,,ii ,calendar ,no4 #dhe #aaeth ,,congress #b;d ,session ,h4 ,r4 #f ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #be1 #bjah,received2 read the first time ,june #bf1 #bjah,read the second time and placed on the calendar ,,an ,,act ,to provide for opioid use disorder prevention1 recovery1 and treatment1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,substance ,use-,disorder ,prevention that ,promotes ,opioid ,recovery and ,treatment for ,patients and ,communities ,act or the ,,support for ,patients and ,communities ,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 ,provisions to ,address the ,opioid ,crisis ,sec4 #ajja4 ,at-risk youth ,medicaid protection4 ,sec4 #ajjb4 ,health ,insurance for ,former ,foster ,youth4 ,sec4 #ajjc4 ,demonstration project to increase substance use provider capacity under the ,medicaid program4 ,sec4 #ajjd4 ,drug management program for at-risk beneficiaries4 ,sec4 #ajje4 ,medicaid drug review and utilization4 ,sec4 #ajjf4 ,guidance to improve care for infants with neonatal abstinence syndrome and their mothers2 ,,gao study on gaps in ,medicaid coverage for pregnant and postpartum women with substance use disorder4 ,sec4 #ajjg4 ,medicaid health homes for opioid-use-disorder ,medicaid enrollees4 ,title ,,ii--,medicare ,provisions to ,address the ,opioid ,crisis ,sec4 #bjja4 ,authority not to apply certain ,medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder4 ,sec4 #bjjb4 ,encouraging the use of non-opioid analgesics for the management of post-surgical pain4 ,sec4 #bjjc4 ,requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the ,welcome to ,medicare initial preventive physical examination4 ,sec4 #bjjd4 ,modification of payment for certain outpatient surgical services4 ,sec4 #bjje4 ,requiring e-prescribing for coverage of covered part ,d controlled substances4 ,sec4 #bjjf4 ,requiring prescription drug plan sponsors under ,medicare to establish drug management programs for at-risk beneficiaries4 ,sec4 #bjjg4 ,medicare coverage of certain services furnished by opioid treatment programs4 ,title ,,iii--,other ,health ,provisions to ,address the ,opioid ,crisis ,sec4 #cjja4 ,clarifying ,,fda regulation of non-addictive pain and addiction therapies4 ,sec4 #cjjb4 ,surveillance and ,testing of ,opioids to ,prevent ,fentanyl ,deaths4 ,sec4 #cjjc4 ,allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders4 ,sec4 #cjjd4 ,high-quality1 evidence-based opioid analgesic prescribing guidelines and report4 ,sec4 #cjje4 ,report on opioids prescribing practices for pregnant women4 ,sec4 #cjjf4 ,guidelines for prescribing naloxone4 ,sec4 #cjjg4 ,requiring a survey of substance use disorder treatment providers receiving ,federal funding4 ,title ,,iv--,offsets ,sec4 #djja4 ,promoting value in ,medicaid managed care4 ,sec4 #djjb4 ,extending period of application of ,medicare secondary payer rules for individuals with end stage renal disease4 ,sec4 #djjc4 ,requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the ,medicare program4 ,title ,v--,other ,medicaid ,provisions ,subtitle ,a--,mandatory reporting with respect to adult behavioral health measures ,sec4 #ejja4 ,mandatory reporting with respect to adult behavioral health measures4 ,subtitle ,b--,medicaid ,,imd ,additional ,info ,sec4 #ejaa4 ,short title4 ,sec4 #ejab4 ,,macpac exploratory study and report on institutions for mental diseases requirements and practices under ,medicaid4 ,subtitle ,c--,,chip ,mental ,health ,parity ,sec4 #ejba4 ,short title4 ,sec4 #ejbb4 ,ensuring access to mental health and substance use disorder services for children and pregnant women under the ,children's ,health ,insurance ,program4 ,subtitle ,d--,medicaid ,reentry ,sec4 #ejca4 ,short title4 ,sec4 #ejcb4 ,promoting ,state innovations to ease transitions integration to the community for certain individuals4 ,subtitle ,e--,medicaid ,partnership ,sec4 #ejda4 ,short title4 ,sec4 #ejdb4 ,medicaid providers are required to note experiences in record systems to help in-need patients4 ,title ,,vi--,other ,medicare ,provisions ,subtitle ,a--,testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology ,sec4 #fjja4 ,testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology4 ,subtitle ,b--,abuse ,deterrent ,access ,sec4 #fjaa4 ,short title4 ,sec4 #fjab4 ,study on abuse-deterrent opioid formulations access barriers under ,medicare4 ,subtitle ,c--,medicare ,opioid ,safety ,education ,sec4 #fjba4 ,short title4 ,sec4 #fjbb4 ,provision of information regarding opioid use and pain management as part of ,medicare ,you handbook4 ,subtitle ,d--,opioid ,addiction ,action ,plan ,sec4 #fjca4 ,short title4 ,sec4 #fjcb4 ,action plan on recommendations for changes under ,medicare and ,medicaid to prevent opioids addictions and enhance access to medication-assisted treatment4 ,subtitle ,e--,advancing ,high ,quality ,treatment for ,opioid ,use ,disorders in ,medicare ,sec4 #fjda4 ,short title4 ,sec4 #fjdb4 ,opioid use disorder treatment demonstration program4 ,subtitle ,f--,responsible ,education ,achieves ,care and ,healthy ,outcomes for ,users' ,treatment ,sec4 #fjea4 ,short title4 ,sec4 #fjeb4 ,grants to provide technical assistance to outlier prescribers of opioids4 ,subtitle ,g--,preventing ,addiction for ,susceptible ,seniors ,sec4 #fjfa4 ,short title4 ,sec4 #fjfb4 ,electronic prior authorization for covered part ,d drugs4 ,sec4 #fjfc4 ,program integrity transparency measures under ,medicare parts ,c and ,d4 ,sec4 #fjfd4 ,expanding eligibility for medication therapy management programs under part ,d4 ,sec4 #fjfe4 ,medicare notifications to outlier prescribers of opioids4 ,sec4 #fjff4 ,no additional funds authorized4 ,subtitle ,h--,expanding ,oversight of ,opioid ,prescribing and ,payment ,sec4 #fjga4 ,short title4 ,sec4 #fjgb4 ,medicare ,payment ,advisory ,commission report on opioid payment1 adverse incentives1 and data under the ,medicare program4 ,sec4 #fjgc4 ,no additional funds authorized4 ,subtitle ,i--,dr4 ,todd ,graham ,pain ,management1 ,treatment1 and ,recovery ,sec4 #fjha4 ,short title4 ,sec4 #fjhb4 ,review and adjustment of payments under the ,medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments4 ,sec4 #fjhc4 ,expanding access under the ,medicare program to addiction treatment in ,federally qualified health centers and rural health clinics4 ,sec4 #fjhd4 ,studying the availability of supplemental benefits designed to treat or prevent substance use disorders under ,medicare ,advantage plans4 ,sec4 #fjhe4 ,clinical psychologist services models under the ,center for ,medicare and ,medicaid ,innovation2 ,,gao study and report4 ,sec4 #fjhf4 ,pain management study4 ,subtitle ,j--,combating ,opioid ,abuse for ,care in ,hospitals ,sec4 #fjia4 ,short title4 ,sec4 #fjib4 ,developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part ,a of the ,medicare program4 ,sec4 #fjic4 ,requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs4 ,sec4 #fjid4 ,technical expert panel on reducing surgical setting opioid use2 ,data collection on perioperative opioid use4 ,sec4 #fjie4 ,requiring the posting and periodic update of opioid prescribing guidance for ,medicare beneficiaries4 ,subtitle ,k--,stop ,excessive ,narcotics in our ,retirement ,communities ,protection ,sec4 #faja4 ,short title4 ,sec4 #fajb4 ,suspension of payments by ,medicare prescription drug plans and ,,ma-,,pd plans pending investigations of credible allegations of fraud by pharmacies4 ,subtitle ,l--,providing ,reliable ,options for ,patients and ,educational ,resources ,sec4 #faaa4 ,short title4 ,sec4 #faab4 ,requiring ,medicare ,advantage plans and part ,d prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain4 ,sec4 #faac4 ,requiring ,medicare ,advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs4 ,sec4 #faad4 ,revising measures used under the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey relating to pain management4 ,title ,,vii--,other ,health ,provisions ,subtitle ,a--,synthetic ,drug ,awareness ,sec4 #gjja4 ,short title4 ,sec4 #gjjb4 ,report on effects on public health of synthetic drug use4 ,subtitle ,b--,empowering ,pharmacists in the ,fight ,against ,opioid ,abuse ,sec4 #gjaa4 ,short title4 ,sec4 #gjab4 ,programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription4 ,subtitle ,c--,indexing ,narcotics1 ,fentanyl1 and ,opioids ,sec4 #gjba4 ,short title4 ,sec4 #gjbb4 ,establishment of substance use disorder information dashboard4 ,sec4 #gjbc4 ,interagency ,substance ,use ,disorder ,coordinating ,committee4 ,subtitle ,d--,ensuring ,access to ,quality ,sober ,living ,sec4 #gjca4 ,short title4 ,sec4 #gjcb4 ,national recovery housing best practices4 ,subtitle ,e--,advancing ,cutting ,edge ,research ,sec4 #gjda4 ,short title4 ,sec4 #gjdb4 ,unique research initiatives4 ,subtitle ,f--,jessie's ,law ,sec4 #gjea4 ,short title4 ,sec4 #gjeb4 ,inclusion of opioid addiction history in patient records4 ,sec4 #gjec4 ,communication with families during emergencies4 ,subtitle ,g--,safe ,disposal of ,unused ,medication ,sec4 #gjfa4 ,short title4 ,sec4 #gjfb4 ,disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program4 ,subtitle ,h--,substance ,use ,disorder ,workforce ,loan ,repayment ,sec4 #gjga4 ,short title4 ,sec4 #gjgb4 ,loan repayment program for substance use disorder treatment employees4 ,subtitle ,i--,preventing ,overdoses ,while in ,emergency ,rooms ,sec4 #gjha4 ,short title4 ,sec4 #gjhb4 ,program to support emergency room discharge and care coordination for drug overdose patients4 ,subtitle ,j--,alternatives to ,opioids in the ,emergency ,department ,sec4 #gjia4 ,short title4 ,sec4 #gjib4 ,emergency department alternatives to opioids demonstration program4 ,subtitle ,k--,stop ,counterfeit ,drugs by ,regulating and ,enhancing ,enforcement ,now ,sec4 #gaja4 ,short title4 ,sec4 #gajb4 ,detention1 refusal1 and destruction of drugs offered for importation4 ,sec4 #gajc4 ,notification1 nondistribution1 and recall of adulterated or misbranded drug products4 ,sec4 #gajd4 ,single source pattern of shipments of adulterated or misbranded drugs4 ,sec4 #gaje4 ,fund to strengthen efforts of ,,fda to combat the opioid and substance use epidemic4 ,sec4 #gajf4 ,consideration of potential for misuse and abuse required for drug approval4 ,subtitle ,l--,treatment1 ,education1 and ,community ,help to ,combat ,addiction ,sec4 #gaaa4 ,short title4 ,sec4 #gaab4 ,establishment of ,regional ,centers of ,excellence in ,substance ,use ,disorder ,education4 ,subtitle ,m--,guidance from ,national ,mental ,health and ,substance ,use ,policy ,laboratory ,sec4 #gaba4 ,guidance from ,national ,mental ,health and ,substance ,use ,policy ,laboratory4 ,subtitle ,n--,comprehensive ,opioid ,recovery ,centers ,sec4 #gaca4 ,short title4 ,sec4 #gacb4 ,comprehensive opioid recovery centers4 ,subtitle ,o--,poison ,center ,network ,enhancement ,sec4 #gada4 ,short title4 ,sec4 #gadb4 ,reauthorization of poison control centers national toll-free number4 ,sec4 #gadc4 ,reauthorization of nationwide public awareness campaign to promote poison control center utilization4 ,sec4 #gadd4 ,reauthorization of the poison control center grant program4 ,subtitle ,p--,eliminating ,opioid ,related ,infectious ,diseases ,sec4 #gaea4 ,short title4 ,sec4 #gaeb4 ,reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors4 ,subtitle ,q--,better ,pain ,management ,through ,better ,data ,sec4 #gafa4 ,short title4 ,sec4 #gafb4 ,guidance addressing alternative approaches to data collection and labeling claims for opioid sparing4 ,subtitle ,r--,special ,registration for ,telemedicine ,clarification ,sec4 #gaga4 ,short title4 ,sec4 #gagb4 ,deadline for interim final regulations for a special registration ,to engage in the practice of telemedicine4 ,subtitle ,s--,peer ,support ,communities of ,recovery ,sec4 #gaha4 ,short title4 ,sec4 #gahb4 ,building communities of recovery4 ,subtitle ,t--,stop ,illicit ,drug ,importation ,sec4 #gaia4 ,short title4 ,sec4 #gaib4 ,detention1 refusal1 and destruction of drugs offered for importation4 ,sec4 #gaic4 ,seizure4 ,sec4 #gaid4 ,debarring violative individuals or companies4 ,subtitle ,u--,creating ,opportunities that ,necessitate ,new and ,enhanced ,connections ,that ,improve ,opioid ,navigation ,strategies ,sec4 #gbja4 ,short title4 ,sec4 #gbjb4 ,preventing overdoses of controlled substances4 ,sec4 #gbjc4 ,prescription drug monitoring program4 ,subtitle ,v--,securing ,opioids and ,unused ,narcotics with ,deliberate ,disposal and ,packaging ,sec4 #gbaa4 ,short title4 ,sec4 #gbab4 ,improved technologies1 controls1 or measures with respect to the packaging or disposal of certain drugs4 ,subtitle ,w--,postapproval study requirements ,sec4 #gbba4 ,postapproval study requirements4 ,title ,,viii--,miscellaneous ,subtitle ,a--,synthetics ,trafficking and ,overdose ,prevention ,sec4 #hjja4 ,short title2 table of contents4 ,sec4 #hjjb4 ,customs fees4 ,sec4 #hjjc4 ,mandatory advance electronic information for postal shipments4 ,sec4 #hjjd4 ,international postal agreements4 ,sec4 #hjje4 ,cost recoupment4 ,sec4 #hjjf4 ,development of technology to detect illicit narcotics4 ,sec4 #hjjg4 ,civil penalties for postal shipments4 ,sec4 #hjjh4 ,report on violations of arrival1 reporting1 entry1 and clearance requirements and falsity or lack of manifest4 ,sec4 #hjji4 ,effective date2 regulations4 ,subtitle ,b--,recognizing ,early ,childhood ,trauma ,related to ,substance ,abuse ,sec4 #hjaa4 ,short title4 ,sec4 #hjab4 ,recognizing ,early ,childhood ,trauma ,related to ,substance ,abuse4 ,subtitle ,c--,assisting ,states' ,implementation of ,plans of ,safe ,care ,sec4 #hjba4 ,short title4 ,sec4 #hjbb4 ,assisting ,states with implementation of plans of safe care4 ,subtitle ,d--,improving the ,federal ,response to ,families ,impacted by ,substance ,use ,disorder ,sec4 #hjca4 ,short title4 ,sec4 #hjcb4 ,interagency ,task ,force to ,improve the ,federal ,response to ,families ,impacted by ,substance ,use ,disorders4 ,subtitle ,e--,establishment of an ,advisory ,committee on ,opioids and the ,workplace ,sec4 #hjda4 ,establishment of an ,advisory ,committee on ,opioids and the ,workplace4 ,subtitle ,f--,veterans ,treatment ,court ,improvement ,sec4 #hjea4 ,short title4 ,sec4 #hjeb4 ,hiring by ,department of ,veterans ,affairs of additional ,veterans ,justice ,outreach ,specialists4 ,subtitle ,g--,peer support counseling program for women veterans ,sec4 #hjfa4 ,peer support counseling program for women veterans4 ,subtitle ,h--,treating ,barriers to ,prosperity ,sec4 #hjga4 ,short title4 ,sec4 #hjgb4 ,drug abuse mitigation initiative4 ,subtitle ,i--,supporting ,grandparents ,raising ,grandchildren ,sec4 #hjha4 ,short title4 ,sec4 #hjhb4 ,findings4 ,sec4 #hjhc4 ,advisory ,council ,to ,support ,grandparents ,raising ,grandchildren4 ,sec4 #hjhd4 ,definitions4 ,subtitle ,j--,reauthorizing and ,extending ,grants for ,recovery from ,opioid ,use ,programs ,sec4 #hjia4 ,short title4 ,sec4 #hjib4 ,reauthorization of the comprehensive opioid abuse grant program4 ,title ,,ix--,,sitsa ,act ,sec4 #ijja4 ,short title4 ,sec4 #ijjb4 ,establishment of schedule ,a4 ,sec4 #ijjc4 ,temporary and permanent scheduling of schedule ,a substances4 ,sec4 #ijjd4 ,penalties4 ,sec4 #ijje4 ,false labeling of schedule ,a controlled substances4 ,sec4 #ijjf4 ,registration requirements for handlers of schedule ,a substances4 ,sec4 #ijjg4 ,additional conforming amendments4 ,sec4 #ijjh4 ,controlled substance analogues4 ,sec4 #ijji4 ,rules of construction4 ,sec4 #ijaj4 ,study by ,comptroller ,general4 ,sec4 #ijaa4 ,report on controlled substance analogues sold by means of the ,internet4 ,sec4 #ijab4 ,controlled substance analogues4 ,title ,x--,,thrive ,act ,sec4 #ajjja4 ,short title4 ,sec4 #ajjjb4 ,demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders4 ,sec4 #ajjjc4 ,repeal of ,rental ,voucher ,demonstration ,program4 ,sec4 #ajjjd4 ,demonstration ,close-,out4 ,sec4 #ajjje4 ,no additional funds authorized4 ,title ,,xi--,,imd ,,care ,act ,sec4 #aajja4 ,short title4 ,sec4 #aajjb4 ,medicaid ,state plan option to provide services for certain individuals with targeted ,s,u,ds in institutions for mental diseases4 ,sec4 #aajjc4 ,promoting value in ,medicaid managed care4 ,i ,medicaid ,provisions to ,address the ,opioid ,crisis #ajja4 ,at-risk youth ,medicaid protection 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 by striking and at the end of paragraph 7#hb72 7,b7 by striking the period at the end of paragraph 7#hc7 and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hc7 the following new paragraph3 7#hd7 provide that-- 7,a7 the ,state shall not terminate eligibility for medical assistance under the ,state plan for an individual who is an eligible juvenile 7as defined in subsection 7nn77#b77 because the juvenile is an inmate of a public institution 7as defined in subsection 7nn77#c771 but may suspend coverage during the period the juvenile is such an inmate2 7,b7 in the case of an individual who is an eligible juvenile described in paragraph 7#b77;,a7 of subsection 7nn71 the ,state shall1 prior to the individual's release from such a public institution1 conduct a redetermination of eligibility for such individual with respect to such medical assistance 7without requiring a new application from the individual7 and1 if the ,state determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance1 the ,state shall restore coverage for such medical assistance to such an individual upon the individual's release from such public institution2 and 7,c7 in the case of an individual who is an eligible juvenile described in paragraph 7#b77;,b7 of subsection 7nn71 the ,state shall process any application for medical assistance submitted by1 or on behalf of1 such individual such that the ,state makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution4 2 and 7#b7 by adding at the end the following new subsection3 7nn7 ,juvenile2 eligible juvenile2 public institution ,for purposes of subsection 7a77#hd7 and this subsection3 7#a7 ,juvenile ,the term juvenile means an individual who is-- 7,a7 under #ba years of age2 or 7,b7 described in subsection 7a77#aj77;,a77i77,,ix74 7#b7 ,eligible juvenile ,the term eligible juvenile means a juvenile who is an inmate of a public institution and who-- 7,a7 was determined eligible for medical assistance under the ,state plan immediately before becoming an inmate of such a public institution2 or 7,b7 is determined eligible for such medical assistance while an inmate of a public institution4 7#c7 ,inmate of a public institution ,the term inmate of a public institution has the meaning given such term for purposes of applying the subdivision 7,a7 following paragraph 7#bi7 of section #aije7;a71 taking into account the exception in such subdivision for a patient of a medical institution4 4 7b7 ,no change in exclusion from medical assistance for inmates of public institutions ,nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision 7,a7 following paragraph 7#bi7 of section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a771 including any applicable restrictions on a ,state submitting claims for ,federal financial participation under title ,,xix of such ,act for such assistance4 7c7 ,no change in continuity of eligibility before adjudication or sentencing ,nothing in this section shall be construed to mandate1 encourage1 or suggest that a ,state suspend or terminate coverage for individuals before they have been adjudicated or sentenced4 7d7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b71 the amendments made by subsection 7a7 shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is #a year after the date of the enactment of this ,act4 7#b7 ,rule for changes requiring state legislation ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by the amendments made by subsection 7a71 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 #ajjb4 ,health ,insurance for ,former ,foster ,youth 7a7 ,coverage continuity for former foster care children up to age #bf 7#a7 ,in general ,section #aijb7;a77#aj77;,a77i77,,ix7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77,,ix77 is amended-- 7,a7 in item 7bb71 by striking are not described in or enrolled under and inserting are not described in and are not enrolled under2 7,b7 in item 7cc71 by striking responsibility of the ,state and inserting responsibility of a ,state2 and 7,c7 in item 7dd71 by striking the ,state plan under this title or under a waiver of the and inserting a ,state plan under this title or under a waiver of such a4 7#b7 ,effective date ,the amendments made by this subsection shall take effect with respect to foster youth who attain #ah years of age on or after ,january #a1 #bjbc4 7b7 ,guidance ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance to ,states1 with respect to the ,state ,medicaid programs of such ,states-- 7#a7 on best practices for-- 7,a7 removing barriers and ensuring streamlined1 timely access to ,medicaid coverage for former foster youth up to age #bf2 and 7,b7 conducting outreach and raising awareness among such youth regarding ,medicaid coverage options for such youth2 and 7#b7 which shall include examples of ,states that have successfully extended ,medicaid coverage to former foster youth up to age #bf4 #ajjc4 ,demonstration project to increase substance use provider capacity under the ,medicaid program ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is amended by adding at the end the following new subsection3 7aa7 ,demonstration project to increase substance use provider capacity 7#a7 ,in general ,not later than the date that is #ahj days after the date of the enactment of this section1 the ,secretary shall1 in consultation1 as appropriate1 with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 conduct a #ed-month demonstration project for the purpose described in paragraph 7#b7 under which the ,secretary shall-- 7,a7 for the first #ah-month period of such project1 award planning grants described in paragraph 7#c72 and 7,b7 for the remaining #cf-month period of such project1 provide to each ,state selected under paragraph 7#d7 payments in accordance with paragraph 7#e74 7#b7 ,purpose ,the purpose described in this paragraph is for each ,state selected under paragraph 7#d7 to increase the treatment capacity of providers participating under the ,state plan 7or a waiver of such plan7 to provide substance use disorder treatment or recovery services under such plan 7or waiver7 through the following activities3 7,a7 ,for the purpose described in paragraph 7#c77;,c77i71 activities that support an ongoing assessment of the behavioral health treatment needs of the ,state1 taking into account the matters described in subclauses 7,i7 through 7,,iv7 of such paragraph4 7,b7 ,activities that1 taking into account the results of the assessment described in subparagraph 7,a71 support the recruitment1 training1 and provision of technical assistance for providers participating under the ,state plan 7or a waiver of such plan7 that offer substance use disorder treatment or recovery services4 7,c7 ,improved reimbursement for and expansion of1 through the provision of education1 training1 and technical assistance1 the number or treatment capacity of providers participating under the ,state plan 7or waiver7 that-- 7i7 are authorized to dispense drugs approved by the ,food and ,drug ,administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder2 7ii7 have in effect a registration or waiver under section #cjc7;g7 of the ,controlled ,substances ,act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the ,assistant ,secretary for ,mental ,health and ,substance ,use for purposes of carrying out the requirements of such section #cjc7;g72 and 7iii7 are qualified under applicable ,state law to provide substance use disorder treatment or recovery services4 7,d7 ,improved reimbursement for and expansion of1 through the provision of education1 training1 and technical assistance1 the number or treatment capacity of providers participating under the ,state plan 7or waiver7 that have the qualifications to address the treatment or recovery needs of-- 7i7 individuals enrolled under the ,state plan 7or a waiver of such plan7 who have neonatal abstinence syndrome1 in accordance with guidelines issued by the ,american ,academy of ,pediatrics and ,american ,college of ,obstetricians and ,gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome2 7ii7 pregnant women1 postpartum women1 and infants1 particularly the concurrent treatment1 as appropriate1 and comprehensive case management of pregnant women1 postpartum women and infants1 enrolled under the ,state plan 7or a waiver of such plan72 7iii7 adolescents and young adults between the ages of #ab and #ba enrolled under the ,state plan 7or a waiver of such plan72 or 7iv7 ,american ,indian and ,alaska ,native individuals enrolled under the ,state plan 7or a waiver of such plan74 7#c7 ,planning grants 7,a7 ,in general ,the ,secretary shall1 with respect to the first #ah-month period of the demonstration project conducted under paragraph 7#a71 award planning grants to at least #aj ,states selected in accordance with subparagraph 7,b7 for purposes of preparing an application described in paragraph 7#d77;,c7 and carrying out the activities described in subparagraph 7,c74 7,b7 ,selection ,in selecting ,states for purposes of this paragraph1 the ,secretary shall-- 7i7 select ,states that have a ,state plan 7or waiver of the ,state plan7 approved under this title2 7ii7 select ,states in a manner that ensures geographic diversity2 and 7iii7 give preference to ,states with a prevalence of substance use disorders 7in particular opioid use disorders7 that is comparable to or higher than the national average prevalence1 as measured by aggregate per capita drug overdoses1 or any other measure that the ,secretary deems appropriate4 7,c7 ,activities described ,activities described in this subparagraph are1 with respect to a ,state1 each of the following3 7i7 ,activities that support the development of an initial assessment of the behavioral health treatment needs of the ,state to determine the extent to which providers are needed 7including the types of such providers and geographic area of need7 to improve the network of providers that treat substance use disorders under the ,state plan 7or waiver71 including the following3 7,i7 ,an estimate of the number of individuals enrolled under the ,state plan 7or a waiver of such plan7 who have a substance use disorder4 7,,ii7 ,information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the ,state plan 7or waiver71 including information on providers who provide such services and their participation under the ,state plan 7or waiver74 7,,iii7 ,information on the gap in substance use disorder treatment or recovery services under the ,state plan 7or waiver7 based on the information described in subclauses 7,i7 and 7,,ii74 7,,iv7 ,projections regarding the extent to which the ,state participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the ,state plan 7or waiver7 during the period of the demonstration project4 7ii7 ,activities that1 taking into account the results of the assessment described in clause 7i71 support the development of ,state infrastructure to1 with respect to the provision of substance use disorder treatment or recovery services under the ,state plan 7or a waiver of such plan71 recruit prospective providers and provide training and technical assistance to such providers4 7,d7 ,funding ,for purposes of subparagraph 7,a71 there is appropriated1 out of any funds in the ,treasury not otherwise appropriated1 #ej1jjj1jjj1 to remain available until expended4 7#d7 ,post-planning ,states 7,a7 ,in general ,the ,secretary shall1 with respect to the remaining #cf-month period of the demonstration project conducted under paragraph 7#a71 select not more than #e ,states in accordance with subparagraph 7,b7 for purposes of carrying out the activities described in paragraph 7#b7 and receiving payments in accordance with paragraph 7#e74 7,b7 ,selection ,in selecting ,states for purposes of this paragraph1 the ,secretary shall-- 7i7 select ,states that received a planning grant under paragraph 7#c72 7ii7 select ,states that submit to the ,secretary an application in accordance with the requirements in subparagraph 7,c71 taking into consideration the quality of each such application2 7iii7 select ,states in a manner that ensures geographic diversity2 and 7iv7 give preference to ,states with a prevalence of substance use disorders 7in particular opioid use disorders7 that is comparable to or higher than the national average prevalence1 as measured by aggregate per capita drug overdoses1 or any other measure that the ,secretary deems appropriate4 7,c7 ,applications 7i7 ,in general ,a ,state seeking to be selected for purposes of this paragraph shall submit to the ,secretary1 at such time and in such form and manner as the ,secretary requires1 an application that includes such information1 provisions1 and assurances1 as the ,secretary may require1 in addition to the following3 7,i7 ,a proposed process for carrying out the ongoing assessment described in paragraph 7#b77;,a71 taking into account the results of the initial assessment described in paragraph 7#c77;,c77i74 7,,ii7 ,a review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the ,state plan 7or waiver7 that may create barriers to increasing the number of providers delivering such services4 7,,iii7 ,the development of a plan1 taking into account activities carried out under paragraph 7#c77;,c77ii71 that will result in long-term and sustainable provider networks under the ,state plan 7or waiver7 that will offer a continuum of care for substance use disorders4 ,such plan shall include the following3 7aa7 ,specific activities to increase the number of providers 7including providers that specialize in providing substance use disorder treatment or recovery services1 hospitals1 health care systems1 ,federally qualified health centers1 and1 as applicable1 certified community behavioral health clinics7 that offer substance use disorder treatment1 recovery1 or support services1 including short-term detoxification services1 outpatient substance use disorder services1 and evidence-based peer recovery services4 7bb7 ,strategies that will incentivize providers described in subparagraphs 7,c7 and 7,d7 of paragraph 7#b7 to obtain the necessary training1 education1 and support to deliver substance use disorder treatment or recovery services in the ,state4 7cc7 ,milestones and timeliness for implementing activities set forth in the plan4 7dd7 ,specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the ,state plan 7or a waiver of such plan74 7,,iv7 ,a proposed process for reporting the information required under paragraph 7#f77;,a71 including information to assess the effectiveness of the efforts of the ,state to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection4 7,v7 ,the expected financial impact of the demonstration project under this subsection on the ,state4 7,,vi7 ,a description of all funding sources available to the ,state to provide substance use disorder treatment or recovery services in the ,state4 7,,vii7 ,a preliminary plan for how the ,state will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project4 7,,viii7 ,a description of how the ,state will coordinate the goals of the demonstration project with any waiver granted 7or submitted by the ,state and pending7 pursuant to section #aaae for the delivery of substance use services under the ,state plan1 as applicable4 7ii7 ,consultation ,in completing an application under clause 7i71 a ,state shall consult with relevant stakeholders1 including ,medicaid managed care plans1 health care providers1 and ,medicaid beneficiary advocates1 and include in such application a description of such consultation4 7#e7 ,payment 7,a7 ,in general ,for each quarter occurring during the period for which the demonstration project is conducted 7after the first #ah months of such period71 the ,secretary shall pay under this subsection1 subject to subparagraph 7,c71 to each ,state selected under paragraph 7#d7 an amount equal to #hj percent of so much of the qualified sums expended during such quarter4 7,b7 ,qualified sums defined ,for purposes of subparagraph 7,a71 the term qualified sums means1 with respect to a ,state and a quarter1 the amount equal to the amount 7if any7 by which the sums expended by the ,state during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the ,state plan 7or a waiver of such plan7 exceeds #a_/d of such sums expended by the ,state during fiscal year #bjah attributable to substance use treatment or recovery services4 7,c7 ,non-duplication of payment ,in the case that payment is made under subparagraph 7,a7 with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the ,state plan 7or a waiver of such plan71 payment may not also be made under subsection 7a7 with respect to expenditures for the same services so furnished4 7#f7 ,reports 7,a7 ,state reports ,a ,state receiving payments under paragraph 7#e7 shall1 for the period of the demonstration project under this subsection1 submit to the ,secretary a quarterly report1 with respect to expenditures for substance use treatment or recovery services for which payment is made to the ,state under this subsection1 on the following3 7i7 ,the specific activities with respect to which payment under this subsection was provided4 7ii7 ,the number of providers that delivered substance use disorder treatment or recovery services in the ,state under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project4 7iii7 ,the number of individuals enrolled under the ,state plan 7or a waiver of such plan7 who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project4 7iv7 ,other matters as determined by the ,secretary4 7,b7 ,,cms reports 7i7 ,initial report ,not later than ,october #a1 #bjbj1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress an initial report on-- 7,i7 the ,states awarded planning grants under paragraph 7#c72 7,,ii7 the criteria used in such selection2 and 7,,iii7 the activities carried out by such ,states under such planning grants4 7ii7 ,interim report ,not later than ,october #a1 #bjbb1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress an interim report-- 7,i7 on activities carried out under the demonstration project under this subsection2 7,,ii7 on the extent to which ,states selected under paragraph 7#d7 have achieved the stated goals submitted in their applications under subparagraph 7,c7 of such paragraph2 7,,iii7 with a description of the strengths and limitations of such demonstration project2 and 7,,iv7 with a plan for the sustainability of such project4 7iii7 ,final report ,not later than ,october #a1 #bjbd1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress a final report-- 7,i7 providing updates on the matters reported in the interim report under clause 7ii72 7,,ii7 including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report2 and 7,,iii7 evaluating such demonstration project4 7,c7 ,,ahrq report ,not later than #c years after the date of the enactment of this subsection1 the ,director of the ,agency for ,healthcare ,research and ,quality1 on consultation with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall submit to ,congress a summary on the experiences of ,states awarded planning grants under paragraph 7#c7 and ,states selected under paragraph 7#d74 7#g7 ,data sharing and best practices ,during the period of the demonstration project under this subsection1 the ,secretary shall1 in collaboration with ,states selected under paragraph 7#d71 facilitate data sharing and the development of best practices between such ,states and ,states that were not so selected4 7#h7 ,,cms funding ,there is appropriated1 out of any funds in the ,treasury not otherwise appropriated1 #e1jjj1jjj to the ,centers for ,medicare ,medicaid ,services for purposes of implementing this subsection4 ,such amount shall remain available until expended4 4 #ajjd4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,title ,,xix of the ,social ,security ,act is amended by inserting after section #aibg 7#db ,u4,s4,c4 #acifr-#h7 the following new section3 #aibg;,a4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,beginning ,january #a1 #bjbj1 a ,state shall operate a qualified drug management program under which a ,state may enroll certain at-risk beneficiaries identified by the ,state under the program4 7b7 ,qualified drug management program ,for purposes of this section1 the term qualified drug management program means1 with respect to a ,state1 a program carried out by the ,state 7including through a contract with a pharmacy benefit manager7 that provides at least for the following3 7#a7 ,identification of at-risk individuals ,under the program1 the ,state identifies1 in accordance with subsection 7c71 individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are at-risk beneficiaries4 7#b7 ,elements of program 7,a7 ,in general ,under the program1 the ,state1 with respect to each individual identified under paragraph 7#a7 and enrolled under the program under paragraph 7#e7-- 7i7 subject to subparagraphs 7,b7 and 7,c71 selects at least one1 but not more than three1 health care providers and at least one1 but not more than three1 pharmacies for each such individual for purposes of clause 7ii71 in accordance with a selection process that takes into account reasonable factors such as the individual's previous utilization of items and services from health care providers and pharmacies1 geographic proximity of the individual to such health care providers and pharmacies1 access of the individual to health care1 reasonable travel time1 information regarding housing status1 and any known preference of the individual for a certain health care provider or pharmacy2 and 7ii7 requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause 7i7 for such individual and dispensed by a pharmacy selected under clause 7i7 for such individual in order for such controlled substance to be covered under the ,state plan 7or waiver74 7,b7 ,beneficiary preference ,in the case of an individual receiving a notice under paragraph 7#c77;,a7 of being identified as potentially being an at-risk beneficiary described in such paragraph1 such individual may submit1 during the #cj-;day period following receipt of such notice1 preferences for which health care providers and pharmacies the individual would prefer the ,state to select under subparagraph 7,a74 ,the ,state shall select or change the selection of health care providers and pharmacies under subparagraph 7,a7 for the individuals based on such preferences1 except that in the case that ,state determines that such selection 7or change of selection7 of a health care provider or pharmacy under subparagraph 7,a7 is contributing or would contribute to prescription drug abuse or drug diversion by the individual1 the ,state may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph4 ,if the ,state selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual1 the ,state shall provide the individual with at least #cj days written notice of the selection or change of selection and a rationale for the selection or change4 7,c7 ,treatment of pharmacy with multiple locations ,for purposes of subparagraph 7,a77i71 in the case of a pharmacy that has multiple locations that share real-time electronic prescription data1 all such locations of the pharmacy shall collectively be treated as one pharmacy4 7,d7 ,treatment of existing ,,ffs drug management programs ,in the case of a patient review and restriction program 7as identified in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d77 operated by a ,state pursuant to section #aiae7;a77#b7 before the date of the enactment of this section1 such program shall be treated as a qualified drug management program4 7,e7 ,reasonable access ,the program shall ensure1 including through waiver of elements of the program 7including under subparagraph 7,a77ii771 reasonable access to health care 7including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph 7,a77 in the case of individuals with multiple residences1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7#c7 ,notification to identified individuals ,under the program1 the ,state provides each individual who is identified under paragraph 7#a71 prior to enrolling such individual under the program1 at least one notification of each of the following3 7,a7 ,notice that the ,state has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance4 7,b7 ,the name1 address1 and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph 7#b77;,a74 7,c7 ,information describing all ,state and ,federal public health resources that are designed to address such abuse or misuse to which the individual has access1 including mental health services1 substance use disorder and recovery services1 and other counseling services4 7,d7 ,notice of1 and information about1 the right of the individual to-- 7i7 submit preferences of the individual for health care providers and pharmacies to be selected under paragraph 7#b77;,a71 including as described in paragraph 7#b77;,b72 7ii7 appeal under paragraph 7#d7-- 7,i7 such identification described in subparagraph 7,a72 and 7,,ii7 the selection of health care providers and pharmacies under paragraph 7#b77;,a74 7,e7 ,an explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance1 including an explanation of the program4 7,f7 ,information1 including a contact list and clear instructions1 that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph 7#b77;,b7 and any other communications relating to the program4 7#d7 ,appeals process ,under the program1 the ,state provides for an appeals process under which1 with respect to an individual identified under paragraph 7#a7-- 7,a7 such individual may appeal-- 7i7 such identification2 and 7ii7 the selection of a health care provider or pharmacy under paragraph 7#b77;,a72 7,b7 in the case of an appeal described in subparagraph 7,a77ii71 the ,state shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph 7#b77;,a71 unless the ,state determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual2 7,c7 such individual is provided a period of not less than #cj days following the date of receipt of the notice described in paragraph 7#c7 to submit such appeal2 and 7,d7 the ,state must make a determination with respect to an appeal described in subparagraph 7,a71 and notify the individual of such determination1 prior to enrollment of such individual in the program4 7#e7 ,enrollment ,under the program1 the ,state initially enrolls individuals who are identified under paragraph 7#a7 in the program for a #ab-month period-- 7,a7 in the case of such an individual who does not submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph1 beginning on the day after the last day of such period2 and 7,b7 in the case of such an individual who does submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph but such appeal is denied1 beginning not later than #cj days after the date of such denial4 7#f7 ,notification of health care providers and pharmacies ,under the program1 the ,state provides to each health care provider and pharmacy selected for an individual under paragraph 7#b7-- 7,a7 notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph 7#b72 7,b7 information on such program and the role of being so selected2 and 7,c7 a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected4 7#g7 ,continuation of enrollment ,under the program1 the ,state1 with respect to an individual enrolled under the program1 provides for a process to-- 7,a7 not later than #cj days before the end of the #ab-month period for which the individual is so enrolled pursuant to paragraph 7#e7-- 7i7 assess1 in accordance with publicly available evidence-based guidelines1 whether or not such individual should continue to be enrolled under the program2 and 7ii7 notify such individual of the results of the assessment under clause 7i72 7,b7 continue1 subject to subparagraph 7,c71 enrollment of such individual if such assessment recommends such continuation2 and 7,c7 appeal the continuation of enrollment in accordance with the appeals process described in paragraph 7#d74 7c7 ,at-,risk beneficiary 7#a7 ,identification ,for purposes of this section1 a ,state shall identify an individual enrolled under the ,state plan 7or waiver of the ,state plan7 as an at-risk beneficiary if the individual is not an exempted individual described in paragraph 7#b7 and-- 7,a7 is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance2 or 7,b7 the ,state received notification from a ,,pdp sponsor or ,medicare ,advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section #ahfj;,d-#d7;c77#e7 and such identification has not been terminated under subparagraph 7,f7 of such section4 7#b7 ,exempted individual described ,for purposes of paragraph 7#a71 an exempted individual described in this paragraph is an individual who-- 7,a7 is receiving-- 7i7 hospice or palliative care2 or 7ii7 treatment for cancer2 7,b7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7,c7 the ,state elects to treat as an exempted individual for purposes of paragraph 7#a74 7d7 ,application of privacy rules clarification ,the ,secretary shall clarify privacy requirements1 including requirements under the regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 related to the sharing of data under subsection 7b77#f7 in the same manner as the ,secretary is required under subparagraph 7,j7 of section #ahfj;,d-#d7;c77#e7 to clarify privacy requirements related to the sharing of data described in such subparagraph4 7e7 ,reports 7#a7 ,annual reports ,a ,state operating a qualified drug management program shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d71 beginning with such reports submitted for #bjba1 the following information3 7,a7 ,the number of individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are enrolled under the program and the percentage of individuals enrolled under the ,state plan 7or waiver7 who are enrolled under such program4 7,b7 ,the number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program1 including the daily morphine milligram equivalents and the quantity prescribed for each such prescription4 7,c7 ,the number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program4 7,d7 ,the number of health care providers writing prescriptions for controlled substances 7other than prescriptions for a refill7 for individuals enrolled under such program4 7,e7 ,any other data that the ,secretary may require4 7,f7 ,any report submitted by a managed care entity under subsection 7f77#a77;,b7 with respect to the year involved4 ,for each such report for a year after #bjba1 the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year4 7#b7 ,,macpac reports and review ,not later than #b years after the date of the enactment of this section1 the ,medicaid and ,,chip ,payment and ,access ,commission 7in this section referred to as ,,macpac71 in consultation with the ,national ,association of ,medicaid ,directors1 pharmacy benefit managers1 managed care organizations1 health care providers 7including pharmacists71 beneficiary advocates1 and other stakeholders1 shall publish a report that includes-- 7,a7 best practices for operating drug management programs1 based on a review of a representative sample of ,states administering such a program2 7,b7 a summary of the experience of the appeals process under drug management programs operated by several ,states1 such as the frequency at which individuals appealed the identification of being an at-risk individual1 the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program1 the timeframes for such appeals1 a summary of the reasons for such appeals1 and the design of such appeals processes2 7,c7 a summary of trends and the effectiveness of qualified drug management programs operated under this section2 and 7,d7 recommendations to ,states on how improvements can be made with respect to the operation of such programs4 ,in reporting on ,state practices1 the ,,macpac shall consider how such programs have been implemented in rural areas1 under fee-for-service as well as managed care arrangements1 and the extent to which such programs have resulted in increased efficiencies to such ,states or to the ,federal ,government under this title4 7#c7 ,report on plan for coordinated care ,not later than ,january #a1 #bjba1 each ,state operating a qualified drug management program shall submit to the ,administrator of the ,centers for ,medicare ,medicaid ,services a report on how such ,state plans to provide coordinated care for individuals enrolled under the ,state plan 7or waiver of the ,state plan7 and-- 7,a7 who are enrolled under the program2 or 7,b7 who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity4 7f7 ,applicability to managed care entities 7#a7 ,in general ,with respect to any contract that a ,state enters into on or after ,january #a1 #bjbj1 with a managed care entity 7as defined in section #aicb7;a77#a77;,b77 pursuant to section #aijc7m71 the ,state shall1 as a condition of the contract1 require the managed care entity-- 7,a7 to operate a qualified drug management program 7as defined in subsection 7b77 for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph 7#b72 7,b7 to submit to the ,state an annual report on the matters described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 and 7,c7 to submit to the ,state a list 7and as necessary update such list7 of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph 7,a7 for purposes of allowing ,state plans for which medical assistance is paid on a fee-for-service basis to have access to such information4 7#b7 ,application ,for purposes of applying1 with respect to a managed care entity-- 7,a7 under paragraph 7#a77;,a7-- 7i7 the definition of the term qualified drug management program under subsection 7b71 other than paragraph 7#b77;,d7 of such subsection2 and 7ii7 the provisions of paragraphs 7#a7 and 7#b7 of subsection 7c72 and 7,b7 under paragraph 7#a77;,b71 the report requirements described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 each reference in such subsection 7b7 and paragraphs of subsection 7c7 to a ,state or the ,state 7other than to a ,state plan or the ,state plan7 shall be deemed a reference to the managed care entity1 each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the ,state plan 7or waiver of the ,state plan7 shall be deemed a reference to individuals enrolled with such entity1 and each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the qualified drug management program operated by the ,state shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity4 7g7 ,controlled substance defined ,for purposes of this section1 the term controlled substance means a drug that is included in schedule ,,ii1 ,,iii1 or ,,iv of section #bjb7;c7 of the ,controlled ,substances ,act1 or any combination thereof1 as specified by the ,state4 4 7b7 ,guidance on at-,risk population transitioning between ,medicaid ,,ffs and managed care ,not later than ,october #a1 #bjai1 the ,secretary of ,health and ,human ,services shall issue guidance for ,state ,medicaid programs1 with respect to individuals who are enrolled under a ,state plan 7or waiver of such plan7 under title ,,xix of the ,social ,security ,act and under a drug management program1 for purposes of providing best practices-- 7#a7 for transitioning1 as applicable1 such individuals from fee-for-service ,medicaid 7and such a program operated by the ,state7 to receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity72 and 7#b7 for transitioning1 as applicable1 such individuals from receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity7 to fee-for-service ,medicaid 7and such a program operated by the ,state74 7c7 ,guidance on at-,risk population transitioning to ,medicare 7#a7 ,in general ,not later than ,january #a1 #bjbj1 the ,secretary of ,health and ,human ,services1 after consultation with the ,federal ,coordinated ,health ,care ,office established under section #bfjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acae;b71 shall issue guidance for ,state ,medicaid programs1 with respect to transitioning individuals1 providing for-- 7,a7 notification to be submitted by the ,state to the ,centers for ,medicare ,medicaid ,services and such individuals of the status of such individuals as transitioning individuals2 7,b7 notification to such individuals about enrollment under a prescription drug plan under part ,d of such title or under a ,,ma-,,pd plan under part ,c of such title2 7,c7 best practices for transitioning such individuals to such a plan2 and 7,d7 best practices for coordination between the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state and a drug management program carried out under such a plan pursuant to section #ahfj;,d-#d7;c77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#e774 7#b7 ,transitioning individuals ,for purposes of paragraph 7#a71 a transitioning individual is an individual who1 with respect to a month-- 7,a7 is enrolled under the ,state plan 7or waiver of the ,state plan7 and under the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state2 and 7,b7 is expected to become eligible for the ,medicare program under title ,,xviii of such ,act during the subsequent #ab-month period4 #ajje4 ,medicaid drug review and utilization 7a7 ,medicaid drug utilization review 7#a7 ,state plan requirement ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a771 as amended by section #aja1 is further amended-- 7,a7 in paragraph 7#hc71 at the end1 by striking and2 7,b7 in paragraph 7#hd71 at the end1 by striking the period and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hd7 the following new paragraph3 7#he7 provide that the ,state is in compliance with the drug review and utilization requirements under subsection 7oo77#a74 4 7#b7 ,drug review and utilization requirements ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 as amended by section #aja1 is further amended by adding at the end the following new subsection3 7oo7 ,drug review and utilization requirements 7#a7 ,in general ,for purposes of subsection 7a77#he71 the drug review and utilization requirements under this subsection are1 subject to paragraph 7#c7 and beginning ,october #a1 #bjai1 the following3 7,a7 ,claims review limitations 7i7 ,in general ,the ,state has in place-- 7,i7 safety edits 7as specified by the ,state7 for subsequent fills for opioids and a claims review automated process 7as designed and implemented by the ,state7 that indicates when an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the ,state2 7,,ii7 safety edits 7as specified by the ,state7 on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 for treatment of chronic pain and a claims review automated process 7as designed and implemented by the ,state7 that indicates when an individual enrolled under the plan 7or waiver7 is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the ,state2 and 7,,iii7 a claims review automated process 7as designed and implemented by the ,state7 that monitors when an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 is concurrently prescribed opioids and-- 7aa7 benzodiazepines2 or 7bb7 antipsychotics4 7ii7 ,managed care entities ,the ,state requires each managed care entity 7as defined in section #aicb7;a77#a77;,b77 with respect to which the ,state has a contract under section #aijc7m7 or under section #aije7t77#c7 to have in place1 subject to paragraph 7#c71 with respect to individuals who are eligible for medical assistance under the ,state plan 7or under a waiver of the ,state plan7 and who are enrolled with the entity1 the limitations described in subclauses 7,i7 and 7,,ii7 of clause 7i7 and a claims review automated process described in subclause 7,,iii7 of such clause4 7iii7 ,rules of construction ,nothing in this subparagraph may be construed as prohibiting a ,state or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims4 ,nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a ,state plan 7or waiver of the ,state plan7 or contracting with a managed care entity regarding the best items and services for an individual enrolled under such ,state plan 7or waiver74 7,b7 ,program to monitor antipsychotic medications by children ,the ,state has in place a program 7as designed and implemented by the ,state7 to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the ,state plan 7or under a waiver of the ,state plan7 and submits annually to the ,secretary such information as the ,secretary may require on activities carried out under such program for individuals not more than the age of #ah years generally and children in foster care specifically4 7,c7 ,fraud and abuse identification ,the ,state has in place a process 7as designed and implemented by the ,state7 that identifies potential fraud or abuse of controlled substances by individuals enrolled under the ,state plan 7or under a waiver of the ,state plan71 health care providers prescribing drugs to individuals so enrolled1 and pharmacies dispensing drugs to individuals so enrolled4 7,d7 ,reports ,the ,state shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d7 information on the limitations1 requirement1 program1 and processes applied by the ,state under subparagraphs 7,a7 through 7,c7 in accordance with such manner and time as specified by the ,secretary4 7,e7 ,clarification ,nothing shall prevent a ,state from satisfying the requirement-- 7i7 described in subparagraph 7,a7 by having safety edits or a claims review automated process described in such subparagraph that was in place before ,october #a1 #bjai2 7ii7 described in subparagraph 7,b7 by having a program described in such subparagraph that was in place before such date2 or 7iii7 described in subparagraph 7,c7 by having a process described in such subparagraph that was in place before such date4 7#b7 ,annual report by ,secretary ,for each fiscal year beginning with fiscal year #bjbj1 the ,secretary shall submit to ,congress a report on the most recent information submitted by ,states under paragraph 7#a77;,d74 7#c7 ,exceptions 7,a7 ,certain individuals exempted ,the drug review and utilization requirements under this subsection shall not apply with respect to an individual who-- 7i7 is receiving-- 7,i7 hospice or palliative care2 or 7,,ii7 treatment for cancer2 7ii7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7iii7 the ,state elects to treat as exempted from such requirements4 7,b7 ,exception relating to ensuring access ,in order to ensure reasonable access to health care1 the ,secretary shall waive the drug review and utilization requirements under this subsection1 with respect to a ,state1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 4 7#c7 ,managed care entities ,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 7i7 ,drug utilization review activities and requirements ,beginning not later than ,october #a1 #bjai1 each contract under a ,state plan with a managed care entity 7other than a primary care case manager7 under section #aijc7m7 shall provide that the entity is in compliance with the applicable provisions of section #dch4c7s77#b7 of title #db of the ,code of ,federal ,regulations1 section #dhc4c7s77#d77 of such title1 and section #dhc4c7s77#e7 of such title1 as such provisions were in effect on ,march #ca1 #bjah4 4 7b7 ,identifying and addressing inappropriate prescribing and billing practices under ,medicaid 7#a7 ,in general ,section #aibg7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;g77 is amended-- 7,a7 in paragraph 7#a77;,a7-- 7i7 by striking of section #aijc7;i77#aj77;,b7 and inserting of section #aijb7;a77#ed72 7ii7 by striking 1 by not later than ,january #a1 #aiic12 7iii7 by inserting after gross overuse1 the following3 excessive utilization12 and 7iv7 by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care1 or prescribing or billing practices that indicate abuse or excessive utilization2 and 7,b7 in paragraph 7#b77;,b7-- 7i7 by inserting after gross overuse1 the following3 excessive utilization12 and 7ii7 by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care1 or prescribing or billing practices that indicate abuse or excessive utilization4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall take effect with respect to retrospective drug use reviews conducted on or after ,october #a1 #bjbj4 #ajjf4 ,guidance to improve care for infants with neonatal abstinence syndrome and their mothers2 ,,gao study on gaps in ,medicaid coverage for pregnant and postpartum women with substance use disorder 7a7 ,guidance ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families4 ,such guidance shall include-- 7#a7 the types of services1 including post-discharge services and parenting supports1 for families of babies with neonatal abstinence syndrome that ,states may cover under the ,medicaid program under title ,,xix of the ,social ,security ,act2 7#b7 best practices from ,states with respect to innovative or evidenced-based payment models that focus on prevention1 screening1 treatment1 plans of safe care1 and post-discharge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes2 7#c7 recommendations for ,states on available financing options under the ,medicaid program under title ,,xix of such ,act and under the ,children's ,health ,insurance ,program under title ,,xxi of such ,act for ,children's ,health ,insurance ,program ,health ,services ,initiative funds for parents with substance use disorders1 infants with neonatal abstinence syndrome1 and home visiting services2 and 7#d7 guidance and technical assistance to ,state ,medicaid agencies regarding additional flexibilities and incentives related to screening1 prevention1 and post-discharge services1 including parenting supports4 7b7 ,,gao study ,not later than #a year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study1 and submit to ,congress a report1 addressing gaps in coverage for pregnant women with substance use disorder under the ,medicaid program under title ,,xix of the ,social ,security ,act1 and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the ,medicaid program under such title4 #ajjg4 ,medicaid health homes for opioid-use-disorder ,medicaid enrollees 7a7 ,extension of enhanced ,,fmap for certain health homes for individuals with substance use disorders ,section #aide of the ,social ,security ,act 7#db ,u4,s4,c4 #acifw-#d7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by inserting subject to paragraph 7#d71 after except that12 and 7,b7 by adding at the end the following new paragraph3 7#d7 ,special rule relating to substance use disorder health homes 7,a7 ,in general ,in the case of a ,state with an ,,sud-focused ,state plan amendment approved by the ,secretary on or after ,october #a1 #bjah1 the ,secretary may1 at the request of the ,state1 extend the application of the ,federal medical assistance percentage described in paragraph 7#a7 to payments for the provision of health home services to ,,sud-eligible individuals under such ,state plan amendment1 in addition to the first #h fiscal year quarters the ,state plan amendment is in effect1 for the subsequent #b fiscal year quarters that the ,state plan amendment is in effect4 ,nothing in this section shall be construed as prohibiting a ,state with a ,state plan amendment that is approved under this section and that is not an ,,sud-focused ,state plan amendment from additionally having approved on or after such date an ,,sud-focused ,state plan amendment under this section1 including for purposes of application of this paragraph4 7,b7 ,report requirements ,in the case of a ,state with an ,,sud-focused ,state plan amendment for which the application of the ,federal medical assistance percentage has been extended under subparagraph 7,a71 such ,state shall1 at the end of the period of such ,state plan amendment1 submit to the ,secretary a report on the following1 with respect to ,,sud-eligible individuals provided health home services under such ,state plan amendment3 7i7 ,the quality of health care provided to such individuals1 with a focus on outcomes relevant to the recovery of each such individual4 7ii7 ,the access of such individuals to health care4 7iii7 ,the total expenditures of such individuals for health care4 ,for purposes of this subparagraph1 the ,secretary shall specify all applicable measures for determining quality1 access1 and expenditures4 7,c7 ,best practices ,not later than ,october #a1 #bjbj1 the ,secretary shall make publicly available on the ,internet website of the ,centers for ,medicare ,medicaid ,services best practices for designing and implementing an ,,sud-focused ,state plan amendment1 based on the experiences of ,states that have ,state plan amendments approved under this section that include ,,sud-eligible individuals4 7,d7 ,definitions ,for purposes of this paragraph3 7i7 ,,sud-eligible individuals ,the term ,,sud-eligible individual means1 with respect to a ,state1 an individual who satisfies all of the following3 7,i7 ,the individual is an eligible individual with chronic conditions4 7,,ii7 ,the individual is an individual with a substance use disorder4 7,,iii7 ,the individual has not previously received health home services under any other ,state plan amendment approved for the ,state under this section by the ,secretary4 7ii7 ,,sud-focused ,state plan amendment ,the term ,,sud-focused ,state plan amendment means a ,state plan amendment under this section that is designed to provide health home services primarily to ,,sud-eligible individuals4 4 7b7 ,requirement for ,state ,medicaid plans to provide coverage for medication-assisted treatment 7#a7 ,requirement for ,state ,medicaid plans to provide coverage for medication-assisted treatment ,section #aijb7;a77#aj77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is amended1 in the matter preceding clause 7i71 by striking and 7#bh7 and inserting 7#bh71 and 7#bi74 7#b7 ,inclusion of medication-assisted treatment as medical assistance ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended-- 7,a7 in paragraph 7#bh71 by striking and at the end2 7,b7 by redesignating paragraph 7#bi7 as paragraph 7#cj72 and 7,c7 by inserting after paragraph 7#bh7 the following new paragraph3 7#bi7 subject to paragraph 7#b7 of subsection 7ee71 for the period beginning ,october #a1 #bjbj1 and ending ,september #cj1 #bjbe1 medication-assisted treatment 7as defined in paragraph 7#a7 of such subsection72 and 4 7#c7 ,medication-assisted treatment defined2 ,waivers ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended by adding at the end the following new subsection3 7ee7 ,medication-assisted treatment 7#a7 ,definition ,for purposes of subsection 7a77#bi71 the term medication-assisted treatment-- 7,a7 means all drugs approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 including methadone1 and all biological products licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 to treat opioid use disorders2 and 7,b7 includes1 with respect to the provision of such drugs and biological products1 counseling services and behavioral therapy4 7#b7 ,exception ,the provisions of paragraph 7#bi7 of subsection 7a7 shall not apply with respect to a ,state for the period specified in such paragraph1 if before the beginning of such period the ,state certifies to the satisfaction of the ,secretary that implementing such provisions statewide for all individuals eligible to enroll in the ,state plan 7or waiver of the ,state plan7 would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment1 or facilities providing such treatment1 that will contract with the ,state or a managed care entity with which the ,state has a contract under section #aijc7m7 or under section #aije7t77#c74 4 7#d7 ,effective date 7,a7 ,in general ,subject to subparagraph 7,b71 the amendments made by this subsection shall apply with respect to medical assistance provided on or after ,october #a1 #bjbj1 and before ,october #a1 #bjbe4 7,b7 ,exception for ,state legislation ,in the case of a ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 that the ,secretary of ,health and ,human ,services determines requires ,state legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session shall be considered to be a separate regular session of the ,state legislature4 ,,ii ,medicare ,provisions to ,address the ,opioid ,crisis #bjja4 ,authority not to apply certain ,medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#b77;,b77i71 by inserting and paragraph 7#g77;,e7 after ,subject to clause 7ii72 and 7#b7 by adding at the end the following new paragraphs3 7#g7 ,authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder 7,a7 ,in general ,for purposes of payment under this subsection1 in the case of telehealth services described in subparagraph 7,c7 furnished on or after ,january #a1 #bjbj1 to an eligible beneficiary 7as defined in subparagraph 7,f77 for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder1 the ,secretary is authorized to1 through rulemaking1 not apply any of the requirements described in subparagraph 7,b74 7,b7 ,requirements described ,for purposes of this paragraph1 the requirements described in this subparagraph are any of the following3 7i7 ,qualifications for an originating site under paragraph 7#d77;,c77ii74 7ii7 ,geographic limitations under paragraph 7#d77;,c77i74 7,c7 ,telehealth services described ,for purposes of this paragraph1 the telehealth services described in this subparagraph are services that are both telehealth services 7as described in paragraph 7#d77;,f77 and identified by the ,secretary1 through rulemaking1 as services that are the most commonly furnished 7as defined by the ,secretary7 under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder4 7,d7 ,clarification ,nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the ,secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph 7,b74 7,e7 ,treatment of originating site facility fee ,no facility fee shall be paid under paragraph 7#b77;,b7 to an originating site with respect to a telehealth service described in subparagraph 7,b7 for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph 7,b7 pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied4 7,f7 ,eligible beneficiary defined ,for purposes of this paragraph1 the term eligible beneficiary means an individual who-- 7i7 is entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under this part2 7ii7 has a diagnosis for a substance use disorder2 and 7iii7 meets such other criteria as the ,secretary determines appropriate4 7,g7 ,report ,not later than #e years after the date of the enactment of this paragraph1 the ,secretary shall submit to ,congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph 7,b7 on 7i7 the utilization of health care services related to substance use disorder1 such as behavioral health services and emergency department visits2 and 7ii7 health outcomes related to substance use disorder1 such as substance use overdose deaths4 7,h7 ,funding ,for purposes of carrying out this paragraph1 in addition to funds otherwise available1 the ,secretary shall provide for the transfer1 from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda1 of #c1jjj1jjj to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account to remain available until expended4 7#h7 ,rule of construction ,nothing in this subsection may be construed as waiving requirements under this title to comply with applicable ,state law1 including ,state licensure requirements4 4 #bjjb4 ,encouraging the use of non-opioid analgesics for the management of post-surgical pain ,section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is amended-- 7#a7 in subparagraph 7,c77i71 by inserting or1 in the case of an eligible non-opioid analgesic 7as defined in subparagraph 7,j771 during a period of #e years1 after #c years12 and 7#b7 by adding at the end the following new subparagraph3 7,j7 ,eligible non-opioid analgesic defined ,in this paragraph1 the term eligible non-opioid analgesic means a drug or biological-- 7i7 that is an analgesic that is not an opioid2 7ii7 that demonstrated substantial clinical improvement1 as determined by the ,secretary2 and 7iii7 for which payment-- 7,i7 as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph2 or 7,,ii7 was being made under this paragraph as of such date4 4 #bjjc4 ,requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the ,welcome to ,medicare initial preventive physical examination 7a7 ,in general ,section #ahfa7ww7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77 is amended-- 7#a7 in paragraph 7#a71 by inserting and a review of current opioid prescriptions and screening for opioid use disorder 7as defined in paragraph 7#d771 before but does not include2 and 7#b7 by adding at the end the following new paragraph3 7#d7 7,a7 ,for purposes of paragraph 7#a71 the term a review of current opioid prescriptions and screening for opioid use disorder means1 with respect to an individual-- 7i7 a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual2 and 7ii7 in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph 7,a7 to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time 7as specified by the ,secretary7-- 7,i7 a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder2 7,,ii7 an evaluation by the physician or practitioner of pain of the individual2 7,,iii7 the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual2 and 7,,iv7 if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph1 an appropriate referral by the physician or practitioner for additional treatment4 7,b7 ,for purposes of this paragraph1 the term qualified non-physician practitioner means a physician assistant1 nurse practitioner1 or clinical nurse specialist4 4 7b7 ,clarification ,nothing in the amendments made by subsection 7a7 shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination4 7c7 ,effective date ,the amendments made by subsection 7a7 shall apply with respect to initial preventive physical examinations furnished on or after ,january #a1 #bjbj4 #bjjd4 ,modification of payment for certain outpatient surgical services 7a7 ,freeze of payment for certain services furnished in ambulatory surgical centers ,section #ahcc7;i77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77 is amended by adding at the end the following new subparagraph3 7,f7 7i7 ,with respect to a targeted procedure 7as defined in clause 7ii77 furnished during #bjbj or a subsequent year 7before #bjbd7 to an individual in an ambulatory surgical center1 the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph 7,d71 without application of this subparagraph1 shall be equal to the payment amount for such procedure furnished in #bjaf4 7ii7 ,for purposes of clause 7i71 the term targeted procedure means a procedure to which ,healthcare ,common ,procedure ,coding ,system code #fbcaj 7or1 for years beginning after #bjaf1 #fbcba71 #fbcaa 7or1 for years beginning after #bjaf1 #fbcbc71 #fbbfd1 #fddij1 #fddic1 or ,g#jbfj1 or any successor code1 apply4 7iii7 ,this subparagraph shall not be applied in a budget-neutral manner4 4 7b7 ,data collection 7#a7 ,in general ,the ,comptroller ,general shall collect data relating to the cost differential between targeted procedures 7as defined in section #ahcc7;i77#b77;,f77ii7 of the ,social ,security ,act1 as added by subsection 7a77 that are performed in a hospital operating room and such procedures that are performed in an office setting within a hospital in order to determine whether such procedures are being properly coded for claims1 based on setting1 for payment under section #ahcc7;i77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 and to determine if further changes are needed in the classification system for covered outpatient department services 7as described in section #ahcc7t77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7#b7 ,report ,not later than #d years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit a report to the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance of the ,senate containing-- 7,a7 a determination of whether procedures described in paragraph 7#a7 are being properly coded for claims1 based on setting1 for payment under section #ahcc7;i77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d772 and 7,b7 recommendations on any changes the ,comptroller ,general determines are needed in the classification system for covered outpatient department services 7as described in section #ahcc7t77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7c7 ,study ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall conduct a study and submit to ,congress a report on the extent to which procedures described in section #ahcc7;i77#b77;,f77ii7 of the ,social ,security ,act1 as added by subsection 7a71 are effective at preventing the need for opioids for individuals furnished such procedures4 #bjje4 ,requiring e-prescribing for coverage of covered part ,d controlled substances 7a7 ,in general ,section #ahfj;,d-#d7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is amended by adding at the end the following3 7#g7 ,requirement of e-prescribing for controlled substances 7,a7 ,in general ,subject to subparagraph 7,b71 a prescription for a covered part ,d drug under a prescription drug plan 7or under an ,,ma-,,pd plan7 for a schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph 7#b74 7,b7 ,exception for certain circumstances ,the ,secretary shall1 pursuant to rulemaking1 specify circumstances with respect to which the ,secretary may waive the requirement under subparagraph 7,a71 with respect to a covered part ,d drug1 including in the case of-- 7i7 a prescription issued when the practitioner and dispenser are the same entity2 7ii7 a prescription issued that cannot be transmitted electronically under the most recently implemented version of the ,national ,council for ,prescription ,drug ,programs ,,script ,standard2 7iii7 a prescription issued by a practitioner who has received a waiver or a renewal thereof for a specified period determined by the ,secretary1 not to exceed #a year1 from the requirement to use electronic prescribing1 pursuant to a process established by regulation by the ,secretary1 due to demonstrated economic hardship1 technological limitations that are not reasonably within the control of the practitioner1 or other exceptional circumstance demonstrated by the practitioner2 7iv7 a prescription issued by a practitioner under circumstances in which1 notwithstanding the practitioner's ability to submit a prescription electronically as required by this subsection1 such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner1 and such delay would adversely impact the individual's medical condition involved2 7v7 a prescription issued by a practitioner allowing for the dispensing of a non-patient specific prescription pursuant to a standing order1 approved protocol for drug therapy1 collaborative drug management1 or comprehensive medication management1 in response to a public health emergency1 or other circumstances where the practitioner may issue a non-patient specific prescription2 7vi7 a prescription issued by a practitioner prescribing a drug under a research protocol2 7vii7 a prescription issued by a practitioner for a drug for which the ,food and ,drug ,administration requires a prescription to contain elements that are not able to be included in electronic prescribing1 such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use2 and 7viii7 a prescription issued by a practitioner for an individual who-- 7,i7 receives hospice care under this title2 or 7,,ii7 is a resident of a skilled nursing facility 7as defined in section #ahai7;a771 or a medical institution or nursing facility for which payment is made for an institutionalized individual under section #aijb7q77#a77;,b71 for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy1 as determined by the ,secretary in accordance with this paragraph4 7,c7 ,dispensing ,nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part1 ,,ma organization offering an ,,ma-,,pd plan under part ,c1 or a pharmacist to verify that a practitioner1 with respect to a prescription for a covered part ,d drug1 has a waiver 7or is otherwise exempt7 under subparagraph 7,b7 from the requirement under subparagraph 7,a74 ,nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists' ability to continue to dispense covered part ,d drugs from otherwise valid written1 oral or fax prescriptions that are consistent with laws and regulations4 ,nothing in this paragraph shall be construed as affecting the ability of the beneficiary involved to designate a particular pharmacy to dispense a prescribed drug to the extent consistent with the requirements under subsection 7b77#a7 and under this paragraph4 7,d7 ,enforcement ,the ,secretary shall1 pursuant to rulemaking1 have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph 7,a74 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to coverage of drugs prescribed on or after ,january #a1 #bjba4 #bjjf4 ,requiring prescription drug plan sponsors under ,medicare to establish drug management programs for at-risk beneficiaries ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,e7 the following new subparagraph3 7,f7 ,with respect to plan years beginning on or after ,january #a1 #bjba1 a drug management program for at-risk beneficiaries described in paragraph 7#e74 2 and 7#b7 in paragraph 7#e77;,a71 by inserting 7and for plan years beginning on or after ,january #a1 #bjba1 a ,,pdp sponsor shall7 after ,a ,,pdp sponsor may4 #bjjg4 ,medicare coverage of certain services furnished by opioid treatment programs 7a7 ,coverage ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 in subparagraph 7,,ff71 by striking at the end and2 7#b7 in subparagraph 7,,gg71 by inserting at the end 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,,hh7 opioid use disorder treatment services 7as defined in subsection 7jjj774 4 7b7 ,opioid use disorder treatment services and opioid treatment program defined ,section #ahfa of the ,social ,security ,act is amended by adding at the end the following new subsection3 7jjj7 ,opioid use disorder treatment services2 opioid treatment program 7#a7 ,opioid use disorder treatment services ,the term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder1 including-- 7,a7 opioid agonist and antagonist treatment medications 7including oral1 injected1 or implanted versions7 that are approved by the ,food and ,drug ,administration under section #eje of the ,federal ,food1 ,drug and ,cosmetic ,act for use in the treatment of opioid use disorder2 7,b7 dispensing and administration of such medications1 if applicable2 7,c7 substance use counseling by a professional to the extent authorized under ,state law to furnish such services2 7,d7 individual and group therapy with a physician or psychologist 7or other mental health professional to the extent authorized under ,state law72 7,e7 toxicology testing1 and 7,f7 other items and services that the ,secretary determines are appropriate 7but in no event to include meals or transportation74 7#b7 ,opioid treatment program ,the term opioid treatment program means an entity that is opioid treatment program 7as defined in section #h4b of title #db of the ,code of ,federal ,regulations1 or any successor regulation7 that-- 7,a7 is enrolled under section #ahff7;j72 7,b7 has in effect a certification by the ,substance ,abuse and ,mental ,health ,services ,administration for such a program2 7,c7 is accredited by an accrediting body approved by the ,substance ,abuse and ,mental ,health ,services ,administration2 and 7,d7 meets such additional conditions as the ,secretary may find necessary to ensure-- 7i7 the health and safety of individuals being furnished services under such program2 and 7ii7 the effective and efficient furnishing of such services4 4 7c7 ,payment 7#a7 ,in general ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and 7,,bb7 and inserting 7,,bb72 and 7,b7 by inserting before the semicolon at the end the following 1 and 7,,cc7 with respect to opioid use disorder treatment services furnished during an episode of care1 the amount paid shall be equal to the amount payable under section #ahcd7w7 less any copayment required as specified by the ,secretary4 7#b7 ,payment determination ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7w7 ,opioid use disorder treatment services 7#a7 ,in general ,the ,secretary shall pay to an opioid treatment program 7as defined in paragraph 7#b7 of section #ahfa7;jjj77 an amount that is equal to #ajj percent of a bundled payment under this part for opioid use disorder treatment services 7as defined in paragraph 7#a7 of such section7 that are furnished by such program to an individual during an episode of care 7as defined by the ,secretary7 beginning on or after ,january #a1 #bjbj4 ,the ,secretary shall ensure1 as determined appropriate by the ,secretary1 that no duplicative payments are made under this part or part ,d for items and services furnished by an opioid treatment program4 7#b7 ,considerations ,the ,secretary may implement this subsection through one or more bundles based on the type of medication provided 7such as buprenorphine1 methadone1 naltrexone1 or a new innovative drug71 the frequency of services1 the scope of services furnished1 characteristics of the individuals furnished such services1 or other factors as the ,secretary determine appropriate4 ,in developing such bundles1 the ,secretary may consider payment rates paid to opioid treatment programs for comparable services under ,state plans under title ,,xix or under the ,,tricare program under chapter #ee of title #aj of the ,united ,states ,code4 7#c7 ,annual updates ,the ,secretary shall provide an update each year to the bundled payment amounts under this subsection4 4 7d7 ,including opioid treatment programs as ,medicare providers ,section #ahff7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7e77 is amended-- 7#a7 in paragraph 7#a71 by striking at the end and2 7#b7 in paragraph 7#b71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new paragraph3 7#c7 opioid treatment programs 7as defined in paragraph 7#b7 of section #ahfa7;jjj771 but only with respect to the furnishing of opioid use disorder treatment services 7as defined in paragraph 7#a7 of such section74 4 ,,iii ,other ,health ,provisions to ,address the ,opioid ,crisis #cjja4 ,clarifying ,,fda regulation of non-addictive pain and addiction therapies 7a7 ,public meetings ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction1 which may include-- 7#a7 the application of novel clinical trial designs 7consistent with section #cjba of the #bast ,century ,cures ,act 7,public ,law #aad-bee771 use of real world evidence 7consistent with section #eje;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g771 and use of patient experience data 7consistent with section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c77 for the development of non-addictive medical products intended to treat pain or addiction2 and 7#b7 the application of eligibility criteria under sections #ejf and #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 for non-addictive medical products intended to treat pain or addiction4 7b7 ,guidance ,not later than #a year after the public meetings are conducted under subsection 7a7 the ,secretary shall issue one or more final guidance documents1 or update existing guidance documents1 to help address challenges to developing non-addictive medical products to treat pain or addiction4 ,such guidance documents shall include information regarding-- 7#a7 how the ,food and ,drug ,administration may apply sections #ejf and #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 to non-addictive medical products intended to treat pain or addiction1 including the circumstances under which the ,secretary-- 7,a7 may apply the eligibility criteria under such sections #ejf and #eae;,b to non-opioid or non-addictive medical products intended to treat pain or addiction2 7,b7 considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need2 and 7,c7 considers pain1 pain control1 or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition2 and 7#b7 the methods by which sponsors may evaluate acute and chronic pain1 endpoints for non-addictive medical products intended to treat pain1 the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions1 taking into consideration the etiology of the underlying disease1 and the manner in which sponsors may use surrogate endpoints1 intermediate endpoints1 and real world evidence4 7c7 ,medical product defined ,in this section1 the term medical product means a drug 7as defined in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7771 biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7771 or device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h7774 #cjjb4 ,surveillance and ,testing of ,opioids to ,prevent ,fentanyl ,deaths 7a7 ,public health laboratories to detect fentanyl ,part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended-- 7#a7 in the heading of part ,f1 by striking and clinical laboratories and inserting 1 clinical laboratories1 and public health laboratories2 and 7#b7 by adding at the end the following new subpart3 #d ,public ,health ,laboratories #cee4 ,public health laboratories to detect fentanyl 7a7 ,in general ,the ,secretary shall establish a program to award grants to ,federal1 ,state1 and local agencies to support the establishment or operation of public health laboratories to detect fentanyl1 its analogues1 and other synthetic opioids1 as described in subsection 7b74 7b7 ,standards ,the ,secretary1 in consultation with the ,director of the ,national ,institute of ,standards and ,technology1 shall-- 7#a7 develop standards for safely and effectively handling and testing fentanyl1 its analogues1 and other synthetic opioids2 7#b7 develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance2 and 7#c7 include in the standards developed pursuant to paragraph 7#a7 procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other ,federal1 ,state1 and local public health laboratories4 7c7 ,laboratories ,the ,secretary shall require grantees under subsection 7a7 to-- 7#a7 follow the standards established under subsection 7b7 and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to ,federal1 ,state1 and local public health officials1 laboratories1 and other entities the ,secretary deems appropriate2 7#b7 work with law enforcement agencies and public health authorities1 as feasible1 to develop real-time information on the purity and movement of fentanyl1 its analogues1 and other synthetic opioids2 7#c7 assist ,state and local law enforcement agencies in testing seized drugs when ,state and local forensic laboratories request additional assistance2 7#d7 provide early warning information and advice to ,federal1 ,state1 and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl1 its analogues1 and other synthetic opioids2 7#e7 provide biosurveillance for non-fatal exposures2 and 7#f7 provide diagnostic testing for non-fatal exposures of emergency personnel4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 7b7 ,enhanced fentanyl surveillance ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cag,t of such ,act 7#db ,u4,s4,c4 #bdg;b-#bb7 the following new section3 #cag,u4 ,enhanced fentanyl surveillance 7a7 ,in general ,the ,director of the ,centers for ,disease ,control and ,prevention shall enhance its drug surveillance program by-- 7#a7 expanding its surveillance program to include all #ej ,states and the territories of the ,united ,states2 7#b7 increasing and accelerating the collection of data on fentanyl1 its analogues1 and other synthetic opioids and new emerging drugs of abuse1 including related overdose data from medical examiners and drug treatment admissions2 and 7#c7 utilizing available and emerging information on fentanyl1 its analogues1 and other synthetic opioids and new emerging drugs of abuse1 including information from-- 7,a7 the ,national ,drug ,early ,warning ,system2 7,b7 ,state and local public health authorities2 and 7,c7 ,federal1 ,state1 and local public health laboratories4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 7c7 ,pilot program for point-of-,use testing of illicit drugs for dangerous contaminants ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#g4 ,pilot program for point-of-,use testing of illicit drugs for dangerous contaminants 7a7 ,in general ,the ,secretary shall-- 7#a7 establish a pilot program through which #e ,state or local agencies conduct1 in #e ,states1 point-of-use testing of illicit drugs for dangerous contaminants2 7#b7 establish metrics to evaluate the success of the pilot program in reducing drug overdose rates2 and 7#c7 based on such metrics1 conduct an annual evaluation of the pilot program and submit an annual report to the ,congress containing the results of such evaluation4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 #cjjc4 ,allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders 7a7 ,conforming applicable number ,subclause 7,,ii7 of section #cjc7;g77#b77;,b77iii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,b77iii77 is amended to read as follows3 7,,ii7 ,the applicable number is-- 7aa7 #ajj if1 not sooner than #a year after the date on which the practitioner submitted the initial notification1 the practitioner submits a second notification to the ,secretary of the need and intent of the practitioner to treat up to #ajj patients2 7bb7 #ajj if the practitioner holds additional credentialing1 as defined in section #h4b of title #db1 ,code of ,federal ,regulations 7or successor regulations72 or 7cc7 #ajj if the practitioner provides medication-assisted treatment 7,,mat7 using covered medications 7as such terms are defined in section #h4b of title #db1 ,code of ,federal ,regulations 7or successor regulations77 in a qualified practice setting 7as described in section #h4fae of title #db1 ,code of ,federal ,regulations 7or successor regulations774 4 7b7 ,eliminating any time limitation for nurse practitioners and physician assistants ,to become qualifying practitioners ,clause 7iii7 of section #cjc7;g77#b77;,g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77 is amended-- 7#a7 in subclause 7,i71 by striking or at the end2 and 7#b7 by amending subclause 7,,ii7 to read as follows3 7,,ii7 a qualifying other practitioner1 as defined in clause 7iv71 who is a nurse practitioner or physician assistant2 or 4 7c7 ,imposing a time limitation for clinical nurse specialists1 certified registered nurse anesthetists1 and certified nurse midwifes ,to become qualifying practitioners ,clause 7iii7 of section #cjc7;g77#b77;,g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g771 as amended by subsection 7b71 is further amended by adding at the end the following3 7,,iii7 for the period beginning on ,october #a1 #bjah1 and ending on ,october #a1 #bjbc1 a qualifying other practitioner1 as defined in clause 7iv71 who is a clinical nurse specialist1 certified registered nurse anesthetist1 or certified nurse midwife4 4 7d7 ,definition of qualifying other practitioner ,section #cjc7;g77#b77;,g77iv7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iv77 is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner1 clinical nurse specialist1 certified registered nurse anesthetist1 certified nurse midwife1 or physician assistant4 7e7 ,report by ,secretary ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,drug ,enforcement ,administration1 shall submit to ,congress a report that assesses the care provided by qualifying practitioners 7as defined in section #cjc7;g77#b77;,g77iii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iii777 who are treating1 in the case of physicians1 more than #ajj patients1 and in the case of qualifying practitioners who are not physicians1 more than #cj patients4 ,such report shall include recommendations on future applicable patient number levels and limits4 ,in preparing such report1 the ,secretary shall study1 with respect to opioid use disorder treatment-- 7#a7 the average frequency with which qualifying practitioners see their patients2 7#b7 the average frequency with which patients receive counseling1 including the rates by which such counseling is provided by such a qualifying practitioner directly1 or by referral2 7#c7 the frequency of toxicology testing1 including the average frequency with which random toxicology testing is administered2 7#d7 the average monthly patient caseload for each type of qualifying practitioner2 7#e7 the treatment retention rates for patients2 7#f7 overdose and mortality rates2 and 7#g7 any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner4 #cjjd4 ,high-quality1 evidence-based opioid analgesic prescribing guidelines and report 7a7 ,guidelines ,the ,commissioner of ,food and ,drugs shall develop high-quality1 evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain in the relevant therapeutic areas where such guidelines do not exist4 7b7 ,public input ,in developing the guidelines under subsection 7a71 the ,commissioner of ,food and ,drugs shall-- 7#a7 conduct a public workshop1 open to representatives of ,state medical societies and medical boards1 various medical specialties including pain medicine specialty societies1 patient groups1 pharmacists1 universities1 and others2 and 7#b7 provide a period for the submission of comments by the public4 7c7 ,report ,not later than the date that is #b years after the date of enactment of this ,act1 the ,commissioner of ,food and ,drugs 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 ,senate1 and post on the public website of the ,food and ,drug ,administration1 a report on how the guidelines under subsection 7a7 will be utilized to protect the public health4 7d7 ,updates ,the ,commissioner of ,food and ,drugs shall periodically-- 7#a7 update the guidelines under subsection 7a71 informed by public input described in subsection 7b72 and 7#b7 submit to the committees specified in subsection 7c7 and post on the public website of the ,food and ,drug ,administration an updated report under subsection 7c74 7e7 ,statement ,to accompany guidelines and recommendations ,the ,commissioner of ,food and ,drugs shall ensure that any opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations1 as applicable-- 7#a7 are intended to help inform clinical decisionmaking by prescribers and patients2 and 7#b7 should not be used by other parties1 including pharmacy benefit management companies1 retail or community pharmacies1 or public and private payors1 for the purposes of restricting1 limiting1 delaying1 or denying coverage for or access to a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice4 7f7 ,definition ,in this section1 the term evidence-based means informed by a robust and systemic review of treatment efficacy and clinical evidence4 #cjje4 ,report on opioids prescribing practices for pregnant women 7a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in coordination with the ,centers for ,disease ,control and ,prevention1 the ,national ,institutes of ,health1 and the ,substance ,abuse and ,mental ,health ,services ,administration shall develop and submit to the ,congress a report-- 7#a7 on opioids prescribing practices for pregnant women and recommendations for such practices2 7#b7 that provides recommendations for identifying and reducing opioids misuse during pregnancy2 7#c7 on prescription opioid misuse during pregnancy in urban and rural areas2 7#d7 on prescription opioid use during pregnancy for the purpose of medication-assisted treatment in urban and rural areas2 7#e7 evaluating current utilization of non-opiate pain management practices in place of prescription opioids during pregnancy2 7#f7 providing guidelines encouraging the use of non-opioid pain management practices during pregnancy when safe and effective2 and 7#g7 that provides recommendations for increasing public awareness and education of opioid use disorder in pregnancy1 including available treatment resources in urban and rural areas4 7b7 ,no additional funds ,no additional funds are authorized to be appropriated for purposes of carrying out subsection 7a74 #cjjf4 ,guidelines for prescribing naloxone 7a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidelines for prescribing an opioid overdose reversal drug4 7b7 ,contents ,in issuing guidelines under subsection 7a71 the ,secretary shall address the following3 7#a7 ,co-prescribing an opioid overdose reversal drug in conjunction with any prescribed opioid4 7#b7 ,dosage safety4 7#c7 ,prescribing an opioid overdose reversal drug to an individual other than a patient4 7#d7 ,standing orders4 7#e7 ,other distribution1 education1 and safety measures as determined necessary4 #cjjg4 ,requiring a survey of substance use disorder treatment providers receiving ,federal funding 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall conduct a survey of all entities that receive ,federal funding for the purpose of providing substance use disorder treatment services4 ,the survey shall direct such entities to provide the following information3 7#a7 ,the length of time the entity has provided substance use disorder treatment services4 7#b7 ,a detailed description of the patient population served by the entity1 including but not limited to the number of patients1 type of addictions1 geographic area served1 as well as gender1 racial1 ethnic and socioeconomic demographics of such patients4 7#c7 ,a detailed description of the types of addiction for which the entity has the experience1 capability1 and capacity to provide such services4 7#d7 ,an explanation of how the entity handles patients requiring treatment for a substance use disorder that the organization is not able to treat4 7#e7 ,a description of what is needed1 in the opinion of the entity1 in order to improve the entity's ability to meet the addiction treatment needs of the communities served by that entity4 7#f7 ,based on the identified needs of the communities served1 a description of unmet needs and inadequate services and how such needs and services could be better addressed through additional ,federal1 ,state1 or local government resources or funding to treat addiction to methamphetamine1 crack cocaine1 other types of cocaine1 heroin1 opioids1 and other commonly abused drugs4 7b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall develop and submit to ,congress a plan to direct appropriate resources to entities that provide substance use disorder treatment services in order to address inadequacies in services or funding identified through the survey described in subsection 7a74 ,,iv ,offsets #djja4 ,promoting value in ,medicaid managed care ,section #aijc7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended by adding at the end the following new paragraph3 7#g7 7,a7 ,with respect to expenditures described in subparagraph 7,b7 that are incurred by a ,state for any fiscal year after fiscal year #bjbj 7and before fiscal year #bjbd71 in determining the pro rata share to which the ,united ,states is equitably entitled under subsection 7d77#c71 the ,secretary shall substitute the ,federal medical assistance percentage that applies for such fiscal year to the ,state under section #aije7;b7 7without regard to any adjustments to such percentage applicable under such section or any other provision of law7 for the percentage that applies to such expenditures under section #aije7y74 7,b7 ,expenditures described in this subparagraph1 with respect to a fiscal year to which subparagraph 7,a7 applies1 are expenditures incurred by a ,state for payment for medical assistance provided to individuals described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i7 by a managed care entity1 or other specified entity 7as defined in subparagraph 7,d77iii771 that are treated as remittances because the ,state-- 7i7 has satisfied the requirement of section #dch4h of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 by electing-- 7,i7 in the case of a ,state described in subparagraph 7,c71 to apply a minimum medical loss ratio 7as defined in subparagraph 7,d77ii77 that is at least #he percent but not greater than the minimum medical loss ratio 7as so defined7 that such ,state applied as of ,may #ca1 #bjah2 or 7,,ii7 in the case of a ,state not described in subparagraph 7,c71 to apply a minimum medical loss ratio that is equal to #he percent2 and 7ii7 recovered all or a portion of the expenditures as a result of the entity's failure to meet such ratio4 7,c7 ,for purposes of subparagraph 7,b71 a ,state described in this subparagraph is a ,state that as of ,may #ca1 #bjah1 applied a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in such subparagraph under the ,state plan under this title 7or a waiver of the plan7 that is equal to or greater than #he percent4 7,d7 ,for purposes of this paragraph3 7i7 ,the term managed care entity means a medicaid managed care organization described in section #aicb7;a77#a77;,b77i74 7ii7 ,the term minimum medical loss ratio means1 with respect to a ,state1 a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in subparagraph 7,b7 under the ,state plan under this title 7or a waiver of the plan74 7iii7 ,the term other specified entity means-- 7,i7 a prepaid inpatient health plan1 as defined in section #dch4b of title #db1 ,code of ,federal ,regulations 7or any successor regulation72 and 7,,ii7 a prepaid ambulatory health plan1 as defined in such section 7or any successor regulation74 4 #djjb4 ,extending period of application of ,medicare secondary payer rules for individuals with end stage renal disease ,section #ahfb7;b77#a77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#a77;,c77 is amended-- 7#a7 in the last sentence1 by inserting and before ,january #a1 #bjbj after date of enactment of the ,balanced ,budget ,act of #aiig2 and 7#b7 by adding at the end the following new sentence3 ,effective for items and services furnished on or after ,january #a1 #bjbj 7with respect to periods beginning on or after ,july #a1 #bjah71 clauses 7i7 and 7ii7 shall be applied by substituting #cc-month for #ab-month each place it appears44 #djjc4 ,requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the ,medicare program ,clause 7i7 of section #ahfb7;b77#g77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#g77;,a77 is amended to read as follows3 7i7 secure from the plan sponsor and plan participants such information as the ,secretary shall specify for the purpose of identifying situations where the group health plan is or has been-- 7,i7 a primary plan to the program under this title2 or 7,,ii7 for calendar quarters beginning on or after ,january #a1 #bjbj1 a primary payer with respect to benefits relating to prescription drug coverage under part ,d2 and 4 ,v ,other ,medicaid ,provisions ,a ,mandatory reporting with respect to adult behavioral health measures #ejja4 ,mandatory reporting with respect to adult behavioral health measures ,section #aaci;,b of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#i;b7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#c7-- 7i7 by striking ,not later than ,january #a1 #bjac and inserting the following3 7,a7 ,voluntary reporting ,not later than ,january #a1 #bjac 2 and 7ii7 by adding at the end the following3 7,b7 ,mandatory reporting with respect to behavioral health measures ,beginning with the ,state report required under subsection 7d77#a7 for #bjbd1 the ,secretary shall require ,states to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information1 using the standardized format for reporting information and procedures developed under subparagraph 7,a71 regarding the quality of behavioral health care for ,medicaid eligible adults4 2 and 7,b7 in paragraph 7#e71 by adding at the end the following new subparagraph3 7,c7 ,behavioral health measures ,beginning with respect to ,state reports required under subsection 7d77#a7 for #bjbd1 the core set of adult health quality measures maintained under this paragraph 7and any updates or changes to such measures7 shall include behavioral health measures4 2 and 7#b7 in subsection 7d77#a77;,a7-- 7,a7 by striking the such plan and inserting such plan2 and 7,b7 by striking subsection 7a77#e7 and inserting subsection 7b77#e7 and1 beginning with the report for #bjbd1 all behavioral health measures included in the core set of adult health quality measures maintained under such subsection 7b77#e7 and any updates or changes to such measures 7as required under subsection 7b77#c774 ,b ,medicaid ,,imd ,additional ,info #ejaa4 ,short title ,this subtitle may be cited as the ,medicaid ,institutes for ,mental ,disease ,are ,decisive in ,delivering ,inpatient ,treatment for ,individuals but ,opportunities for ,needed ,access are ,limited without ,information ,needed about ,facility ,obligations ,act or the ,medicaid ,,imd ,,additional ,,info ,act4 #ejab4 ,,macpac exploratory study and report on institutions for mental diseases requirements and practices under ,medicaid 7a7 ,in general ,not later than ,january #a1 #bjbj1 the ,medicaid and ,,chip ,payment and ,access ,commission established under section #aijj of the ,social ,security ,act 7#db ,u4,s4,c4 #acif7 shall conduct an exploratory study1 using data from a representative sample of ,states1 and submit to ,congress a report on at least the following information1 with respect to services furnished to individuals enrolled under ,state plans under the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 7or waivers of such plans7 who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such ,state plans 7or waivers73 7#a7 ,a description of such institutions for mental diseases in each such ,state1 including at a minimum-- 7,a7 the number of such institutions in the ,state2 7,b7 the facility type of such institutions in the ,state2 and 7,c7 any coverage limitations under each such ,state plan 7or waiver7 on scope1 duration1 or frequency of such services4 7#b7 ,with respect to each such institution for mental diseases in each such ,state1 a description of-- 7,a7 such services provided at such institution2 7,b7 the process1 including any timeframe1 used by such institution to clinically assess and reassess such individuals2 and 7,c7 the discharge process used by such institution1 including any care continuum of relevant services or facilities provided or used in such process4 7#c7 ,a description of-- 7,a7 any ,federal waiver that each such ,state has for such institutions and the ,federal statutory authority for such waiver2 and 7,b7 any other ,medicaid funding sources used by each such ,state for funding such institutions1 such as supplemental payments4 7#d7 ,a summary of ,state requirements 7such as certification1 licensure1 and accreditation7 applied by each such ,state to such institutions in order for such institutions to receive payment under the ,state plan 7or waiver7 and how each such ,state determines if such requirements have been met4 7#e7 ,a summary of ,state standards 7such as quality standards1 clinical standards1 and facility standards7 that such institutions must meet to receive payment under such ,state plans 7or waivers7 and how each such ,state determines if such standards have been met4 7#f7 ,recommendations for actions by ,congress and the ,centers for ,medicare ,medicaid ,services4 such as how ,state ,medicaid programs may improve care and improve standards and including a recommendation for how the ,centers for ,medicare ,medicaid ,services can improve data collection from such programs to address any gaps in information4 7b7 ,stakeholder input ,in carrying out subsection 7a71 the ,medicaid and ,,chip ,payment and ,access ,commission shall seek input from ,state ,medicaid directors and stakeholders1 including at a minimum the ,substance ,abuse and ,mental ,health ,services ,administration1 ,centers for ,medicare ,medicaid ,services1 ,state ,medicaid officials1 ,state mental health authorities1 ,medicaid beneficiary advocates1 health care providers1 and ,medicaid managed care organizations4 7c7 ,definitions ,in this section3 7#a7 ,representative sample of ,states ,the term representative sample of ,states means a non-probability sample in which at least two ,states are selected based on the knowledge and professional judgment of the selector4 7#b7 ,state ,the term ,state means each of the #ej ,states1 the ,district of ,columbia1 and any commonwealth or territory of the ,united ,states4 7#c7 ,institution for mental diseases ,the term institution for mental diseases has the meaning given such term in section #dce4ajji of title #db1 ,code of ,federal ,regulations1 or any successor regulation4 ,c ,,chip ,mental ,health ,parity #ejba4 ,short title ,this subtitle may be cited as the ,,chip ,mental ,health ,parity ,act4 #ejbb4 ,ensuring access to mental health and substance use disorder services for children and pregnant women under the ,children's ,health ,insurance ,program 7a7 ,in general ,section #bajc7;c77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77#a77 is amended by adding at the end the following new subparagraph3 7,e7 ,mental health and substance use disorder services 7as defined in paragraph 7#e774 4 7b7 ,mental health and substance use disorder services 7#a7 ,in general ,section #bajc7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77 is amended-- 7,a7 by redesignating paragraphs 7#e71 7#f71 7#g71 and 7#h7 as paragraphs 7#f71 7#g71 7#h71 and 7#i71 respectively2 and 7,b7 by inserting after paragraph 7#d7 the following new paragraph3 7#e7 ,mental health and substance use disorder services ,regardless of the type of coverage elected by a ,state under subsection 7a71 child health assistance provided under such coverage for targeted low-income children and1 in the case that the ,state elects to provide pregnancy-related assistance under such coverage pursuant to section #baab1 such pregnancy-related assistance for targeted low-income women 7as defined in section #baab7;d77 shall-- 7,a7 include coverage of mental health services 7including behavioral health treatment7 necessary to prevent1 diagnose1 and treat a broad range of mental health symptoms and disorders1 including substance use disorders2 and 7,b7 be delivered in a culturally and linguistically appropriate manner4 4 7#b7 ,conforming amendments 7,a7 ,section #bajc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7a77 is amended1 in the matter before paragraph 7#a71 by striking paragraphs 7#e71 7#f71 and 7#g7 and inserting paragraphs 7#e71 7#f71 7#g71 and 7#h74 7,b7 ,section #baaj7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7a77 is amended-- 7i7 in paragraph 7#ah71 by striking substance abuse each place it appears and inserting substance use2 and 7ii7 in paragraph 7#ai71 by striking substance abuse and inserting substance use4 7,c7 ,section #baaj7;b77#e77;,a77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7b77#e77;,a77i77 is amended by striking subsection 7c77#e7 and inserting subsection 7c77#f74 7c7 ,assuring access to care ,section #bajb7;a77#g77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb7c77#b77 is amended by striking section #bajc7;c77#e7 and inserting paragraphs 7#e7 and 7#f7 of section #bajc7;c74 7d7 ,mental health services parity ,subparagraph 7,a7 of paragraph 7#g7 of section #bajc7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77 7as redesignated by subsection 7b77#a77 is amended to read as follows3 7,a7 ,in general ,a ,state child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services 7as described in paragraph 7#e77 provided under such plan comply with the requirements of section #bgbf7;a7 of the ,public ,health ,service ,act in the same manner as such requirements or limitations apply to a group health plan under such section4 4 7e7 ,effective date 7#a7 ,in general ,subject to paragraph 7#b71 the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is #a year after the date of the enactment of this ,act4 7#b7 ,exception for ,state legislation ,in the case of a ,state child health plan under title ,,xxi of the ,social ,security ,act 7or a waiver of such plan71 which the ,secretary of ,health and ,human ,services determines requires ,state legislation in order for the respective plan 7or waiver7 to meet any requirement imposed by the amendments made by this section1 the respective plan 7or waiver7 shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of enactment of this section4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session shall be considered to be a separate regular session of the ,state legislature4 ,d ,medicaid ,reentry #ejca4 ,short title ,this subtitle may be cited as the ,medicaid ,reentry ,act4 #ejcb4 ,promoting ,state innovations to ease transitions integration to the community for certain individuals 7a7 ,stakeholder group development of best practices2 ,state ,medicaid program innovation 7#a7 ,stakeholder group best practices ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a stakeholder group of representatives of managed care organizations1 ,medicaid beneficiaries1 health care providers1 the ,national ,association of ,medicaid ,directors1 and other relevant representatives from local1 ,state1 and ,federal jail and prison systems to develop best practices 7and submit to the ,secretary and ,congress a report on such best practices7 for ,states-- 7,a7 to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community1 including best practices for ensuring continuity of health insurance coverage or coverage under the ,state ,medicaid plan under title ,,xix of the ,social ,security ,act1 as applicable1 and relevant social services2 and 7,b7 to carry out1 with respect to such an individual1 such health care-related transition not later than #cj days after such individual is released from the public institution4 7#b7 ,state ,medicaid program innovation ,the ,secretary of ,health and ,human ,services shall work with ,states on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the ,medicaid program under title ,,xix of the ,social ,security ,act transition1 with respect to enrollment for medical assistance under such program1 seamlessly to the community4 7b7 ,guidance on innovative service delivery systems demonstration project opportunities ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 through the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall issue a ,state ,medicaid ,director letter1 based on best practices developed under subsection 7a77#a71 regarding opportunities to design demonstration projects under section #aaae of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7 to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title ,,xix of such ,act1 including systems for1 with respect to a period 7not to exceed #cj days7 immediately prior to the day on which such individuals are expected to be released from such institution-- 7#a7 providing assistance and education for enrollment under a ,state plan under the ,medicaid program under title ,,xix of such ,act for such individuals during such period2 and 7#b7 providing health care services for such individuals during such period4 7c7 ,rule of construction ,nothing under title ,,xix of the ,social ,security ,act or any other provision of law precludes a ,state from reclassifying or suspending 7rather than terminating7 eligibility of an individual for medical assistance under title ,,xix of the ,social ,security ,act while such individual is an inmate of a public institution4 ,e ,medicaid ,partnership #ejda4 ,short title ,this subtitle may be cited as the ,medicaid ,providers ,are ,required ,to ,note ,experiences in ,record ,systems to ,help ,in-need ,patients ,act or the ,medicaid ,,partnership ,act4 #ejdb4 ,medicaid providers are required to note experiences in record systems to help in-need patients 7a7 ,requirements under the ,medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances ,title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is amended by inserting after section #aidc the following new section3 #aidd4 ,requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances 7a7 ,in general ,beginning ,october #a1 #bjba1 a ,state shall1 subject to subsection 7d71 require each covered provider to check1 in accordance with such timing1 manner1 and form as specified by the ,state1 the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection 7b7 before prescribing to such individual a controlled substance4 7b7 ,qualified prescription drug monitoring program described ,a qualified prescription drug monitoring program described in this subsection is1 with respect to a ,state1 a prescription drug monitoring program administered by the ,state that1 at a minimum1 satisfies each of the following criteria3 7#a7 ,the program facilitates access by a covered provider to1 at a minimum1 the following information with respect to a covered individual1 in as close to real-time as possible3 7,a7 ,information regarding the prescription drug history of a covered individual with respect to controlled substances4 7,b7 ,the number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent #ab-month period4 7,c7 ,the name1 location1 and contact information 7or other identifying number selected by the ,state1 such as a national provider identifier issued by the ,national ,plan and ,provider ,enumeration ,system of the ,centers for ,medicare ,medicaid ,services7 of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent #ab-month period4 7#b7 ,the program facilitates the integration of information described in paragraph 7#a7 into the workflow of a covered provider1 which may include the electronic system the covered provider uses to prescribe controlled substances4 ,a qualified prescription drug monitoring program described in this subsection1 with respect to a ,state1 may have in place1 in accordance with applicable ,state and ,federal law1 a data sharing agreement with the ,state ,medicaid program that allows the medical director and pharmacy director of such program 7and any designee of such a director who reports directly to such director7 to access the information described in paragraph 7#a7 in an electronic format4 ,the ,state ,medicaid program under this title may facilitate reasonable and limited access1 as determined by the ,state and ensuring documented beneficiary protections regarding the use of such data1 to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity 7as defined under section #aicb7;a77#a77;,b77 that has a contract with the ,state under section #aijc7m7 or under section #aije7t77#c71 or the medical director or pharmacy director of any entity has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the ,state plan 7or waiver of the ,state plan74 ,all applicable ,state and ,federal security and privacy laws shall apply to the directors or designees of such directors of any ,state ,medicaid program or entity accessing a qualified prescription drug monitoring program under this section4 7c7 ,application of privacy rules clarification ,the ,secretary shall clarify privacy requirements1 including requirements under the regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 related to the sharing of data under subsection 7b7 in the same manner as the ,secretary is required under subparagraph 7,j7 of section #ahfj;,d-#d7;c77#e7 to clarify privacy requirements related to the sharing of data described in such subparagraph4 7d7 ,ensuring access ,in order to ensure reasonable access to health care1 the ,secretary shall waive the application of the requirement under subsection 7a71 with respect to a ,state1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7e7 ,reports 7#a7 ,state reports ,each ,state shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d71 beginning with such reports submitted for #bjbc1 information including1 at a minimum1 the following information for the most recent #ab-month period3 7,a7 ,the percentage of covered providers 7as determined pursuant to a process established by the ,state7 who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection 7b7 before prescribing to such individual a controlled substance4 7,b7 ,aggregate trends with respect to prescribing controlled substances such as-- 7i7 the quantity of daily morphine milligram equivalents prescribed for controlled substances2 7ii7 the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual2 and 7iii7 the types of controlled substances prescribed1 including the dates of such prescriptions1 the supplies authorized 7including the duration of such supplies71 and the period of validity of such prescriptions1 in different populations 7such as individuals who are elderly1 individuals with disabilities1 and individuals who are enrolled under both this title and title ,,xviii74 7,c7 ,whether or not the ,state requires 7and a detailed explanation as to why the ,state does or does not require7 pharmacists to check the prescription drug history of a covered individual through a qualified drug management program before dispensing a controlled substance to such individual4 7#b7 ,report by ,,cms ,not later than ,october #a1 #bjbc1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall publish on the publicly available website of the ,centers for ,medicare ,medicaid ,services a report including the following information3 7,a7 ,guidance for ,states on how ,states can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection 7b74 7,b7 ,best practices for how ,states and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances4 7f7 ,increase to ,federal matching rate for certain expenditures relating to qualified prescription drug management programs ,the ,secretary shall increase the ,federal medical assistance percentage or ,federal matching rate that would otherwise apply to a ,state under section #aijc7;a7 for a calendar quarter occurring during the period beginning ,october #a1 #bjah1 and ending ,september #cj1 #bjba1 for expenditures by the ,state for activities under the ,state plan 7or waiver of the ,state plan7 to implement a prescription drug management program that satisfies the criteria described in paragraphs 7#a7 and 7#b7 of subsection 7b7 if the ,state 7in this subsection referred to as the administering ,state7 has in place agreements with all ,states that are contiguous to such administering ,state that1 when combined1 enable covered providers in all such contiguous ,states to access1 through the prescription drug management program1 the information that is described in subsection 7b77#a7 of covered individuals of such administering ,state and that covered providers in such administering ,state are able to access through such program4 ,in no case shall an increase under this subsection result in a ,federal medical assistance percentage or ,federal matching rate that exceeds #ajj percent4 7g7 ,rule of construction ,nothing in this section prevents a ,state from requiring pharmacists to check the prescription drug history of covered individuals through a qualified drug management program before dispensing controlled substances to such individuals4 7h7 ,definitions ,in this section3 7#a7 ,controlled substance ,the term controlled substance means a drug that is included in schedule ,,ii of section #bjb7;c7 of the ,controlled ,substances ,act and1 at the option of the ,state involved1 a drug included in schedule ,,iii or ,,iv of such section4 7#b7 ,covered individual ,the term covered individual means1 with respect to a ,state1 an individual who is enrolled in the ,state plan 7or under a waiver of such plan74 ,such term does not include an individual who-- 7,a7 is receiving-- 7i7 hospice or palliative care2 or 7ii7 treatment for cancer2 7,b7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7,c7 the ,state elects to treat as exempted from such term4 7#c7 ,covered provider 7,a7 ,in general ,the term covered provider means1 subject to subparagraph 7,b71 with respect to a ,state1 a health care provider who is participating under the ,state plan 7or waiver of the ,state plan7 and licensed1 registered1 or otherwise permitted by the ,state to prescribe a controlled substance 7or the designee of such provider74 7,b7 ,exceptions 7i7 ,in general ,beginning ,october #a1 #bjba1 for purposes of this section1 such term does not include a health care provider included in any type of health care provider determined by the ,secretary to be exempt from application of this section under clause 7ii74 7ii7 ,exceptions process ,not later than ,october #a1 #bjbj1 the ,secretary1 after consultation with the ,national ,association of ,medicaid ,directors1 national health care provider associations1 ,medicaid beneficiary advocates1 and advocates for individuals with rare diseases1 shall determine1 based on such consultations1 the types of health care providers 7if any7 that should be exempted from the definition of the term covered provider for purposes of this section4 4 7b7 ,guidance ,not later than ,october #a1 #bjai1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of ,medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs4 7c7 ,development of model ,state practices 7#a7 ,in general ,not later than ,october #a1 #bjbj1 the ,secretary of ,health and ,human ,services shall develop and publish model practices to assist ,state ,medicaid program operations in identifying and implementing strategies to utilize data sharing agreements described in the matter following paragraph 7#b7 of section #aidd7;b7 of the ,social ,security ,act1 as added by subsection 7a71 for the following purposes3 7,a7 ,monitoring and preventing fraud1 waste1 and abuse4 7,b7 ,improving health care for individuals enrolled in a ,state plan under title ,,xix of such ,act 7or waiver of such plan7 who-- 7i7 transition in and out of coverage under such title2 7ii7 may have sources of health care coverage in addition to coverage under such title2 or 7iii7 pay for prescription drugs with cash4 7,c7 ,any other purposes specified by the ,secretary4 7#b7 ,elements of model practices ,the model practices described in paragraph 7#a7-- 7,a7 shall include strategies for assisting ,states in allowing the medical director or pharmacy director 7or designees of such a director7 of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set1 in an electronic format2 and 7,b7 shall include any appropriate beneficiary protections and privacy guidelines4 7#c7 ,consultation ,in developing model practices under this subsection1 the ,secretary shall consult with the ,national ,association of ,medicaid ,directors1 managed care entities 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with contracts with ,states pursuant to section #aijc7m7 of such ,act1 pharmaceutical benefit managers1 physicians and other health care providers1 beneficiary advocates1 and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records4 7d7 ,report by ,comptroller ,general ,not later than ,october #a1 #bjbj1 the ,comptroller ,general of the ,united ,states shall issue a report examining the operation of prescription drug monitoring programs administered by ,states1 including data security and access standards used by such programs4 ,,vi ,other ,medicare ,provisions ,a ,testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology #fjja4 ,testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology ,section #aaae;,a7b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b77 is amended by adding at the end the following new clause3 7xxv7 ,providing1 for the adoption and use of certified ,,ehr technology 7as defined in section #ahdh7o77#d77 to improve the quality and coordination of care through the electronic documentation and exchange of health information1 incentive payments to behavioral health providers 7such as psychiatric hospitals 7as defined in section #ahfa7;f771 community mental health centers 7as defined in section #ahfa7;ff77#c77;,b771 hospitals that participate in a ,state plan under title ,,xix or a waiver of such plan1 treatment facilities that participate in such a ,state plan or such a waiver1 mental health or substance use disorder providers that participate in such a ,state plan or such a waiver1 clinical psychologists 7as defined in section #ahfa7;ii771 nurse practitioners 7as defined in section #ahfa7;aa77#e77 with respect to the provision of psychiatric services1 and clinical social workers 7as defined in section #ahfa7;hh77#a7774 4 ,b ,abuse ,deterrent ,access #fjaa4 ,short title ,this subtitle may be cited at the ,abuse ,deterrent ,access ,act of #bjah4 #fjab4 ,study on abuse-deterrent opioid formulations access barriers under ,medicare 7a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall conduct a study and submit to ,congress a report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an ,,ma-,,pd plan under part ,c of title ,,xviii of the ,social ,security ,act or a prescription drug plan under part ,d of such title of such ,act1 taking into account any barriers preventing such individuals from accessing such formulations under such ,,ma-,,pd or part ,d plans1 such as cost-sharing tiers1 fail-first requirements1 the price of such formulations1 and prior authorization requirements4 7b7 ,definition of abuse-deterrent opioid formulation ,in this section1 the term abuse-deterrent opioid formulation means an opioid that is a prodrug or that has certain abuse-deterrent properties1 such as physical or chemical barriers1 agonist or antagonist combinations1 aversion properties1 delivery system mechanisms1 or other features designed to prevent abuse of such opioid4 ,c ,medicare ,opioid ,safety ,education #fjba4 ,short title ,this subtitle may be cited as the ,medicare ,opioid ,safety ,education ,act of #bjah4 #fjbb4 ,provision of information regarding opioid use and pain management as part of ,medicare ,you handbook 7a7 ,in general ,section #ahjd of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#b7 is amended by adding at the end the following new subsection3 7d7 ,the notice provided under subsection 7a7 shall include-- 7#a7 educational resources1 compiled by the ,secretary1 regarding opioid use and pain management2 and 7#b7 a description of alternative1 non-opioid pain management treatments covered under this title4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to notices distributed prior to each ,medicare open enrollment period beginning after ,january #a1 #bjai4 ,d ,opioid ,addiction ,action ,plan #fjca4 ,short title ,this subtitle may be cited as the ,opioid ,addiction ,action ,plan ,act4 #fjcb4 ,action plan on recommendations for changes under ,medicare and ,medicaid to prevent opioids addictions and enhance access to medication-assisted treatment 7a7 ,in general ,not later than ,january #a1 #bjai1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary71 in collaboration with the ,pain ,management ,best ,practices ,inter-,agency ,task ,force convened under section #aja7;b7 of the ,comprehensive ,addiction and ,recovery ,act of #bjaf 7,public ,law #aad-aih71 shall develop an action plan that provides recommendations described in subsection 7b74 7b7 ,action plan components ,recommendations described in this subsection are1 based on an examination by the ,secretary of potential obstacles to an effective response to the opioid crisis1 recommendations1 as determined appropriate by the ,secretary1 on the following3 7#a7 ,recommendations on changes to the ,medicare program under title ,,xviii of the ,social ,security ,act and the ,medicaid program under title ,,xix of such ,act that would enhance coverage and payment under such programs of all medication-assisted treatment approved by the ,food and ,drug ,administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction1 including recommendations on changes to the ,medicare prospective payment system for hospital inpatient department services under section #ahhf7;d7 of such ,act 7#db ,u4,s4,c4 #acieww7d77 and the ,medicare prospective payment system for hospital outpatient department services under section #ahcc7t7 of such ,act 7#db ,u4,s4,c4 #aciel7t77 that would allow for separate payment for such therapies1 if medically appropriate and if necessary to encourage development and adoption of such therapies4 7#b7 ,recommendations for payment and service delivery models to be tested by the ,center for ,medicare and ,medicaid ,innovation and other federally authorized demonstration projects1 including value-based models1 that may encourage the use of appropriate medication-assisted treatment approved by the ,food and ,drug ,administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treat and minimize risk of opioid addiction4 7#c7 ,recommendations for data collection that could facilitate research and policy making regarding prevention of opioid addiction and coverage and payment under the ,medicare and ,medicaid programs of appropriate opioid addiction treatments4 7#d7 ,recommendations for policies under the ,medicare program and under the ,medicaid program that can expand access for rural1 or medically underserved communities to the full range of medication-assisted treatment approved by the ,food and ,drug ,administration for the treatment of opioid addiction and other therapies that manage chronic and acute pain and treatment and minimize risk of opioid addiction4 7#e7 ,recommendations on changes to the ,medicare program and the ,medicaid program to address coverage or payment barriers to patient access to medical devices that are non-opioid based treatments approved by the ,food and ,drug ,administration for the management of acute pain and chronic pain1 for monitoring substance use withdrawal and preventing overdoses of controlled substances1 and for treating substance use disorder4 7c7 ,stakeholder meetings 7#a7 ,in general ,beginning not later than #c months after the date of the enactment of this ,act1 the ,secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan recommendations described in subsection 7b74 7#b7 ,participants ,participants of meetings described in paragraph 7#a7 shall include representatives from the ,food and ,drug ,administration and ,national ,institutes of ,health1 biopharmaceutical industry members1 medical researchers1 health care providers1 the medical device industry1 the ,medicare program1 the ,medicaid program1 and patient advocates4 7d7 ,request for information ,not later than #c months after the date of the enactment of this section1 the ,secretary shall issue a request for information seeking public feedback regarding ways in which the ,centers for ,medicare ,medicaid ,services can help address the opioid crisis through the development of and application of the action plan4 7e7 ,report to ,congress ,not later than ,june #a1 #bjai1 the ,secretary shall submit to ,congress1 and make public1 a report that includes-- 7#a7 a summary of recommendations that have emerged under the action plan2 7#b7 the ,secretary's planned next steps with respect to the action plan2 and 7#c7 an evaluation of price trends for drugs used to reverse opioid overdoses 7such as naloxone71 including recommendations on ways to lower such prices for consumers4 7f7 ,definition of ,medication-,assisted treatment ,in this section1 the term medication-assisted treatment includes opioid treatment programs1 behavioral therapy1 and medications to treat substance abuse disorder4 ,e ,advancing ,high ,quality ,treatment for ,opioid ,use ,disorders in ,medicare #fjda4 ,short title ,this subtitle may be cited as the ,advancing ,high ,quality ,treatment for ,opioid ,use ,disorders in ,medicare ,act4 #fjdb4 ,opioid use disorder treatment demonstration program ,title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 is amended by inserting after section #ahff;,e 7#db ,u4,s4,c4 #acie;cc-#e7 the following new section3 #ahff;,f4 ,opioid use disorder treatment demonstration program 7a7 ,implementation of #d-year demonstration program 7#a7 ,in general ,not later than ,january #a1 #bjba1 the ,secretary shall implement a #d-year demonstration program under this title 7in this section referred to as the ,program7 to increase access of applicable beneficiaries to opioid use disorder treatment services1 improve physical and mental health outcomes for such beneficiaries1 and to the extent possible1 reduce expenditures under this title4 ,under the ,program1 the ,secretary shall make payments under subsection 7e7 to participants 7as defined in subsection 7c77#a77;,a77 for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams1 or arranging for such services to be furnished1 to applicable beneficiaries participating in the ,program4 7#b7 ,opioid use disorder treatment services ,for purposes of this section1 the term opioid use disorder treatment services-- 7,a7 means1 with respect to an applicable beneficiary1 services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act for the treatment of opioid use disorders in an outpatient setting2 and 7,b7 includes-- 7i7 medication assisted treatment2 7ii7 treatment planning2 7iii7 psychiatric1 psychological1 or counseling services 7or any combination of such services71 as appropriate2 7iv7 social support services1 as appropriate2 and 7v7 care management and care coordination services1 including coordination with other providers of services and suppliers not on an opioid use disorder care team4 7b7 ,program design 7#a7 ,in general ,the ,secretary shall design the ,program in such a manner to allow for the evaluation of the extent to which the ,program accomplishes the following purposes3 7,a7 ,reduces hospitalizations and emergency department visits4 7,b7 ,increases use of medication-assisted treatment for opioid use disorders4 7,c7 ,improves health outcomes of individuals with opioid use disorders1 including by reducing the incidence of infectious diseases 7such as hepatitis ,c and ,,hiv74 7,d7 ,does not increase the total spending on items and services under this title4 7,e7 ,reduces deaths from opioid overdose4 7,f7 ,reduces the utilization of inpatient residential treatment4 7#b7 ,consultation ,in designing the ,program1 including the criteria under subsection 7e77#b77;,a71 the ,secretary shall1 not later than #c months after the date of the enactment of this section1 consult with specialists in the field of addiction1 clinicians in the primary care community1 and beneficiary groups4 7c7 ,participants2 opioid use disorder care teams 7#a7 ,participants 7,a7 ,definition ,in this section1 the term participant means an entity or individual-- 7i7 that is otherwise enrolled under this title and that is-- 7,i7 a physician 7as defined in section #ahfa7r77#a772 7,,ii7 a group practice comprised of at least one physician described in subclause 7,i72 7,,iii7 a hospital outpatient department2 7,,iv7 a federally qualified health center 7as defined in section #ahfa7;aa77#d772 7,v7 a rural health clinic 7as defined in section #ahfa7;aa77#b772 7,,vi7 a community mental health center 7as defined in section #ahfa7;ff77#c77;,b772 7,,vii7 a clinic certified as a certified community behavioral health clinic pursuant to section #bbc of the ,protecting ,access to ,medicare ,act of #bjad2 or 7,,viii7 any other individual or entity specified by the ,secretary2 7ii7 that applied for and was selected to participate in the ,program pursuant to an application and selection process established by the ,secretary2 and 7iii7 that establishes an opioid use disorder care team 7as defined in paragraph 7#b77 through employing or contracting with health care practitioners described in paragraph 7#b77;,a71 and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the ,program4 7,b7 ,preference ,in selecting participants for the ,program1 the ,secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence4 7#b7 ,opioid use disorder care teams 7,a7 ,in general ,for purposes of this section1 the term opioid use disorder care team means a team of health care practitioners established by a participant described in paragraph 7#a77;,a7 that-- 7i7 shall include-- 7,i7 at least one physician 7as defined in section #ahfa7r77#a77 furnishing primary care services or addiction treatment services to an applicable beneficiary2 and 7,,ii7 at least one eligible practitioner 7as defined in paragraph 7#c77;,a771 who may be a physician who meets the criterion in subclause 7,i72 and 7ii7 may include other practitioners licensed under ,state law to furnish psychiatric1 psychological1 counseling1 and social services to applicable beneficiaries4 7,b7 ,requirements for receipt of payment under ,program ,in order to receive payments under subsection 7e71 each participant in the ,program shall-- 7i7 furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services2 7ii7 meet minimum criteria1 as established by the ,secretary2 and 7iii7 submit to the ,secretary1 in such form1 manner1 and frequency as specified by the ,secretary1 with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team1 data and such other information as the ,secretary determines appropriate to-- 7,i7 monitor and evaluate the ,program2 7,,ii7 determine if minimum criteria are met under clause 7ii72 and 7,,iii7 determine the incentive payment under subsection 7e74 7#c7 ,eligible practitioners2 ,other provider-related definitions and application provisions 7,a7 ,eligible practitioners ,for purposes of this section1 the term eligible practitioner means a physician or other health care practitioner1 such as a nurse practitioner1 that-- 7i7 is enrolled under section #ahff7;j77#a72 7ii7 is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment2 and 7iii7 has in effect a waiver in accordance with section #cjc7;g7 of the ,controlled ,substances ,act for such purpose and is otherwise in compliance with regulations promulgated by the ,substance ,abuse and ,mental ,health ,services ,administration to carry out such section4 7,b7 ,addiction specialists ,for purposes of subsection 7e77#a77;,b77iv71 the term addiction specialist means a physician that possesses expert knowledge and skills in addiction medicine1 as evidenced by appropriate certification from a specialty body1 a certificate of advanced qualification in addiction medicine1 or completion of an accredited residency or fellowship in addiction medicine or addiction psychiatry1 as determined by the ,secretary4 7d7 ,participation of applicable beneficiaries 7#a7 ,applicable beneficiary defined ,in this section1 the term applicable beneficiary means an individual who-- 7,a7 is entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under part ,b2 7,b7 is not enrolled in a ,medicare ,advantage plan under part ,c2 7,c7 has a current diagnosis for an opioid use disorder2 and 7,d7 meets such other criteria as the ,secretary determines appropriate4 ,such term shall include an individual who is dually eligible for benefits under this title and title ,,xix if such individual satisfies the criteria described in subparagraphs 7,a7 through 7,d74 7#b7 ,voluntary beneficiary participation2 limitation on number of beneficiaries ,an applicable beneficiary may participate in the ,program on a voluntary basis and may terminate participation in the ,program at any time4 ,not more than #bj1jjj applicable beneficiaries may participate in the ,program at any time4 7#c7 ,services ,in order to participate in the ,program1 an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant4 ,participation under the ,program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary4 7#d7 ,beneficiary access to services ,nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the ,program4 7e7 ,payments 7#a7 ,per applicable beneficiary per month care management fee 7,a7 ,in general ,the ,secretary shall establish a schedule of per applicable beneficiary per month care management fees4 ,such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant's opioid use disorder care team or1 if applicable1 to the participant4 ,a participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries1 including services not otherwise eligible for payment under this title4 7,b7 ,payment amounts ,in carrying out subparagraph 7,a71 the ,secretary shall-- 7i7 consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries2 7ii7 pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care2 7iii7 pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months1 to reflect the greater time and costs required for the planning and initiation of treatment1 as compared to maintenance of treatment2 7iv7 pay higher per applicable beneficiary per month care management fees for participants that have established opioid use disorder care teams that include an addiction specialist 7as defined in subsection 7c77#c77;,b772 and 7v7 take into account whether a participant's opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services4 7,c7 ,no duplicate payment ,the ,secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month4 7#b7 ,incentive payments 7,a7 ,in general ,under the ,program1 the ,secretary shall establish a performance-based incentive payment1 which shall be paid 7using a methodology established and at a time determined appropriate by the ,secretary7 to participants based on the performance of participants with respect to criteria1 as determined appropriate by the ,secretary1 in accordance with subparagraph 7,b74 7,b7 ,criteria 7i7 ,in general ,criteria described in subparagraph 7,a7 may include consideration of the following3 7,i7 ,patient engagement and retention in treatment4 7,,ii7 ,evidence-based medication-assisted treatment4 7,,iii7 ,other criteria established by the ,secretary4 7ii7 ,required consultation and consideration ,in determining criteria described in subparagraph 7,a71 the ,secretary shall-- 7,i7 consult with stakeholders1 including clinicians in the primary care community and in the field of addiction medicine2 and 7,,ii7 consider existing clinical guidelines for the treatment of opioid use disorders4 7,c7 ,no duplicate payment ,the ,secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary4 7f7 ,multipayer strategy ,in carrying out the ,program1 the ,secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the ,program under subsection 7e77#b77;,c74 ,the ,secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the ,program4 7g7 ,evaluation 7#a7 ,in general ,the ,secretary shall conduct an intermediate and final evaluation of the program4 ,each such evaluation shall determine the extent to which each of the purposes described in subsection 7b7 have been accomplished under the ,program4 7#b7 ,reports ,the ,secretary shall submit to the ,secretary and ,congress-- 7,a7 a report with respect to the intermediate evaluation under paragraph 7#a7 not later than #c years after the date of the implementation of the ,program2 and 7,b7 a report with respect to the final evaluation under paragraph 7#a7 not later than #f years after such date4 7h7 ,funding 7#a7 ,administrative funding ,for the purposes of implementing1 administering1 and carrying out the ,program 7other than for purposes described in paragraph 7#b771 #e1jjj1jjj shall be available from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda4 7#b7 ,care management fees and incentives ,for the purposes of making payments under subsection 7e71 #aj1jjj1jjj shall be available from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda for each of fiscal years #bjba through #bjbd4 7#c7 ,availability ,amounts transferred under this subsection for a fiscal year shall be available until expended4 7i7 ,waivers ,the ,secretary may waive any provision of this title as may be necessary to carry out the ,program under this section4 4 ,f ,responsible ,education ,achieves ,care and ,healthy ,outcomes for ,users' ,treatment #fjea4 ,short title ,this subtitle may be cited as the ,responsible ,education ,achieves ,care and ,healthy ,outcomes for ,users' ,treatment ,act of #bjah or the ,,reach ,,out ,act of #bjah4 #fjeb4 ,grants to provide technical assistance to outlier prescribers of opioids 7a7 ,grants authorized ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall1 through the ,centers for ,medicare ,medicaid ,services1 award grants1 contracts1 or cooperative agreements to eligible entities for the purposes described in subsection 7b74 7b7 ,use of funds ,grants1 contracts1 and cooperative agreements awarded under subsection 7a7 shall be used to support eligible entities through technical assistance-- 7#a7 to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids2 7#b7 to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies2 and 7#c7 to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids4 7c7 ,application ,each eligible entity seeking to receive a grant1 contract1 or cooperative agreement under subsection 7a7 shall submit to the ,secretary an application1 at such time1 in such manner1 and containing such information as the ,secretary may require4 7d7 ,geographic distribution ,in awarding grants1 contracts1 and cooperative agreements under this section1 the ,secretary shall prioritize establishing technical assistance resources in each ,state4 7e7 ,definitions ,in this section3 7#a7 ,eligible entity ,the term eligible entity means-- 7,a7 an organization-- 7i7 that has demonstrated experience providing technical assistance to health care professionals on a ,state or regional basis2 and 7ii7 that has at least-- 7,i7 one individual who is a representative of consumers on its governing body2 and 7,,ii7 one individual who is a representative of health care providers on its governing body2 or 7,b7 an entity that is a quality improvement entity with a contract under part ,b of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;c et seq474 7#b7 ,outlier prescriber of opioids ,the term outlier prescriber of opioids means a prescriber1 identified by the ,secretary of ,health and ,human ,services 7through use of prescriber information provided by prescriber ,national ,provider ,identifiers included pursuant to section #ahfj;,d-#d7;c77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#d77;,a77 on claims for covered part ,d drugs for part ,d eligible individuals enrolled in prescription drug plans under part ,d of title ,,xviii of such ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 and ,,ma-,,pd plans under part ,c of such title 7#db ,u4,s4,c4 #aciew-#ba et seq477 as prescribing1 as compared to other prescribers in the specialty of the prescriber and geographic area1 amounts of opioids in excess of a threshold 7and other criteria7 specified by the ,secretary1 after consultation with stakeholders4 7#c7 ,prescribers ,the term prescriber means any health care professional1 including a nurse practitioner or physician assistant1 who is licensed to prescribe opioids by the ,state or territory in which such professional practices4 7f7 ,funding ,for purposes of implementing this section1 #ge1jjj1jjj shall be available from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet71 to remain available until expended4 ,g ,preventing ,addiction for ,susceptible ,seniors #fjfa4 ,short title ,this subtitle may be cited as the ,preventing ,addiction for ,susceptible ,seniors ,act of #bjah or the ,,pass ,act of #bjah 4 #fjfb4 ,electronic prior authorization for covered part ,d drugs 7a7 ,inclusion in electronic prescription program ,section #ahfj;,d-#d7;e77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is amended by adding at the end the following new subparagraph3 7,e7 ,electronic prior authorization 7i7 ,in general ,not later than ,january #a1 #bjba1 the program shall provide for the secure electronic transmission of-- 7,i7 a prior authorization request from the prescribing health care professional for coverage of a covered part ,d drug for a part ,d eligible individual enrolled in a part ,d plan 7as defined in section #ahfj;,d-#bc7;a77#e77 to the ,,pdp sponsor or ,medicare ,advantage organization offering such plan2 and 7,,ii7 a response1 in accordance with this subparagraph1 from such ,,pdp sponsor or ,medicare ,advantage organization1 respectively1 to such professional4 7ii7 ,electronic transmission 7,i7 ,exclusions ,for purposes of this subparagraph1 a facsimile1 a proprietary payer portal that does not meet standards specified by the ,secretary1 or an electronic form shall not be treated as an electronic transmission described in clause 7i74 7,,ii7 ,standards ,in order to be treated1 for purposes of this subparagraph1 as an electronic transmission described in clause 7i71 such transmission shall comply with technical standards adopted by the ,secretary in consultation with the ,national ,council for ,prescription ,drug ,programs1 other standard setting organizations determined appropriate by the ,secretary1 and stakeholders including ,,pdp sponsors1 ,medicare ,advantage organizations1 health care professionals1 and health information technology software vendors4 7,,iii7 ,application ,notwithstanding any other provision of law1 for purposes of this subparagraph1 the ,secretary may require the use of such standards adopted under subclause 7,,ii7 in lieu of any other applicable standards for an electronic transmission described in clause 7i7 for a covered part ,d drug for a part ,d eligible individual4 4 7b7 ,sense of ,congress regarding electronic prior authorization ,it is the sense of the ,congress that-- 7#a7 there should be increased use of electronic prior authorizations for coverage of covered part ,d drugs for part ,d eligible individuals enrolled in prescription drug plans under part ,d of title ,,xviii of the ,social ,security ,act and ,,ma-,,pd plans under part ,c of such title to reduce access delays by resolving coverage issues before prescriptions for such drugs are transmitted2 and 7#b7 greater priority should be placed on increasing the adoption of use of such electronic prior authorizations among prescribers of such drugs1 pharmacies1 ,,pdp sponsors1 and ,medicare ,advantage organizations4 #fjfc4 ,program integrity transparency measures under ,medicare parts ,c and ,d 7a7 ,in general ,section #ahei of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bh7 is amended by adding at the end the following new subsection3 7i7 ,program integrity transparency measures 7#a7 ,program integrity portal 7,a7 ,in general ,not later than #b years after the date of the enactment of this subsection1 the ,secretary shall1 after consultation with stakeholders1 establish a secure ,internet website portal 7or other successor technology7 that would allow a secure path for communication between the ,secretary1 ,,ma plans under this part1 prescription drug plans under part ,d1 and an eligible entity with a contract under section #ahic 7such as a ,medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part ,d7 for the purpose of enabling through such portal 7or other successor technology7-- 7i7 the referral by such plans of substantiated fraud1 waste1 and abuse for initiating or assisting investigations conducted by the eligible entity2 and 7ii7 data sharing among such ,,ma plans1 prescription drug plans1 and the ,secretary4 7,b7 ,required uses of portal ,the ,secretary shall disseminate the following information to ,,ma plans under this part and prescription drug plans under part ,d through the secure ,internet website portal 7or other successor technology7 established under subparagraph 7,a73 7i7 ,providers of services and suppliers that have been referred pursuant to subparagraph 7,a77i7 during the previous #ab-month period4 7ii7 ,providers of services and suppliers who are the subject of an active exclusion under section #aabh or who are subject to a suspension of payment under this title pursuant to section #ahfb7o7 or otherwise4 7iii7 ,providers of services and suppliers who are the subject of an active revocation of participation under this title1 including for not satisfying conditions of participation4 7iv7 ,in the case of such a plan that makes a referral under subparagraph 7,a77i7 through the portal 7or other successor technology7 with respect to activities of substantiated fraud1 waste1 or abuse of a provider of services or supplier1 if such provider or supplier has been the subject of an administrative action under this title or title ,,xi with respect to similar activities1 a notification to such plan of such action so taken4 7,c7 ,rulemaking ,for purposes of this paragraph1 the ,secretary shall1 through rulemaking1 specify what constitutes substantiated fraud1 waste1 and abuse1 using guidance such as what is provided in the ,medicare ,program ,integrity ,manual #d4g4a4 ,in carrying out this subsection1 a fraud hotline tip 7as defined by the ,secretary7 without further evidence shall not be treated as sufficient evidence for substantiated fraud1 waste1 or abuse4 7,d7 ,,hipaa compliant information only ,for purposes of this subsection1 communications may only occur if the communications are permitted under the ,federal regulations 7concerning the privacy of individually identifiable health information7 promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif4 7#b7 ,quarterly reports ,beginning #b years after the date of enactment of this subsection1 the ,secretary shall make available to ,,ma plans under this part and prescription drug plans under part ,d in a timely manner 7but no less frequently than quarterly7 and using information submitted to an entity described in paragraph 7#a7 through the portal 7or other successor technology7 described in such paragraph or pursuant to section #ahic1 information on fraud1 waste1 and abuse schemes and trends in identifying suspicious activity4 ,information included in each such report shall-- 7,a7 include administrative actions1 pertinent information related to opioid overprescribing1 and other data determined appropriate by the ,secretary in consultation with stakeholders2 and 7,b7 be anonymized information submitted by plans without identifying the source of such information4 7#c7 ,clarification ,nothing in this subsection shall be construed as precluding or otherwise affecting referrals described in subparagraph 7,a7 that may otherwise be made to law enforcement entities or to the ,secretary4 4 7b7 ,contract requirement to communicate plan corrective actions against opioid over-prescribers ,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#e7 ,communicating plan corrective actions against opioids over-prescribers 7,a7 ,in general ,beginning with plan years beginning on or after ,january #a1 #bjba1 a contract under this section with an ,,ma organization shall require the organization to submit to the ,secretary1 through the process established under subparagraph 7,b71 information on the investigations and other actions taken by such plans related to providers of services who prescribe a high volume of opioids4 7,b7 ,process ,not later than ,january #a1 #bjba1 the ,secretary shall1 in consultation with stakeholders1 establish a process under which ,,ma plans and prescription drug plans shall submit to the ,secretary information described in subparagraph 7,a74 7,c7 ,regulations ,for purposes of this paragraph1 including as applied under section #ahfj;,d-#ab7;b77#c77;,d71 the ,secretary shall1 pursuant to rulemaking-- 7i7 specify a definition for the term high volume of opioids and a method for determining if a provider of services prescribes such a high volume2 and 7ii7 establish the process described in subparagraph 7,b7 and the types of information that shall be submitted through such process4 4 7c7 ,reference under part ,d to program integrity transparency measures ,section #ahfj;,d-#d of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is amended by adding at the end the following new subsection3 7m7 ,program integrity transparency measures ,for program integrity transparency measures applied with respect to prescription drug plan and ,,ma plans1 see section #ahei7;i74 4 #fjfd4 ,expanding eligibility for medication therapy management programs under part ,d ,section #ahfj;,d-#d7;c77#b77;,a77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#b77;,a77ii77 is amended-- 7#a7 by redesignating subclauses 7,i7 through 7,,iii7 as items 7aa7 through 7cc71 respectively1 and adjusting the margins accordingly2 7#b7 by striking are part ,d eligible individuals who-- and inserting are the following3 7,i7 ,part ,d eligible individuals who-- 2 and 7#c7 by adding at the end the following new subclause3 7,,ii7 ,beginning ,january #a1 #bjba1 at-risk beneficiaries for prescription drug abuse 7as defined in paragraph 7#e77;,c774 4 #fjfe4 ,medicare notifications to outlier prescribers of opioids ,section #ahfj;,d-#d7;c77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#d77 is amended by adding at the end the following new subparagraph3 7,d7 ,outlier prescriber notification 7i7 ,notification ,beginning not later than #b years after the date of the enactment of this subparagraph1 the ,secretary shall1 in the case of a prescriber identified by the ,secretary under clause 7ii7 to be an outlier prescriber of opioids1 provide1 subject to clause 7iv71 an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information specified in accordance with clause 7iii74 7ii7 ,identification of outlier prescribers of opioids 7,i7 ,in general ,the ,secretary shall1 subject to subclause 7,,iii71 using the valid prescriber ,national ,provider ,identifiers included pursuant to subparagraph 7,a7 on claims for covered part ,d drugs for part ,d eligible individuals enrolled in prescription drug plans under this part or ,,ma-,,pd plans under part ,c and based on the threshold established under subclause 7,,ii71 conduct an analysis to identify prescribers that are outlier opioid prescribers for a period specified by the ,secretary4 7,,ii7 ,establishment of threshold ,for purposes of subclause 7,i7 and subject to subclause 7,,iii71 the ,secretary shall1 after consultation with stakeholders1 establish a threshold1 based on prescriber specialty and geographic area1 for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area4 7,,iii7 ,exclusions ,the ,secretary may exclude the following individuals and prescribers from the analysis under this clause3 7aa7 ,individuals receiving hospice services4 7bb7 ,individuals with a cancer diagnosis4 7cc7 ,prescribers who are the subject of an investigation by the ,centers for ,medicare ,medicaid ,services or the ,office of ,inspector ,general of the ,department of ,health and ,human ,services4 7iii7 ,contents of notification ,the ,secretary shall1 based on input from stakeholders1 specify the resources and other information to be included in notifications provided under clause 7i74 7iv7 ,modifications and expansions 7,i7 ,frequency ,beginning #e years after the date of the enactment of this subparagraph1 the ,secretary may change the frequency of the notifications described in clause 7i7 based on stakeholder input4 7,,ii7 ,expansion to other prescriptions ,the ,secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered ,part ,d drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination1 as determined by the ,secretary4 7v7 ,opioids defined ,for purposes of this subparagraph1 the term opioids has such meaning as specified by the ,secretary through program instruction or otherwise4 4 #fjff4 ,no additional funds authorized ,no additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle4 ,such requirements shall be carried out using amounts otherwise authorized to be appropriated4 ,h ,expanding ,oversight of ,opioid ,prescribing and ,payment #fjga4 ,short title ,this subtitle may be cited as the ,expanding ,oversight of ,opioid ,prescribing and ,payment ,act of #bjah4 #fjgb4 ,medicare ,payment ,advisory ,commission report on opioid payment1 adverse incentives1 and data under the ,medicare program ,not later than ,march #ae1 #bjai1 the ,medicare ,payment ,advisory ,commission shall submit to ,congress a report on1 with respect to the ,medicare program under title ,,xviii of the ,social ,security ,act1 the following3 7#a7 ,a description of how the ,medicare program pays for pain management treatments 7both opioid and non-opioid pain management alternatives7 in both inpatient and outpatient hospital settings4 7#b7 ,the identification of incentives under the hospital inpatient prospective payment system under section #ahhf of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 and incentives under the hospital outpatient prospective payment system under section #ahcc7t7 of such ,act 7#db ,u4,s4,c4 #aciel7t77 for prescribing opioids and incentives under each such system for prescribing non-opioid treatments1 and recommendations as the ,commission deems appropriate for addressing any of such incentives that are adverse incentives4 7#c7 ,a description of how opioid use is tracked and monitored through ,medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use4 #fjgc4 ,no additional funds authorized ,no additional funds are authorized to be appropriated to carry out the requirements of this subtitle4 ,such requirements shall be carried out using amounts otherwise authorized to be appropriated4 ,i ,dr4 ,todd ,graham ,pain ,management1 ,treatment1 and ,recovery #fjha4 ,short title ,this subtitle may be cited as the ,dr4 ,todd ,graham ,pain ,management1 ,treatment1 and ,recovery ,act of #bjah4 #fjhb4 ,review and adjustment of payments under the ,medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments 7a7 ,outpatient prospective payment system ,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#bb7 ,review and revisions of payments for non-opioid alternative treatments 7,a7 ,in general ,with respect to payments made under this subsection for covered ,,opd services 7or groups of services71 including covered ,,opd services assigned to a comprehensive ambulatory payment classification1 the ,secretary-- 7i7 shall1 as soon as practicable1 conduct a review 7part of which may include a request for information7 of payments for opioids and evidence-based non-opioid alternatives for pain management 7including drugs and devices1 nerve blocks1 surgical injections1 and neuromodulation7 with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives2 7ii7 may1 as the ,secretary determines appropriate1 conduct subsequent reviews of such payments2 and 7iii7 shall consider the extent to which revisions under this subsection to such payments 7such as the creation of additional groups of covered ,,opd services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management7 would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management4 7,b7 ,priority ,in conducting the review under clause 7i7 of subparagraph 7,a7 and considering revisions under clause 7iii7 of such subparagraph1 the ,secretary shall focus on covered ,,opd services 7or groups of services7 assigned to a comprehensive ambulatory payment classification1 ambulatory payment classifications that primarily include surgical services1 and other services determined by the ,secretary which generally involve treatment for pain management4 7,c7 ,revisions ,if the ,secretary identifies revisions to payments pursuant to subparagraph 7,a77iii71 the ,secretary shall1 as determined appropriate1 begin making such revisions for services furnished on or after ,january #a1 #bjbj4 ,revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph 7#i77;,b74 7,d7 ,rules of construction ,nothing in this paragraph shall be construed to preclude the ,secretary-- 7i7 from conducting a demonstration before making the revisions described in subparagraph 7,c72 or 7ii7 prior to implementation of this paragraph1 from changing payments under this subsection for covered ,,opd services 7or groups of services7 which include opioids or non-opioid alternatives for pain management4 4 7b7 ,ambulatory surgical centers ,section #ahcc7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77 is amended by adding at the end the following new paragraph3 7#h7 ,the ,secretary shall conduct a similar type of review as required under paragraph 7#bb7 of section #ahcc7t771 including the second sentence of subparagraph 7,c7 of such paragraph1 to payment for services under this subsection1 and make such revisions under this paragraph1 in an appropriate manner 7as determined by the ,secretary74 4 #fjhc4 ,expanding access under the ,medicare program to addiction treatment in ,federally qualified health centers and rural health clinics 7a7 ,federally qualified health centers ,section #ahcd7o7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77 is amended by adding at the end the following new paragraph3 7#c7 ,additional payments for certain ,f,q,h,cs with physicians or other practitioners receiving ,,data #bjjj waivers 7,a7 ,in general ,in the case of a ,federally qualified health center with respect to which1 beginning on or after ,january #a1 #bjai1 ,federally-qualified health center services 7as defined in section #ahfa7;aa77#c77 are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph 7,c7 the ,secretary shall1 subject to availability of funds under subparagraph 7,d71 make a payment 7at such time and in such manner as specified by the ,secretary7 to such ,federally qualified health center after receiving and approving an application submitted by such ,federally qualified health center under subparagraph 7,b74 ,such a payment shall be in an amount determined by the ,secretary1 based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph 7,c77ii74 ,such a payment may be made only one time with respect to each such physician or practitioner4 7,b7 ,application ,in order to receive a payment described in subparagraph 7,a71 a ,federally-qualified health center shall submit to the ,secretary an application for such a payment at such time1 in such manner1 and containing such information as specified by the ,secretary4 ,a ,federally-qualified health center may apply for such a payment for each physician or practitioner described in subparagraph 7,a7 furnishing services described in such subparagraph at such center4 7,c7 ,requirements ,for purposes of subparagraph 7,a71 the requirements described in this subparagraph1 with respect to a physician or practitioner1 are the following3 7i7 ,the physician or practitioner is employed by or working under contract with a ,federally qualified health center described in subparagraph 7,a7 that submits an application under subparagraph 7,b74 7ii7 ,the physician or practitioner first receives a waiver under section #cjc7;g7 of the ,controlled ,substances ,acton or after ,january #a1 #bjai4 7,d7 ,funding ,for purposes of making payments under this paragraph1 there are appropriated1 out of amounts in the ,treasury not otherwise appropriated1 #f1jjj1jjj1 which shall remain available until expended4 4 7b7 ,rural health clinic ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7#a7 by redesignating the subsection 7z7 relating to medical review of spinal subluxation services as subsection 7aa72 and 7#b7 by adding at the end the following new subsection3 7bb7 ,additional payments for certain rural health clinics with physicians or practitioners receiving ,,data #bjjj waivers 7#a7 ,in general ,in the case of a rural health clinic with respect to which1 beginning on or after ,january #a1 #bjai1 rural health clinic services 7as defined in section #ahfa7;aa77#a77 are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph 7#c71 the ,secretary shall1 subject to availability of funds under paragraph 7#d71 make a payment 7at such time and in such manner as specified by the ,secretary7 to such rural health clinic after receiving and approving an application described in paragraph 7#b74 ,such payment shall be in an amount determined by the ,secretary1 based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph 7#c77;,b74 ,such payment may be made only one time with respect to each such physician or practitioner4 7#b7 ,application ,in order to receive a payment described in paragraph 7#a71 a rural health clinic shall submit to the ,secretary an application for such a payment at such time1 in such manner1 and containing such information as specified by the ,secretary4 ,a rural health clinic may apply for such a payment for each physician or practitioner described in paragraph 7#a7 furnishing services described in such paragraph at such clinic4 7#c7 ,requirements ,for purposes of paragraph 7#a71 the requirements described in this paragraph1 with respect to a physician or practitioner1 are the following3 7,a7 ,the physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph 7#a7 that submits an application under paragraph 7#b74 7,b7 ,the physician or practitioner first receives a waiver under section #cjc7;g7 of the ,controlled ,substances ,acton or after ,january #a1 #bjai4 7#d7 ,funding ,for purposes of making payments under this subsection1 there are appropriated1 out of amounts in the ,treasury not otherwise appropriated1 #b1jjj1jjj1 which shall remain available until expended4 4 #fjhd4 ,studying the availability of supplemental benefits designed to treat or prevent substance use disorders under ,medicare ,advantage plans 7a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall submit to ,congress a report on the availability of supplemental health care benefits 7as described in section #aheb7;a77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#c77;,a777 designed to treat or prevent substance use disorders under ,medicare ,advantage plans offered under part ,c of title ,,xviii of such ,act4 ,such report shall include the analysis described in subsection 7c7 and any differences in the availability of such benefits under specialized ,,ma plans for special needs individuals 7as defined in section #ahei7;b77#f7 of such ,act 7#db ,u4,s4,c4 #aciew-#bh7;b77#f777 offered to individuals entitled to medical assistance under title ,,xix of such ,act and other such ,medicare ,advantage plans4 7b7 ,consultation ,the ,secretary shall develop the report described in subsection 7a7 in consultation with relevant stakeholders1 including-- 7#a7 individuals entitled to benefits under part ,a or enrolled under part ,b of title ,,xviii of the ,social ,security ,act2 7#b7 entities who advocate on behalf of such individuals2 7#c7 ,medicare ,advantage organizations2 7#d7 pharmacy benefit managers2 and 7#e7 providers of services and suppliers 7as such terms are defined in section #ahfa of such ,act 7#db ,u4,s4,c4 #aciex774 7c7 ,contents ,the report described in subsection 7a7 shall include an analysis on the following3 7#a7 ,the extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of-- 7,a7 medication-assisted treatments for opioid use1 substance use disorder counseling1 peer recovery support services1 or other forms of substance use disorder treatments 7whether furnished in an inpatient or outpatient setting72 and 7,b7 non-opioid alternatives for the treatment of pain4 7#b7 ,challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph 7,a7 or 7,b7 of paragraph 7#a74 7#c7 ,the impact1 if any1 of increasing the applicable rebate percentage determined under section #ahed7;b77#a77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bd7;b77#a77;,c77 for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under ,medicare ,advantage plans4 7#d7 ,potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage4 #fjhe4 ,clinical psychologist services models under the ,center for ,medicare and ,medicaid ,innovation2 ,,gao study and report 7a7 ,,cmi models ,section #aaae;,a7b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b7 is amended by adding at the end the following new clauses3 7xxv7 ,supporting ways to familiarize individuals with the availability of coverage under part ,b of title ,,xviii for qualified psychologist services 7as defined in section #ahfa7;ii774 7xxvi7 ,exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services 7such as for treating depression7 through use of a #bd-;hour1 #g-;day a week help line that may inform individuals about the availability of treatment options1 including the availability of qualified psychologist services 7as defined in section #ahfa7;ii774 4 7b7 ,,gao study and report ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study1 and submit to ,congress a report1 on mental and behavioral health services under the ,medicare program under title ,,xviii of the ,social ,security ,act1 including an examination of the following3 7#a7 ,information about services furnished by psychiatrists1 clinical psychologists1 and other professionals4 7#b7 ,information about ways that ,medicare beneficiaries familiarize themselves about the availability of ,medicare payment for qualified psychologist services 7as defined in section #ahfa7;ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ii77 and ways that the provision of such information could be improved4 #fjhf4 ,pain management study 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the 8,secretary07 shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title ,,xviii of the ,social ,security ,act and submit to the ,committee on ,ways and ,means and the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,finance of the ,senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary1 evidence-based1 non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part ,a or enrolled under part ,b of title ,,xviii of the ,social ,security ,act4 ,the ,secretary shall make such report available on the public website of the ,centers for ,medicare ,medicaid ,services4 7b7 ,consultation ,in developing the report described in subsection 7a71 the ,secretary shall consult with-- 7#a7 relevant agencies within the ,department of ,health and ,human ,services2 7#b7 licensed and practicing osteopathic and allopathic physicians1 behavioral health practitioners1 physician assistants1 nurse practitioners1 dentists1 pharmacists1 and other providers of health services2 7#c7 providers and suppliers of services 7as such terms are defined in section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex772 7#d7 substance abuse and mental health professional organizations2 7#e7 pain management professional organizations and advocacy entities1 including individuals who personally suffer chronic pain2 7#f7 medical professional organizations and medical specialty organizations2 7#g7 licensed health care providers who furnish alternative pain management services2 7#h7 organizations with expertise in the development of innovative medical technologies for pain management2 7#i7 beneficiary advocacy organizations2 and 7#aj7 other organizations with expertise in the assessment1 diagnosis1 treatment1 and management of pain1 as determined appropriate by the ,secretary4 7c7 ,contents ,the report described in subsection 7a7 shall include the following3 7#a7 ,an analysis of payment and coverage under title ,,xviii of the ,social ,security ,act with respect to the following3 7,a7 ,evidence-based treatments and technologies for chronic or acute pain1 including such treatments that are covered1 not covered1 or have limited coverage under such title4 7,b7 ,evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids4 7,c7 ,evidence-based treatments and technologies that treat substance use disorders4 7,d7 ,items and services furnished by practitioners through a multi-disciplinary treatment model for pain management1 including the patient-centered medical home4 7,e7 ,medical devices1 non-opioid based drugs1 and other therapies 7including interventional and integrative pain therapies7 approved or cleared by the ,food and ,drug ,administration for the treatment of pain4 7,f7 ,items and services furnished to beneficiaries with psychiatric disorders1 substance use disorders1 or who are at risk of suicide1 or have comorbidities and require consultation or management of pain with one or more specialists in pain management1 mental health1 or addiction treatment4 7#b7 ,an evaluation of the following3 7,a7 ,barriers inhibiting individuals entitled to benefits under part ,a or enrolled under part ,b of such title from accessing treatments and technologies described in subparagraphs 7,a7 through 7,f7 of paragraph 7#a74 7,b7 ,costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain1 such as acupuncture1 therapeutic massage1 and items and services furnished by integrated pain management programs4 7,c7 ,pain management guidance published by the ,federal ,government that may be relevant to coverage determinations or other coverage requirements under title ,,xviii of the ,social ,security ,act4 7#c7 ,an assessment of all guidance published by the ,department of ,health and ,human ,services on or after ,january #a1 #bjaf1 relating to the prescribing of opioids4 ,such assessment shall consider incorporating into such guidance relevant elements of the ,va_/,do,d ,clinical ,practice ,guideline for ,opioid ,therapy for ,chronic ,pain published in ,february #bjag by the ,department of ,veterans ,affairs and ,department of ,defense1 including adoption of elements of the ,department of ,defense and ,department of ,veterans ,affairs pain rating scale4 7#d7 ,the options described in subsection 7d74 7#e7 ,the impact analysis described in subsection 7e74 7d7 ,options ,the options described in this subsection are1 with respect to individuals entitled to benefits under part ,a or enrolled under part ,b of title ,,xviii of the ,social ,security ,act1 legislative and administrative options for accomplishing the following3 7#a7 ,improving coverage of and payment for pain management therapies without the use of opioids1 including interventional pain therapies1 and options to augment opioid therapy with other clinical and complementary1 integrative health services to minimize the risk of substance use disorder1 including in a hospital setting4 7#b7 ,improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the ,food and ,drug ,administration for the treatment of pain as an alternative or augment to opioid therapy4 7#c7 ,improving and disseminating treatment strategies for beneficiaries with psychiatric disorders1 substance use disorders1 or who are at risk of suicide1 and treatment strategies to address health disparities related to opioid use and opioid abuse treatment4 7#d7 ,improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management1 mental health1 or addiction treatment1 including in a hospital setting4 7#e7 ,educating providers on risks of coadministration of opioids and other drugs1 particularly benzodiazepines4 7#f7 ,ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings1 or between opioid therapy to non-opioid therapy1 which may include the use of care transition plans4 7#g7 ,expanding outreach activities designed to educate providers of services and suppliers under the ,medicare program and individuals entitled to benefits under part ,a or under part ,b of such title on alternative1 non-opioid therapies to manage and treat acute and chronic pain4 7#h7 ,creating a beneficiary education tool on alternatives to opioids for chronic pain management4 7e7 ,impact analysis ,the impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection 7d7 would have-- 7#a7 on expenditures under the ,medicare program2 and 7#b7 on preventing or reducing opioid addiction for individuals receiving benefits under the ,medicare program4 ,j ,combating ,opioid ,abuse for ,care in ,hospitals #fjia4 ,short title ,this subtitle may be cited as the ,combating ,opioid ,abuse for ,care in ,hospitals ,act of #bjah or the ,,coach ,act of #bjah4 #fjib4 ,developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part ,a of the ,medicare program 7a7 ,in general ,not later than ,january #a1 #bjai1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall develop and publish on the public website of the ,centers for ,medicare ,medicaid ,services guidance for hospitals receiving payment under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part4 7b7 ,consultation ,in developing the guidance described in subsection 7a71 the ,secretary shall consult with relevant stakeholders1 including-- 7#a7 medical professional organizations2 7#b7 providers and suppliers of services 7as such terms are defined in section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex772 7#c7 health care consumers or groups representing such consumers2 and 7#d7 other entities determined appropriate by the ,secretary4 7c7 ,contents ,the guidance described in subsection 7a7 shall include1 with respect to hospitals and individuals described in such subsection1 the following3 7#a7 ,best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder1 including-- 7,a7 methods to identify such individuals at-risk of opioid use disorder1 including risk stratification2 7,b7 ways to prevent1 recognize1 and treat opioid overdoses2 and 7,c7 resources available to such individuals1 such as opioid treatment programs1 peer support groups1 and other recovery programs4 7#b7 ,best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders1 including education on-- 7,a7 the adverse effects of prolonged opioid use2 7,b7 non-opioid1 evidence-based1 non-pharmacological pain management treatments2 7,c7 monitoring programs for individuals who have been prescribed opioids2 and 7,d7 the prescribing of naloxone along with an initial opioid prescription4 7#c7 ,best practices for such hospitals to make such individuals aware of the risks associated with opioid use 7which may include use of the notification template described in paragraph 7#d774 7#d7 ,a notification template developed by the ,secretary1 for use as appropriate1 for such individuals who are prescribed an opioid that-- 7,a7 explains the risks and side effects associated with opioid use 7including the risks of addiction and overdose7 and the importance of adhering to the prescribed treatment regimen1 avoiding medications that may have an adverse interaction with such opioid1 and storing such opioid safely and securely2 7,b7 highlights multimodal and evidence-based non-opioid alternatives for pain management2 7,c7 encourages such individuals to talk to their health care providers about such alternatives2 7,d7 provides for a method 7through signature or otherwise7 for such an individual1 or person acting on such individual's behalf1 to acknowledge receipt of such notification template2 7,e7 is worded in an easily understandable manner and made available in multiple languages determined appropriate by the ,secretary2 and 7,f7 includes any other information determined appropriate by the ,secretary4 7#e7 ,best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital1 including-- 7,a7 ways for such hospital to establish target levels1 taking into account the specialties of such practitioners and the geographic area in which such hospital is located1 with respect to opioids prescribed by such practitioners2 7,b7 guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs2 7,c7 strategies to reduce long-term opioid prescriptions2 and 7,d7 methods to identify such practitioners who may be over-prescribing opioids4 7#f7 ,other information the ,secretary determines appropriate1 including any such information from the ,opioid ,safety ,initiative established by the ,department of ,veterans ,affairs or the ,opioid ,overdose ,prevention ,toolkit published by the ,substance ,abuse and ,mental ,health ,services ,administration4 #fjic4 ,requiring the review of quality measures relating to opioids and opioid use disorder treatments furnished under the medicare program and other federal health care programs 7a7 ,in general ,section #ahij;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa-#a7 is amended by adding at the end the following new subsection3 7g7 ,technical expert panel review of opioid and opioid use disorder quality measures 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this subsection1 the ,secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders1 including care1 prevention1 diagnosis1 health outcomes1 and treatment furnished to individuals with opioid use disorders4 ,the ,secretary may use the entity with a contract under section #ahij7;a7 and amend such contract as necessary to provide for the establishment of such technical expert panel4 7#b7 ,review and assessment ,not later than #a year after the date the technical expert panel described in paragraph 7#a7 is established 7and periodically thereafter as the ,secretary determines appropriate71 the technical expert panel shall-- 7,a7 review quality measures that relate to opioids and opioid use disorders1 including existing measures and those under development2 7,b7 identify gaps in areas of quality measurement that relate to opioids and opioid use disorders1 and identify measure development priorities for such measure gaps2 and 7,c7 make recommendations to the ,secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care1 prevention1 diagnosis1 health outcomes1 and treatment1 including recommendations for revisions of such measures1 need for development of new measures1 and recommendations for including such measures in the ,merit-,based ,incentive ,payment ,system under section #ahdh7q71 the alternative payment models under section #ahcc7z77#c77;,c71 the shared savings program under section #ahii1 the quality reporting requirements for inpatient hospitals under section #ahhf7;b77#c77;,b77viii71 and the hospital value-based purchasing program under section #ahhf7o74 7#c7 ,consideration of measures by secretary ,the ,secretary shall consider-- 7,a7 using opioid and opioid use disorder measures 7including measures used under the ,merit-,based ,incentive ,payment ,system under section #ahdh7q71 measures recommended under paragraph 7#b77;,c71 and other such measures identified by the ,secretary7 in alternative payment models under section #ahcc7z77#c77;,c7 and in the shared savings program under section #ahii2 and 7,b7 using opioid measures described in subparagraph 7,a71 as applicable1 in the quality reporting requirements for inpatient hospitals under section #ahhf7;b77#c77;,b77viii71and in the hospital value-based purchasing program under section #ahhf7o74 7#d7 ,prioritization of measure development ,the ,secretary shall prioritize for measure development the gaps in quality measures identified under paragraph 7#b77;,b74 4 7b7 ,expedited endorsement process for opioid measures ,section #ahij7;b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa7b77#b77 is amended by adding at the end the following new flush sentence3 ,such endorsement process shall1 as determined practicable by the entity1 provide for an expedited process with respect to the endorsement of such measures relating to opioids and opioid use disorders4 4 #fjid4 ,technical expert panel on reducing surgical setting opioid use2 ,data collection on perioperative opioid use 7a7 ,technical expert panel on reducing surgical setting opioid use 7#a7 ,in general ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a technical expert panel1 including medical and surgical specialty societies and hospital organizations1 to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management1 including with respect to the following3 7,a7 ,approaches that limit patient exposure to opioids during the perioperative period1 including pre-surgical and post-surgical injections1 and that identify such patients at risk of opioid use disorder pre-operation4 7,b7 ,shared decision making with patients and families on pain management1 including recommendations for the development of an evaluation and management code for purposes of payment under the ,medicare program under title ,,xviii of the ,social ,security ,act that would account for time spent on shared decision making4 7,c7 ,education on the safe use1 storage1 and disposal of opioids4 7,d7 ,prevention of opioid misuse and abuse after discharge4 7,e7 ,development of a clinical algorithm to identify and treat at-risk1 opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period4 7#b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall submit to ,congress and make public a report containing the recommendations developed under paragraph 7#a7 and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting4 7b7 ,data collection on perioperative opioid use ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report that contains the following3 7#a7 ,the diagnosis-related group codes identified by the ,secretary as having the highest volume of surgeries4 7#b7 ,with respect to each of such diagnosis-related group codes so identified1 a determination by the ,secretary of the data that is both available and reported on opioid use following such surgeries1 such as with respect to-- 7,a7 surgical volumes1 practices1 and opioid prescribing patterns2 7,b7 opioid consumption1 including-- 7i7 perioperative days of therapy2 7ii7 average daily dose at the hospital1 including dosage greater than #ij milligram morphine equivalent2 7iii7 post-discharge prescriptions and other combination drugs that are used before intervention and after intervention2 7iv7 quantity and duration of opioid prescription at discharge2 and 7v7 quantity consumed and number of refills2 7,c7 regional anesthesia and analgesia practices1 including pre-surgical and post-surgical injections2 7,d7 naloxone reversal2 7,e7 post-operative respiratory failure2 7,f7 information about storage and disposal2 and 7,g7 such other information as the ,secretary may specify4 7#c7 ,recommendations for improving data collection on perioperative opioid use1 including an analysis to identify and reduce barriers to collecting1 reporting1 and analyzing the data described in paragraph 7#b71 including barriers related to technological availability4 #fjie4 ,requiring the posting and periodic update of opioid prescribing guidance for ,medicare beneficiaries 7a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall post on the public website of the ,centers for ,medicare ,medicaid ,services all guidance published by the ,department of ,health and ,human ,services on or after ,january #a1 #bjaf1 relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 or enrolled under part ,b of such title of such ,act 7#db ,u4,s4,c4 #acie;j et seq474 7b7 ,update of guidance 7#a7 ,periodic update ,the ,secretary shall1 in consultation with the entities specified in paragraph 7#b71 periodically 7as determined appropriate by the ,secretary7 update guidance described in subsection 7a7 and revise the posting of such guidance on the website described in such subsection4 7#b7 ,consultation ,the entities specified in this paragraph are the following3 7,a7 ,medical professional organizations4 7,b7 ,providers and suppliers of services 7as such terms are defined in section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex774 7,c7 ,health care consumers or groups representing such consumers4 7,d7 ,other entities determined appropriate by the ,secretary4 ,k ,stop ,excessive ,narcotics in our ,retirement ,communities ,protection #faja4 ,short title ,this subtitle may be cited as the ,stop ,excessive ,narcotics in our ,retirement ,communities ,protection ,act of #bjah or the ,,senior ,communities ,protection ,act of #bjah4 #fajb4 ,suspension of payments by ,medicare prescription drug plans and ,,ma-,,pd plans pending investigations of credible allegations of fraud by pharmacies 7a7 ,in general ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#g7 ,suspension of payments pending investigation of credible allegations of fraud by pharmacies 7,a7 ,in general ,the provisions of section #ahfb7o7 shall apply with respect to a ,,pdp sponsor with a contract under this part1 a pharmacy1 and payments to such pharmacy under this part in the same manner as such provisions apply with respect to the ,secretary1 a provider of services or supplier1 and payments to such provider of services or supplier under this title4 7,b7 ,rule of construction ,nothing in this paragraph shall be construed as limiting the authority of a ,,pdp sponsor to conduct postpayment review4 4 7b7 ,application to ,,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,d7 ,suspension of payments pending investigation of credible allegations of fraud by pharmacies ,section #ahfj;,d-#ab7;b77#g74 4 7c7 ,conforming amendment ,section #ahfb7o77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7o77#c77 is amended by inserting 1 section #ahfj;,d-#ab7;b77#g7 7including as applied pursuant to section #aheg7;f77#c77;,d771 after this subsection4 7d7 ,clarification relating to credible allegation of fraud ,section #ahfb7o7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7o77 is amended by adding at the end the following new paragraph3 7#d7 ,credible allegation of fraud ,in carrying out this subsection1 section #ahfj;,d-#ab7;b77#g7 7including as applied pursuant to section #aheg7;f77#c77;,d771 and section #aijc7;i77#b77;,c71 a fraud hotline tip 7as defined by the ,secretary7 without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud4 4 7e7 ,effective date ,the amendments made by this section shall apply with respect to plan years beginning on or after ,january #a1 #bjbj4 ,l ,providing ,reliable ,options for ,patients and ,educational ,resources #faaa4 ,short title ,this subtitle may be cited as the ,providing ,reliable ,options for ,patients and ,educational ,resources ,act of #bjah or the ,,proper ,act of #bjah4 #faab4 ,requiring ,medicare ,advantage plans and part ,d prescription drug plans to include information on risks associated with opioids and coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain ,section #ahfj;,d-#d7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77 is amended-- 7#a7 in subparagraph 7,a71 by inserting 1 subject to subparagraph 7,c71 before including2 7#b7 in subparagraph 7,b71 by adding at the end the following new clause3 7vi7 ,for plan year #bjba and each subsequent plan year1 subject to subparagraph 7,c71 with respect to the treatment of pain-- 7,i7 the risks associated with prolonged opioid use2 and 7,,ii7 coverage of nonpharmacological therapies1 devices1 and nonopioid medications-- 7aa7 in the case of an ,,ma-,,pd plan under part ,c1 under such plan2 and 7bb7 in the case of a prescription drug plan1 under such plan and under parts ,a and ,b4 2 and 7#c7 by adding at the end the following new subparagraph3 7,c7 ,targeted provision of information ,a ,,pdp sponsor of a prescription drug plan may1 in lieu of disclosing the information described in subparagraph 7,b77vi7 to each enrollee under the plan1 disclose such information through mail or electronic communications to a subset of enrollees under the plan1 such as enrollees who have been prescribed an opioid in the previous #b-year period4 4 #faac4 ,requiring ,medicare ,advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs 7a7 ,medicare ,advantage ,section #aheb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7 is amended by adding at the end the following new subsection3 7n7 ,provision of information relating to the safe disposal of certain prescription drugs 7#a7 ,in general ,in the case of an individual enrolled under an ,,ma or ,,ma-,,pd plan who is furnished an in-home health risk assessment on or after ,january #a1 #bjba1 such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph 7#b74 ,such information shall include information on drug takeback programs that meet such requirements determined appropriate by the ,secretary and information on in-home disposal4 7#b7 ,criteria ,the ,secretary shall1 through rulemaking1 establish criteria the ,secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances4 4 7b7 ,prescription drug plans ,section #ahfj;,d-#d7;c77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#b77;,b77 is amended-- 7#a7 by striking may include elements that promote2 7#b7 by redesignating clauses 7i7 through 7iii7 as subclauses 7,i7 through 7,,iii7 and adjusting the margins accordingly2 7#c7 by inserting before subclause 7,i71 as so redesignated1 the following new clause3 7i7 may include elements that promote-- 2 7#d7 in subclause 7,,iii71 as so redesignated1 by striking the period at the end and inserting 2 and2 and 7#e7 by adding at the end the following new clause3 7ii7 with respect to plan years beginning on or after ,january #a1 #bjba1 shall provide for-- 7,i7 the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section #aheb7n77#b71 including information on drug takeback programs that meet such requirements determined appropriate by the ,secretary and information on in-home disposal2 and 7,,ii7 cost-effective means by which an enrollee may so safely dispose of such drugs4 4 #faad4 ,revising measures used under the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey relating to pain management 7a7 ,restriction on the use of pain questions in ,,hcahps ,section #ahhf7;b77#c77;,b77viii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77viii77 is amended by adding at the end the following new subclause3 7,,xii7 7aa7 ,with respect to a ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey 7or a successor survey7 conducted on or after ,january #a1 #bjai1 such survey may not include questions about communication by hospital staff with an individual about such individual's pain unless such questions take into account1 as applicable1 whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain4 7bb7 ,the ,secretary shall not include on the ,hospital ,compare ,internet website any measures based on the questions appearing on the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey in #bjah about communication by hospital staff with an individual about such individual's pain4 4 7b7 ,restriction on use of #bjah pain questions in the hospital value-based purchasing program ,section #ahhf7o77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o77#b77;,b77 is amended by adding at the end the following new clause3 7iii7 ,,hcahps pain questions ,the ,secretary may not include under subparagraph 7,a7 a measure that is based on the questions appearing on the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey in #bjah about communication by hospital staff with an individual about the individual's pain4 4 ,,vii ,other ,health ,provisions ,a ,synthetic ,drug ,awareness #gjja4 ,short title ,this subtitle may be cited as the ,synthetic ,drug ,awareness ,act of #bjah4 #gjjb4 ,report on effects on public health of synthetic drug use 7a7 ,in general ,not later than #c years after the date of the enactment of this ,act1 the ,surgeon ,general of the ,public ,health ,service shall submit to ,congress a report on the health effects of new psychoactive substances 7including synthetic drugs7 used since ,january #bjaj by persons who are at least #ab years of age but no more than #ah years of age4 7b7 ,new psychoactive substance defined ,for purposes of subsection 7a71 the term new psychoactive substance means a controlled substance analogue 7as defined in section #ajb7cb7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7cb774 ,b ,empowering ,pharmacists in the ,fight ,against ,opioid ,abuse #gjaa4 ,short title ,this subtitle may be cited as the ,empowering ,pharmacists in the ,fight ,against ,opioid ,abuse ,act4 #gjab4 ,programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription 7a7 ,in general ,not later than #a 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 the ,commissioner of ,food and ,drugs1 the ,director of the ,centers for ,disease ,control and ,prevention1 and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 shall develop and disseminate programs and materials for training pharmacists1 health care providers1 and patients on-- 7#a7 circumstances under which a pharmacist may1 consistent with section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 and regulations thereunder1 including section #acjf4jd of title #ba1 ,code of ,federal ,regulations1 decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent1 forged1 or otherwise indicative of abuse or diversion2 and 7#b7 any ,federal requirements pertaining to declining to fill a prescription under such circumstances4 7b7 ,materials included ,in developing materials under subsection 7a71 the ,secretary of ,health and ,human ,services shall include information educating-- 7#a7 pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription2 and 7#b7 other health care practitioners and the public on a pharmacist's responsibility to decline to fill prescriptions in certain circumstances4 7c7 ,stakeholder input ,in developing the programs and materials required under subsection 7a71 the ,secretary of ,health and ,human ,services shall seek input from relevant national1 ,state1 and local associations1 boards of pharmacy1 medical societies1 licensing boards1 health care practitioners1 and patients4 ,c ,indexing ,narcotics1 ,fentanyl1 and ,opioids #gjba4 ,short title ,this subtitle may be cited as the ,indexing ,narcotics1 ,fentanyl1 and ,opioids ,act of #bjah or the ,,info ,act4 #gjbb4 ,establishment of substance use disorder information dashboard ,title ,,xvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjju et seq47 is amended by adding at the end the following new section3 #agaa4 ,establishment of substance use disorder information dashboard 7a7 ,in general ,not later than #f months after the date of the enactment of this section1 the ,secretary of ,health and ,human ,services shall1 in consultation with the ,director of ,national ,drug ,control ,policy1 establish and periodically update a public information dashboard that-- 7#a7 coordinates information on programs within the ,department of ,health and ,human ,services related to the reduction of opioid abuse and other substance use disorders2 7#b7 provides access to publicly available data from other ,federal agencies2 ,state1 local1 and ,tribal governments2 nonprofit organizations2 law enforcement2 medical experts2 public health educators2 and research institutions regarding prevention1 treatment1 recovery1 and other services for opioid use disorder and other substance use disorders2 7#c7 provides comparable data on substance use disorder prevention and treatment strategies in different regions and population of the ,united ,states2 7#d7 provides recommendations for health care providers on alternatives to controlled substances for pain management1 including approaches studied by the ,national ,institutes of ,health ,pain ,consortium and the ,national ,center for ,complimentary and ,integrative ,health2 and 7#e7 provides guidelines and best practices for health care providers regarding treatment of substance use disorders4 7b7 ,controlled substance defined ,in this section1 the term controlled substance has the meaning given that term in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74 4 #gjbc4 ,interagency ,substance ,use ,disorder ,coordinating ,committee 7a7 ,establishment ,not later than #c months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall1 in consultation with the ,director of ,national ,drug ,control ,policy1 establish a committee1 to be known as the ,interagency ,substance ,use ,disorder ,coordinating ,committee 7in this section referred to as the ,committee 71 to coordinate all efforts within the ,department of ,health and ,human ,services concerning substance use disorder4 7b7 ,membership 7#a7 ,federal members ,the following individuals shall be the ,federal members of the ,committee3 7,a7 ,the ,secretary1 who shall service as the ,chair of the ,committee4 7,b7 ,the ,attorney ,general of the ,united ,states4 7,c7 ,the ,secretary of ,labor4 7,d7 ,the ,secretary of ,housing and ,urban ,development4 7,e7 ,the ,secretary of ,education4 7,f7 ,the ,secretary of ,veterans ,affairs4 7,g7 ,the ,commissioner of ,social ,security4 7,h7 ,the ,assistant ,secretary for ,mental ,health and ,substance ,use4 7,i7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,j7 ,the ,director of the ,national ,institutes of ,health and the ,directors of such national research institutes of the ,national ,institutes of ,health as the ,secretary determines appropriate4 7,k7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7,l7 ,the ,director of ,national ,drug ,control ,policy4 7,m7 ,representatives of other ,federal agencies that serve individuals with substance use disorder4 7#b7 ,non-,federal members ,the ,committee shall include a minimum of #ag non-,federal members appointed by the ,secretary1 of which-- 7,a7 at least two such members shall be an individual who has received treatment for a diagnosis of an opioid use disorder2 7,b7 at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder other than an opioid use disorder2 7,c7 at least two such members shall be a ,state ,alcohol and ,substance ,abuse ,director2 7,d7 at least two such members shall be a representative of a leading research1 advocacy1 or service organization for adults with substance use disorder2 7,e7 at least two such members shall-- 7i7 be a physician1 licensed mental health professional1 advance practice registered nurse1 or physician assistant2 and 7ii7 have experience in treating individuals with opioid use disorder or other substance use disorders2 7,f7 at least one such member shall be a substance use disorder treatment professional who is employed with an opioid treatment program2 7,g7 at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations2 7,h7 at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations2 7,i7 at least one such member shall be a ,state-certified substance use disorder peer support specialist2 7,j7 at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder2 7,k7 at least one such member shall be a law enforcement officer or correctional officer with extensive experience in interacting with adults with a substance use disorder2 and 7,l7 at least one such member shall be an individual with experience providing services for homeless individuals and working with adults with a substance use disorder4 7c7 ,terms 7#a7 ,in general ,a member of the ,committee appointed under subsection 7b77#b7 shall be appointed for a term of #c years and may be reappointed for one or more #c-year terms4 7#b7 ,vacancies ,a vacancy on the ,committee shall be filled in the same manner in which the original appointment was made4 ,any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed4 7d7 ,meetings ,the ,committee shall meet not fewer than two times each year4 7e7 ,duties ,the ,committee shall-- 7#a7 monitor opioid use disorder and other substance use disorder research1 services1 and support and prevention activities across all relevant ,federal agencies1 including coordination of ,federal activities with respect to opioid use disorder and other substance use disorders2 7#b7 identify and provide to the ,secretary recommendations for improving ,federal grants and programs for the prevention and treatment of1 and recovery from1 opioid use disorder and other substance use disorders2 7#c7 review substance use disorder prevention and treatment strategies in different regions and populations in the ,united ,states and evaluate the extent to which ,federal substance use disorder prevention and treatment strategies are aligned with ,state and local substance use disorder prevention and treatment strategies2 7#d7 make recommendations to the ,secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs 7#a7 through 7#c72 7#e7 make recommendations to the ,secretary regarding public participation in decisions relating to opioid use disorder and other substance use disorders and the process by which public feedback can be better integrated into such decisions2 and 7#f7 make recommendations to ensure that opioid use disorder and other substance use disorder research1 services1 and support and prevention activities of the ,department of ,health and ,human ,services and other ,federal agencies are not unnecessarily duplicative4 7f7 ,annual report 7#a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 and annually thereafter for the life of the ,committee1 the ,committee shall publish on the public information dashboard established under section #gjbb7;a7 a report summarizing the activities carried out by the ,committee pursuant to subsection 7e71 including any findings resulting from such activities4 7#b7 ,recommendation for ,committee extension ,after the publication of the second report of the ,committee under paragraph 7#a71 the ,secretary shall submit to ,congress a recommendation on whether or not the operations of the ,committee should continue after the termination date described in subsection 7i74 7g7 ,working groups ,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 enable the working group to carry out the duties delegated to the working group4 7h7 ,federal ,advisory ,committee ,act ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,committee only to the extent that the provisions of such ,act do not conflict with the requirements of this section4 7i7 ,sunset ,the ,committee shall terminate on the date that is #f years after the date on which the ,committee is established under subsection 7a74 ,d ,ensuring ,access to ,quality ,sober ,living #gjca4 ,short title ,this subtitle may be cited as the ,ensuring ,access to ,quality ,sober ,living ,act of #bjah4 #gjcb4 ,national recovery housing best practices ,part ,p of title ,,iii of the ,public ,health ,service ,act is amended by adding at the end the following new section3 #cii,v-#g4 ,national recovery housing best practices 7a7 ,best practices ,the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary for ,housing and ,urban ,development1 patients with a history of opioid use disorder1 and other stakeholders1 which may include ,state accrediting entities and reputable providers1 analysts1 and stakeholders of recovery housing services1 such as the ,national ,alliance for ,recovery ,residences1 shall identify or facilitate the development of best practices1 which may include model laws for implementing suggested minimum standards1 for operating recovery housing4 7b7 ,dissemination ,the ,secretary shall disseminate the best practices identified or developed under subsection 7a7 to-- 7#a7 ,state agencies1 which may include the provision of technical assistance to ,state agencies seeking to adopt or implement such best practices2 7#b7 recovery housing entities2 and 7#c7 the public1 as appropriate4 7c7 ,definitions ,in this section3 7#a7 ,the term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services1 including medication-assisted treatment services1 that promote sustained recovery from substance use disorders4 7#b7 ,the term ,state includes any of the several ,states1 the ,district of ,columbia1 each ,indian tribe or tribal organization 7as those terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 and any territory or possession of the ,united ,states4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #c1jjj1jjj for the period of fiscal years #bjai through #bjba4 4 ,e ,advancing ,cutting ,edge ,research #gjda4 ,short title ,this subtitle may be cited as the ,advancing ,cutting ,edge ,research ,act or the ,,ace ,research ,act4 #gjdb4 ,unique research initiatives ,section #djb7n77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7n77#a77 is amended-- 7#a7 in subparagraph 7,a71 by striking or2 7#b7 in subparagraph 7,b71 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7,c7 high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention1 diagnosis1 or treatment of diseases and disorders1 or research urgently required to respond to a public health threat4 4 ,f ,jessie's ,law #gjea4 ,short title ,this subtitle may be cited as ,jessie's ,law4 #gjeb4 ,inclusion of opioid addiction history in patient records 7a7 ,best practices 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with appropriate stakeholders1 including a patient with a history of opioid use disorder1 an expert in electronic health records1 an expert in the confidentiality of patient health information and records1 and a health care provider1 shall identify or facilitate the development of best practices regarding-- 7,a7 the circumstances under which information that a patient has provided to a health care provider regarding such patient's history of opioid use disorder should1 only at the patient's request1 be prominently displayed in the medical records 7including electronic health records7 of such patient2 7,b7 what constitutes the patient's request for the purpose described in subparagraph 7,a72 and 7,c7 the process and methods by which the information should be so displayed4 7#b7 ,dissemination ,the ,secretary shall disseminate the best practices developed under paragraph 7#a7 to health care providers and ,state agencies4 7b7 ,requirements ,in identifying or facilitating the development of best practices under subsection 7a71 as applicable1 the ,secretary1 in consultation with appropriate stakeholders1 shall consider the following3 7#a7 ,the potential for addiction relapse or overdose1 including overdose death1 when opioid medications are prescribed to a patient recovering from opioid use disorder4 7#b7 ,the benefits of displaying information about a patient's opioid use disorder history in a manner similar to other potentially lethal medical concerns1 including drug allergies and contraindications4 7#c7 ,the importance of prominently displaying information about a patient's opioid use disorder when a physician or medical professional is prescribing medication1 including methods for avoiding alert fatigue in providers4 7#d7 ,the importance of a variety of appropriate medical professionals1 including physicians1 nurses1 and pharmacists1 to have access to information described in this section when prescribing or dispensing opioid medication1 consistent with ,federal and ,state laws and regulations4 7#e7 ,the importance of protecting patient privacy1 including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations4 7#f7 ,all applicable ,federal and ,state laws and regulations4 #gjec4 ,communication with families during emergencies 7a7 ,promoting awareness of authorized disclosures during emergencies ,the ,secretary of ,health and ,human ,services1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,administrator of the ,health ,resources and ,services ,administration1 shall annually develop and disseminate written materials 7electronically or by other means7 to health care providers regarding permitted disclosures under ,federal health care privacy law during emergencies1 including overdoses1 of certain health information to families1 caregivers1 and health care providers4 7b7 ,use of material ,for the purposes of carrying out subsection 7a71 the ,secretary of ,health and ,human ,services may use material produced under section #aajjd of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #acbj;d-#b note74 ,g ,safe ,disposal of ,unused ,medication #gjfa4 ,short title ,this subtitle may be cited as the ,safe ,disposal of ,unused ,medication ,act4 #gjfb4 ,disposal of controlled substances of a deceased hospice patient by employees of a qualified hospice program ,subsection 7g7 of section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by adding at the end the following3 7#e7 7,a7 ,in the case of a person receiving hospice care1 an employee of a qualified hospice program1 acting within the scope of employment1 may handle1 without being registered under this section1 any controlled substance that was lawfully dispensed to the person receiving hospice care1 for the purpose of disposal of the controlled substance after the death of such person1 so long as such disposal occurs onsite in accordance with all applicable ,federal1 ,state1 ,tribal1 and local law4 7,b7 ,for the purposes of this paragraph3 7i7 ,the terms hospice care and hospice program have the meanings given to those terms in section #ahfa7;dd7 of the ,social ,security ,act4 7ii7 ,the term employee of a qualified hospice program means a physician1 nurse1 or other person who-- 7,i7 is employed by1 or pursuant to arrangements made by1 a qualified hospice program2 7,,ii7 7aa7 is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located2 and 7bb7 is acting within the scope of such employment in accordance with applicable ,state law2 and 7,,iii7 has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse1 misuse1 or diversion4 7iii7 ,the term qualified hospice program means a hospice program that-- 7,i7 has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person's death2 7,,ii7 at the time when the controlled substances are first ordered-- 7aa7 provides a copy of the written policies and procedures to the patient or patient representative and family2 7bb7 discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances2 and 7cc7 documents in the patient's clinical record that the written policies and procedures were provided and discussed2 and 7,,iii7 at the time following the disposal of the controlled substances-- 7aa7 documents in the patient's clinical record the type of controlled substance1 dosage1 route of administration1 and quantity so disposed2 and 7bb7 the time1 date1 and manner in which that disposal occurred4 4 ,h ,substance ,use ,disorder ,workforce ,loan ,repayment #gjga4 ,short title ,this subtitle may be cited as the ,substance ,use ,disorder ,workforce ,loan ,repayment ,act of #bjah4 #gjgb4 ,loan repayment program for substance use disorder treatment employees ,title ,,vii of the ,public ,health ,service ,act is amended-- 7#a7 by redesignating part ,f as part ,g2 and 7#b7 by inserting after part ,e 7#db ,u4,s4,c4 #bidn et seq47 the following3 ,f ,substance use disorder treatment employees #gha4 ,loan repayment program for substance use disorder treatment employees 7a7 ,in general ,the ,secretary1 acting through the ,administrator of the ,health ,resources and ,services ,administration1 shall carry out a program under which-- 7#a7 the ,secretary enters into agreements with individuals to make payments in accordance with subsection 7b7 on the principal of and interest on any eligible loan2 and 7#b7 the individuals each agree to complete a period of service in a substance use disorder treatment job1 as described in subsection 7d74 7b7 ,payments ,for each year of obligated service by an individual pursuant to an agreement under subsection 7a71 the ,secretary shall make a payment to such individual as follows3 7#a7 ,service in a shortage area ,the ,secretary shall pay-- 7,a7 for each year of obligated service by an individual pursuant to an agreement under subsection 7a71 #a_/f of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement2 and 7,b7 for completion of the sixth and final year of such service1 the remainder of such principal and interest4 7#b7 ,maximum amount ,the total amount of payments under this section to any individual shall not exceed #bej1jjj4 7c7 ,eligible loans ,the loans eligible for repayment under this section are each of the following3 7#a7 ,any loan for education or training for a substance use disorder treatment job4 7#b7 ,any loan under part ,e of title ,,viii 7relating to nursing student loans74 7#c7 ,any ,federal ,direct ,stafford ,loan1 ,federal ,direct ,,plus ,loan1 or ,federal ,direct ,unsubsidized ,stafford ,loan1 or ,federal ,direct ,consolidation ,loan 7as such terms are used in section #dee of the ,higher ,education ,act of #aife74 7#d7 ,any ,federal ,perkins ,loan under part ,e of title ,i of the ,higher ,education ,act of #aife4 7#e7 ,any other ,federal loan as determined appropriate by the ,secretary4 7d7 ,period of service ,the period of service required by an agreement under subsection 7a7 shall consist of up to #f years of full-time employment1 with no more than #a year passing between any #b years of covered employment1 in a substance use disorder treatment job in the ,united ,states in-- 7#a7 a ,mental ,health ,professional ,shortage ,area1 as designated under section #ccb2 or 7#b7 a county 7or a municipality1 if not contained within any county7 where the mean drug overdose death rate per #ajj1jjj people over the past #c years for which official data is available from the ,state1 is higher than the most recent available national average overdose death rate per #ajj1jjj people1 as reported by the ,centers for ,disease ,control and ,prevention4 7e7 ,ineligibility for double benefits ,no borrower may1 for the same service1 receive a reduction of loan obligations or a loan repayment under both-- 7#a7 this subsection2 and 7#b7 any ,federally supported loan forgiveness program1 including under section #cch;,b1 #cch;,i1 or #hdf of this ,act1 or section #dbh;,j1 #dbh,l1 #dee7m71 or #dfj of the ,higher ,education ,act of #aife4 7f7 ,breach 7#a7 ,liquidated damages formula ,the ,secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection 7a74 7#b7 ,limitation ,the failure by an individual to complete the full period of service obligated pursuant to such an agreement1 taken alone1 shall not constitute a breach of the agreement1 so long as the individual completed in good faith the years of service for which payments were made to the individual under this section4 7g7 ,additional criteria ,the ,secretary-- 7#a7 may establish such criteria and rules to carry out this section as the ,secretary determines are needed and in addition to the criteria and rules specified in this section2 and 7#b7 shall give notice to the committees specified in subsection 7h7 of any criteria and rules so established4 7h7 ,report to ,congress ,not later than #e years after the date of enactment of the ,substance ,use ,disorder ,workforce ,loan ,repayment ,act of #bjah1 and every other year thereafter1 the ,secretary shall prepare and 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-- 7#a7 the number and location of borrowers who have qualified for loan repayments under this section2 and 7#b7 the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection 7d74 7i7 ,definition ,in this section3 7#a7 ,the term municipality means a city1 town1 or other public body created by or pursuant to ,state law1 or an ,indian ,tribe4 7#b7 ,the term substance use disorder treatment job means a full-time job 7including a fellowship7-- 7,a7 where the primary intent and function of the job is the direct treatment or recovery support of patients with or in recovery from a substance use disorder1 such as a physician1 physician assistant1 registered nurse1 nurse practitioner1 advanced practice registered nurse1 social worker1 recovery coach1 mental health counselor1 addictions counselor1 psychologist or other behavioral health professional1 or any other relevant professional as determine by the ,secretary2 and 7,b7 which is located at a substance use disorder treatment program1 private physician practice1 hospital or health system-affiliated inpatient treatment center or outpatient clinic 7including an academic medical center-affiliated treatment program71 correctional facility or program1 youth detention center or program1 inpatient psychiatric facility1 crisis stabilization unit1 community health center1 community mental health or other specialty community behavioral health center1 recovery center1 school1 community-based organization1 telehealth platform1 migrant health center1 health program or facility operated by a tribe or tribal organization1 ,federal medical facility1 or any other facility as determined appropriate for purposes of this section by the ,secretary4 7j7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #be1jjj1jjj for each of fiscal years #bjai through #bjbh4 4 ,i ,preventing ,overdoses ,while in ,emergency ,rooms #gjha4 ,short title ,this subtitle may be cited as the ,preventing ,overdoses ,while in ,emergency ,rooms ,act of #bjah4 #gjhb4 ,program to support emergency room discharge and care coordination for drug overdose patients 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall establish a program 7in this subtitle referred to as the ,program7 to develop protocols for discharging patients who have presented with a drug overdose and enhance the integration and coordination of care and treatment options for individuals with substance use disorder after discharge4 7b7 ,grant establishment and participation 7#a7 ,in general ,in carrying out the ,program1 the ,secretary shall award grants on a competitive basis to not more than #bj eligible entities described in paragraph 7#b74 7#b7 ,eligibility 7,a7 ,in general ,to be eligible for a grant under this subsection1 an entity shall be-- 7i7 a health care site described in subparagraph 7,b72 or 7ii7 a health care site coordinator described in subparagraph 7,c74 7,b7 ,health care sites ,to be eligible for a grant under this section1 a health care site shall-- 7i7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as specified by the ,secretary2 7ii7 have an emergency department2 7iii7 7,i7 have a licensed health care professional onsite who has a waiver under section #cjc7;g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77 to dispense or prescribe covered drugs2 or 7,,ii7 have a demonstrable plan to hire a sufficient number of full-time licensed health care professionals who have waivers described in subclause 7,i7 to administer such treatment onsite2 7iv7 have in place an agreement with a sufficient number and range of entities certified under applicable ,state and ,federal law1 such as pursuant to registration or a waiver under section #cjc7;g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77 or certification as described in section #h4b of title #db of the ,code of ,federal ,regulations1 to provide treatment for substance use disorder such that the entity or the resulting network of entities with an agreement with the hospital cumulatively are capable of providing all evidence-based services for the treatment of substance use disorder1 as medically appropriate for the individual involved1 including-- 7,i7 medication-assisted treatment2 7,,ii7 withdrawal and detoxification services that include patient evaluation1 stabilization1 and readiness for and entry into treatment2 and 7,,iii7 counseling2 7v7 deploy onsite peer recovery specialists to help connect patients with treatment and recovery support services2 and 7vi7 include the provision of overdose reversal medication in discharge protocols for opioid overdose patients4 7,c7 ,health care site coordinators ,to be eligible for a grant under this section1 a health care site coordinator shall-- 7i7 be an organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf 7and exempt from tax under section #eja7;a7 of such ,code7 or a ,state1 local1 or ,tribal government2 7ii7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as specified by the ,secretary2 and 7iii7 have an agreement with multiple eligible health care sites described in subparagraph 7,b74 7#c7 ,preference ,in awarding grants under this section1 the ,secretary may give preference to eligible entities described in paragraph 7#b7 that meet either or both of the following criteria3 7,a7 ,the eligible health care site is1 or the eligible health care site coordinator has an agreement described in paragraph 7#b77;,c77iii7 with a site that is1 a critical access hospital 7as defined in section #ahfa7mm77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7mm77#a7771 a low-volume hospital 7as defined in section #ahhf7;d77#ab77;,c77i7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#ab77;,c77i7771 or a sole community hospital 7as defined in section #ahhf7;d77#e77;,d77iii7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,d77iii7774 7,b7 ,the eligible health care site or the eligible health care site coordinator is located in a geographic area with a drug overdose rate that is higher than the national rate1 or in a geographic area with a rate of emergency department visits for overdoses that is higher than the national rate1 as determined by the ,secretary based on the most recent data from the ,centers for ,disease ,control and ,prevention4 7#d7 ,medication-assisted treatment defined ,for purposes of this section1 the term medication-assisted treatment means the use of a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 in combination with behavioral health services1 to provide an individualized approach to the treatment of substance use disorders1 including opioid use disorders4 7c7 ,period of grant ,a grant awarded to an eligible entity under this section shall be for a period of at least #b years4 7d7 ,grant uses 7#a7 ,required uses ,a grant awarded under this section to an eligible entity shall be used for both of the following purposes3 7,a7 ,to establish policies and procedures that address the provision of overdose reversal medication1 prescription and dispensing of medication-assisted treatment to an emergency department patient who has had a non-fatal overdose or who is at risk of a drug overdose1 and the subsequent referral to evidence-based treatment upon discharge for patients who have experienced a non-fatal drug overdose or who are at risk of a drug overdose4 7,b7 ,to develop best practices for treating non-fatal drug overdoses1 including with respect to care coordination and integrated care models for long term treatment and recovery options for individuals who have experienced a non-fatal drug overdose4 7#b7 ,additional permissible uses ,a grant awarded under this section to an eligible entity may be used for any of the following purposes3 7,a7 ,to hire emergency department peer recovery specialists2 counselors2 therapists2 social workers2 or other licensed medical professionals specializing in the treatment of substance use disorder4 7,b7 ,to establish integrated models of care for individuals who have experienced a non-fatal drug overdose which may include patient assessment1 follow up1 and transportation to treatment facilities4 7,c7 ,to provide for options for increasing the availability and access of medication-assisted treatment and other evidence-based treatment for individuals with substance use disorders4 7,d7 ,to offer consultation with and referral to other supportive services that help in treatment and recovery4 7e7 ,reporting requirements 7#a7 ,reports by grantees ,each eligible entity awarded a grant under this section shall submit to the ,secretary an annual report for each year for which the entity has received such grant that includes information on-- 7,a7 the number of individuals treated at the site 7or1 in the case of an eligible health care site coordinator1 at sites covered by the agreement referred to in subsection 7b77#b77;,c77iii77 for non-fatal overdoses in the emergency department2 7,b7 the number of individuals administered each medication-assisted treatment at such site or sites in the emergency department2 7,c7 the number of individuals referred by such site or sites to other treatment facilities after a non-fatal overdose1 the types of such other facilities1 and the number of such individuals admitted to such other facilities pursuant to such referrals2 7,d7 the frequency and number of patient readmissions for non-fatal overdoses and substance use disorder2 7,e7 for what the grant funding was used2 and 7,f7 the effectiveness of1 and any other relevant additional data regarding1 having an onsite health care professional to administer and begin medication-assisted treatment for substance use disorders4 7#b7 ,report by ,secretary ,not less than #a year after the conclusion of the ,program1 the ,secretary shall submit to ,congress a report that includes-- 7,a7 findings of the ,program2 7,b7 overall patient outcomes under the ,program1 such as with respect to hospital readmission2 7,c7 what percentage of patients treated by a site funded through a grant under this section were readmitted to a hospital for non-fatal or fatal overdose2 7,d7 an evaluation determining the effectiveness of having a practitioner onsite to administer and begin medication-assisted treatment for substance use disorder2 and 7,e7 a compilation of voluntary guidelines and best practices from the reports submitted under paragraph 7#a74 7f7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subtitle #ej1jjj1jjj for the period of fiscal years #bjai through #bjbc4 ,j ,alternatives to ,opioids in the ,emergency ,department #gjia4 ,short title ,this subtitle may be cited as the ,alternatives to ,opioids in the ,emergency ,department ,act or the ,,alto ,act4 #gjib4 ,emergency department alternatives to opioids demonstration program 7a7 ,demonstration program grants ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall carry out a demonstration program under which the ,secretary shall award grants to hospitals and emergency departments1 including freestanding emergency departments1 to develop1 implement1 enhance1 or study alternative pain management protocols and treatments that limit the use and prescription of opioids in emergency departments4 7b7 ,eligibility ,to be eligible to receive a grant under subsection 7a71 a hospital or emergency department shall submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 7c7 ,geographic diversity ,in awarding grants under this section1 the ,secretary shall seek to ensure geographical diversity among grant recipients4 7d7 ,use of funds ,grants under subsection 7a7 shall be used to-- 7#a7 target common painful conditions1 such as renal colic1 sciatica1 headaches1 musculoskeletal pain1 and extremity fractures2 7#b7 train providers and other hospital personnel on protocols and the use of treatments that limit the use and prescription of opioids in the emergency department2 and 7#c7 provide alternatives to opioids to patients with painful conditions1 not including patients who present with pain related to cancer1 end-of-life symptom palliation1 or complex multisystem trauma4 7e7 ,consultation ,the ,secretary shall implement a process for recipients of grants under subsection 7a7 to consult 7in a manner that allows for sharing of evidence-based best practices7 with each other and with persons having robust knowledge1 including emergency departments and physicians that have successfully deployed alternative pain management protocols1 such as non-drug approaches studied through the ,national ,center for ,complimentary and ,integrative ,health including acupuncture that limit the use of opioids4 ,the ,secretary shall offer to each recipient of a grant under subsection 7a7 technical support as necessary4 7f7 ,report to the ,secretary ,each recipient of a grant under this section shall submit to the ,secretary 7during the period of such grant7 annual reports on the progress of the program funded through the grant4 ,these reports shall include1 in accordance with ,state and ,federal statutes and regulations regarding disclosure of patient information-- 7#a7 a description of and specific information about the alternative pain management protocols employed2 7#b7 data on the alternative pain management protocols and treatments employed1 including-- 7,a7 during a baseline period before the program began1 as defined by the ,secretary2 7,b7 at various stages of the program1 as determined by the ,secretary2 and 7,c7 the conditions for which the alternative pain management protocols and treatments were employed2 7#c7 the success of each specific alternative pain management protocol2 7#d7 data on the opioid prescriptions written1 including-- 7,a7 during a baseline period before the program began1 as defined by the ,secretary2 7,b7 at various stages of the program1 as determined by the ,secretary2 and 7,c7 the conditions for which the opioids were prescribed2 7#e7 the demographic characteristics of patients who were treated with an alternative pain management protocol1 including age1 sex1 race1 ethnicity1 and insurance status and type2 7#f7 data on patients who were eventually prescribed opioids after alternative pain management protocols and treatments were employed2 and 7#g7 any other information the ,secretary deems necessary4 7g7 ,report to ,congress ,not later than #a year after completion of the demonstration program under this section1 the ,secretary shall submit a report to the ,congress on the results of the demonstration program and include in the report-- 7#a7 the number of applications received and the number funded2 7#b7 a summary of the reports described in subsection 7f71 including standardized data2 and 7#c7 recommendations for broader implementation of pain management protocols that limit the use and prescription of opioids in emergency departments or other areas of the health care delivery system4 7h7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjai through #bjba4 ,k ,stop ,counterfeit ,drugs by ,regulating and ,enhancing ,enforcement ,now #gaja4 ,short title ,this subtitle may be cited as the ,stop ,counterfeit ,drugs by ,regulating and ,enhancing ,enforcement ,now ,act or the ,,screen ,act4 #gajb4 ,detention1 refusal1 and destruction of drugs offered for importation 7a7 ,increasing the maximum dollar amount of drugs subject to destruction ,the sixth sentence in section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking except that the ,secretary and all that follows through the two periods at the end and inserting except that the ,secretary of ,health and ,human ,services may destroy1 without the opportunity for export1 any drug refused admission under this section1 if such drug is declared to be valued at an amount that is #b1ejj or less 7or such higher amount as the ,secretary of the ,treasury may set by regulation pursuant to section #dih7;a77#a7 of the ,tariff ,act of #aicj or such higher amount as the ,commissioner of ,food and ,drugs may set based on a finding by the ,commissioner that the higher amount is in the interest of public health71 or if such drug is entering the ,united ,states by mail1 and was not brought into compliance as described under subsection 7b744 7b7 ,destruction of articles of concern ,the sixth sentence of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a771 as amended by subsection 7a71 is further amended by inserting before the period at the end the following3 2 and the ,secretary of ,health and ,human ,services may destroy1 without the opportunity for export1 any article refused admission under clause 7#f7 of the third sentence of this subsection4 7c7 ,technical amendments ,the seventh1 eighth1 and ninth sentences of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 are amended-- 7#a7 by striking a drug each place it appears and inserting an article2 and 7#b7 by striking the drug each place it appears and inserting the article4 7d7 ,rule of construction ,the last sentence in section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended to read as follows3 ,clauses 7#b71 7#e71 and 7#f7 of the third sentence of this subsection shall not be construed to prohibit the admission of narcotic or nonnarcotic drugs or other substances1 the importation of which is permitted under the ,controlled ,substances ,import and ,export ,act44 #gajc4 ,notification1 nondistribution1 and recall of adulterated or misbranded drug products 7a7 ,prohibited ,acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7eee7 ,the failure to comply with any order issued under section #efi;,d4 4 7b7 ,notification1 nondistribution1 and recall of adulterated or misbranded drugs ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by adding at the end the following3 #efi;,d4 ,notification1 ,nondistribution1 ,and ,recall ,of ,adulterated ,or ,misbranded ,drugs 7a7 ,order ,to cease distribution and recall 7#a7 ,in general ,upon a determination that the use or consumption of1 or exposure to1 a drug may present an imminent or substantial hazard to the public health1 the ,secretary shall issue an order requiring any person who distributes the drug to immediately cease distribution of the drug4 7#b7 ,hearing ,an order under paragraph 7#a7 shall provide the person subject to the order with an opportunity for an informal hearing1 to be held not later than #aj days after the date of issuance of the order1 on-- 7,a7 the actions required by the order2 and 7,b7 whether the order should be amended to require a recall of the drug4 7#c7 ,inadequate grounds ,if1 after providing an opportunity for a hearing under paragraph 7#b71 the ,secretary determines that inadequate grounds exist to support the actions required by the order1 the ,secretary shall vacate the order4 7#d7 ,amendment to order to require recall ,if1 after providing an opportunity for an informal hearing under paragraph 7#b71 the ,secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued1 the ,secretary shall-- 7,a7 amend the order to require a recall2 and 7,b7 after consultation with the drug sponsor1 specify a timetable in which the recall will occur4 7#e7 ,notice to persons affected ,an order under this subsection shall require any person who distributes the drug to provide for notice1 including to individuals as appropriate1 to persons who may be affected by the order to cease distribution of or recall the drug1 as applicable4 7#f7 ,action following order ,any person who is subject to an order under paragraph 7#a7 or 7#d7 shall immediately cease distribution of or recall1 as applicable1 the drug and provide notification as required by such order4 7b7 ,notice to consumers and health officials ,the ,secretary shall1 as the ,secretary determines to be necessary1 provide notice of a recall order under this section to-- 7#a7 consumers to whom the drug was1 or may have been1 distributed2 and 7#b7 appropriate ,state and local health officials4 7c7 ,order ,to recall 7#a7 ,contents ,an order to recall a drug under subsection 7a7 shall-- 7,a7 require periodic reports to the ,secretary describing the progress of the recall2 and 7,b7 provide for notice1 including to individuals as appropriate1 to persons who may be affected by the recall4 7#b7 ,assistance allowed ,in providing for notice under paragraph 7#a77;,b71 the ,secretary may allow for the assistance of health professionals1 ,state or local officials1 or other individuals designated by the ,secretary4 7#c7 ,nondelegation ,an order under this section shall be ordered by the ,secretary or an official designated by the ,secretary4 ,an official may not be so designated under this section unless the official is the ,director of the ,center for ,drug ,evaluation and ,research1 is an official senior to such ,director1 or is so designated by such ,director4 7d7 ,savings clause ,nothing contained in this section shall be construed as limiting-- 7#a7 the authority of the ,secretary to issue an order to cease distribution of1 or to recall1 an drug under any other provision of this ,act or the ,public ,health ,service ,act2 or 7#b7 the ability of the ,secretary to request any person to perform a voluntary activity related to any drug subject to this ,act or the ,public ,health ,service ,act4 4 7c7 ,drugs subject to refusal ,the third sentence of subsection 7a7 of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is amended by inserting or 7#e7 in the case of a drug1 such drug is subject to an order under section #efh to cease distribution of or recall the drug1 before then such article shall be refused admission4 7d7 ,application ,sections #cja7;eee7 and #efi;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsections 7a7 and 7b71 shall apply with respect to a drug as of such date1 not later than #a year after the date of the enactment of this ,act1 as the ,secretary of ,health and ,human ,services shall specify4 #gajd4 ,single source pattern of shipments of adulterated or misbranded drugs ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by adding at the end the following3 7t7 ,single source pattern of shipments of adulterated or misbranded drugs ,if the ,secretary identifies a pattern of adulterated or misbranded drugs being offered for import from the same manufacturer1 distributor1 or importer1 the ,secretary may by order choose to treat all drugs being offered for import from such manufacturer1 distributor1 or importer as adulterated or misbranded unless otherwise demonstrated4 4 #gaje4 ,fund to strengthen efforts of ,,fda to combat the opioid and substance use epidemic ,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 ,fund to strengthen efforts of ,,fda to combat the opioid and substance use epidemic 7a7 ,in general ,the ,commissioner of ,food and ,drugs shall use any funds appropriated pursuant to the authorization of appropriations under subsection 7c7 to carry out the programs and activities described in subsection 7d7 to strengthen and facilitate the ,food and ,drug ,administration's efforts to address the opioid and substance use epidemic4 ,such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities4 7b7 ,,fda ,opioid and ,substance ,use ,epidemic ,response ,fund 7#a7 ,establishment of fund ,there is established in the ,treasury a fund1 to be known as the ,,fda ,opioid and ,substance ,use ,epidemic ,response ,fund 7referred to in this subsection as the ,fund71 for purposes of funding the programs and activities described in subsection 7d74 7#b7 ,transfer ,for the period of fiscal years #bjai through #bjbc1 #aaj1jjj1jjj shall be transferred to the ,fund from the general fund of the ,treasury4 7#c7 ,amounts deposited ,any amounts transferred under paragraph 7#b7 shall remain unavailable in the ,fund until such amounts are appropriated pursuant to subsection 7c74 7c7 ,appropriations 7#a7 ,authorization of appropriations ,for the period of fiscal years #bjai through #bjbc1 there is authorized to be appropriated from the ,fund to the ,food and ,drug ,administration1 for the purpose of carrying out the programs and activities described in subsection 7d71 an amount not to exceed the total amount transferred to the ,fund under subsection 7b77#b74 ,notwithstanding subsection 7g71 such funds shall remain available until expended4 7#b7 ,offsetting future appropriations ,for any of fiscal years #bjai through #bjbc1 for any discretionary appropriation out of the ,fund to the ,food and ,drug ,administration pursuant to the authorization of appropriations under paragraph 7#a7 for the purpose of carrying out the programs and activities described in subsection 7d71 the total amount of such appropriations for the applicable fiscal year 7not to exceed the total amount remaining in the ,fund7 shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the ,congressional ,budget and ,impoundment ,control ,act of #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and the amount transferred to the ,fund shall be reduced by the same amount4 7d7 ,food and ,drug ,administration ,the entirety of the funds made available pursuant to subsection 7c77#a7 shall be for the ,commissioner of ,food and ,drugs1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 or this ,act and other applicable ,federal law1 to support widespread innovation in non-opioid and non-addictive medical products for pain treatment1 access to opioid addiction treatments1 appropriate use of approved opioids1 and efforts to reduce illicit importation of opioids4 ,such support may include the following programs and activities3 7#a7 ,obligating contract funds beginning in fiscal year #bjai for an educational campaign that will-- 7,a7 educate patients and their families to differentiate opioid medications2 7,b7 raise awareness about preferred storage and disposal methods2 and 7,c7 inform patients1 families1 and communities about medication-assisted treatment options4 7#b7 ,building the ,food and ,drug ,administration's presence in international mail facilities1 including through-- 7,a7 improvements in equipment and information technology enhancements to identify unapproved1 counterfeit1 or other unlawful pharmaceuticals for destruction2 7,b7 increased and improved surveillance2 7,c7 renovations at international mail facility locations2 and 7,d7 the purchase of laboratory equipment4 7#c7 ,enhancing the identification and targeting of entities offering products and products being offered by such entities for import into the ,united ,states through review and analysis of ,internet websites1 import data1 and other sources of intelligence for purposes of making the best use of the ,food and ,drug ,administration's inspection and analytical resources4 7#d7 ,increasing the number of staff of the ,food and ,drug ,administration to increase the number of packages being examined1 ensuring the safety of the staff undertaking such examinations1 and ensuring that packages identified as illegal1 counterfeit1 misbranded1 or adulterated are removed from commerce through available authorities1 including administrative destruction4 7#e7 ,enhancing the ,food and ,drug ,administration's criminal investigations resources 7including full-time equivalent employees and equipment71 imports surveillance1 and international work4 7#f7 ,obtaining for the ,food and ,drug ,administration equipment and full-time equivalent employees needed to efficiently screen and analyze products offered for import1 including by building data libraries of new substances and analogues to facilitate identification and evaluation of pharmaceutical-based agents and by purchasing screening technologies for use at international mail facilities4 7#g7 ,operating the ,food and ,drug ,administration's forensic laboratory facility to ensure adequate laboratory space and functionality for additional work and full-time equivalent employees4 7e7 ,accountability and oversight 7#a7 ,work plan 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,commissioner of ,food and ,drugs shall submit to the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection 7c7 for each of fiscal years #bjai through #bjbc and the contents described in subparagraph 7,b74 7,b7 ,contents ,the work plan submitted under subparagraph 7,a7 shall include-- 7i7 the amount of money to be obligated or expended out of the ,fund in each fiscal year for each program and activity described in subsection 7d72 and 7ii7 a description and justification of each such program and activity4 7#b7 ,reports 7,a7 ,annual reports ,not later than ,october #a of each of fiscal years #bjbj through #bjbd1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes-- 7i7 the amount of money obligated or expended out of the ,fund in the prior fiscal year for each program and activity described in subsection 7d72 7ii7 a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection 7c72 and 7iii7 how the programs and activities are advancing public health4 7,b7 ,additional reports ,at the request of the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate or the ,committee on ,energy and ,commerce of the ,house of ,representatives1 the ,commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the programs and activities undertaken with such funding4 7f7 ,limitations ,notwithstanding any transfer authority authorized by this section or any appropriations ,act1 any funds made available pursuant to the authorization of appropriations under subsection 7c7 may not be used for any purpose other than the programs and activities described in subsection 7d7 to strengthen and facilitate the ,food and ,drug ,administration's efforts to address the opioid and substance use epidemic4 7g7 ,sunset ,this section shall expire on ,september #cj1 #bjbb1 except that-- 7#a7 this subsection does not apply to reporting under subsection 7e77#b72 and 7#b7 this section shall remain in effect until such time1 and to such extent1 as may be necessary for the funds transferred by subsection 7b77#b7 to be fully expended4 4 #gajf4 ,consideration of potential for misuse and abuse required for drug approval 7a7 ,in general ,section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d77 is amended-- 7#a7 in the first sentence-- 7,a7 by striking or 7#g7 and inserting 7#g72 and 7,b7 by inserting or 7#h7 if the drug is or contains a controlled substance for which a listing in any schedule is in effect under the ,controlled ,substances ,act or that is permanently scheduled pursuant to section #bja of such ,act1 on the basis of information submitted to him as part of the application1 or upon the basis of any other information before him with respect to such drug1 the drug is unsafe for use due to the risks of abuse or misuse or there is insufficient information to show that the drug is safe for use considering such risks2 before he shall issue an order refusing to approve the application2 and 7#b7 in the second sentence1 by striking 7#f7 and inserting 7#h74 7b7 ,withdrawal authority ,section #eje7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;e77 is amended in the first sentence-- 7#a7 by striking or 7#e7 and inserting 7#e72 and 7#b7 by inserting the following3 2 or 7#f7 that1 in the case of a drug that is or contains a controlled substance for which a listing in any schedule is in effect under the ,controlled ,substances ,act or that is permanently scheduled pursuant to section #bja of such ,act1 on the basis of new information before him with respect to such drug1 evaluated together with the information available to him when the application was approved1 that the drug is unsafe for use due to the risks of abuse or misuse after of a material fact4 7c7 ,rule of construction ,nothing in the amendments made by this section shall be construed to limit or narrow1 in any manner1 the meaning or application of the provisions of paragraphs 7#a71 7#b71 7#c71 7#d71 7#e71 and 7#g7 of section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d77 or paragraphs 7#a7 and 7#b7 of section #eje7;e7 of such ,act 7#ba ,u4,s4,c4 #cee7;e774 ,l ,treatment1 ,education1 and ,community ,help to ,combat ,addiction #gaaa4 ,short title ,this subtitle may be cited as the ,treatment1 ,education1 and ,community ,help to ,combat ,addiction ,act of #bjah or the ,,teach to ,combat ,addiction ,act of #bjah4 #gaab4 ,establishment of ,regional ,centers of ,excellence in ,substance ,use ,disorder ,education ,part ,d of title ,v of the ,public ,health ,service ,act is amended by inserting after section #edi 7#db ,u4,s4,c4 #bij;ee-#d7 the following new section3 #eej4 ,regional ,centers of ,excellence in ,substance ,use ,disorder ,education 7a7 ,in general ,the ,secretary1 in consultation with such other agencies as are appropriate1 shall1 subject to the availability of appropriations1 establish a solicitation process and award cooperative agreements to eligible entities for the designation of such entities as ,regional ,centers of ,excellence in ,substance ,use ,disorder ,education and support of such regional centers of excellence to enhance and improve how health professionals are educated in substance use disorder prevention1 treatment1 and recovery through development1 evaluation1 and distribution of evidence-based curricula for health profession schools4 ,an eligible entity designated by the ,secretary as a ,regional ,center of ,excellence in ,substance ,use ,disorder ,education shall carry out the activities described in subsection 7b74 7b7 ,selection of centers of excellence 7#a7 ,eligible entities ,to be eligible to receive a cooperative agreement under subsection 7a71 an entity shall-- 7,a7 be an entity specified by the ,secretary that offers education to students in various health professions1 which may include-- 7i7 a health system2 7ii7 a teaching hospital2 7iii7 a medical school2 7iv7 a certified behavioral health clinic2 or 7v7 any other health profession school1 school of public health1 or ,cooperative ,extension ,program at institutions of higher education engaged in an aspect of the prevention1 treatment1 or recovery of substance use disorders2 7,b7 be accredited by the appropriate educational accreditation body2 7,c7 demonstrate an existing strategy1 and have in place a plan for continuing such strategy1 or a proposed strategy to implement a curriculum based on best practices for substance use disorder prevention1 treatment1 and recovery2 7,d7 demonstrate community engagement and participation through community partners1 including other health profession schools1 mental health counselors1 social workers1 peer recovery specialists1 substance use treatment programs1 community health centers1 physicians' offices1 certified behavioral health clinics1 law enforcement1 and the business community2 and 7,e7 provide to the ,secretary such information1 at such time1 and in such manner1 as the ,secretary may require4 7#b7 ,diversity ,in awarding cooperative agreements under subsection 7a71 the ,secretary shall take into account regional differences among eligible entities and shall make an effort to ensure geographic diversity4 7c7 ,dissemination of information 7#a7 ,public posting ,the ,secretary shall make information provided to the ,secretary under subsection 7b77#a77;,e7 publically available on the ,internet website of the ,department of ,health and ,human ,services4 7#b7 ,evaluation ,the ,secretary shall evaluate each project carried out by a ,regional ,center of ,excellence in ,substance ,use ,disorder ,education under this section and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities4 7d7 ,funding ,there is authorized to be appropriated to carry out this section1 #d1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 ,m ,guidance from ,national ,mental ,health and ,substance ,use ,policy ,laboratory #gaba4 ,guidance from ,national ,mental ,health and ,substance ,use ,policy ,laboratory ,section #eja;,a7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#j7;b77 is amended-- 7#a7 in paragraph 7#e71 by striking and at the end2 7#b7 in paragraph 7#f71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#g7 issue and periodically update guidance for entities applying for grants from the ,substance ,abuse and ,mental ,health ,services ,administration in order to-- 7,a7 encourage the funding of evidence-based practices2 7,b7 encourage the replication of promising or effective practices2 and 7,c7 inform applicants on how to best articulate the rationale for the funding of a program or activity4 4 ,n ,comprehensive ,opioid ,recovery ,centers #gaca4 ,short title ,this subtitle may be cited as the ,comprehensive ,opioid ,recovery ,centers ,act of #bjah4 #gacb4 ,comprehensive opioid recovery centers 7a7 ,in general ,part ,d of title ,v of the ,public ,health ,service ,act is amended by adding at the end the following new section3 #eej4 ,comprehensive opioid recovery centers 7a7 ,in general ,the ,secretary shall award grants on a competitive basis to eligible entities to establish or operate a comprehensive opioid recovery center 7referred to in this section as a ,center74 7b7 ,grant period 7#a7 ,in general ,a grant awarded under subsection 7a7 shall be for a period not less than #c years and not more than #e years4 7#b7 ,renewal ,a grant awarded under subsection 7a7 may be renewed1 on a competitive basis1 for additional periods of time1 as determined by the ,secretary4 ,in determining whether to renew a grant under this paragraph1 the ,secretary shall consider the data submitted under subsection 7h74 7c7 ,minimum number of ,centers ,the ,secretary shall allocate the amounts made available under subsection 7i7 in such amounts that not fewer than #aj ,centers will be established across the ,united ,states4 7d7 ,application ,in order to be eligible for a grant under subsection 7a71 an entity shall submit an application to the ,secretary at such time and in such manner as the ,secretary may require4 ,such application shall include-- 7#a7 evidence that such entity carries out1 or is capable of coordinating with other entities to carry out1 the activities described in subsection 7g72 and 7#b7 such other information as the ,secretary may require4 7e7 ,priority ,in awarding grants under subsection 7a71 the ,secretary shall give priority to eligible entities located in a ,state or ,indian country 7as defined in section #aaea of title #ah1 ,united ,states ,code7-- 7#a7 with a high per capita drug overdose mortality rate1 as determined by the ,director of the ,centers for ,disease ,control and ,prevention2 or 7#b7 based on any other criteria or need1 as determined by the ,secretary4 7f7 ,use of grant funds ,an eligible entity awarded a grant under subsection 7a7 shall use the grant funds to establish or operate a ,center to carry out the activities described in subsection 7g74 7g7 ,center activities and services ,each ,center shall1 at a minimum1 carry out the activities described in this subsection4 ,in the case of a ,center that determines that a service described in paragraph 7#b7 cannot reasonably be carried out by the ,center1 such ,center shall contract with such other entities as may be necessary to ensure that patients have access to the full range of services described in such paragraph4 7#a7 ,community outreach ,each ,center shall carry out the following outreach activities3 7,a7 ,train and supervise outreach staff to work with schools1 workplaces1 faith-based organizations1 ,state and local health departments1 law enforcement1 and first responders to ensure that such institutions are aware of the services of the ,center4 7,b7 ,disseminate and make available online evidence-based resources that educate professionals and the public on opioid use disorder and other substance use disorders4 7#b7 ,treatment and recovery services ,each ,center shall provide the following treatment and recovery services3 7,a7 ,ensure that intake evaluations meet the clinical needs of patients4 7,b7 ,periodically conduct patient assessments to ensure continued and meaningful recovery1 as defined by the ,assistant ,secretary for ,mental ,health and ,substance ,use4 7,c7 ,provide the full continuum of treatment services1 including-- 7i7 all drugs approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and all biological products licensed under section #cea of this ,act1 including methadone1 to treat substance use disorders1 including opioid use disorder and alcohol use disorder2 7ii7 withdrawal management1 which shall include medically supervised detoxification that includes patient evaluation1 stabilization1 and readiness for and entry into treatment2 7iii7 counseling and case management1 including counseling and recovery services for any possible co-occurring mental illness2 7iv7 residential rehabilitation2 7v7 recovery housing2 7vi7 community-based and peer recovery support services2 7vii7 job training and placement assistance to support reintegration into the workforce2 and 7viii7 other best practices1 as determined by the ,secretary4 7,d7 ,administer an onsite pharmacy and provide toxicology services4 7,e7 ,establish and operate a secure and confidential electronic health information system4 7,f7 ,offer family support services such as child care1 family counseling1 and parenting interventions to help stabilize families impacted by substance use disorder4 7h7 ,data reporting and program oversight ,with respect to a grant awarded under subsection 7a7 to an eligible entity for a ,center1 not later than #ij days after the end of the first year of the grant period1 and annually thereafter for the duration of the grant period 7including the duration of any renewal period for such grant71 the entity shall submit data1 as appropriate1 to the ,secretary regarding-- 7#a7 the programs and activities funded by the grant2 7#b7 health outcomes of individuals with a substance use disorder who received services from the ,center2 7#c7 the effectiveness of interventions designed1 tested1 and evaluated by the ,center2 and 7#d7 any other information that the ,secretary may require for the purpose of-- 7,a7 evaluating the effectiveness of the ,center2 and 7,b7 ensuring that the ,center is complying with all the requirements of the grant1 including providing the full continuum of services described in subsection 7g77#b77;,c7 and providing drugs and devices for overdose reversal under such subsection4 7i7 ,authorization of appropriations ,there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjai through #bjbc for purposes of carrying out this section4 4 7b7 ,reports to ,congress 7#a7 ,preliminary report ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a preliminary report that analyzes data submitted under section #eej7;h7 of the ,public ,health ,service ,act1 as added by subsection 7a74 7#b7 ,final report ,not later than #a year after submitting the preliminary report required under paragraph 7#a71 the ,secretary of ,health and ,human ,services shall submit to ,congress a final report that includes-- 7,a7 an evaluation of the effectiveness of comprehensive opioid recovery centers established or operated pursuant to section #eej of the ,public ,health ,service ,act1 as added by subsection 7a72 7,b7 recommendations on whether the grant program established under such section #eej should be reauthorized and expanded2 and 7,c7 standards and best practices for the treatment of substance use disorders1 as identified through such grant program4 ,o ,poison ,center ,network ,enhancement #gada4 ,short title ,this subtitle may be cited as the ,poison ,center ,network ,enhancement ,act of #bjah4 #gadb4 ,reauthorization of poison control centers national toll-free number ,section #abga of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#ga7 is amended to read as follows3 #abga4 ,establishment and maintenance of the national toll-free number and enhanced communications capabilities 7a7 ,in general ,the ,secretary shall provide coordination and assistance to poison control centers for-- 7#a7 the development1 establishment1 implementation1 and maintenance of a nationwide toll-free phone number2 and 7#b7 the enhancement of communications capabilities1 which may include text capabilities4 7b7 ,consultation ,the ,secretary may consult with nationally recognized professional organizations in the field of poison control to determine the best and most effective means of achieving the goals described in paragraphs 7#a7 and 7#b7 of subsection 7a74 7c7 ,rule of construction ,in assisting with public health emergencies1 responses1 or preparedness1 nothing in this section shall be construed to restrict the work of poison control centers or the use of their resources by the ,secretary or other governmental agencies4 7d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section #gjj1jjj for each of fiscal years #bjai through #bjbc4 4 #gadc4 ,reauthorization of nationwide public awareness campaign to promote poison control center utilization ,section #abgb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#gb7 is amended to read as follows3 #abgb4 ,nationwide public awareness campaign to promote poison control center utilization and their public health emergency response capabilities 7a7 ,in general ,the ,secretary shall-- 7#a7 carry out1 and expand upon1 a national public awareness campaign to educate the public and health care providers about-- 7,a7 poisoning1 toxic exposure1 and drug misuse prevention2 and 7,b7 the availability of poison control center resources in local communities2 and 7#b7 as part of such campaign1 highlight the nationwide toll-free number and enhanced communications capabilities supported under section #abga4 7b7 ,consultation ,in carrying out and expanding upon the national campaign under subsection 7a71 the ,secretary may consult with nationally recognized professional organizations in the field of poison control response for the purpose of determining the best and most effective methods for achieving public awareness4 7c7 ,contract with entity ,the ,secretary may carry out subsection 7a7 by entering into contracts with one or more public or private entities1 including nationally recognized professional organizations in the field of poison control and national media firms1 for the development and implementation of the awareness campaign under subsection 7a71 which may include-- 7#a7 the development and distribution of poisoning and toxic exposure prevention1 poison control center1 and public health emergency awareness and response materials2 7#b7 television1 radio1 internet1 and newspaper public service announcements2 and 7#c7 other means and activities to provide for public and professional awareness and education4 7d7 ,evaluation ,the ,secretary shall-- 7#a7 establish baseline measures and benchmarks to quantitatively evaluate the impact of the nationwide public awareness campaign carried out under this section2 and 7#b7 on a biennial basis1 prepare and submit to the appropriate committees of ,congress an evaluation of the nationwide public awareness campaign4 7e7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 #hjj1jjj for each of fiscal years #bjai through #bjbc4 4 #gadd4 ,reauthorization of the poison control center grant program ,section #abgc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#gc7 is amended to read as follows3 #abgc4 ,maintenance of the poison control center grant program 7a7 ,authorization of program ,the ,secretary shall award grants to poison control centers accredited under subsection 7c7 7or granted a waiver under subsection 7d77 and nationally recognized professional organizations in the field of poison control for the purposes of-- 7#a7 preventing1 and providing treatment recommendations for1 poisonings and toxic exposures including opioid and drug misuse2 7#b7 assisting with public health emergencies1 responses1 and preparedness2 and 7#c7 complying with the operational requirements needed to sustain the accreditation of the center under subsection 7c74 7b7 ,additional uses of funds ,in addition to the purposes described in subsection 7a71 a poison center or professional organization awarded a grant under such subsection may also use amounts received under such grant-- 7#a7 to research1 establish1 implement1 and evaluate best practices in the ,united ,states for poisoning prevention1 poison control center outreach1 opioid and drug misuse information and response1 and public health emergency1 response1 and preparedness programs2 7#b7 to research1 develop1 implement1 revise1 and communicate standard patient management guidelines for commonly encountered toxic exposures2 7#c7 to improve national toxic exposure and opioid misuse surveillance by enhancing cooperative activities between poison control centers in the ,united ,states and the ,centers for ,disease ,control and ,prevention and other governmental agencies2 7#d7 to research1 improve1 and enhance the communications and response capability and capacity of the ,nation's network of poison control centers to facilitate increased access to the centers through the integration and modernization of the current poison control centers communications and data system1 including enhancing the network's telephony1 internet1 data1 and social networking technologies2 7#e7 to develop1 support1 and enhance technology and capabilities of nationally recognized professional organizations in the field of poison control to collect national poisoning1 toxic occurrence1 and related public health data2 7#f7 to develop initiatives to foster the enhanced public health utilization of national poison data collected by such organizations2 7#g7 to support and expand the toxicologic expertise within poison control centers2 and 7#h7 to improve the capacity of poison control centers to answer high volumes of contacts and internet communications1 and to sustain and enhance the poison control center's network capability to respond during times of national crisis or other public health emergencies4 7c7 ,accreditation ,except as provided in subsection 7d71 the ,secretary may award a grant to a poison control center under subsection 7a7 only if-- 7#a7 the center has been accredited by a nationally recognized professional organization in the field of poison control1 and the ,secretary has approved the organization as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning2 or 7#b7 the center has been accredited by a ,state government1 and the ,secretary has approved the ,state government as having in effect standards for accreditation that reasonably provide for the protection of the public health with respect to poisoning4 7d7 ,waiver of accreditation requirements 7#a7 ,in general ,the ,secretary may grant a waiver of the accreditation requirements of subsection 7c7 with respect to a nonaccredited poison control center that applies for a grant under this section if such center can reasonably demonstrate that the center will obtain such an accreditation within a reasonable period of time as determined appropriate by the ,secretary4 7#b7 ,renewal ,the ,secretary may renew a waiver under paragraph 7#a74 7#c7 ,limitation ,the ,secretary may not1 after the date of enactment of the ,poison ,control ,network ,enhancement ,act of #bjah1 grant to a poison control center waivers or renewals that total more than #e years4 7e7 ,supplement not supplant ,amounts made available to a poison control center under this section shall be used to supplement and not supplant other ,federal1 ,state1 or local funds provided for such center4 7f7 ,maintenance of effort ,a poison control center1 in utilizing the proceeds of a grant under this section1 shall maintain the annual recurring expenditures of the center for its activities at a level that is not less than #hj percent of the average level of such recurring expenditures maintained by the center for the preceding #c fiscal years for which a grant is received4 7g7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 #bh1fjj1jjj for each of fiscal years #bjai through #bjbc4 ,the ,secretary may utilize an amount not to exceed #f percent of the amount appropriated pursuant to the preceding sentence for each fiscal year for coordination1 dissemination1 technical assistance1 program evaluation1 data activities1 and other program administration functions1 which are determined by the ,secretary to be appropriate for carrying out the program under this section4 4 ,p ,eliminating ,opioid ,related ,infectious ,diseases #gaea4 ,short title ,this subtitle may be cited as the ,eliminating ,opioid ,related ,infectious ,diseases ,act of #bjah4 #gaeb4 ,reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors ,section #cag,n of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ae7 is amended to read as follows3 #cag,n4 ,surveillance and education regarding infections associated with illicit drug use and other risk factors 7a7 ,in general ,the ,secretary may 7directly and through grants to public and nonprofit private entities7 provide for programs for the following3 7#a7 ,to cooperate with the ,states and ,indian tribes in implementing or maintaining a surveillance system to determine the incidence of infections commonly associated with illicit drug use1 including infections commonly associated with injection drug use such as viral hepatitis1 human immunodeficiency virus1 and infective endocarditis1 and to assist the ,states in determining the prevalence of such infections1 which may include the reporting of cases of such infections4 7#b7 ,to identify1 counsel1 and offer testing to individuals who are at risk of infections as a result of injection drug use1 receiving blood transfusions prior to ,july #aiib1 or other risk factors4 7#c7 ,to provide appropriate referrals for counseling1 testing1 and medical treatment of individuals identified under paragraph 7#b7 and to ensure1 to the extent practicable1 the provision of appropriate follow-up services4 7#d7 ,to develop and disseminate public information and education programs for the detection and control of infections described in paragraph 7#a71 with priority given to high-risk populations as determined by the ,secretary4 7#e7 ,to improve the education1 training1 and skills of health professionals in the detection and control of infections and the coordination of treatment of addiction and infectious diseases described in paragraph 7#a71 with priority given to substance use disorder treatment providers1 pediatricians and other primary care providers1 obstetrician-gynecologists1 infectious diseases clinicians1 and ,,hiv clinicians4 7b7 ,laboratory procedures ,the ,secretary may 7directly or through grants to public and nonprofit private entities7 carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection 7a77#a74 7c7 ,definitions ,in this section3 7#a7 ,the term ,indian tribe has the meaning given that term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#b7 ,the term injection drug use means-- 7,a7 intravenous administration of a substance in schedule ,i under section #bjb of the ,controlled ,substances ,act2 7,b7 intravenous administration of a substance in schedule ,,ii1 ,,iii1 ,,iv1 or ,v under section #bjb of the ,controlled ,substances ,act that has not been approved for intravenous use under-- 7i7 section #eje of the ,federal ,food1 ,drug and ,cosmetic ,act2 or 7ii7 section #cea of the ,public ,health ,service ,act2 or 7,c7 intravenous administration of a substance in schedule ,,ii1 ,,iii1 ,,iv1 or ,v under section #bjb of the ,controlled ,substances ,act that has not been prescribed to the person using the substance4 7d7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated #dj1jjj1jjj for each of the fiscal years #bjai through #bjbc4 4 ,q ,better ,pain ,management ,through ,better ,data #gafa4 ,short title ,this subtitle may be cited as the ,better ,pain ,management ,through ,better ,data ,act of #bjah4 #gafb4 ,guidance addressing alternative approaches to data collection and labeling claims for opioid sparing 7a7 ,in general ,for purposes of assisting sponsors in collecting and incorporating opioid-sparing data in product labeling1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conduct a public meeting and update or issue one or more guidances in accordance with subsection 7b74 7b7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall update or issue one or more guidances addressing-- 7,a7 alternative methods for data collection on opioid sparing2 7,b7 alternative methods for inclusion of such data in product labeling2 and 7,c7 investigations other than clinical trials1 including partially controlled studies and objective trials without matched controls such as historically controlled analyses1 open-label studies1 and meta-analyses1 on opioid sparing for inclusion in product labeling4 7#b7 ,contents ,the guidances under paragraph 7#a7 shall address-- 7,a7 innovative clinical trial designs for ethically and efficiently collecting data on opioid sparing for inclusion in product labeling2 7,b7 primary and secondary endpoints for the reduction of opioid use while maintaining adequate pain control2 7,c7 use of real world evidence1 including patient registries1 and patient reported outcomes to support inclusion of opioid-sparing data in product labeling2 and 7,d7 how sponsors may obtain feedback from the ,secretary relating to such issues prior to-- 7i7 commencement of such data collection2 or 7ii7 the submission of resulting data to the ,secretary4 7#c7 ,public meeting ,prior to updating or issuing the guidances required by paragraph 7#a71 the ,secretary shall consult with stakeholders1 including representatives of regulated industry1 academia1 patients1 and provider organizations1 through a public meeting to be held not later than #ab months after the date of enactment of this ,act4 7#d7 ,timing ,the ,secretary shall-- 7,a7 not later than #ab months after the date of the public meeting required by paragraph 7#c71 update or issue the one or more draft guidances required by paragraph 7#a72 and 7,b7 not later than #ab months after the date on which the public comment period for such draft guidances closes1 finalize such guidances4 7c7 ,definition ,in this section3 7#a7 ,the terms opioid sparing and opioid-sparing refer to the use of drugs or devices 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 that reduce pain while enabling the reduction1 replacement1 or avoidance of oral opioids4 7#b7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 ,r ,special ,registration for ,telemedicine ,clarification #gaga4 ,short title ,this subtitle may be cited as the ,special ,registration for ,telemedicine ,clarification ,act of #bjah4 #gagb4 ,deadline for interim final regulations for a special registration ,to engage in the practice of telemedicine ,section #caa7;h77#b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hca7;h77#b77 is amended by striking ,the ,attorney ,general shall1 with the concurrence of the ,secretary1 promulgate regulations and inserting ,not later than #a year after the date of enactment of the ,special ,registration for ,telemedicine ,clarification ,act of #bjah1 the ,attorney ,general shall1 with the concurrence of the ,secretary1 promulgate interim final regulations4 ,s ,peer ,support ,communities of ,recovery #gaha4 ,short title ,this subtitle may be cited as the ,peer ,support ,communities of ,recovery ,act4 #gahb4 ,building communities of recovery ,section #edg of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;ee-#b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the heading1 by striking ,definition and inserting ,definitions2 7,b7 in the matter preceding paragraph 7#a71 by striking ,in this section1 the term recovery community organization means an independent nonprofit organization that-- and inserting ,in this section32 7,c7 by redesignating paragraphs 7#a7 and 7#b7 as subparagraphs 7,a7 and 7,b71 respectively1 and moving such subparagraphs 7as so redesignated7 #b ems to the right2 7,d7 by inserting before subparagraph 7,a7 7as so redesignated7 the following3 7#a7 ,recovery community organization ,the term recovery community organization means an independent nonprofit organization that-- 2 and 7,e7 by adding at the end the following3 7#b7 ,eligible entity ,the term eligible entity means-- 7,a7 a national nonprofit entity focused on substance use disorder with a network of local affiliates and partners that are geographically and organizationally diverse2 or 7,b7 a nonprofit organization-- 7i7 focused on substance use disorder2 7ii7 established by individuals in personal or family recovery2 and 7iii7 serving prevention1 treatment1 recovery1 payor1 faith-based1 and criminal justice stakeholders in the implementation of local addiction and recovery initiatives4 2 7#b7 in subsection 7b7-- 7,a7 by striking ,the ,secretary shall award grants to recovery community organizations and inserting ,the ,secretary-- 7#a7 shall award grants to recovery community organizations 2 7,b7 by striking services4 and inserting services and allow such organizations to use such grant funds to carry out the activities described in subparagraphs 7,a7 through 7,c7 of subsection 7c77#b72 and2 and 7,c7 by adding at the end the following3 7#b7 may award grants to eligible entities for purposes of establishing regional technical assistance centers1 in accordance with subsection 7c77#b77;,d74 2 7#c7 by striking subsection 7c72 7#d7 by redesignating subsections 7d7 and 7e7 as subsections 7c7 and 7d71 respectively2 7#e7 in subsection 7c7 7as so redesignated7-- 7,a7 in paragraph 7#a71 by striking shall be used and inserting to a recovery community organization shall be used2 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting before build the following3 in the case of a grant awarded to a recovery community organization12 7ii7 in subparagraph 7,b7-- 7,i7 by inserting before reduce the following3 in the case of a grant awarded to a recovery community organization12 and 7,,ii7 by striking and at the end2 7iii7 in subparagraph 7,c7-- 7,i7 by inserting before conduct the following3 in the case of a grant awarded to a recovery community organization12 and 7,,ii7 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following3 7,d7 in the case of a grant awarded to an eligible entity1 provide for the establishment of regional technical assistance centers to provide regional technical assistance for the following3 7i7 ,implementation of regionally driven1 peer-delivered addiction recovery support services before1 during1 after1 or in conjunction with addiction treatment4 7ii7 ,establishment of recovery community organizations4 7iii7 ,establishment of recovery community centers4 2 and 7#f7 in subsection 7d7 7as so redesignated71 by inserting before the period the following3 1 and #ae1jjj1jjj for each of fiscal years #bjai through #bjbc4 ,t ,stop ,illicit ,drug ,importation #gaia4 ,short title ,this short title may be cited as the ,stop ,illicit ,drug ,importation ,act of #bjah4 #gaib4 ,detention1 refusal1 and destruction of drugs offered for importation 7a7 ,articles treated as drugs for purposes of importation ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is amended by adding at the end the following3 7t7 ,articles treated as drugs for purposes of this section 7#a7 ,labeled articles ,an article shall not be treated as a drug pursuant to this subsection if-- 7,a7 an electronic import entry for such article is submitted using an authorized electronic data interchange system2 and 7,b7 such article is designated in such system as a drug1 device1 dietary supplement1 or other product that is regulated under this ,act4 7#b7 ,articles covered ,subject to paragraph 7#a71 for purposes of this section1 an article described in this paragraph may be treated by the ,secretary as a drug if it-- 7,a7 is or contains an ingredient that is an active ingredient that is contained within-- 7i7 a drug that has been approved under section #eje of this ,act2 or 7ii7 a biological product that has been approved under section #cea of the ,public ,health ,service ,act2 7,b7 is or contains an ingredient that is an active ingredient in a drug or biological product if-- 7i7 an investigational use exemption has been authorized for such drug or biological product under section #eje7;i7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act2 7ii7 substantial clinical investigation has been instituted for such drug or biological product2 and 7iii7 the existence of such clinical investigation has been made public2 or 7,c7 is or contains a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subparagraph 7,a7 or 7,b74 7#c7 ,effect ,except to the extent that an article may be treated as a drug pursuant to paragraph 7#b71 this subsection shall not be construed as bearing on or being relevant to the question of whether any article is a drug as defined in section #bja7;g74 4 7b7 ,articles of concern 7#a7 ,delivery by ,treasury to ,,hhs ,the first sentence of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking and cosmetics and inserting cosmetics1 and potential articles of concern 7as defined in subsection 7u774 7#b7 ,refused admission ,the third sentence of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking then such article shall be refused admission and inserting or 7#e7 such article is an article of concern 7as defined in subsection 7u771 or 7#f7 such article is a drug that is being imported or offered for import in violation of section #cja7;cc71 then such article shall be refused admission4 7#c7 ,definition of article of concern ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha71 as amended1 is further amended by adding at the end the following3 7u7 ,article of concern defined ,for purposes of subsection 7a71 the term article of concern means an article that is or contains a drug or other substance-- 7#a7 for which1 during the #bd-month period prior to the article being imported or offered for import1 the ,secretary of ,health and ,human ,services-- 7,a7 has requested that1 based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section #bja of the ,controlled ,substances ,act1 the ,attorney ,general initiate the process to control the drug or other substance in accordance with such ,act2 or 7,b7 has1 following the publication by the ,attorney ,general of a notice in the ,federal ,register of the intention to issue an order temporarily scheduling such drug or substance in schedule ,i of section #bjb of the ,controlled ,substances ,act pursuant to section #bja7;h7 of such ,act1 made a determination that such article presents an imminent hazard to public safety2 and 7#b7 with respect to which the ,attorney ,general has not-- 7,a7 scheduled the drug or other substance under such ,act2 or 7,b7 notified the ,secretary of ,health and ,human ,services that the ,attorney ,general has made a determination not to schedule the drug or other substance under such ,act4 4 #gaic4 ,seizure ,section #cjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;b77 is amended by striking the first sentence and inserting the following3 ,the article1 equipment1 or other thing proceeded against shall be liable to seizure by process pursuant to the libel1 and the procedure in cases under this section shall conform1 as nearly as may be1 to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section #ihc of title #ah1 ,united ,states ,code4 ,on demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury4 ,a seizure brought under this section is not governed by ,rule ,g of the ,supplemental ,rules of ,admiralty or ,maritime ,claims and ,asset ,forfeiture ,actions4 ,exigent circumstances shall be deemed to exist for all seizures brought under this section1 and in such cases1 the summons and arrest warrant shall be issued by the clerk of the court without court review4 4 #gaid4 ,debarring violative individuals or companies 7a7 ,prohibited act ,section #cja7;cc7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;cc77 is amended-- 7#a7 by inserting after an article of food the following3 or a drug2 and 7#b7 by inserting after a person debarred the following3 from such activity4 7b7 ,debarment ,section #cjf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#b7 and inserting paragraph 7#b7 or 7#c72 7,b7 in subparagraph 7,b71 by striking or at the end2 7,c7 in subparagraph 7,c71 by striking the period at the end and inserting 1 or2 and 7,d7 by adding at the end the following3 7,d7 a person from importing or offering to import into the ,united ,states-- 7i7 a controlled substance as defined in section #ajb7f7 of the ,controlled ,substances ,act2 or 7ii7 any drug1 if such drug is declared to be valued at an amount that is #b1ejj or less 7or such higher amount as the ,secretary of the ,treasury may set by regulation pursuant to section #dih7;a77#a7 of the ,tariff ,act of #aicj71 or if such drug is entering the ,united ,states by mail4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in the paragraph heading after food by inserting or drug2 7,b7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and moving the indentation of each such clause #b ems to the right2 7,c7 after making the amendments required by subparagraph 7,b71 by striking ,a person is subject and inserting the following3 7,a7 ,food ,a person is subject 2 and 7,d7 by adding at the end the following3 7,b7 ,importation of drugs ,a person is subject to debarment under paragraph 7#a77;,d7 if-- 7i7 the person has been convicted of a felony for conduct relating to the importation into the ,united ,states of any drug or controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act72 or 7ii7 the person has engaged in a pattern of importing or offering for import articles of drug that are-- 7,i7 7aa7 adulterated1 misbranded1 or in violation of section #eje2 and 7bb7 present a threat of serious adverse health consequences or death to humans or animals2 or 7,,ii7 controlled substances whose importation is prohibited pursuant to section #dja7m7 of the ,tariff ,act of #aicj4 7,c7 ,definition ,for purposes of subparagraph 7,b71 the term pattern of importing or offering for import articles of drug means importing or offering for import articles of drug described in subclause 7,i7 or 7,,ii7 of subparagraph 7,b77ii7 in an amount1 frequency1 or dosage that is inconsistent with personal or household use by the importer4 4 ,u ,creating ,opportunities that ,necessitate ,new and ,enhanced ,connections ,that ,improve ,opioid ,navigation ,strategies #gbja4 ,short title ,this subtitle may be cited as the ,creating ,opportunities that ,necessitate ,new and ,enhanced ,connections ,that ,improve ,opioid ,navigation ,strategies ,act of #bjah or the ,,connections ,act4 #gbjb4 ,preventing overdoses of controlled substances ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#g4 ,preventing overdoses of controlled substances 7a7 ,evidence-,based prevention grants 7#a7 ,in general ,the ,director of the ,centers for ,disease ,control and ,prevention may-- 7,a7 to the extent practicable1 carry out any evidence-based prevention activity described in paragraph 7#b72 7,b7 provide training and technical assistance to ,states1 localities1 and ,indian tribes for purposes of carrying out any such activity2 and 7,c7 award grants to ,states1 localities1 and ,indian tribes for purposes of carrying out any such activity4 7#b7 ,evidence-based prevention activities ,an evidence-based prevention activity described in this paragraph is any of the following activities3 7,a7 ,with respect to a ,state1 improving the efficiency and use of the ,state prescription drug monitoring program by-- 7i7 encouraging all authorized users 7as specified by the ,state7 to register with and use the program and making the program easier to use2 7ii7 enabling such users to access any updates to information collected by the program in as close to real-time as possible2 7iii7 providing for a mechanism for the program to automatically flag any potential misuse or abuse of controlled substances and any detection of inappropriate prescribing practices relating to such substances2 7iv7 enhancing interoperability between the program and any electronic health records system1 including by integrating the use of electronic health records into the program for purposes of improving clinical decisionmaking2 7v7 continually updating program capabilities to respond to technological innovation for purposes of appropriately addressing a controlled substance overdose epidemic as such epidemic may occur and evolve2 7vi7 facilitating data sharing between the program and the prescription drug monitoring programs of neighboring ,states2 and 7vii7 meeting the purpose of the program established under section #cii,o1 as described in section #cii,o7a74 7,b7 ,achieving community or health system interventions through activities such as-- 7i7 establishing or improving controlled substances prescribing interventions for insurers and health systems2 7ii7 enhancing the use of evidence-based controlled substances prescribing guidelines across sectors and health care settings2 and 7iii7 implementing strategies to align the prescription of controlled substances with the guidelines described in clause 7ii74 7,c7 ,evaluating interventions to better understand what works to prevent overdoses1 including those involving prescription and illicit controlled substances4 7,d7 ,implementing projects to advance an innovative prevention approach with respect to new and emerging public health crises and opportunities to address such crises1 such as enhancing public education and awareness on the risks associated with opioids4 7b7 ,enhanced surveillance of controlled substance overdose grants 7#a7 ,in general ,the ,director of the ,centers for ,disease ,control and ,prevention may-- 7,a7 to the extent practicable1 carry out any controlled substance overdose surveillance activity described in paragraph 7#b72 7,b7 provide training and technical assistance to ,states for purposes of carrying out any such activity2 7,c7 award grants to ,states for purposes of carrying out any such activity2 and 7,d7 coordinate with the ,assistant ,secretary for ,mental ,health and ,substance ,use to collect data pursuant to section #eje7;d77#a77;,a7 7relating to the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of alcohol or other drugs74 7#b7 ,controlled substance overdose surveillance activities ,a controlled substance overdose surveillance activity described in this paragraph is any of the following activities3 7,a7 ,enhancing the timeliness of reporting data to the public1 including data on fatal and nonfatal overdoses of controlled substances4 7,b7 ,enhancing comprehensiveness of data on controlled substances overdoses by collecting information on such overdoses from appropriate sources such as toxicology reports1 autopsy reports1 death scene investigations1 and other risk factors4 7,c7 ,using data to help identify risk factors associated with controlled substances overdoses4 7,d7 ,with respect to a ,state1 supporting entities involved in providing information to inform efforts within the ,state1 such as by coroners and medical examiners1 to improve accurate testing and reporting of causes and contributing factors to controlled substances overdoses4 7,e7 ,working to enable information sharing regarding controlled substances overdoses among data sources4 7c7 ,definitions ,in this section3 7#a7 ,controlled substance ,the term controlled substance has the meaning given that term in section #ajb of the ,controlled ,substances ,act4 7#b7 ,indian tribe ,the term ,indian tribe has the meaning given that term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7d7 ,authorization of appropriations ,for purposes of carrying out this section and section #cii,o1 there is authorized to be appropriated #dhf1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 #gbjc4 ,prescription drug monitoring program ,section #cii,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c7 is amended to read as follows3 #cii,o4 ,prescription drug monitoring program 7a7 ,program 7#a7 ,in general ,each fiscal year1 the ,secretary1 in consultation with the ,director of ,national ,drug ,control ,policy1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 the ,assistant ,secretary for ,mental ,health and ,substance ,use1 and the ,national ,coordinator for ,health ,information ,technology1 shall support ,states for the purpose of improving the efficiency and use of ,p,d,m,ps1 including-- 7,a7 establishment and implementation of a ,,pdmp2 7,b7 maintenance of a ,,pdmp2 7,c7 improvements to a ,,pdmp by-- 7i7 enhancing functional components to work toward-- 7,i7 universal use of ,p,d,m,ps among providers and their delegates1 to the extent that ,state laws allow1 within a ,state2 7,,ii7 more timely inclusion of data within a ,,pdmp2 7,,iii7 active management of the ,,pdmp1 in part by sending proactive or unsolicited reports to providers to inform prescribing2 and 7,,iv7 ensuring the highest level of ease in use and access of ,p,d,m,ps by providers and their delegates1 to the extent that ,state laws allow2 7ii7 improving the intrastate interoperability of ,p,d,m,ps by-- 7,i7 making ,p,d,m,ps more actionable by integrating ,p,d,m,ps within electronic health records and health information technology infrastructure2 and 7,,ii7 linking ,,pdmp data to other data systems within the ,state1 including-- 7aa7 the data of pharmacy benefit managers1 medical examiners and coroners1 and the ,state's ,medicaid program2 7bb7 worker's compensation data2 and 7cc7 prescribing data of providers of the ,department of ,veterans ,affairs and the ,indian ,health ,service within the ,state2 7iii7 improving the interstate interoperability of ,p,d,m,ps through-- 7,i7 sharing of dispensing data in near-real time across ,state lines2 and 7,,ii7 integration of automated queries for multistate ,,pdmp data and analytics into clinical workflow to improve the use of such data and analytics by practitioners and dispensers2 or 7iv7 improving the ability to include treatment availability resources and referral capabilities within the ,,pdmp4 7#b7 ,state legislation ,as a condition on the receipt of support under this section1 the ,secretary shall require a ,state to demonstrate that the ,state has enacted legislation or regulations-- 7,a7 to provide for the implementation of the ,,pdmp2 and 7,b7 to permit the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the ,,pdmp4 7b7 ,,pdmp strategies ,the ,secretary shall encourage a ,state1 in establishing1 improving1 or maintaining a ,,pdmp1 to implement strategies that improve-- 7#a7 the reporting of dispensing in the ,state of a controlled substance to an ultimate user so the reporting occurs not later than #bd hours after the dispensing event2 7#b7 the consultation of the ,,pdmp by each prescribing practitioner1 or their designee1 in the ,state before initiating treatment with a controlled substance1 or any substance as required by the ,state to be reported to the ,,pdmp1 and over the course of ongoing treatment for each prescribing event2 7#c7 the consultation of the ,,pdmp before dispensing a controlled substance1 or any substance as required by the ,state to be reported to the ,,pdmp2 7#d7 the proactive notification to a practitioner when patterns indicative of controlled substance misuse by a patient1 including opioid misuse1 are detected2 7#e7 the availability of data in the ,,pdmp to other ,states1 as allowable under ,state law2 and 7#f7 the availability of nonidentifiable information to the ,centers for ,disease ,control and ,prevention for surveillance1 epidemiology1 statistical research1 or educational purposes4 7c7 ,drug misuse and abuse ,in consultation with practitioners1 dispensers1 and other relevant and interested stakeholders1 a ,state receiving support under this section-- 7#a7 shall establish a program to notify practitioners and dispensers of information that will help to identify and prevent the unlawful diversion or misuse of controlled substances2 and 7#b7 may1 to the extent permitted under ,state law1 notify the appropriate authorities responsible for carrying out drug diversion investigations if the ,state determines that information in the ,,pdmp maintained by the ,state indicates an unlawful diversion or abuse of a controlled substance4 7d7 ,evaluation and reporting ,as a condition on receipt of support under this section1 the ,state shall report on interoperability with ,p,d,m,ps of other ,states and ,federal agencies1 where appropriate1 intrastate interoperability with health information technology systems such as electronic health records1 health information exchanges1 and e-prescribing1 where appropriate1 and whether or not the ,state provides automatic1 up-to-date1 or daily information about a patient when a practitioner 7or the designee of a practitioner1 where permitted7 requests information about such patient4 7e7 ,evaluation and reporting ,a ,state receiving support under this section shall provide the ,secretary with aggregate nonidentifiable information1 as permitted by ,state law1 to enable the ,secretary-- 7#a7 to evaluate the success of the ,state's program in achieving the purpose described in subsection 7a72 or 7#b7 to prepare and submit to the ,congress the report required by subsection 7i77#b74 7f7 ,education and access to the monitoring system ,a ,state receiving support under this section shall take steps to-- 7#a7 facilitate prescribers and dispensers1 and their delegates1 as permitted by ,state law1 to use the ,,pdmp1 to the extent practicable2 and 7#b7 educate prescribers and dispensers1 and their delegates on the benefits of the use of ,p,d,m,ps4 7g7 ,electronic format ,the ,secretary may issue guidelines specifying a uniform electronic format for the reporting1 sharing1 and disclosure of information pursuant to ,p,d,m,ps4 7h7 ,rules of construction 7#a7 ,functions otherwise authorized by law ,nothing in this section shall be construed to restrict the ability of any authority1 including any local1 ,state1 or ,federal law enforcement1 narcotics control1 licensure1 disciplinary1 or program authority1 to perform functions otherwise authorized by law4 7#b7 ,additional privacy protections ,nothing in this section shall be construed as preempting any ,state from imposing any additional privacy protections4 7#c7 ,federal privacy requirements ,nothing in this section shall be construed to supersede any ,federal privacy or confidentiality requirement1 including the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia2 #aaj ,stat4 #bjcc7 and section #edc of this ,act4 7#d7 ,no ,federal private cause of action ,nothing in this section shall be construed to create a ,federal private cause of action4 7i7 ,progress report ,not later than #c years after the date of enactment of the ,,connections ,act1 the ,secretary shall-- 7#a7 complete a study that-- 7,a7 determines the progress of ,states in establishing and implementing ,p,d,m,ps consistent with this section2 7,b7 provides an analysis of the extent to which the operation of ,p,d,m,ps has-- 7i7 reduced inappropriate use1 abuse1 diversion of1 and overdose with1 controlled substances2 7ii7 established or strengthened initiatives to ensure linkages to substance use disorder treatment services2 or 7iii7 affected patient access to appropriate care in ,states operating ,p,d,m,ps2 7,c7 determine the progress of ,states in achieving interstate interoperability and intrastate interoperability of ,p,d,m,ps1 including an assessment of technical1 legal1 and financial barriers to such progress and recommendations for addressing these barriers2 7,d7 determines the progress of ,states in implementing near real-time electronic ,p,d,m,ps2 7,e7 provides an analysis of the privacy protections in place for the information reported to the ,,pdmp in each ,state receiving support under this section and any recommendations of the ,secretary for additional ,federal or ,state requirements for protection of this information2 7,f7 determines the progress of ,states in implementing technological alternatives to centralized data storage1 such as peer-to-peer file sharing or data pointer systems1 in ,p,d,m,ps and the potential for such alternatives to enhance the privacy and security of individually identifiable data2 and 7,g7 evaluates the penalties that ,states have enacted for the unauthorized use and disclosure of information maintained in ,p,d,m,ps1 and the criteria used by the ,secretary to determine whether such penalties qualify as appropriate for purposes of subsection 7a77#b72 and 7#b7 submit a report to the ,congress on the results of the study4 7j7 ,advisory council 7#a7 ,establishment ,a ,state may establish an advisory council to assist in the establishment1 improvement1 or maintenance of a ,,pdmp consistent with this section4 7#b7 ,limitation ,a ,state may not use ,federal funds for the operations of an advisory council to assist in the establishment1 improvement1 or maintenance of a ,,pdmp4 7#c7 ,sense of ,congress ,it is the sense of the ,congress that1 in establishing an advisory council to assist in the establishment1 improvement1 or maintenance of a ,,pdmp1 a ,state should consult with appropriate professional boards and other interested parties4 7k7 ,definitions ,for purposes of this section3 7#a7 ,the term controlled substance means a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act7 in schedule ,,ii1 ,,iii1 or ,,iv of section #bjb of such ,act4 7#b7 ,the term dispense means to deliver a controlled substance to an ultimate user by1 or pursuant to the lawful order of1 a practitioner1 irrespective of whether the dispenser uses the internet or other means to effect such delivery4 7#c7 ,the term dispenser means a physician1 pharmacist1 or other person that dispenses a controlled substance to an ultimate user4 7#d7 ,the term interstate interoperability with respect to a ,,pdmp means the ability of the ,,pdmp to electronically share reported information with another ,state if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other ,state1 or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other ,state4 7#e7 ,the term intrastate interoperability with respect to a ,,pdmp means the integration of ,,pdmp data within electronic health records and health information technology infrastructure or linking of a ,,pdmp to other data systems within the ,state1 including the ,state's ,medicaid program1 workers' compensation programs1 and medical examiners or coroners4 7#f7 ,the term nonidentifiable information means information that does not identify a practitioner1 dispenser1 or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner1 dispenser1 or an ultimate user4 7#g7 ,the term ,,pdmp means a prescription drug monitoring program that is ,state-controlled4 7#h7 ,the term practitioner means a physician1 dentist1 veterinarian1 scientific investigator1 pharmacy1 hospital1 or other person licensed1 registered1 or otherwise permitted1 by the ,united ,states or the jurisdiction in which the individual practices or does research1 to distribute1 dispense1 conduct research with respect to1 administer1 or use in teaching or chemical analysis1 a controlled substance in the course of professional practice or research4 7#i7 ,the term ,state means each of the #ej ,states1 the ,district of ,columbia1 and any commonwealth or territory of the ,united ,states4 7#aj7 ,the term ultimate user means a person who has obtained from a dispenser1 and who possesses1 a controlled substance for the person's own use1 for the use of a member of the person's household1 or for the use of an animal owned by the person or by a member of the person's household4 7#aa7 ,the term clinical workflow means the integration of automated queries for prescription drug monitoring programs data and analytics into health information technologies such as electronic health record systems1 health information exchanges1 and_/or pharmacy dispensing software systems1 thus streamlining provider access through automated queries4 4 ,v ,securing ,opioids and ,unused ,narcotics with ,deliberate ,disposal and ,packaging #gbaa4 ,short title ,this subtitle may be cited as the ,securing ,opioids and ,unused ,narcotics with ,deliberate ,disposal and ,packaging ,act of #bjah or the ,,sound ,disposal and ,packaging ,act4 #gbab4 ,improved technologies1 controls1 or measures with respect to the packaging or disposal of certain drugs 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje-a 7#ba ,u4,s4,c4 #cee-a7 the following new section3 #eje-b4 ,safety-enhancing packaging and disposal features 7a7 ,orders 7#a7 ,in general ,the ,secretary may issue an order requiring the holder of a covered application to implement or modify one or more technologies1 controls1 or measures with respect to the packaging or disposal of one or more drugs identified in the covered application1 if the ,secretary determines such technologies1 controls1 or measures to be appropriate to help mitigate the risk of abuse or misuse of such drug or drugs1 which may include by reducing the availability of unused drugs4 7#b7 ,prior consultation ,the ,secretary may not issue an order under paragraph 7#a7 unless the ,secretary has consulted with relevant stakeholders1 through a public meeting1 workshop1 or otherwise1 about matters that are relevant to the subject of the order4 7#c7 ,assuring access and minimizing burden ,technologies1 controls1 or measures required under paragraph 7#a7 shall-- 7,a7 be commensurate with the specific risk of abuse or misuse of the drug listed in the covered application2 7,b7 considering such risk1 not be unduly burdensome on patient access to the drug1 considering in particular any available evidence regarding the expected or demonstrated public health impact of such technologies1 controls1 or measures2 and 7,c7 reduce the risk of abuse or misuse of such drug4 7#d7 ,order contents ,an order issued under paragraph 7#a7 may-- 7,a7 provide for a range of options for implementing or modifying the technologies1 controls1 or measures required to be implemented by such order2 and 7,b7 incorporate by reference standards regarding packaging or disposal set forth in an official compendium1 established by a nationally or internationally recognized standard development organization1 or described on the public website of the ,food and ,drug ,administration1 so long as the order includes the rationale for incorporation of such standard4 7#e7 ,orders applicable to drug class ,when a concern about the risk of abuse or misuse of a drug relates to a pharmacological class1 the ,secretary may1 after consultation with relevant stakeholders1 issue an order under paragraph 7#a7 which applies to the pharmacological class4 7b7 ,compliance ,the holder of a covered application shall-- 7#a7 submit a supplement containing proposed changes to the covered application to comply with an order issued under subsection 7a7 not later than-- 7,a7 #ahj calendar days after the date on which the order is issued2 or 7,b7 7i7 such longer time period as specified by the ,secretary in such order2 or 7ii7 if a request for an alternative date is submitted by the holder of such application not later than #fj calendar days after the date on which such order is issued-- 7,i7 such requested alternative date if agreed to by the ,secretary2 or 7,,ii7 another date as specified by the ,secretary2 and 7#b7 implement the changes approved pursuant to such supplement not later than the later of-- 7,a7 #ij calendar days after the date on which the supplement is approved2 or 7,b7 the end of such longer period as is-- 7i7 determined to be appropriate by the ,secretary2 or 7ii7 approved by the ,secretary pursuant to a request by the holder of the covered application that explains why such longer period is needed1 including to satisfy any other applicable ,federal statutory or regulatory requirements4 7c7 ,alternative measures ,the holder of the covered application may propose1 and the ,secretary shall approve1 technologies1 controls1 or measures regarding packaging1 storage1 or disposal other than those specified in the applicable order issued under subsection 7a71 if such technologies1 controls1 or measures are supported by data and information demonstrating that such alternative technologies1 controls1 or measures can be expected to mitigate the risk of abuse or misuse of the drug or drugs involved1 including by reducing the availability of unused drugs1 to at least the same extent as the technologies1 controls1 or measures specified in such order4 7d7 ,dispute resolution ,if a dispute arises in connection with a supplement submitted under subsection 7b71 the holder of the covered application may appeal a determination made with respect to such supplement using applicable dispute resolution procedures specified by the ,secretary in regulations or guidance4 7e7 ,definitions ,in this section-- 7#a7 the term covered application means an application submitted under subsection 7b7 or 7j7 of section #eje for approval under such section or an application submitted under section #cea of ,public ,health ,service ,act for approval under such section1 with respect to a drug that is or contains an opioid for which a listing in schedule ,,ii or ,,iii 7on a temporary or permanent basis7 is in effect under section #bjb of the ,controlled ,substances ,act2 and 7#b7 the term relevant stakeholders may include scientific experts within the drug manufacturing industry2 brand and generic drug manufacturers2 standard development organizations2 wholesalers and distributors2 payers2 health care providers2 pharmacists2 pharmacies2 manufacturers2 poison centers2 and representatives of the ,national ,institute on ,drug ,abuse1 the ,national ,institutes of ,health1 the ,centers for ,disease ,control and ,prevention1 the ,centers for ,medicare ,medicaid ,services1 the ,drug ,enforcement ,agency1 the ,consumer ,product ,safety ,commission1 individuals who specialize in treating addiction1 and patient and caregiver groups4 4 7b7 ,prohibited acts ,section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is amended by inserting after paragraph 7j7 the following3 7k7 ,if it is a drug approved under a covered application 7as defined in section #eje-b7;e771 the holder of which does not meet the requirements of paragraphs 7#a7 and 7#b7 of subsection 7b7 of such section4 4 7c7 ,required content of an abbreviated new drug application ,section #eje7;j77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a77 is amended-- 7#a7 in clause 7vii77,,iv71 by striking and at the end2 7#b7 in clause 7viii71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7ix7 if the drug is or contains an opioid for which a listing in schedule ,,ii or ,,iii 7on a temporary or permanent basis7 is in effect under section #bjb of the ,controlled ,substances ,act1 information to show that the applicant has proposed technologies1 controls1 or measures related to the packaging or disposal of the drug that provide protections comparable to those provided by the technologies1 controls1 or measures required for the applicable listed drug under section #eje-b1 if applicable4 4 7d7 ,grounds for refusing ,to approve an abbreviated new drug application ,section #eje7;j77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#d771 is amended-- 7#a7 in subparagraph 7,j71 by striking or at the end2 7#b7 in subparagraph 7,k71 by striking the period at the end and inserting 2 or2 and 7#c7 by adding at the end the following3 7,l7 if the drug is a drug described in paragraph 7#b77;,a77ix7 and the applicant has not proposed technologies1 controls1 or measures related to the packaging or disposal of such drug that the ,secretary determines provide protections comparable to those provided by the technologies1 controls1 or measures required for the applicable listed drug under section #eje-b4 4 7e7 ,rules of construction 7#a7 ,any labeling describing technologies1 controls1 or measures related to packaging or disposal intended to mitigate the risk of abuse or misuse of a drug product that is subject to an abbreviated new drug application1 including labeling describing differences from the reference listed drug resulting from the application of section #eje-b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 shall not be construed-- 7,a7 as changes to labeling not permissible under clause 7v7 of section #eje7;j77#b77;,a7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a771 or a change in the conditions of use prescribed1 recommended1 or suggested in the labeling proposed for the new drug under clause 7i7 of such section2 or 7,b7 to preclude approval of an abbreviated new drug application under subparagraph 7,b7 or 7,g7 of section #eje7;j77#d7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#d774 7#b7 ,for a covered application that is an application submitted under subsection 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 subsection 7j77#b77;,a7 of such section #eje shall not be construed to limit the type of data or information the ,secretary of ,health and ,human ,services may request or consider in connection with making any determination under section #eje-b4 7f7 ,,gao report ,not later than #ab months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall prepare and submit to the ,congress a report containing-- 7#a7 a description of available evidence1 if any1 on the effectiveness of site-of-use1 in-home controlled substance disposal products and packaging technologies2 7#b7 identification of ways in which such disposal products intended for use by patients1 consumers1 and other end users that are not registrants under the ,controlled ,substances ,act1 are made available to the public and barriers to the use of such disposal products2 7#c7 identification of ways in which packaging technologies are made available to the public and barriers to the use of such technologies2 7#d7 a description of ,federal oversight1 if any1 of site-of-use1 in-home controlled substance disposal products1 including-- 7,a7 identification of the ,federal agencies that oversee such products2 7,b7 identification of the methods of disposal of controlled substances recommended by these agencies for site-of-use1 in-home disposal2 and 7,c7 a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances2 7#e7 a description of ,federal oversight1 if any1 of controlled substance packaging technologies1 including-- 7,a7 identification of the ,federal agencies that oversee such technologies2 7,b7 identification of the technologies recommended by these agencies1 including unit dose packaging1 packaging that provides a set duration1 or other packaging systems that may mitigate abuse or misuse2 and 7,c7 a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances2 and 7#f7 recommendations on-- 7,a7 whether site-of-use1 in-home controlled substance disposal products and packaging technologies require ,federal oversight and1 if so1 which agencies should be responsible for such oversight and1 as applicable1 approval of such products or technologies2 and 7,b7 the potential role of the ,federal ,government in evaluating such products to ensure product efficacy4 ,w ,postapproval study requirements #gbba4 ,postapproval study requirements 7a7 ,purposes of study ,section #eje7o77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,b77 is amended by adding at the end the following3 7iv7 ,to assess a potential reduction in effectiveness of the drug for the conditions of use prescribed1 recommended1 or suggested in the labeling thereof if-- 7,i7 the drug involved-- 7aa7 is or contains a substance for which a listing in any schedule is in effect 7on a temporary or permanent basis7 under section #bja of the ,controlled ,substances ,act2 or 7bb7 is a drug that has not been approved under this section or licensed under section #cea of the ,public ,health ,service ,act1 for which an application for such approval or licensure is pending or anticipated1 and for which the ,secretary provides notice to the sponsor that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act2 and 7,,ii7 the potential reduction in effectiveness could result in the benefits of the drug no longer outweighing the risks4 4 7b7 ,establishment of requirement ,section #eje7o77#c77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,c77 is amended by striking such requirement and all that follows through safety information4 and inserting the following3 such requirement-- 7i7 in the case of a purpose described in clause 7i71 7ii71 or 7iii7 of subparagraph 7,b71 only if the ,secretary becomes aware of new safety information2 and 7ii7 in the case of a purpose described in clause 7iv7 of such subparagraph1 if the ,secretary determines that new effectiveness information exists4 4 7c7 ,applicability ,section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77 is amended by adding at the end the following new subparagraph3 7,g7 ,applicability ,the conduct of a study or clinical trial required pursuant to this paragraph for the purpose specified in subparagraph 7,b77iv7 shall not be considered a new clinical investigation for the purpose of a period of exclusivity under clause 7iii7 or 7iv7 of subsection 7c77#c77;,e7 or clause 7iii7 or 7iv7 of subsection 7j77#e77;,f74 4 7d7 ,new effectiveness information defined ,section #eje7o77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,new effectiveness information ,the term new effectiveness information1 with respect to a drug that is or contains a controlled substance for which a listing in any schedule is in effect 7on a temporary or permanent basis7 under section #bja of the ,controlled ,substances ,act1 means new information about the effectiveness of the drug1 including a new analysis of existing information1 derived from-- 7i7 a clinical trial2 an adverse event report2 a postapproval study or clinical trial 7including a study or clinical trial under paragraph 7#c772 7ii7 peer-reviewed biomedical literature2 7iii7 data derived from the postmarket risk identification and analysis system under subsection 7k72 or 7iv7 other scientific data determined to be appropriate by the ,secretary4 4 7e7 ,conforming amendments with respect to labeling changes ,section #eje7o77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#d77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 in the heading1 by inserting or new effectiveness after safety2 7,b7 by striking safety information and inserting new safety information or new effectiveness information such2 and 7,c7 by striking believes should be and inserting believes changes should be made to2 7#b7 in subparagraph 7,b77i7-- 7,a7 by striking new safety information and by inserting new safety information or new effectiveness information2 and 7,b7 by inserting indications1 after boxed warnings12 7#c7 in subparagraph 7,c71 by inserting or new effectiveness information after safety information2 and 7#d7 in subparagraph 7,e71 by inserting or new effectiveness information after safety information4 7f7 ,rule of construction ,nothing in the amendments made by this section shall be construed to alter1 in any manner1 the meaning or application of the provisions of paragraph 7#c7 of section #eje7o7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77 with respect to the authority of the ,secretary of ,health and ,human ,services to require a postapproval study or clinical trial for a purpose specified in clauses 7i7 through 7iii7 of subparagraph 7,b7 of such paragraph 7#c7 or paragraph 7#d7 of such section #eje7o7 with respect to the ,secretary's authority to require safety labeling changes4 ,,viii ,miscellaneous ,a ,synthetics ,trafficking and ,overdose ,prevention #hjja4 ,short title2 table of contents ,this subtitle may be cited as the ,synthetics ,trafficking and ,overdose ,prevention ,act of #bjah or ,,stop ,act of #bjah4 #hjjb4 ,customs fees 7a7 ,in general ,section #acjca7;b77#i7 of the ,consolidated ,omnibus ,budget ,reconciliation ,act of #aihe 7#ai ,u4,s4,c4 #eh;c7b77#i77 is amended by adding at the end the following3 7,d7 7i7 ,with respect to the processing of items that are sent to the ,united ,states through the international postal network by ,inbound ,express ,mail service or ,inbound ,,ems 7as that service is described in the mail classification schedule referred to in section #cfca of title #ci1 ,united ,states ,code71 the following payments are required3 7,i7 #a per ,inbound ,,ems item4 7,,ii7 ,if an ,inbound ,,ems item is formally entered1 the fee provided for under subsection 7a77#i71 if applicable4 7ii7 ,notwithstanding section #dea of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #adea71 the payments required by clause 7i71 as allocated pursuant to clause 7iii77,i71 shall be the only payments required for reimbursement of ,u4,s4 ,customs and ,border ,protection for customs services provided in connection with the processing of an ,inbound ,,ems item4 7iii7 7,i7 ,the payments required by clause 7i77,i7 shall be allocated as follows3 7aa7 #ej percent of the amount of the payments shall be paid on a quarterly basis by the ,united ,states ,postal ,service to the ,commissioner of ,u4,s4 ,customs and ,border ,protection in accordance with regulations prescribed by the ,secretary of the ,treasury to reimburse ,u4,s4 ,customs and ,border ,protection for customs services provided in connection with the processing of ,inbound ,,ems items4 7bb7 #ej percent of the amount of the payments shall be retained by the ,postal ,service to reimburse the ,postal ,service for services provided in connection with the customs processing of ,inbound ,,ems items4 7,,ii7 ,payments received by ,u4,s4 ,customs and ,border ,protection under subclause 7,i77aa7 shall1 in accordance with section #ebd of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #aebd71 be deposited in the ,customs ,user ,fee ,account and used to directly reimburse each appropriation for the amount paid out of that appropriation for the costs incurred in providing services to international mail facilities4 ,amounts deposited in accordance with the preceding sentence shall be available until expended for the provision of such services4 7,,iii7 ,payments retained by the ,postal ,service under subclause 7,i77bb7 shall be used to directly reimburse the ,postal ,service for the costs incurred in providing services in connection with the customs processing of ,inbound ,,ems items4 7iv7 ,beginning in fiscal year #bjba1 the ,secretary1 in consultation with the ,postmaster ,general1 may adjust1 not more frequently than once each fiscal year1 the amount described in clause 7i77,i7 to an amount commensurate with the costs of services provided in connection with the customs processing of ,inbound ,,ems items1 consistent with the obligations of the ,united ,states under international agreements4 4 7b7 ,conforming amendments ,section #acjca7;a7 of the ,consolidated ,omnibus ,budget ,reconciliation ,act of #aihe 7#ai ,u4,s4,c4 #eh;c7a77 is amended-- 7#a7 in paragraph 7#f71 by inserting 7other than an item subject to a fee under subsection 7b77#i77;,d77 after customs officer2 and 7#b7 in paragraph 7#aj7-- 7,a7 in subparagraph 7,c71 in the matter preceding clause 7i71 by inserting 7other than ,inbound ,,ems items described in subsection 7b77#i77;,d77 after release2 and 7,b7 in the flush at the end1 by inserting or of ,inbound ,,ems items described in subsection 7b77#i77;,d71 after 7,c714 7c7 ,effective date ,the amendments made by this section shall take effect on ,january #a1 #bjbj4 #hjjc4 ,mandatory advance electronic information for postal shipments 7a7 ,mandatory advance electronic information 7#a7 ,in general ,section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is amended to read as follows3 7,k7 7i7 ,the ,secretary shall prescribe regulations requiring the ,united ,states ,postal ,service to transmit the information described in paragraphs 7#a7 and 7#b7 to the ,commissioner of ,u4,s4 ,customs and ,border ,protection for international mail shipments by the ,postal ,service 7including shipments to the ,postal ,service from foreign postal operators that are transported by private carrier7 consistent with the requirements of this subparagraph4 7ii7 ,in prescribing regulations under clause 7i71 the ,secretary shall impose requirements for the transmission to the ,commissioner of information described in paragraphs 7#a7 and 7#b7 for mail shipments described in clause 7i7 that are comparable to the requirements for the transmission of such information imposed on similar non-mail shipments of cargo1 taking into account the parameters set forth in subparagraphs 7,a7 through 7,j74 7iii7 ,the regulations prescribed under clause 7i7 shall require the transmission of the information described in paragraphs 7#a7 and 7#b7 with respect to a shipment as soon as practicable in relation to the transportation of the shipment1 consistent with subparagraph 7,h74 7iv7 ,regulations prescribed under clause 7i7 shall allow for the requirements for the transmission to the ,commissioner of information described in paragraphs 7#a7 and 7#b7 for mail shipments described in clause 7i7 to be implemented in phases1 as appropriate1 by-- 7,i7 setting incremental targets for increasing the percentage of such shipments for which information is required to be transmitted to the ,commissioner2 and 7,,ii7 taking into consideration-- 7aa7 the risk posed by such shipments2 7bb7 the volume of mail shipped to the ,united ,states by or through a particular country2 and 7cc7 the capacities of foreign postal operators to provide that information to the ,postal ,service4 7v7 7,i7 ,notwithstanding clause 7iv71 the ,postal ,service shall1 not later than ,december #ca1 #bjah1 arrange for the transmission to the ,commissioner of the information described in paragraphs 7#a7 and 7#b7 for not less than #gj percent of the aggregate number of mail shipments1 including #ajj percent of mail shipments from the ,people's ,republic of ,china1 described in clause 7i74 7,,ii7 ,if the requirements of subclause 7,i7 are not met1 the ,comptroller ,general of the ,united ,states shall submit to the appropriate congressional committees1 not later than ,june #cj1 #bjai1 a report-- 7aa7 assessing the reasons for the failure to meet those requirements2 and 7bb7 identifying recommendations to improve the collection by the ,postal ,service of the information described in paragraphs 7#a7 and 7#b74 7vi77,i7 ,notwithstanding clause 7iv71 the ,postal ,service shall1 not later than ,december #ca1 #bjbj1 arrange for the transmission to the ,commissioner of the information described in paragraphs 7#a7 and 7#b7 for #ajj percent of the aggregate number of mail shipments described in clause 7i74 7,,ii7 ,the ,commissioner1 in consultation with the ,postmaster ,general1 may determine to exclude a country from the requirement described in subclause 7,i7 to transmit information for mail shipments described in clause 7i7 from the country if the ,commissioner determines that the country-- 7aa7 does not have the capacity to collect and transmit such information2 7bb7 represents a low risk for mail shipments that violate relevant ,united ,states laws and regulations2 and 7cc7 accounts for low volumes of mail shipments that can be effectively screened for compliance with relevant ,united ,states laws and regulations through an alternate means4 7,,iii7 ,the ,commissioner shall1 at a minimum on an annual basis1 re-evaluate any determination made under subclause 7,,ii7 to exclude a country from the requirement described in subclause 7,i74 ,if1 at any time1 the ,commissioner determines that a country no longer meets the requirements under subclause 7,,ii71 the ,commissioner may not further exclude the country from the requirement described in subclause 7,i74 7,,iv7 ,the ,commissioner shall1 on an annual basis1 submit to the appropriate congressional committees-- 7aa7 a list of countries with respect to which the ,commissioner has made a determination under subclause 7,,ii7 to exclude the countries from the requirement described in subclause 7,i72 and 7bb7 information used to support such determination with respect to such countries4 7vii7 7,i7 ,the ,postmaster ,general shall1 in consultation with the ,commissioner1 refuse any shipments received after ,december #ca1 #bjbj1 for which the information described in paragraphs 7#a7 and 7#b7 is not transmitted as required under this subparagraph1 except as provided in subclause 7,,ii74 7,,ii7 ,if remedial action is warranted in lieu of refusal of shipments pursuant to subclause 7,i71 the ,postmaster ,general and the ,commissioner shall take remedial action with respect to the shipments1 including destruction1 seizure1 controlled delivery or other law enforcement initiatives1 or correction of the failure to provide the information described in paragraphs 7#a7 and 7#b7 with respect to the shipments4 7viii7 ,nothing in this subparagraph shall be construed to limit the authority of the ,secretary to obtain information relating to international mail shipments from private carriers or other appropriate parties4 7ix7 ,in this subparagraph1 the term appropriate congressional committees means-- 7,i7 the ,committee on ,finance and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate2 and 7,,ii7 the ,committee on ,ways and ,means1 the ,committee on ,oversight and ,government ,reform1 and the ,committee on ,homeland ,security of the ,house of ,representatives4 4 7#b7 ,joint strategic plan on mandatory advance information ,not later than #fj days after the date of the enactment of this ,act1 the ,secretary of ,homeland ,security and the ,postmaster ,general shall develop and submit to the appropriate congressional committees a joint strategic plan detailing specific performance measures for achieving-- 7,a7 the transmission of information as required by section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb1 as amended by paragraph 7#a72 and 7,b7 the presentation by the ,postal ,service to ,u4,s4 ,customs and ,border ,protection of all mail targeted by ,u4,s4 ,customs and ,border ,protection for inspection4 7b7 ,capacity building 7#a7 ,in general ,section #cdc7;a7 of the ,trade ,act of #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is amended by adding at the end the following3 7#e7 ,capacity building 7,a7 ,in general ,the ,secretary1 with the concurrence of the ,secretary of ,state1 and in coordination with the ,postmaster ,general and the heads of other ,federal agencies1 as appropriate1 may provide technical assistance1 equipment1 technology1 and training to enhance the capacity of foreign postal operators-- 7i7 to gather and provide the information required by paragraph 7#c77,k72 and 7ii7 to otherwise gather and provide postal shipment information related to-- 7,i7 terrorism2 7,,ii7 items the importation or introduction of which into the ,united ,states is prohibited or restricted1 including controlled substances2 and 7,,iii7 such other concerns as the ,secretary determines appropriate4 7,b7 ,provision of equipment and technology ,with respect to the provision of equipment and technology under subparagraph 7,a71 the ,secretary may lease1 loan1 provide1 or otherwise assist in the deployment of such equipment and technology under such terms and conditions as the ,secretary may prescribe1 including nonreimbursable loans or the transfer of ownership of equipment and technology4 4 7#b7 ,joint strategic plan on capacity building ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,homeland ,security and the ,postmaster ,general shall1 in consultation with the ,secretary of ,state1 jointly develop and submit to the appropriate congressional committees a joint strategic plan-- 7,a7 detailing the extent to which ,u4,s4 ,customs and ,border ,protection and the ,united ,states ,postal ,service are engaged in capacity building efforts under section #cdc7;a77#e7 of the ,trade ,act of #bjjb1 as added by paragraph 7#a72 7,b7 describing plans for future capacity building efforts2 and 7,c7 assessing how capacity building has increased the ability of ,u4,s4 ,customs and ,border ,protection and the ,postal ,service to advance the goals of this subtitle and the amendments made by this subtitle4 7c7 ,report and consultations by ,secretary of ,homeland ,security and ,postmaster ,general 7#a7 ,report ,not later than #ahj days after the date of the enactment of this ,act1 and annually thereafter until #c years after the ,postmaster ,general has met the requirement under clause 7vi7 of subparagraph 7,k7 of section #cdc7;a77#c7 of the ,trade ,act of #bjjb1 as amended by subsection 7a77#a71 the ,secretary of ,homeland ,security and the ,postmaster ,general shall1 in consultation with the ,secretary of ,state1 jointly submit to the appropriate congressional committees a report on compliance with that subparagraph that includes the following3 7,a7 ,an assessment of the status of the regulations required to be promulgated under that subparagraph4 7,b7 ,an update regarding new and existing agreements reached with foreign postal operators for the transmission of the information required by that subparagraph4 7,c7 ,a summary of deliberations between the ,united ,states ,postal ,service and foreign postal operators with respect to issues relating to the transmission of that information4 7,d7 ,a summary of the progress made in achieving the transmission of that information for the percentage of shipments required by that subparagraph4 7,e7 ,an assessment of the quality of that information being received by foreign postal operators1 as determined by the ,secretary of ,homeland ,security1 and actions taken to improve the quality of that information4 7,f7 ,a summary of policies established by the ,universal ,postal ,union that may affect the ability of the ,postmaster ,general to obtain the transmission of that information4 7,g7 ,a summary of the use of technology to detect illicit synthetic opioids and other illegal substances in international mail parcels and planned acquisitions and advancements in such technology4 7,h7 ,such other information as the ,secretary of ,homeland ,security and the ,postmaster ,general consider appropriate with respect to obtaining the transmission of information required by that subparagraph4 7#b7 ,consultations ,not later than #ahj days after the date of the enactment of this ,act1 and every #ahj days thereafter until the ,postmaster ,general has met the requirement under clause 7vi7 of section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb1 as amended by subsection 7a77#a71 to arrange for the transmission of information with respect to #ajj percent of the aggregate number of mail shipments described in clause 7i7 of that section1 the ,secretary of ,homeland ,security and the ,postmaster ,general shall provide briefings to the appropriate congressional committees on the progress made in achieving the transmission of that information for that percentage of shipments4 7d7 ,government ,accountability ,office report ,not later than ,june #cj1 #bjai1 the ,comptroller ,general of the ,united ,states shall submit to the appropriate congressional committees a report-- 7#a7 assessing the progress of the ,united ,states ,postal ,service in achieving the transmission of the information required by subparagraph 7,k7 of section #cdc7;a77#c7 of the ,trade ,act of #bjjb1 as amended by subsection 7a77#a71 for the percentage of shipments required by that subparagraph2 7#b7 assessing the quality of the information received from foreign postal operators for targeting purposes2 7#c7 assessing the specific percentage of targeted mail presented by the ,postal ,service to ,u4,s4 ,customs and ,border ,protection for inspection2 7#d7 describing the costs of collecting the information required by such subparagraph 7,k7 from foreign postal operators and the costs of implementing the use of that information2 7#e7 assessing the benefits of receiving that information with respect to international mail shipments2 7#f7 assessing the feasibility of assessing a customs fee under section #acjca7;b77#i7 of the ,consolidated ,omnibus ,budget ,reconciliation ,act of #aihe1 as amended by section #hjjb1 on international mail shipments other than ,inbound ,express ,mail service in a manner consistent with the obligations of the ,united ,states under international agreements2 and 7#g7 identifying recommendations1 including recommendations for legislation1 to improve the compliance of the ,postal ,service with such subparagraph 7,k71 including an assessment of whether the detection of illicit synthetic opioids in the international mail would be improved by-- 7,a7 requiring the ,postal ,service to serve as the consignee for international mail shipments containing goods2 or 7,b7 designating a customs broker to act as an importer of record for international mail shipments containing goods4 7e7 ,technical correction ,section #cdc of the ,trade ,act of #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is amended in the section heading by striking advanced and inserting advance4 7f7 ,appropriate congressional committees defined ,in this section1 the term appropriate congressional committees means-- 7#a7 the ,committee on ,finance and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate2 and 7#b7 the ,committee on ,ways and ,means1 the ,committee on ,oversight and ,government ,reform1 and the ,committee on ,homeland ,security of the ,house of ,representatives4 #hjjd4 ,international postal agreements 7a7 ,existing agreements 7#a7 ,in general ,in the event that any provision of this subtitle1 or any amendment made by this ,act1 is determined to be in violation of obligations of the ,united ,states under any postal treaty1 convention1 or other international agreement related to international postal services1 or any amendment to such an agreement1 the ,secretary of ,state should negotiate to amend the relevant provisions of the agreement so that the ,united ,states is no longer in violation of the agreement4 7#b7 ,rule of construction ,nothing in this subsection shall be construed to permit delay in the implementation of this subtitle or any amendment made by this subtitle4 7b7 ,future agreements 7#a7 ,consultations ,before entering into1 on or after the date of the enactment of this ,act1 any postal treaty1 convention1 or other international agreement related to international postal services1 or any amendment to such an agreement1 that is related to the ability of the ,united ,states to secure the provision of advance electronic information by foreign postal operators1 the ,secretary of ,state should consult with the appropriate congressional committees 7as defined in section #hjjc7;f774 7#b7 ,expedited negotiation of new agreement ,to the extent that any new postal treaty1 convention1 or other international agreement related to international postal services would improve the ability of the ,united ,states to secure the provision of advance electronic information by foreign postal operators as required by regulations prescribed under section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb1 as amended by section #hjjc7;a77#a71 the ,secretary of ,state should expeditiously conclude such an agreement4 #hjje4 ,cost recoupment 7a7 ,in general ,the ,united ,states ,postal ,service shall1 to the extent practicable and otherwise recoverable by law1 ensure that all costs associated with complying with this subtitle and amendments made by this subtitle are charged directly to foreign shippers or foreign postal operators4 7b7 ,costs not considered revenue ,the recovery of costs under subsection 7a7 shall not be deemed revenue for purposes of subchapter ,i and ,,ii of chapter #cf of title #ci1 ,united ,states ,code1 or regulations prescribed under that chapter4 #hjjf4 ,development of technology to detect illicit narcotics 7a7 ,in general ,the ,postmaster ,general and the ,commissioner of ,u4,s4 ,customs and ,border ,protection1 in coordination with the heads of other agencies as appropriate1 shall collaborate to identify and develop technology for the detection of illicit fentanyl1 other synthetic opioids1 and other narcotics and psychoactive substances entering the ,united ,states by mail4 7b7 ,outreach to private sector ,the ,postmaster ,general and the ,commissioner shall conduct outreach to private sector entities to gather information regarding the current state of technology to identify areas for innovation relating to the detection of illicit fentanyl1 other synthetic opioids1 and other narcotics and psychoactive substances entering the ,united ,states4 #hjjg4 ,civil penalties for postal shipments ,section #dcf of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #adcf7 is amended by adding at the end the following new subsection3 7e7 ,civil penalties for postal shipments 7#a7 ,civil penalty ,a civil penalty shall be imposed against the ,united ,states ,postal ,service if the ,postal ,service accepts a shipment in violation of section #cdc7;a77#c77,k77vii77,i7 of the ,trade ,act of #bjjb4 7#b7 ,modification of civil penalty 7,a7 ,in general ,u4,s4 ,customs and ,border ,protection shall reduce or dismiss a civil penalty imposed pursuant to paragraph 7#a7 if ,u4,s4 ,customs and ,border ,protection determines that the ,united ,states ,postal ,service-- 7i7 has a low error rate in compliance with section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb2 7ii7 is cooperating with ,u4,s4 ,customs and ,border ,protection with respect to the violation of section #cdc7;a77#c77,k77vii77,i7 of the ,trade ,act of #bjjb2 or 7iii7 has taken remedial action to prevent future violations of section #cdc7;a77#c77,k77vii77,i7 of the ,trade ,act of #bjjb4 7,b7 ,written notification ,u4,s4 ,customs and ,border ,protection shall issue a written notification to the ,postal ,service with respect to each exercise of the authority of subparagraph 7,a7 to reduce or dismiss a civil penalty imposed pursuant to paragraph 7#a74 7#c7 ,ongoing lack of compliance ,if ,u4,s4 ,customs and ,border ,protection determines that the ,united ,states ,postal ,service-- 7,a7 has repeatedly committed violations of section #cdc7;a77#c77,k77vii77,i7 of the ,trade ,act of #bjjb1 7,b7 has failed to cooperate with ,u4,s4 ,customs and ,border ,protection with respect to violations of section #cdc7;a77#c77,k77vii77,i7 of the ,trade ,act of #bjjb1 and 7,c7 has an increasing error rate in compliance with section #cdc7;a77#c77,k7 of the ,trade ,act of #bjjb1 civil penalties may be imposed against the ,united ,states ,postal ,service until corrective action1 satisfactory to ,u4,s4 ,customs and ,border ,protection1 is taken4 4 #hjjh4 ,report on violations of arrival1 reporting1 entry1 and clearance requirements and falsity or lack of manifest 7a7 ,in general ,the ,commissioner of ,u4,s4 ,customs and ,border ,protection shall submit to the appropriate congressional committees an annual report that contains the information described in subsection 7b7 with respect to each violation of section #dcf of the ,tariff ,act of #aicj 7#ai ,u4,s4,c4 #adcf71 as amended by section #hjjg1 and section #ehd of such ,act 7#ai ,u4,s4,c4 #aehd7 that occurred during the previous year4 7b7 ,information described ,the information described in this subsection is the following3 7#a7 ,the name and address of the violator4 7#b7 ,the specific violation that was committed4 7#c7 ,the location or port of entry through which the items were transported4 7#d7 ,an inventory of the items seized1 including a description of the items and the quantity seized4 7#e7 ,the location from which the items originated4 7#f7 ,the entity responsible for the apprehension or seizure1 organized by location or port of entry4 7#g7 ,the amount of penalties assessed by ,u4,s4 ,customs and ,border ,protection1 organized by name of the violator and location or port of entry4 7#h7 ,the amount of penalties that ,u4,s4 ,customs and ,border ,protection could have levied1 organized by name of the violator and location or port of entry4 7#i7 ,the rationale for negotiating lower penalties1 organized by name of the violator and location or port of entry4 7c7 ,appropriate congressional committees defined ,in this section1 the term appropriate congressional committees means-- 7#a7 the ,committee on ,finance and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate2 and 7#b7 the ,committee on ,ways and ,means1 the ,committee on ,oversight and ,government ,reform1 and the ,committee on ,homeland ,security of the ,house of ,representatives4 #hjji4 ,effective date2 regulations 7a7 ,effective date ,this subtitle and the amendments made by this subtitle 7other than the amendments made by section #hjjb7 shall take effect on the date of the enactment of this ,act4 7b7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 such regulations as are necessary to carry out this subtitle and the amendments made by this subtitle shall be prescribed4 ,b ,recognizing ,early ,childhood ,trauma ,related to ,substance ,abuse #hjaa4 ,short title ,this subtitle may be cited as the ,recognizing ,early ,childhood ,trauma ,related to ,substance ,abuse ,act of #bjah4 #hjab4 ,recognizing ,early ,childhood ,trauma ,related to ,substance ,abuse 7a7 ,dissemination of information ,the ,secretary of ,health and ,human ,services shall disseminate information1 resources1 and1 if requested1 technical assistance to early childhood care and education providers and professionals working with young children on-- 7#a7 ways to properly recognize children who may be impacted by trauma related to substance abuse by a family member or other adult2 and 7#b7 how to respond appropriately in order to provide for the safety and well-being of young children and their families4 7b7 ,goals ,the information1 resources1 and technical assistance provided under subsection 7a7 shall-- 7#a7 educate early childhood care and education providers and professionals working with young children on understanding and identifying the early signs and risk factors of children who might be impacted by trauma due to exposure to substance abuse2 7#b7 suggest age-appropriate communication tools1 procedures1 and practices for trauma-informed care1 including ways to prevent or mitigate the effects of trauma2 7#c7 provide options for responding to children impacted by trauma due to exposure to substance abuse that consider the needs of the child and family1 including recommending resources and referrals for evidence-based services to support such family2 and 7#d7 promote whole-family and multi-generational approaches to prevent separation and support re-unification of families whenever possible and in the best interest of the child4 7c7 ,rule of construction ,such information1 resources1 and if applicable1 technical assistance1 shall not be construed to amend the requirements under-- 7#a7 the ,child ,care and ,development ,block ,grant ,act of #aiij 7#db ,u4,s4,c4 #iheh et seq472 7#b7 the ,head ,start ,act 7#db ,u4,s4,c4 #ihca et seq472 or 7#c7 the ,individuals with ,disabilities ,education ,act 7#bj ,u4,s4,c4 #adjj et seq474 ,c ,assisting ,states' ,implementation of ,plans of ,safe ,care #hjba4 ,short title ,this subtitle may be cited as the ,assisting ,states' ,implementation of ,plans of ,safe ,care ,act4 #hjbb4 ,assisting ,states with implementation of plans of safe care 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall provide written guidance and1 if appropriate1 technical assistance to support ,states in complying with1 and implementing1 subsections 7b77#b77;,b77iii7 and 7d77#ah7 of section #ajf of the ,child ,abuse ,prevention and ,treatment ,act 7#db ,u4,s4,c4 #eajf;a7 in order to promote better protections for young children and family-centered responses4 7b7 ,requirements ,the guidance and technical assistance shall-- 7#a7 enhance ,states' understanding of requirements and flexibilities under the law1 including clarifying key terms2 7#b7 address ,state-identified challenges with developing1 implementing1 and monitoring plans of safe care2 7#c7 disseminate best practices related to developing and implementing plans of safe care1 including differential response1 collaboration and coordination1 and identification and delivery of services1 while recognizing needs of different populations and varying community approaches across ,states2 7#d7 support collaboration between health care providers1 social service agencies1 public health agencies1 and the child welfare system1 to promote a family-centered treatment approach2 7#e7 prevent separation and support reunification of families if in the best interests of the child2 7#f7 recommend treatment approaches for serving infants1 pregnant women1 and postpartum women whose infants may be affected by substance use that are designed to keep infants with their mothers and families whenever appropriate1 including recommendations to encourage pregnant women to receive health and other support services during pregnancy2 7#g7 support ,state efforts to develop technology systems to manage and monitor implementation of plans of safe care2 and 7#h7 help ,states improve the long-term safety and well-being of young children and their families4 7c7 ,construction ,the guidance and technical assistance shall not be construed to amend the requirements of the ,child ,abuse ,prevention and ,treatment ,act 7#db ,u4,s4,c4 #eaja et seq474 7d7 ,definition ,for purposes of this section1 the term ,state has the meaning given such term in section #c of the ,child ,abuse ,prevention and ,treatment ,act 7#db ,u4,s4,c4 #eaja note74 ,d ,improving the ,federal ,response to ,families ,impacted by ,substance ,use ,disorder #hjca4 ,short title ,this subtitle may be cited as the ,improving the ,federal ,response to ,families ,impacted by ,substance ,use ,disorder ,act4 #hjcb4 ,interagency ,task ,force to ,improve the ,federal ,response to ,families ,impacted by ,substance ,use ,disorders 7a7 ,establishment ,there is established a task force1 to be known as the ,interagency ,task ,force to ,improve the ,federal ,response to ,families ,impacted by ,substance ,use ,disorders 7in this section referred to as 8,task ,force074 7b7 ,responsibilities ,the ,task ,force-- 7#a7 shall identify1 evaluate1 and recommend ways in which ,federal agencies can better coordinate responses to substance use disorders and the opioid crisis2 and 7#b7 shall carry out the additional duties described in subsection 7d74 7c7 ,membership 7#a7 ,number and appointment ,the ,task ,force shall be composed of #ab ,federal officials having responsibility for1 or administering programs related to1 the duties of the ,task ,force4 ,the ,secretary of ,health and ,human ,services1 the ,secretary of ,education1 the ,secretary of ,agriculture1 and the ,secretary of ,labor shall each appoint two members to the ,task ,force from among the ,federal officials employed by the ,department of which they are the head4 ,additional ,federal agency officials appointed by the ,secretary of ,health and ,human ,services shall fill the remaining positions of the ,task ,force4 7#b7 ,chairperson ,the ,secretary of ,health and ,human ,services shall designate a ,federal official employed by the ,department of ,health and ,human ,services to serve as the chairperson of the ,task ,force4 7#c7 ,deadline for appointment ,each member shall be appointed to the ,task ,force not later than #fj days after the date of the enactment of this ,act4 7#d7 ,additional agency input ,the ,task ,force may seek input from other ,federal agencies and offices with experience1 expertise1 or information relevant in responding to the opioid crisis4 7#e7 ,vacancies ,a vacancy in the ,task ,force shall be filled in the manner in which the original appointment was made4 7#f7 ,prohibition of compensation ,members of the ,task ,force may not receive pay1 allowances1 or benefits by reason of their service on the ,task ,force4 7d7 ,duties ,the ,task ,force shall carry out the following duties3 7#a7 ,solicit input from stakeholders1 including frontline service providers1 medical professionals1 educators1 mental health professionals1 researchers1 experts in infant1 child1 and youth trauma1 child welfare professionals1 and the public1 in order to inform the activities of the ,task ,force4 7#b7 ,develop a strategy on how the ,task ,force and participating ,federal agencies will collaborate1 prioritize1 and implement a coordinated ,federal approach with regard to responding to substance use disorders1 including opioid misuse1 that shall include-- 7,a7 identifying options for the coordination of existing grants that support infants1 children1 and youth1 and their families as appropriate1 who have experienced1 or are at risk of experiencing1 exposure to substance abuse disorders1 including opioid misuse2 and 7,b7 other ways to improve coordination1 planning1 and communication within and across ,federal agencies1 offices1 and programs1 to better serve children and families impacted by substance use disorders1 including opioid misuse4 7#c7 ,based off the strategy developed under paragraph 7#b71 evaluate and recommend opportunities for local- and ,state-level partnerships1 professional development1 or best practices that-- 7,a7 are designed to quickly identify and refer children and families1 as appropriate1 who have experienced or are at risk of experiencing exposure to substance abuse2 7,b7 utilize and develop partnerships with early childhood education programs1 local social services organizations1 and health care services aimed at preventing or mitigating the effects of exposure to substance use disorders1 including opioid misuse2 7,c7 offer community-based prevention activities1 including educating families and children on the effects of exposure to substance use disorders1 including opioid misuse1 and how to build resilience and coping skills to mitigate those effects2 7,d7 in accordance with ,federal privacy protections1 utilize non-personally identifiable data from screenings1 referrals1 or the provision of services and supports to evaluate and improve processes addressing exposure to substance use disorders1 including opioid misuse2 and 7,e7 are designed to prevent separation and support reunification of families if in the best interest of the child4 7#d7 ,in fulfilling the requirements of paragraphs 7#b7 and 7#c71 consider evidence-based1 evidence-informed1 and promising best practices related to identifying1 referring1 and supporting children and families at risk of experiencing exposure to substance abuse or experiencing substance use disorder1 including opioid misuse1 including-- 7,a7 prevention strategies for those at risk of experiencing or being exposed to substance abuse1 including misuse of opioids2 7,b7 whole-family and multi-generational approaches2 7,c7 community-based initiatives2 7,d7 referral to1 and implementation of1 trauma-informed practices and supports2 and 7,e7 multi-generational practices that assist parents1 foster parents1 and kinship and other caregivers 7e7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app4 #b7 shall not apply to the ,task ,force4 7f7 ,action plan2 reports ,the ,task ,force-- 7#a7 shall prepare a detailed action plan to be implemented by participating ,federal agencies to create a collaborative1 coordinated response to the opioid crisis1 which shall include-- 7,a7 relevant information identified and collected under subsection 7d72 7,b7 a proposed timeline for implementing recommendations and efforts identified under subsection 7d72 and 7,c7 a description of how other ,federal agencies and offices with experience1 expertise1 or information relevant in responding to the opioid crisis that have provided input under subsection 7c77#d7 will be participating in the coordinated approach2 7#b7 shall submit to the ,congress a report describing the action plan prepared under paragraph 7#a71 including1 where applicable1 identification of any recommendations included in such plan that require additional legislative authority to implement2 and 7#c7 shall submit a report to the ,governors describing the opportunities for local- and ,state-level partnerships1 professional development1 or best practices recommended under subsection 7d77#c74 7g7 ,dissemination 7#a7 ,in general ,the action plan and reports required under subsection 7f7 shall be-- 7,a7 disseminated widely1 including among the participating ,federal agencies and the ,governors2 and 7,b7 be made publicly available online in an accessible format4 7#b7 ,deadline ,the action plan and reports required under subsection 7f7 may be released on separate dates but shall be released not later than #i months after the date of the enactment of this ,act4 7h7 ,termination ,the ,task ,force shall terminate #cj days after the dissemination of the action plan and reports under subsection 7g74 7i7 ,funding ,the administrative expenses of the ,task ,force shall be paid out of existing ,department of ,health and ,human ,services funds or appropriations4 7j7 ,definitions ,for purposes of this section3 7#a7 ,the term ,governor means the chief executive officer of a ,state4 7#b7 ,the term participating ,federal agencies means all the ,executive agencies 7as defined in section #aje of title #e1 ,united ,states ,code7 whose officials have been appointed to the ,task ,force4 7#c7 ,the term ,state means each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 and the ,commonwealth of the ,northern ,mariana ,islands4 ,e ,establishment of an ,advisory ,committee on ,opioids and the ,workplace #hjda4 ,establishment of an ,advisory ,committee on ,opioids and the ,workplace 7a7 ,establishment ,not later than #ij days after enactment of this ,act1 the ,secretary of ,labor shall establish an ,advisory ,committee on ,opioids and the ,workplace 7referred to in this subtitle as the ,advisory ,committee7 to advise the ,secretary on actions the ,department of ,labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids4 7b7 ,membership 7#a7 ,composition ,the ,secretary of ,labor shall appoint as members of the ,advisory ,committee #ai individuals with expertise in employment1 workplace health programs1 human resources1 substance use disorder1 and other relevant fields4 ,the ,advisory ,committee shall be composed as follows3 7,a7 ,four of the members shall be individuals representative of employers or other organizations representing employers4 7,b7 ,four of the members shall be individuals representative of workers or other organizations representing workers1 of which at least two must be representatives designated by labor organizations4 7,c7 ,three of the members shall be individuals representative of health benefit plans1 employee assistance plan providers1 workers' compensation program administrators1 and workplace safety and health professionals4 7,d7 ,eight of the members shall be individuals representative of substance abuse treatment and recovery experts1 including medical doctors1 licensed addiction therapists1 and scientific and academic researchers1 of which one individual may be a representative of a local or ,state government agency that oversees or coordinates programs that address substance use disorder4 7#b7 ,chair ,from the members appointed under paragraph 7#a71 the ,secretary of ,labor shall appoint a chairperson4 7#c7 ,terms ,each member of the ,advisory ,committee shall serve for a term of #c years4 ,a member appointed to fill a vacancy shall be appointed only for the remainder of such term4 7#d7 ,quorum ,a majority of members of the ,advisory ,committee shall constitute a quorum and action shall be taken only by a majority vote of the members4 7#e7 ,voting ,the ,advisory ,committee shall establish voting procedures4 7#f7 ,no compensation ,members of the ,advisory ,committee shall serve without compensation4 7#g7 ,disclosure ,every member of the ,advisory ,committee must disclose the entity1 if applicable1 that he or she is representing4 7c7 ,duties 7#a7 ,advisement 7,a7 ,in general ,the ,advisory ,committee established under subsection 7a7 shall advise the ,secretary of ,labor on actions the ,department of ,labor can take to provide informational resources and best practices on how to appropriately address the impact of opioid abuse on the workplace and support workers abusing opioids4 7,b7 ,considerations ,in providing such advice1 the ,advisory ,committee shall take into account-- 7i7 evidence-based and other employer substance abuse policies and best practices regarding opioid use or abuse1 including benefits provided by employee assistance programs or other employer-provided benefits1 programs1 or resources2 7ii7 the effect of opioid use or abuse on the safety of the workplace as well as policies and procedures addressing workplace safety and health2 7iii7 the impact of opioid abuse on productivity and absenteeism1 and assessments of model human resources policies that support workers abusing opioids1 such as policies that facilitate seeking and receiving treatment and returning to work2 7iv7 the extent to which alternative pain management treatments other than opioids are or should be covered by employer-sponsored health plans2 7v7 the legal requirements protecting employee privacy and health information in the workplace1 as well as the legal requirements related to nondiscrimination2 7vi7 potential interactions of opioid abuse with other substance use disorders2 7vii7 any additional benefits or resources available to an employee abusing opioids that promote retaining employment or reentering the workforce2 7viii7 evidence-based initiatives that engage employers1 employees1 and community leaders to promote early identification of opioid abuse1 intervention1 treatment1 and recovery2 7ix7 workplace policies regarding opioid abuse that reduce stigmatization among fellow employees and management2 and 7x7 the legal requirements of the ,mental ,health ,parity and ,addiction ,equity ,act and other laws related to health coverage of substance abuse and mental health services and medications4 7#b7 ,report ,prior to its termination as provided in subsection 7j71 the ,advisory ,committee shall issue a report to the ,secretary of ,labor and to the ,committee on ,education and the ,workforce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 detailing successful programs and policies involving workplace resources and benefits1 including recommendations or examples of best practices for how employers can support and respond to employees impacted by opioid abuse4 7d7 ,meetings ,the ,advisory ,committee shall meet at least twice a year at the call of the chairperson4 7e7 ,staff support ,the ,secretary of ,labor shall make available staff necessary for the ,advisory ,committee to carry out its responsibilities4 7f7 ,federal ,advisory ,committee ,act ,the ,federal ,advisory ,committee ,act shall apply to the ,advisory ,committee established under this subtitle4 7g7 ,no appropriated funds ,no additional funds are authorized to be appropriated to carry out this subtitle4 ,expenses of the ,advisory ,committee shall be paid with funds otherwise appropriated to ,departmental ,management within the ,department of ,labor4 7h7 ,ex officio ,three nonvoting representatives from agencies within the ,department of ,health and ,human ,services whose responsibilities include opioid prescribing guidelines1 workplace safety1 and monitoring of substance abuse and prevention programs shall be appointed by the ,secretary of ,labor and designated as ex officio members4 7i7 ,agenda ,the ,secretary of ,labor or a representative of the ,secretary shall consult with the ,chair in establishing the agenda for ,committee meetings4 7j7 ,termination ,the ,advisory ,committee established under this subtitle shall terminate #c years after the date of enactment of this ,act4 ,f ,veterans ,treatment ,court ,improvement #hjea4 ,short title ,this subtitle may be cited as the ,veterans ,treatment ,court ,improvement ,act of #bjah4 #hjeb4 ,hiring by ,department of ,veterans ,affairs of additional ,veterans ,justice ,outreach ,specialists 7a7 ,hiring of additional ,veterans ,justice ,outreach ,specialists 7#a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,veterans ,affairs shall hire not fewer than #ej ,veterans ,justice ,outreach ,specialists and place each such ,veterans ,justice ,outreach ,specialist at an eligible ,department of ,veterans ,affairs medical center in accordance with this section4 7#b7 ,requirements ,the ,secretary shall ensure that each ,veterans ,justice ,outreach ,specialist employed under paragraph 7#a7-- 7,a7 serves1 either exclusively or in addition to other duties1 as part of a justice team in a veterans treatment court or other veteran-focused court2 and 7,b7 otherwise meets ,department hiring guidelines for ,veterans ,justice ,outreach ,specialists4 7b7 ,eligible ,department of ,veterans ,affairs medical centers ,for purposes of this section1 an eligible ,department of ,veterans ,affairs medical center is any ,department of ,veterans ,affairs medical center that-- 7#a7 complies with all ,department guidelines and regulations for placement of a ,veterans ,justice ,outreach ,specialist2 7#b7 works within a local criminal justice system with justice-involved veterans2 7#c7 maintains an affiliation with one or more veterans treatment courts or other veteran-focused courts2 and 7#d7 either-- 7,a7 routinely provides ,veterans ,justice ,outreach ,specialists to serve as part of a justice team in a veterans treatment court or other veteran-focused court2 or 7,b7 establishes a plan that is approved by the ,secretary to provide ,veterans ,justice ,outreach ,specialists employed under subsection 7a77#a7 to serve as part of a justice team in a veterans treatment court or other veteran-focused court4 7c7 ,placement priority ,the ,secretary shall prioritize the placement of ,veterans ,justice ,outreach ,specialists employed under subsection 7a77#a7 at eligible ,department of ,veterans ,affairs medical centers that have or intend to establish an affiliation1 for the purpose of carrying out the ,veterans ,justice ,outreach ,program1 with a veterans treatment court1 or other veteran-focused court1 that-- 7#a7 was established on or after the date of the enactment of this ,act2 or 7#b7 7,a7 was established before the date of the enactment of this ,act2 and 7,b7 is not fully staffed with ,veterans ,justice ,outreach ,specialists4 7d7 ,reports 7#a7 ,report by ,secretary of ,veterans ,affairs 7,a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,veterans ,affairs shall submit to ,congress a report on the implementation of this section and its effect on the ,veterans ,justice ,outreach ,program4 7,b7 ,contents ,the report submitted under paragraph 7#a7 shall include the following3 7i7 ,the status of the efforts of the ,secretary to hire ,veterans ,justice ,outreach ,specialists pursuant to subsection 7a77#a71 including the total number of ,veterans ,justice ,outreach ,specialists hired by the ,secretary pursuant to such subsection and the number that the ,secretary expects to hire pursuant to such subsection4 7ii7 ,the total number of ,veterans ,justice ,outreach ,specialists assigned to each ,department of ,veterans ,affairs medical center that participates in the ,veterans ,justice ,outreach ,program1 including the number of ,veterans ,justice ,outreach ,specialists hired under subsection 7a77#a7 disaggregated by ,department of ,veterans ,affairs medical center4 7iii7 ,the total number of eligible ,department of ,veterans ,affairs medical centers that sought placement of a ,veterans ,justice ,outreach ,specialist under subsection 7a77#a71 how many ,veterans ,justice ,outreach ,specialists each such center sought1 and how many of such medical centers received no placement of a ,veterans ,justice ,outreach ,specialist under subsection 7a77#a74 7iv7 ,for each eligible ,department of ,veterans ,affairs medical center-- 7,i7 the number of justice-involved veterans who were served or are expected to be served by a ,veterans ,justice ,outreach ,specialist hired under subsection 7a77#a72 and 7,,ii7 the number of justice-involved veterans who do not have access to a ,veterans ,justice ,outreach ,specialist4 7#b7 ,report by ,comptroller ,general of the ,united ,states 7,a7 ,in general ,not later than #c years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the implementation of this section and the effectiveness of the ,veterans ,justice ,outreach ,program4 7,b7 ,contents ,the report required by subparagraph 7,a7 shall include the following3 7i7 ,an assessment of whether the ,secretary has fulfilled the ,secretary's obligations under this section4 7ii7 ,the number of veterans who are served by ,veterans ,justice ,outreach ,specialists hired under subsection 7a77#a71 disaggregated by demographics 7including discharge status74 7iii7 ,an identification of any subgroups of veterans who underutilize services provided under laws administered by the ,secretary1 including an assessment of whether these veterans have access to ,veterans ,justice ,outreach ,specialists under the ,veterans ,justice ,outreach ,program4 7iv7 ,such recommendations as the ,comptroller ,general may have for the ,secretary to improve the effectiveness of the ,veterans ,justice ,outreach ,program4 7e7 ,definitions ,in this section3 7#a7 ,justice team ,the term justice team means the group of individuals1 which may include a judge1 court coordinator1 prosecutor1 public defender1 treatment provider1 probation or other law enforcement officer1 program mentor1 and ,veterans ,justice ,outreach ,specialist1 who assist justice-involved veterans in a veterans treatment court or other veteran-focused court4 7#b7 ,justice-involved veteran ,the term justice-involved veteran means a veteran with active1 ongoing1 or recent contact with some component of a local criminal justice system4 7#c7 ,local criminal justice system ,the term local criminal justice system means law enforcement1 jails1 prisons1 and ,federal1 ,state1 and local courts4 7#d7 ,veterans ,justice ,outreach ,program ,the term ,veterans ,justice ,outreach ,program means the program through which the ,department of ,veterans ,affairs identifies justice-involved veterans and provides such veterans with access to ,department services4 7#e7 ,veterans ,justice ,outreach ,specialist ,the term ,veterans ,justice ,outreach ,specialist means an employee of the ,department of ,veterans ,affairs who serves as a liaison between the ,department and the local criminal justice system on behalf of a justice-involved veteran4 7#f7 ,veterans treatment court ,the term veterans treatment court means a ,state or local court that is participating in the veterans treatment court program 7as defined in section #biia7;i77#a7 of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#db ,u4,s4,c4 #cgig;aa7i77#a7774 ,g ,peer support counseling program for women veterans #hjfa4 ,peer support counseling program for women veterans 7a7 ,in general ,section #agbj;,f7j7 of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new paragraph3 7#d7 7,a7 ,as part of the counseling program under this subsection1 the ,secretary shall emphasize appointing peer support counselors for women veterans4 ,to the degree practicable1 the ,secretary shall seek to recruit women peer support counselors with expertise in-- 7i7 female gender-specific issues and services2 7ii7 the provision of information about services and benefits provided under laws administered by the ,secretary2 or 7iii7 employment mentoring4 7,b7 ,to the degree practicable1 the ,secretary shall emphasize facilitating peer support counseling for women veterans who are eligible for counseling and services under section #agbj;,d of this title1 have post-traumatic stress disorder or suffer from another mental health condition1 are homeless or at risk of becoming homeless1 or are otherwise at increased risk of suicide1 as determined by the ,secretary4 7,c7 ,the ,secretary shall conduct outreach to inform women veterans about the program and the assistance available under this paragraph4 7,d7 ,in carrying out this paragraph1 the ,secretary shall coordinate with such community organizations1 ,state and local governments1 institutions of higher education1 chambers of commerce1 local business organizations1 organizations that provide legal assistance1 and other organizations as the ,secretary considers appropriate4 7,e7 ,in carrying out this paragraph1 the ,secretary shall provide adequate training for peer support counselors1 including training carried out under the national program of training required by section #cjd7;c7 of the ,caregivers and ,veterans ,omnibus ,health ,services ,act of #bjaj 7#ch ,u4,s4,c4 #agab;,a note74 4 7b7 ,funding ,the ,secretary of ,veterans ,affairs shall carry out paragraph 7#d7 of section #agbj;,f7j7 of title #ch1 ,united ,states ,code1 as added by subsection 7a71 using funds otherwise made available to the ,secretary4 ,no additional funds are authorized to be appropriated by reason of such paragraph4 7c7 ,report to ,congress ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of ,veterans ,affairs shall submit to the ,committees on ,veterans' ,affairs of the ,senate and ,house of ,representatives a report on the peer support counseling program under section #agbj;,f7j7 of title #ch1 ,united ,states ,code1 as amended by this section4 ,such report shall include-- 7#a7 the number of peer support counselors in the program2 7#b7 an assessment of the effectiveness of the program2 and 7#c7 a description of the oversight of the program4 ,h ,treating ,barriers to ,prosperity #hjga4 ,short title ,this subtitle may be cited as the ,treating ,barriers to ,prosperity ,act of #bjah4 #hjgb4 ,drug abuse mitigation initiative 7a7 ,in general ,chapter #ade of title #dj1 ,united ,states ,code1 is amended by inserting after section #adeji the following3 #adeaj4 ,drug abuse mitigation initiative 7a7 ,in general ,the ,appalachian ,regional ,commission may provide technical assistance to1 make grants to1 enter into contracts with1 or otherwise provide amounts to individuals or entities in the ,appalachian region for projects and activities to address drug abuse1 including opioid abuse1 in the region1 including projects and activities-- 7#a7 to facilitate the sharing of best practices among ,states1 counties1 and other experts in the region with respect to reducing such abuse2 7#b7 to initiate or expand programs designed to eliminate or reduce the harm to the workforce and economic growth of the region that results from such abuse2 7#c7 to attract and retain relevant health care services1 businesses1 and workers2 and 7#d7 to develop relevant infrastructure1 including broadband infrastructure that supports the use of telemedicine4 7b7 ,limitation on available amounts ,of the cost of any activity eligible for a grant under this section-- 7#a7 not more than #ej percent may be provided from amounts appropriated to carry out this section2 and 7#b7 notwithstanding paragraph 7#a7-- 7,a7 in the case of a project to be carried out in a county for which a distressed county designation is in effect under section #adebf1 not more than #hj percent may be provided from amounts appropriated to carry out this section2 and 7,b7 in the case of a project to be carried out in a county for which an at-risk designation is in effect under section #adebf1 not more than #gj percent may be provided from amounts appropriated to carry out this section4 7c7 ,sources of assistance ,subject to subsection 7b71 a grant provided under this section may be provided from amounts made available to carry out this section in combination with amounts made available-- 7#a7 under any other ,federal program 7subject to the availability of subsequent appropriations72 or 7#b7 from any other source4 7d7 ,federal share ,notwithstanding any provision of law limiting the ,federal share under any other ,federal program1 amounts made available to carry out this section may be used to increase that ,federal share1 as the ,appalachian ,regional ,commission determines to be appropriate4 4 7b7 ,clerical amendment ,the analysis for chapter #ade of title #dj1 ,united ,states ,code1 is amended by inserting after the item relating to section #adeji the following3 #adeaj4 ,drug abuse mitigation initiative4 4 ,i ,supporting ,grandparents ,raising ,grandchildren #hjha4 ,short title ,this subtitle may be cited as the ,supporting ,grandparents ,raising ,grandchildren ,act4 #hjhb4 ,findings ,congress finds the following3 7#a7 ,more than #b1ejj1jjj grandparents in the ,united ,states are the primary caretaker of their grandchildren1 and experts report that such numbers are increasing as the opioid epidemic expands4 7#b7 ,between #bjji and #bjaf1 the incidence of parental alcohol or other drug use as a contributing factor for children's out-of-home placement rose from #be4d to #cg4d percent4 7#c7 ,when children cannot remain safely with their parents1 placement with relatives is preferred over placement in foster care with nonrelatives because placement with relatives provides stability for children and helps them maintain family connections4 7#d7 ,the number of foster children placed with a grandparent or other relative increased from #bd percent in #bjjf to #cb percent in #bjaf1 according to data from the ,department of ,health and ,human ,services4 7#e7 ,grandparents' lives are enhanced by caring for their grandchildren2 the overwhelming majority of grandparents report experiencing significant benefits in serving as their grandchildren's primary caregivers4 7#f7 ,providing full-time care to their grandchildren may decrease grandparents' ability to address their own physical and mental health needs and personal well-being4 7#g7 ,grandparents would benefit from better coordination and dissemination of information and resources available to support them in their caregiving responsibilities4 #hjhc4 ,advisory ,council ,to ,support ,grandparents ,raising ,grandchildren 7a7 ,establishment ,there is established an ,advisory ,council to ,support ,grandparents ,raising ,grandchildren4 7b7 ,membership 7#a7 ,in general ,the ,advisory ,council shall be composed of the following members1 or their designee3 7,a7 ,the ,secretary of ,health and ,human ,services4 7,b7 ,the ,secretary of ,education4 7,c7 ,the ,administrator of the ,administration for ,community ,living4 7,d7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,e7 ,the ,assistant ,secretary for ,mental ,health and ,substance ,use4 7,f7 ,the ,assistant ,secretary for the ,administration for ,children and ,families4 7,g7 ,a grandparent raising a grandchild4 7,h7 ,an older relative caregiver of children4 7,i7 ,as appropriate1 the head of other ,federal departments1 or agencies1 identified by the ,secretary of ,health and ,human ,services as having responsibilities1 or administering programs1 relating to current issues affecting grandparents or other older relatives raising children4 7#b7 ,lead agency ,the ,department of ,health and ,human ,services shall be the lead agency for the ,advisory ,council4 7c7 ,duties 7#a7 ,in general 7,a7 ,information ,the ,advisory ,council shall identify1 promote1 coordinate1 and disseminate to the public information1 resources1 and the best practices available to help grandparents and other older relatives-- 7i7 meet the health1 educational1 nutritional1 and other needs of the children in their care2 and 7ii7 maintain their own physical and mental health and emotional well-being4 7,b7 ,opioids ,in carrying out the duties described in subparagraph 7,a71 the ,advisory ,council shall consider the needs of those affected by the opioid crisis4 7,c7 ,native ,americans ,in carrying out the duties described in subparagraph 7,a71 the ,advisory ,council shall consider the needs of members of ,native ,american tribes4 7#b7 ,report 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,advisory ,council shall submit a report to-- 7i7 the appropriate committees2 7ii7 the ,state agencies that are responsible for carrying out family caregiver programs2 and 7iii7 the public online in an accessible format4 7,b7 ,report format ,the report shall include-- 7i7 best practices1 resources1 and other useful information for grandparents and other older relatives raising children identified under paragraph 7#a77;,a7 including1 if applicable1 any information related to the needs of children who have been impacted by the opioid epidemic2 7ii7 an identification of any gaps in items under clause 7i72 and 7iii7 where applicable1 identification of any additional ,federal legislative authority necessary to implement the activities described in clause 7i7 and 7ii74 7#c7 ,follow-up report ,not later than #b years after the date on which the report required under paragraph 7#b77;,a7 is submitted1 the ,advisory ,council shall submit a follow-up report that includes the information identified in paragraph 7#b77;,b7 to-- 7,a7 the appropriate committees2 7,b7 the ,state agencies that are responsible for carrying out family caregiver programs2 and 7,c7 the public online in an accessible format4 7#d7 ,public input 7,a7 ,in general ,the ,advisory ,council shall establish a process for public input to inform the development of1 and provide updates to1 the best practices1 resources1 and other information described in paragraph 7#a7 that shall include-- 7i7 outreach to ,states1 local entities1 and organizations that provide information to1 or support for1 grandparents or other older relatives raising children2 and 7ii7 outreach to grandparents and other older relatives with experience raising children4 7,b7 ,nature of outreach ,such outreach shall ask individuals to provide input on-- 7i7 information1 resources1 and best practices available1 including identification of any gaps and unmet needs2 and 7ii7 recommendations that would help grandparents and other older relatives better meet the health1 educational1 nutritional1 and other needs of the children in their care1 as well as maintain their own physical and mental health and emotional well-being4 7d7 ,,faca ,the ,advisory ,council shall be exempt from the requirements of the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7e7 ,funding ,no additional funds are authorized to be appropriated to carry out this subtitle4 7f7 ,sunset ,the ,advisory ,council shall terminate on the date that is #c years after the date of enactment of this ,act4 #hjhd4 ,definitions ,in this subtitle3 7#a7 ,advisory ,council ,in this subtitle1 the term ,advisory ,council means the ,advisory ,council to ,support ,grandparents ,raising ,grandchildren that is established under section #hjhc4 7#b7 ,appropriate committees ,in this subtitle1 the term appropriate committees means the following3 7,a7 ,the ,special ,committee on ,aging of the ,senate4 7,b7 ,the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7,c7 ,the ,committee on ,education and the ,workforce of the ,house of ,representatives4 7,d7 ,the ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,j ,reauthorizing and ,extending ,grants for ,recovery from ,opioid ,use ,programs #hjia4 ,short title ,this subtitle may be cited as the ,reauthorizing and ,extending ,grants for ,recovery from ,opioid ,use ,programs ,act of #bjah or the ,,regroup ,act of #bjah4 #hjib4 ,reauthorization of the comprehensive opioid abuse grant program ,section #ajja7;a77#bg7 of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbfa7;a77#bg77 is amended by striking through #bjba and inserting and #bjah1 and #ccj1jjj1jjj for each of fiscal years #bjai through #bjbc4 ,,ix ,,sitsa ,act #ijja4 ,short title ,this title may be cited as the ,stop the ,importation and ,trafficking of ,synthetic ,analogues ,act of #bjag or the ,,sitsa ,act4 #ijjb4 ,establishment of schedule ,a ,section #bjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7 is amended-- 7#a7 in subsection 7a71 by striking five schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 and ,v and inserting six schedules of controlled substances1 to be known as schedules ,i1 ,,ii1 ,,iii1 ,,iv1 ,v1 and ,a2 7#b7 in subsection 7b71 by adding at the end the following3 7#f7 ,schedule ,a 7,a7 ,in general ,the drug or substance-- 7i7 has-- 7,i7 a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7,,ii7 an actual or predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 and 7ii7 is not-- 7,i7 listed or otherwise included in any other schedule in this section or by regulation of the ,attorney ,general2 and 7,,ii7 with respect to a particular person1 subject to an exemption that is in effect for investigational use1 for that person1 under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 to the extent conduct with respect to such substance is pursuant to such exemption4 7,b7 ,predicted stimulant1 depressant1 or hallucinogenic effect ,for purpose of this paragraph1 a predicted stimulant1 depressant1 or hallucinogenic effect on the central nervous system may be based on-- 7i7 the chemical structure and-- 7,i7 the structure activity relationships2 or 7,,ii7 binding receptor assays and other relevant scientific information about the substance2 7ii7 7,i7 the current or relative potential for abuse of the substance2 and 7,,ii7 the clandestine importation1 manufacture1 or distribution1 or diversion from legitimate channels1 of the substance2 or 7iii7 the capacity of the substance to cause a state of dependence1 including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v4 2 and 7#c7 in subsection 7c71 in the matter preceding schedule ,i1 by striking ,,iv1 and ,v and inserting ,,iv1 ,v1 and ,a4 #ijjc4 ,temporary and permanent scheduling of schedule ,a substances ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by adding at the end the following3 7k7 ,temporary and permanent scheduling of schedule ,a substances 7#a7 ,the ,attorney ,general may issue a temporary order adding a drug or substance to schedule ,a if the ,attorney ,general finds that-- 7,a7 the drug or other substance satisfies the criteria for being considered a schedule ,a substance2 and 7,b7 adding such drug or substance to schedule ,a will assist in preventing abuse of the drug or other substance4 7#b7 ,a temporary scheduling order issued under paragraph 7#a7 shall not take effect until #cj days after the date of the publication by the ,attorney ,general of a notice in the ,federal ,register of the intention to issue such order and the grounds upon which such order is to be issued4 ,the temporary scheduling order shall expire not later than #e years after the date it becomes effective1 except that the ,attorney ,general may1 during the pendency of proceedings under paragraph 7#e71 extend the temporary scheduling order for up to #ahj days4 7#c7 ,a temporary scheduling order issued under paragraph 7#a7 shall be vacated upon the issuance of a permanent order issued under paragraph 7#e7 with regard to the same substance1 or upon the subsequent issuance of any scheduling order under this section4 7#d7 ,a temporary scheduling order issued under paragraph 7#a7 shall not be subject to judicial review4 7#e7 7,a7 ,beginning no earlier than #c years after issuing an order temporarily scheduling a drug or other substance under this subsection1 the ,attorney ,general may1 by rule1 issue a permanent order adding a drug or other substance to schedule ,a if such drug or substance satisfies the criteria for being considered a controlled substance in schedule ,a under this subsection1 except as provided in subparagraph 7,b74 7,b7 ,if the ,secretary has determined1 based on relevant scientific studies and necessary data requested by the ,secretary and gathered by the ,attorney ,general1 that a drug or other substance that has been temporarily placed in schedule ,a does not have sufficient potential for abuse to warrant control in any schedule1 and so advises the ,attorney ,general in writing1 the ,attorney ,general may not issue a permanent scheduling order under subparagraph 7,a7 and shall1 within #cj days of receiving the ,secretary's advice issue an order immediately terminating the temporary scheduling order4 7#f7 ,before initiating proceedings under paragraph 7#a71 the ,attorney ,general shall transmit notice of a temporary order proposed to be issued to the ,secretary of ,health and ,human ,services4 ,in issuing an order under paragraph 7#a71 the ,attorney ,general shall take into consideration any comments submitted by the ,secretary of ,health and ,human ,services in response to a notice transmitted pursuant to this paragraph4 7#g7 ,on the date of the publication of a notice in the ,federal ,register pursuant to paragraph 7#b71 the ,attorney ,general shall transmit the same notice to ,congress4 ,the temporary scheduling order shall take effect according to paragraph 7#b71 except that the temporary scheduling order may be disapproved by an ,act of ,congress within #ahj days from the date of publication of the notice in the ,federal ,register4 4 #ijjd4 ,penalties 7a7 ,controlled ,substances ,act ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended-- 7#a7 in section #dja7;b77#a7 7#ba ,u4,s4,c4 #hda7;b77#a771 by adding at the end the following3 7,f7 7i7 ,in the case of any controlled substance in schedule ,a1 such person shall be sentenced to a term of imprisonment of not more than #aj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than #ae years1 a fine not to exceed the greater of that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #ejj1jjj if the defendant is an individual or #b4e million if the defendant is other than an individual1 or both4 7ii7 ,if any person commits such a violation after a prior conviction for a felony drug offense has become final1 such person shall be sentenced to a term of imprisonment of not more than #bj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than #cj years1 a fine not to exceed the greater of twice that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #a million if the defendant is an individual or #e million if the defendant is other than an individual1 or both4 7iii7 ,any sentence imposing a term of imprisonment under this subparagraph shall1 in the absence of such a prior conviction1 impose a term of supervised release of not less than #b years in addition to such term of imprisonment and shall1 if there was such a prior conviction1 impose a term of supervised release of not less than #d years in addition to such term of imprisonment4 2 7#b7 in section #djc7;a7 7#ba ,u4,s4,c4 #hdc7;a77-- 7,a7 in paragraph 7#h71 by striking or at the end2 7,b7 in paragraph 7#i71 by striking the period at the end and inserting 2 or2 and 7,c7 by inserting after paragraph 7#i7 the following3 7#aj7 to export a substance in violation of the controlled substance laws of the country to which the substance is exported4 2 and 7#c7 in section #djd 7#ba ,u4,s4,c4 #hdd71 by inserting after subsection 7a7 the following3 7b7 ,a person shall not be subject to a criminal or civil penalty under this title or under any other ,federal law solely for possession of a schedule ,a controlled substance4 4 7b7 ,controlled ,substances ,import and ,export ,act ,section #ajaj7;b7 of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is amended by adding at the end the following3 7#h7 ,in the case of a violation under subsection 7a7 involving a controlled substance in schedule ,a1 the person committing such violation shall be sentenced to a term of imprisonment of not more than #bj years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not more than life1 a fine not to exceed the greater of that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #a million if the defendant is an individual or #e million if the defendant is other than an individual1 or both4 ,if any person commits such a violation after a prior conviction for a felony drug offense has become final1 such person shall be sentenced to a term of imprisonment of not more than #cj years and if death or serious bodily injury results from the use of such substance shall be sentenced to not more than life imprisonment1 a fine not to exceed the greater of twice that authorized in accordance with the provisions of title #ah1 ,united ,states ,code1 or #b million if the defendant is an individual or #aj million if the defendant is other than an individual1 or both4 ,notwithstanding section #cehc of title #ah1 ,united ,states ,code1 any sentence imposing a term of imprisonment under this paragraph shall1 in the absence of such a prior conviction1 impose a term of supervised release of not less than #c years in addition to such term of imprisonment and shall1 if there was such a prior conviction1 impose a term of supervised release of not less than #f years in addition to such term of imprisonment4 ,notwithstanding the prior sentence1 and notwithstanding any other provision of law1 the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results4 4 #ijje4 ,false labeling of schedule ,a controlled substances 7a7 ,in general ,section #cje of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbe7 is amended by adding at the end the following3 7f7 ,false labeling of schedule ,a controlled substances 7#a7 ,it shall be unlawful to import1 export1 manufacture1 distribute1 dispense1 or possess with intent to manufacture1 distribute1 or dispense1 a schedule ,a substance or product containing a schedule ,a substance1 unless the substance or product bears a label clearly identifying a schedule ,a substance or product containing a schedule ,a substance by the nomenclature used by the ,international ,union of ,pure and ,applied ,chemistry 7,,iupac74 7#b7 7,a7 ,a product described in subparagraph 7,b7 is exempt from the ,international ,union of ,pure and ,applied ,chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,b7 ,a product is described in this subparagraph if the product-- 7i7 is the subject of an approved application as described in section #eje7;b7 or 7j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7ii7 is exempt from the provisions of section #eje of such ,act relating to new drugs because-- 7,i7 it is intended solely for investigational use as described in section #eje7;i7 of such ,act2 and 7,,ii7 such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application4 4 7b7 ,penalties ,section #djb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7 is amended-- 7#a7 in subsection 7a77#af71 by inserting or subsection 7f7 after subsection 7e72 and 7#b7 in subsection 7c77#a77;,d71 by inserting or a schedule ,a substance after anabolic steroid4 #ijjf4 ,registration requirements for handlers of schedule ,a substances 7a7 ,controlled ,substances ,act ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7k7 7#a7 ,the ,attorney ,general shall register an applicant to manufacture schedule ,a substances if-- 7,a7 the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 the ,attorney ,general determines that such registration is consistent with the public interest and with the ,united ,states obligations under international treaties1 conventions1 or protocols in effect on the date of enactment of this subsection4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider-- 7,a7 maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule ,a compounded therefrom into other than legitimate medical1 scientific1 research1 or industrial channels1 by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical1 scientific1 research1 and industrial purposes2 7,b7 compliance with applicable ,state and local law2 7,c7 promotion of technical advances in the art of manufacturing substances described in subparagraph 7,a7 and the development of new substances2 7,d7 prior conviction record of applicant under ,federal and ,state laws relating to the manufacture1 distribution1 or dispensing of substances described in paragraph 7,a72 7,e7 past experience in the manufacture of controlled substances1 and the existence in the establishment of effective control against diversion2 and 7,f7 such other factors as may be relevant to and consistent with the public health and safety4 7#c7 ,if an applicant is registered to manufacture controlled substances in schedule ,i or ,,ii under subsection 7a71 the applicant shall not be required to apply for a separate registration under this subsection4 7l7 7#a7 ,the ,attorney ,general shall register an applicant to distribute schedule ,a substances-- 7,a7 if the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider-- 7,a7 maintenance of effective control against diversion of particular controlled substances into other than legitimate medical1 scientific1 and industrial channels2 7,b7 compliance with applicable ,state and local law2 7,c7 prior conviction record of applicant under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of substances described in subparagraph 7,a72 7,d7 past experience in the distribution of controlled substances2 and 7,e7 such other factors as may be relevant to and consistent with the public health and safety4 7#c7 ,if an applicant is registered to distribute a controlled substance in schedule ,i or ,,ii under subsection 7b71 the applicant shall not be required to apply for a separate registration under this subsection4 7m7 7#a7 7,a7 ,not later than #ij days after the date on which a substance is placed in schedule ,a1 any practitioner who was engaged in research on the substance before the placement of the substance in schedule ,a and any manufacturer or distributor who was handling the substance before the placement of the substance in schedule ,a shall register with the ,attorney ,general4 7,b7 7i7 ,if an applicant described in subparagraph 7,a7 is registered pursuant to subsection 7f7 to conduct research with a controlled substance in schedule ,i or ,,ii on the date on which another substance is placed in schedule ,a1 the applicant may1 subject to clause 7iii71 conduct research with that other controlled substance in schedule ,a while the application for registration pursuant to subparagraph 7,a7 is pending4 7ii7 ,if an applicant described in subparagraph 7,a7 is registered pursuant to subsection 7f7 as described in clause 7i7 to conduct research with a controlled substance in schedule ,,iii1 ,,iv1 or ,v on the date on which another substance is placed in schedule ,a1 the applicant may1 subject to clause 7iii71 conduct research with that other controlled substance in schedule ,a while the application for registration pursuant to subparagraph 7,a7 is pending1 provided the substance for which the applicant is registered to conduct research is in the same schedule as1 or a less-restricted schedule than1 the controlled substance whose similarity in chemical structure and actual or predicted effect to the controlled substance in schedule ,a formed the basis for placement of the substance in schedule ,a1 as set forth in the order published in the ,federal ,register placing the substance in schedule ,a4 7iii7 ,the permission to conduct research pursuant to clause 7i7 or clause 7ii7 is conditional on the applicant's complying with the registration and other requirements for controlled substances in schedule ,a4 7iv7 ,this subparagraph does not apply to applicants registered pursuant to subsection 7f7 whose authorization to conduct research with any controlled substances is limited to doing so as a coincident activity pursuant to applicable regulations of the ,attorney ,general4 7#b7 7,a7 ,not later than #fj days after the date on which the ,attorney ,general receives an application for registration to conduct research on a schedule ,a substance1 the ,attorney ,general shall-- 7i7 grant1 or initiate proceedings under section #cjd7;c7 to deny1 the application2 or 7ii7 request supplemental information from the applicant4 7,b7 ,not later than #cj days after the date on which the ,attorney ,general receives supplemental information requested under subparagraph 7,a77ii7 in connection with an application described in subparagraph 7,a71 the ,attorney ,general shall grant or deny the application4 7n7 7#a7 ,the ,attorney ,general shall register a scientific investigator or a qualified research institution to conduct research with controlled substances in schedule ,a in accordance with this subsection4 ,in evaluating applications for such registration1 the ,attorney ,general shall apply the criteria set forth in subsection 7f7 of this section that apply to practitioners seeking a registration to conduct research with a schedule ,i controlled substance1 except that the applicant shall not be required to submit a research protocol4 7#b7 ,if the applicant is not currently registered under subsection 7f7 to conduct research with a schedule ,i controlled substance1 the ,attorney ,general shall refer the application to the ,secretary1 who shall determine whether the applicant will be engaged in bona fide research and is qualified to conduct such research4 ,the #fj-;day period under subsection 7m77#b77;,a7 shall be tolled during the period beginning on the date on which the ,attorney ,general refers an application to the ,secretary under this paragraph1 and ending on the date on which the ,secretary submits a determination related to such referral to the ,attorney ,general4 7#c7 ,an applicant who meets the criteria under subsection 7m77#a77;,b7 with respect to a particular schedule ,a controlled substance shall be considered qualified to conduct research with that substance4 ,the ,attorney ,general shall modify such applicant's registration to include such schedule ,a controlled substance in accordance with this paragraph4 ,the applicant shall notify the ,attorney ,general of his intent to conduct research with a controlled substance in schedule ,a4 ,upon receiving such notification1 the ,attorney ,general shall modify the practitioner's existing registration to authorize research with schedule ,a controlled substances1 unless the ,attorney ,general determines that the registration modification would be inconsistent with the public interest based on the criteria of subsection 7f74 7#d7 ,registrations issued under this subsection to a qualified research institution will apply to all agents and employees of that institution acting within the scope of their professional practice4 7#e7 ,at least #cj days prior to conducting any research with a controlled substance in schedule ,a1 the registrant shall provide the ,attorney ,general with written notification of the following3 7,a7 ,the name of and drug code for each substance4 7,b7 ,the name of each individual with access to each substance4 7,c7 ,the amount of each substance4 7,d7 ,other similar information the ,attorney ,general may require4 7#f7 ,the quantity of a schedule ,a controlled substance possessed by a person registered under this subsection shall be appropriate for the research being conducted1 subject to the additional limitations set forth in this paragraph4 ,to reduce the risk of diversion1 the ,attorney ,general may establish limitations on the quantity of schedule ,a controlled substances that may be manufactured or possessed for purposes of research under this subsection and shall publish such limitations on the website of the ,drug ,enforcement ,administration4 ,a person registered under this subsection may1 based on legitimate research needs1 apply to the ,attorney ,general to manufacture or possess an amount greater than that so specified by the ,attorney ,general4 ,the ,attorney ,general shall specify the manner in which such applications shall be submitted4 ,the ,attorney ,general shall act on an application filed under this subparagraph within #cj days of receipt of such application4 ,if the ,attorney ,general fails to act within #cj days1 the registrant shall be allowed to manufacture and possess up to the amount requested4 ,the ,attorney ,general shall have the authority to reverse the increase for cause4 7#g7 ,the ,attorney ,general shall by regulation specify the manner in which applications for registration under this subsection shall be submitted4 7#h7 ,registrants authorized under this subsection may manufacture and possess schedule ,a controlled substances up to the approved amounts only for use in their own research setting or institution4 ,manufacturing for use in any other setting or institution shall require a manufacturer's registration under section #cjc7;a74 4 7b7 ,controlled ,substances ,import and ,export ,act ,section #ajjh of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ieh7 is amended by adding at the end the following3 7j7 7#a7 ,the ,attorney ,general shall register an applicant to import or export a schedule ,a substance if-- 7,a7 the applicant demonstrates that the schedule ,a substances will be used for research1 analytical1 or industrial purposes approved by the ,attorney ,general2 and 7,b7 the ,attorney ,general determines that such registration is consistent with the public interest and with the ,united ,states obligations under international treaties1 conventions1 or protocols in effect on the date of enactment of this subsection4 7#b7 ,in determining the public interest under paragraph 7#a77;,b71 the ,attorney ,general shall consider the factors described in subparagraphs 7,a7 through 7,f7 of section #cjc7k77#b74 7#c7 ,if an applicant is registered to import or export a controlled substance in schedule ,i or ,,ii under subsection 7a71 the applicant shall not be required to apply for a separate registration under this subsection4 4 #ijjg4 ,additional conforming amendments 7a7 ,controlled ,substances ,act ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended-- 7#a7 in section #cjc7;c7 7#ba ,u4,s4,c4 #hbc7;c77-- 7,a7 by striking subsections 7a7 and 7b7 and inserting subsection 7a71 7b71 7k71 or 7l72 and 7,b7 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#b7 in section #cjf 7#ba ,u4,s4,c4 #hbf7-- 7,a7 in subsection 7a71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7,b7 in subsection 7b71 in the second sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7,c7 in subsection 7c71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7,d7 in subsection 7d71 in the first sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7,e7 in subsection 7e71 in the first sentence1 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,f7 in subsection 7f71 in the first sentence1 by striking schedules ,i and ,,ii and inserting schedules ,i1 ,,ii1 and ,a2 7#c7 in section #cjh7;a7 7#ba ,u4,s4,c4 #hbh7;a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#d7 in section #djb7;b7 7#ba ,u4,s4,c4 #hdb7;b771 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#e7 in section #djc7;a77#a7 7#ba ,u4,s4,c4 #hdc7;a77#a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7#f7 in section #eaa7;f7 7#ba ,u4,s4,c4 #hha7;f771 by striking schedule ,i or ,,ii each place it appears and inserting schedule ,i1 ,,ii1 or ,a4 7b7 ,controlled ,substances ,import ,export ,act ,the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is amended-- 7#a7 in section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,b7 in paragraph 7#b71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#b7 in section #ajjc 7#ba ,u4,s4,c4 #iec7-- 7,a7 in subsection 7c71 in the matter preceding paragraph 7#a71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7,b7 in subsection 7d71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 7#c7 in section #ajjd7a7 7#ba ,u4,s4,c4 #ied7a771 by striking schedule ,i and inserting schedule ,i or ,a2 7#d7 in section #ajje 7#ba ,u4,s4,c4 #iee71 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a2 and 7#e7 in section #ajji7;a7 7#ba ,u4,s4,c4 #iei7;a771 by striking schedule ,i or ,,ii and inserting schedule ,i1 ,,ii1 or ,a4 #ijjh4 ,controlled substance analogues ,section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7 is amended-- 7#a7 in paragraph 7#f71 by striking or ,v and inserting ,v1 or ,a2 7#b7 in paragraph 7#ad7-- 7,a7 by striking schedule ,i7c7 and and inserting schedule ,i7c71 schedule ,a1 and2 and 7,b7 by striking schedule ,i7c71 and inserting schedule ,i7c7 and schedule ,a12 and 7#c7 in paragraph 7#cb77;,a71 by striking 7#cb77;,a7 and all that follows through clause 7iii7 and inserting the following3 7#cb7 7,a7 ,except as provided in subparagraph 7,c71 the term controlled substance analogue means a substance whose chemical structure is substantially similar to the chemical structure of a controlled substance in schedule ,i or ,,ii-- 7i7 which has a stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i or ,,ii2 or 7ii7 with respect to a particular person1 which such person represents or intends to have a stimulant1 depressant1 or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant1 depressant1 or hallucinogenic effect on the central nervous system of a controlled substance in schedule ,i or ,,ii4 4 #ijji4 ,rules of construction ,nothing in this title1 or the amendments made by this title1 may be construed to limit-- 7#a7 the prosecution of offenses involving controlled substance analogues under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq472 or 7#b7 the authority of the ,attorney ,general to temporarily or permanently schedule1 reschedule1 or decontrol controlled substances under provisions of section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 that are in effect on the day before the date of enactment of this title4 #ijaj4 ,study by ,comptroller ,general ,not later than #b years after the date of enactment of this title1 the ,comptroller ,general of the ,united ,states shall complete a study and submit a report to the ,committees on the ,judiciary of the ,house of ,representatives and of the ,senate regarding the costs associated with the amendments made by section #d1 including-- 7#a7 the annual amounts expended by ,federal agencies in carrying out the amendments2 7#b7 the costs associated with arrests1 trials1 convictions1 imprisonment1 or imposition of other sanctions in accordance with the amendments2 and 7#c7 the impact 7including the fiscal impact7 of the amendments on existing correctional facilities and the likelihood that those amendments will create a need for additional capacity for housing prisoners4 #ijaa4 ,report on controlled substance analogues sold by means of the ,internet ,not later than #a year after the date of the enactment of this title1 and annually thereafter1 the ,administrator of the ,drug ,enforcement ,administration shall make publicly available on the website of the ,drug ,enforcement ,administration a report on1 for the previous year1 the lawful and unlawful sale of controlled substance analogues 7as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb77 by means of the ,internet1 including the following information3 7#a7 ,the types of controlled substance analogues that were sold1 and the number of sales for each such substance4 7#b7 ,the name of each person1 entity1 or ,internet site1 whether in the ,united ,states or abroad1 that knowingly or intentionally delivers1 distributes1 or dispenses1 or offers or attempts to deliver1 distribute1 or dispense1 a controlled substance analogue by means of the ,internet1 whether lawfully or unlawfully4 7#c7 ,an estimate of the total revenue for all of the vendors described in paragraph 7#b7 for all of the sales described in paragraph 7#a74 #ijab4 ,controlled substance analogues ,section #bjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hac7 is amended-- 7#a7 by striking ,a controlled and inserting 7a7 ,in general4--,a controlled2 and 7#b7 by adding at the end the following3 7b7 ,determination ,in determining whether a controlled substance analogue was intended for human consumption under subsection 7a71 the following factors may be considered1 along with any other relevant factors3 7#a7 ,the marketing1 advertising1 and labeling of the substance4 7#b7 ,the known efficacy or usefulness of the substance for the marketed1 advertised or labeled purpose4 7#c7 ,the difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold4 7#d7 ,the diversion of the substance from legitimate channels and the clandestine importation1 manufacture1 or distribution of the substance4 7#e7 ,whether the defendant knew or should have known the substance was intended to be consumed by injection1 inhalation1 ingestion1 or any other immediate means4 7#f7 ,any controlled substance analogue that is manufactured1 formulated1 sold1 distributed1 or marketed with the intent to avoid the provisions of existing drug laws4 7c7 ,limitation ,for purposes of this section1 evidence that a substance was not marketed1 advertised1 or labeled for human consumption1 by itself1 shall not be sufficient to establish that the substance was not intended for human consumption4 4 ,x ,,thrive ,act #ajjja4 ,short title ,this title may be cited as the ,transitional ,housing for ,recovery in ,viable ,environments ,demonstration ,program ,act or the ,,thrive ,act4 #ajjjb4 ,demonstration program to study the impact of using rental vouchers for supportive housing for individuals recovering from opioid use disorders or other substance use disorders ,section #h7o7 of the ,united ,states ,housing ,act of #aicg 7#db ,u4,s4,c4 #adcg;f7o77 is amended by adding at the end the following new paragraph3 7#ba7 ,rental ,voucher ,demonstration ,program for supportive housing for individuals recovering from opioid use disorders or other substance use disorders 7,a7 ,establishment ,the ,secretary shall establish a demonstration program under which the ,secretary shall set aside1 allocate1 and distribute directly to eligible entities1 from amounts made available for rental assistance under this subsection1 the amounts specified in subparagraph 7,b7 for an eligible entity to provide a voucher for such assistance to a covered individual through a supportive housing program that provides treatment for opioid use disorders or other substance use disorders 7as applicable71 coordination with workforce development providers1 and such assistance1 as determined by the entity4 7,b7 ,amount ,the amount specified in this subparagraph is1 for fiscal year #bjai1 the amount necessary to provide the lesser of-- 7i7 #j4e percent of the total number of vouchers renewed under this subsection during the fiscal year ending immediately before the date of the enactment of this paragraph2 or 7ii7 #aj1jjj vouchers4 7,c7 ,criteria for eligible entities ,an eligible entity shall-- 7i7 provide an evidence-based treatment program and demonstrate the ability to coordinate with workforce development providers for individuals recovering from an opioid use disorder or other substance use disorder1 as applicable1 that meet standards established by the ,secretary2 and 7ii7 demonstrate prior experience administering rental assistance vouchers1 demonstrate prior experience administering supportive housing programs under the ,mc,kinney-,vento ,homeless ,act1 or demonstrate a partnership with a public housing agency or a housing program of a ,state1 unit of local government1 or ,indian tribe 7as such term is defined in section #d of the ,native ,american ,housing and ,self-,determination ,act of #aiif 7#be ,u4,s4,c4 #dajc77 that ensures effective administration of rental assistance vouchers4 7,d7 ,application ,to receive a rental assistance voucher under this paragraph1 an eligible entity shall submit an application to the ,secretary that shall include-- 7i7 a description of the terms of treatment program1 coordination with workforce development providers1 and rental assistance to be provided to a covered individual1 and assurances that such description shall be communicated to covered individuals that receive vouchers pursuant to the demonstration program established under this paragraph2 7ii7 a transitional plan that begins on the date on which a covered individual completes the treatment program of the eligible entity that includes information on additional treatment1 coordination with workforce development opportunities1 and housing resources and services available to such covered individual2 and 7iii7 evidence sufficient to demonstrate that the local government having jurisdiction over the location of any supportive housing facility to be used by the eligible entity in connection with the demonstration program under this paragraph permits such facilities in such location4 7,e7 ,selection ,in selecting eligible entities to receive rental assistance vouchers under this paragraph1 the ,secretary shall-- 7i7 ensure that such eligible entities-- 7,i7 are diverse2 7,,ii7 represent an appropriate balance of eligible entities located in urban and rural areas1 including tribal communities2 7,,iii7 have adequate resources for treatment1 recovery1 and supportive services2 7,,iv7 fully comply with the ,fair ,housing ,act 7#db ,u4,s4,c4 #cfja et seq47 and the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;a et seq472 7,v7 appropriately reflect the impact that opioids are having in tribal communities2 and 7,,vi7 provide supportive and transitional housing programs in diverse geographic regions with high rates of mortality due to opioid use disorders or other substance use disorders1 as applicable1 based on data of the ,centers for ,disease ,control and ,prevention2 and 7ii7 consider1 in consultation with the ,secretary of ,health and ,human ,services and the ,secretary of ,labor-- 7,i7 the success of each recipient eligible entity at helping individuals complete the treatment program of the eligible entity and refrain from illicit opioid or other substance usage1 as applicable2 7,,ii7 the coordination with workforce development providers by the eligible entity2 7,,iii7 the percentage of participants in unsubsidized employment during the second and fourth calendar quarter after exit from the program2 and 7,,iv7 the percentage of participants in the treatment program of the eligible entity that do not relapse into opioid or other substance usage1 as applicable4 7,f7 ,reissuance of voucher ,upon termination of the provision of rental assistance through a voucher to a covered individual1 the eligible entity that initially offered such voucher may use such voucher to provide rental assistance to another covered individual4 7,g7 ,duration ,the ,secretary shall not make rental assistance available under this paragraph after the expiration of the #e-year period beginning on the date of the enactment of this paragraph4 7,h7 ,waivers ,the ,secretary may1 through publication of a notice in the ,federal ,register1 waive or specify alternative requirements for any provision of statue or regulation governing the use of vouchers under this subsection 7except for requirements relating to fair housing1 nondiscrimination1 labor standards1 or the environment7 upon a finding by the ,secretary that such waiver or alternative requirement is necessary for the purposes of this paragraph4 7,i7 ,reports 7i7 ,by the eligible entity ,an eligible entity that receives a rental assistance voucher under this paragraph shall submit to the ,secretary-- 7,i7 annually1 the transitional plan described in subparagraph 7,d77ii7 and information on each covered individual's housing upon termination of the provision of rental assistance through a voucher to such covered individual in a manner that protects the privacy of such covered individual2 and 7,,ii7 not later than #d years after the date of the enactment of this paragraph1 a plan describing the treatment and housing options for any covered individual assisted by such voucher who will not have completed the program before the day that is #e years after such date of enactment4 7ii7 ,by the ,secretary ,the ,secretary shall submit to ,congress a report that analyzes the impact of rental assistance provided under this paragraph-- 7,i7 not later than #b years after the date of the enactment of this paragraph2 and 7,,ii7 not later than #d years after the date of the enactment of this paragraph4 7,j7 ,definitions ,in this paragraph3 7i7 ,eligible entity ,the term eligible entity means a tribally designated housing entity 7as such term is defined in section #d of the ,native ,american ,housing and ,self-,determination ,act of #aiif 7#bd ,u4,s4,c4 #dajc771 or a nonprofit organization1 that meets the criteria described under subparagraph 7,c74 7ii7 ,covered individual ,the term covered individual means an individual recovering from an opioid use disorder or other substance use disorder4 4 #ajjjc4 ,repeal of ,rental ,voucher ,demonstration ,program ,effective the day that is #e years after the date of the enactment of this title1 paragraph 7#ba7 of section #h7o7 of the ,united ,states ,housing ,act of #aicg 7#db ,u4,s4,c4 #adcg;f7o771 as added by this title1 is repealed4 #ajjjd4 ,demonstration ,close-,out ,an eligible entity that provided vouchers for rental assistance under paragraph 7#ba7 of section #h7o7 of the ,united ,states ,housing ,act of #aicg 7#db ,u4,s4,c4 #adcg;f7o771 as added by this title1 shall return any such vouchers to the ,secretary of ,housing and ,urban ,development not later than the day that is #e years after the date of the enactment of this title for use only for renewals of expiring contracts for such assistance4 #ajjje4 ,no additional funds authorized ,no additional funds are authorized to be appropriated to carry out the requirements of this title and the amendments made by this title4 ,such requirements shall be carried out using amounts otherwise authorized to be appropriated4 ,,xi ,,imd ,,care ,act #aajja4 ,short title ,this title may be cited as the ,individuals in ,medicaid ,deserve ,care that is ,appropriate and ,responsible in its ,execution ,act or the ,,imd ,,care ,act4 #aajjb4 ,medicaid ,state plan option to provide services for certain individuals with targeted ,s,u,ds in institutions for mental diseases ,section #aiae of the ,social ,security ,act 7#db ,u4,s4,c4 #acifn7 is amended by adding at the end the following new subsection3 7l7 ,state plan option ,to provide services for certain individuals in institutions for mental diseases 7#a7 ,in general ,with respect to calendar quarters beginning during the period beginning ,january #a1 #bjai1 and ending ,december #ca1 #bjbc1 a ,state may elect1 through a ,state plan amendment1 to1 notwithstanding section #aije7;a71 provide medical assistance for services furnished in institutions for mental diseases and for other medically necessary services furnished to eligible individuals with targeted ,s,u,ds1 in accordance with the requirements of this subsection4 7#b7 ,payments 7,a7 ,in general ,amounts expended under a ,state plan amendment under paragraph 7#a7 for services described in such paragraph furnished1 with respect to a #ab-month period1 to an eligible individual with a targeted ,,sud who is a patient in an institution for mental diseases shall be treated as medical assistance for which payment is made under section #aijc7;a7 but only to the extent that such services are furnished for not more than a period of #cj days 7whether or not consecutive7 during such #ab-month period4 7,b7 ,clarification ,payment made under this paragraph for expenditures under a ,state plan amendment under this subsection with respect to services described in paragraph 7#a7 furnished to an eligible individual with a targeted ,,sud shall not affect payment that would otherwise be made under section #aijc7;a7 for expenditures under the ,state plan 7or waiver of such plan7 for medical assistance for such individual4 7#c7 ,information required in ,state plan amendment 7,a7 ,in general ,a ,state electing to provide medical assistance pursuant to this subsection shall include with the submission of the ,state plan amendment under paragraph 7#a7 to the ,secretary-- 7i7 a plan on how the ,state will improve access to outpatient care during the period of the ,state plan amendment1 including a description of-- 7,i7 the process by which eligible individuals with targeted ,s,u,ds will make the transition from receiving inpatient services in an institution for mental diseases to appropriate outpatient care2 and 7,,ii7 the process the ,state will undertake to ensure eligible individuals with targeted ,s,u,ds are provided care in the most integrated setting appropriate to the needs of the individuals2 and 7ii7 a description of how the ,state plan amendment ensures an appropriate clinical screening of eligible individuals with targeted ,s,u,ds1 including assessments to determine level of care and length of stay recommendations based upon the multidimensional assessment criteria of the ,american ,society of ,addiction ,medicine and to determine the appropriate setting for such care4 7,b7 ,report ,not later than the sooner of ,december #ca1 #bjbd1 or #a year after the date of the termination of a ,state plan amendment under this subsection1 the ,state shall submit to the ,secretary a report that includes at least-- 7i7 the number of eligible individuals with targeted ,s,u,ds who received services pursuant to such ,state plan amendment2 7ii7 the length of the stay of each such individual in an institution for mental diseases2 7iii7 the type of outpatient treatment1 including medication-assisted treatment1 each such individual received after being discharged from such institution2 7iv7 the number of eligible individuals with any co-occuring disorders who received services pursuant to such ,state plan amendment and the co-occuring disorders from which they suffer2 and 7v7 information regarding the effects of a ,state plan amendment on access to community care for individuals suffering from a mental disease other than substance use disorder4 7#d7 ,definitions ,in this subsection3 7,a7 ,eligible individual with a targeted ,,sud ,the term eligible individual with a targeted ,,sud means an individual who-- 7i7 with respect to a ,state1 is enrolled for medical assistance under the ,state plan 7or a waiver of such plan72 7ii7 is at least #ba years of age2 7iii7 has not attained #fe years of age2 and 7iv7 has been diagnosed with at least one targeted ,,sud4 7,b7 ,institution for mental diseases ,the term institution for mental diseases has the meaning given such term in section #aije7;i74 7,c7 ,opioid prescription pain reliever ,the term opioid prescription pain reliever includes hydrocodone products1 oxycodone products1 tramadol products1 codeine products1 morphine products1 fentanyl products1 buprenorphine products1 oxymorphone products1 meperidine products1 hydromorphone products1 methadone1 and any other prescription pain reliever identified by the ,assistant ,secretary for ,mental ,health and ,substance ,use4 7,d7 ,other medically necessary services ,the term other medically necessary services means1 with respect to an eligible individual with a targeted ,,sud who is a patient in an institution for mental diseases1 items and services that are provided to such individual outside of such institution to the extent that such items and services would be treated as medical assistance for such individual if such individual were not a patient in such institution4 7,e7 ,targeted ,,sud 7i7 ,in general ,the term targeted ,,sud means an opioid use disorder or a cocaine use disorder4 7ii7 ,cocaine use disorder ,the term cocaine use disorder means a disorder that meets the criteria of the ,diagnostic and ,statistical ,manual of ,mental ,disorders1 #dth ,edition 7or a successor edition71 for either dependence or abuse for cocaine1 including cocaine base 7commonly referred to as crack cocaine74 7iii7 ,opioid use disorder ,the term opioid use disorder means a disorder that meets the criteria of the ,diagnostic and ,statistical ,manual of ,mental ,disorders1 #dth ,edition 7or a successor edition71 for heroin use disorder or pain reliever use disorder 7including with respect to opioid prescription pain relievers74 4 #aajjc4 ,promoting value in ,medicaid managed care ,section #aijc7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended by adding at the end the following new paragraph3 7#g7 7,a7 ,with respect to expenditures described in subparagraph 7,b7 that are incurred by a ,state for any fiscal year after fiscal year #bjbj 7and before fiscal year #bjbd71 in determining the pro rata share to which the ,united ,states is equitably entitled under subsection 7d77#c71 the ,secretary shall substitute the ,federal medical assistance percentage that applies for such fiscal year to the ,state under section #aije7;b7 7without regard to any adjustments to such percentage applicable under such section or any other provision of law7 for the percentage that applies to such expenditures under section #aije7y74 7,b7 ,expenditures described in this subparagraph1 with respect to a fiscal year to which subparagraph 7,a7 applies1 are expenditures incurred by a ,state for payment for medical assistance provided to individuals described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i7 by a managed care entity1 or other specified entity 7as defined in subparagraph 7,d77iii771 that are treated as remittances because the ,state-- 7i7 has satisfied the requirement of section #dch4h of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 by electing-- 7,i7 in the case of a ,state described in subparagraph 7,c71 to apply a minimum medical loss ratio 7as defined in subparagraph 7,d77ii77 that is at least #he percent but not greater than the minimum medical loss ratio 7as so defined7 that such ,state applied as of ,may #ca1 #bjah2 or 7,,ii7 in the case of a ,state not described in subparagraph 7,c71 to apply a minimum medical loss ratio that is equal to #he percent2 and 7ii7 recovered all or a portion of the expenditures as a result of the entity's failure to meet such ratio4 7,c7 ,for purposes of subparagraph 7,b71 a ,state described in this subparagraph is a ,state that as of ,may #ca1 #bjah1 applied a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in such subparagraph under the ,state plan under this title 7or a waiver of the plan7 that is equal to or greater than #he percent4 7,d7 ,for purposes of this paragraph3 7i7 ,the term managed care entity means a medicaid managed care organization described in section #aicb7;a77#a77;,b77i74 7ii7 ,the term minimum medical loss ratio means1 with respect to a ,state1 a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in subparagraph 7,b7 under the ,state plan under this title 7or a waiver of the plan74 7iii7 ,the term other specified entity means-- 7,i7 a prepaid inpatient health plan1 as defined in section #dch4b of title #db1 ,code of ,federal ,regulations 7or any successor regulation72 and 7,,ii7 a prepaid ambulatory health plan1 as defined in such section 7or any successor regulation74 4 ,passed the ,house of ,representatives ,june #bb1 #bjah4,karen ,l4 ,haas1,clerk ,june #bf1 #bjah,read the second time and placed on the calendar