #b years after the date of enactment of this subsection1 and at least once every #b years thereafter1 the ,secretary shall publish a report on enforcement and oversight actions and activities undertaken by the ,secretary with respect to the requirements under section #ahfj;,d-#d7;b77#a74 7#b7 ,limitation ,a report under paragraph 7#a7 shall not disclose-- 7,a7 identifiable information about individuals or entities unless such information is otherwise publicly available2 or 7,b7 trade secrets with respect to any entities4 4 7f7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #ahh1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this section4 #bbg4 ,modernizing and ,ensuring ,,pbm ,accountability 7a7 ,in general 7#a7 ,prescription drug plans ,section #ahfj;,d-#ab of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is amended by adding at the end the following new subsection3 7h7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbh3 7#a7 ,agreements with pharmacy benefit managers ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the ,,pdp sponsor under which the pharmacy benefit manager1 and any affiliates of such pharmacy benefit manager1 as applicable1 agree to meet the following requirements3 7,a7 ,no income other than bona fide service fees 7i7 ,in general ,the pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual1 in connection with the utilization of covered part ,d drugs1 from any such entity or individual other than bona fide service fees1 subject to clauses 7ii7 and 7iii74 7ii7 ,incentive payments ,for the purposes of this subsection1 an incentive payment 7as determined by the ,secretary7 paid by a ,,pdp sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee 7even if such payment does not otherwise meet the definition of such term under paragraph 7#g77;,b77 if such payment is a flat dollar amount1 is consistent with fair market value 7as specified by the ,secretary71 is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager1 on behalf of the ,,pdp sponsor making such payment1 in connection with the utilization of covered part ,d drugs1 and meets additional requirements1 if any1 as determined appropriate by the ,secretary4 7iii7 ,clarification on rebates and discounts used to lower costs for covered part d drugs ,rebates1 discounts1 and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers1 even if such price concessions are calculated as a percentage of a drug's price1 shall not be considered a violation of the requirements of clause 7i7 if they are fully passed through to a ,,pdp sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part1 including in cases where a ,,pdp sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such ,,pdp sponsor4 7iv7 ,evaluation of remuneration arrangements ,components of subsets of remuneration arrangements 7such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager71 as determined appropriate by the ,secretary1 between pharmacy benefit managers or affiliates of such pharmacy benefit managers1 as applicable1 and other entities involved in the dispensing or utilization of covered part ,d drugs 7including ,,pdp sponsors1 manufacturers1 pharmacies1 and other entities as determined appropriate by the ,secretary7 shall be subject to review by the ,secretary1 in consultation with the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 as determined appropriate by the ,secretary4 ,the ,secretary1 in consultation with the ,office of the ,inspector ,general1 shall review whether remuneration under such arrangements is consistent with fair market value 7as specified by the ,secretary7 through reviews and assessments of such remuneration1 as determined appropriate4 7v7 ,disgorgement ,the pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the ,,pdp sponsor4 7vi7 ,additional requirements ,the pharmacy benefit manager shall-- 7,i7 enter into a written agreement with any affiliate of such pharmacy benefit manager1 under which the affiliate shall identify and disgorge any remuneration described in clause 7v7 to the pharmacy benefit manager2 and 7,,ii7 attest1 subject to any requirements determined appropriate by the ,secretary1 that the pharmacy benefit manager has entered into a written agreement described in subclause 7,i7 with any relevant affiliate of the pharmacy benefit manager4 7,b7 ,transparency regarding guarantees and cost performance evaluations ,the pharmacy benefit manager shall-- 7i7 define1 interpret1 and apply1 in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates1 discounts1 price concessions1 or net costs1 terms such as-- 7,i7 generic drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,ii7 brand name drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,iii7 specialty drug2 7,,iv7 rebate2 and 7,v7 discount2 7ii7 identify any drugs1 claims1 or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner2 and 7iii7 where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 of a drug1 calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure4 7,c7 ,provision of information 7i7 ,in general ,not later than ,july #a of each year1 beginning in #bjbh1 the pharmacy benefit manager shall submit to the ,,pdp sponsor1 and to the ,secretary1 a report1 in accordance with this subparagraph1 and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the ,secretary under paragraph 7#e74 ,each such report shall include1 with respect to such ,,pdp sponsor and each plan offered by such sponsor1 the following information with respect to the previous plan year3 7,i7 ,a list of all drugs covered by the plan that were dispensed including1 with respect to each such drug-- 7aa7 the brand name1 generic or non-proprietary name1 and ,national ,drug ,code2 7bb7 the number of plan enrollees for whom the drug was dispensed1 the total number of prescription claims for the drug 7including original prescriptions and refills1 counted as separate claims71 and the total number of dosage units of the drug dispensed2 7cc7 the number of prescription claims described in item 7bb7 by each type of dispensing channel through which the drug was dispensed1 including retail1 mail order1 specialty pharmacy1 long term care pharmacy1 home infusion pharmacy1 or other types of pharmacies or providers2 7dd7 the average wholesale acquisition cost1 listed as cost per day's supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7ee7 the average wholesale price for the drug1 listed as price per day's supply1 price per dosage unit1 and price per typical course of treatment 7as applicable72 7ff7 the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan1 including plan enrollee spending through copayments1 coinsurance1 and deductibles2 7gg7 total rebates paid by the manufacturer on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7hh7 all other direct or indirect remuneration on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7ii7 the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item 7cc72 7jj7 the average ,national ,average ,drug ,acquisition ,cost 7,,nadac72 and 7kk7 total manufacturer-derived revenue1 inclusive of bona fide service fees1 attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager4 7,,ii7 ,in the case of a pharmacy benefit manager that has an affiliate that is a retail1 mail order1 or specialty pharmacy1 with respect to drugs covered by such plan that were dispensed1 the following information3 7aa7 ,the percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug4 7bb7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7cc7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7dd7 ,the lowest total combined cost paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for each drug that is available from any pharmacy included in the pharmacy network of such plan4 7ee7 ,the difference between the average acquisition cost of the affiliate1 such as a pharmacy or other entity that acquires prescription drugs1 that initially acquires the drug and the amount reported under subclause 7,i77jj7 for each drug4 7ff7 ,a list inclusive of the brand name1 generic or non-proprietary name1 and ,national ,drug ,code of covered part ,d drugs subject to an agreement with a covered entity under section #cdj;,b of the ,public ,health ,service ,act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan4 7,,iii7 ,where a drug approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7referred to in this subclause as the listed drug7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug1 or are subject to utilization management that the listed drug is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the listed drug4 7cc7 ,where a generic drug listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the listed drug1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the generic drugs described in item 7aa71 had the plan provided coverage for such drugs on the same formulary tier as the listed drug4 7dd7 ,a written justification for providing more favorable coverage of the listed drug than the generic drugs described in item 7aa74 7ee7 ,the number of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug4 7,,iv7 ,where a reference product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act pursuant to an application that refers to such reference product that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product1 or are subject to utilization management that the reference product is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the reference product4 7cc7 ,where a biosimilar biological product listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the reference product1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the biosimilar biological products described in item 7aa71 had the plan provided coverage for such products on the same formulary tier as the reference product4 7dd7 ,a written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item 7aa74 7ee7 ,the number of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act1 pursuant to an application that refers to such reference product4 7,v7 ,total gross spending on covered part ,d drugs by the plan1 not net of rebates1 fees1 discounts1 or other direct or indirect remuneration4 7,,vi7 ,the total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part ,d drugs under that plan1 inclusive of bona fide service fees4 7,,vii7 ,the total spending on covered part ,d drugs net of rebates1 fees1 discounts1 or other direct and indirect remuneration by the plan4 7,,viii7 ,an explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager1 such as mail and specialty home delivery programs1 and retail and mail auto-refill programs4 7,,ix7 ,the following information3 7aa7 ,a list of all brokers1 consultants1 advisors1 and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals1 consulting1 auditing1 or other services offered to ,,pdp sponsors related to pharmacy benefit management services4 7bb7 ,the amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker1 consultant1 advisor1 and auditor4 7cc7 ,the methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate1 for each such broker1 consultant1 advisor1 and auditor4 7,x7 ,a list of all affiliates of the pharmacy benefit manager4 7,,xi7 ,a summary document submitted in a standardized template developed by the ,secretary that includes such information described in subclauses 7,i7 through 7,x74 7ii7 ,written explanation of contracts or agreements with drug manufacturers 7,i7 ,in general ,the pharmacy benefit manager shall1 not later than #cj days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer 7or subsidiary1 agent1 or entity affiliated with such drug manufacturer7 that makes rebates1 discounts1 payments1 or other financial incentives related to one or more covered part ,d drugs or other prescription drugs1 as applicable1 of the manufacturer directly or indirectly contingent upon coverage1 formulary placement1 or utilization management conditions on any other covered part ,d drugs or other prescription drugs1 as applicable1 submit to the ,,pdp sponsor a written explanation of such contract or agreement4 7,,ii7 ,requirements ,a written explanation under subclause 7,i7 shall-- 7aa7 include the manufacturer subject to the contract or agreement1 all covered part ,d drugs and other prescription drugs1 as applicable1 subject to the contract or agreement and the manufacturers of such drugs1 and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs2 and 7bb7 be certified by the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or ,general ,counsel of such pharmacy benefit manager1 or affiliate of such pharmacy benefit manager1 as applicable1 or an individual delegated with the authority to sign on behalf of one of these officers1 who reports directly to the officer4 7,,iii7 ,definition of other prescription drugs ,for purposes of this clause1 the term other prescription drugs means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part4 7,d7 ,audit rights 7i7 ,in general ,not less than once a year1 at the request of the ,,pdp sponsor1 the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph 7,c74 7ii7 ,auditor ,the ,,pdp sponsor shall have the right to select an auditor4 ,the pharmacy benefit manager shall not impose any limitations on the selection of such auditor4 7iii7 ,provision of information ,the pharmacy benefit manager shall make available to such auditor all records1 data1 contracts1 and other information necessary to confirm the accuracy of information provided under subparagraph 7,c71 subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information4 7iv7 ,timing ,the pharmacy benefit manager must provide information under clause 7iii7 and other information1 data1 and records relevant to the audit to such auditor within #f months of the initiation of the audit and respond to requests for additional information from such auditor within #cj days after the request for additional information4 7v7 ,information from affiliates ,the pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph 7,c7 or under clause 7iii7 of this subparagraph that is owned or held by an affiliate of such pharmacy benefit manager4 7#b7 ,enforcement 7,a7 ,in general ,each ,,pdp sponsor shall-- 7i7 disgorge to the ,secretary any amounts disgorged to the ,,pdp sponsor by a pharmacy benefit manager under paragraph 7#a77;,a77v72 7ii7 require1 in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager1 that such pharmacy benefit manager or affiliate reimburse the ,,pdp sponsor for any civil money penalty imposed on the ,,pdp sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph 7#a7 that are applicable to the pharmacy benefit manager or affiliate under the agreement2 and 7iii7 require1 in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager1 that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph 7#a74 7,b7 ,reporting of alleged violations ,the ,secretary shall make available and maintain a mechanism for manufacturers1 ,,pdp sponsors1 pharmacies1 and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report1 on a confidential basis1 alleged violations of paragraph 7#a77;,a7 or subparagraph 7,c74 7,c7 ,anti-retaliation and anti-coercion ,consistent with applicable ,federal or ,state law1 a ,,pdp sponsor shall not-- 7i7 retaliate against an individual or entity for reporting an alleged violation under subparagraph 7,b72 or 7ii7 coerce1 intimidate1 threaten1 or interfere with the ability of an individual or entity to report any such alleged violations4 7#c7 ,certification of compliance 7,a7 ,in general ,each ,,pdp sponsor shall furnish to the ,secretary 7at a time and in a manner specified by the ,secretary7 an annual certification of compliance with this subsection1 as well as such information as the ,secretary determines necessary to carry out this subsection4 7,b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 7#d7 ,rule of construction ,nothing in this subsection shall be construed as-- 7,a7 prohibiting flat dispensing fees or reimbursement or payment for ingredient costs 7including customary1 industry-standard discounts directly related to drug acquisition that are retained by pharmacies or wholesalers7 to entities that acquire or dispense prescription drugs2 or 7,b7 modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment1 reimbursement1 or dispensing fees4 7#e7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbg1 the ,secretary shall specify standard1 machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph 7#a77;,c77i74 7,b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 7#f7 ,confidentiality 7,a7 ,in general ,information disclosed by a pharmacy benefit manager1 an affiliate of a pharmacy benefit manager1 a ,,pdp sponsor1 or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the ,secretary or a ,,pdp sponsor receiving the information1 except that the ,secretary may disclose the information for the following purposes3 7i7 ,as the ,secretary determines necessary to carry out this part4 7ii7 ,to permit the ,comptroller ,general to review the information provided4 7iii7 ,to permit the ,director of the ,congressional ,budget ,office to review the information provided4 7iv7 ,to permit the ,executive ,director of the ,medicare ,payment ,advisory ,commission to review the information provided4 7v7 ,to the ,attorney ,general for the purposes of conducting oversight and enforcement under this title4 7vi7 ,to the ,inspector ,general of the ,department of ,health and ,human ,services in accordance with its authorities under the ,inspector ,general ,act of #aigh 7section #djf of title #e1 ,united ,states ,code71 and other applicable statutes4 7,b7 ,restriction on use of information ,the ,secretary1 the ,comptroller ,general1 the ,director of the ,congressional ,budget ,office1 and the ,executive ,director of the ,medicare ,payment ,advisory ,commission shall not report on or disclose information disclosed pursuant to subparagraph 7,a7 to the public in a manner that would identify-- 7i7 a specific pharmacy benefit manager1 affiliate1 pharmacy1 manufacturer1 wholesaler1 ,,pdp sponsor1 or plan2 or 7ii7 contract prices1 rebates1 discounts1 or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs4 7#g7 ,definitions ,for purposes of this subsection3 7,a7 ,affiliate ,the term affiliate means1 with respect to any pharmacy benefit manager or ,,pdp sponsor1 any entity that1 directly or indirectly-- 7i7 owns or is owned by1 controls or is controlled by1 or is otherwise related in any ownership structure to such pharmacy benefit manager or ,,pdp sponsor2 or 7ii7 acts as a contractor1 principal1 or agent to such pharmacy benefit manager or ,,pdp sponsor1 insofar as such contractor1 principal1 or agent performs any of the functions described under subparagraph 7,c74 7,b7 ,bona fide service fee ,the term bona fide service fee means a fee that is reflective of the fair market value 7as specified by the ,secretary1 through notice and comment rulemaking7 for a bona fide1 itemized service actually performed on behalf of an entity1 that the entity would otherwise perform 7or contract for7 in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer1 whether or not the entity takes title to the drug4 ,such fee must be a flat dollar amount and shall not be directly or indirectly based on1 or contingent upon-- 7i7 drug price1 such as wholesale acquisition cost or drug benchmark price 7such as average wholesale price72 7ii7 the amount of discounts1 rebates1 fees1 or other direct or indirect remuneration with respect to covered part ,d drugs dispensed to enrollees in a prescription drug plan1 except as permitted pursuant to paragraph 7#a77;,a77ii72 7iii7 coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement2 or 7iv7 any other amounts or methodologies prohibited by the ,secretary4 7,c7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,,pdp sponsor or prescription drug plan1 or manages the prescription drug benefits provided by such sponsor or plan1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the adjudication of appeals or grievances related to the prescription drug benefit1 contracting with network pharmacies1 controlling the cost of covered part ,d drugs1 or the provision of related services4 ,such term includes any person or entity that carries out one or more of the activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c771 as amended by section #bbf7;d77#b71 is amended by adding at the end the following new subparagraph3 7,g7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbh1 section #ahfj;,d-#ab7;h74 4 7#c7 ,nonapplication of ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the implementation of this subsection4 7#d7 ,funding 7,a7 ,secretary ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #aac1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this subsection4 7,b7 ,,oig ,in addition to amounts otherwise available1 there is appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services1 out of any money in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this subsection4 7b7 ,,gao ,study and ,report on ,price-,related ,compensation ,across the ,supply ,chain 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall conduct a study describing the use of compensation and payment structures related to a prescription drug's price within the retail prescription drug supply chain in part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 ,such study shall summarize information from ,federal agencies and industry experts1 to the extent available1 with respect to the following3 7,a7 ,the type1 magnitude1 other features 7such as the pricing benchmarks used71 and prevalence of compensation and payment structures related to a prescription drug's price1 such as calculating fee amounts as a percentage of a prescription drug's price1 between intermediaries in the prescription drug supply chain1 including-- 7i7 pharmacy benefit managers2 7ii7 ,,pdp sponsors offering prescription drug plans and ,medicare ,advantage organizations offering ,,ma-,,pd plans2 7iii7 drug wholesalers2 7iv7 pharmacies2 7v7 manufacturers2 7vi7 pharmacy services administrative organizations2 7vii7 brokers1 auditors1 consultants1 and other entities that-- 7,i7 advise ,,pdp sponsors offering prescription drug plans and ,medicare ,advantage organizations offering ,,ma-,,pd plans regarding pharmacy benefits2 or 7,,ii7 review ,,pdp sponsor and ,medicare ,advantage organization contracts with pharmacy benefit managers2 and 7viii7 other service providers that contract with any of the entities described in clauses 7i7 through 7vii7 that may use price-related compensation and payment structures1 such as rebate aggregators 7or other entities that negotiate or process price concessions on behalf of pharmacy benefit managers1 plan sponsors1 or pharmacies74 7,b7 ,the primary business models and compensation structures for each category of intermediary described in subparagraph 7,a74 7,c7 ,variation in price-related compensation structures between affiliated entities 7such as entities with common ownership1 either full or partial1 and subsidiary relationships7 and unaffiliated entities4 7,d7 ,potential conflicts of interest among contracting entities related to the use of prescription drug price-related compensation structures1 such as the potential for fees or other payments set as a percentage of a prescription drug's price to advantage formulary selection1 distribution1 or purchasing of prescription drugs with higher prices4 7,e7 ,notable differences1 if any1 in the use and level of price-based compensation structures over time and between different market segments1 such as under part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 and the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq474 7,f7 ,the effects of drug price-related compensation structures and alternative compensation structures on ,federal health care programs and program beneficiaries1 including with respect to cost-sharing1 premiums1 ,federal outlays1 biosimilar and generic drug adoption and utilization1 drug shortage risks1 and the potential for fees set as a percentage of a drug's price to advantage the formulary selection1 distribution1 or purchasing of drugs with higher prices4 7,g7 ,other issues determined to be relevant and appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than #b years after the date of enactment of this section1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7c7 ,med,p,a,c reports on agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans 7#a7 ,in general ,the ,medicare ,payment ,advisory ,commission shall submit to ,congress the following reports3 7,a7 ,initial report ,not later than the first ,march #ae occurring after the date that is #b years after the date on which the ,secretary makes the data available to the ,commission1 a report regarding agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans4 ,such report shall include1 to the extent practicable-- 7i7 a description of trends and patterns1 including relevant averages1 totals1 and other figures for the types of information submitted2 7ii7 an analysis of any differences in agreements and their effects on plan enrollee out-of-pocket spending and average pharmacy reimbursement1 and other impacts2 and 7iii7 any recommendations the ,commission determines appropriate4 7,b7 ,final report ,not later than #b years after the date on which the ,commission submits the initial report under subparagraph 7,a71 a report describing any changes with respect to the information described in subparagraph 7,a7 over time1 together with any recommendations the ,commission determines appropriate4 7#b7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,medicare ,payment ,advisory ,commission1 out of any money in the ,treasury not otherwise appropriated1 #a1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this subsection4 #bbh4 ,requiring a separate identification number and an attestation for each off-campus outpatient department of a provider 7a7 ,in general ,section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is amended by adding at the end the following new paragraph3 7#bc7 ,use of unique health identifiers2 attestation 7,a7 ,in general ,no payment may be made under this subsection 7or under an applicable payment system pursuant to paragraph 7#ba77 for items and services furnished on or after ,january #a1 #bjbf1 by an off-campus outpatient department of a provider 7as defined in subparagraph 7,c77 unless-- 7i7 such department has obtained1 and such items and services are billed under1 a standard unique health identifier for health care providers 7as described in section #aagc7;b77 that is separate from such identifier for such provider2 7ii7 such provider has submitted to the ,secretary1 during the #b-year period ending on the date such items and services are so furnished1 an initial provider-based status attestation that such department is compliant with the requirements described in section #dac4fe of title #db1 ,code of ,federal ,regulations 7or a successor regulation72 and 7iii7 after such provider has submitted an attestation under clause 7ii71 such provider has submitted a subsequent attestation within the timeframe specified by the ,secretary4 7,b7 ,process for submission and review ,not later than #a year after the date of enactment of this paragraph1 the ,secretary shall1 through notice and comment rulemaking1 establish a process for each provider with an off-campus outpatient department of a provider to submit an initial and subsequent attestation pursuant to clauses 7ii7 and 7iii71 respectively1 of subparagraph 7,a71 and for the ,secretary to review each such attestation and determine1 through site visits1 remote audits1 or other means 7as determined appropriate by the ,secretary71 whether such department is compliant with the requirements described in such subparagraph4 7,c7 ,off-campus outpatient department of a provider defined ,for purposes of this paragraph1 the term off-campus outpatient department of a provider means a department of a provider 7as defined in section #dac4fe of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 that is not located-- 7i7 on the campus 7as defined in such section7 of such provider2 or 7ii7 within the distance 7described in such definition of campus7 from a remote location of a hospital facility 7as defined in such section74 4 7b7 ,,hhs ,,oig analysis ,not later than ,january #a1 #bjcj1 the ,inspector ,general of the ,department of ,health and ,human ,services shall submit to ,congress-- 7#a7 an analysis of the process established by the ,secretary of ,health and ,human ,services to conduct the reviews and determinations described in section #ahcc7t77#bc77;,b7 of the ,social ,security ,act1 as added by subsection 7a7 of this section2 and 7#b7 recommendations based on such analysis1 as the ,inspector ,general determines appropriate4 #bbi4 ,medicare sequestration ,section #bea;,a7#f7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ija;a7#f77 is amended-- 7#a7 in subparagraph 7,d71 by striking such that1 and all that follows and inserting such that the payment reduction shall be #b4j percent42 and 7#b7 by adding at the end the following3 7,f7 ,on the date on which the ,president submits the budget under section #aaje of title #ca1 ,united ,states ,code1 for fiscal year #bjcc1 the ,president shall order a sequestration of payments for the ,medicare programs specified in section #bef7;d71 effective upon issuance1 such that1 notwithstanding the #b percent limit specified in subparagraph 7,a7 for such payments-- 7i7 with respect to the first #b months in which such order is effective for such fiscal year1 the payment reduction shall be #b4j percent2 and 7ii7 with respect to the last #aj months in which such order is effective for such fiscal year1 the payment reduction shall be #j percent4 4 #bcj4 ,medicare improvement fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is amended by striking #a1bea1jjj1jjj and inserting #a1ich1jjj1jjj4 ,,iii ,human ,services #cja4 ,sexual risk avoidance education extension ,section #eaj of the ,social ,security ,act 7#db ,u4,s4,c4 #gaj7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by striking and for the period and inserting for the period2 7ii7 by inserting for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and for the period beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe1 before allot to each ,state2 and 7iii7 by striking for fiscal year #bjbd or #bjbe and inserting for fiscal year #bjbd1 #bjbe1 or #bjbf2 and 7,b7 in paragraph 7#b71 by striking or #bjbe each place it appears and inserting 1 #bjbe1 or #bjbf2 and 7#b7 in subsection 7f77#a71 by striking and for the period beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbd and inserting for the period beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe1 and for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbd1 and for the period beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbe #cjb4 ,personal responsibility education extension ,section #eac of the ,social ,security ,act 7#db ,u4,s4,c4 #gac7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i7-- 7i7 by striking and for the period and inserting for the period2 and 7ii7 by inserting for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and for the period beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe1 before the ,secretary shall allot2 and 7,b7 in subparagraph 7,b77i7-- 7i7 by striking and for the period and inserting for the period2 and 7ii7 by inserting 1 for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and for the period beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe before the period2 7#b7 in subsection 7c77#c71 by striking fiscal year #bjbd or #bjbe and inserting fiscal year #bjbd1 #bjbe1 or #bjbf2 and 7#c7 in subsection 7f71 by striking and for the period beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbd and inserting for the period beginning on ,october #a1 #bjbd1 and ending on ,march #ca1 #bjbe1 and for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbd1 and for the period beginning on ,october #a1 #bjbe1 and ending on ,december #ca1 #bjbe1 an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year #bjbe4 #cjc4 ,extension of funding for family-to-family health information centers ,section #eja7;c77#a77;,a77viii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #gja7;c77#a77;,a77viii77 is amended-- 7#a7 by striking #c1jjj1jjj and inserting #g1ejj1jjj2 and 7#b7 by striking for the portion of fiscal year #bjbe before ,april #a1 #bjbe and inserting for the period beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbe4 ,,iv ,public health extenders ,a ,extensions #dja4 ,extension for community health centers1 ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs 7a7 ,extension for community health centers ,section #ajejc7;b77#a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77 is amended-- 7#a7 in subparagraph 7,h71 by striking and at the end2 7#b7 in subparagraph 7,i71 by striking the period and inserting 1 and #b1cae1cdb1dff for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe2 and2 and 7#c7 by adding at the end the following3 7,j7 #d1fjj1jjj1jjj for fiscal year #bjbf2 and 4 7b7 ,extension for the ,national ,health ,service ,corps ,section #ajejc7;b77#b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77 is amended-- 7#a7 in subparagraph 7,i71 by striking and at the end2 7#b7 in subparagraph 7,j71 by striking the period and inserting 1 and #agf1gab1cbi for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe2 and2 and 7#c7 by adding at the end the following3 7,j7 #cej1jjj1jjj for fiscal year #bjbf4 4 7c7 ,teaching health centers that operate graduate medical education programs ,section #cdj;,h7g77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is amended-- 7#a7 in subparagraph 7,d71 by striking 2 and and inserting a semicolon2 7#b7 in subparagraph 7,e71 by striking the period and inserting a semicolon2 and 7#c7 by adding at the end the following3 7,f7 #aab1hdi1cae for the period beginning on ,january #a1 #bjbe1 and ending on ,september #cj1 #bjbe2 7,g7 #bbe1jjj1jjj for fiscal year #bjbf2 7,h7 #bej1jjj1jjj for fiscal year #bjbg2 7,i7 #bge1jjj1jjj for fiscal year #bjbh2 and 7,j7 #cjj1jjj1jjj for fiscal year #bjbi4 4 7d7 ,application of provisions ,amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in ,public ,law #aah-dg for funds for programs authorized under sections #ccj through #cdj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b et seq474 7e7 ,conforming amendments ,section #cjad7;h77#d7 of title #ah1 ,united ,states ,code1 is amended by striking and section #caja7;d7 of the ,health ,extensions and ,other ,matters ,act1 #bjbe and inserting section #caja7;d7 of the ,health ,extensions and ,other ,matters ,act1 #bjbe1 and section #dja7;d7 of the ,bipartisan ,health ,care ,act4 #djb4 ,extension of special diabetes programs 7a7 ,extension of special diabetes programs for type ,i diabetes ,section #ccj;,b7b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77 is amended-- 7#a7 in subparagraph 7,e71 by striking and at the end2 7#b7 in subparagraph 7,f71 by striking the period at the end and inserting 1 and #aaj1cbg1bif for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe2 and2 and 7#c7 by adding at the end the following3 7,g7 #bjj1jjj1jjj for fiscal year #bjbf1 to remain available until expended4 4 7b7 ,extending funding for special diabetes programs for ,indians ,section #ccj;,c7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77 is amended-- 7#a7 in subparagraph 7,e71 by striking and at the end2 7#b7 in subparagraph 7,f71 by striking the period at the end and inserting 1 and #aaj1cbg1bif for the period beginning on ,april #a1 #bjbe1 and ending on ,september #cj1 #bjbe2 and2 and 7#c7 by adding at the end the following3 7,g7 #bjj1jjj1jjj for fiscal year #bjbf1 to remain available until expended4 4 ,b ,world ,trade ,center ,health ,program #daa4 #i_/aa responder and survivor health funding corrections 7a7 ,in general ,section #ccea7;a77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjmm-#fa7;a77#b77;,a77 is amended-- 7#a7 in clause 7x71 by striking 2 and and inserting a semicolon2 7#b7 by redesignating clause 7xi7 as clause 7xii72 and 7#c7 by inserting after clause 7x71 the following3 7xi7 for each of fiscal years #bjbf through #bjdj-- 7,i7 the amount determined under this subparagraph for the previous fiscal year multiplied by #a4je2 multiplied by 7,,ii7 the ratio of-- 7aa7 the total number of individuals enrolled in the ,,wtc ,program on ,july #a of such previous fiscal year2 to 7bb7 the total number of individuals so enrolled on ,july #a of the fiscal year prior to such previous fiscal year2 and 4 7b7 ,report to ,congress 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 shall conduct an assessment of anticipated budget authority and outlays of the ,world ,trade ,center ,health ,program 7referred to in this subsection as the ,program7 through the duration of the ,program and submit a report summarizing such assessment to-- 7,a7 the ,speaker and minority leader of the ,house of ,representatives2 7,b7 the majority and minority leaders of the ,senate2 7,c7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on the ,budget of the ,senate2 and 7,d7 the ,committee on ,energy and ,commerce and the ,committee on the ,budget of the ,house of ,representatives4 7#b7 ,inclusions ,the report required under paragraph 7#a7 shall include-- 7,a7 a projection of ,program budgetary needs on a per-fiscal year basis through fiscal year #bjij2 7,b7 a review of ,program modeling for each of fiscal years #bjag through the fiscal year prior to the fiscal year in which the report is issued to assess how anticipated budgetary needs compared to actual expenditures2 7,c7 an assessment of the projected budget authority and expenditures of the ,program through fiscal year #bjij by comparing-- 7i7 such projected authority and expenditures resulting from application of section #ccea7;a77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjmm-#fa7;a77#b77;,a771 as amended by subsection 7a72 and 7ii7 such projected authority and expenditures that would result if such section were amended so that the formula under clause 7xi7 of such section1 as amended by subsection 7a71 were to be extended through fiscal year #bjij2 and 7,d7 any recommendations of the ,secretary to make changes to the formula under such section #ccea7;a77#b77;,a71 as so amended1 to fully offset anticipated ,program expenditures through fiscal year #bjij4 7c7 ,technical amendments ,title ,,xxxiii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjmm et seq47 is amended-- 7#a7 in section #cceb7;d7 7#db ,u4,s4,c4 #cjjmm-#fb7;d771 by striking ,any amounts and inserting ,any unobligated amounts2 7#b7 in section #ccec7;d7 7#db ,u4,s4,c4 #cjjmm-#fc7;d771 by striking ,any amounts and inserting ,any unobligated amounts2 and 7#c7 in section #cced7;d7 7#db ,u4,s4,c4 #cjjmm-#fd7;d771 by striking ,any amounts and inserting ,any unobligated amounts4 ,v ,,support ,act ,reauthorization #eja4 ,short title ,this title may be cited as the ,,support for ,patients and ,communities ,reauthorization ,act of #bjbe4 ,a ,prevention #eaa4 ,prenatal and postnatal health ,section #cag,l7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ac7;d77 is amended by striking such sums as may be necessary for each of the fiscal years #bjai through #bjbc and inserting #d1bej1jjj for each of fiscal years #bjbe through #bjbi4 #eab4 ,monitoring and education regarding infections associated with illicit drug use and other risk factors ,section #cag,n7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ae7;d77 is amended by striking fiscal years #bjai through #bjbc and inserting fiscal years #bjbe through #bjbi4 #eac4 ,preventing overdoses of controlled substances 7a7 ,in general ,section #cib;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a7 is amended-- 7#a7 in subsection 7a77#b7-- 7,a7 in subparagraph 7,c71 by inserting and associated risks before the period at the end2 and 7,b7 in subparagraph 7,d71 by striking opioids and inserting substances causing overdose2 and 7#b7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,b71 by inserting 1 and associated risk factors1 after such overdoses2 7,b7 in subparagraph 7,c71 by striking coding and inserting monitoring and identifying2 7,c7 in subparagraph 7,e7-- 7i7 by inserting a comma after public health laboratories2 and 7ii7 by inserting and other emerging substances related after analogues2 and 7,d7 in subparagraph 7,f71 by inserting and associated risk factors after overdoses4 7b7 ,additional grants ,section #cib;,a7a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a7;a77#c77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by striking and ,indian ,tribes-- and inserting and ,indian ,tribes for the following purposes32 7#b7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,to carry out innovative projects for grantees to detect1 identify1 and rapidly respond to controlled substance misuse1 abuse1 and overdoses1 and associated risk factors1 including changes in patterns of such controlled substance use4 ,such projects may include the use of innovative1 evidence-based strategies for detecting such patterns1 such as wastewater surveillance1 if proven to support actionable prevention strategies1 in a manner consistent with applicable ,federal and ,state privacy laws4 2 and 7#c7 in subparagraph 7,b71 by striking for any and inserting ,for any4 7c7 ,authorization of appropriations ,section #cib;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a7;e77 is amended by striking #dif1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #eje1egi1jjj for each of fiscal years #bjbe through #bjbi4 #ead4 ,support for individuals and families impacted by fetal alcohol spectrum disorder 7a7 ,in general ,part ,o of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;f et seq47 is amended to read as follows3 ,o ,fetal alcohol syndrome prevention and services program #cii;,h4 ,fetal alcohol spectrum disorders prevention1 intervention1 and services delivery program 7a7 ,in general ,the ,secretary shall establish or continue activities to support a comprehensive fetal alcohol spectrum disorders 7referred to in this section as ,,fasd7 education1 prevention1 identification1 intervention1 and services delivery program1 which may include-- 7#a7 an education and public awareness program to support1 conduct1 and evaluate the effectiveness of-- 7,a7 educational programs targeting health professions schools1 social and other supportive services1 educators and counselors and other service providers in all phases of childhood development1 and other relevant service providers1 concerning the prevention1 identification1 and provision of services for infants1 children1 adolescents and adults with ,,fasd2 7,b7 strategies to educate school-age children1 including pregnant and high-risk youth1 concerning ,,fasd2 7,c7 public and community awareness programs concerning ,,fasd2 and 7,d7 strategies to coordinate information and services across affected community agencies1 including agencies providing social services such as foster care1 adoption1 and social work1 agencies providing health services1 and agencies involved in education1 vocational training and civil and criminal justice2 7#b7 supporting and conducting research on ,,fasd1 as appropriate1 including to-- 7,a7 develop appropriate medical diagnostic methods for identifying ,,fasd2 and 7,b7 develop effective culturally and linguistically appropriate evidence-based or evidence-informed interventions and appropriate supports for preventing prenatal alcohol exposure1 which may co-occur with exposure to other substances2 7#c7 building ,state and ,tribal capacity for the identification1 treatment1 and support of individuals with ,,fasd and their families1 which may include-- 7,a7 utilizing and adapting existing ,federal1 ,state1 or ,tribal programs to include ,,fasd identification and ,,fasd-informed support2 7,b7 developing and expanding screening and diagnostic capacity for ,,fasd2 7,c7 developing1 implementing1 and evaluating targeted ,,fasd-informed intervention programs for ,,fasd2 7,d7 providing training with respect to ,,fasd for professionals across relevant sectors2 and 7,e7 disseminating information about ,,fasd and support services to affected individuals and their families2 and 7#d7 an applied research program concerning intervention and prevention to support and conduct service demonstration projects1 clinical studies and other research models providing advocacy1 educational and vocational training1 counseling1 medical and mental health1 and other supportive services1 as well as models that integrate and coordinate such services1 that are aimed at the unique challenges facing individuals with ,fetal ,alcohol ,syndrome or ,fetal ,alcohol ,effect and their families4 7b7 ,grants and ,technical ,assistance 7#a7 ,in general ,the ,secretary may award grants1 cooperative agreements and contracts and provide technical assistance to eligible entities to carry out subsection 7a74 7#b7 ,eligible entities ,to be eligible to receive a grant1 or enter into a cooperative agreement or contract1 under this section1 an entity shall-- 7,a7 be a ,state1 ,indian ,tribe or ,tribal organization1 local government1 scientific or academic institution1 or nonprofit organization2 and 7,b7 prepare and submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require1 including a description of the activities that the entity intends to carry out using amounts received under this section4 7#c7 ,additional application contents ,the ,secretary may require that an eligible entity include in the application submitted under paragraph 7#b77;,b7-- 7,a7 a designation of an individual to serve as a ,,fasd ,state or ,tribal coordinator of activities such eligible entity proposes to carry out through a grant1 cooperative agreement1 or contract under this section2 and 7,b7 a description of an advisory committee the entity will establish to provide guidance for the entity on developing and implementing a statewide or ,tribal strategic plan to prevent ,,fasd and provide for the identification1 treatment1 and support of individuals with ,,fasd and their families4 7c7 ,definition of ,,fasd-,informed ,for purposes of this section1 the term ,,fasd-informed1 with respect to support or an intervention program1 means that such support or intervention program uses culturally and linguistically informed evidence-based or practice-based interventions and appropriate resources to support an improved quality of life for an individual with ,,fasd and the family of such individual4 #cii;,i4 ,strengthening capacity and education for fetal alcohol spectrum disorders 7a7 ,in general ,the ,secretary shall award grants1 contracts1 or cooperative agreements1 as the ,secretary determines appropriate1 to public or nonprofit private entities with demonstrated expertise in the field of fetal alcohol spectrum disorders 7referred to in this section as ,,fasd74 ,such awards shall be for the purposes of building local1 ,tribal1 ,state1 and nationwide capacities to prevent the occurrence of ,,fasd by carrying out the programs described in subsection 7b74 7b7 ,programs ,an entity receiving an award under subsection 7a7 may use such award for the following purposes3 7#a7 ,developing and supporting public education and outreach activities to raise public awareness of the risks associated with alcohol consumption during pregnancy4 7#b7 ,acting as a clearinghouse for evidence-based resources on ,,fasd prevention1 identification1 and culturally and linguistically appropriate best practices to help inform systems of care for individuals with ,,fasd across their lifespan4 7#c7 ,increasing awareness and understanding of efficacious1 evidence-based screening tools and culturally and linguistically appropriate evidence-based intervention services and best practices1 which may include improving the capacity for ,state1 ,tribal1 and local affiliates4 7#d7 ,providing technical assistance to recipients of grants1 cooperative agreements1 or contracts under section #cii;,h1 as appropriate4 7c7 ,application ,to be eligible for a grant1 contract1 or cooperative agreement under this section1 an entity shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7d7 ,subcontracting ,a public or private nonprofit entity may carry out the following activities required under this section through contracts or cooperative agreements with other public and private nonprofit entities with demonstrated expertise in ,,fasd3 7#a7 ,resource development and dissemination4 7#b7 ,intervention services4 7#c7 ,training and technical assistance4 #cii;,j4 ,authorization of appropriations ,there are authorized to be appropriated to carry out this part #ab1ejj1jjj for each of fiscal years #bjbe through #bjbi4 4 7b7 ,report ,not later than #d years after the date of enactment of this ,act1 and every year thereafter1 the ,secretary of ,health and ,human ,services shall prepare and 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-- 7#a7 a review of the activities carried out pursuant to sections #cii;,h and #cii;,i of the ,public ,health ,service ,act1 as amended1 to advance public education and awareness of fetal alcohol spectrum disorders 7referred to in this section as ,,fasd72 7#b7 a description of-- 7,a7 the activities carried out pursuant to such sections #cii;,h and #cii;,i to identify1 prevent1 and treat ,,fasd2 and 7,b7 methods used to evaluate the outcomes of such activities2 and 7#c7 an assessment of activities carried out pursuant to such sections #cii;,h and #cii;,i to support individuals with ,,fasd4 #eae4 ,promoting ,state choice in ,,pdmp systems ,section #cii,o7h7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c7;h77 is amended by adding at the end the following3 7#e7 ,promoting ,state choice ,nothing in this section shall be construed to authorize the ,secretary to require ,states to use a specific vendor or a specific interoperability connection other than to align with nationally recognized1 consensus-based open standards1 such as in accordance with sections #cjja and #cjjd4 4 #eaf4 ,first responder training program ,section #edf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ee-#a7 is amended-- 7#a7 in subsection 7a71 by striking tribes and tribal and inserting ,tribes and ,tribal2 7#b7 in subsections 7a71 7c71 and 7d7-- 7,a7 by striking approved or cleared each place it appears and inserting approved1 cleared1 or otherwise legally marketed2 and 7,b7 by striking opioid each place it appears2 7#c7 in subsection 7f7-- 7,a7 by striking approved or cleared each place it appears and inserting approved1 cleared1 or otherwise legally marketed2 7,b7 in paragraph 7#a71 by striking opioid2 7,c7 in paragraph 7#b7-- 7i7 by striking opioid and heroin and inserting opioid1 heroin1 and other drug2 and 7ii7 by striking opioid overdose and inserting overdose2 and 7,d7 in paragraph 7#c71 by striking opioid and heroin2 and 7#d7 in subsection 7h71 by striking #cf1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #ef1jjj1jjj for each of fiscal years #bjbe through #bjbi4 #eag4 ,donald ,j4 ,cohen ,national ,child ,traumatic ,stress ,initiative 7a7 ,technical amendment ,the second part ,g of title ,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bijkk et seq471 as added by section #add of the ,community ,renewal ,tax ,relief ,act 7,public ,law #ajf-eed71 is amended-- 7#a7 by redesignating such part as part ,j2 and 7#b7 by redesignating sections #eha through #ehd as sections #eif through #eif;,c1 respectively4 7b7 ,in general ,section #ehb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;hh-#a7 is amended-- 7#a7 in the section heading1 by striking ,,violence ,,related ,,stress and inserting ,,traumatic ,,events2 7#b7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking tribes and tribal and inserting ,tribes and ,tribal2 and 7,b7 in paragraph 7#b71 by inserting and dissemination after the development2 7#c7 in subsection 7b71 by inserting and dissemination after the development2 7#d7 in subsection 7d7-- 7,a7 by striking ,the ,,nctsi and inserting the following3 7#a7 ,coordinating center ,the ,,nctsi 2 and 7,b7 by adding at the end the following3 7#b7 ,nctsi grantees ,in carrying out subsection 7a77#b71 ,,nctsi grantees shall develop trainings and other resources1 as applicable and appropriate1 to support implementation of the evidence-based practices developed and disseminated under such subsection4 2 7#e7 in subsection 7e7-- 7,a7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively1 and adjusting the margins accordingly2 7,b7 in subparagraph 7,a71 as so redesignated1 by inserting and implementation after the dissemination2 7,c7 by striking ,the ,,nctsi and inserting the following3 7#a7 ,coordinating center ,the ,,nctsi 2 and 7,d7 by adding at the end the following3 7#b7 ,nctsi grantees ,,nctsi grantees shall1 as appropriate1 collaborate with other such grantees1 the ,,nctsi coordinating center1 and the ,secretary in carrying out subsections 7a77#b7 and 7d77#b74 2 7#f7 by amending subsection 7h7 to read as follows3 7h7 ,application and evaluation ,to be eligible to receive a grant1 contract1 or cooperative agreement under subsection 7a71 a public or nonprofit private entity or an ,indian ,tribe or ,tribal organization shall submit to the ,secretary an application at such time1 in such manner1 and containing such information and assurances as the ,secretary may require1 including-- 7#a7 a plan for the evaluation of the activities funded under the grant1 contract1 or agreement1 including both process and outcomes evaluation1 and the submission of an evaluation at the end of the project period2 and 7#b7 a description of how such entity1 ,indian ,tribe1 or ,tribal organization will support efforts led by the ,secretary or the ,,nctsi coordinating center1 as applicable1 to evaluate activities carried out under this section4 2 and 7#g7 by amending subsection 7j7 to read as follows3 7j7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section-- 7#a7 #ic1hhg1jjj for fiscal year #bjbe2 7#b7 #ie1jjj1jjj for fiscal year #bjbf2 7#c7 #ig1jjj1jjj for fiscal year #bjbg2 7#d7 #ajj1jjj1jjj for fiscal year #bjbh2 and 7#e7 #ajj1jjj1jjj for fiscal year #bjbi4 4 #eah4 ,protecting suicide prevention lifeline from cybersecurity incidents 7a7 ,national suicide prevention lifeline program ,section #ebj;,e-#c7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7b77 is amended-- 7#a7 in paragraph 7#d71 by striking and at the end2 7#b7 in paragraph 7#e71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#f7 taking such steps as may be necessary to ensure the suicide prevention hotline is protected from cybersecurity incidents and eliminates known cybersecurity vulnerabilities4 4 7b7 ,reporting ,section #ebj;,e-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 is amended-- 7#a7 by redesignating subsection 7f7 as subsection 7g72 and 7#b7 by inserting after subsection 7e7 the following3 7f7 ,cybersecurity reporting 7#a7 ,notification 7,a7 ,in general ,the program's network administrator receiving ,federal funding pursuant to subsection 7a7 shall report to the ,assistant ,secretary1 in a manner that protects personal privacy1 consistent with applicable ,federal and ,state privacy laws-- 7i7 any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such a vulnerability2 and 7ii7 any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident4 7,b7 ,local and regional crisis centers ,local and regional crisis centers participating in the program shall report to the program's network administrator identified under subparagraph 7,a71 in a manner that protects personal privacy1 consistent with applicable ,federal and ,state privacy laws-- 7i7 any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such vulnerability2 and 7ii7 any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident4 7#b7 ,notification ,if the program's network administrator receiving funding pursuant to subsection 7a7 discovers1 or is informed by a local or regional crisis center pursuant to paragraph 7#a77;,b7 of1 a cybersecurity vulnerability or incident1 within a reasonable amount of time after such discovery or receipt of information1 such entity shall report the vulnerability or incident to the ,assistant ,secretary4 7#c7 ,clarification 7,a7 ,oversight 7i7 ,local and regional crisis centers ,except as provided in clause 7ii71 local and regional crisis centers participating in the program shall oversee all technology each center employs in the provision of services as a participant in the program4 7ii7 ,network administrator ,the program's network administrator receiving ,federal funding pursuant to subsection 7a7 shall oversee the technology each crisis center employs in the provision of services as a participant in the program if such oversight responsibilities are established in the applicable network participation agreement4 7,b7 ,supplement1 not supplant ,the cybersecurity incident reporting requirements under this subsection shall supplement1 and not supplant1 cybersecurity incident reporting requirements under other provisions of applicable ,federal law that are in effect on the date of the enactment of the ,,support for ,patients and ,communities ,reauthorization ,act of #bjbe4 4 7c7 ,study ,not later than #ahj days after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct and complete a study that evaluates cybersecurity risks and vulnerabilities associated with the #i-h-h ,national ,suicide ,prevention ,lifeline2 and 7#b7 submit a report on the findings of 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 #eai4 ,bruce's law 7a7 ,youth prevention and recovery ,section #gajb7;c7 of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #bij;bb-#g;a7c77 is amended-- 7#a7 in paragraph 7#c77;,a77i71 by inserting 1 which may include strategies to increase education and awareness of the potency and dangers of synthetic opioids 7including drugs contaminated with fentanyl7 and1 as appropriate1 other emerging drug use or misuse issues before the semicolon2 and 7#b7 in paragraph 7#d77;,a71 by inserting and strategies to increase education and awareness of the potency and dangers of synthetic opioids 7including drugs contaminated with fentanyl7 and1 as appropriate1 emerging drug use or misuse issues before the semicolon4 7b7 ,interdepartmental substance use disorders coordinating committee ,section #gjbb of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #bij;aa note7 is amended-- 7#a7 by striking subsection 7g7 and inserting the following3 7g7 ,working groups 7#a7 ,in general ,the ,committee may establish working groups for purposes of carrying out the duties described in subsection 7e74 ,any such working group shall be composed of members of the ,committee 7or the designees of such members7 and may hold such meetings as are necessary to carry out the duties delegated to the working group4 7#b7 ,additional federal interagency work group on fentanyl contamination of illegal drugs 7,a7 ,establishment ,the ,secretary1 acting through the ,committee1 shall establish a ,federal ,interagency ,work ,group on ,fentanyl ,contamination of ,illegal ,drugs 7referred to in this paragraph as the ,work ,group7 consisting of representatives from relevant ,federal departments and agencies on the ,committee4 7,b7 ,consultation ,the ,work ,group shall consult with relevant stakeholders and subject matter experts1 including-- 7i7 ,state1 ,tribal1 and local subject matter experts in reducing1 preventing1 and responding to drug overdose caused by fentanyl-contamination of illicit drugs2 and 7ii7 family members of both adults and youth who have overdosed by fentanyl-contaminated illicit drugs4 7,c7 ,duties ,the ,work ,group shall-- 7i7 examine ,federal efforts to reduce and prevent drug overdose by fentanyl-contaminated illicit drugs2 7ii7 identify strategies to improve ,state1 ,tribal1 and local responses to overdose by fentanyl-contaminated illicit drugs2 7iii7 coordinate with the ,secretary1 as appropriate1 in carrying out activities to raise public awareness of synthetic opioids and other emerging drug use and misuse issues2 7iv7 make recommendations to ,congress for improving ,federal programs1 including with respect to the coordination of efforts across such programs2 and 7v7 make recommendations for educating youth on the potency and dangers of drugs contaminated by fentanyl4 7,d7 ,annual report to secretary ,the ,work ,group shall annually prepare and submit to the ,secretary1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce and the ,committee on ,education and the ,workforce of the ,house of ,representatives1 a report on the activities carried out by the ,work ,group under subparagraph 7,c71 including recommendations to reduce and prevent drug overdose by fentanyl contamination of illegal drugs1 in all populations1 and specifically among youth at risk for substance misuse4 2 and 7#b7 by striking subsection 7i7 and inserting the following3 7i7 ,sunset ,the ,committee shall terminate on ,september #cj1 #bjbi4 4 #ebj4 ,guidance on at-home drug disposal systems 7a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,administrator of the ,drug ,enforcement ,administration1 shall publish guidance to facilitate the use of at-home safe disposal systems for applicable drugs4 7b7 ,contents ,the guidance under subsection 7a7 shall include-- 7#a7 recommended standards for effective at-home drug disposal systems to meet applicable requirements enforced by the ,food and ,drug ,administration2 7#b7 recommended information to include as instructions for use to disseminate with at-home drug disposal systems2 7#c7 best practices and educational tools to support the use of an at-home drug disposal system1 as appropriate2 and 7#d7 recommended use of licensed health providers for the dissemination of education1 instruction1 and at-home drug disposal systems1 as appropriate4 #eba4 ,assessment of opioid drugs and actions 7a7 ,in general ,not later than one 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 publish on the website of the ,food and ,drug ,administration 7referred to in this section as the ,,fda7 a report that outlines a plan for assessing opioid analgesic drugs that are approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that addresses the public health effects of such opioid analgesic drugs as part of the benefit-risk assessment and the activities of the ,,fda that relate to facilitating the development of nonaddictive medical products intended to treat pain or addiction4 ,such report shall include-- 7#a7 an update on the actions taken by the ,,fda to consider the effectiveness1 safety1 benefit-risk profile1 and use of approved opioid analgesic drugs2 7#b7 a timeline for an assessment of the potential need1 as appropriate1 for labeling changes1 revised or additional postmarketing requirements1 enforcement actions1 or withdrawals for opioid analgesic drugs2 7#c7 an overview of the steps that the ,,fda has taken to support the development and approval of nonaddictive medical products intended to treat pain or addiction1 and actions planned to further support the development and approval of such products2 and 7#d7 an overview of the consideration by the ,,fda of clinical trial methodologies for analgesic drugs1 including the enriched enrollment randomized withdrawal methodology1 and the benefits and drawbacks associated with different trial methodologies for such drugs1 incorporating any public input received under subsection 7b74 7b7 ,public input ,in carrying out subsection 7a71 the ,secretary shall provide an opportunity for public input concerning the regulation by the ,,fda of opioid analgesic drugs1 including scientific evidence that relates to conditions of use1 safety1 or benefit-risk assessment 7including consideration of the public health effects7 of such opioid analgesic drugs4 #ebb4 ,grant program for ,state and ,tribal response to opioid use disorders ,the activities carried out pursuant to section #ajjc7;b77#d77;,a7 of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #bij;ee-#c;a7b77#d77;,a77 may include facilitating access to products used to prevent overdose deaths by detecting the presence of one or more substances1 such as fentanyl and xylazine test strips1 to the extent the purchase and possession of such products is consistent with ,federal and ,state law4 ,b ,treatment #eca4 ,residential treatment program for pregnant and postpartum women ,section #ejh of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#a7 is amended-- 7#a7 in subsection 7d77#aa77;,c71 by striking providing health services and inserting providing health care services2 7#b7 in subsection 7g7-- 7,a7 by inserting a plan describing after will provide2 and 7,b7 by adding at the end the following3 ,such plan may include a description of how such applicant will target outreach to women disproportionately impacted by maternal substance use disorder42 and 7#c7 in subsection 7s71 by striking #bi1ica1jjj for each of fiscal years #bjai through #bjbc and inserting #ch1ica1jjj for each of fiscal years #bjbe through #bjbi4 #ecb4 ,improving access to addiction medicine providers ,section #eig of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bijll7 is amended-- 7#a7 in subsection 7a77#a71 by inserting diagnosis1 after related to2 and 7#b7 in subsection 7b71 by inserting addiction medicine1 after psychiatry14 #ecc4 ,mental and behavioral health education and training grants ,section #gef7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid;e-#a7;f77 is amended by striking fiscal years #bjbc through #bjbg and inserting fiscal years #bjbe through #bjbi4 #ecd4 ,loan repayment program for substance use disorder treatment workforce ,section #gha7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bie;h7j77 is amended by striking #be1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #dj1jjj1jjj for each of fiscal years #bjbe through #bjbi4 #ece4 ,development and dissemination of model training programs for substance use disorder patient records ,section #gjec of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #bij;dd-#b note7 is amended by striking subsection 7e74 #ecf4 ,task force on best practices for trauma-informed identification1 referral1 and support ,section #gacb of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga2 #acb ,stat4 #djdf7 is amended-- 7#a7 in subsection 7b77#a7-- 7,a7 by redesignating subparagraph 7,,cc7 as subparagraph 7,,dd72 and 7,b7 by inserting after subparagraph 7,,bb7 the following3 7,,cc7 ,the ,administration for ,community ,living4 2 7#b7 in subsection 7d77#a71 in the matter preceding subparagraph 7,a71 by inserting 1 developmental disability service providers before 1 individuals who are2 and 7#c7 in subsection 7i71 by striking #bjbc and inserting #bjbi4 #ecg4 ,grants to enhance access to substance use disorder treatment ,section #cbjc of the ,,support for ,patients and ,communities ,act 7#ba ,u4,s4,c4 #hbc note7 is amended-- 7#a7 by striking subsection 7b72 and 7#b7 by striking 7a7 ,in general4--,the ,secretary and inserting the following3 ,the ,secretary4 #ech4 ,state guidance related to individuals with serious mental illness and children with serious emotional disturbance 7a7 ,review of use of certain funding ,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 acting through the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall conduct a review of ,state use of funds made available under the ,community ,mental ,health ,services ,block ,grant program under subpart ,i of part ,b of title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx et seq47 7referred to in this section as the block grant program7 for first episode psychosis activities4 ,such review shall consider the following3 7#a7 ,how ,states use funds for evidence-based treatments and services according to the standard of care for individuals with early serious mental illness and children with a serious emotional disturbance4 7#b7 ,the percentages of the ,state funding under the block grant program expended on early serious mental illness and first episode psychosis1 and the number of individuals served under such funds4 7b7 ,report and guidance 7#a7 ,report ,not later than #ahj days after the completion of the review under subsection 7a71 the ,secretary 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 ,representatives a report describing-- 7,a7 the findings of the review under subsection 7a72 and 7,b7 any recommendations for changes to the block grant program that would facilitate improved outcomes for individuals with serious mental illness and children with serious emotional disturbance4 7#b7 ,guidance ,not later than #a year after the date on which the report is submitted under paragraph 7#a71 the ,secretary shall update the guidance provided to ,states under the block grant program on coordinated specialty care and other evidence-based mental health care services for individuals with serious mental illness and children with a serious emotional disturbance1 based on the findings and recommendations of such report4 #eci4 ,reviewing the scheduling of approved products containing a combination of buprenorphine and naloxone 7a7 ,secretary of ,,hhs ,the ,secretary of ,health and ,human ,services shall1 consistent with the requirements and procedures set forth in sections #bja and #bjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa1 #hab7-- 7#a7 review the relevant data pertaining to the scheduling of products containing a combination of buprenorphine and naloxone that have been approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 and 7#b7 if appropriate1 request that the ,attorney ,general initiate rulemaking proceedings to revise the schedules accordingly with respect to such products4 7b7 ,attorney general ,the ,attorney ,general shall review any request made by the ,secretary of ,health and ,human ,services under subsection 7a77#b7 and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections #bja and #bjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa1 #hab74 ,c ,recovery #eda4 ,building communities of recovery ,section #edg7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ee-#b7;f77 is amended by striking #e1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #af1jjj1jjj for each of fiscal years #bjbe through #bjbi4 #edb4 ,peer support technical assistance center ,section #edg;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ee-#b;a7 is amended-- 7#a7 in subsection 7b77#d71 by striking building2 and and inserting the following3 building1 such as-- 7,a7 professional development of peer support specialists2 and 7,b7 making recovery support services available in nonclinical settings2 and 2 7#b7 by redesignating subsections 7d7 and 7e7 as subsections 7e7 and 7f71 respectively2 7#c7 by inserting after subsection 7c7 the following3 7d7 ,regional centers 7#a7 ,in general ,the ,secretary may establish one regional technical assistance center 7referred to in this subsection as the ,regional ,center71 with existing resources1 to assist the ,center in carrying out activities described in subsection 7b7 within the geographic region of such ,regional ,center in a manner that is tailored to the needs of such region4 7#b7 ,evaluation ,not later than #d years after the date of enactment of the ,,support for ,patients and ,communities ,reauthorization ,act of #bjbe1 the ,secretary shall evaluate the activities of the ,regional ,center and 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 findings of such evaluation1 including-- 7,a7 a description of the distinct roles and responsibilities of the ,regional ,center and the ,center2 7,b7 available information relating to the outcomes of the ,regional ,center under this subsection1 such as any impact on the operations and efficiency of the ,center relating to requests for technical assistance and support within the region of such ,regional ,center2 7,c7 a description of any gaps or areas of duplication relating to the activities of the ,regional ,center and the ,center within such region2 and 7,d7 recommendations relating to the modification1 expansion1 or termination of the ,regional ,center under this subsection4 7#c7 ,termination ,this subsection shall terminate on ,september #cj1 #bjbi4 2 and 7#d7 in subsection 7f71 as so redesignated1 by striking #a1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #b1jjj1jjj for each of fiscal years #bjbe through #bjbi4 #edc4 ,comprehensive opioid recovery centers ,section #eeb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ee-#g7 is amended-- 7#a7 in subsection 7d77#b7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking and in such manner and inserting 1 in such manner1 and containing such information and assurances1 including relevant documentation12 and 7,b7 in subparagraph 7,a71 by striking is capable of coordinating with other entities to carry out and inserting has the demonstrated capability to carry out1 through referral or contractual arrangements2 7#b7 in subsection 7h7-- 7,a7 by redesignating paragraphs 7#a7 through 7#d7 as subparagraphs 7,a7 through 7,d71 respectively1 and adjusting the margins accordingly2 7,b7 by striking ,with respect to and inserting the following3 7#a7 ,in general ,with respect to 2 and 7,c7 by adding at the end the following3 7#b7 ,additional reporting for certain eligible entities ,an entity carrying out activities described in subsection 7g7 through referral or contractual arrangements shall include in the submissions required under paragraph 7#a7 information related to the status of such referrals or contractual arrangements1 including an assessment of whether such referrals or contractual arrangements are supporting the ability of such entity to carry out such activities4 2 and 7#c7 in subsection 7j71 by striking #bjai through #bjbc and inserting #bjbe through #bjbi4 #edd4 ,youth prevention and recovery ,section #gajb7;c7 of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #bij;bb-#g;a7c77 7as amended by section #aaj7;a77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i7-- 7,i7 by inserting 1 or a consortium of local educational agencies1 after a local educational agency2 and 7,,ii7 by striking high schools and inserting secondary schools2 and 7ii7 in clause 7vi71 by striking tribe1 or tribal and inserting ,tribe1 or ,tribal2 7,b7 by amending subparagraph 7,e7 to read as follows3 7,e7 ,indian tribe2 tribal organization ,the terms ,indian ,tribe and ,tribal organization have the meanings given such terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 2 7,c7 by redesignating subparagraph 7,k7 as subparagraph 7,l72 and 7,d7 by inserting after subparagraph 7,j7 the following3 7,k7 ,secondary school ,the term secondary school has the meaning given such term in section #haja of the ,elementary and ,secondary ,education ,act of #aife 7#bj ,u4,s4,c4 #ghja74 2 7#b7 in paragraph 7#c77;,a71 in the matter preceding clause 7i7-- 7,a7 by striking and abuse2 and 7,b7 by inserting at increased risk for substance misuse after specific populations2 7#c7 in paragraph 7#d7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking ,indian tribes and inserting ,indian ,tribes2 7,b7 in subparagraph 7,a71 by striking and abuse2 and 7,c7 in subparagraph 7,b71 by striking peer mentoring and inserting peer-to-peer support2 7#d7 in paragraph 7#e71 by striking tribal and inserting ,tribal2 7#e7 in paragraph 7#f77;,a7-- 7,a7 in clause 7iv71 by striking 2 and and inserting a semicolon2 and 7,b7 by adding at the end the following3 7vi7 a plan to sustain the activities carried out under the grant program1 after the grant program has ended2 and 2 7#f7 in paragraph 7#h71 by striking #bjbb and inserting #bjbg2 and 7#g7 by amending paragraph 7#i7 to read as follows3 7#i7 ,authorization of appropriations ,to carry out this subsection1 there are authorized to be appropriated-- 7,a7 #aj1jjj1jjj for fiscal year #bjbe2 7,b7 #ab1jjj1jjj for fiscal year #bjbf2 7,c7 #ac1jjj1jjj for fiscal year #bjbg2 7,d7 #ad1jjj1jjj for fiscal year #bjbh2 and 7,e7 #ae1jjj1jjj for fiscal year #bjbi4 4 #ede4 ,,career ,act 7a7 ,in general ,section #gahc of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #bij;ee-#h7 is amended-- 7#a7 in the section heading1 by inserting 2 ,,treatment1 ,,recovery1 ,,and ,,workforce ,,support ,,grants after ,,career ,,act2 7#b7 in subsection 7b71 by inserting each before for a period2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by striking the rates described in paragraph 7#b7 and inserting the average rates for calendar years #bjah through #bjbb described in paragraph 7#b72 and 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,rates ,the rates described in this paragraph are the following3 7,a7 ,the highest age-adjusted average rates of drug overdose deaths for calendar years #bjah through #bjbb based on data from the ,centers for ,disease ,control and ,prevention1 including1 if necessary1 provisional data for calendar year #bjbb4 7,b7 ,the highest average rates of unemployment for calendar years #bjah through #bjbb based on data provided by the ,bureau of ,labor ,statistics4 7,c7 ,the lowest average labor force participation rates for calendar years #bjah through #bjbb based on data provided by the ,bureau of ,labor ,statistics4 2 7#d7 in subsection 7g7-- 7,a7 in each of paragraphs 7#a7 and 7#c71 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7,b7 by redesignating paragraphs 7#a7 through 7#c7 as subparagraphs 7,a7 through 7,c71 respectively1 and adjusting the margins accordingly2 7,c7 in the matter preceding subparagraph 7,a7 7as so redesignated71 by striking ,an entity and inserting the following3 7#a7 ,in general ,an entity 2 and 7,d7 by adding at the end the following3 7#b7 ,transportation services ,an entity receiving a grant under this section may use not more than #e percent of the funds for providing transportation for individuals to participate in an activity supported by a grant under this section1 which transportation shall be to or from a place of work or a place where the individual is receiving vocational education or job training services or receiving services directly linked to treatment of or recovery from a substance use disorder4 7#c7 ,limitation ,the ,secretary may not require an entity to1 or give priority to an entity that plans to1 use the funds of a grant under this section for activities that are not specified in this subsection4 2 7#e7 in subsection 7i77#b71 by inserting 1 which shall include employment and earnings outcomes described in subclauses 7,i7 and 7,,iii7 of section #aaf7;b77#b77;,a77i7 of the ,workforce ,innovation and ,opportunity ,act 7#bi ,u4,s4,c4 #cada7;b77#b77;,a77i77 with respect to the participation of such individuals with a substance use disorder in programs and activities funded by the grant under this section after subsection 7g72 7#f7 in subsection 7j7-- 7,a7 in paragraph 7#a71 by inserting for grants awarded prior to the date of enactment of the ,,support for ,patients and ,communities ,reauthorization ,act of #bjbe after grant period under this section2 and 7,b7 in paragraph 7#b7-- 7i7 in the matter preceding subparagraph 7,a71 by striking #b years after submitting the preliminary report required under paragraph 7#a7 and inserting ,september #cj1 #bjbi2 and 7ii7 in subparagraph 7,a71 by striking 7g77#c7 and inserting 7g77#a77;,c72 and 7#g7 in subsection 7k71 by striking #e1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #ab1jjj1jjj for each of fiscal years #bjbe through #bjbi4 7b7 ,reauthorization of the ,,career ,act2 ,recovery ,housing ,pilot ,program 7#a7 ,in general ,section #hjga of the ,,support for ,patients and ,communities ,act 7#db ,u4,s4,c4 #ecja note2 ,public ,law #aae-bga7 is amended-- 7,a7 by striking the section heading and inserting ,,career ,act2 ,recovery ,housing ,pilot ,program2 7,b7 in subsection 7a71 by striking through #bjbc and inserting through #bjbi2 7,c7 in subsection 7b7-- 7i7 in paragraph 7#a71 by striking not later than #fj days after the date of enactment of this ,act and inserting not later than #fj days after the date of enactment of the ,,support for ,patients and ,communities ,reauthorization ,act of #bjbe2 and 7ii7 in paragraph 7#b77;,b77i7-- 7,i7 in subclause 7,i7-- 7aa7 by striking for calendar years #bjac through #bjag2 and 7bb7 by inserting for calendar years #bjah through #bjbb after rates of unemployment2 7,,ii7 in subclause 7,,ii7-- 7aa7 by striking for calendar years #bjac through #bjag2 and 7bb7 by inserting for calendar years #bjah through #bjbb after participation rates2 and 7,,iii7 by striking subclause 7,,iii7 and inserting the following3 7,,iii7 ,the highest age-adjusted average rates of drug overdose deaths for calendar years #bjah through #bjbb based on data from the ,centers for ,disease ,control and ,prevention1 including1 if necessary1 provisional data for calendar year #bjbb4 2 and 7,d7 in subsection 7f71 by striking ,for the #b-year period following the date of enactment of this ,act1 the and inserting ,the4 7#b7 ,conforming amendment ,subtitle ,f of title ,,viii of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga2 #acb ,stat4 #djie7 is amended by striking the subtitle heading and inserting the following3 ,subtitle ,f--,,career ,act2 ,recovery ,housing ,pilot ,program4 7c7 ,clerical amendments ,the table of contents in section #a7;b7 of the ,,support for ,patients and ,communities ,act 7,public ,law #aae-bga2 #acb ,stat4 #chid7 is amended-- 7#a7 by striking the item relating to section #gahc and inserting the following3 ,sec4 #gahc4 ,,career ,act2 treatment1 recovery1 and workforce support grants4 2 7#b7 by striking the item relating to subtitle ,f of title ,,viii and inserting the following3 ,subtitle ,f--,,career ,act2 ,recovery ,housing ,pilot ,program 2 and 7#c7 by striking the item relating to section #hjga and inserting the following3 ,sec4 #hjga4 ,,career ,act2 ,recovery ,housing ,pilot ,program4 4 #edf4 ,addressing economic and workforce impacts of the opioid crisis ,section #hjda7;g77#a7 of the ,,support for ,patients and ,communities ,act 7#bi ,u4,s4,c4 #cbbe;a7g77#a77 is amended by striking #bjbc and inserting #bjbi4 ,d ,miscellaneous matters #eea4 ,delivery of a controlled substance by a pharmacy to a prescribing practitioner ,section #cji;,a7a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbi;a7a77 is amended by striking paragraph 7#b7 and inserting the following3 7#b7 the controlled substance is a drug in schedule ,,iii1 ,,iv1 or ,v to be administered-- 7,a7 by injection or implantation for the purpose of maintenance or detoxification treatment2 or 7,b7 subject to a risk evaluation and mitigation strategy pursuant to section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 that includes elements to assure safe use of the drug described in subsection 7f77#c77;,e7 of such section1 including a requirement for post-administration monitoring by a health care provider4 4 #eeb4 ,technical correction on controlled substances dispensing ,effective as if included in the enactment of ,public ,law #aag-cbh-- 7#a7 section #abeb7;a7 of division ,,ff of ,public ,law #aag-cbh 7#acf ,stat4 #efha7 is amended1 in the matter being inserted into section #cjb7;e7 of the ,controlled ,substances ,act1 by striking #cjc7;g7 and inserting #cjc7;h72 7#b7 section #abfb of division ,,ff of ,public ,law #aag-cbh 7#acf ,stat4 #efha7 is amended-- 7,a7 in subsection 7a7-- 7i7 in the matter preceding paragraph 7#a71 by striking #cjc7;g7 and inserting #cjc7;h72 7ii7 in the matter being stricken by subsection 7a77#b71 by striking 7g77#a7 and inserting 7h77#a72 and 7iii7 in the matter being inserted by subsection 7a77#b71 by striking 7g7 ,practitioners and inserting 7h7 ,practitioners2 and 7,b7 in subsection 7b7-- 7i7 in the matter being stricken by paragraph 7#a71 by striking #cjc7;g77#a7 and inserting #cjc7;h77#a72 7ii7 in the matter being inserted by paragraph 7#a71 by striking #cjc7;g7 and inserting #cjc7;h72 7iii7 in the matter being stricken by paragraph 7#b77;,a71 by striking #cjc7;g77#b7 and inserting #cjc7;h77#b72 7iv7 in the matter being stricken by paragraph 7#c71 by striking #cjc7;g77#b77;,b7 and inserting #cjc7;h77#b77;,b72 7v7 in the matter being stricken by paragraph 7#e71 by striking #cjc7;g7 and inserting #cjc7;h72 and 7vi7 in the matter being stricken by paragraph 7#f71 by striking #cjc7;g7 and inserting #cjc7;h72 and 7#c7 section #abfc7;b7 of division ,,ff of ,public ,law #aag-cbh 7#acf ,stat4 #efhe7 is amended-- 7,a7 by striking #cjc7;g77#b7 and inserting #cjc7;h77#b72 and 7,b7 by striking 7#ba ,u4,s4,c4 #hbc7;g77#b77 and inserting 7#ba ,u4,s4,c4 #hbc7;h77#b774 #eec4 ,required training for prescribers of controlled substances 7a7 ,in general ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended-- 7#a7 by redesignating the second subsection designated as subsection 7l7 as subsection 7m72 and 7#b7 in subsection 7m77#a71 as so redesignated-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7iv7-- 7,i7 in subclause 7,i7-- 7aa7 by inserting the ,american ,academy of ,family ,physicians1 the ,american ,podiatric ,medical ,association1 the ,academy of ,general ,dentistry1 the ,american ,optometric ,association1 before or any other organization2 7bb7 by striking or the ,commission and inserting the ,commission2 and 7cc7 by inserting 1 or the ,council on ,podiatric ,medical ,education before the semicolon at the end2 and 7,,ii7 in subclause 7,,iii71 by inserting or the ,american ,academy of ,family ,physicians after ,association2 and 7ii7 in clause 7v71 in the matter preceding subclause 7,i7-- 7,i7 by striking osteopathic medicine1 dental surgery and inserting osteopathic medicine1 podiatric medicine1 dental surgery2 and 7,,ii7 by striking or dental medicine curriculum and inserting or dental or podiatric medicine curriculum2 and 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i7-- 7,i7 by inserting the ,american ,pharmacists ,association1 the ,accreditation ,council on ,pharmacy ,education1 the ,american ,psychiatric ,nurses ,association1 the ,american ,academy of ,nursing1 the ,american ,academy of ,family ,physicians1 before or any other organization2 and 7,,ii7 by inserting 1 the ,american ,academy of ,family ,physicians1 before or the ,accreditation ,council2 and 7ii7 in clause 7ii7-- 7,i7 by striking or accredited school and inserting 1 an accredited school2 and 7,,ii7 by inserting 1 or an accredited school of pharmacy before in the ,united ,states4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if enacted on ,december #bi1 #bjbb4 #eed4 ,extension of temporary order for fentanyl-related substances ,effective as if included in the enactment of the ,temporary ,reauthorization and ,study of the ,emergency ,scheduling of ,fentanyl ,analogues ,act 7,public ,law #aaf-aad71 section #b of such ,act is amended by striking ,march #ca1 #bjbe and inserting ,september #cj1 #bjbf4 ,,vi ,pandemic and ,all-,hazards ,preparedness and ,response #fja4 ,short title ,this title may be cited as the ,pandemic and ,all-,hazards ,preparedness and ,response ,act4 ,a ,state and local readiness and response #faa4 ,temporary reassignment of ,state and local personnel during a public health emergency ,section #cai7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7e77 is amended-- 7#a7 in paragraph 7#a71 by striking tribal organization or such ,governor or tribal organization's designee and inserting ,tribal organization or the designee of the ,governor or ,tribal organization1 or the ,state or ,tribal health official2 7#b7 in paragraph 7#b77;,b7-- 7,a7 in the matter preceding clause 7i71 by striking tribal organization and inserting ,tribal organization1 or the ,state or ,tribal health official2 and 7,b7 in clause 7v71 by striking tribal organization and inserting ,tribal organization or ,state or ,tribal health official2 7#c7 in paragraph 7#f7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking ,reauthorization ,act of #bjac and inserting and ,response ,act2 and 7ii7 by striking appropriate committees of the ,congress and inserting ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7,b7 in subparagraph 7,a71 by inserting 1 including requests from ,state or ,tribal health officials before the semicolon2 7#d7 in paragraph 7#g77;,a71 by striking tribal organization and inserting ,tribal organization2 and 7#e7 in paragraph 7#h71 by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbf4 #fab4 ,public ,health ,emergency ,preparedness program ,section #cai;,c-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a77ii71 by striking influenza and inserting response planning2 and 7,b7 in subparagraph 7,h71 by inserting 1 such as community-based organizations1 including faith-based organizations1 and other public and private entities after stakeholders2 7#b7 in subsection 7g7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting and the ability of each entity receiving an award under subsection 7a7 to respond to all-hazards threats before the period at the end of the first sentence2 7,b7 in paragraph 7#b7-- 7i7 in the paragraph heading1 by striking influenza and inserting response2 and 7ii7 in subparagraph 7,a7-- 7,i7 by striking to pandemic influenza and inserting to a pathogen causing a pandemic1 including pandemic influenza2 and 7,,ii7 by striking such pandemic influenza and inserting such pandemic response2 7,c7 in paragraph 7#e7-- 7i7 in the paragraph heading1 by striking influenza and inserting pandemic response2 7ii7 in the matter preceding subparagraph 7,a71 by striking #bjai and inserting #bjbf2 7iii7 in subparagraph 7,a71 by striking #bjah and inserting #bjbe2 and 7iv7 in subparagraph 7,b71 by striking pandemic influenza and inserting a pathogen causing a pandemic2 and 7,d7 in paragraph 7#f7-- 7i7 in subparagraph 7,a71 in the matter preceding clause 7i71 by striking ,the amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section #cai;,c-#b and inserting ,the ,secretary shall withhold from an entity pursuant to paragraph 7#e7 for noncompliance with the requirements of this section or section #cai;,c-#b as follows2 and 7ii7 in subparagraph 7,b71 by inserting with respect to the requirements of this section or section #cai;,c-#b after paragraph 7#e72 and 7#c7 in subsection 7h77#a77;,a71 by striking #fhe1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #gce1jjj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fac4 ,hospital ,preparedness ,program 7a7 ,increasing participation by ,,ems in the hospital preparedness program 7#a7 ,in general ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7,a7 in subsection 7b77#a77;,a7-- 7i7 in clause 7iii77,,iii71 by striking 2 and and inserting a semicolon2 and 7ii7 by striking clause 7iv7 and inserting the following3 7iv7 one or more emergency medical service organizations2 and 7v7 to the extent practicable1 one or more emergency management organizations2 and 2 and 7,b7 in subsection 7g77#a7-- 7i7 by striking 7#a7 ,local response capabilities and inserting3 7#a7 ,local response capabilities 7,a7 ,program coordination 2 7ii7 by striking extent practicable1 ensure and inserting the following3 8extent practicable-- 7i7 ensure 2 7iii7 by striking the period and inserting 2 and2 and 7iv7 by adding at the end the following3 7ii7 seek to increase participation of eligible entities described in subsection 7b77#a77;,a7 with lower participation rates relative to other eligible entities1 such as emergency medical services organizations and health care facilities in underserved areas4 4 7#b7 ,preferences ,section #cai;,c-#b7;d77#a77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77iii77 is amended by striking subsection 7b77#a77;,a77ii7 and inserting clauses 7ii7 and 7iv7 of subsection 7b77#a77;,a74 7b7 ,improving medical readiness and response capabilities ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 7,b7 in subparagraph 7,b71 by striking the period and inserting 2 and2 and 7,c7 by inserting at the end the following3 7,c7 designate a lead entity to administer such award and support coordination between entities described in this subsection4 2 7#b7 in subsection 7g77#a71 as amended by subsection 7a77#a77;,b71 by adding at the end the following3 7,b7 ,regional operations ,an eligible entity shall establish and maintain1 or leverage an existing1 capability to enable coordination of regional medical operations1 which may include systems to facilitate information sharing and coordination1 within a coalition described under subsection 7b77#a77;,a7 and1 as appropriate1 among multiple coalitions that are in close geographic proximity to each other4 2 and 7#c7 in subsection 7j77#a7-- 7,a7 in subparagraph 7,a71 by striking for each of fiscal years #bjai through #bjbc and inserting for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf2 and 7,b7 in subparagraph 7,b77iii71 by striking ,september #cj1 #bjbc and inserting ,december #ca1 #bjbf4 #fad4 ,facilities and capacities of the ,centers for ,disease ,control and ,prevention to combat public health security threats ,section #cai;,d7h7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7;h77 is amended-- 7#a7 in paragraph 7#a71 by striking #be1jjj1jjj for each of fiscal years #bjbb and #bjbc and inserting #dj1jjj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf2 and 7#b7 in paragraph 7#b71 by striking #bjbb and #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fae4 ,pilot program to support ,state medical stockpiles 7a7 ,in general ,section #cai;,f-#b7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7i77 is amended-- 7#a7 in paragraph 7#b77;,b77i7-- 7,a7 in subclause 7,i71 by striking and #bjbd and inserting through #bjbe2 and 7,b7 in subclause 7,,ii71 by striking #bjbe and inserting #bjbf2 7#b7 in paragraph 7#d7-- 7,a7 in subparagraph 7,g71 by striking 2 and at the end and inserting a semicolon2 7,b7 by redesignating subparagraph 7,h7 as subparagraph 7,i72 7,c7 by inserting after subparagraph 7,g7 the following3 7,h7 facilitate the sharing of best practices among ,states within a consortia of ,states in receipt of funding related to establishing and maintaining a stockpile of medical products2 and 2 and 7,d7 in subparagraph 7,i71 as so redesignated1 by striking ,state efforts and inserting ,state or regional efforts2 7#c7 by redesignating paragraphs 7#e7 through 7#i7 as paragraphs 7#f7 through 7#aj71 respectively2 7#d7 by inserting after paragraph 7#d7 the following3 7#e7 ,coordination ,an entity in receipt of an award under paragraph 7#a71 in carrying out the activities under this subsection1 shall coordinate with appropriate health care entities1 health officials1 and emergency management officials within the jurisdiction of such ,state or ,states4 2 and 7#e7 in paragraph 7#aj71 as so redesignated1 by striking #c1ejj1jjj1jjj for each of fiscal years #bjbc and #bjbd and inserting #c1cfe1jjj1jjj for fiscal year #bjbe1 and #c1bfe1jjj1jjj for fiscal year #bjbf4 7b7 ,,gao report ,section #bdji7;b7 of the ,,prevent ,pandemics ,act 7,public ,law #aag-cbh7 is amended-- 7#a7 in paragraph 7#b71 by striking 2 and and inserting a semicolon2 7#b7 in paragraph 7#c71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7#d7 the impact of any regional stockpiling approaches carried out under subsection 7i77#a7 of section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 4 #faf4 ,enhancing domestic wastewater surveillance for pathogen detection 7a7 ,in general ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cag,v 7#db ,u4,s4,c4 #bdg;b-#bd7 the following3 #cag,w4 ,wastewater surveillance for pathogen detection 7a7 ,wastewater surveillance system ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other ,federal departments and agencies1 shall award grants1 contracts1 or cooperative agreements to eligible entities to establish1 maintain1 or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes4 7b7 ,eligible entities ,to be eligible to receive an award under this section1 an entity shall-- 7#a7 be a ,state1 ,tribal1 or local health department1 or a partnership between such a health department and other public and private entities2 and 7#b7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 which shall include-- 7,a7 a description of activities proposed to be carried out pursuant to an award under subsection 7a72 7,b7 factors such entity proposes to use to select wastewater sampling sites2 7,c7 factors such entity proposes to use to determine whether a response to findings from such wastewater sampling may be warranted1 and a plan for responding1 as appropriate1 consistent with applicable plans developed by such entity pursuant to section #cai;,c-#a2 7,d7 a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period2 and 7,e7 any additional information the ,secretary may require4 7c7 ,consideration ,in making awards under subsection 7a71 the ,secretary may give priority to eligible entities that have submitted an application that-- 7#a7 details plans to provide public access to deidentified data generated through such wastewater surveillance activities in a manner that allows for comparison to such data generated by other recipients of an award under subsection 7a72 and 7#b7 provides an assessment of community needs related to ongoing infectious disease monitoring1 including estimates of the incidence and prevalence of infectious diseases that can be detected in wastewater and availability1 at the time of the application1 of other forms of infectious disease detection in the jurisdiction4 7d7 ,use of funds ,an eligible entity shall1 as appropriate1 use amounts awarded under this section to-- 7#a7 establish or enhance existing capacity and capabilities to conduct wastewater sampling1 testing1 and related analysis2 7#b7 conduct wastewater surveillance1 as appropriate1 in areas or facilities with increased risk of infectious disease outbreaks and limited ability to utilize other forms of infectious disease detection1 such as at individual facilities1 institutions1 and locations in rural areas or areas in which wastewater is not treated through the relevant local utility of the jurisdiction2 and 7#c7 implement projects that use evidence-based or innovative practices to conduct wastewater surveillance activities4 7e7 ,partnerships ,in carrying out activities under this section1 eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities1 as appropriate and consistent with this section4 7f7 ,technical assistance ,the ,secretary1 in consultation with the heads of other applicable ,federal agencies and departments1 as appropriate1 shall provide technical assistance to recipients of awards under this section to facilitate the planning1 development1 and implementation of activities described in subsection 7d74 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #bj1jjj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 4 7b7 ,wastewater surveillance research 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall continue to conduct or support research on the use of wastewater surveillance to detect and monitor emerging infectious diseases1 which may include-- 7,a7 research to improve the efficiency and effectiveness of wastewater sample collection and analysis and increase the sensitivity and specificity of wastewater testing methods2 and 7,b7 implementation and development of evidence-based practices to facilitate the estimation of the incidence and prevalence of infectious disease within a community4 7#b7 ,non-duplication of effort ,the ,secretary shall ensure that activities carried out under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the ,department of ,health and ,human ,services related to wastewater surveillance4 #fag4 ,reauthorization of ,mosquito ,abatement for ,safety and ,health program ,section #cag,s of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ba7 is amended-- 7#a7 in subsection 7a77#c77;,a71 by striking subsection 7b77#c7 and inserting subsection 7b77#d72 7#b7 in subsection 7b7-- 7,a7 by redesignating paragraphs 7#c7 through 7#f7 as paragraphs 7#d7 through 7#g71 respectively2 and 7,b7 by inserting after paragraph 7#b7 the following3 7#c7 ,considerations ,the ,secretary may consider the use of innovative and novel technology for mosquito prevention and control in making grants under paragraph 7#a74 2 7#c7 by amending subsection 7d7 to read as follows3 7d7 ,uses of funds ,amounts appropriated under subsection 7f7 may be used by the ,secretary to provide training and technical assistance with respect to the planning1 development1 and operation of assessments and plans under subsection 7a7 and control programs under subsection 7b74 ,the ,secretary may provide such training and technical assistance directly or through awards of grants or contracts to public and private entities4 2 and 7#d7 in subsection 7f77#a71 by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 ,b ,federal planning and coordination #fba4 ,all-,hazards ,emergency ,preparedness and ,response ,section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#c7-- 7i7 by striking ,oversee advanced research1 development1 and procurement and inserting the following3 7,a7 ,in general ,oversee advanced research1 development1 procurement1 and replenishment 2 and 7ii7 by adding at the end the following3 7,b7 ,development of requirements ,lead the development and approval1 and1 on a routine basis1 the review and update1 of requirements for such countermeasures and products1 including related capabilities1 to inform the advanced research1 development1 procurement1 and replenishment decisions of the ,secretary4 2 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,f7-- 7,i7 in the matter preceding clause 7i71 by striking and in consultation with the ,secretary of ,homeland ,security12 and 7,,ii7 in clause 7i71 by inserting enhance after capabilities and2 7ii7 in subparagraph 7,g7-- 7,i7 in the matter preceding clause 7i71 by inserting the ,office of ,pandemic ,preparedness and ,response ,policy1 after ,veterans ,affairs12 7,,ii7 in clause 7i71 by striking based on and inserting based on--2 7,,iii7 in clause 7ii71 by striking 2 and at the end and inserting a semicolon2 7,,iv7 in clause 7iii71 by striking the period and inserting 2 and2 and 7,v7 by adding at the end the following3 7iv7 that include1 as appropriate1 participation by relevant industry1 academia1 professional societies1 and other stakeholders4 2 7iii7 in subparagraph 7,h7-- 7,i7 by inserting and the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy after ,security ,affairs2 and 7,,ii7 by inserting and medical product and supply capacity planning pursuant to subparagraph 7,j71 including discussion of any relevant identified supply chain vulnerabilities before the period at the end2 7iv7 in subparagraph 7,i71 by inserting the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy1 after ,security ,affairs12 and 7v7 in subparagraph 7,j77i71 in the matter preceding subclause 7,i71 by inserting 7including ancillary medical supplies and components of medical products1 such as active pharmaceutical ingredients1 key starting materials1 medical device components1 testing kits1 reagents1 and other testing supplies7 after supply needs2 and 7,c7 in paragraph 7#g7-- 7i7 in the matter preceding subparagraph 7,a71 by inserting and the requirements developed pursuant to paragraph 7#c77;,b7 after subsection 7d72 7ii7 by redesignating subparagraphs 7,e7 and 7,f7 as subparagraphs 7,f7 and 7,g71 respectively2 and 7iii7 by inserting after subparagraph 7,d7 the following3 7,e7 include a professional judgment of anticipated budget needs for each future fiscal year accounted for in such plan to account for the full range of anticipated medical countermeasure needs and life-cycle costs to address such priorities and requirements2 2 7#b7 in subsection 7d7-- 7,a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general ,not later than ,march #ae1 #bjbj1 and biennially thereafter1 the ,assistant ,secretary for ,preparedness and ,response shall develop and 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 coordinated strategy for medical countermeasures to address chemical1 biological1 radiological1 and nuclear threats1 informed by the requirements developed pursuant to subsection 7b77#c77;,b74 ,not later than #ahj days after the submission of such strategy to such committees1 the ,assistant ,secretary for ,preparedness and ,response shall submit an accompanying implementation plan to such committees4 ,in developing such a strategy and plan1 the ,assistant ,secretary for ,preparedness and ,response shall consult with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a4 ,such strategy and plan shall be known as the ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan4 2 and 7,b7 in paragraph 7#b71 in the matter preceding subparagraph 7,a71 by inserting strategy and before plan2 and 7#c7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting 1 including such agents that are an emerging infectious disease after become a pandemic2 and 7,b7 in paragraph 7#b77;,a71 by striking #bej1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #cce1jjj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fbb4 ,national ,health ,security ,strategy ,section #bhjb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 by striking ,in #bjbb1 the and inserting ,the2 and 7,b7 by inserting 1 maintaining1 and sustaining after establishing2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting that support interagency coordination and availability of information1 as appropriate before the period2 7ii7 in subparagraph 7,b71 by inserting rapid testing1 after and supplies12 7,b7 in paragraph 7#c7-- 7i7 in the matter preceding subparagraph 7,a71 by inserting and blood banks after dental health facilities2 7ii7 in subparagraph 7,c71 by inserting and current capacity of facilities within such systems1 as applicable before the period2 and 7iii7 in subparagraph 7,d71 by inserting and other medical products and medical supplies consistent with the activities carried out under section #bhaa7;b77#d77;,j7 before the period2 7,c7 in paragraph 7#e71 by inserting applicable federally funded activities and after 7including2 7,d7 in paragraph 7#h7-- 7i7 in subparagraph 7,a71 by inserting public health and medical before activities2 and 7ii7 in subparagraph 7,b71 by striking familiarity with and inserting understanding of1 and coordination between12 7,e7 by redesignating paragraphs 7#i7 and 7#aj7 as paragraphs 7#aj7 and 7#ab71 respectively2 7,f7 by inserting after paragraph 7#h7 the following3 7#i7 ,other settings ,supporting ,federal1 ,state1 local1 and ,tribal coordination and planning with respect to facilities in which there is an increased risk of infectious disease outbreaks1 including such facilities that address the needs of at-risk individuals1 in the event of a public health emergency declared under section #cai4 2 7,g7 by inserting after subparagraph 7#aj71 as so redesignated1 the following3 7#aa7 ,other hazards ,assessing current and potential health security threats from natural disasters with respect to public health and medical preparedness and response4 2 7,h7 by inserting after paragraph 7#ab71 as so redesignated1 the following3 7#ac7 ,cybersecurity resiliency of health care systems ,consistent with the requirements of section #bbah of the ,homeland ,security ,act of #bjjb1 strengthening the ability of ,states1 local communities1 and ,tribal communities to prepare for1 respond to1 and be resilient against cybersecurity vulnerabilities or cybersecurity attacks that affect public health and health information technology1 and encouraging health care facilities to use recognized security practices meeting or exceeding the approaches established under section #dje7;d7 of the ,cybersecurity ,act of #bjae4 2 and 7,i7 by striking tribal each place it appears and inserting ,tribal4 #fbc4 ,improving development and distribution of diagnostic tests ,section #cai;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#b7 is amended to read as follows3 #cai;,b4 ,improving development and distribution of diagnostic tests 7a7 ,diagnostic testing preparedness plan ,the ,secretary shall develop1 make publicly available1 not later than #a year after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,response ,act1 and update not less frequently than every #c years thereafter1 a plan for the rapid development1 validation1 authorization1 manufacture1 procurement1 and distribution of diagnostic tests1 and for rapid scaling of testing capacity1 in response to chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases1 for which a public health emergency is declared under section #cai1 or that has significant potential to cause such a public health emergency4 7b7 ,purposes ,the purpose of the plan under subsection 7a7 shall be to-- 7#a7 facilitate the development and utilization of diagnostic tests2 7#b7 describe the processes for the rapid development1 validation1 authorization1 manufacture1 procurement1 and distribution of diagnostic tests1 and for rapid scaling of testing capacity2 and 7#c7 facilitate coordination and collaboration among public and private entities to improve the rapid development and utilization of diagnostic testing during a public health emergency4 7c7 ,considerations ,the plan under subsection 7a7 shall take into consideration-- 7#a7 domestic capacity1 including any such capacity established through partnerships with public and private entities pursuant to subsection 7e71 to support the development1 validation1 manufacture1 procurement1 and distribution of tests1 and the rapid scaling of testing capacity2 7#b7 novel technologies and platforms that-- 7,a7 may be used to improve testing capabilities1 including-- 7i7 high-throughput laboratory diagnostics2 7ii7 point-of-care diagnostics2 and 7iii7 rapid at-home diagnostics2 7,b7 improve the accessibility of diagnostic tests2 and 7,c7 facilitate the development and manufacture of diagnostic tests2 7#c7 medical supply needs related to testing1 including diagnostic testing1 equipment1 supplies1 and component parts1 and any potential vulnerabilities related to the availability of such medical supplies and related planning needs1 consistent with section #bhaa7;b77#d77;,j72 7#d7 strategies for the rapid and efficient distribution of tests locally1 regionally1 or nationwide and appropriate scaling of laboratory testing capacity2 and 7#e7 assessment of such strategies through drills and operational exercises carried out under section #bhaa7;b77#d77;,g71 as appropriate4 7d7 ,coordination ,to inform the development and update of the plan under subsection 7a71 and in carrying out activities to implement such plan1 the ,secretary shall coordinate with industry1 such as device manufacturers1 clinical and reference laboratories1 and medical product distributors1 ,states1 local governmental entities1 ,indian ,tribes and ,tribal organizations1 and other relevant public and private entities4 7e7 ,capacity building ,the ,secretary may contract with public and private entities1 as appropriate1 to increase domestic capacity in the rapid development1 validation1 authorization1 manufacture1 procurement1 and distribution of diagnostic tests1 as appropriate1 to ,state1 local1 and ,tribal health departments and other appropriate entities for immediate public health response activities to address an infectious disease with respect to which a public health emergency is declared under section #cai1 or that has significant potential to cause such a public health emergency4 4 #fbd4 ,combating antimicrobial resistance 7a7 ,in general ,section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by inserting and activities after ,federal programs2 7,b7 in paragraph 7#b7-- 7i7 by striking public health constituencies1 manufacturers1 veterinary and medical professional societies and others and inserting the ,advisory ,council described in subsection 7b7 and relevant public and private entities2 and 7ii7 by inserting 1 pursuant to paragraph 7#d71 after comprehensive plan2 7,c7 by amending paragraph 7#c7 to read as follows3 7#c7 ,agenda ,the task force described in paragraph 7#a7 shall consider factors the ,secretary considers appropriate1 including factors to-- 7,a7 slow the emergence of resistant bacteria and fungi and prevent the spread of resistant infections2 7,b7 strengthen activities to combat resistance with respect to zoonotic diseases2 7,c7 advance development and use of rapid and innovative capabilities1 including diagnostic tests1 for identification and characterization of resistant bacteria and fungi2 7,d7 accelerate basic and applied research and development for new antibiotics1 antifungals1 and other related therapeutics and vaccines2 and 7,e7 support international collaboration and capacities for antimicrobial-resistance prevention1 detection1 and control4 2 7,d7 by redesignating paragraph 7#d7 as paragraph 7#e72 7,e7 by inserting after paragraph 7#c7 the following3 7#d7 ,action plan ,not later than ,october #a1 #bjbf1 and every #e years thereafter1 the task force described in paragraph 7#a7 shall develop and 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 ,representatives a plan regarding ,federal programs and activities to combat antimicrobial resistance1 including measurable outcomes1 as appropriate1 informed by-- 7,a7 the agenda described in paragraph 7#c72 7,b7 input provided by the ,advisory ,council described in subsection 7b72 and 7,c7 input from other relevant stakeholders provided pursuant to paragraph 7#b74 2 7#b7 by redesignating subsections 7b7 through 7o7 as subsections 7c7 through 7p71 respectively2 7#c7 by inserting after subsection 7a7 the following3 7b7 ,advisory council 7#a7 ,in general ,the ,secretary may continue the ,presidential ,advisory ,council on ,combating ,antibiotic-,resistant ,bacteria1 referred to in this subsection as the ,advisory ,council4 7#b7 ,duties ,the ,advisory ,council shall advise and provide information and recommendations to the ,secretary1 acting through the ,task ,force established under subsection 7a71 regarding ,federal programs and activities intended to reduce or combat antimicrobial-resistant bacteria or fungi that may present a public health threat and improve capabilities to prevent1 diagnose1 mitigate1 or treat such resistance4 ,such advice1 information1 and recommendations may be related to improving ,federal efforts related to factors described in subsection 7a77#c7 and other topics related to antimicrobial resistance1 as appropriate4 7#c7 ,meetings and coordination 7,a7 ,meetings ,the ,advisory ,council shall meet not less frequently than biannually and1 to the extent practicable1 in coordination with meetings of the task force established under subsection 7a74 7,b7 ,coordination ,the ,advisory ,council shall1 to the greatest extent practicable1 coordinate activities carried out by the ,council with the task force established under subsection 7a74 7#d7 ,,faca ,chapter #aj of title #e1 ,united ,states ,code1 shall apply to the activities and duties of the ,advisory ,council4 7#e7 ,sunset 7,a7 ,in general ,the ,advisory ,council under this subsection shall terminate on ,december #ca1 #bjbf4 7,b7 ,extension of ,advisory ,council ,not later than ,october #a1 #bjbf1 the ,secretary 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 that includes a recommendation on whether the ,advisory ,council should be extended1 and identifying whether there are other committees1 councils1 or task forces that have overlapping or similar duties to that of the ,advisory ,council1 and whether such committees1 councils1 or task forces should be combined1 restructured1 or eliminated1 including with respect to the task force established under subsection 7a74 2 and 7#d7 in subsection 7n71 as so redesignated1 by striking 7f7 through 7j7 and inserting 7g7 through 7k74 7b7 ,conforming amendment ,section #eje of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai 7#db ,u4,s4,c4 #bdg;d-#e note2 ,public ,law #aaf-bb7 is amended by striking subsection 7a7 and all that follows through ,not later in subsection 7e7 and inserting the following3 ,not later 4 #fbe4 ,strategic ,national ,stockpile and material threats ,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 7a7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting ,such review shall include a description of how the ,secretary manages and mitigates risks associated with gaps between current inventory levels and stockpiling goals1 prioritizes such risks1 and tracks progress toward mitigation of such risks4 after the first sentence2 and 7ii7 in subparagraph 7,b77i71 by amending subclause 7,,iv7 to read as follows3 7,,iv7 the emergency health security threat or threats such countermeasure procurement is intended to address1 including-- 7aa7 whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats2 and 7bb7 in the case of a countermeasure that addresses a biological agent1 whether such agent has an increased likelihood to become resistant to1 more resistant to1 or evade1 such countermeasure relative to other available medical countermeasures2 2 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,b71 by striking are followed1 regularly reviewed1 and updated with respect to such stockpile and inserting with respect to such stockpile are followed1 regularly reviewed1 and updated to reflect best practices2 7ii7 in subparagraph 7,i71 by inserting 1 through a standard operating procedure1 after ensure2 7iii7 by redesignating subparagraphs 7,h7 through 7,k7 as subparagraphs 7,i7 through 7,l71 respectively2 7iv7 by inserting after subparagraph 7,g7 the following3 7,h7 utilize tools to enable the timely and accurate tracking of the contents of the stockpile throughout the deployment of such contents1 including tracking of the location and geographic distribution and utilization of such contents2 2 7v7 in subparagraph 7,k71 as so redesignated1 by striking 2 and at the end and inserting a semicolon2 7vi7 in subparagraph 7,l71 as so redesignated1 by striking the period and inserting 2 and2 and 7vii7 by adding at the end the following3 7,m7 communicate to relevant vendors regarding modifications1 renewals1 extensions1 or terminations of contracts1 or the intent to exercise options for such contracts1 within #cj days1 as practicable1 of such determination1 including through the development of a contract notification process4 2 7,c7 in paragraph 7#e77;,b71 in the matter preceding clause 7i71 by inserting 1 which may accompany the review required under paragraph 7#b71 after ,representatives a report2 and 7,d7 in paragraph 7#f77;,a7-- 7i7 by redesignating clauses 7viii7 through 7x7 as clauses 7ix7 through 7xi71 respectively2 and 7ii7 by inserting after clause 7vii7 the following3 7viii7 with respect to any change in the ,federal organizational management of the stockpile1 an assessment and comparison of any differences in the processes and operations resulting from such change1 including-- 7,i7 planning for potential countermeasure deployment1 distribution1 or dispensing capabilities2 7,,ii7 organizational structure2 7,,iii7 communication with relevant stakeholders related to procurement decisions2 7,,iv7 processes related to procurement1 deployment1 and use of stockpiled countermeasures2 7,v7 communication and coordination with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise and other related ,federal entities2 7,,vi7 inventory management2 and 7,,vii7 availability and use of resources for such activities2 2 and 7#b7 in subsection 7c77#b77;,c71 by striking promptly and inserting 1 not later than #fj days after each such determination12 7#c7 in subsection 7f77#a71 by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjba1 and #gej1jjj1jjj for each of fiscal years #bjbb and #bjbc and inserting #a1ajj1jjj1jjj for fiscal year #bjbe1 and #a1baj1jjj1jjj for fiscal year #bjbf2 and 7#d7 in subsection 7g77#a71 by striking #bjai through #bjbh and inserting #bjbe through #bjcd4 #fbf4 ,medical countermeasures for viral threats with pandemic potential ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#d7-- 7i7 in subparagraph 7,d7-- 7,i7 in clause 7ii71 by striking 2 and and inserting a semicolon2 and 7,,ii7 by redesignating clause 7iii7 as clause 7iv72 and 7,,iii7 by inserting after clause 7ii7 the following3 7iii7 research and development of medical countermeasures for priority virus families that have significant potential to cause a pandemic1 including such countermeasures that take either pathogen-specific or pathogen-agnostic approaches1 and platform technologies to improve the development and manufacture of such medical countermeasures2 and 2 and 7ii7 in subparagraph 7,f77ii71 by inserting or priority virus families and other viral pathogens that pose a threat due to their significant potential to cause a pandemic1 after pandemic influenza12 and 7,b7 in paragraph 7#e71 by adding at the end the following3 7,i7 ,notification ,in awarding contracts1 grants1 cooperative agreements1 or other transactions under this section1 the ,secretary shall communicate to relevant vendors regarding modifications1 renewals1 extensions1 or terminations of contracts1 including through the development of a contract notification process1 within #cj days of such determination1 as practicable4 2 7#b7 in subsection 7d77#b71 by striking #faa1gjj1jjj for each of fiscal years #bjai through #bjbc and inserting #iej1jjj1jjj for each of fiscal years #bjbe and #bjbf2 and 7#c7 in subsection 7e77#a71 by amending subparagraph 7,d7 to read as follows3 7,d7 ,sunset ,this paragraph shall cease to have force or effect after ,december #ca1 #bjbf4 4 #fbg4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,section #bhaa-a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is amended-- 7#a7 in subsection 7b7-- 7,a7 by redesignating paragraph 7#aa7 as paragraph 7#ac72 7,b7 by inserting after paragraph 7#aj7 the following3 7#aa7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7#ab7 ,the ,director of the ,strategic ,national ,stockpile4 2 and 7,c7 in paragraph 7#ac71 as so redesignated1 by striking the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 the ,director of the ,strategic ,national ,stockpile1 the ,director of the ,national ,institute of ,allergy and ,infectious ,diseases1 and inserting the ,director of the ,national ,institute of ,allergy and ,infectious ,diseases2 and 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#a7-- 7i7 by redesignating subparagraph 7,d7 as subparagraph 7,e72 and 7ii7 by inserting after subparagraph 7,c7 the following3 7,d7 ,assist the ,secretary in developing strategies for appropriate and evidence-based allocation and distribution of countermeasures to jurisdictions1 in a manner that supports the availability and use of such countermeasures1 for public health and medical preparedness and response needs4 2 7,b7 in paragraph 7#b71 by inserting relevant stakeholders1 including industry1 after consider input from2 and 7,c7 by adding at the end the following3 7#c7 ,information sharing ,the ,secretary shall1 as appropriate and in a manner that does not compromise national security1 communicate and share information related to recommendations made and strategies developed under paragraph 7#a7 with relevant stakeholders1 including industry and ,state1 local1 and ,tribal public health departments4 4 #fbh4 ,fellowship and training programs ,section #cag;,g of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#h7 is amended-- 7#a7 by striking ,the ,secretary1 and inserting the following3 7a7 ,in general ,the ,secretary1 2 and 7#b7 by adding at the end the following3 7b7 ,noncompetitive conversion 7#a7 ,in general ,the ,secretary may noncompetitively convert an individual who has completed an epidemiology1 surveillance1 or laboratory fellowship or training program under subsection 7a7 to a career-conditional appointment without regard to the provisions of subchapter ,i of chapter #cc of title #e1 ,united ,states ,code1 provided that such individual meets qualification requirements for the appointment4 4 #fbi4 ,regional biocontainment research laboratories 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall make awards to establish or maintain1 as applicable1 not fewer than #ab regional biocontainment laboratories1 for purposes of-- 7#a7 conducting biomedical research to support public health and medical preparedness for1 and rapid response to1 biological agents1 including emerging infectious diseases2 7#b7 ensuring the availability of surge capacity for purposes of responding to such biological agents2 7#c7 supporting information sharing between1 and the dissemination of findings to1 researchers and other relevant individuals to facilitate collaboration between industry and academia2 and 7#d7 providing1 as appropriate and applicable1 technical assistance and training to researchers and other relevant individuals to support the biomedical research workforce in improving the management and mitigation of safety and security risks in the conduct of research involving such biological agents4 7b7 ,requirements ,as a condition of receiving a grant under this section1 a regional biocontainment laboratory shall agree to such oversight activities as the ,secretary determines appropriate1 including periodic meetings with relevant officials of the ,department of ,health and ,human ,services1 facility inspections1 and other activities as necessary and appropriate to ensure compliance with the terms and conditions of such award4 7c7 ,working group ,the ,secretary shall establish a ,working ,group1 consisting of a representative from each entity in receipt of an award under subsection 7a74 ,the ,working ,group shall make recommendations to the ,secretary in administering awards under this section1 for purposes of-- 7#a7 improving the quality and consistency of applicable procedures and practices within laboratories funded pursuant to subsection 7a72 and 7#b7 ensuring coordination1 as appropriate1 of federally funded activities carried out at such laboratories4 7d7 ,definition ,in this section1 the term regional biocontainment laboratory means a ,biosafety or ,animal ,biosafety ,level-#c and ,level-#b facility located at an institution in the ,united ,states that is designated by the ,secretary to carry out the activities described in subsection 7a74 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #eb1jjj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 7f7 ,administrative expenses ,of the amount available to carry out this section for a fiscal year1 the ,secretary may use not more than #e percent for the administrative expenses of carrying out this section1 including expenses related to carrying out subsection 7c74 7g7 ,report to ,congress ,not later than #a year after the date of the enactment of this ,act1 and biannually thereafter1 the ,secretary1 in consultation with the heads of applicable ,federal departments and agencies shall 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 activities and accomplishments of the regional biocontainment laboratories2 7#b7 any published or disseminated research findings based on research conducted in such laboratories in the applicable year2 7#c7 oversight activities carried out by the ,secretary pursuant to subsection 7b72 7#d7 activities undertaken by the ,secretary to take into consideration the capacity and capabilities of the network of regional biocontainment laboratories in activities to prepare for and respond to biological agents1 which may include leveraging such capacity and capabilities to support the ,laboratory ,response ,network1 as applicable and appropriate2 7#e7 plans for the maintenance and sustainment of federally funded activities conducted at the regional biocontainment laboratories1 consistent with the strategy required under section #bcab of the ,,prevent ,pandemics ,act 7,public ,law #aag-cbh72 and 7#f7 activities undertaken by the ,secretary to coordinate with the heads of other relevant ,federal departments and agencies to ensure that work carried out by each such facility on behalf of the ,secretary and such other relevant heads is prioritized1 is complementary to the work carried out by other such facilities and other relevant federally funded activities1 and avoids unnecessary duplication4 #fbi;,a4 ,limitation related to countries of concern conducting certain research ,section #bcae7;c7 of the ,,prevent ,pandemics ,act 7#db ,u4,s4,c4 #ffbg7 is amended to read as follows3 7c7 ,limitations on countries of concern conducting certain research 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall not fund research that may reasonably be anticipated to involve the creation1 transfer1 and use of enhanced pathogens of pandemic potential or biological agents or toxins listed pursuant to section #cea;,a7a77#a7 of the ,public ,health ,service ,act if such research is conducted by a foreign entity at a facility located in a country that is determined to be a country of concern as defined in paragraph 7#b74 7#b7 ,countries of concern 7,a7 ,definition ,for purposes of this subsection1 a country of concern means the ,people's ,republic of ,china1 the ,democratic ,people's ,republic of ,korea1 the ,russian ,federation1 the ,islamic ,republic of ,iran1 and any other country as determined pursuant to subparagraph 7,b74 7,b7 ,additional countries ,the ,director of ,national ,intelligence 7referred to in this subsection as the ,director7 shall1 in consultation with the ,secretary1 add additional countries of concern for purposes of paragraph 7#a71 only if-- 7i7 the ,director determines that evidence exists that a country has malicious intent related to the creation1 enhancement1 transfer1 or use of pathogens of pandemic potential or biological agents or toxins listed pursuant to such section #cea;,a7a77#a72 and 7ii7 in a manner that does not compromise national security1 the ,director provides such evidence in a report submitted 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,c7 ,limitation ,paragraph 7#a7 shall not take effect with respect to a country of concern identified under subparagraph 7,b7 until the date that is #ae days after the date on which the ,director submits the report described in subparagraph 7,b77ii74 7#c7 ,clarification 7,a7 ,in general ,the requirement of paragraph 7#a7 may be waived by the ,president for the duration of the initial response to an outbreak of a novel emerging infectious disease if the ,president determines that such requirement impedes the ability of the ,federal ,government to immediately respond to such outbreak4 7,b7 ,notification ,the ,president shall notify such committees of ,congress not later than #dh hours after exercising the waiver under subparagraph 7,a71 and shall provide updates to such committees related to the use of such waiver every #ae days thereafter4 7#d7 ,sunset ,the limitation under this subsection shall expire on ,december #ca1 #bjbf4 4 ,c ,addressing the needs of all individuals #fca4 ,improving access to certain programs 7a7 ,procedures related to the transition of certain claims 7#a7 ,procedures for correcting submissions 7,a7 ,requests initially submitted under section #cai;,f-#d 7i7 ,in general ,in the case of a request for compensation submitted under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 for an injury or death related to a medical product for active immunization to prevent coronavirus disease #bjai that the ,secretary determines to be ineligible pursuant to subsection 7b77#d77;,b7 of such section #cai;,f-#d1 the ,secretary shall1 not later than #cj days after such determination1 notify the individual submitting the request of such determination4 7ii7 ,submission of petition ,an individual who receives a notification described in clause 7i7 shall be eligible to submit a petition to the ,united ,states ,court of ,federal ,claims under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 with respect to the same medical product administration claimed in the request submitted under section #cai;,f-#d of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 provided such petition is submitted not later than the later of-- 7,i7 #a year after receiving such notification under clause 7i72 or 7,,ii7 the last date on which the individual otherwise would be eligible to submit a petition relating to such injury1 as specified in section #baaf of such ,act 7#db ,u4,s4,c4 #cjj;aa-#af74 7iii7 ,eligibility ,to be eligible to submit a petition in accordance with clause 7ii71 the petitioner shall have submitted the request that was determined to be ineligible as described in clause 7i7 not later than the applicable deadline for filing a petition under such section #baaf4 7,b7 ,requests initially submitted under section #baaa 7i7 ,in general ,if a special master determines that-- 7,i7 a petition submitted under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 related to a medical product for active immunization to prevent coronavirus disease #bjai that is ineligible for the program under subtitle #b of title ,,xxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 because it relates to a medical product administered at a time when the medical product was not included in the table under section #baad of such ,act 7#db ,u4,s4,c4 #cjj;aa-#ad72 and 7,,ii7 the medical product was administered when it was a covered countermeasure subject to a declaration under section #cai;,f-#c7;b7 of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b771 the special master shall1 not later than #cj days after such determination1 notify the petitioner of such determination4 7ii7 ,submission of request ,an individual who receives a notification described in clause 7i7 shall be eligible to submit a request for compensation under section #cai;,f-#d7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7b77 with respect to the same medical product administration claimed in the petition submitted under section #baaa of such ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7-- 7,i7 not later than #a year after receiving such notification2 or 7,,ii7 in the case that the notification is issued after judicial review of the petition under subsection 7e7 or 7f7 of section #baab of such ,act 7#db ,u4,s4,c4 #cjj;aa-#ab71 not later than #a year after the judgment of the ,united ,states ,court of ,federal ,claims or the mandate is issued by the ,united ,states ,court of ,appeals for the ,federal ,circuit pursuant to such subsection 7e7 or 7f74 7iii7 ,eligibility ,to be eligible to submit a request for compensation in accordance with clause 7ii71 the individual submitting the request shall have submitted the petition under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 that was determined to be ineligible not later than #a year after the date of administration of the medical product4 7#b7 ,changes to certain programs 7,a7 ,section #cai;,f-#d ,section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is amended-- 7i7 in subsection 7b77#d7-- 7,i7 by striking ,except as provided and inserting the following3 7,a7 ,in general ,except as provided 2 and 7,,ii7 by adding at the end the following3 7,b7 ,exclusion of injuries eligible for petition under title ,,xxi ,notwithstanding any other provision of this section1 no individual may be eligible for compensation under this section with respect to a vaccine that1 at the time it was administered1 was included in the ,vaccine ,injury ,table under section #baad4 2 and 7ii7 in subsection 7d77#c7-- 7,i7 by striking ,this section and inserting the following3 7,a7 ,in general ,this section 2 and 7,,ii7 by adding at the end the following3 7,b7 ,exhaustion of remedies ,a covered individual shall not be considered to have exhausted remedies as described in paragraph 7#a71 nor be eligible to seek remedy under section #cai;,f-#c7;d71 unless such individual has provided to the ,secretary all supporting documentation necessary to facilitate the determinations required under subsection 7b77#d74 4 7,b7 ,title ,,xxi ,title ,,xxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is amended-- 7i7 in section #baaa7;a77#b77;,a7 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a771 in the matter preceding clause 7i71 by inserting containing the information required under subsection 7c7 after unless a petition2 7ii7 in section #baab7;d7 7#db ,u4,s4,c4 #cjj;aa-#ab7;d77-- 7,i7 by adding at the end of paragraph 7#a7 the following3 ,such designation shall not occur until the petitioner has filed all materials required under section #baaa7;c742 and 7,,ii7 in paragraph 7#c77;,a77ii71 by striking the petition was filed and inserting on which the chief special master makes the designation pursuant to paragraph 7#a72 7iii7 in section #baad7;e7 7#db ,u4,s4,c4 #cjj;aa-#ad7;e771 by adding at the end the following3 7#d7 ,licensure requirement ,notwithstanding paragraphs 7#b7 and 7#c71 the ,secretary may not revise the ,vaccine ,injury ,table to include a vaccine for which the ,centers for ,disease ,control and ,prevention has issued a recommendation for routine use in children or pregnant women until at least one application for such vaccine has been approved under section #cea4 ,upon such revision of the ,vaccine ,injury ,table1 all vaccines in a vaccine category on the ,vaccine ,injury ,table1 including vaccines authorized under emergency use pursuant to section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 shall be considered included in the ,vaccine ,injury ,table4 2 and 7iv7 in section #baaf 7#db ,u4,s4,c4 #cjj;aa-#af71 by adding at the end the following3 7d7 ,clarification ,notwithstanding subsections 7a7 and 7b71 an injury or death related to a vaccine administered at a time when the vaccine was a covered countermeasure subject to a declaration under section #cai;,f-#c7;b7 shall not be eligible for compensation under the ,program4 4 7b7 ,accelerating injury compensation program administration and ensuring program integrity 7#a7 ,petitions for compensation ,section #baaa7;a77#b77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a77i77 is amended-- 7,a7 in subclause 7,i71 by striking 1 and and inserting a semicolon2 7,b7 in subclause 7,,ii7-- 7i7 by moving the margin #b ems to the right2 and 7ii7 by striking 1 or and inserting 2 and2 and 7,c7 by adding at the end the following3 7,,iii7 the judgment described in subclause 7,i7 does not result from a petitioner's motion to dismiss the case2 or 4 7#b7 ,determination of good faith ,section #baae7;e77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ae7;e77#a77 is amended by adding at the end the following3 ,when making a determination of good faith under this paragraph1 the special master or court may consider whether the petitioner demonstrated an intention to obtain compensation on such petition and was not merely seeking to satisfy the exhaustion requirement under section #baba7;b744 7c7 ,extension of deadlines ,to submit requests for compensation for certain injuries 7#a7 ,in general ,with respect to claims filed under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 alleging a covered injury caused by the administration or use of a covered countermeasure pursuant to a declaration under section #cai;,f-#c7;b7 of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b77 relating to coronavirus disease #bjai1 the following shall apply3 7,a7 ,notwithstanding the filing deadline applicable under such section #cai;,f-#d1 the claim shall be filed within #c years of the administration or use of the covered countermeasure1 or #a year after the date of enactment of this ,act1 whichever is later1 and1 if a claim filed under such section #cai;,f-#d with respect to such administration or use was filed before the date of enactment of this ,act and denied on the basis of having not been filed within the time period required under subsection 7b77#d7 of such section #cai;,f-#d1 such claim may be refiled pursuant to this subparagraph4 7,b7 ,with respect to a claim relating to the administration of a medical product for active immunization to prevent coronavirus disease #bjai such a claim may be filed under the such section #cai;,f-#d only if the administration of such vaccine occurred prior to the addition of the vaccine to the ,vaccine ,injury ,table under section #baad of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ad74 #fcb4 ,supporting at-risk individuals during emergency responses 7a7 ,technical assistance for at-,risk individuals and disasters 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 may provide appropriate technical assistance to ,states1 localities1 ,tribes1 and other applicable entities related to addressing the unique needs and considerations of at-risk individuals1 as defined in section #bhjb7;b77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d771 in the event of a public health emergency declared by the ,secretary pursuant to section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d74 7#b7 ,technical assistance ,the technical assistance described in paragraph 7#a7 shall include-- 7,a7 developing1 identifying1 evaluating1 and disseminating evidence-based or evidence-informed strategies to improve health and address other near-term or long-term outcomes for at-risk individuals related to public health emergencies1 including by addressing such unique needs and considerations in carrying out public health and medical activities to prepare for1 respond to1 and recover from1 such public health emergencies2 and 7,b7 assisting applicable entities1 through contracts or cooperative agreements1 as appropriate1 in the implementation of such evidence-based strategies4 7#c7 ,consultation ,in carrying out activities under paragraph 7#b71 the ,secretary shall take into consideration relevant findings and recommendations of1 and1 as appropriate1 consult with1 the ,national ,advisory ,committee on ,individuals with ,disabilities and ,disasters established under section #bhaa;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d71 the ,national ,advisory ,committee on ,children and ,disasters under section #bhaa;,a of such ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b71 and the ,national ,advisory ,committee on ,seniors and ,disasters under section #bhaa;,b of such ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c74 7b7 ,crisis standards of care ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 acting through the ,director of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 shall issue guidance to ,states and localities on the development or modification of ,state and local crisis standards of care for use during the response to a public health emergency declared by the ,governor of a ,state or by the ,secretary under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d71 or a major disaster or emergency declared by the ,president under section #dja or #eja1 respectively1 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eagj1 #eaia7 to ensure that such standards of care are consistent with the nondiscrimination requirements of section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 title ,,ii of the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaca et seq471 and the ,age ,discrimination ,act of #aige 7#db ,u4,s4,c4 #faja et seq474 #fcc4 ,national advisory committees 7a7 ,national ,advisory ,committee on ,children and ,disasters ,subsection 7g7 of section #bhaa;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b7 is amended to read as follows3 7g7 ,sunset 7#a7 ,in general ,the ,advisory ,committee shall terminate on ,december #ca1 #bjbf4 7#b7 ,extension of ,advisory ,committee ,not later than ,october #a1 #bjbe1 the ,secretary shall submit to ,congress a recommendation on whether the ,advisory ,committee should be extended beyond the date described in paragraph 7#a74 4 7b7 ,national advisory committee on seniors and disasters ,section #bhaa;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c7 is amended-- 7#a7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting and departments after agencies2 and 7ii7 by striking #ag members and inserting #be members2 and 7,b7 in paragraph 7#b7-- 7i7 by striking subparagraphs 7,j7 and 7,k72 7ii7 by redesignating subparagraphs 7,a7 through 7,i7 and 7,l7 as clauses 7i7 through 7x71 respectively1 and adjusting the margins accordingly2 7iii7 by inserting before clause 7i71 as so redesignated1 the following3 7,b7 ,federal members ,the ,federal members shall include the following3 2 and 7iv7 by inserting before subparagraph 7,b71 as so designated1 the following3 7,a7 ,non-,federal members ,the ,secretary in consultation with such other heads of agencies and departments as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals1 including the following3 7i7 ,at least #c non-,federal health care providers with expertise in geriatric medical disaster planning1 preparedness1 response1 or recovery4 7ii7 ,at least #c representatives of ,state1 local1 territorial1 or ,tribal agencies with expertise in geriatric disaster planning1 preparedness1 response1 or recovery4 7iii7 ,at least #b non-,federal professionals with training in gerontology1 such as social workers1 scientists1 human services specialists1 or other non-medical professionals1 with experience in disaster planning1 preparedness1 response1 or recovery among other adults4 2 and 7#b7 by amending subsection 7g7 to read as follows3 7g7 ,sunset ,the ,advisory ,committee shall terminate on ,december #ca1 #bjbf4 4 7c7 ,national advisory committee on individuals with disabilities and disasters ,section #bhaa;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d7 is amended-- 7#a7 by redesignating subsections 7c7 through 7g7 as subsections 7d7 through 7h71 respectively2 7#b7 by inserting after subsection 7b7 the following3 7c7 ,additional duties ,the ,advisory ,committee may provide advice and recommendations to the ,secretary with respect to individuals with disabilities and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this title and title ,,iii4 2 7#c7 in subsection 7d71 as so redesignated-- 7,a7 in paragraph 7#a71 by striking #ag members and inserting #be members2 7,b7 in paragraph 7#b7-- 7i7 by striking subparagraphs 7,k7 through 7,m72 7ii7 by redesignating subparagraphs 7,a7 through 7,j7 as clauses 7i7 through 7x71 respectively1 and adjusting the margins accordingly2 7iii7 by inserting before clause 7i71 as so redesignated1 the following3 7,b7 ,federal members ,the ,federal members shall include the following3 2 7iv7 by adding at the end of subparagraph 7,b71 as so designated1 the following3 7xi7 ,representatives of such other ,federal agencies as the ,secretary determines necessary to fulfill the duties of the ,advisory ,committee4 2 and 7v7 by inserting before subparagraph 7,b71 as so designated1 the following3 7,a7 ,non-,federal members ,the ,secretary in consultation with such other heads of agencies and departments as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals1 including the following3 7i7 ,at least #d non-,federal health care professionals with expertise in disability accessibility before1 during1 and after disasters1 medical and mass care disaster planning1 preparedness1 response1 or recovery4 7ii7 ,at least #c representatives of ,state1 local1 ,tribal1 or territorial agencies with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities4 7iii7 ,at least #d individuals with a disability with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities4 7iv7 ,other members as the ,secretary determines appropriate1 of whom-- 7,i7 at least one such member shall represent a local1 ,state1 or national organization with expertise in individuals with disabilities2 7,,ii7 at least one such member shall be an individual with a disability2 and 7,,iii7 at least one such member shall be an individual with expertise in the needs of housing services1 including during the response to1 and recovery from1 disasters4 2 and 7,c7 by adding at the end the following3 7#c7 ,consideration ,in appointing members1 including the ,chair1 to the ,committee under this subsection1 the ,secretary may give consideration to disability status4 2 and 7#d7 by amending subsection 7h71 as so redesignated1 to read as follows3 7h7 ,sunset ,the ,advisory ,committee shall terminate on ,december #ca1 #bjbf4 4 #fcd4 ,national ,academies study on prizes 7a7 ,in general ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall seek to enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7referred to in this section as the ,national ,academies7 to conduct a study to examine-- 7#a7 alternative models for directly funding1 or stimulating investment in1 biomedical research and development that delink research and development costs from the prices of drugs1 including the progressive replacement of patents and regulatory exclusivities on new drugs with a combination of expanded support for research and innovation prizes to reward the successful development of drugs or achievement of related milestones2 7#b7 the dollar amount of innovation prizes for different stages of research and development of different classes or types of drugs1 and total annual funding1 that would be necessary to stimulate investment sufficient to achieve such successful drug development and related milestones2 7#c7 the relative effectiveness and efficiency of such alternative models in stimulating innovation1 compared to the status quo that includes patents and regulatory exclusivities2 7#d7 strategies to implement such alternative models described in paragraph 7#a71 including a phased transition2 and 7#e7 the anticipated economic and societal impacts of such alternative models1 including an assessment of impact on-- 7,a7 the number and variety of new drugs that would be developed1 approved1 and marketed in the ,united ,states1 including such new drugs intended to prevent1 diagnose1 or treat a rare disease or condition2 7,b7 the rate at which new drugs would be developed1 approved1 and marketed in the ,united ,states2 7,c7 access to medication2 7,d7 health outcomes2 7,e7 average lifespan and disease burden in the ,united ,states2 7,f7 the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time2 7,g7 ,federal discretionary and mandatory spending2 and 7,h7 public and private insurance markets4 7b7 ,requirements ,in conducting the study pursuant to subsection 7a71 the ,national ,academies shall hold not fewer than #b public listening sessions to solicit feedback from interested parties1 including representatives of academia1 professional societies1 patient advocates1 public health organizations1 relevant ,federal departments and agencies1 drug developers1 representatives of other relevant industries1 and subject matter experts4 7c7 ,report ,not later than #b years after the agreement under subsection 7a71 the ,national ,academies 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 ,representatives a report on the study conducted pursuant to subsection 7a74 ,d ,additional reauthorizations #fda4 ,medical countermeasure priority review voucher ,section #efe;,a7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended by striking ,october #a1 #bjbc and inserting ,december #ca1 #bjbf4 #fdb4 ,epidemic ,intelligence ,service ,section #cag;,f7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#g7;c77#b77 is amended by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdc4 ,monitoring and distribution of certain medical countermeasures ,section #cai;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdd4 ,regional health care emergency preparedness and response systems ,section #cai;,c-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;c7 is amended-- 7#a7 in subsection 7b77#c71 by striking under the and all that follows through such ,act7 and inserting under law2 and 7#b7 in subsection 7e77#b71 by striking ,september #cj1 #bjbc and inserting ,december #ca1 #bjbf4 #fde4 ,emergency system for advance registration of volunteer health professionals 7#a7 ,in general ,section #cai;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 is amended-- 7,a7 in subsection 7a71 by striking ,not later than #ab months after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,act1 the ,secretary shall link existing ,state verification systems to maintain a single national interoperable network of systems1 and inserting ,the ,secretary shall continue to maintain a single national interoperable network of verification systems1 and 7,b7 in subsection 7k71 by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdf4 ,ensuring collaboration and coordination in medical countermeasure development ,section #cai,l-#a7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;f7b77 is amended by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbf4 #fdg4 ,military and civilian partnership for trauma readiness ,section #abia7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#ia7;g77 is amended by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdh4 ,national ,disaster ,medical ,system ,section #bhab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 is amended-- 7#a7 in subsection 7c77#d77;,b71 by striking ,march #ca1 #bjbe and inserting ,december #ca1 #bjbf2 and 7#b7 in subsection 7g71 by striking #eg1djj1jjj for each of fiscal years #bjai through #bjbc and inserting #fe1ijj1jjj for each of fiscal years #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdi4 ,volunteer ,medical ,reserve ,corps ,section #bhac7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is amended by striking #bjai through #bjbc and inserting #bjbe through #bjbf1 to remain available through ,december #ca1 #bjbf4 #fdi;,a4 ,epidemiology-laboratory capacity ,section #bhba7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7;b77 is amended1 in the matter preceding paragraph 7#a71 by striking #bjai through #bjbc and inserting #bjbe and #bjbf1 to remain available through ,december #ca1 #bjbf4 ,,vii ,public ,health ,programs #gja4 ,action for dental health ,section #cdj;,g7f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;g7f77 is amended by striking #ac1ijc1jjj for each of fiscal years #bjai through #bjbc and inserting #ae1jjj1jjj for each of fiscal years #bjbe through #bjbi1 to remain available until expended4 #gjb4 ,,preemie 7a7 ,research relating to preterm labor and delivery and the care1 treatment1 and outcomes of preterm and low birthweight infants 7#a7 ,in general ,section #c7;e7 of the ,prematurity ,research ,expansion and ,education for ,mothers who deliver ,infants ,early ,act 7#db ,u4,s4,c4 #bdg;b-#d;f7e77 is amended by striking fiscal years #bjai through #bjbc and inserting fiscal years #bjbe through #bjbi4 7#b7 ,technical correction ,effective as if included in the enactment of the ,,preemie ,reauthorization ,act of #bjah 7,public ,law #aae-cbh71 section #b of such ,act is amended1 in the matter preceding paragraph 7#a71 by striking ,section #b and inserting ,section #c4 7b7 ,interagency working group ,section #e7;a7 of the ,,preemie ,reauthorization ,act of #bjah 7,public ,law #aae-cbh7 is amended by striking ,the ,secretary of ,health and ,human ,services1 in collaboration with other departments1 as appropriate1 may establish and inserting ,not later than #ah months after the date of the enactment of the ,bipartisan ,health ,care ,act1 the ,secretary of ,health and ,human ,services1 in collaboration with other departments1 as appropriate1 shall establish4 7c7 ,study on preterm births 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall enter into appropriate arrangements with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine under which the ,national ,academies shall-- 7,a7 not later than #cj days after the date of enactment of this ,act1 convene a committee of experts in maternal health to study premature births in the ,united ,states2 and 7,b7 upon completion of the study under subparagraph 7,a7-- 7i7 approve by consensus a report on the results of such study2 7ii7 include in such report-- 7,i7 an assessment of each of the topics listed in paragraph 7#b72 7,,ii7 the analysis required by paragraph 7#c72 and 7,,iii7 the raw data used to develop such report2 and 7iii7 not later than #bd months after the date of enactment of this ,act1 transmit such report to-- 7,i7 the ,secretary of ,health and ,human ,services2 7,,ii7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7,,iii7 the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7#b7 ,assessment topics ,the topics listed in this subsection are each of the following3 7,a7 ,the financial costs of premature birth to society1 including-- 7i7 an analysis of stays in neonatal intensive care units and the cost of such stays2 7ii7 long-term costs of stays in such units to society and the family involved post-discharge2 and 7iii7 health care costs for families post-discharge from such units 7such as medications1 therapeutic services1 co-payments for visits1 and specialty equipment74 7,b7 ,the factors that impact preterm birth rates4 7,c7 ,opportunities for earlier detection of premature birth risk factors1 including-- 7i7 opportunities to improve maternal and infant health2 and 7ii7 opportunities for public health programs to provide support and resources for parents in-hospital1 in non-hospital settings1 and post-discharge4 7#c7 ,analysis ,the analysis required by this subsection is an analysis of-- 7,a7 targeted research strategies to develop effective drugs1 treatments1 or interventions to bring at-risk pregnancies to term2 7,b7 ,state and other programs' best practices with respect to reducing premature birth rates2 and 7,c7 precision medicine and preventative care approaches starting early in the life course 7including during pregnancy7 with a focus on behavioral and biological influences on premature birth1 child health1 and the trajectory of such approaches into adulthood4 #gjc4 ,preventing maternal deaths 7a7 ,maternal mortality review committee ,section #cag,k7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;d77 is amended-- 7#a7 in paragraph 7#a77;,a71 by inserting 7including obstetricians and gynecologists7 after clinical specialties2 and 7#b7 in paragraph 7#c77;,a77i7-- 7,a7 in subclause 7,i71 by striking as applicable and inserting if available2 and 7,b7 in subclause 7,,iii71 by striking 1 as appropriate and inserting and coordinating with death certifiers to improve the collection of death record reports and the quality of death records1 including by amending cause of death information on a death certificate1 as appropriate4 7b7 ,best practices relating to the prevention of maternal mortality ,section #cag,k of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7 is amended-- 7#a7 by redesignating subsections 7e7 and 7f7 as subsections 7f7 and 7g71 respectively2 and 7#b7 by inserting after subsection 7d7 the following3 7e7 ,best practices relating to the prevention of maternal mortality 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 in consultation with the ,administrator of the ,health ,resources and ,services ,administration1 disseminate to hospitals1 ,state professional society groups1 and perinatal quality collaboratives1 best practices on how to prevent maternal mortality and morbidity that consider and reflect best practices identified through other relevant ,federal maternal health programs4 7#b7 ,frequency ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall disseminate the best practices referred to in paragraph 7#a7 not less than once per fiscal year4 4 7c7 ,extension ,subsection 7g7 of section #cag,k of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab71 as redesignated by subsection 7b71 is amended by striking #eh1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #ajj1jjj1jjj for each of fiscal years #bjbe through #bjbi4 #gjd4 ,sickle cell disease prevention and treatment 7a7 ,in general ,section #aajf7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#e7;b77 is amended-- 7#a7 in paragraph 7#a77;,a77iii71 by striking prevention and treatment of sickle cell disease and inserting treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease2 7#b7 in paragraph 7#b77;,d71 by striking prevention and treatment of sickle cell disease and inserting treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease2 7#c7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a71 by striking enter into a contract with and inserting make a grant to1 or enter into a contract or cooperative agreement with12 and 7,b7 in subparagraph 7,b71 in each of clauses 7ii7 and 7iii71 by striking prevention and treatment of sickle cell disease and inserting treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease2 and 7#d7 in paragraph 7#f71 by striking #d1dee1jjj for each of fiscal years #bjai through #bjbc and inserting #h1bje1jjj for each of fiscal years #bjbe through #bjbi4 7b7 ,sense of ,congress ,it is the sense of ,congress that further research should be undertaken to expand the understanding of the causes of1 and to find cures for1 heritable blood disorders1 including sickle cell disease4 #gje4 ,traumatic brain injuries 7a7 ,the ,bill ,pascrell1 ,jr41 national program for traumatic brain injury surveillance and registries 7#a7 ,prevention of traumatic brain injury ,section #cic;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a;c7 is amended-- 7,a7 in subsection 7a71 by inserting and prevalence after incidence2 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a71 by inserting and reduction of associated injuries and fatalities before the semicolon2 7ii7 in paragraph 7#b71 by inserting and related risk factors before the semicolon2 and 7iii7 in paragraph 7#c7-- 7,i7 in the matter preceding subparagraph 7,a71 by striking #bjbj each place it appears and inserting #bjcj2 and 7,,ii7 in subparagraph 7,a7-- 7aa7 in clause 7i71 by striking 2 and and inserting a semicolon2 7bb7 by redesignating clause 7ii7 as clause 7iv72 7cc7 by inserting after clause 7i7 the following3 7ii7 populations at higher risk of traumatic brain injury1 including populations whose increased risk is due to occupational or circumstantial factors2 7iii7 causes of1 and risk factors for1 traumatic brain injury2 and 2 and 7dd7 in clause 7iv71 as so redesignated1 by striking arising from traumatic brain injury and inserting 1 which may include related mental health and other conditions1 arising from traumatic brain injury1 including2 and 7,c7 in subsection 7c71 by inserting 1 and other relevant ,federal departments and agencies before the period at the end4 7#b7 ,national program for traumatic brain injury surveillance and registries ,section #cic;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#a;d7 is amended-- 7,a7 by amending the section heading to read as follows3 ,the ,bill ,pascrell1 ,jr41 national program for traumatic brain injury surveillance and registries2 7,b7 in subsection 7a7-- 7i7 in the matter preceding paragraph 7#a71 by inserting to identify populations that may be at higher risk for traumatic brain injuries1 to collect data on the causes of1 and risk factors for1 traumatic brain injuries1 after related disability12 7ii7 in paragraph 7#a71 by inserting 1 including the occupation of the individual1 when relevant to the circumstances surrounding the injury before the semicolon2 and 7iii7 in paragraph 7#d71 by inserting short- and long-term before outcomes2 7,c7 by striking subsection 7b72 7,d7 by redesignating subsection 7c7 as subsection 7b72 7,e7 in subsection 7b71 as so redesignated1 by inserting and evidence-based practices to identify and address concussion before the period at the end2 and 7,f7 by adding at the end the following3 7c7 ,availability of information ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall make publicly available aggregated information on traumatic brain injury and concussion described in this section1 including on the website of the ,centers for ,disease ,control and ,prevention4 ,such website1 to the extent feasible1 shall include aggregated information on populations that may be at higher risk for traumatic brain injuries and strategies for preventing or reducing risk of traumatic brain injury that are tailored to such populations4 4 7#c7 ,authorization of appropriations ,section #cid;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;b-#c7 is amended-- 7,a7 in subsection 7a71 by striking #aiid1 and and inserting #aiid12 and 7,b7 in subsection 7b71 by striking #bjbj through #bjbd and inserting #bjbe through #bjbi4 7b7 ,state grant programs 7#a7 ,state grants for projects regarding traumatic brain injury ,section #abeb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#eb7 is amended-- 7,a7 in subsection 7b77#b7-- 7i7 by inserting 1 taking into consideration populations that may be at higher risk for traumatic brain injuries after outreach programs2 and 7ii7 by inserting ,tribal1 after ,state12 7,b7 in subsection 7c71 by adding at the end the following3 7#c7 ,maintenance of effort ,with respect to activities for which a grant awarded under subsection 7a7 is to be expended1 a ,state or ,american ,indian consortium shall agree to maintain expenditures of non-,federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the ,state or ,american ,indian consortium for the fiscal year preceding the fiscal year for which the ,state or ,american ,indian consortium receives such a grant4 7#d7 ,waiver ,the ,secretary may1 upon the request of a ,state or ,american ,indian consortium1 waive not more than #ej percent of the matching fund amount under paragraph 7#a71 if the ,secretary determines that such matching fund amount would result in an inability of the ,state or ,american ,indian consortium to carry out the purposes under subsection 7a74 ,a waiver provided by the ,secretary under this paragraph shall apply only to the fiscal year involved4 2 7,c7 in subsection 7e77#c77;,b7-- 7i7 by striking 7such as third party payers1 ,state agencies1 community-based providers1 schools1 and educators72 and 7ii7 by inserting 7such as third party payers1 ,state agencies1 community-based providers1 schools1 and educators7 after professionals2 7,d7 in subsection 7h71 by striking paragraphs 7#a7 and 7#b7 and inserting the following3 7#a7 ,american ,indian consortium2 ,state ,the terms ,american ,indian consortium and ,state have the meanings given such terms in section #abec4 7#b7 ,traumatic brain injury 7,a7 ,in general ,subject to subparagraph 7,b71 the term traumatic brain injury-- 7i7 means an acquired injury to the brain2 7ii7 may include-- 7,i7 brain injuries caused by anoxia due to trauma2 and 7,,ii7 damage to the brain from an internal or external source that results in infection1 toxicity1 surgery1 or vascular disorders not associated with aging2 and 7iii7 does not include brain dysfunction caused by congenital or degenerative disorders1 or birth trauma4 7,b7 ,revisions to definition ,the ,secretary may revise the definition of the term traumatic brain injury under this paragraph1 as the ,secretary determines necessary1 after consultation with ,states and other appropriate public or nonprofit private entities4 2 and 7,e7 in subsection 7i71 by striking #bjbj through #bjbd and inserting #bjbe through #bjbi4 7#b7 ,state grants for protection and advocacy services ,section #abec7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#ec7l77 is amended by striking #bjbj through #bjbd and inserting #bjbe through #bjbi4 7c7 ,report to ,congress ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this ,act as the ,secretary7 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 that contains-- 7#a7 an overview of populations who may be at higher risk for traumatic brain injury1 such as individuals affected by domestic violence or sexual assault and public safety officers as defined in section #abjd of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd72 7#b7 an outline of existing surveys and activities of the ,centers for ,disease ,control and ,prevention on traumatic brain injuries and any steps the agency has taken to address gaps in data collection related to such higher risk populations1 which may include leveraging surveys such as the ,national ,intimate ,partner and ,sexual ,violence ,survey to collect data on traumatic brain injuries2 7#c7 an overview of any outreach or education efforts to reach such higher risk populations2 and 7#d7 any challenges associated with reaching such higher risk populations4 7d7 ,study on long-,term symptoms or conditions related to traumatic brain injury 7#a7 ,in general ,the ,secretary1 in consultation with stakeholders and the heads of other relevant ,federal departments and agencies1 as appropriate1 shall conduct1 either directly or through a contract with a nonprofit private entity1 a study to-- 7,a7 examine the incidence and prevalence of long-term or chronic symptoms or conditions in individuals who have experienced a traumatic brain injury2 7,b7 examine the evidence base of research related to the chronic effects of traumatic brain injury across the lifespan2 7,c7 examine any correlations between traumatic brain injury and increased risk of other conditions1 such as dementia and mental health conditions2 7,d7 assess existing services available for individuals with such long-term or chronic symptoms or conditions2 and 7,e7 identify any gaps in research related to such long-term or chronic symptoms or conditions of individuals who have experienced a traumatic brain injury4 7#b7 ,public report ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall-- 7,a7 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 findings1 conclusions1 and recommendations of the study described in paragraph 7#a72 and 7,b7 in the case that such study is conducted directly by the ,secretary1 make the report described in subparagraph 7,a7 publicly available on the website of the ,department of ,health and ,human ,services4 #gjf4 ,lifespan respite care 7a7 ,definition of family caregiver ,section #bija7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;ii7#e77 is amended by striking unpaid adult and inserting unpaid individual4 7b7 ,funding ,section #bije of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;ii-#d7 is amended by striking fiscal years #bjbj through fiscal year #bjbd and inserting fiscal years #bjbe through #bjbi4 #gjg4 ,dr4 ,lorna ,breen health care provider protection 7a7 ,dissemination of best practices ,section #b of the ,dr4 ,lorna ,breen ,health ,care ,provider ,protection ,act 7,public ,law #aag-aje7 is amended by striking #b years and inserting #e years4 7b7 ,education and awareness initiative encouraging use of mental health and substance use disorder services by health care professionals ,section #c of the ,dr4 ,lorna ,breen ,health ,care ,provider ,protection ,act 7,public ,law #aag-aje7 is amended-- 7#a7 in subsection 7b71 by inserting and annually thereafter1 after of this ,act12 and 7#b7 in subsection 7c71 by striking #bjbb through #bjbd and inserting #bjbe through #bjbi4 7c7 ,programs ,to promote mental health among the health professional workforce ,the second section #gfd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bidt71 as added by section #d of the ,dr4 ,lorna ,breen ,health ,care ,provider ,protection ,act 7,public ,law #aag-aje71 is amended-- 7#a7 by redesignating such section #gfd as section #gfd;,a2 7#b7 in subsection 7a77#c7-- 7,a7 by striking to eligible entities in and inserting 8to eligible entities that-- 7,a7 are in 2 7,b7 by striking the period and inserting 2 or2 and 7,c7 by adding at the end the following3 7,b7 have a focus on the reduction of administrative burden on health care workers4 2 7#c7 in subsection 7c71 by inserting not less than after period of2 and 7#d7 in subsection 7f71 by striking #bjbb through #bjbd and inserting #bjbe through #bjbi4 #gjh4 ,,screens for ,cancer 7a7 ,national ,breast and ,cervical ,cancer ,early ,detection ,program ,title ,,xv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjk et seq47 is amended-- 7#a7 in section #aeja 7#db ,u4,s4,c4 #cjjk7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#b71 by striking the provision of appropriate follow-up services and support services such as case management and inserting that appropriate follow-up services are provided2 7ii7 in paragraph 7#c71 by striking programs for the detection and control and inserting for the prevention1 detection1 and control2 7iii7 in paragraph 7#d71 by striking the detection and control and inserting the prevention1 detection1 and control2 7iv7 in paragraph 7#e7-- 7,i7 by striking monitor and inserting ensure2 and 7,,ii7 by striking 2 and and inserting a semicolon2 7v7 by redesignating paragraph 7#f7 as paragraph 7#i72 7vi7 by inserting after paragraph 7#e7 the following3 7#f7 to enhance appropriate support activities to increase breast and cervical cancer screenings1 such as navigation of health care services1 implementation of evidence-based or evidence-informed strategies to increase breast and cervical cancer screening in health care settings1 and facilitation of access to health care settings2 7#g7 to reduce disparities in breast and cervical cancer incidence1 morbidity1 and mortality1 including in populations with higher than average rates2 7#h7 to improve access to breast and cervical cancer screening and diagnostic services and reduce related barriers1 including factors that relate to negative health outcomes2 and 2 and 7vii7 in paragraph 7#i71 as so redesignated1 by striking through 7#e7 and inserting through 7#h72 and 7,b7 by striking subsection 7d72 7#b7 in section #aejc 7#db ,u4,s4,c4 #cjjm7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by striking that1 initially and all that follows through the semicolon and inserting that appropriate breast and cervical cancer screening and diagnostic services are provided consistent with relevant evidence-based recommendations2 and2 7ii7 by striking paragraphs 7#b7 and 7#d72 7iii7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7iv7 in paragraph 7#b71 as so redesignated1 by striking 2 and and inserting a period2 and 7,b7 by striking subsection 7d72 7#c7 in section #aejh7;b7 7#db ,u4,s4,c4 #cjjn-#d7;b77-- 7,a7 by striking #a year after the date of the enactment of the ,national ,breast and ,cervical ,cancer ,early ,detection ,program ,reauthorization of #bjjg1 and annually thereafter1 and inserting #b years after the date of enactment of the ,bipartisan ,health ,care ,act1 and every #e years thereafter12 7,b7 by striking ,labor and ,human ,resources and inserting ,health1 ,education1 ,labor1 and ,pensions2 and 7,c7 by striking preceding fiscal year and inserting preceding #b fiscal years in the case of the first report after the date of enactment of the ,bipartisan ,health ,care ,act and preceding #e fiscal years for each report thereafter2 and 7#d7 in section #aeaj7;a7 7#db ,u4,s4,c4 #cjjn-#e7;a77-- 7,a7 by striking #bjaa1 and and inserting #bjaa12 and 7,b7 by inserting 1 and #bce1ejj1jjj for each of fiscal years #bjbe through #bjbi before the period at the end before the period at the end4 7b7 ,,gao study ,not later than ,september #cj1 #bjbg1 the ,comptroller ,general of the ,united ,states shall 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 work of the ,national ,breast and ,cervical ,cancer ,early ,detection ,program1 including-- 7#a7 an estimate of the number of individuals eligible for services provided under such program2 7#b7 a summary of trends in the number of individuals served through such program2 and 7#c7 an assessment of any factors that may be driving the trends identified under paragraph 7#b71 including any barriers to accessing breast and cervical cancer screenings provided by such program4 #gji4 ,de,ondra ,dixon ,,include ,project ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq47 is amended by adding at the end the following3 #dji,k4 ,down syndrome research 7a7 ,in general ,the ,director of ,,nih shall carry out a program of research1 training1 and investigation related to ,down syndrome to be known as the ,i,nvestigation of ,co-occurring conditions across the ,lifespan to ,understand ,down syndrom,e ,project or the ,,include ,project4 7b7 ,program elements ,the program under subsection 7a7 shall include-- 7#a7 high-risk1 high reward research on the effects of trisomy #ba on human development and health2 7#b7 promoting research for participants with ,down syndrome across the lifespan1 including cohort studies to facilitate improved understanding of ,down syndrome and co-occurring conditions and development of new interventions2 7#c7 expanding the number of clinical trials that are inclusive of1 or expressly for1 participants with ,down syndrome1 including novel biomedical and pharmacological interventions and other therapies designed to promote or enhance activities of daily living2 7#d7 research on the biological mechanisms in individuals with ,down syndrome pertaining to structural1 functional1 and behavioral anomalies and dysfunction as well as stunted growth2 7#e7 supporting research to improve diagnosis and treatment of conditions co-occurring with ,down syndrome1 including the identification of biomarkers related to risk factors1 diagnosis1 and clinical research and therapeutics2 7#f7 research on the causes of increased prevalence1 and concurrent treatment1 of co-occurring conditions1 such as ,alzheimer's disease and related dementias and autoimmunity1 in individuals with ,down syndrome2 and 7#g7 research1 training1 and investigation on improving the quality of life of individuals with ,down syndrome and their families4 7c7 ,coordination2 ,prioritizing nonduplicative research ,the ,director of ,,nih shall ensure that-- 7#a7 the programs and activities of the institutes and centers of the ,national ,institutes of ,health relating to ,down syndrome and co-occurring conditions are coordinated1 including through the ,office of the ,director of ,,nih and priority-setting reviews conducted pursuant to section #djb7;b77#c72 and 7#b7 such institutes and centers1 prioritize1 as appropriate1 ,down syndrome research that does not duplicate existing research activities of the ,national ,institutes of ,health4 7d7 ,consultation with stakeholders ,in carrying out activities under this section1 the ,director of ,,nih shall1 as appropriate and to the maximum extent feasible1 consult with relevant stakeholders1 including patient advocates1 to ensure that such activities take into consideration the needs of individuals with ,down syndrome4 7e7 ,biennial reports to ,congress 7#a7 ,in general ,the ,director of ,,nih shall submit1 on a biennial basis1 to the ,committee on ,energy and ,commerce and the ,subcommittee on ,labor1 ,health and ,human ,services1 ,education1 and ,related ,agencies of the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,subcommittee on ,labor1 ,health and ,human ,services1 ,education1 and ,related ,agencies of the ,committee on ,appropriations of the ,senate1 a report that catalogs the research conducted or supported under this section4 7#b7 ,contents ,each report under paragraph 7#a7 shall include-- 7,a7 identification of the institute or center involved2 7,b7 a statement of whether the research is or was being carried out directly by such institute or center or by multiple institutes and centers2 and 7,c7 identification of any resulting real-world evidence that is or may be used for clinical research and medical care for patients with ,down syndrome4 4 #gaj4 ,,improve ,initiative ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq471 as amended by section #gaj1 is further amended by adding at the end the following3 #dji,l4 ,,improve initiative 7a7 ,in general ,the ,director of the ,national ,institutes of ,health shall carry out a program of research to improve health outcomes to be known as the ,implementing a ,maternal health and ,p,regnancy ,outcomes ,vision for ,everyone ,initiative 7referred to in this section as the ,initiative74 7b7 ,objectives ,the ,initiative shall-- 7#a7 advance research to-- 7,a7 reduce preventable causes of maternal mortality and severe maternal morbidity2 7,b7 reduce health disparities related to maternal health outcomes1 including such disparities associated with medically underserved populations2 and 7,c7 improve health for pregnant and postpartum women before1 during1 and after pregnancy2 7#b7 use an integrated approach to understand the factors1 including biological1 behavioral1 and other factors1 that affect maternal mortality and severe maternal morbidity by building an evidence base for improved outcomes in specific regions of the ,united ,states2 and 7#c7 target health disparities associated with maternal mortality and severe maternal morbidity by-- 7,a7 implementing and evaluating community-based interventions for disproportionately affected women2 and 7,b7 identifying risk factors and the underlying biological mechanisms associated with leading causes of maternal mortality and severe maternal morbidity in the ,united ,states4 7c7 ,sunset ,the authority under this section shall expire on ,september #cj1 #bjbi4 4 #gaa4 ,organ ,procurement and ,transplantation ,network ,section #cgb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 by moving the margins of subparagraphs 7,m7 through 7,o7 #b ems to the left2 7,b7 in subparagraph 7,a7-- 7i7 in clause 7i71 by striking 1 and and inserting 2 and2 and 7ii7 in clause 7ii71 by striking the comma at the end and inserting a semicolon2 7,c7 in subparagraph 7,c71 by striking twenty-four-hour telephone service and inserting #bd-;hour telephone or information technology service2 7,d7 in each of subparagraphs 7,b7 through 7,m71 by striking the comma at the end and inserting a semicolon2 7,e7 in subparagraph 7,n71 by striking transportation1 and and inserting transportation22 7,f7 in subparagraph 7,o71 by striking the period and inserting a semicolon2 and 7,g7 by adding at the end the following3 7,p7 encourage the integration of electronic health records systems through application programming interfaces 7or successor technologies7 among hospitals1 organ procurement organizations1 and transplant centers1 including the use of automated electronic hospital referrals and the grant of remote1 electronic access to hospital electronic health records of potential donors by organ procurement organizations1 in a manner that complies with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif1 at part #afj of title #de1 ,code of ,federal ,regulations1 and subparts ,a1 ,c1 and ,e of part #afd of such title 7or any successor regulations72 and 7,q7 consider establishing a dashboard to display the number of transplants performed1 the types of transplants performed1 the number and types of organs that entered the ,organ ,procurement and ,transplantation ,network system and failed to be transplanted1 and other appropriate statistics1 which should be updated more frequently than annually4 2 and 7#b7 by adding at the end the following3 7d7 ,registration fees 7#a7 ,in general ,the ,secretary may collect registration fees from any member of the ,organ ,procurement and ,transplantation ,network for each transplant candidate such member places on the list described in subsection 7b77#b77;,a77i74 ,such registration fees shall be collected and distributed only to support the operation of the ,organ ,procurement and ,transplantation ,network4 ,such registration fees are authorized to remain available until expended4 7#b7 ,collection ,the ,secretary may collect the registration fees under paragraph 7#a7 directly or through awards made under subsection 7b77#a77;,a74 7#c7 ,distribution ,any amounts collected under this subsection shall-- 7,a7 be credited to the currently applicable appropriation1 account1 or fund of the ,department of ,health and ,human ,services as discretionary offsetting collections2 and 7,b7 be available1 only to the extent and in the amounts provided in advance in appropriations ,acts1 to distribute such fees among awardees described in subsection 7b77#a77;,a74 7#d7 ,transparency ,the ,secretary shall-- 7,a7 promptly post on the website of the ,organ ,procurement and ,transplantation ,network-- 7i7 the amount of registration fees collected under this subsection from each member of the ,organ ,procurement and ,transplantation ,network2 and 7ii7 a list of activities such fees are used to support2 and 7,b7 update the information posted pursuant to subparagraph 7,a71 as applicable for each calendar quarter for which fees are collected under paragraph 7#a74 7#e7 ,,gao review ,not later than #b years after the date of enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall1 to the extent data are available-- 7,a7 conduct a review concerning the activities under this subsection2 and 7,b7 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,finance of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on such review1 including related recommendations1 as applicable4 7#f7 ,sunset ,the authority to collect registration fees under paragraph 7#a7 shall expire on the date that is #c years after the date of enactment of the ,bipartisan ,health ,care ,act4 4 #gab4 ,honor ,our ,living ,donors 7a7 ,no consideration of income of organ recipient ,section #cgg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd;f7 is amended-- 7#a7 by redesignating subsections 7c7 through 7f7 as subsections 7d7 through 7g71 respectively2 7#b7 by inserting after subsection 7b7 the following3 7c7 ,no consideration of income of organ recipient ,the recipient of a grant under this section1 in providing reimbursement to a donating individual through such grant1 shall not give any consideration to the income of the organ recipient4 2 and 7#c7 in subsection 7f71 as so redesignated-- 7,a7 in paragraph 7#a71 by striking subsection 7c77#a7 and inserting subsection 7d77#a72 and 7,b7 in paragraph 7#b71 by striking subsection 7c77#b7 and inserting subsection 7d77#b74 7b7 ,removal of expectation of payments by organ recipients ,section #cgg7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd;f7e771 as redesignated by subsection 7a77#a71 is amended-- 7#a7 in paragraph 7#a71 by adding or at the end2 7#b7 in paragraph 7#b71 by striking 2 or and inserting a period2 and 7#c7 by striking paragraph 7#c74 7c7 ,annual report ,section #cgg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd;f71 as amended by subsections 7a7 and 7b71 is amended by adding at the end the following3 7h7 ,annual report ,not later than ,december #ca of each year1 beginning in fiscal year #bjbf1 the ,secretary shall-- 7#a7 prepare1 submit to the ,congress1 and make public a report on whether grants under this section provided adequate funding during the preceding fiscal year to reimburse all donating individuals participating in the grant program under this section for all qualifying expenses2 and 7#b7 include in each such report-- 7,a7 the estimated number of all donating individuals participating in the grant program under this section who did not receive reimbursement for all qualifying expenses during the preceding fiscal year2 and 7,b7 the total amount of funding that is estimated to be necessary to fully reimburse all donating individuals participating in the grant program under this section for all qualifying expenses4 4 #gac4 ,program for pediatric studies of drugs ,section #dji;,i7d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is amended by striking section1 and all that follows through the period at the end and inserting section1 #be1jjj1jjj for each of fiscal years #bjbe through #bjbg44 ,,viii ,food and ,drug ,administration ,a ,give ,kids a ,chance #hja4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs 7a7 ,in general 7#a7 ,additional active ingredient for application drug2 limitation regarding novel-combination application drug ,section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is amended-- 7,a7 by redesignating subparagraphs 7,b7 and 7,c7 as subparagraphs 7,c7 and 7,d71 respectively2 and 7,b7 by striking subparagraph 7,a7 and inserting the following3 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of-- 7i7 the drug or biological product for which the application referred to in such paragraph is submitted2 or 7ii7 such drug or biological product used in combination with-- 7,i7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;j7 under this ,act or under section #cea7k7 of the ,public ,health ,service ,act is in effect2 and 7bb7 that is determined by the ,secretary1 after consultation with the applicant1 to be part of the standard of care for treating a pediatric cancer2 or 7,,ii7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph 7#a77;,b72 and 7bb7 that is directed at a molecular target that the ,secretary determines to be substantially relevant to the growth or progression of a pediatric cancer4 7,b7 ,additional requirements 7i7 ,design of investigation ,a molecularly targeted pediatric cancer investigation referred to in subparagraph 7,a7 shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required1 regarding dosing1 safety1 and preliminary efficacy to inform potential pediatric labeling4 7ii7 ,limitation ,an investigation described in subparagraph 7,a77ii7 may be required only if the drug or biological product for which the application referred to in paragraph 7#a77;,b7 contains either-- 7,i7 a single new active ingredient2 or 7,,ii7 more than one active ingredient1 if an application for the combination of active ingredients has not previously been approved but each active ingredient is in a drug product that has been previously approved to treat an adult cancer4 7iii7 ,results of already-completed preclinical studies of application drug ,with respect to an investigation required pursuant to paragraph 7#a77;,b71 the ,secretary may require the results of any completed preclinical studies relevant to the initial pediatric study plan be submitted to the ,secretary at the same time that the initial pediatric study plan required under subsection 7e77#a7 is submitted4 7iv7 ,rule of construction regarding inactive ingredients ,with respect to a combination of active ingredients referred to in subparagraph 7,a77ii71 such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination4 4 7#b7 ,determination of applicable requirements ,section #eje;,b7e77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is amended by adding at the end the following3 ,the ,secretary shall determine whether subparagraph 7,a7 or 7,b7 of subsection 7a77#a7 applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph 7#b77;,a744 7#c7 ,clarifying applicability ,section #eje;,b7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is amended by adding at the end the following3 7,c7 ,rule of construction ,no application that is subject to the requirements of subparagraph 7,b7 shall be subject to the requirements of subparagraph 7,a71 and no application 7or supplement to an application7 that is subject to the requirements of subparagraph 7,a7 shall be subject to the requirements of subparagraph 7,b74 4 7#d7 ,conforming amendments ,section #eje;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is amended-- 7,a7 in paragraph 7#c77;,c71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking investigations described in this paragraph and inserting investigations referred to in subparagraph 7,a72 and 7,b7 in paragraph 7#c77;,d71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking the assessments under paragraph 7#b77;,b7 and inserting the assessments required under paragraph 7#a77;,a74 7b7 ,guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 not later than #ab months after the date of enactment of this ,act1 issue draft guidance on the implementation of the amendments made by subsection 7a72 and 7#b7 not later than #ab months after closing the comment period on such draft guidance1 finalize such guidance4 7c7 ,applicability ,the amendments made by this section apply with respect to any application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 and any application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 that is submitted on or after the date that is #c years after the date of enactment of this ,act4 7d7 ,reports to ,congress 7#a7 ,secretary of ,health and ,human ,services ,not later than #f years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 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 on the ,secretary's efforts1 in coordination with industry1 to ensure implementation of the amendments made by subsection 7a74 7#b7 ,,gao study and report 7,a7 ,study ,not later than #h years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of requiring assessments and investigations described in section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 as amended by subsection 7a71 in the development of drugs and biological products for pediatric cancer indications1 including consideration of any benefits to1 or burdens on1 pediatric cancer drug development4 7,b7 ,findings ,not later than #aj years after the date of enactment of this ,act1 the ,comptroller ,general 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 containing the findings of the study conducted under subparagraph 7,a74 #hjb4 ,ensuring completion of pediatric study requirements 7a7 ,equal accountability for pediatric study requirements ,section #eje;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77 is amended-- 7#a7 in paragraph 7#a71 by striking ,beginning #bgj and inserting ,noncompliance letter4--,beginning #bgj2 7#b7 in paragraph 7#b7-- 7,a7 by striking ,the drug or and inserting ,effect of noncompliance4--,the drug or2 and 7,b7 by striking 7except that the drug or biological product shall not be subject to action under section #cjc7 and inserting 7except that the drug or biological product shall be subject to action under section #cjc only if such person demonstrated a lack of due diligence in satisfying the applicable requirement72 and 7#c7 by adding at the end the following3 7#c7 ,limitation ,the ,secretary shall not issue enforcement actions under section #cjc for failures under this subsection in the case of a drug or biological product that is no longer marketed4 4 7b7 ,due diligence ,section #eje;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d771 as amended by subsection 7a71 is further amended by adding at the end the following3 7#d7 ,due diligence ,before the ,secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph 7#a71 the ,secretary shall-- 7,a7 issue a noncompliance letter pursuant to paragraph 7#a72 7,b7 provide such person with a #de-;day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph2 and 7,c7 after reviewing such written response1 determine whether the person demonstrated a lack of due diligence in satisfying such requirement4 4 7c7 ,conforming amendments ,section #cjc7;f77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#d77;,a77 is amended by striking or #eje-a and inserting #eje-a1 or #eje;,b4 7d7 ,transition rule ,the ,secretary of ,health and ,human ,services may take enforcement action under section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 only for failures described in section #eje;,b7d7 of such ,act 7#ba ,u4,s4,c4 #cee;c7d77 that occur on or after the date that is #ahj days after the date of enactment of this ,act4 #hjc4 ,,fda report on ,,prea enforcement ,section #ejh7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is amended-- 7#a7 in paragraph 7#aa71 by striking the semicolon at the end and inserting 1 including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions22 7#b7 in paragraph 7#ae71 by striking and at the end2 7#c7 in paragraph 7#af71 by striking the period at the end and inserting 2 and2 and 7#d7 by adding at the end the following3 7#ag7 a listing of penalties1 settlements1 or payments under section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 for failure to comply with requirements under such section #eje;,b1 including1 for each penalty1 settlement1 or payment1 the name of the drug1 the sponsor thereof1 and the amount of the penalty1 settlement1 or payment imposed2 and 4 #hjd4 ,extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases 7a7 ,extension ,paragraph 7#e7 of section #ebi7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is amended by striking ,december #bj1 #bjbd1 unless and all that follows through the period at the end and inserting ,september #cj1 #bjbi44 7b7 ,user fee payment ,section #ebi7;c77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7c77#d77 is amended by striking subparagraph 7,a7 and inserting the following3 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 ,all other user fees associated with the human drug application shall be due as required by the ,secretary or under applicable law4 4 7c7 ,,gao report on effectiveness of rare pediatric disease priority voucher awards in incentivizing rare pediatric disease drug development 7#a7 ,,gao study 7,a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff71 as amended by subsection 7a71 in the development of human drug products that treat or prevent rare pediatric diseases 7as defined in such section #ebi74 7,b7 ,contents of study ,in conducting the study under subparagraph 7,a71 the ,comptroller ,general shall examine the following3 7i7 ,the indications for each drug or biological product that-- 7,i7 is the subject of a rare pediatric disease product application 7as defined in section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff77 for which a priority review voucher was awarded2 and 7,,ii7 was approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,whether1 and to what extent1 an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval or licensure of such a drug or biological product4 7iii7 ,the size of the company to which a priority review voucher was awarded under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 for such a drug or biological product4 7iv7 ,the value of such priority review voucher if transferred4 7v7 ,identification of each drug for which a priority review voucher awarded under such section #ebi was used4 7vi7 ,the size of the company using each priority review voucher awarded under such section #ebi4 7vii7 ,the length of the period of time between the date on which a priority review voucher was awarded under such section #ebi and the date on which it was used4 7viii7 ,whether1 and to what extent1 an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 of a drug for which a priority review voucher was used4 7ix7 ,whether1 and to what extent1 companies were motivated by the availability of priority review vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 to attempt to develop a drug for a rare pediatric disease4 7x7 ,whether1 and to what extent1 pediatric review vouchers awarded under such section were successful in stimulating development and expedited patient access to drug products for treatment or prevention of a rare pediatric disease that wouldn't otherwise take place without the incentive provided by such vouchers4 7xi7 ,the impact of such priority review vouchers on the workload1 review process1 and public health prioritization efforts of the ,food and ,drug ,administration4 7xii7 ,any other incentives in ,federal law that exist for companies developing drugs or biological products described in clause 7i74 7#b7 ,report on findings ,not later than #e years after the date of the enactment of this ,act1 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 ,labor1 and ,pensions of the ,senate a report containing the findings of the study conducted under paragraph 7#a74 #hje4 ,limitations on exclusive approval or licensure of orphan drugs 7a7 ,in general ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended-- 7#a7 in subsection 7a71 in the matter following paragraph 7#b71 by striking same disease or condition and inserting same approved use or indication within such rare disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking same rare disease or condition and inserting same approved use or indication for which such #g-year period applies to such already approved or licensed drug2 and 7,b7 in paragraph 7#a71 by inserting 1 relating to the approved use or indication1 after the needs2 7#c7 in subsection 7c77#a71 by striking same rare disease or condition as the already approved drug and inserting same use or indication for which the already approved or licensed drug was approved or licensed2 and 7#d7 by adding at the end the following3 7f7 ,approved use or indication defined ,in this section1 the term approved use or indication means the use or indication approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act for a drug designated under section #ebf for a rare disease or condition4 4 7b7 ,application of amendments ,the amendments made by subsection 7a7 shall apply with respect to any drug designated under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 regardless of the date on which the drug was so designated1 and regardless of the date on which the drug was approved under section #eje of such ,act 7#ba ,u4,s4,c4 #cee7 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,b ,united ,states-,abraham ,accords ,cooperation and ,security #haa4 ,establishment of ,abraham ,accords ,office within ,food and ,drug ,administration 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 #ajae4 ,abraham ,accords ,office 7a7 ,in general ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall establish within the ,food and ,drug ,administration an office1 to be known as the ,abraham ,accords ,office1 to be headed by a director4 7b7 ,office ,not later than #b years after the date of enactment of this section1 the ,secretary shall-- 7#a7 in consultation with the governments of ,abraham ,accords countries1 as well as appropriate ,united ,states ,government diplomatic and security personnel-- 7,a7 select the location of the ,abraham ,accords ,office in an ,abraham ,accords country2 and 7,b7 establish such office2 and 7#b7 assign to such office such personnel of the ,food and ,drug ,administration as the ,secretary determines necessary to carry out the functions of such office4 7c7 ,duties ,the ,secretary1 acting through the ,director of the ,abraham ,accords ,office1 shall-- 7#a7 after the ,abraham ,accords ,office is established-- 7,a7 as part of the ,food and ,drug ,administration's work to strengthen the international oversight of regulated commodities1 provide technical assistance to regulatory partners in ,abraham ,accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products1 including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the ,food and ,drug ,administration2 and 7,b7 facilitate interactions between the ,food and ,drug ,administration and interested parties in ,abraham ,accords countries1 including by sharing relevant information regarding ,united ,states regulatory pathways with such parties1 and facilitate feedback on the research1 development1 and manufacturing of products regulated in accordance with this ,act2 and 7#b7 carry out other functions and activities as the ,secretary determines to be necessary to carry out this section4 7d7 ,abraham ,accords country defined ,in this section1 the term ,abraham ,accords country means a country identified by the ,department of ,state as having signed the ,abraham ,accords ,declaration4 7e7 ,national security ,nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the ,federal ,government4 4 7b7 ,report to ,congress 7#a7 ,in general ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,congress a report on the ,abraham ,accords ,office1 including-- 7,a7 an evaluation of how the ,office has advanced progress toward conformance with ,food and ,drug ,administration regulatory requirements by manufacturers in the ,abraham ,accords countries2 7,b7 a numerical count of parties that the ,office has helped facilitate interactions or feedback pursuant to section #ajae7;c77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a772 7,c7 a summary of technical assistance provided to regulatory partners in ,abraham ,accords countries pursuant to subparagraph 7,a7 of such section #ajae7;c77#a72 and 7,d7 recommendations for increasing and improving coordination between the ,food and ,drug ,administration and entities in ,abraham ,accords countries4 7#b7 ,abraham ,accords country defined ,in this subsection1 the term ,abraham ,accords country has the meaning given such term in section #ajae7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,,ix ,lowering prescription drug costs #ija4 ,oversight of pharmacy benefit management services 7a7 ,public ,health ,service ,act ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended-- 7#a7 in part ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by adding at the end the following new section3 #bgii;,a-#aa4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of this section 7referred to in this subsection and subsection 7b7 as the effective date71 a group health plan or a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer1 shall not enter into a contract1 including an extension or renewal of a contract1 entered into on or after the effective date1 with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit or delay the disclosure of information to the group health plan 7including such a plan offered through a health insurance issuer7 in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection 7b72 and 7#b7 provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the effective date1 in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer1 including an extension or renewal of such a contract1 entered into on or after the effective date1 the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer1 not less frequently than every #f months 7or1 at the request of a group health plan1 not less frequently than quarterly1 and under the same conditions1 terms1 and cost of the semiannual report under this subsection71 shall submit to the group health plan a report in accordance with this section4 ,each such report shall be made available to such group health plan in plain language1 in a machine-readable format1 and as the ,secretary may determine1 other formats4 ,each such report shall include the information described in paragraph 7#b74 7#b7 ,information described ,for purposes of paragraph 7#a71 the information described in this paragraph is1 with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period-- 7,a7 in the case of a group health plan that is offered by a specified large employer or that is a specified large plan1 and is not offered as health insurance coverage1 or in the case of health insurance coverage for which the election under paragraph 7#c7 is made for the applicable reporting period-- 7i7 a list of drugs for which a claim was filed and1 with respect to each such drug on such list-- 7,i7 the contracted compensation paid by the group health plan or health insurance issuer for each covered drug 7identified by the ,national ,drug ,code7 to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer2 7,,ii7 the contracted compensation paid to the pharmacy1 by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer1 for each covered drug 7identified by the ,national ,drug ,code72 7,,iii7 for each such claim1 the difference between the amount paid under subclause 7,i7 and the amount paid under subclause 7,,ii72 7,,iv7 the proprietary name1 established name or proper name1 and the ,national ,drug ,code2 7,v7 for each claim for the drug 7including original prescriptions and refills7 and for each dosage unit of the drug for which a claim was filed1 the type of dispensing channel used to furnish the drug1 including retail1 mail order1 or specialty pharmacy2 7,,vi7 with respect to each drug dispensed1 for each type of dispensing channel 7including retail1 mail order1 or specialty pharmacy7-- 7aa7 whether such drug is a brand name drug or a generic drug1 and-- 7,,aa7 in the case of a brand name drug1 the wholesale acquisition cost1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7,,bb7 in the case of a generic drug1 the average wholesale price1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7bb7 the total number of-- 7,,aa7 prescription claims 7including original prescriptions and refills72 7,,bb7 participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel2 7,,cc7 dosage units and dosage units per fill of such drug2 and 7,,dd7 days supply of such drug per fill2 7,,vii7 the net price per course of treatment or single fill1 such as a #cj-;day supply or #ij-;day supply to the plan or coverage after rebates1 fees1 alternative discounts1 or other remuneration received from applicable entities2 7,,viii7 the total amount of out-of-pocket spending by participants and beneficiaries on such drug1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage1 or for which no claim is submitted under the plan or coverage2 7,,ix7 the total net spending on the drug2 7,x7 the total amount received1 or expected to be received1 by the plan or issuer from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 7,,xi7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of such drug or spending on such drug2 and 7,,xii7 to the extent feasible1 information on the total amount of remuneration for such drug1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer71 to the participants and beneficiaries enrolled in such plan or coverage2 7ii7 a list of each therapeutic class 7as defined by the ,secretary7 for which a claim was filed under the group health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic class-- 7,i7 the total gross spending on drugs in such class before rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,ii7 the net spending in such class after such rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,iii7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of drugs or drug spending2 7,,iv7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,v7 the number of participants and beneficiaries who filled a prescription for a drug in such class1 including the ,national ,drug ,code for each such drug2 7,,vi7 if applicable1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 and 7,,vii7 the total out-of-pocket spending under the plan or coverage by participants and beneficiaries1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage2 7iii7 with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period or1 in the case that gross spending under the group health plan or coverage exceeded #aj1jjj during the reporting period with respect to fewer than #ej drugs1 with respect to the #ej prescription drugs with the highest spending during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for the formulary placement of such drug in that therapeutic category or class1 selected from a list of standard rationales established by the ,secretary1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 and 7iv7 in the case that such plan or issuer 7or an entity providing pharmacy benefit management services on behalf of such plan or issuer7 has an affiliated pharmacy or pharmacy under common ownership1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost sharing assistance incentives funded by an entity providing pharmacy benefit services-- 7,i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies2 7,,ii7 the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage2 and 7,,iii7 a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage1 and1 with respect to each drug dispensed-- 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 or per #ij-;day supply 7as applicable7 to the plan or issuer1 and to participants and beneficiaries2 7bb7 the median amount charged to such plan or issuer1 and the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan or coverage2 7cc7 the lowest cost per dosage unit1 per #cj-;day supply and per #ij-;day supply1 for each such drug1 including amounts charged to the plan or coverage and to participants and beneficiaries1 that is available from any pharmacy included in the network of such plan or coverage2 and 7dd7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if such drug is subject to a maximum price discount2 and 7,b7 with respect to any group health plan1 including group health insurance coverage offered in connection with such a plan1 regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan-- 7i7 a summary document for the group health plan that includes such information described in clauses 7i7 through 7iv7 of subparagraph 7,a71 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking71 that the ,secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services1 such as an estimated net price to group health plan and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 7ii7 a summary document for plans and issuers to provide to participants and beneficiaries1 which shall be made available to participants or beneficiaries upon request to their group health plan 7including in the case of group health insurance coverage offered in connection with such a plan71 that-- 7,i7 contains such information described in clauses 7iii71 7iv71 7v71 and 7vi71 as applicable1 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking7 that the ,secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage2 7,,ii7 contains only aggregate information2 and 7,,iii7 states that participants and beneficiaries may request specific1 claims-level information required to be furnished under subsection 7c7 from the group health plan or health insurance issuer2 and 7iii7 with respect to drugs covered by such plan or coverage during such reporting period-- 7,i7 the total net spending by the plan or coverage for all such drugs2 7,,ii7 the total amount received1 or expected to be received1 by the plan or issuer from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 and 7,,iii7 to the extent feasible1 information on the total amount of remuneration for such drugs1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer7 to participants and beneficiaries2 7iv7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act7 to brokerage firms1 brokers1 consultants1 advisors1 or any other individual or firm1 for-- 7,i7 the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services1 including the identity of the recipient of such amounts2 7,,ii7 consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer2 or 7,,iii7 the retention of the entity by the group health plan or health insurance issuer2 7v7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives directly or indirectly funded by such entity2 and 7vi7 total gross spending on all drugs under the plan or coverage during the reporting period4 7#c7 ,opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan ,in the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan1 such group health plan may1 on an annual basis1 for plan years beginning on or after the date that is #cj months after the date of enactment of this section1 elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph 7#b77;,a71 in addition to the information described in paragraph 7#b77;,b74 7#d7 ,privacy requirements 7,a7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph 7#a7 in a manner consistent with the privacy regulations promulgated under section #acdjb7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act and consistent with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations7 7referred to in this paragraph as the ,,hipaa privacy regulations7 and shall restrict the use and disclosure of such information according to such privacy regulations and such ,,hipaa privacy regulations4 7,b7 ,additional requirements 7i7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph 7#a7 shall ensure that such report contains only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7ii7 ,restrictions ,in carrying out this subsection1 a group health plan shall comply with section #afd4ejd7;f7 of title #de1 ,code of ,federal ,regulations 7or a successor regulation71 and a plan sponsor shall act in accordance with the terms of the agreement described in such section4 7,c7 ,rule of construction 7i7 ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations4 7ii7 ,nothing in this section shall be construed to affect the application of any ,federal or ,state privacy or civil rights law1 including the ,,hipaa privacy regulations1 the ,genetic ,information ,nondiscrimination ,act of #bjjh 7,public ,law #aaj-bcc7 7including the amendments made by such ,act71 the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d71 and title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,written notice ,each plan year1 group health plans1 including with respect to group health insurance coverage offered in connection with a group health plan1 shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph 7#a71 as applicable1 which may include incorporating such notification in plan documents provided to the participant or beneficiary1 or providing individual notification4 7,e7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to the entity from which the report was received or to that entity's business associates as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations7 or as permitted by the ,,hipaa privacy regulations4 7,f7 ,clarification regarding public disclosure of information ,nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage1 from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a71 except that such plan1 issuer1 or entity may not-- 7i7 restrict disclosure of such report to the ,department of ,health and ,human ,services1 the ,department of ,labor1 or the ,department of the ,treasury2 or 7ii7 prevent disclosure for the purposes of subsection 7c71 or any other public disclosure requirement under this section4 7,g7 ,limited form of report ,the ,secretary shall define through rulemaking a limited form of the report under paragraph 7#a7 required with respect to any group health plan established by a plan sponsor that is1 or is affiliated with1 a drug manufacturer1 drug wholesaler1 or other direct participant in the drug supply chain1 in order to prevent anti-competitive behavior4 7#e7 ,standard format and regulations 7,a7 ,in general ,not later than #ah months after the date of enactment of this section1 the ,secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage1 to submit reports required under paragraph 7#a74 7,b7 ,additional regulations ,not later than #ah months after the date of enactment of this section1 the ,secretary shall1 through rulemaking1 promulgate any other final regulations necessary to implement the requirements of this section4 ,in promulgating such regulations1 the ,secretary shall1 to the extent practicable1 align the reporting requirements under this section with the reporting requirements under section #bgii;,a-#aj4 7c7 ,requirement ,to provide information to participants or beneficiaries ,a group health plan1 including with respect to group health insurance coverage offered in connection with a group health plan1 upon request of a participant or beneficiary1 shall provide to such participant or beneficiary-- 7#a7 the summary document described in subsection 7b77#b77;,b77ii72 and 7#b7 the information described in subsection 7b77#b77;,a77i77,,iii7 with respect to a claim made by or on behalf of such participant or beneficiary4 7d7 ,enforcement 7#a7 ,in general ,the ,secretary shall enforce this section4 ,the enforcement authority under this subsection shall apply only with respect to group health plans 7including group health insurance coverage offered in connection with such a plan7 to which the requirements of subparts ,i and ,,ii of part ,a and part ,d apply in accordance with section #bgbb1 and with respect to entities providing pharmacy benefit management services on behalf of such plans and applicable entities providing services on behalf of such plans4 7#b7 ,failure to provide information ,a group health plan1 a health insurance issuer offering group health insurance coverage1 an entity providing pharmacy benefit management services on behalf of such a plan or issuer1 or an applicable entity providing services on behalf of such a plan or issuer that violates subsection 7a72 an entity providing pharmacy benefit management services on behalf of such a plan or issuer that fails to provide the information required under subsection 7b72 or a group health plan that fails to provide the information required under subsection 7c71 shall be subject to a civil monetary penalty in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7#c7 ,false information ,a health insurance issuer1 an entity providing pharmacy benefit management services1 or a third party administrator providing services on behalf of such issuer offered by a health insurance issuer that knowingly provides false information under this section shall be subject to a civil monetary penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil monetary penalty shall be in addition to other penalties as may be prescribed by law4 7#d7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under such section4 7#e7 ,waivers ,the ,secretary may waive penalties under paragraph 7#b71 or extend the period of time for compliance with a requirement of this section1 for an entity in violation of this section that has made a good-faith effort to comply with the requirements in this section4 7e7 ,rule of construction ,nothing in this section shall be construed to permit a health insurance issuer1 group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 7c71 or 7d7 by such issuer1 plan1 or entity4 7f7 ,definitions ,in this section3 7#a7 ,applicable entity ,the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary may specify through rulemaking4 7#b7 ,applicable group purchasing organization ,the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services4 7#c7 ,contracted compensation ,the term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug 7inclusive of the out-of-pocket costs to the participant or beneficiary71 or another analogous compensation structure that the ,secretary may specify through regulations4 7#d7 ,gross spending ,the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#e7 ,net spending ,the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#f7 ,plan sponsor ,the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd4 7#g7 ,remuneration ,the term remuneration has the meaning given such term by the ,secretary through rulemaking1 which shall be reevaluated by the ,secretary every #e years4 7#h7 ,specified large employer ,the term specified large employer means1 in connection with a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a single employer1 with respect to a calendar year or a plan year1 as applicable1 an employer who employed an average of at least #ajj employees on business days during the preceding calendar year or plan year and who employs at least #a employee on the first day of the calendar year or plan year4 7#i7 ,specified large plan ,the term specified large plan means a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a plan sponsor described in clause 7ii7 or 7iii7 of section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd that had an average of at least #ajj participants on business days during the preceding calendar year or plan year1 as applicable4 7#aj7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 2 and 7#b7 in section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7ii7 in paragraph 7#b71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 7ii7 in paragraph 7#b77;,a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7iii7 in paragraph 7#b77;,c77ii71 by inserting 7other than section #bgii;,a-#aa7 after part ,d4 7b7 ,employee ,retirement ,income ,security ,act of #aigd 7#a7 ,in general ,subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is amended-- 7,a7 in subpart ,b of part #g 7#bi ,u4,s4,c4 #aahe et seq471 by adding at the end the following3 #gbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of this section 7referred to in this subsection and subsection 7b7 as the effective date71 a group health plan or a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer1 shall not enter into a contract1 including an extension or renewal of a contract1 entered into on or after the effective date1 with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit or delay the disclosure of information to the group health plan 7including such a plan offered through a health insurance issuer7 in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection 7b72 and 7#b7 provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the effective date1 in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer1 including an extension or renewal of such a contract1 entered into on or after the effective date1 the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer1 not less frequently than every #f months 7or1 at the request of a group health plan1 not less frequently than quarterly1 and under the same conditions1 terms1 and cost of the semiannual report under this subsection71 shall submit to the group health plan a report in accordance with this section4 ,each such report shall be made available to such group health plan in plain language1 in a machine-readable format1 and as the ,secretary may determine1 other formats4 ,each such report shall include the information described in paragraph 7#b74 7#b7 ,information described ,for purposes of paragraph 7#a71 the information described in this paragraph is1 with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period-- 7,a7 in the case of a group health plan that is offered by a specified large employer or that is a specified large plan1 and is not offered as health insurance coverage1 or in the case of health insurance coverage for which the election under paragraph 7#c7 is made for the applicable reporting period-- 7i7 a list of drugs for which a claim was filed and1 with respect to each such drug on such list-- 7,i7 the contracted compensation paid by the group health plan or health insurance issuer for each covered drug 7identified by the ,national ,drug ,code7 to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer2 7,,ii7 the contracted compensation paid to the pharmacy1 by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer1 for each covered drug 7identified by the ,national ,drug ,code72 7,,iii7 for each such claim1 the difference between the amount paid under subclause 7,i7 and the amount paid under subclause 7,,ii72 7,,iv7 the proprietary name1 established name or proper name1 and the ,national ,drug ,code2 7,v7 for each claim for the drug 7including original prescriptions and refills7 and for each dosage unit of the drug for which a claim was filed1 the type of dispensing channel used to furnish the drug1 including retail1 mail order1 or specialty pharmacy2 7,,vi7 with respect to each drug dispensed1 for each type of dispensing channel 7including retail1 mail order1 or specialty pharmacy7-- 7aa7 whether such drug is a brand name drug or a generic drug1 and-- 7,,aa7 in the case of a brand name drug1 the wholesale acquisition cost1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7,,bb7 in the case of a generic drug1 the average wholesale price1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7bb7 the total number of-- 7,,aa7 prescription claims 7including original prescriptions and refills72 7,,bb7 participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel2 7,,cc7 dosage units and dosage units per fill of such drug2 and 7,,dd7 days supply of such drug per fill2 7,,vii7 the net price per course of treatment or single fill1 such as a #cj-;day supply or #ij-;day supply to the plan or coverage after rebates1 fees1 alternative discounts1 or other remuneration received from applicable entities2 7,,viii7 the total amount of out-of-pocket spending by participants and beneficiaries on such drug1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage1 or for which no claim is submitted under the plan or coverage2 7,,ix7 the total net spending on the drug2 7,x7 the total amount received1 or expected to be received1 by the plan or issuer from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 7,,xi7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of such drug or spending on such drug2 and 7,,xii7 to the extent feasible1 information on the total amount of remuneration for such drug1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer71 to the participants and beneficiaries enrolled in such plan or coverage2 7ii7 a list of each therapeutic class 7as defined by the ,secretary7 for which a claim was filed under the group health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic class-- 7,i7 the total gross spending on drugs in such class before rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,ii7 the net spending in such class after such rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,iii7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of drugs or drug spending2 7,,iv7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,v7 the number of participants and beneficiaries who filled a prescription for a drug in such class1 including the ,national ,drug ,code for each such drug2 7,,vi7 if applicable1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 and 7,,vii7 the total out-of-pocket spending under the plan or coverage by participants and beneficiaries1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage2 7iii7 with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period or1 in the case that gross spending under the group health plan or coverage exceeded #aj1jjj during the reporting period with respect to fewer than #ej drugs1 with respect to the #ej prescription drugs with the highest spending during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for the formulary placement of such drug in that therapeutic category or class1 selected from a list of standard rationales established by the ,secretary1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 and 7iv7 in the case that such plan or issuer 7or an entity providing pharmacy benefit management services on behalf of such plan or issuer7 has an affiliated pharmacy or pharmacy under common ownership1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost sharing assistance incentives funded by an entity providing pharmacy benefit services-- 7,i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies2 7,,ii7 the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage2 and 7,,iii7 a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage1 and1 with respect to each drug dispensed-- 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 or per #ij-;day supply 7as applicable7 to the plan or issuer1 and to participants and beneficiaries2 7bb7 the median amount charged to such plan or issuer1 and the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan or coverage2 7cc7 the lowest cost per dosage unit1 per #cj-;day supply and per #ij-;day supply1 for each such drug1 including amounts charged to the plan or coverage and to participants and beneficiaries1 that is available from any pharmacy included in the network of such plan or coverage2 and 7dd7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if such drug is subject to a maximum price discount2 and 7,b7 with respect to any group health plan1 including group health insurance coverage offered in connection with such a plan1 regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan-- 7i7 a summary document for the group health plan that includes such information described in clauses 7i7 through 7iv7 of subparagraph 7,a71 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking71 that the ,secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services1 such as an estimated net price to group health plan and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 7ii7 a summary document for plans and issuers to provide to participants and beneficiaries1 which shall be made available to participants or beneficiaries upon request to their group health plan 7including in the case of group health insurance coverage offered in connection with such a plan71 that-- 7,i7 contains such information described in clauses 7iii71 7iv71 7v71 and 7vi71 as applicable1 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking7 that the ,secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage2 7,,ii7 contains only aggregate information2 and 7,,iii7 states that participants and beneficiaries may request specific1 claims-level information required to be furnished under subsection 7c7 from the group health plan or health insurance issuer2 and 7iii7 with respect to drugs covered by such plan or coverage during such reporting period-- 7,i7 the total net spending by the plan or coverage for all such drugs2 7,,ii7 the total amount received1 or expected to be received1 by the plan or issuer from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 and 7,,iii7 to the extent feasible1 information on the total amount of remuneration for such drugs1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer7 to participants and beneficiaries2 7iv7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa77 to brokerage firms1 brokers1 consultants1 advisors1 or any other individual or firm1 for-- 7,i7 the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services1 including the identity of the recipient of such amounts2 7,,ii7 consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer2 or 7,,iii7 the retention of the entity by the group health plan or health insurance issuer2 7v7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives directly or indirectly funded by such entity2 and 7vi7 total gross spending on all drugs under the plan or coverage during the reporting period4 7#c7 ,opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan ,in the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan1 such group health plan may1 on an annual basis1 for plan years beginning on or after the date that is #cj months after the date of enactment of this section1 elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph 7#b77;,a71 in addition to the information described in paragraph 7#b77;,b74 7#d7 ,privacy requirements 7,a7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph 7#a7 in a manner consistent with the privacy regulations promulgated under section #acdjb7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agicb7;a77 and consistent with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations7 7referred to in this paragraph as the ,,hipaa privacy regulations7 and shall restrict the use and disclosure of such information according to such privacy regulations and such ,,hipaa privacy regulations4 7,b7 ,additional requirements 7i7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph 7#a7 shall ensure that such report contains only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7ii7 ,restrictions ,in carrying out this subsection1 a group health plan shall comply with section #afd4ejd7;f7 of title #de1 ,code of ,federal ,regulations 7or a successor regulation71 and a plan sponsor shall act in accordance with the terms of the agreement described in such section4 7,c7 ,rule of construction 7i7 ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations4 7ii7 ,nothing in this section shall be construed to affect the application of any ,federal or ,state privacy or civil rights law1 including the ,,hipaa privacy regulations1 the ,genetic ,information ,nondiscrimination ,act of #bjjh 7,public ,law #aaj-bcc7 7including the amendments made by such ,act71 the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d71 and title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,written notice ,each plan year1 group health plans1 including with respect to group health insurance coverage offered in connection with a group health plan1 shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph 7#a71 as applicable1 which may include incorporating such notification in plan documents provided to the participant or beneficiary1 or providing individual notification4 7,e7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to the entity from which the report was received or to that entity's business associates as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations7 or as permitted by the ,,hipaa privacy regulations4 7,f7 ,clarification regarding public disclosure of information ,nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage1 from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a71 except that such plan1 issuer1 or entity may not-- 7i7 restrict disclosure of such report to the ,department of ,health and ,human ,services1 the ,department of ,labor1 or the ,department of the ,treasury2 or 7ii7 prevent disclosure for the purposes of subsection 7c71 or any other public disclosure requirement under this section4 7,g7 ,limited form of report ,the ,secretary shall define through rulemaking a limited form of the report under paragraph 7#a7 required with respect to any group health plan established by a plan sponsor that is1 or is affiliated with1 a drug manufacturer1 drug wholesaler1 or other direct participant in the drug supply chain1 in order to prevent anti-competitive behavior4 7#e7 ,standard format and regulations 7,a7 ,in general ,not later than #ah months after the date of enactment of this section1 the ,secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage1 to submit reports required under paragraph 7#a74 7,b7 ,additional regulations ,not later than #ah months after the date of enactment of this section1 the ,secretary shall1 through rulemaking1 promulgate any other final regulations necessary to implement the requirements of this section4 ,in promulgating such regulations1 the ,secretary shall1 to the extent practicable1 align the reporting requirements under this section with the reporting requirements under section #gbe4 7c7 ,requirement ,to provide information to participants or beneficiaries ,a group health plan1 including with respect to group health insurance coverage offered in connection with a group health plan1 upon request of a participant or beneficiary1 shall provide to such participant or beneficiary-- 7#a7 the summary document described in subsection 7b77#b77;,b77ii72 and 7#b7 the information described in subsection 7b77#b77;,a77i77,,iii7 with respect to a claim made by or on behalf of such participant or beneficiary4 7d7 ,rule of construction ,nothing in this section shall be construed to permit a health insurance issuer1 group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 or 7c7 of this section or section #ejb7;c77#ac7 by such issuer1 plan1 or entity4 7e7 ,definitions ,in this section3 7#a7 ,applicable entity ,the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary may specify through rulemaking4 7#b7 ,applicable group purchasing organization ,the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services4 7#c7 ,contracted compensation ,the term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug 7inclusive of the out-of-pocket costs to the participant or beneficiary71 or another analogous compensation structure that the ,secretary may specify through regulations4 7#d7 ,gross spending ,the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#e7 ,net spending ,the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#f7 ,plan sponsor ,the term plan sponsor has the meaning given such term in section #c7af77;,b74 7#g7 ,remuneration ,the term remuneration has the meaning given such term by the ,secretary through rulemaking1 which shall be reevaluated by the ,secretary every #e years4 7#h7 ,specified large employer ,the term specified large employer means1 in connection with a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a single employer1 with respect to a calendar year or a plan year1 as applicable1 an employer who employed an average of at least #ajj employees on business days during the preceding calendar year or plan year and who employs at least #a employee on the first day of the calendar year or plan year4 7#i7 ,specified large plan ,the term specified large plan means a group health plan 7including group health insurance coverage offered in connection with such a plan7 established or maintained by a plan sponsor described in clause 7ii7 or 7iii7 of section #c7af77;,b7 that had an average of at least #ajj participants on business days during the preceding calendar year or plan year1 as applicable4 7#aj7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7,b7 in section #ejb 7#bi ,u4,s4,c4 #aacb7-- 7i7 in subsection 7a77#f71 by striking or 7#i7 and inserting 7#i71 or 7#ac72 7ii7 in subsection 7b77#c71 by striking under subsection 7c77#i7 and inserting under paragraphs 7#i7 and 7#ac7 of subsection 7c72 and 7iii7 in subsection 7c71 by adding at the end the following3 7#ac7 ,secretarial enforcement authority relating to oversight of pharmacy benefit management services 7,a7 ,failure to provide information ,the ,secretary may impose a penalty against a plan administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer1 or an applicable entity 7as defined in section #gbf7;f77 that violates section #gbf7;a72 an entity providing pharmacy benefit management services on behalf of such a plan or issuer that fails to provide the information required under section #gbf7;b72 or any person who causes a group health plan to fail to provide the information required under section #gbf7;c71 in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7,b7 ,false information ,the ,secretary may impose a penalty against a plan administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 an entity providing pharmacy benefit management services1 or an applicable entity 7as defined in section #gbf7;f77 that knowingly provides false information under section #gbf1 in an amount not to exceed #ajj1jjj for each item of false information4 ,such penalty shall be in addition to other penalties as may be prescribed by law4 7,c7 ,waivers ,the ,secretary may waive penalties under subparagraph 7,a71 or extend the period of time for compliance with a requirement of this section1 for an entity in violation of section #gbf that has made a good-faith effort to comply with the requirements of section #gbf4 2 and 7,c7 in section #gcb7;a7 7#bi ,u4,s4,c4 #aaia;a7a771 by striking section #gaa and inserting sections #gaa and #gbf4 7#b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gbe the following new item3 ,sec4 #gbf4 ,oversight of entities that provide pharmacy benefit management services4 4 7c7 ,internal ,revenue ,code of #aihf 7#a7 ,in general ,chapter #ajj of the ,internal ,revenue ,code of #aihf is amended-- 7,a7 by adding at the end of subchapter ,b the following3 #ihbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of this section 7referred to in this subsection and subsection 7b7 as the effective date71 a group health plan1 or an entity providing pharmacy benefit management services on behalf of such a plan1 shall not enter into a contract1 including an extension or renewal of a contract1 entered into on or after the effective date1 with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit or delay the disclosure of information to the group health plan in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan from making the reports described in subsection 7b72 and 7#b7 provide the entity providing pharmacy benefit management services on behalf of a group health plan relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the effective date1 in the case of any contract between a group health plan and an entity providing pharmacy benefit management services on behalf of such plan1 including an extension or renewal of such a contract1 entered into on or after the effective date1 the entity providing pharmacy benefit management services on behalf of such a group health plan1 not less frequently than every #f months 7or1 at the request of a group health plan1 not less frequently than quarterly1 and under the same conditions1 terms1 and cost of the semiannual report under this subsection71 shall submit to the group health plan a report in accordance with this section4 ,each such report shall be made available to such group health plan in plain language1 in a machine-readable format1 and as the ,secretary may determine1 other formats4 ,each such report shall include the information described in paragraph 7#b74 7#b7 ,information described ,for purposes of paragraph 7#a71 the information described in this paragraph is1 with respect to drugs covered by a group health plan during each reporting period-- 7,a7 in the case of a group health plan that is offered by a specified large employer or that is a specified large plan1 and is not offered as health insurance coverage1 or in the case of health insurance coverage for which the election under paragraph 7#c7 is made for the applicable reporting period-- 7i7 a list of drugs for which a claim was filed and1 with respect to each such drug on such list-- 7,i7 the contracted compensation paid by the group health plan for each covered drug 7identified by the ,national ,drug ,code7 to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan2 7,,ii7 the contracted compensation paid to the pharmacy1 by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan1 for each covered drug 7identified by the ,national ,drug ,code72 7,,iii7 for each such claim1 the difference between the amount paid under subclause 7,i7 and the amount paid under subclause 7,,ii72 7,,iv7 the proprietary name1 established name or proper name1 and the ,national ,drug ,code2 7,v7 for each claim for the drug 7including original prescriptions and refills7 and for each dosage unit of the drug for which a claim was filed1 the type of dispensing channel used to furnish the drug1 including retail1 mail order1 or specialty pharmacy2 7,,vi7 with respect to each drug dispensed1 for each type of dispensing channel 7including retail1 mail order1 or specialty pharmacy7-- 7aa7 whether such drug is a brand name drug or a generic drug1 and-- 7,,aa7 in the case of a brand name drug1 the wholesale acquisition cost1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7,,bb7 in the case of a generic drug1 the average wholesale price1 listed as cost per days supply and cost per dosage unit1 on the date such drug was dispensed2 and 7bb7 the total number of-- 7,,aa7 prescription claims 7including original prescriptions and refills72 7,,bb7 participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel2 7,,cc7 dosage units and dosage units per fill of such drug2 and 7,,dd7 days supply of such drug per fill2 7,,vii7 the net price per course of treatment or single fill1 such as a #cj-;day supply or #ij-;day supply to the plan after rebates1 fees1 alternative discounts1 or other remuneration received from applicable entities2 7,,viii7 the total amount of out-of-pocket spending by participants and beneficiaries on such drug1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan1 or for which no claim is submitted under the plan2 7,,ix7 the total net spending on the drug2 7,x7 the total amount received1 or expected to be received1 by the plan from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 7,,xi7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of such drug or spending on such drug2 and 7,,xii7 to the extent feasible1 information on the total amount of remuneration for such drug1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer71 to the participants and beneficiaries enrolled in such plan2 7ii7 a list of each therapeutic class 7as defined by the ,secretary7 for which a claim was filed under the group health plan during the reporting period1 and1 with respect to each such therapeutic class-- 7,i7 the total gross spending on drugs in such class before rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,ii7 the net spending in such class after such rebates1 price concessions1 alternative discounts1 or other remuneration from applicable entities2 7,,iii7 the total amount received1 or expected to be received1 by the entity providing pharmacy benefit management services1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration from such entities-- 7aa7 for claims incurred during the reporting period2 and 7bb7 that is related to utilization of drugs or drug spending2 7,,iv7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,v7 the number of participants and beneficiaries who filled a prescription for a drug in such class1 including the ,national ,drug ,code for each such drug2 7,,vi7 if applicable1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 and 7,,vii7 the total out-of-pocket spending under the plan by participants and beneficiaries1 including spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted under the plan2 7iii7 with respect to any drug for which gross spending under the group health plan exceeded #aj1jjj during the reporting period or1 in the case that gross spending under the group health plan exceeded #aj1jjj during the reporting period with respect to fewer than #ej drugs1 with respect to the #ej prescription drugs with the highest spending during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for the formulary placement of such drug in that therapeutic category or class1 selected from a list of standard rationales established by the ,secretary1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 and 7iv7 in the case that such plan 7or an entity providing pharmacy benefit management services on behalf of such plan7 has an affiliated pharmacy or pharmacy under common ownership1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost sharing assistance incentives funded by an entity providing pharmacy benefit services-- 7,i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order1 specialty1 or retail pharmacies2 7,,ii7 the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan2 and 7,,iii7 a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan1 and1 with respect to each drug dispensed-- 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 or per #ij-;day supply 7as applicable7 to the plan1 and to participants and beneficiaries2 7bb7 the median amount charged to such plan1 and the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan2 7cc7 the lowest cost per dosage unit1 per #cj-;day supply and per #ij-;day supply1 for each such drug1 including amounts charged to the plan and to participants and beneficiaries1 that is available from any pharmacy included in the network of such plan2 and 7dd7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if such drug is subject to a maximum price discount2 and 7,b7 with respect to any group health plan1 regardless of whether the plan is offered by a specified large employer or whether it is a specified large plan-- 7i7 a summary document for the group health plan that includes such information described in clauses 7i7 through 7iv7 of subparagraph 7,a71 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking71 that the ,secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services1 such as an estimated net price to group health plan and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 7ii7 a summary document for plans to provide to participants and beneficiaries1 which shall be made available to participants or beneficiaries upon request to their group health plan1 that-- 7,i7 contains such information described in clauses 7iii71 7iv71 7v71 and 7vi71 as applicable1 as specified by the ,secretary through guidance1 program instruction1 or otherwise 7with no requirement of notice and comment rulemaking7 that the ,secretary determines useful to participants or beneficiaries in better understanding the plan or benefits under such plan2 7,,ii7 contains only aggregate information2 and 7,,iii7 states that participants and beneficiaries may request specific1 claims-level information required to be furnished under subsection 7c7 from the group health plan2 and 7iii7 with respect to drugs covered by such plan during such reporting period-- 7,i7 the total net spending by the plan for all such drugs2 7,,ii7 the total amount received1 or expected to be received1 by the plan from any applicable entity in rebates1 fees1 alternative discounts1 or other remuneration2 and 7,,iii7 to the extent feasible1 information on the total amount of remuneration for such drugs1 including copayment assistance dollars paid1 copayment cards applied1 or other discounts provided by each drug manufacturer 7or entity administering copayment assistance on behalf of such drug manufacturer7 to participants and beneficiaries2 7iv7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,,aa777 to brokerage firms1 brokers1 consultants1 advisors1 or any other individual or firm1 for-- 7,i7 the referral of the group health plan's business to an entity providing pharmacy benefit management services1 including the identity of the recipient of such amounts2 7,,ii7 consideration of the entity providing pharmacy benefit management services by the group health plan2 or 7,,iii7 the retention of the entity by the group health plan2 7v7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives directly or indirectly funded by such entity2 and 7vi7 total gross spending on all drugs under the plan during the reporting period4 7#c7 ,opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan ,in the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan1 such group health plan may1 on an annual basis1 for plan years beginning on or after the date that is #cj months after the date of enactment of this section1 elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph 7#b77;,a71 in addition to the information described in paragraph 7#b77;,b74 7#d7 ,privacy requirements 7,a7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan shall report information under paragraph 7#a7 in a manner consistent with the privacy regulations promulgated under section #acdjb7;a7 of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agicb7;a77 and consistent with the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations7 7referred to in this paragraph as the ,,hipaa privacy regulations7 and shall restrict the use and disclosure of such information according to such privacy regulations and such ,,hipaa privacy regulations4 7,b7 ,additional requirements 7i7 ,in general ,an entity providing pharmacy benefit management services on behalf of a group health plan that submits a report under paragraph 7#a7 shall ensure that such report contains only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7ii7 ,restrictions ,in carrying out this subsection1 a group health plan shall comply with section #afd4ejd7;f7 of title #de1 ,code of ,federal ,regulations 7or a successor regulation71 and a plan sponsor shall act in accordance with the terms of the agreement described in such section4 7,c7 ,rule of construction 7i7 ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations4 7ii7 ,nothing in this section shall be construed to affect the application of any ,federal or ,state privacy or civil rights law1 including the ,,hipaa privacy regulations1 the ,genetic ,information ,nondiscrimination ,act of #bjjh 7,public ,law #aaj-bcc7 7including the amendments made by such ,act71 the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d71 and title ,,vii of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,written notice ,each plan year1 group health plans shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan to submit reports to group health plans under paragraph 7#a71 as applicable1 which may include incorporating such notification in plan documents provided to the participant or beneficiary1 or providing individual notification4 7,e7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to the entity from which the report was received or to that entity's business associates as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations7 or as permitted by the ,,hipaa privacy regulations4 7,f7 ,clarification regarding public disclosure of information ,nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan1 from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a71 except that such plan or entity may not-- 7i7 restrict disclosure of such report to the ,department of ,health and ,human ,services1 the ,department of ,labor1 or the ,department of the ,treasury2 or 7ii7 prevent disclosure for the purposes of subsection 7c71 or any other public disclosure requirement under this section4 7,g7 ,limited form of report ,the ,secretary shall define through rulemaking a limited form of the report under paragraph 7#a7 required with respect to any group health plan established by a plan sponsor that is1 or is affiliated with1 a drug manufacturer1 drug wholesaler1 or other direct participant in the drug supply chain1 in order to prevent anti-competitive behavior4 7#e7 ,standard format and regulations 7,a7 ,in general ,not later than #ah months after the date of enactment of this section1 the ,secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans1 to submit reports required under paragraph 7#a74 7,b7 ,additional regulations ,not later than #ah months after the date of enactment of this section1 the ,secretary shall1 through rulemaking1 promulgate any other final regulations necessary to implement the requirements of this section4 ,in promulgating such regulations1 the ,secretary shall1 to the extent practicable1 align the reporting requirements under this section with the reporting requirements under section #ihbe4 7c7 ,requirement ,to provide information to participants or beneficiaries ,a group health plan1 upon request of a participant or beneficiary1 shall provide to such participant or beneficiary-- 7#a7 the summary document described in subsection 7b77#b77;,b77ii72 and 7#b7 the information described in subsection 7b77#b77;,a77i77,,iii7 with respect to a claim made by or on behalf of such participant or beneficiary4 7d7 ,rule of construction ,nothing in this section shall be construed to permit a health insurance issuer1 group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 or 7c7 of this section or section #dihj;,d7g7 by such issuer1 plan1 or entity4 7e7 ,definitions ,in this section3 7#a7 ,applicable entity ,the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary may specify through rulemaking4 7#b7 ,applicable group purchasing organization ,the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services4 7#c7 ,contracted compensation ,the term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug 7inclusive of the out-of-pocket costs to the participant or beneficiary71 or another analogous compensation structure that the ,secretary may specify through regulations4 7#d7 ,gross spending ,the term gross spending1 with respect to prescription drug benefits under a group health plan1 means the amount spent by a group health plan on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#e7 ,net spending ,the term net spending1 with respect to prescription drug benefits under a group health plan1 means the amount spent by a group health plan on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration4 7#f7 ,plan sponsor ,the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b774 7#g7 ,remuneration ,the term remuneration has the meaning given such term by the ,secretary1 through rulemaking1 which shall be reevaluated by the ,secretary every #e years4 7#h7 ,specified large employer ,the term specified large employer means1 in connection with a group health plan established or maintained by a single employer1 with respect to a calendar year or a plan year1 as applicable1 an employer who employed an average of at least #ajj employees on business days during the preceding calendar year or plan year and who employs at least #a employee on the first day of the calendar year or plan year4 7#i7 ,specified large plan ,the term specified large plan means a group health plan established or maintained by a plan sponsor described in clause 7ii7 or 7iii7 of section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b77 that had an average of at least #ajj participants on business days during the preceding calendar year or plan year1 as applicable4 7#aj7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7#b7 ,exception for certain group health plans ,section #ihca7;a77#b7 of the ,internal ,revenue ,code of #aihf is amended by inserting other than with respect to section #ihbf1 before any group health plan4 7#c7 ,enforcement ,section #dihj;,d of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subsection3 7g7 ,application to requirements imposed on certain entities providing pharmacy benefit management services ,in the case of any requirement under section #ihbf that applies with respect to an entity providing pharmacy benefit management services on behalf of a group health plan1 any reference in this section to such group health plan 7and the reference in subsection 7e77#a7 to the employer7 shall be treated as including a reference to such entity4 4 7#d7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new item3 ,sec4 #ihbf4 ,oversight of entities that provide pharmacy benefit management services44 #ijb4 ,full rebate pass through to plan2 exception for innocent plan fiduciaries 7a7 ,in general ,section #djh7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is amended-- 7#a7 in subparagraph 7,b77viii7-- 7,a7 by redesignating subclauses 7,,ii7 through 7,,iv7 as subclauses 7,,iii7 through 7,v71 respectively2 7,b7 in subclause 7,i7-- 7i7 by striking subclause 7,,ii7 and inserting subclause 7,,iii72 and 7ii7 by striking subclauses 7,,ii7 and 7,,iii7 and inserting subclauses 7,,iii7 and 7,,iv72 and 7,c7 by inserting after subclause 7,i7 the following3 7,,ii7 ,pursuant to subsection 7a71 subparagraphs 7,c7 and 7,d7 of section #djf7;a77#a7 shall not apply to a responsible plan fiduciary1 notwithstanding any failure to remit required amounts under subparagraph 7,c77i71 if the following conditions are met3 7aa7 ,the responsible plan fiduciary did not know that the covered service provider failed or would fail to make required remittances and reasonably believed that the covered service provider remitted such required amounts4 7bb7 ,the responsible plan fiduciary1 upon discovering that the covered service provider failed to remit the required amounts1 requests in writing that the covered service provider remit such amounts4 7cc7 ,if the covered service provider fails to comply with a written request described in subclause 7,,iii7 within #ij days of the request1 the responsible plan fiduciary notifies the ,secretary of the covered service provider's failure1 in accordance with subclauses 7,,iii7 and 7,,iv74 2 and 7#b7 by adding at the end the following3 7,c7 7i7 7,i7 ,for plan years beginning on or after the date that is #cj months after the date of enactment of this subparagraph 7referred to in this clause as the effective date71 no contract or arrangement or renewal or extension of a contract or arrangement1 entered into on or after the effective date1 for services between a covered plan and a covered service provider1 through a health insurance issuer offering group health insurance coverage1 a third-party administrator1 an entity providing pharmacy benefit management services1 or other entity1 for pharmacy benefit management services1 is reasonable within the meaning of this paragraph unless such entity providing pharmacy benefit management services-- 7aa7 remits #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs or drug spending under such health plan or health insurance coverage1 to the group health plan or health insurance issuer offering group health insurance coverage2 and 7bb7 does not enter into any contract for pharmacy benefit management services on behalf of such a plan or coverage1 with an applicable entity unless #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received under such contract that are related to the utilization of drugs or drug spending under such group health plan or health insurance coverage are remitted to the group health plan or health insurance issuer by the entity providing pharmacy benefit management services4 7,,ii7 ,nothing in subclause 7,i7 shall be construed to affect the term of a contract or arrangement1 as in effect on the effective date 7as described in such subclause71 except that such subclause shall apply to any renewal or extension of such a contract or arrangement entered into on or after such effective date1 as so described4 7ii7 ,with respect to such rebates1 fees1 alternative discounts1 and other remuneration-- 7,i7 the rebates1 fees1 alternative discounts1 and other remuneration under clause 7i77,i7 shall be-- 7aa7 remitted-- 7,,aa7 on a quarterly basis1 to the group health plan or the group health insurance issuer1 not later than #ij days after the end of each quarter2 or 7,,bb7 in the case of an underpayment in a remittance for a prior quarter1 as soon as practicable1 but not later than #ij days after notice of the underpayment is first given2 7bb7 fully disclosed and enumerated to the group health plan or health insurance issuer2 and 7cc7 returned to the covered service provider for pharmacy benefit management services on behalf of the group health plan if any audit by a plan sponsor1 issuer or a third party designated by a plan sponsor1 indicates that the amounts received are incorrect after such amounts have been paid to the group health plan or health insurance issuer2 7,,ii7 the ,secretary may establish procedures for the remittance of rebates fees1 alternative discounts1 and other remuneration under subclause 7,i77aa7 and the disclosure of rebates1 fees1 alternative discounts1 and other remuneration under subclause 7,i77bb72 and 7,,iii7 the records of such rebates1 fees1 alternative discounts1 and other remuneration shall be available for audit by the plan sponsor1 issuer1 or a third party designated by a plan sponsor1 not less than once per plan year4 7iii7 ,to ensure that an entity providing pharmacy benefit management services is able to meet the requirements of clause 7ii77,i71 a rebate aggregator 7or other purchasing entity designed to aggregate rebates7 and an applicable group purchasing organization shall remit such rebates to the entity providing pharmacy benefit management services not later than #de days after the end of each quarter4 7iv7 ,a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or a covered service provider for pharmacy benefit management services under such health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third party1 subject to reasonable restrictions 7as determined by the ,secretary7 on confidentiality to prevent re-disclosure of such contracts or use of such information in audits for purposes unrelated to this section4 7v7 ,audits carried out under clauses 7ii77,,iii7 and 7iv7 shall be performed by an auditor selected by the responsible plan fiduciary4 ,payment for such audits shall not be made1 whether directly or indirectly1 by the entity providing pharmacy benefit management services4 7vi7 ,nothing in this subparagraph shall be construed to-- 7,i7 prohibit reasonable payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subparagraph1 provided that such fees are transparent and quantifiable to group health plans and health insurance issuers2 7,,ii7 require a third-party administrator of a group health plan or covered service provider for pharmacy benefit management services under such health plan or health insurance coverage to remit bona fide service fees to the group health plan2 7,,iii7 limit the ability of a group health plan or health insurance issuer to pass through rebates1 fees1 alternative discounts1 and other remuneration to the participant or beneficiary2 or 7,,iv7 modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the privacy regulations promulgated under the ,health ,insurance ,portability and ,accountability ,act of #aiif in part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7vii7 ,for purposes of this subparagraph-- 7,i7 the terms applicable entity and applicable group purchasing organization have the meanings given such terms in section #gbf7;e72 7,,ii7 the terms covered plan1 covered service provider1 and responsible plan fiduciary have the meanings given such terms in subparagraph 7,b72 and 7,,iii7 the terms group health insurance coverage1 health insurance coverage1 and health insurance issuer have the meanings given such terms in section #gcc4 4 7b7 ,rule of construction ,subclause 7,,ii77aa7 of section #djh7;b77#b77;,b77viii7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77viii771 as amended by subsection 7a71 shall not be construed to relieve or limit a responsible plan fiduciary from the duty to monitor the practices of any covered service provider that contracts with the applicable covered plan1 including for the purposes of ensuring the reasonableness of compensation4 ,for purposes of this subsection1 the terms covered plan1 covered service provider1 and responsible plan fiduciary have the meanings given such terms in section #djh7;b77#b77;,b77ii7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii774 7c7 ,clarification of covered service provider 7#a7 ,services 7,a7 ,in general ,section #djh7;b77#b77;,b77ii77,i77bb7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77 is amended-- 7i7 in subitem 7,,aa7 by striking ,brokerage services1 and inserting ,services 7including brokerage services712 and 7ii7 in subitem 7,,bb7-- 7,i7 by striking ,consulting1 and inserting ,other services12 and 7,,ii7 by striking related to the development or implementation of plan design and all that follows through the period at the end and inserting including any of the following3 plan design1 insurance or insurance product selection 7including vision and dental71 recordkeeping1 medical management1 benefits administration selection 7including vision and dental71 stop-loss insurance1 pharmacy benefit management services1 wellness design and management services1 transparency tools1 group purchasing organization agreements and services1 participation in and services from preferred vendor panels1 disease management1 compliance services1 employee assistance programs1 or third-party administration services1 or consulting services related to any such services44 7,b7 ,sense of ,congress ,it is the sense of ,congress that the amendment made by subparagraph 7,a7 clarifies the existing requirement of covered service providers with respect to services described in section #djh7;b77#b77;,b77ii77,i77bb77,,bb7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77,,bb77 that were in effect since the application date described in section #bjb7;e7 of the ,no ,surprises ,act 7,public ,law #aaf-bfj2 #bi ,u4,s4,c4 #aajh note71 and does not impose any additional requirement under section #djh7;b77#b77;,b7 of such ,act4 7#b7 ,certain arrangements for pharmacy benefit management services considered as indirect 7,a7 ,in general ,section #djh7;b77#b77;,b77i7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77i77 is amended-- 7i7 by striking requirements of this clause and inserting requirements of this subparagraph2 and 7ii7 by adding at the end the following3 ,for purposes of applying section #djf7;a77#a77;,c7 with respect to a transaction described under this subparagraph or subparagraph 7,c71 a contract or arrangement for services between a covered plan and an entity providing services to the plan1 including a health insurance issuer providing health insurance coverage in connection with the covered plan1 in which such entity contracts1 in connection with such plan1 with a service provider for pharmacy benefit management services1 shall be considered an indirect furnishing of goods1 services1 or facilities between the covered plan and the service provider for pharmacy benefit management services acting as the party in interest44 7,b7 ,health insurance issuer and health insurance coverage defined ,section #djh7;b77#b77;,b77ii77,i77aa7 of such ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77aa77 is amended by inserting before the period at the end and the terms health insurance coverage and health insurance issuer have the meanings given such terms in section #gcc7;b74 7,c7 ,technical amendment ,section #djh7;b77#b77;,b77ii77,i77aa7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77aa77 is amended by inserting in after defined4 #ijc4 ,increasing transparency in generic drug applications 7a7 ,in general ,section #eje7;j77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is amended by adding at the end the following3 7,h7 7i7 ,upon request 7in controlled correspondence or an analogous process7 by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentrations as the listed drug referred to1 or for which the ,secretary determines there is a scientific justification for an approach that is in vitro1 in whole or in part1 to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentrations as the listed drug referred to1 the ,secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug4 ,the ,secretary may also provide such information to such a person on the ,secretary's own initiative during the review of an abbreviated application under this subsection for such drug4 7ii7 ,notwithstanding section #cja7;j71 if the ,secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug1 the ,secretary shall identify and disclose to the person-- 7,i7 the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug2 and 7,,ii7 for any ingredient for which there is an identified quantitative deviation1 the amount of such deviation4 7iii7 ,if the ,secretary determines that such drug is qualitatively and quantitatively the same as the listed drug1 the ,secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless-- 7,i7 the formulation of the listed drug has been changed and the ,secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness2 or 7,,ii7 the ,secretary makes a written determination that the prior determination must be changed because an error has been identified4 7iv7 ,if the ,secretary makes a written determination described in clause 7iii77,,ii71 the ,secretary shall provide notice and a copy of the written determination to the person making the request under clause 7i74 7v7 ,the disclosures authorized under clauses 7i7 and 7ii7 are disclosures authorized by law1 including for purposes of section #aije of title #ah1 ,united ,states ,code4 ,this subparagraph shall not otherwise be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug1 or to affect the status1 if any1 of such information as trade secret or confidential commercial information for purposes of section #cja7;j7 of this ,act1 section #eeb of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,guidance 7#a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance1 or update guidance1 describing how the ,secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug 7as such terms are used in section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a771 including with respect to assessing p,h adjusters4 7#b7 ,process ,in issuing guidance under this subsection1 the ,secretary of ,health and ,human ,services shall-- 7,a7 publish draft guidance2 7,b7 provide a period of at least #fj days for comment on the draft guidance2 and 7,c7 after considering any comments received and not later than one year after the close of the comment period on the draft guidance1 publish final guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 applies beginning on the date of enactment of this ,act1 irrespective of the date on which the guidance required by subsection 7b7 is finalized4 #ijd4 ,title #ce amendments 7a7 ,in general ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in paragraph 7#b77;,c71 in the flush text following clause 7ii71 by adding at the end the following3 ,with respect to a submission described in clause 7ii71 the act of infringement shall extend to any patent that claims the biological product1 a method of using the biological product1 or a method or product used to manufacture the biological product42 and 7#b7 by adding at the end the following3 7#g7 7,a7 ,subject to subparagraphs 7,c71 7,d71 and 7,e71 if the sponsor of an approved application for a reference product1 as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77 7referred to in this paragraph as the reference product sponsor71 brings an action for infringement under this section against an applicant for approval of a biological product under section #cea7k7 of such ,act that references that reference product 7referred to in this paragraph as the subsection 7k7 applicant71 the reference product sponsor may assert in the action a total of not more than #bj patents of the type described in subparagraph 7,b71 not more than #aj of which shall have issued after the date specified in section #cea7l77#g77;,a7 of such ,act4 7,b7 ,the patents described in this subparagraph are patents that satisfy each of the following requirements3 7i7 ,patents that claim the biological product that is the subject of an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 7or a use of that product7 or a method or product used in the manufacture of such biological product4 7ii7 ,patents that are included on the list of patents described in paragraph 7#c77;,a7 of section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l771 including as provided under paragraph 7#g7 of such section #cea7l74 7iii7 ,patents that-- 7,i7 have an actual filing date of more than #d years after the date on which the reference product is approved2 or 7,,ii7 include a claim to a method in a manufacturing process that is not used by the reference product sponsor4 7,c7 ,the court in which an action described in subparagraph 7,a7 is brought may increase the number of patents limited under that subparagraph-- 7i7 if the request to increase that number is made without undue delay2 and 7ii7 7,i7 if the interest of justice so requires2 or 7,,ii7 for good cause shown1 which-- 7aa7 shall be established if the subsection 7k7 applicant fails to provide information required section #cea7k77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77 that would enable the reference product sponsor to form a reasonable belief with respect to whether a claim of infringement under this section could reasonably be asserted2 and 7bb7 may be established-- 7,,aa7 if there is a material change to the biological product 7or process with respect to the biological product7 of the subsection 7k7 applicant that is the subject of the application2 7,,bb7 if1 with respect to a patent on the supplemental list described in section #cea7l77#g77;,a7 of ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#g77;,a771 the patent would have issued before the date specified in such section #cea7l77#g77;,a7 but for the failure of the ,office to issue the patent or a delay in the issuance of the patent1 as described in paragraph 7#a7 of section #aed7;b7 and subject to the limitations under paragraph 7#b7 of such section #aed7;b72 or 7,,cc7 for another reason that shows good cause1 as determined appropriate by the court4 7,d7 ,in determining whether good cause has been shown for the purposes of subparagraph 7,c77ii77,,ii71 a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection 7k7 application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted4 7,e7 ,the limitation imposed under subparagraph 7,a7-- 7i7 shall apply only if the subsection 7k7 applicant completes all actions required under paragraphs 7#b77;,a71 7#c77;,b77ii71 7#e71 7#f77;,c77i71 7#g71 and 7#h77;,a7 of section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l772 and 7ii7 shall not apply with respect to any patent that claims1 with respect to a biological product1 a method for using that product in therapy1 diagnosis1 or prophylaxis1 such as an indication or method of treatment or other condition of use4 4 7b7 ,applicability ,the amendments made by subsection 7a7 shall apply with respect to an application submitted under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 on or after the date of enactment of this ,act4 ,x ,miscellaneous #ajja4 ,extension of safe harbor for absence of deductible for telehealth ,section #bbc7;c77#b77;,e77ii7 of the ,internal ,revenue ,code of #aihf is amended to read as follows3 7ii7 ,safe harbor for absence of deductible for telehealth 7,i7 ,in general ,in the case of an eligible month or an eligible plan year1 a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for telehealth and other remote care services4 7,,ii7 ,eligible month ,for purposes of this clause1 the term eligible month means months beginning after ,march #ca1 #bjbb1 and before ,january #a1 #bjbc1 and months beginning after ,march #ca1 #bjbe1 and before ,january #a1 #bjbf4 7,,iii7 ,eligible plan year ,for purposes of this clause1 the term eligible plan year means plan years beginning-- 7aa7 on or before ,december #ca1 #bjba1 7bb7 after ,december #ca1 #bjbb1 and before ,january #a1 #bjbe1 or 7cc7 after ,december #ca1 #bjbd1 and before ,january #a1 #bjbg4 4