114 S524 EAH: Comprehensive Opioid Abuse Reduction Act of 2016 U.S. Senate 2016-05-13 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. 114th CONGRESS2d Session In the House of Representatives, U. S., May 13, 2016 AMENDMENTS:
That the bill from the Senate (S. 524) entitled ‘‘An Act to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use.’’, do pass with the following
Strike out all after the enacting clause and insert:
1.
Table of Contents
The table of contents for this Act is as follows: Sec. 1. Table of Contents. Title I—Pain Management Best Practices Inter-Agency Task Force Sec. 101. Development of best practices for the use of prescription opioids. Title II—Comprehensive Opioid Abuse Reduction Act Sec. 201. Short title. Sec. 202. Comprehensive Opioid Abuse Grant Program. Sec. 203. Audit and accountability of grantees. Sec. 204. Veterans treatment courts. Sec. 205. Emergency Federal law enforcement assistance. Sec. 206. Inclusion of services for pregnant women under family-based substance abuse grants. Sec. 207. GAO study and report on Department of Justice programs and research relative to substance use and substance use disorders among adolescents and young adults. Title III—Jason Simcakoski PROMISE Act Sec. 301. Short title. Sec. 302. Improvement of opioid safety measures by Department of Veterans Affairs. Sec. 303. Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense. Sec. 304. Review, investigation, and report on use of opioids in treatment by Department of Veterans Affairs. Sec. 305. Mandatory disclosure of certain veteran information to State controlled substance monitoring programs. Sec. 306. Modification to limitation on awards and bonuses. Title IV—Kingpin Designation Improvement Act Sec. 401. Short title. Sec. 402. Protection of classified information in Federal court challenges relating to designations under the Narcotics Kingpin Designation Act. Title V—Good Samaritan Assessment Act Sec. 501. Short title. Sec. 502. Finding. Sec. 503. GAO Study on Good Samaritan laws pertaining to treatment of opioid overdoses. Sec. 504. Definitions. Title VI—OPEN Act Sec. 601. Short title. Sec. 602. Evaluation of performance of Department of Justice program. Sec. 603. Evaluation of performance of Department of Health and Human Services program. Sec. 604. Definition. Sec. 605. No additional funds authorized. Sec. 606. Matters regarding certain Federal law enforcement assistance. Title VII—Infant Plan of Safe Care Improvement Act Sec. 701. Short title. Sec. 702. Best practices for development of plans of safe care. Sec. 703. State plans. Sec. 704. Data reports. Sec. 705. Monitoring and oversight. Sec. 706. Rule of construction. Title VIII—NAS Healthy Babies Act Sec. 801. Short title. Sec. 802. GAO report on neonatal abstinence syndrome (NAS). Sec. 803. Excluding abuse-deterrent formulations of prescription drugs from the Medicaid additional rebate requirement for new formulations of prescription drugs. Sec. 804. Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse. Sec. 805. Medicaid Improvement Fund. Title IX—Co-Prescribing to Reduce Overdoses Act Sec. 901. Short title. Sec. 902. Opioid overdose reversal drugs prescribing grant program. Sec. 903. Providing information to prescribers in certain Federal health care and medical facilities on best practices for prescribing opioid overdose reversal drugs. Sec. 904. Authorization of appropriations. Sec. 905. Cut-Go Compliance. Title X—Improving Treatment for Pregnant and Postpartum Women Act Sec. 1001. Short title. Sec. 1002. Reauthorization of residential treatment programs for pregnant and postpartum women. Sec. 1003. Pilot program grants for State substance abuse agencies. Sec. 1004. Cut-Go Compliance. Title XI—Veteran Emergency Medical Technician Support Act Sec. 1101. Short title. Sec. 1102. Assisting veterans with military emergency medical training to meet requirements for becoming civilian emergency medical technicians. Title XII—John Thomas Decker Act Sec. 1201. Short title. Sec. 1202. Information materials and resources to prevent addiction related to youth sports injuries. Title XIII—Lali's Law Sec. 1301. Short title. Sec. 1302. Opioid overdose reversal medication access and education grant programs. Sec. 1303. Cut-Go Compliance. Title XIV—Reducing Unused Medications Act Sec. 1401. Short title. Sec. 1402. Partial fills of schedule II controlled substances. Title XV—Opioid Review Modernization Act Sec. 1501. Short title. Sec. 1502. FDA opioid action plan. Sec. 1503. Prescriber education. Sec. 1504. Guidance on evaluating the abuse deterrence of generic solid oral opioid drug products. Title XVI—Examining Opioid Treatment Infrastructure Act Sec. 1601. Short title. Sec. 1602. Study on treatment infrastructure. Title XVII—Opioid Use Disorder Treatment Expansion and Modernization Act Sec. 1701. Short title. Sec. 1702. Finding. Sec. 1703. Opioid use disorder treatment modernization. Sec. 1704. Sense of Congress. Sec. 1705. Partial fills of schedule II controlled substances. Title XVIII—National All Schedules Prescription Electronic Reporting Reauthorization Act Sec. 1801. Short title. Sec. 1802. Amendment to purpose. Sec. 1803. Amendments to controlled substance monitoring program.
<enum>I</enum><header>Pain Management Best Practices Inter-Agency Task Force</header> <section id="HD35854F294A74D2F8555B6A4C500DF14" section-type="subsequent-section"><enum>101.</enum><header>Development of best practices for the use of prescription opioids</header> <subsection id="H106F3DF81CD64D8DABFBB8D8C1D1C302"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="HE5BB32A16DE245B4A6B7981082A9A220"><enum>(1)</enum><text>the term <term>Secretary</term> means the Secretary of Health and Human Services; and</text></paragraph> <paragraph id="H9E2445A979E0465DAF7D2DE545E90ABB"><enum>(2)</enum><text>the term <term>task force</term> means the Pain Management Best Practices Inter-Agency Task Force convened under subsection (b).</text></paragraph></subsection> <subsection id="HC4755A1F31A842119A6847406AE9E2B6"><enum>(b)</enum><header>Inter-Agency Task Force</header><text>Not later than December 14, 2018, the Secretary, in cooperation with the Secretary of Veterans Affairs, the Secretary of Defense, and the Administrator of the Drug Enforcement Administration, shall convene a Pain Management Best Practices Inter-Agency Task Force to review, modify, and update, as appropriate, best practices for pain management (including chronic and acute pain) and prescribing pain medication.</text></subsection> <subsection id="H73168AB53E554574A5C9E1C8853F6606"><enum>(c)</enum><header>Membership</header><text>The task force shall be comprised of—</text> <paragraph id="H3FAA554407764331B695FD6322685682"><enum>(1)</enum><text>representatives of—</text> <subparagraph id="H6B8D7C0647FB4DC58E1ECF8C79DB3BC0"><enum>(A)</enum><text>the Department of Health and Human Services;</text></subparagraph> <subparagraph id="HA4A9DB668CD94763AD877EC7BA507A2E"><enum>(B)</enum><text>the Department of Veterans Affairs;</text></subparagraph> <subparagraph id="H06FD2ED9D1ED4BF99B7BA60F8873A757"><enum>(C)</enum><text>the Food and Drug Administration;</text></subparagraph> <subparagraph id="H1350CBA82F014682BA2CC3066E45435B"><enum>(D)</enum><text>the Department of Defense;</text></subparagraph> <subparagraph id="HA7D6821CBE194373AC3A765CA732E24A"><enum>(E)</enum><text>the Drug Enforcement Administration;</text></subparagraph> <subparagraph id="H6A5BF1440CE3445FB97B0DEFC2F92F78"><enum>(F)</enum><text>the Centers for Disease Control and Prevention;</text></subparagraph> <subparagraph id="HA3AE8FF6B2D145A1A3DA1631850FE0C2"><enum>(G)</enum><text display-inline="yes-display-inline">the Health Resources and Services Administration;</text></subparagraph> <subparagraph display-inline="no-display-inline" id="HB5625D83CDDA4B61BA3A70BD783CB0B7"><enum>(H)</enum><text display-inline="yes-display-inline">the Indian Health Service;</text></subparagraph> <subparagraph id="H9DC5214245A34C4198DAF0DBCB62311C"><enum>(I)</enum><text>the National Academy of Medicine;</text></subparagraph> <subparagraph id="H379894C2014B41849480D8F42DB8C6F1"><enum>(J)</enum><text>the National Institutes of Health;</text></subparagraph> <subparagraph id="H78F63F02877A46F98B5FB84FBCD14793"><enum>(K)</enum><text>the Office of National Drug Control Policy;</text></subparagraph> <subparagraph id="H89339FD42E6640998ADEA82572B86A34"><enum>(L)</enum><text display-inline="yes-display-inline">the Substance Abuse and Mental Health Services Administration; and</text></subparagraph> <subparagraph id="H6AB69F44058044449336FF0660A28F4A"><enum>(M)</enum><text>the Office of Women’s Health;</text></subparagraph></paragraph> <paragraph id="HA22546D62BE2494AB56BFA3EEC575862"><enum>(2)</enum><text display-inline="yes-display-inline">State medical boards;</text></paragraph> <paragraph id="H762A89BDAAEB4B10A490D07565304039"><enum>(3)</enum><text display-inline="yes-display-inline">subject to subsection (e), physicians, dentists, and nonphysician prescribers;</text></paragraph> <paragraph id="HEE1B89F578B44A38BA4DAC732EEE25B3"><enum>(4)</enum><text display-inline="yes-display-inline">hospitals;</text></paragraph> <paragraph id="H670DB189F1954032BDD888DBD1A8CC28"><enum>(5)</enum><text display-inline="yes-display-inline">subject to subsection (e), pharmacists and pharmacies;</text></paragraph> <paragraph id="H40E3B5738A854EFC8C4F30CA8A419704"><enum>(6)</enum><text>first responders;</text></paragraph> <paragraph id="H26A12307498947CFBAA403EB074E47C1"><enum>(7)</enum><text>experts in the fields of pain research and addiction research;</text></paragraph> <paragraph id="H547EB47927DF4020A2448E8A3CBB05D0"><enum>(8)</enum><text>experts in the fields of adolescent and young adult addiction research;</text></paragraph> <paragraph id="H7072FC65898F412D840173E38FBE50DF"><enum>(9)</enum><text>representatives of—</text> <subparagraph id="H85197F55BEEE4F3A873AA1D224376084"><enum>(A)</enum><text>pain management professional organizations;</text></subparagraph> <subparagraph id="HE5BEE7A6358D4197AE6E28CFD63564BC"><enum>(B)</enum><text>the mental health treatment community;</text></subparagraph> <subparagraph id="H10E7A6A56394498ABD9711CB1BCFC9EC"><enum>(C)</enum><text>the addiction treatment and recovery community;</text></subparagraph> <subparagraph id="H15DAB091D61C44D9972B3BA552287F41"><enum>(D)</enum><text>pain advocacy groups;</text></subparagraph> <subparagraph id="HACB955D2212145789EBE929F506DEDC1"><enum>(E)</enum><text>veteran service organizations; and</text></subparagraph> <subparagraph id="HB0DDE9716BA440C7BB571A3432482AD8"><enum>(F)</enum><text>groups with expertise on overdose reversal;</text></subparagraph></paragraph> <paragraph id="HAFBC8EEE6FF94C49A056B4124ED03E34"><enum>(10)</enum><text display-inline="yes-display-inline">a person in recovery from addiction to medication for chronic pain;</text></paragraph> <paragraph id="HA53BC6CFD22D4D66BEFCB3F7800BD8D6"><enum>(11)</enum><text>a person in recovery from addiction to medication for chronic pain, whose addiction began in adolescence or young adulthood;</text></paragraph> <paragraph id="H8729FAEE1CFE4444BA42C13330AAD7A6"><enum>(12)</enum><text>a person with chronic pain;</text></paragraph> <paragraph id="H2B40EC80A0FC4FE0BDB4E7C32CBC1BB1"><enum>(13)</enum><text>an expert on active duty military, armed forces personnel, and veteran health and prescription opioid addiction;</text></paragraph> <paragraph id="H4B9E90D77A7643C2837880F8D608AC0D"><enum>(14)</enum><text display-inline="yes-display-inline">an expert in the field of minority health; and</text></paragraph> <paragraph id="HE89FB123E90F42C98243FB366FA88B22"><enum>(15)</enum><text>other stakeholders, as the Secretary determines appropriate.</text></paragraph></subsection> <subsection id="H70512B208A38430BA4D0B4659097DBAB"><enum>(d)</enum><header>Condition on participation on task force</header><text display-inline="yes-display-inline">An individual representing a profession or entity described in paragraph (3) or (5) of subsection (c) may not serve as a member of the task force unless such individual—</text> <paragraph id="H3239E63FA6E64F0B96AF17532EBA17C9"><enum>(1)</enum><text>is currently licensed in a State in which such individual is practicing (as defined by such State) such profession (or, in the case of an individual representing an entity, a State in which the entity is engaged in business); and</text></paragraph> <paragraph id="H69BEA2894BE341178C9CBA03F1C3A2F7"><enum>(2)</enum><text display-inline="yes-display-inline">is currently practicing (as defined by such State) such profession (or, in the case of an individual representing an entity, the entity is in operation).</text></paragraph></subsection> <subsection id="HA99CF9D7F9DA485C8C2AFD083DDA9A10"><enum>(e)</enum><header>Duties</header><text>The task force shall—</text> <paragraph id="H0027BAFDC2F942D9AE5258090958F2E5"><enum>(1)</enum><text>not later than 180 days after the date on which the task force is convened under subsection (b), review, modify, and update, as appropriate, best practices for pain management (including chronic and acute pain) and prescribing pain medication, taking into consideration—</text> <subparagraph id="H5442475446A542BE864712AC1AE1770B"><enum>(A)</enum><text>existing pain management research;</text></subparagraph> <subparagraph id="H36C76BF668B04E9D8DF0764D232638CE"><enum>(B)</enum><text display-inline="yes-display-inline">research on trends in areas and communities in which the prescription opioid abuse rate and fatality rate exceed the national average prescription opioid abuse rate and fatality rate;</text></subparagraph> <subparagraph id="H060ADB7ABD21466493C967E672C17B09"><enum>(C)</enum><text display-inline="yes-display-inline">recommendations from relevant conferences and existing relevant evidence-based guidelines;</text></subparagraph> <subparagraph id="H0E86AE729DEF42F4B44EB33BA11F1399"><enum>(D)</enum><text display-inline="yes-display-inline">ongoing efforts at the State and local levels and by medical professional organizations to develop improved pain management strategies, including consideration of differences within and between classes of opioids, the availability of opioids with abuse deterrent technology, and pharmacological, nonpharmacological, medical device alternatives to opioids to reduce opioid monotherapy in appropriate cases and the coordination of information collected from State prescription drug monitoring programs for the purpose of preventing the diversion of pain medication;</text></subparagraph> <subparagraph id="H5AC65725FE74468FAE07A85E01576081"><enum>(E)</enum><text>ongoing efforts at the Federal, State, and local levels to examine the potential benefits of electronic prescribing of opioids, including any public comments collected in the course of those efforts;</text></subparagraph> <subparagraph id="H975252907CD141E1870BB5855278F04A"><enum>(F)</enum><text>the management of high-risk populations, other than populations who suffer pain, who—</text> <clause id="H81ED77D42EB349A1A3BA7CB4E241142D"><enum>(i)</enum><text>may use or be prescribed benzodiazepines, alcohol, and diverted opioids; or</text></clause> <clause id="H12138D91EFBB415595A2CA33FACB774F"><enum>(ii)</enum><text>receive opioids in the course of medical care; </text></clause></subparagraph> <subparagraph id="H6865BE4C53B04D80B5DCFD92FDA13987"><enum>(G)</enum><text>the distinct needs of adolescents and young adults with respect to pain management, pain medication, substance use disorder, and medication-assisted treatment; </text></subparagraph> <subparagraph id="H41716AC1298D4F6CA9CCBCF7A04D2CA7"><enum>(H)</enum><text display-inline="yes-display-inline">the 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention; </text></subparagraph> <subparagraph id="HBBFF41FE34E34BF09713230693E3DF59"><enum>(I)</enum><text>the practice of co-prescribing naloxone for both pain patients receiving chronic opioid therapy and patients being treated for opioid use disorders;</text></subparagraph> <subparagraph id="H1220221401AC4D7292E3E93CCA6C46F6"><enum>(J)</enum><text display-inline="yes-display-inline">research that has been, or is being, conducted or supported by the Federal Government on prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults relative to any unique circumstances (including social and biological circumstances) of adolescents and young adults that may make adolescent-specific and young adult-specific treatment protocols necessary, including any effects that substance use and substance use disorders may have on brain development and the implications for treatment and recovery;</text></subparagraph> <subparagraph id="HA3B5977FF82F425DA5A373C06D2ECD6C"><enum>(K)</enum><text display-inline="yes-display-inline">Federal non-research programs and activities that address prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults, including an assessment of the effectiveness of such programs and activities in—</text> <clause id="H610E2FF366754E7D93B9D2ED770C0FAE"><enum>(i)</enum><text>preventing substance use by and substance use disorders among adolescents and young adults;</text></clause> <clause id="H37A2C202669B48A0930999C8C3C70515"><enum>(ii)</enum><text>treating such adolescents and young adults in a way that accounts for any unique circumstances faced by adolescents and young adults; and</text></clause> <clause id="H31CB458DE95C4BA5A4D862BD8D76347C"><enum>(iii)</enum><text>supporting long-term recovery among adolescents and young adults; and</text></clause></subparagraph> <subparagraph id="HF037E210A21940FE922E1A5C880C5F44"><enum>(L)</enum><text display-inline="yes-display-inline">gaps that have been identified by Federal officials and experts in Federal efforts relating to prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults, including gaps in research, data collection, and measures to evaluate the effectiveness of Federal efforts, and the reasons for such gaps;</text></subparagraph></paragraph> <paragraph id="H4DED657EBC5B47959246027B3A444A94"><enum>(2)</enum><text>solicit and take into consideration public comment on the practices developed under paragraph (1), amending such best practices if appropriate; </text></paragraph> <paragraph id="HE29779474FC94ACC8923467ADC260DB1"><enum>(3)</enum><text display-inline="yes-display-inline">develop a strategy for disseminating information about the best practices developed under paragraphs (1) and (2) to prescribers, pharmacists, State medical boards, educational institutions that educate prescribers and pharmacists, and other parties, as the Secretary determines appropriate; </text></paragraph> <paragraph id="H401FCCA8AC184661891BF8B0042D1006" display-inline="no-display-inline"><enum>(4)</enum><text>review, modify, and update best practices for pain management and prescribing pain medication, specifically as it pertains to physician education and consumer education; and</text></paragraph> <paragraph id="HC18657089F9A46258B89C03A60241ED7"><enum>(5)</enum><text display-inline="yes-display-inline">examine and identify—</text> <subparagraph id="HD9890EB0F0DA4427B54576DA32D7F093"><enum>(A)</enum><text display-inline="yes-display-inline">the extent of the need for the development of new pharmacological, nonpharmacological, and medical device alternatives to opioids;</text></subparagraph> <subparagraph id="H4454901BC9D64C74AAD38F07FB2A52E7"><enum>(B)</enum><text>the current status of research efforts to develop such alternatives; and</text></subparagraph> <subparagraph id="H4C83831804834190B656A6BA892C54E0"><enum>(C)</enum><text display-inline="yes-display-inline">the pharmacological, nonpharmacological, and medical device alternatives to opioids that are currently available that could be better utilized.</text></subparagraph></paragraph></subsection> <subsection id="H6758FDF1716043A49119F1ECD8C6A004" display-inline="no-display-inline"><enum>(f)</enum><header>Consideration of study results</header><text display-inline="yes-display-inline">In reviewing, modifying, and updating, best practices for pain management and prescribing pain medication, the task force shall take into consideration existing private sector, State, and local government efforts related to pain management and prescribing pain medication.</text></subsection> <subsection id="H02F3E2D6EAD343B7856BF391D3121727"><enum>(g)</enum><header>Limitation</header><text>The task force shall not have rulemaking authority.</text></subsection> <subsection id="H436EE815BDFB41F09AF25370C4DBC2BD"><enum>(h)</enum><header>Report</header><text>Not later than 270 days after the date on which the task force is convened under subsection (b), the task force shall submit to Congress a report that includes—</text> <paragraph id="HFD93AC4766764B78865F37A7BB13C6CC"><enum>(1)</enum><text>the strategy for disseminating best practices for pain management (including chronic and acute pain) and prescribing pain medication, as developed under subsection (e);</text></paragraph> <paragraph id="H0B1A8EB9D18B412598F476F6475066CA"><enum>(2)</enum><text>the results of a feasibility study on linking the best practices described in paragraph (1) to receiving and renewing registrations under section 303(f) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(f)</external-xref>); </text></paragraph> <paragraph id="H6906A476A17F44E89F6B248507D69A53"><enum>(3)</enum><text display-inline="yes-display-inline">recommendations for effectively applying the best practices described in paragraph (1) to improve prescribing practices at medical facilities, including medical facilities of the Veterans Health Administration and Indian Health Service; </text></paragraph> <paragraph id="H20DD0CA819594EE2A3B0F83CE8A16B5F"><enum>(4)</enum><text>the modified and updated best practices described in subsection (e)(4); and</text></paragraph> <paragraph id="HF0FC3DD0049E4CC2A7B89DB8B1BB0768"><enum>(5)</enum><text display-inline="yes-display-inline">the results of the examination and identification conducted pursuant to subsection (e)(4), and recommendations regarding—</text> <subparagraph id="H35555CC3FB164A8394A082D5D96303CB"><enum>(A)</enum><text display-inline="yes-display-inline">the development of new pharmacological, nonpharmacological, and medical device alternatives to opioids; and</text></subparagraph> <subparagraph id="H0BF86700768045F1A358C658EEB5FE75"><enum>(B)</enum><text display-inline="yes-display-inline">the improved utilization of pharmacological, nonpharmacological, and medical device alternatives to opioids that are currently available.</text></subparagraph></paragraph></subsection></section> <enum>II</enum><header>Comprehensive Opioid Abuse Reduction Act</header> <section id="H4C2BBE9CE3D54F81BE40387E0621585F" section-type="subsequent-section"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Comprehensive Opioid Abuse Reduction Act of 2016</short-title></quote>.</text></section> <section id="HC1F6D9CEBAA3490AA01D3D519E4BCF39"><enum>202.</enum><header>Comprehensive Opioid Abuse Grant Program</header> <subsection id="HD6B8DA4E470B4257893AE8C0A058BEC9"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Title I of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/42/3711">42 U.S.C. 3711 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H04FD943E757D43D094FB5CAA64F3A7D9" style="OLC"> <part id="HDEF24D3350B74E81B953A834A74DE8C6"><enum>LL</enum><header>Comprehensive Opioid Abuse Grant Program</header> <section id="HFAB9D5AF0AB0483190EE15F1D4FBB8F0"><enum>3021.</enum><header>Description</header> <subsection id="H667B1746D5DE4972A8C2751AADDA019D"><enum>(a)</enum><header>Grants authorized</header><text display-inline="yes-display-inline">From amounts made available to carry out this part, the Attorney General may make grants to States, units of local government, and Indian tribes, for use by the State, unit of local government, or Indian tribe to provide services primarily relating to opioid abuse, including for any one or more of the following:</text> <paragraph commented="no" display-inline="no-display-inline" id="HFD44C7857BE240B29DC36A6F15023F93"><enum>(1)</enum><text display-inline="yes-display-inline">Developing, implementing, or expanding a treatment alternative to incarceration program, which may include—</text> <subparagraph id="HB0F080B21DFD4B06A244B26946FEBC7B"><enum>(A)</enum><text display-inline="yes-display-inline">pre-booking or post-booking components, which may include the activities described in part DD or HH of this title;</text></subparagraph> <subparagraph id="HBD1358FE1DCF4FE187B00E43570B8DC8"><enum>(B)</enum><text>training for criminal justice agency personnel on substance use disorders and co-occurring mental illness and substance use disorders;</text></subparagraph> <subparagraph id="H0E9863D954FF41EFBDF903D63A8DD724"><enum>(C)</enum><text display-inline="yes-display-inline">a mental health court, including the activities described in part V of this title;</text></subparagraph> <subparagraph id="HE24BF8FA953749409298595A43C4B6D3"><enum>(D)</enum><text display-inline="yes-display-inline">a drug court, including the activities described in part EE of this title;</text></subparagraph> <subparagraph id="HCF9B31FE1C014E1A8903C7586352F79D"><enum>(E)</enum><text display-inline="yes-display-inline">a veterans treatment court program, including the activities described in subsection (i) of section 2991 of this title;</text></subparagraph> <subparagraph id="H5EA06FCF0F32442E8F8534BE6D266C3D"><enum>(F)</enum><text display-inline="yes-display-inline">a focus on parents whose incarceration could result in their children entering the child welfare system; and </text></subparagraph> <subparagraph id="H100C0600682341429D69797D4C4B10EF"><enum>(G)</enum><text display-inline="yes-display-inline">a community-based substance use diversion program sponsored by a law enforcement agency.</text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HEAD503B4EFCE475BB96662DD4A04D22C"><enum>(2)</enum><text display-inline="yes-display-inline">In the case of a State, facilitating or enhancing planning and collaboration between State criminal justice agencies and State substance abuse systems in order to more efficiently and effectively carry out programs described in paragraph (1) that address problems related to opioid abuse.</text></paragraph> <paragraph id="H33413B5BCFE74F44A45D91D802357325"><enum>(3)</enum><text display-inline="yes-display-inline">Providing training and resources for first responders on carrying and administering an opioid overdose reversal drug or device approved by the Food and Drug Administration, and purchasing such a drug or device for first responders who have received such training to carry and administer.</text></paragraph> <paragraph id="HB74588DB442846CBB5D38619B9CEF2A8"><enum>(4)</enum><text display-inline="yes-display-inline">Investigative purposes to locate or investigate illicit activities related to the unlawful distribution of opioids.</text></paragraph> <paragraph id="H90B5CC2A5A864CDDBCD2F6F84F8C9CFB"><enum>(5)</enum><text display-inline="yes-display-inline">Developing, implementing, or expanding a medication-assisted treatment program used or operated by a criminal justice agency, which may include training criminal justice agency personnel on medication-assisted treatment, and carrying out the activities described in part S of this title.</text></paragraph> <paragraph id="H1C67C7082CAA41F0A0A49BCC86BD05FE"><enum>(6)</enum><text display-inline="yes-display-inline">In the case of a State, developing, implementing, or expanding a prescription drug monitoring program to collect and analyze data related to the prescribing of schedules II, III, and IV controlled substances through a centralized database administered by an authorized State agency, which includes tracking the dispensation of such substances, and providing for interoperability and data sharing with other States.</text></paragraph> <paragraph id="HE84300701E3F440BBC1C1CFE4A1112A6"><enum>(7)</enum><text>Developing, implementing, or expanding a program to prevent and address opioid abuse by juveniles.</text></paragraph> <paragraph id="HFE50E8862D444BEE849DC7ECFEE4D1B5"><enum>(8)</enum><text display-inline="yes-display-inline">Developing, implementing, or expanding an integrated and comprehensive opioid abuse response program, including prevention and recovery programs.</text></paragraph> <paragraph id="H48BABB014D334A38A058AC60ECC5C182"><enum>(9)</enum><text display-inline="yes-display-inline">Developing, implementing, or expanding a program (which may include demonstration projects) to utilize technology that provides a secure container for prescription drugs that would prevent individuals, particularly adolescents, from gaining access to opioid medications that are lawfully prescribed for other individuals. </text></paragraph> <paragraph id="H591136670BEF42FAB3BE030EDBF587F6"><enum>(10)</enum><text display-inline="yes-display-inline">Developing, implementing, or expanding a program to prevent and address opioid abuse by veterans.</text></paragraph> <paragraph id="H795FBCB63E02413FB8AD7B1B994D369D"><enum>(11)</enum><text>Developing, implementing, or expanding a prescription drug take-back program.</text></paragraph></subsection> <subsection display-inline="no-display-inline" id="H5715EA358B88485D9BBC968901864EB6"><enum>(b)</enum><header>Contracts and subawards</header><text display-inline="yes-display-inline">A State, unit of local government, or Indian tribe may, in using a grant under this subpart for purposes authorized by subsection (a), use all or a portion of that grant to contract with or make one or more subawards to one or more—</text> <paragraph id="H61D13FE0DF7F4FAB8F29C360AD8C25DA"><enum>(1)</enum><text>local or regional organizations that are private and nonprofit, including faith-based organizations;</text></paragraph> <paragraph id="HAF322B84A28F439AB151F2685A618923"><enum>(2)</enum><text>units of local government; or</text></paragraph> <paragraph id="HC95584BB5B2F44CFA533333D37AAE1BD"><enum>(3)</enum><text>tribal organizations.</text></paragraph></subsection> <subsection id="H51CDD879DD1047F4B39DEBB981C38E91"><enum>(c)</enum><header>Program Assessment Component; Waiver</header> <paragraph id="HBD921CE40F37459C839207FB83C9614F"><enum>(1)</enum><header>Program Assessment Component</header><text>Each program funded under this subpart shall contain a program assessment component, developed pursuant to guidelines established by the Attorney General, in coordination with the National Institute of Justice.</text></paragraph> <paragraph id="H5CFBD2C4A68B4BFE8F9D4A2FC8EC9608"><enum>(2)</enum><header>Waiver</header><text>The Attorney General may waive the requirement of paragraph (1) with respect to a program if, in the opinion of the Attorney General, the program is not of sufficient size to justify a full program assessment.</text></paragraph></subsection> <subsection id="H73581ACF284A45E68E5C37E8A7B80FC3"><enum>(d)</enum><header>Administrative costs</header><text>Not more than 10 percent of a grant made under this subpart may be used for costs incurred to administer such grant.</text></subsection> <subsection id="H26E37B1779314486A9D3B8B176A8A436"><enum>(e)</enum><header>Period</header><text>The period of a grant made under this part may not be longer than 4 years, except that renewals and extensions beyond that period may be granted at the discretion of the Attorney General.</text></subsection></section> <section display-inline="no-display-inline" id="H62A2BC99DAE1439D846A6AF3E7D48229" section-type="subsequent-section"><enum>3022.</enum><header>Applications</header><text display-inline="no-display-inline">To request a grant under this part, the chief executive officer of a State, unit of local government, or Indian tribe shall submit an application to the Attorney General at such time and in such form as the Attorney General may require. Such application shall include the following:</text> <paragraph id="H44E71AC815234B1B90CFC69856106D21"><enum>(1)</enum><text>A certification that Federal funds made available under this subpart will not be used to supplant State, local, or tribal funds, but will be used to increase the amounts of such funds that would, in the absence of Federal funds, be made available for the activities described in section 3021(a).</text></paragraph> <paragraph id="HEA508FA932434058A1CA9F92B0CBE335"><enum>(2)</enum><text>An assurance that, for each fiscal year covered by an application, the applicant shall maintain and report such data, records, and information (programmatic and financial) as the Attorney General may reasonably require.</text></paragraph> <paragraph id="HE20BEAA4C1E94C2FAFAD0AA1A62B41EE"><enum>(3)</enum><text>A certification, made in a form acceptable to the Attorney General and executed by the chief executive officer of the applicant (or by another officer of the applicant, if qualified under regulations promulgated by the Attorney General), that—</text> <subparagraph id="HAAD6D4C7BF484D92A002F09EDD629CAC"><enum>(A)</enum><text>the programs to be funded by the grant meet all the requirements of this part;</text></subparagraph> <subparagraph id="HCDE8343579504B7AB13E24B6A8978FF1"><enum>(B)</enum><text>all the information contained in the application is correct;</text></subparagraph> <subparagraph id="H02FDDEF0383E48B79E7999D9E2CBAF5C"><enum>(C)</enum><text>there has been appropriate coordination with affected agencies; and</text></subparagraph> <subparagraph id="HA5F8CF056659437FA82E0E976BDBA500"><enum>(D)</enum><text>the applicant will comply with all provisions of this part and all other applicable Federal laws.</text></subparagraph></paragraph> <paragraph id="HE4BD55D2C7F540C2831F14F3342FA304"><enum>(4)</enum><text display-inline="yes-display-inline">An assurance that the applicant will work with the Drug Enforcement Administration to develop an integrated and comprehensive strategy to address opioid abuse.</text></paragraph></section> <section id="HC48C287CA6DF430AAF0230B7F11EF657"><enum>3023.</enum><header>Review of applications</header><text display-inline="no-display-inline">The Attorney General shall not finally disapprove any application (or any amendment to that application) submitted under this part without first affording the applicant reasonable notice of any deficiencies in the application and opportunity for correction and reconsideration.</text></section> <section id="H5412E13EDF55441D835DB9CE79E96DFB"><enum>3024.</enum><header>Equitable distribution of funds</header><text display-inline="no-display-inline">In awarding grants under this part, the Attorney General shall ensure equitable distribution of funds based on the following:</text> <paragraph id="HAE4A2FB0718446D3B80CAEFC88441C9C"><enum>(1)</enum><text display-inline="yes-display-inline">The geographic distribution of grants under this part, taking into consideration the needs of underserved populations, including rural and tribal communities.</text></paragraph> <paragraph id="HCBA3F197733846AF8B4616E964DFDF53"><enum>(2)</enum><text>The needs of communities to address the problems related to opioid abuse, taking into consideration the prevalence of opioid abuse and overdose-related death in a community. </text></paragraph></section> <section id="H70239B53594349CC9BBB03AE5CC3EF69"><enum>3025.</enum><header>Definitions</header><text display-inline="no-display-inline">In this part:</text> <paragraph commented="no" display-inline="no-display-inline" id="HEDF015909C5D4377B05C8D7F968A31DF"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>first responder</term> includes a firefighter, law enforcement officer, paramedic, emergency medical technician, or other individual (including an employee of a legally organized and recognized volunteer organization, whether compensated or not), who, in the course of professional duties, responds to fire, medical, hazardous material, or other similar emergencies.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H5051F2075130411DB7A90DE428F00460"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>medication-assisted treatment</term> means the use of medications approved by the Food and Drug Administration for the treatment of opioid abuse.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HCD857CDB5A584016BA74CFDC9A4A7E5C"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>opioid</term> means any drug, including heroin, having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HDC464AFAE73E40F2B20B58167AD83FE2"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>schedule II, III, or IV controlled substance</term> means a controlled substance that is listed on schedule II, schedule III, or schedule IV of section 202(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812(c)</external-xref>).</text></paragraph> <paragraph id="HBA04AF510DC345A3B453DDFC04EB7D24"><enum>(5)</enum><text>The terms <term>drug</term> and <term>device</term> have the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text></paragraph> <paragraph id="HB0110D4D56BE4FC7A380E559BE243F78"><enum>(6)</enum><text>The term <term>criminal justice agency</term> means a State, local, or tribal—</text> <subparagraph id="H8958C840A61B4201B20142DE639BAFC8"><enum>(A)</enum><text>court;</text></subparagraph> <subparagraph id="H301B238CF9494C2CAA0365CFE5426402"><enum>(B)</enum><text>prison;</text></subparagraph> <subparagraph id="H68940EBA91434E68B3601DCFFD714CE8"><enum>(C)</enum><text>jail;</text></subparagraph> <subparagraph id="H474499EEE93A4905A074C5861EE9324B"><enum>(D)</enum><text>law enforcement agency; or</text></subparagraph> <subparagraph id="H35AD56E660D444B9B0F518EA9EF2CD1F"><enum>(E)</enum><text>other agency that performs the administration of criminal justice, including prosecution, pretrial services, and community supervision.</text></subparagraph></paragraph> <paragraph id="H3D661588FA3A4A9EB18347733F9AEA02"><enum>(7)</enum><text display-inline="yes-display-inline">The term <quote>tribal organization</quote> has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/450b">25 U.S.C. 450b</external-xref>).</text></paragraph></section></part><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H5E7C9E18B2794EE78A84CB5FADCED87E"><enum>(b)</enum><header>Authorization of appropriations</header><text>Section 1001(a) of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/42/3793">42 U.S.C. 3793(a)</external-xref>) is amended by inserting after paragraph (26) the following:</text> <quoted-block display-inline="no-display-inline" id="H3C3F66C058C4482988F5B33501F92D07" style="OLC"> <paragraph id="H51A35F0E976640B2B817B0E668646EA4"><enum>(27)</enum><text display-inline="yes-display-inline">There are authorized to be appropriated to carry out part LL $103,000,000 for each of fiscal years 2017 through 2021.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="HC9E01A5C38944E3AAB412B929B50ECF5"><enum>203.</enum><header>Audit and accountability of grantees</header> <subsection id="H7349021D069F4D0AA424B5B935BA6E3F"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="HDAB6ED4EB0A04DFD9FD64F160B1D5298"><enum>(1)</enum><text>the term <term>covered grant program</term> means a grant program operated by the Department of Justice;</text></paragraph> <paragraph id="HA8C800FCB7474D128A06A060BB0B04CC"><enum>(2)</enum><text>the term <term>covered grantee</term> means a recipient of a grant from a covered grant program;</text></paragraph> <paragraph id="HA65E1B0FC11444E5B97E015401384893"><enum>(3)</enum><text>the term <term>nonprofit</term>, when used with respect to an organization, means an organization that is described in <external-xref legal-doc="usc" parsable-cite="usc/26/501">section 501(c)(3)</external-xref> of the Internal Revenue Code of 1986, and is exempt from taxation under section 501(a) of such Code; and</text></paragraph> <paragraph id="HD0D9A33B31E0442CA1A6BA3162193B94"><enum>(4)</enum><text>the term <term>unresolved audit finding</term> means an audit report finding in a final audit report of the Inspector General of the Department of Justice that a covered grantee has used grant funds awarded to that grantee under a covered grant program for an unauthorized expenditure or otherwise unallowable cost that is not closed or resolved during a 12-month period prior to the date on which the final audit report is issued.</text></paragraph></subsection> <subsection id="H5EDCDFE680C04345BE5357D9502D9D4D"><enum>(b)</enum><header>Audit requirement</header><text>Beginning in fiscal year 2016, and annually thereafter, the Inspector General of the Department of Justice shall conduct audits of covered grantees to prevent waste, fraud, and abuse of funds awarded under covered grant programs. The Inspector General shall determine the appropriate number of covered grantees to be audited each year.</text></subsection> <subsection id="H8F4D79DF8BE840FD93EC39225726BD37"><enum>(c)</enum><header>Mandatory exclusion</header><text>A grantee that is found to have an unresolved audit finding under an audit conducted under subsection (b) may not receive grant funds under a covered grant program in the fiscal year following the fiscal year to which the finding relates.</text></subsection> <subsection id="H422C1AF36F8943B8A0ED3FB8F9F63A1C"><enum>(d)</enum><header>Reimbursement</header><text>If a covered grantee is awarded funds under the covered grant program from which it received a grant award during the 1-fiscal-year period during which the covered grantee is ineligible for an allocation of grant funds under subsection (c), the Attorney General shall—</text> <paragraph id="HFCA58A48A58944A0BFC86D1EC639B0D3"><enum>(1)</enum><text>deposit into the General Fund of the Treasury an amount that is equal to the amount of the grant funds that were improperly awarded to the covered grantee; and</text></paragraph> <paragraph id="HA670ED661BB349CBAF4EF92BEEE7FAC5"><enum>(2)</enum><text>seek to recoup the costs of the repayment to the Fund from the covered grantee that was improperly awarded the grant funds.</text></paragraph></subsection> <subsection id="HD47DEEC81AD84EA79FE68A3DE7FEB29A"><enum>(e)</enum><header>Priority of grant awards</header><text>The Attorney General, in awarding grants under a covered grant program shall give priority to eligible entities that during the 2-year period preceding the application for a grant have not been found to have an unresolved audit finding.</text></subsection> <subsection id="HCC808CE5318B4664A0DFA5769756FFFC"><enum>(f)</enum><header>Nonprofit requirements</header> <paragraph id="H09D88E1459044BEEA305F29A8E388AB0"><enum>(1)</enum><header>Prohibition</header><text>A nonprofit organization that holds money in offshore accounts for the purpose of avoiding the tax described in <external-xref legal-doc="usc" parsable-cite="usc/26/511">section 511(a)</external-xref> of the Internal Revenue Code of 1986, shall not be eligible to receive, directly or indirectly, any funds from a covered grant program.</text></paragraph> <paragraph id="HAA50F3B2C78141FFB865A6421F7FB55F"><enum>(2)</enum><header>Disclosure</header><text>Each nonprofit organization that is a covered grantee shall disclose in its application for such a grant, as a condition of receipt of such a grant, the compensation of its officers, directors, and trustees. Such disclosure shall include a description of the criteria relied on to determine such compensation.</text></paragraph></subsection></section> <section commented="no" display-inline="no-display-inline" id="H951895B42B1145D4ADE841E614A2C906" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Veterans treatment courts</header><text display-inline="no-display-inline">Section 2991 of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/42/3797aa">42 U.S.C. 3797aa</external-xref>) is amended—</text> <paragraph id="H8B012A2FE41941C99AC9BBBA15DCE1F7"><enum>(1)</enum><text>by redesignating subsection (i) as subsection (j); and</text></paragraph> <paragraph id="HC11A8D7EE0444FD29C2CC26C7E083330"><enum>(2)</enum><text>by inserting after subsection (h) the following:</text> <quoted-block display-inline="no-display-inline" id="HBA490D9F60B44B17BC490FE201F085B7" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="H83C211B0E946400BAC6FB40547C70BD7"><enum>(i)</enum><header display-inline="yes-display-inline">Assisting veterans</header> <paragraph commented="no" display-inline="no-display-inline" id="HFDB44792483B4BB48DFB67427E80080C"><enum>(1)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection:</text> <subparagraph commented="no" display-inline="no-display-inline" id="H70665C00B7DB4C80B03E0F5C7D4BEC43"><enum>(A)</enum><header display-inline="yes-display-inline">Peer to peer services or programs</header><text display-inline="yes-display-inline">The term <term>peer to peer services or programs</term> means services or programs that connect qualified veterans with other veterans for the purpose of providing support and mentorship to assist qualified veterans in obtaining treatment, recovery, stabilization, or rehabilitation.</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H4A50195F6AF94870BB5D39D271DB6483"><enum>(B)</enum><header display-inline="yes-display-inline">Qualified veteran</header><text display-inline="yes-display-inline">The term <term>qualified veteran</term> means a preliminarily qualified offender who—</text> <clause commented="no" display-inline="no-display-inline" id="H370DCC939170430490CD8718C58C659A"><enum>(i)</enum><text display-inline="yes-display-inline">served on active duty in any branch of the Armed Forces, including the National Guard or Reserves; and</text></clause> <clause commented="no" display-inline="no-display-inline" id="HB779196C5E494436B8E79171CAEC4428"><enum>(ii)</enum><text display-inline="yes-display-inline">was discharged or released from such service under conditions other than dishonorable.</text></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HAB73E27950154711822529F80D07637B"><enum>(C)</enum><header display-inline="yes-display-inline">Veterans treatment court program</header><text display-inline="yes-display-inline">The term <term>veterans treatment court program</term> means a court program involving collaboration among criminal justice, veterans, and mental health and substance abuse agencies that provides qualified veterans with—</text> <clause commented="no" display-inline="no-display-inline" id="HAC5F72679B0A4D2AA4D13816F9D465AC"><enum>(i)</enum><text display-inline="yes-display-inline">intensive judicial supervision and case management, which may include random and frequent drug testing where appropriate;</text></clause> <clause commented="no" display-inline="no-display-inline" id="HE280EB7608874B9ABAABCD6D75D02EBF"><enum>(ii)</enum><text display-inline="yes-display-inline">a full continuum of treatment services, including mental health services, substance abuse services, medical services, and services to address trauma;</text></clause> <clause commented="no" display-inline="no-display-inline" id="H6443BE831CDC4A2B92527BE8A4BD938C"><enum>(iii)</enum><text display-inline="yes-display-inline">alternatives to incarceration; or</text></clause> <clause commented="no" display-inline="no-display-inline" id="HB69E12AA8CEE4BF2B8609F2D53698382"><enum>(iv)</enum><text display-inline="yes-display-inline">other appropriate services, including housing, transportation, mentoring, employment, job training, education, or assistance in applying for and obtaining available benefits.</text></clause></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H56570EB5875B4AA0A93BCD883482533C"><enum>(2)</enum><header display-inline="yes-display-inline">Veterans assistance program</header> <subparagraph commented="no" display-inline="no-display-inline" id="H522F14FDB2F24834ADC70B18B7D267AE"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Attorney General, in consultation with the Secretary of Veterans Affairs, may award grants under this subsection to applicants to establish or expand—</text> <clause commented="no" display-inline="no-display-inline" id="HB5AC4AEE1B884227927BA987B65E9D95"><enum>(i)</enum><text display-inline="yes-display-inline">veterans treatment court programs;</text></clause> <clause commented="no" display-inline="no-display-inline" id="H85B5D92BBD0F46258179A5DB33E3B6B1"><enum>(ii)</enum><text display-inline="yes-display-inline">peer to peer services or programs for qualified veterans;</text></clause> <clause commented="no" display-inline="no-display-inline" id="HAEF09D055A4C4DF49B7F77B90AFB9E82"><enum>(iii)</enum><text display-inline="yes-display-inline">practices that identify and provide treatment, rehabilitation, legal, transitional, and other appropriate services to qualified veterans who have been incarcerated; or</text></clause> <clause commented="no" display-inline="no-display-inline" id="H7F47DA6BBA834C468C9DDB3A57E92BD9"><enum>(iv)</enum><text display-inline="yes-display-inline">training programs to teach criminal justice, law enforcement, corrections, mental health, and substance abuse personnel how to identify and appropriately respond to incidents involving qualified veterans.</text></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H82B9E277B0A9485EBB9862D18DD37F17"><enum>(B)</enum><header display-inline="yes-display-inline">Priority</header><text display-inline="yes-display-inline">In awarding grants under this subsection, the Attorney General shall give priority to applications that—</text> <clause commented="no" display-inline="no-display-inline" id="H98C54E0E267347F4A9FC21E808209712"><enum>(i)</enum><text display-inline="yes-display-inline">demonstrate collaboration between and joint investments by criminal justice, mental health, substance abuse, and veterans service agencies;</text></clause> <clause commented="no" display-inline="no-display-inline" id="H3271213828E4470AA115373445192E32"><enum>(ii)</enum><text display-inline="yes-display-inline">promote effective strategies to identify and reduce the risk of harm to qualified veterans and public safety; and</text></clause> <clause commented="no" display-inline="no-display-inline" id="H121570DF185D4ECEA74B34F4685503BA"><enum>(iii)</enum><text display-inline="yes-display-inline">propose interventions with empirical support to improve outcomes for qualified veterans.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H67FCC52DDD934D389FBC5E90C7C7F429"><enum>205.</enum><header>Emergency Federal law enforcement assistance</header><text display-inline="no-display-inline">Section 609Y(a) of the Justice Assistance Act of 1984 (<external-xref legal-doc="usc" parsable-cite="usc/42/10513">42 U.S.C. 10513(a)</external-xref>) is amended by striking <quote>September 30, 1984</quote> and inserting <quote>September 30, 2021</quote>.</text></section> <section id="H35B6BBA88E244BBFAE839BFE550805C5"><enum>206.</enum><header>Inclusion of services for pregnant women under family-based substance abuse grants</header><text display-inline="no-display-inline">Part DD of title I of the Omnibus Crime Control and Safe Streets Act (<external-xref legal-doc="usc" parsable-cite="usc/42/3797s">42 U.S.C. 3797s et seq.</external-xref>) is amended—</text> <paragraph id="H38D02A055CC743D3B7820F0358FB7D7A"><enum>(1)</enum><text>in section 2921(2), by inserting before the period at the end <quote>or pregnant women</quote>; and</text></paragraph> <paragraph id="HFD76EFD02FA744FCBEE40880A95D1AA1"><enum>(2)</enum><text>in section 2927—</text> <subparagraph id="HA2DDB607BDA34FCCA5AB486876728B36"><enum>(A)</enum><text>in paragraph (1)(A), by inserting <quote>pregnant or</quote> before <quote>a parent</quote>; and</text></subparagraph> <subparagraph id="H32FFA913D2F047B5AA6278BA552EA11B"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (3), by inserting <quote>or pregnant women</quote> after <quote>incarcerated parents</quote>. </text></subparagraph></paragraph></section> <section id="H6C2F61F09E30455DB1E96375ADD7803D"><enum>207.</enum><header>GAO study and report on Department of Justice programs and research relative to substance use and substance use disorders among adolescents and young adults</header> <subsection id="H553549068FED4E71BD8C2265766A6D42"><enum>(a)</enum><header>Study</header><text>The Comptroller General of the United States shall conduct a study on how the Department of Justice, through grant programs, is addressing prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults. Such study shall include an analysis of each of the following:</text> <paragraph id="H5083E8B0530048C78DEE2AD05E29483F"><enum>(1)</enum><text>The research that has been, and is being, conducted or supported pursuant to grant programs operated by the Department of Justice on prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults, including an assessment of—</text> <subparagraph id="H8E26C466F14E4EBD87163F16929EF72D"><enum>(A)</enum><text>such research relative to any unique circumstances (including social and biological circumstances) of adolescents and young adults that may make adolescent-specific and young adult-specific treatment protocols necessary, including any effects that substance use and substance use disorders may have on brain development and the implications for treatment and recovery; and</text></subparagraph> <subparagraph id="H8EBC1B6624914B4695503645C280BEB8"><enum>(B)</enum><text>areas of such research in which greater investment or focus is necessary relative to other areas of such research.</text></subparagraph></paragraph> <paragraph id="H96F0B7833C3947DA97FE505FE1A90F02"><enum>(2)</enum><text>Department of Justice non-research programs and activities that address prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults, including an assessment of the effectiveness of such programs and activities in preventing substance use by and substance use disorders among adolescents and young adults, treating such adolescents and young adults in a way that accounts for any unique circumstances faced by adolescents and young adults, and supports long term recovery among adolescents and young adults.</text></paragraph> <paragraph id="H7000B5C03ED44495B990F0760041CCCF"><enum>(3)</enum><text>Gaps that have been identified by officials of the Department of Justice or experts in the efforts supported by grant programs operated by the Department of Justice relating to prevention of, treatment for, and recovery from substance use by and substance use disorders among adolescents and young adults, including gaps in research, data collection, and measures to evaluate the effectiveness of such efforts, and the reasons for such gaps.</text></paragraph></subsection> <subsection id="H97AD4D923FD0422296D90B646F9CFCF6"><enum>(b)</enum><header>Report</header><text>Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit to the appropriate committees of the Congress a report containing the results of the study conducted under subsection (a), including—</text> <paragraph id="H44408796B3834B57AFCA366B522CAC1F"><enum>(1)</enum><text>a summary of the findings of the study; and</text></paragraph> <paragraph id="H37002D2F2ED2414B9DED2DD55884A933"><enum>(2)</enum><text>recommendations based on the results of the study, including recommendations for such areas of research and legislative and administrative action as the Comptroller General determines appropriate.</text></paragraph></subsection></section> <enum>III</enum><header>Jason Simcakoski PROMISE Act</header> <section id="HA295158B4E574BEDAAF291D8692C5670" section-type="subsequent-section"><enum>301.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act</short-title></quote> or the <quote>Jason Simcakoski PROMISE Act</quote>.</text></section> <section id="HD21C6385D960468EB0A1D35ED6133735" section-type="subsequent-section"><enum>302.</enum><header>Improvement of opioid safety measures by Department of Veterans Affairs</header> <subsection id="HB027DE7850AA43449AC6CA36414C3EF0"><enum>(a)</enum><header>Expansion of opioid safety initiative</header> <paragraph id="H3FC83E7834FA4C8EA4F677514EF20EEF"><enum>(1)</enum><header>Inclusion of all medical facilities</header><text>Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall expand the Opioid Safety Initiative of the Department of Veterans Affairs to include all medical facilities of the Department.</text></paragraph> <paragraph id="H6AB450FD8BA7475A833FE1BF04372D3C"><enum>(2)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Secretary shall establish guidance that each health care provider of the Department of Veterans Affairs, before initiating opioid therapy to treat a patient as part of the comprehensive assessment conducted by the health care provider, use the Opioid Therapy Risk Report tool of the Department of Veterans Affairs (or any subsequent tool), which shall include information from the prescription drug monitoring program of each participating State as applicable, that includes the most recent information to date relating to the patient that accessed such program to assess the risk for adverse outcomes of opioid therapy for the patient, including the concurrent use of controlled substances such as benzodiazepines, as part of the comprehensive assessment conducted by the health care provider.</text></paragraph> <paragraph id="H0B9C66915DD1451F8DF48C5B014B00DD"><enum>(3)</enum><header>Enhanced standards</header><text>The Secretary shall establish enhanced standards with respect to the use of routine and random urine drug tests for all patients before and during opioid therapy to help prevent substance abuse, dependence, and diversion, including—</text> <subparagraph id="H74D323184EF243BC9CB4607AB88EC7BC"><enum>(A)</enum><text>that such tests occur not less frequently than once each year; and</text></subparagraph> <subparagraph id="H3D9704A3F4F94217A7852399F987EA1B"><enum>(B)</enum><text>that health care providers appropriately order, interpret and respond to the results from such tests to tailor pain therapy, safeguards, and risk management strategies to each patient.</text></subparagraph></paragraph></subsection> <subsection id="HDE16FDEDFE8944B4A138C10B222648A5"><enum>(b)</enum><header>Pain management education and training</header> <paragraph id="H5F94E214DB4740CBA8416AA2C89E234F"><enum>(1)</enum><header>In general</header><text>In carrying out the Opioid Safety Initiative of the Department, the Secretary shall require all employees of the Department responsible for prescribing opioids to receive education and training described in paragraph (2).</text></paragraph> <paragraph id="HC6D5B1D4D4B648AA8A552180AB5A111A"><enum>(2)</enum><header>Education and training</header><text>Education and training described in this paragraph is education and training on pain management and safe opioid prescribing practices for purposes of safely and effectively managing patients with chronic pain, including education and training on the following:</text> <subparagraph id="HB6CCE78D18DD45E6B336CECA0EC76FEC"><enum>(A)</enum><text>The implementation of and full compliance with the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain, including any update to such guideline.</text></subparagraph> <subparagraph id="H5541FC1C143E4EE39B2BB474C18E744C"><enum>(B)</enum><text display-inline="yes-display-inline">The use of evidence-based pain management therapies, including cognitive-behavioral therapy, non-opioid alternatives, and non-drug methods and procedures to managing pain and related health conditions including medical devices approved or cleared by the Food and Drug Administration for the treatment of patients with chronic pain and complementary alternative medicines.</text></subparagraph> <subparagraph id="HDFD81C6A1F984E6A82FFFA4D33843FD7"><enum>(C)</enum><text>Screening and identification of patients with substance use disorder, including drug-seeking behavior, before prescribing opioids, assessment of risk potential for patients developing an addiction, and referral of patients to appropriate addiction treatment professionals if addiction is identified or strongly suspected.</text></subparagraph> <subparagraph id="H6D6E0A6155BC46F6B83E8B6FC3AD72F5"><enum>(D)</enum><text>Communication with patients on the potential harm associated with the use of opioids and other controlled substances, including the need to safely store and dispose of supplies relating to the use of opioids and other controlled substances.</text></subparagraph> <subparagraph id="H613A8D504C924BC5A0D3F12A56E97E4A"><enum>(E)</enum><text>Such other education and training as the Secretary considers appropriate to ensure that veterans receive safe and high-quality pain management care from the Department.</text></subparagraph></paragraph> <paragraph id="H83080F53C1CD4518A17FC41E4104224C"><enum>(3)</enum><header>Use of existing program</header><text>In providing education and training described in paragraph (2), the Secretary shall use the Interdisciplinary Chronic Pain Management Training Team Program of the Department (or success program).</text></paragraph></subsection> <subsection id="H0E6FA9E3B83C45C19B3C0391891AD75D"><enum>(c)</enum><header>Pain management teams</header> <paragraph id="H829C1E4837164C178877D45B6352DA38"><enum>(1)</enum><header>In general</header><text>In carrying out the Opioid Safety Initiative of the Department, the director of each medical facility of the Department shall identify and designate a pain management team of health care professionals, which may include board certified pain medicine specialists, responsible for coordinating and overseeing pain management therapy at such facility for patients experiencing acute and chronic pain that is non-cancer related.</text></paragraph> <paragraph id="H4757139632974A3E81DC792CFD7111AC"><enum>(2)</enum><header>Establishment of protocols</header> <subparagraph id="H7CB96E7CEE8342E99A09D3D2957ED734"><enum>(A)</enum><header>In general</header><text>In consultation with the Directors of each Veterans Integrated Service Network, the Secretary shall establish standard protocols for the designation of pain management teams at each medical facility within the Department.</text></subparagraph> <subparagraph id="H99F63703BB7A43FF9ACF71D7BD1803E9"><enum>(B)</enum><header>Consultation on prescription of opioids</header><text>Each protocol established under subparagraph (A) shall ensure that any health care provider without expertise in prescribing analgesics or who has not completed the education and training under subsection (b), including a mental health care provider, does not prescribe opioids to a patient unless that health care provider—</text> <clause id="H22E9356CE3C545E4A57AC195A14D5912"><enum>(i)</enum><text>consults with a health care provider with pain management expertise or who is on the pain management team of the medical facility; and</text></clause> <clause id="H553B69C407504A239D63BDEEB4297F0B"><enum>(ii)</enum><text>refers the patient to the pain management team for any subsequent prescriptions and related therapy.</text></clause></subparagraph></paragraph> <paragraph id="H40470BCE18284E12B51AF47A75119823"><enum>(3)</enum><header>Report</header> <subparagraph id="H92EDF3AE004F41C0A9A45A5D9D27BBDB"><enum>(A)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the director of each medical facility of the Department shall submit to the Under Secretary for Health and the director of the Veterans Integrated Service Network in which the medical facility is located a report identifying the health care professionals that have been designated as members of the pain management team at the medical facility pursuant to paragraph (1).</text></subparagraph> <subparagraph id="H27FDA8AA55074532B0EF7E34AEA0DD4E"><enum>(B)</enum><header>Elements</header><text>Each report submitted under subparagraph (A) with respect to a medical facility of the Department shall include—</text> <clause id="HDC6977AC7CEB43058F61F7508C649A18"><enum>(i)</enum><text>a certification as to whether all members of the pain management team at the medical facility have completed the education and training required under subsection (b);</text></clause> <clause id="H50B09A01FF9F488891566C0F5D54A925"><enum>(ii)</enum><text>a plan for the management and referral of patients to such pain management team if health care providers without expertise in prescribing analgesics prescribe opioid medications to treat acute and chronic pain that is non-cancer related; and</text></clause> <clause id="H3572DA4F71BA4272B0B498D5040A7061"><enum>(iii)</enum><text display-inline="yes-display-inline">a certification as to whether the medical facility—</text> <subclause id="HBB584FD5D6F54DE8A31CB8D57C5A735F"><enum>(I)</enum><text>fully complies with the stepped-care model of pain management and other pain management policies contained in Directive 2009–053 of the Veterans Health Administration, or successor directive; or</text></subclause> <subclause id="H56C68601E17649959236C593B51F144A"><enum>(II)</enum><text display-inline="yes-display-inline">does not fully comply with such stepped-care model of pain management and other pain management policies but is carrying out a corrective plan of action to ensure such full compliance.</text></subclause></clause></subparagraph></paragraph></subsection> <subsection id="H60F5A49EDFF44D2198C744E08E7F1F49"><enum>(d)</enum><header>Tracking and monitoring of opioid use</header> <paragraph id="HEF0EEE4A111F412DA6BB1CF45479D429"><enum>(1)</enum><header>Prescription drug monitoring programs of states</header><text>In carrying out the Opioid Safety Initiative and the Opioid Therapy Risk Report tool of the Department, the Secretary shall—</text> <subparagraph id="H5F934FE225BD4502AE71F667D475F7FE"><enum>(A)</enum><text>ensure access by health care providers of the Department to information on controlled substances, including opioids and benzodiazepines, prescribed to veterans who receive care outside the Department through the prescription drug monitoring program of each State with such a program, including by seeking to enter into memoranda of understanding with States to allow shared access of such information between States and the Department;</text></subparagraph> <subparagraph id="H5B10F3B6C3FB43ACB52D11C1A0DB7DC1"><enum>(B)</enum><text>include such information in the Opioid Therapy Risk Report; and</text></subparagraph> <subparagraph id="HA04ED66FC0AB4897911C2E34D714E8E2"><enum>(C)</enum><text>require health care providers of the Department to submit to the prescription drug monitoring program of each State information on prescriptions of controlled substances received by veterans in that State under the laws administered by the Secretary.</text></subparagraph></paragraph> <paragraph id="H27575A7EF07B4F138CC2936C6AB7AA05"><enum>(2)</enum><header>Report on tracking of data on opioid use</header><text display-inline="yes-display-inline">Not later than 18 months after the date of the enactment of this Act, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on the feasibility and advisability of improving the Opioid Therapy Risk Report tool of the Department to allow for more advanced real-time tracking of and access to data on—</text> <subparagraph id="H1461261ED57F484A8FF6A51EF9479E62"><enum>(A)</enum><text>the key clinical indicators with respect to the totality of opioid use by veterans;</text></subparagraph> <subparagraph id="HC442F31D573C4C0EB4F4AC858A43B6AD"><enum>(B)</enum><text>concurrent prescribing by health care providers of the Department of opioids in different health care settings, including data on concurrent prescribing of opioids to treat mental health disorders other than opioid use disorder; and</text></subparagraph> <subparagraph id="H60CDD22C852445BEA08BE6CF03CB5624"><enum>(C)</enum><text>mail-order prescriptions of opioid prescribed to veterans under the laws administered by the Secretary.</text></subparagraph></paragraph></subsection> <subsection id="H2AD7BD11C43547CA9039591923234871"><enum>(e)</enum><header>Availability of opioid receptor antagonists</header> <paragraph id="HA7664B37A630428BB3216FD8B84D5392"><enum>(1)</enum><header>Increased availability and use</header> <subparagraph id="H37EE54A764D14E8688DD9D5B745355BC"><enum>(A)</enum><header>In general</header><text>The Secretary shall maximize the availability of opioid receptor antagonists approved by the Food and Drug Administration, including naloxone, to veterans.</text></subparagraph> <subparagraph id="H69A6F2687DE048FF8A453326CA7E1A35"><enum>(B)</enum><header>Availability, training, and distributing</header><text>In carrying out subparagraph (A), not later than 90 days after the date of the enactment of this Act, the Secretary shall—</text> <clause id="H2BF16747759C4C999595DAE2B48ABC52"><enum>(i)</enum><text>equip each pharmacy of the Department with opioid receptor antagonists approved by the Food and Drug Administration to be dispensed to outpatients as needed; and</text></clause> <clause id="HEEC40B2C900C4FB3BB2F9D341D11B5D3"><enum>(ii)</enum><text>expand the Overdose Education and Naloxone Distribution program of the Department to ensure that all veterans in receipt of health care under laws administered by the Secretary who are at risk of opioid overdose may access such opioid receptor antagonists and training on the proper administration of such opioid receptor antagonists.</text></clause></subparagraph> <subparagraph id="H1B82C96B7DBF437EB4DDA78DB86E4E45"><enum>(C)</enum><header>Veterans who are at risk</header><text>For purposes of subparagraph (B), veterans who are at risk of opioid overdose include—</text> <clause id="HA415664B759E4E1582306019856DF0F4"><enum>(i)</enum><text>veterans receiving long-term opioid therapy;</text></clause> <clause id="HD3D5CBBE596740878B48E7A9A9ED97E1"><enum>(ii)</enum><text>veterans receiving opioid therapy who have a history of substance use disorder or prior instances of overdose; and</text></clause> <clause id="H0C55D66F502840B3B8AFC8977035B228"><enum>(iii)</enum><text>veterans who are at risk as determined by a health care provider who is treating the veteran.</text></clause></subparagraph></paragraph> <paragraph id="HB105FB094E6E4914BDBEF96D819C32F0"><enum>(2)</enum><header>Report</header><text>Not later than 120 days after the date of the enactment of this Act, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on carrying out paragraph (1), including an assessment of any remaining steps to be carried out by the Secretary to carry out such paragraph.</text></paragraph></subsection> <subsection id="HF1DEF36E67A646FC93FBCE9B2DDC33F9"><enum>(f)</enum><header>Inclusion of certain information and capabilities in opioid therapy risk report tool of the Department</header> <paragraph id="HDF07DD9584944E8A93973FCD03993B33"><enum>(1)</enum><header>Information</header><text>The Secretary shall include in the Opioid Therapy Risk Report tool of the Department—</text> <subparagraph id="H2260A90989D44D7E90A7516EF33B2127"><enum>(A)</enum><text>information on the most recent time the tool was accessed by a health care provider of the Department with respect to each veteran; and</text></subparagraph> <subparagraph id="H1F57905C1EA74ECA8DDB97DCA63FDD5D"><enum>(B)</enum><text>information on the results of the most recent urine drug test for each veteran.</text></subparagraph></paragraph> <paragraph id="H009275BEC36B4C468FC7B3856DD28F71"><enum>(2)</enum><header>Capabilities</header><text>The Secretary shall include in the Opioid Therapy Risk Report tool the ability of the health care providers of the Department to determine whether a health care provider of the Department prescribed opioids to a veteran without checking the information in the tool with respect to the veteran.</text></paragraph></subsection> <subsection id="H859A0742BED14C499B2B79DF55664647"><enum>(g)</enum><header>Notifications of risk in computerized health record</header><text>The Secretary shall modify the computerized patient record system of the Department to ensure that any health care provider that accesses the record of a veteran, regardless of the reason the veteran seeks care from the health care provider, will be immediately notified whether the veteran—</text> <paragraph id="HA05836C872864BAE89889969EA957736"><enum>(1)</enum><text>is receiving opioid therapy and has a history of substance use disorder or prior instances of overdose;</text></paragraph> <paragraph id="HFC854F7B5F444FB1BB1006A18C76BF04"><enum>(2)</enum><text>has a history of opioid abuse; or</text></paragraph> <paragraph id="HF923A628BF3241A587D0643DFF4CA8A5"><enum>(3)</enum><text>is at risk of becoming an opioid abuser as determined by a health care provider who is treating the veteran.</text></paragraph></subsection> <subsection id="HF04FCFA5D4C444B7B07BCB208A1E9D5C"><enum>(h)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HECF346C85BE24055B3D0110CA0D660D5"><enum>(1)</enum><text>The term <term>controlled substance</term> has the meaning given that term in section 102 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802</external-xref>).</text></paragraph> <paragraph id="H2FF780BF0CDD4B40A905C1FE0DDC20EB"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>State</term> means each of the several States, territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.</text></paragraph></subsection></section> <section id="H0693821F5B1A4CB88C8DF327C5D0E076"><enum>303.</enum><header>Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense</header> <subsection id="H8BD51D8E64254DFEA43B860A2802EAB5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 90 days after the date of enactment of this Act, the Secretary of Veterans Affairs and the Secretary of Defense shall ensure that the Pain Management Working Group of the Health Executive Committee of the Department of Veterans Affairs–Department of Defense Joint Executive Committee (Pain Management Working Group) established under section 320 of title 38, United States Code, includes a focus on the following:</text> <paragraph id="HF0C8AC8C8C88468BA1DFF4CB80255335"><enum>(1)</enum><text>The opioid prescribing practices of health care providers of each Department.</text></paragraph> <paragraph id="H7D3842CCADC24FC086898452EDAC0540"><enum>(2)</enum><text>The ability of each Department to manage acute and chronic pain among individuals receiving health care from the Department, including training health care providers with respect to pain management.</text></paragraph> <paragraph id="H2B6FE94A3B094FFEBF434BF3F125D05E"><enum>(3)</enum><text>The use by each Department of complementary and integrative health and complementary alternative medicines in treating such individuals.</text></paragraph> <paragraph id="HA26C3010F7AB4DE8B69860C6C17A9605"><enum>(4)</enum><text>The concurrent use by health care providers of each Department of opioids and prescription drugs to treat mental health disorders, including benzodiazepines.</text></paragraph> <paragraph id="H195D6112B0894FF6923FD5F34B24CB2D"><enum>(5)</enum><text>The practice by health care providers of each Department of prescribing opioids to treat mental health disorders.</text></paragraph> <paragraph id="H08458BE33A074D14A0E9CD3F43C78AA8"><enum>(6)</enum><text>The coordination in coverage of and consistent access to medications prescribed for patients transitioning from receiving health care from the Department of Defense to receiving health care from the Department of Veterans Affairs.</text></paragraph> <paragraph id="H3B434ECA4F594D24AFCA33C14D901D84"><enum>(7)</enum><text>The ability of each Department to identify and treat substance use disorders among individuals receiving health care from that Department.</text></paragraph></subsection> <subsection id="H27BF7E9BD0C4411C9953FADC631A56D9"><enum>(b)</enum><header>Coordination and consultation</header><text>The Secretary of Veterans Affairs and the Secretary of Defense shall ensure that the working group described in subsection (a)—</text> <paragraph id="H4E041941A172496A8312604C5467BFEA"><enum>(1)</enum><text>coordinates the activities of the working group with other relevant working groups established under section 320 of title 38, United States Code;</text></paragraph> <paragraph id="H389CFABBBE3C4A3491A757A0E4BD1EF5"><enum>(2)</enum><text>consults with other relevant Federal agencies with respect to the activities of the working group; and</text></paragraph> <paragraph id="H1D0C5E87C5214011A2DD2F124A2C28DA"><enum>(3)</enum><text>consults with the Department of Veterans Affairs and the Department of Defense with respect to, reviews, and comments on the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain, or any successor guideline, before any update to the guideline is released.</text></paragraph></subsection> <subsection id="HFD857FF85E624D23B8C33D01C021FC26"><enum>(c)</enum><header>Clinical practice guidelines</header> <paragraph id="H99DA996E5D3D456BA74A81F34144D291"><enum>(1)</enum><header>In general</header><text>Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs and the Secretary of Defense shall issue an update to the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.</text></paragraph> <paragraph id="H38CD9BA41FD5412584920008F8C9CE30"><enum>(2)</enum><header>Matters included</header><text>In conducting the update under subsection (a), the Pain Management Working Group, in coordination with the Clinical Practice Guideline VA/DOD Management of Opioid Therapy for Chronic Pain Working Group, shall examine whether the Clinical Practical Guideline should include the following:</text> <subparagraph id="HF59413655B4540CE9E19AB6912C3B0CD"><enum>(A)</enum><text>Enhanced guidance with respect to—</text> <clause id="H735402B34686472A9E7665967B4F2CC9"><enum>(i)</enum><text>the coadministration of an opioid and other drugs, including benzodiazepines, that may result in life-limiting drug interactions;</text></clause> <clause id="H8040F7C76F3447C98E983A8D27569F9B"><enum>(ii)</enum><text>the treatment of patients with current acute psychiatric instability or substance use disorder or patients at risk of suicide; and</text></clause> <clause id="HF15477DC2D7847D9BFEDAA08E5FC9937"><enum>(iii)</enum><text>the use of opioid therapy to treat mental health disorders other than opioid use disorder.</text></clause></subparagraph> <subparagraph id="H5CCC9A8954BD4F57BE6E11B9B2D0EF90"><enum>(B)</enum><text display-inline="yes-display-inline">Enhanced guidance with respect to the treatment of patients with behaviors or comorbidities, such as post-traumatic stress disorder or other psychiatric disorders, or a history of substance abuse or addiction, that requires a consultation or comanagement of opioid therapy with one or more specialists in pain management, mental health, or addictions.</text></subparagraph> <subparagraph id="H7ACC4678910146C894CF3FE093986486"><enum>(C)</enum><text display-inline="yes-display-inline">Enhanced guidance with respect to health care providers—</text> <clause id="H135A40BF16B34275A960A26C9E8A97D0"><enum>(i)</enum><text>conducting an effective assessment for patients beginning or continuing opioid therapy, including understanding and setting realistic goals with respect to achieving and maintaining an expected level of pain relief, improved function, or a clinically appropriate combination of both; and</text></clause> <clause id="HEFD18911C1AD4AF0BB459AD39C9C7C85"><enum>(ii)</enum><text>effectively assessing whether opioid therapy is achieving or maintaining the established treatment goals of the patient or whether the patient and health care provider should discuss adjusting, augmenting, or discontinuing the opioid therapy.</text></clause></subparagraph> <subparagraph id="HD969D2432C724BB49815191977C138DB"><enum>(D)</enum><text>Guidelines to govern the methodologies used by health care providers of the Department of Veterans Affairs and the Department of Defense to taper opioid therapy when adjusting or discontinuing the use of opioid therapy.</text></subparagraph> <subparagraph id="HAE6A684503724E46A315909110ED2463"><enum>(E)</enum><text>Guidelines with respect to appropriate case management for patients receiving opioid therapy who transition between inpatient and outpatient health care settings, which may include the use of care transition plans.</text></subparagraph> <subparagraph id="H941C5600724E4BEA9255810FAC294088"><enum>(F)</enum><text>Guidelines with respect to appropriate case management for patients receiving opioid therapy who transition from receiving care during active duty to post-military health care networks.</text></subparagraph> <subparagraph id="H4A8CBEBF96EF4193B86ECB38C3F8FD09"><enum>(G)</enum><text display-inline="yes-display-inline">Guidelines with respect to providing options, before initiating opioid therapy, for pain management therapies without the use of opioids and options to augment opioid therapy with other clinical and complementary and integrative health services to minimize opioid dependence.</text></subparagraph> <subparagraph id="H847C2A6430EC4124ACA61D8EC8FB4F22"><enum>(H)</enum><text>Guidelines with respect to the provision of evidence-based non-opioid treatments within the Department of Veterans Affairs and the Department of Defense, including medical devices and other therapies approved or cleared by the Food and Drug Administration for the treatment of chronic pain as an alternative to or to augment opioid therapy.</text></subparagraph></paragraph></subsection></section> <section id="H2E418B23423F4CCF9551421DB2A8B111"><enum>304.</enum><header>Review, investigation, and report on use of opioids in treatment by Department of Veterans Affairs</header> <subsection id="H1C306A84616D4B4CB4D6D7DA4D658FC2"><enum>(a)</enum><header>Comptroller general report</header> <paragraph id="HD3335930ABD544499D3D75D48ABCC814"><enum>(1)</enum><header>In general</header><text>Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on the Opioid Safety Initiative of the Department of Veterans Affairs and the opioid prescribing practices of health care providers of the Department.</text></paragraph> <paragraph id="H28BE5B7AC7FF46E6BA68DF3AFEB56F61"><enum>(2)</enum><header>Elements</header><text>The report submitted under paragraph (1) shall include the following:</text> <subparagraph id="H4681F4967CA241F7A43F8CAB56B40CF9"><enum>(A)</enum><text>Recommendations on such improvements to the Opioid Safety Initiative of the Department as the Comptroller General considers appropriate.</text></subparagraph> <subparagraph id="H60ABB6FE2EF84802B7FE2BC87F45C61D"><enum>(B)</enum><text>Information with respect to—</text> <clause id="H662D4C5D97384EF0A7A156E792FBFCA8"><enum>(i)</enum><text>deaths resulting from sentinel events involving veterans prescribed opioids by a health care provider of the Department;</text></clause> <clause id="H4849307E42F44A00935D999C656FEF6E"><enum>(ii)</enum><text>overall prescription rates and prescriptions indications of opioids to treat non-cancer, non-palliative, and non-hospice care patients;</text></clause> <clause id="H2620818F2FD14937B1705F9143C59F47"><enum>(iii)</enum><text>the prescription rates and prescriptions indications of benzodiazepines and opioids concomitantly by health care providers of the Department;</text></clause> <clause id="H64C51E2E1B6945EB85D650CAF8930838"><enum>(iv)</enum><text>the practice by health care providers of the Department of prescribing opioids to treat patients without any pain, including to treat patients with mental health disorders other than opioid use disorder; and</text></clause> <clause id="HCC689E0944CB439DB7E75B786FC44552"><enum>(v)</enum><text>the effectiveness of opioid therapy for patients receiving such therapy, including the effectiveness of long-term opioid therapy.</text></clause></subparagraph> <subparagraph id="H634157F2AB5842AC8E28929997CC3269"><enum>(C)</enum><text display-inline="yes-display-inline">An evaluation of processes of the Department in place to oversee opioid use among veterans, including procedures to identify and remedy potential over-prescribing of opioids by health care providers of the Department.</text></subparagraph> <subparagraph id="H5CE344E81A8C4091BB8F544680912C58"><enum>(D)</enum><text display-inline="yes-display-inline">An assessment of the implementation by the Secretary of the VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.</text></subparagraph></paragraph></subsection> <subsection id="H9BACD2CBF61D45EEA5F03447506D7CAE"><enum>(b)</enum><header>Quarterly progress report on implementation of comptroller general recommendations</header><text>Not later than 2 years after the date of the enactment of this Act, and not later than 30 days after the end of each quarter thereafter, the Secretary of Veterans Affairs shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a progress report detailing the actions by the Secretary during the period covered by the report to address any outstanding findings and recommendations by the Comptroller General of the United States under subsection (a) with respect to the Veterans Health Administration.</text></subsection> <subsection id="H4492F06C0D3E4D698C642707253D3A5C"><enum>(c)</enum><header>Annual review of prescription rates</header><text>Not later than 1 year after the date of the enactment of this Act, and not less frequently than annually for the following 5 years, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report, with respect to each medical facility of the Department of Veterans Affairs, to collect and review information on opioids prescribed by health care providers at the facility to treat non-cancer, non-palliative, and non-hospice care patients that contains, for the 1-year period preceding the submission of the report, the following:</text> <paragraph id="HAD87525BB1F24AEC9EAB474695FB8286"><enum>(1)</enum><text>The number of patients and the percentage of the patient population of the Department who were prescribed benzodiazepines and opioids concurrently by a health care provider of the Department.</text></paragraph> <paragraph id="H37AF3E0687C747FC99DADD6A1C76E65F"><enum>(2)</enum><text>The number of patients and the percentage of the patient population of the Department without any pain who were prescribed opioids by a health care provider of the Department, including those who were prescribed benzodiazepines and opioids concurrently.</text></paragraph> <paragraph id="HFFAA8FC7E8D84A6E8F1576B4F31EADF8"><enum>(3)</enum><text>The number of non-cancer, non-palliative, and non-hospice care patients and the percentage of such patients who were treated with opioids by a health care provider of the Department on an inpatient-basis and who also received prescription opioids by mail from the Department while being treated on an inpatient-basis.</text></paragraph> <paragraph id="HDC18582616A94B24BC935A41D0AF3DEC"><enum>(4)</enum><text>The number of non-cancer, non-palliative, and non-hospice care patients and the percentage of such patients who were prescribed opioids concurrently by a health care provider of the Department and a health care provider that is not health care provider of the Department.</text></paragraph> <paragraph id="H2B9BB09712114BC9857DFEC02A0A671F"><enum>(5)</enum><text>With respect to each medical facility of the Department, information on opioids prescribed by health care providers at the facility to treat non-cancer, non-palliative, and non-hospice care patients, including information on—</text> <subparagraph id="H319B017C96E048FB89CF360D39FC2A24"><enum>(A)</enum><text>the prescription rate at which each health care provider at the facility prescribed benzodiazepines and opioids concurrently to such patients and the aggregate such prescription rate for all health care providers at the facility;</text></subparagraph> <subparagraph id="H36E8B1ADE5C64A90AFDDA651380B47EE"><enum>(B)</enum><text>the prescription rate at which each health care provider at the facility prescribed benzodiazepines or opioids to such patients to treat conditions for which benzodiazepines or opioids are not approved treatment and the aggregate such prescription rate for all health care providers at the facility;</text></subparagraph> <subparagraph id="H3C74DB65B496405F85655D5F371449D0"><enum>(C)</enum><text>the prescription rate at which each health care provider at the facility prescribed or dispensed mail-order prescriptions of opioids to such patients while such patients were being treated with opioids on an inpatient-basis and the aggregate of such prescription rate for all health care providers at the facility; and</text></subparagraph> <subparagraph id="HCDCE19A82F58428C8F06F02B9FD1607F"><enum>(D)</enum><text>the prescription rate at which each health care provider at the facility prescribed opioids to such patients who were also concurrently prescribed opioids by a health care provider that is not a health care provider of the Department and the aggregate of such prescription rates for all health care providers at the facility.</text></subparagraph></paragraph> <paragraph id="HFF9F8006153D458CBD8B9AFF5ADED36C"><enum>(6)</enum><text>With respect to each medical facility of the Department, the number of times a pharmacist at the facility overrode a critical drug interaction warning with respect to an interaction between opioids and another medication before dispensing such medication to a veteran.</text></paragraph></subsection> <subsection id="HC8F774307B9E493A8A7459B03A8EAA8C"><enum>(d)</enum><header>Investigation of prescription rates</header><text>If the Secretary determines that a prescription rate with respect to a health care provider or medical facility of the Department conflicts with or is otherwise inconsistent with the standards of appropriate and safe care, the Secretary shall—</text> <paragraph id="HC16F64FC16BA481080688B80D07BC34A"><enum>(1)</enum><text display-inline="yes-display-inline">immediately notify the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives of such determination, including information relating to such determination, prescription rate, and health care provider or medical facility, as the case may be; and</text></paragraph> <paragraph display-inline="no-display-inline" id="H134802137B704C41AC30EF971458B1D8"><enum>(2)</enum><text>through the Office of the Medical Inspector of the Veterans Health Administration, conduct a full investigation of the health care provider or medical facility, as the case may be.</text></paragraph></subsection> <subsection id="H5E54B565809A4F4BBFD7F71DCFCABDB7"><enum>(e)</enum><header>Prescription rate defined</header><text>In this section, the term <term>prescription rate</term> means, with respect to a health care provider or medical facility of the Department, each of the following:</text> <paragraph id="HB58CBBB480114286A0B6AFAE6BB0147A"><enum>(1)</enum><text>The number of patients treated with opioids by the health care provider or at the medical facility, as the case may be, divided by the total number of pharmacy users of that health care provider or medical facility.</text></paragraph> <paragraph id="HABF39E5387CE4115AD6533C08671FBE7"><enum>(2)</enum><text>The average number of morphine equivalents per day prescribed by the health care provider or at the medical facility, as the case may be, to patients being treated with opioids.</text></paragraph> <paragraph id="HCC902D7121F144E8BF9407777711CB03"><enum>(3)</enum><text>Of the patients being treated with opioids by the health care provider or at the medical facility, as the case may be, the average number of prescriptions of opioids per patient.</text></paragraph></subsection></section> <section id="HF4130382D3834EDE9B929527D59D2026" section-type="subsequent-section" display-inline="no-display-inline"><enum>305.</enum><header>Mandatory disclosure of certain veteran information to State controlled substance monitoring programs</header><text display-inline="no-display-inline">Section 5701(l) of title 38, United States Code, is amended by striking <quote>may</quote> and inserting <quote>shall</quote>.</text></section> <section id="HAAE09285BD2843FD996F7B0EC7F91718" display-inline="no-display-inline" section-type="subsequent-section"><enum>306.</enum><header>Modification to limitation on awards and bonuses</header><text display-inline="no-display-inline">Section 705 of the Veterans Access, Choice, and Accountability Act of 2014 (<external-xref legal-doc="public-law" parsable-cite="pl/113/146">Public Law 113–146</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/38/703">38 U.S.C. 703</external-xref> note) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H9AB9DD4C4E00479FB6D674CB7836A794" style="OLC"> <section id="H024D84DB508943F68C2F067DB214EA4D"><enum>705.</enum><header>Limitation on awards and bonuses paid to employees of Department of Veterans Affairs</header><text display-inline="no-display-inline">The Secretary of Veterans Affairs shall ensure that the aggregate amount of awards and bonuses paid by the Secretary in a fiscal year under chapter 45 or 53 of title 5, United States Code, or any other awards or bonuses authorized under such title or title 38, United States Code, does not exceed the following amounts:</text> <paragraph id="HDF46D848D14F45C3A9F1221EFBD6717E" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">With respect to each of fiscal years 2017 through 2021, $230,000,000.</text></paragraph> <paragraph id="HB7B7CB8D86D141F59F58B2785F71DE7B" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">With respect to each of fiscal years 2022 through 2024, $360,000,000.</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>IV</enum><header>Kingpin Designation Improvement Act</header> <section id="H15C7B327F01B42B8A8DADCEA7407FEDF" section-type="subsequent-section"><enum>401.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Kingpin Designation Improvement Act of 2016</short-title></quote>.</text></section> <section id="H2AA58499CB3449C9A6404CD1B7B6D3FC"><enum>402.</enum><header>Protection of classified information in Federal court challenges relating to designations under the Narcotics Kingpin Designation Act</header><text display-inline="no-display-inline">Section 804 of the Foreign Narcotics Kingpin Designation Act (<external-xref legal-doc="usc" parsable-cite="usc/21/1903">21 U.S.C. 1903</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H6C6B2E743D38471EB2A53B47D6D8D053" style="OLC"> <subsection id="H3AACF7657F014FC382E8D15A46A0C3ED"><enum>(i)</enum><header>Protection of classified information in Federal court challenges relating to designations</header><text display-inline="yes-display-inline">In any judicial review of a determination made under this section, if the determination was based on classified information (as defined in section 1(a) of the Classified Information Procedures Act) such information may be submitted to the reviewing court ex parte and in camera. This subsection does not confer or imply any right to judicial review.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>V</enum><header>Good Samaritan Assessment Act</header> <section id="HADA78A20A1C04E0CBC2305FDEFCF66A1" section-type="subsequent-section"><enum>501.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Good Samaritan Assessment Act of 2016</short-title></quote>.</text></section> <section id="H483426F4F681403BBC2B9C1B84AB94AB"><enum>502.</enum><header>Finding</header><text display-inline="no-display-inline">The Congress finds that the executive branch, including the Office of National Drug Control Policy, has a policy focus on preventing and addressing prescription drug misuse and heroin use, and has worked with States and municipalities to enact Good Samaritan laws that would protect caregivers, law enforcement personnel, and first responders who administer opioid overdose reversal drugs or devices.</text></section> <section id="H3C006E1F942E42C1A454072219496966"><enum>503.</enum><header>GAO Study on Good Samaritan laws pertaining to treatment of opioid overdoses</header><text display-inline="no-display-inline">The Comptroller General of the United States shall submit to the Committee on the Judiciary of the House of Representatives, the Committee on Oversight and Government Reform of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Homeland Security and Governmental Affairs of the Senate a report on—</text> <paragraph id="HCE41451E9442407BA57AD0E3CFD02488"><enum>(1)</enum><text>the extent to which the Director of National Drug Control Policy has reviewed Good Samaritan laws, and any findings from such a review, including findings related to the potential effects of such laws, if available;</text></paragraph> <paragraph id="H0102D8E5C48E40BFBEB2A8E70FC52925"><enum>(2)</enum><text display-inline="yes-display-inline">efforts by the Director to encourage the enactment of Good Samaritan laws; and</text></paragraph> <paragraph id="H43F41384879B461CAACD183712EBB240"><enum>(3)</enum><text display-inline="yes-display-inline">a compilation of Good Samaritan laws in effect in the States, the territories, and the District of Columbia.</text></paragraph></section> <section id="H329F03D237E845A5941BEBBFA584DC20"><enum>504.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title—</text> <paragraph id="HBE34B03B69074C0A9997F4CED321C9BE"><enum>(1)</enum><text display-inline="yes-display-inline">the term <quote>Good Samaritan law</quote> means a law of a State or unit of local government that exempts from criminal or civil liability any individual who administers an opioid overdose reversal drug or device, or who contacts emergency services providers in response to an overdose; and</text></paragraph> <paragraph id="H76A44E0558904A60BBE84F7BF4FB1EB4"><enum>(2)</enum><text>the term <quote>opioid</quote> means any drug, including heroin, having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.</text></paragraph></section> <enum>VI</enum><header>OPEN Act</header> <section id="H348224867C2D4B1984ABD1FE320A094A" section-type="subsequent-section"><enum>601.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Opioid Program Evaluation Act</short-title></quote> or the <quote>OPEN Act</quote>. </text></section> <section id="H0A005044C6664868ACFB5502C9FB5A0F"><enum>602.</enum><header>Evaluation of performance of Department of Justice program</header> <subsection id="H8F7E4D07C54B4C259AD190897D2936D8"><enum>(a)</enum><header>Evaluation of Justice Department Comprehensive Opioid Abuse Grant Program</header><text display-inline="yes-display-inline">Not later than 5 years after the date of enactment of this Act, the Attorney General shall complete an evaluation of the effectiveness of the Comprehensive Opioid Abuse Grant Program under part LL of the Omnibus Crime Control and Safe Streets Act of 1968 administered by the Department of Justice based upon the information reported under subsection (d) of this section.</text></subsection> <subsection id="H33820EEBBB8144DEB04D8C0CA3EAB729"><enum>(b)</enum><header>Interim evaluation</header><text display-inline="yes-display-inline">Not later than 3 years after the date of enactment of this Act, the Attorney General shall complete an interim evaluation assessing the nature and extent of the incidence of opioid abuse and illegal opioid distribution in the United States.</text></subsection> <subsection id="H7EA7548BFA1742D7981A26107E51F7A2"><enum>(c)</enum><header>Metrics and outcomes for evaluation</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this Act, the Attorney General shall identify outcomes that are to be achieved by activities funded by the Comprehensive Opioid Grant Abuse Program and the metrics by which the achievement of such outcomes shall be determined.</text></subsection> <subsection id="HC62706F81DA64A75833B850217E21DBC"><enum>(d)</enum><header>Metrics data collection</header><text display-inline="yes-display-inline">The Attorney General shall require grantees under the Comprehensive Opioid Abuse Grant Program (and those receiving subawards under section 3021(b) of part LL of the Omnibus Crime Control and Safe Streets Act of 1968) to collect and annually report to the Department of Justice data based upon the metrics identified under subsection (c).</text></subsection> <subsection id="H4F60C5A55F724BF4AC613179ABD1E865"><enum>(e)</enum><header>Publication of data and findings</header> <paragraph id="HA459BCF893AB4E57BF57B090841B77E0"><enum>(1)</enum><header>Publication of outcomes and metrics</header><text>The Attorney General shall, not later than 30 days after completion of the requirement under subsection (c), publish the outcomes and metrics identified under that subsection.</text></paragraph> <paragraph id="HD2F10CB78200448BB278F035A39A9B69"><enum>(2)</enum><header>Publication of evaluation</header><text display-inline="yes-display-inline">In the case of the interim evaluation under subsection (b), and the final evaluation under subsection (a), the National Academy of Sciences shall, not later than 90 days after such an evaluation is completed, publish the results of such evaluation and issue a report on such evaluation to the Committee on the Judiciary of the House of Representatives and the Committee on the Judiciary of the Senate. Such report shall also be published along with the data used to make such evaluation.</text></paragraph></subsection> <subsection id="HBAE258CEC49D44E9AAB88BA9C44830BA"><enum>(f)</enum><header>Arrangement with the National Academy of Sciences</header><text display-inline="yes-display-inline">For purposes of subsections (a), (b), and (c), the Attorney General shall enter into an arrangement with the National Academy of Sciences.</text></subsection></section> <section id="HF9BCA5071936421A9FD2651872FFC232" display-inline="no-display-inline" section-type="subsequent-section"><enum>603.</enum><header>Evaluation of performance of Department of Health and Human Services program</header> <subsection id="H1C6BEAC435FA45B2B9E3B7AC80F71637"><enum>(a)</enum><header>Evaluation of Department of Health and Human Services programs</header><text display-inline="yes-display-inline">Not later than 5 years after the date of enactment of this Act, except as otherwise provided in this section, the Secretary of Health and Human Services shall complete an evaluation of any program administered by the Secretary that provides grants for the primary purpose of providing assistance in addressing problems pertaining to opioid abuse based upon the information reported under subsection (d) of this section.</text></subsection> <subsection id="H34EFC6A1208D485ABDEEB254AC349F16"><enum>(b)</enum><header>Interim evaluation</header><text display-inline="yes-display-inline">Not later than 3 years after the date of enactment of this Act, the Secretary shall complete an interim evaluation assessing the nature and extent of the incidence of opioid abuse and illegal opioid distribution in the United States.</text></subsection> <subsection id="H3D74F9E3A67B4C8ABFD99CBA361EA48A"><enum>(c)</enum><header>Metrics and outcomes for evaluation</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this Act, the Secretary shall identify outcomes that are to be achieved by activities funded by the programs described in subsection (a) and the metrics by which the achievement of such outcomes shall be determined.</text></subsection> <subsection id="HBD7F26D4B307492C927EF6E81A725269"><enum>(d)</enum><header>Metrics data collection</header><text display-inline="yes-display-inline">The Secretary shall require grantees under the programs described in subsection (a) to collect and annually report to the Department of Health and Human Services data based upon the metrics identified under subsection (c).</text></subsection> <subsection id="H3B18799B697047188E01AB536C3A2631"><enum>(e)</enum><header>Publication of data and findings</header> <paragraph id="HCF719295ABB9490CAD175A8CB7929467"><enum>(1)</enum><header>Publication of outcomes and metrics</header><text>The Secretary shall, not later than 30 days after completion of the requirement under subsection (c), publish the outcomes and metrics identified under that subsection.</text></paragraph> <paragraph id="HAE697AB6E20F46DD94B35AC12AA9A4B5"><enum>(2)</enum><header>Publication of evaluation</header><text display-inline="yes-display-inline">In the case of the interim evaluation under subsection (b), and each final evaluation under subsection (a), the National Academy of Sciences shall, not later than 90 days after such an evaluation is completed, publish the results of such evaluation and issue a report on such evaluation to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate. Such report shall also be published along with the data used to make such evaluation.</text></paragraph></subsection> <subsection id="H65DF34B2C5C047B89C4361B2D6C4A300"><enum>(f)</enum><header>Arrangement with the National Academy of Sciences</header><text display-inline="yes-display-inline">For purposes of subsections (a), (b), and (c), the Secretary shall—</text> <paragraph id="H8F4011CE89C34BD89FFF13CFC1F918B7"><enum>(1)</enum><text>enter into an arrangement with the National Academy of Sciences; or</text></paragraph> <paragraph id="HC0BEAF250EF748AA992BF8AEB10CCFE5"><enum>(2)</enum><text display-inline="yes-display-inline">enter into a contract or cooperative agreement with an entity that is not an agency of the Federal Government.</text></paragraph></subsection> <subsection id="H7143DB700D7D40CEBBF7BE013B445125"><enum>(g)</enum><header>Exception</header><text display-inline="yes-display-inline">If a program described under subsection (a) is subject to an evaluation substantially similar to the evaluation under subsection (a) pursuant to another provision of law, the Secretary may opt not to conduct an evaluation under subsection (a) of such program.</text></subsection></section> <section id="H9FB4E66F35EC429E94DC8403D1435046"><enum>604.</enum><header>Definition</header><text display-inline="no-display-inline">In this title, the term <quote>opioid</quote> has the meaning given the term <quote>opiate</quote> in section 102 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802</external-xref>).</text></section> <section id="HCC05B16C93B7429EB5299D36CA003A8C" commented="no"><enum>605.</enum><header>No additional funds authorized</header><text display-inline="no-display-inline">No additional funds are authorized to be appropriated to carry out this Act.</text></section> <section id="H5A2DA6A7C6C1483381D0FE4628DD2B13"><enum>606.</enum><header>Matters regarding certain Federal law enforcement assistance</header><text display-inline="no-display-inline">Section 609Y of the Justice Assistance Act of 1984 (<external-xref legal-doc="usc" parsable-cite="usc/42/10513">42 U.S.C. 10513</external-xref>) is amended—</text> <paragraph id="H022DF008031642A597AD2D12ECC140FD"><enum>(1)</enum><text>in subsection (a), by striking <quote>There is</quote> and inserting <quote>Except as provided in subsection (c), there is</quote>; and</text></paragraph> <paragraph id="HAF3C182F77A34F109B7DD98C0264EBA0"><enum>(2)</enum><text>by adding at the end the following: </text> <quoted-block style="OLC" id="HA3011A0FE2A847429A605D2BBE69D805" display-inline="no-display-inline"> <subsection id="HD6F326BEA9EF43578F132AD6A17AD3E7"><enum>(c)</enum><text display-inline="yes-display-inline">For fiscal year 2022, there is authorized to be appropriated $16,000,000, to provide under this chapter Federal law enforcement assistance in the form of funds.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <enum>VII</enum><header>Infant Plan of Safe Care Improvement Act</header> <section id="HBC5357C498EF49E6BE2761C301400559" section-type="subsequent-section"><enum>701.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Infant Plan of Safe Care Improvement Act</short-title></quote>.</text></section> <section id="H68CA5746705A43DE926EC7CA73B2D782"><enum>702.</enum><header>Best practices for development of plans of safe care</header><text display-inline="no-display-inline">Section 103(b) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5104">42 U.S.C. 5104(b)</external-xref>) is amended—</text> <paragraph id="HD9F9D1990A6944D4A6B04CA5520CAE95"><enum>(1)</enum><text>by redesignating paragraphs (5) through (8) as paragraphs (6) through (9), respectively; and</text></paragraph> <paragraph id="H0BC2342FD1814FF49DA6B43988CF647A"><enum>(2)</enum><text>by inserting after paragraph (4), the following:</text> <quoted-block id="H3343D4A35BA34073B0B3F44EF5B2A3C2" style="OLC"> <paragraph id="HD54E673E2B22426DB020A0F1D20B8FAA"><enum>(5)</enum><text display-inline="yes-display-inline">maintain and disseminate information about the requirements of section 106(b)(2)(B)(iii) and best practices relating to the development of plans of safe care as described in such section for infants born and identified as being affected by illegal substance abuse or withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder;</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section commented="no" id="HD134830C79D24619807BF22F2A1DB3D9"><enum>703.</enum><header>State plans</header><text display-inline="no-display-inline">Section 106(b)(2)(B)(iii) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5106a">42 U.S.C. 5106a(b)(2)(B)(iii)</external-xref>) is amended by inserting before the semicolon at the end the following: <quote>to ensure the safety and well-being of such infant following release from the care of healthcare providers, including through—</quote></text> <quoted-block style="OLC" id="HA455E81A17E84E349E86715345E41B82" display-inline="no-display-inline"> <subclause id="HE09FA441FFD4451F9DA5CB150E531BBD"><enum>(I)</enum><text display-inline="yes-display-inline">addressing the health and substance use disorder treatment needs of the infant and affected family or caregiver; and</text></subclause> <subclause id="HFAA14B6177F24ED69D10D2D448BDFECC"><enum>(II)</enum><text display-inline="yes-display-inline">the development and implementation by the State of monitoring systems regarding the implementation of such plans to determine whether and in what manner local entities are providing, in accordance with State requirements, referrals to and delivery of appropriate services for the infant and affected family or caregiver </text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H25A5012693FA4CD7A56852F9EA2F974F"><enum>704.</enum><header>Data reports</header> <subsection id="H46D2F3718A8B47EFAF73209D5586C706"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 106(d) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5106a">42 U.S.C. 5106a(d)</external-xref>) is amended by adding at the end of the following:</text> <quoted-block display-inline="no-display-inline" id="H3DFF822FC08241338F843E28876ADDE2" style="OLC"> <paragraph id="H5A94591EED004341BADEA12DA154E745"><enum>(17)</enum> <subparagraph id="HA08241418DCA4E7DB34F22D0A9B3E834" display-inline="yes-display-inline"><enum>(A)</enum><text>The number of infants identified under subsection (b)(2)(B)(ii).</text></subparagraph> <subparagraph id="HC38A8FFDE19C4887BA3D37F8E8DD228B" indent="paragraph"><enum>(B)</enum><text display-inline="yes-display-inline">The number of infants for whom a plan of safe care was developed under subsection (b)(2)(B)(iii).</text></subparagraph> <subparagraph id="HB654FFB79E6143389916DAA111B59549" indent="paragraph"><enum>(C)</enum><text display-inline="yes-display-inline">The number of infants for whom a referral was made for appropriate services, including services for the affected family or caregiver, under subsection (b)(2)(B)(iii).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection commented="no" id="H58D6459A3FFF4B2CBCACB54618648529"><enum>(b)</enum><header>Redesignation</header><text display-inline="yes-display-inline">Effective on May 29, 2017, section 106(d) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5106a">42 U.S.C. 5106a(d)</external-xref>) is amended by redesignating paragraph (17) (as added by subsection (a)) as paragraph (18).</text></subsection></section> <section id="H50680D50838C49FCAD5558BAF69EDADF"><enum>705.</enum><header>Monitoring and oversight</header> <subsection id="H198B451464504AC28B5B4BFFFBD7119B"><enum>(a)</enum><header>Amendment</header><text display-inline="yes-display-inline">Title I of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5101">42 U.S.C. 5101 et seq.</external-xref>) is further amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H2636109EBCF44148B7A01899638F2383" style="OLC"> <section id="H9BC5CCA89000477A8F1871FB7BD7989E"><enum>114.</enum><header>Monitoring and oversight</header><text display-inline="no-display-inline">The Secretary shall conduct monitoring to ensure that each State that receives a grant under section 106 is in compliance with the requirements of section 106(b), which—</text> <paragraph id="H1C70FA41D7704C48A99D871736C29FD4"><enum>(1)</enum><text>shall—</text> <subparagraph id="HF5CB739C9B0A418E9BD464D636FCC614"><enum>(A)</enum><text>be in addition to the review of the State plan upon its submission under section 106(b)(1)(A); and</text></subparagraph> <subparagraph id="H70B6B73F71504B5CB54794D0D4D4BC17"><enum>(B)</enum><text>include monitoring of State policies and procedures required under clauses (ii) and (iii) of section 106(b)(2)(B); and</text></subparagraph></paragraph> <paragraph id="H95E5240478034D58ABC5D3A59E391606"><enum>(2)</enum><text>may include—</text> <subparagraph id="H0FCFE54B1648475FBB967EA051E32894"><enum>(A)</enum><text>a comparison of activities carried out by the State to comply with the requirements of section 106(b) with the State plan most recently approved under section 432 of the Social Security Act;</text></subparagraph> <subparagraph id="H671DB993416B44EFA9FAFF6521110E5A"><enum>(B)</enum><text display-inline="yes-display-inline">a review of information available on the Website of the State relating to its compliance with the requirements of section 106(b);</text></subparagraph> <subparagraph id="HBC9043A6545745B4BD1ABB8BA38ABFB4"><enum>(C)</enum><text>site visits, as may be necessary to carry out such monitoring; and</text></subparagraph> <subparagraph id="H4F6D2644283C4E08BA0FBEA9C281B2BE"><enum>(D)</enum><text>a review of information available in the State’s Annual Progress and Services Report most recently submitted under section 1357.16 of title 45, Code of Federal Regulations (or successor regulations).</text></subparagraph></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H1CF77D9FD8FA4276A9168AB627568F1D"><enum>(b)</enum><header>Table of contents</header><text>The table of contents in section 1(b) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5101">42 U.S.C. 5101</external-xref> note) is amended by inserting after the item relating to section 113, the following:</text> <quoted-block display-inline="no-display-inline" id="HF76A8C7DFBE64549A83724FEB4E35B42" style="OLC"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 114. Monitoring and oversight.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="H66BCE169D75C4D25B28951D65D827FD8"><enum>706.</enum><header>Rule of construction</header><text display-inline="no-display-inline">Nothing in this Act, or the amendments made by this Act, shall be construed to authorize the Secretary of Health and Human Services or any other officer of the Federal Government to add new requirements to section 106(b) of the Child Abuse Prevention and Treatment Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5106a">42 U.S.C. 5106a(b)</external-xref>), as amended by this Act.</text></section> <enum>VIII</enum><header>NAS Healthy Babies Act</header> <section id="H4612FD3BCF2B4CFC83EECBE5C588A564" section-type="subsequent-section"><enum>801.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Nurturing And Supporting Healthy Babies Act</short-title></quote> or as the <quote><short-title>NAS Healthy Babies Act</short-title></quote>.</text></section> <section id="HEFCEB9C235CD424CAF1EFF4BE812F2CB"><enum>802.</enum><header>GAO report on neonatal abstinence syndrome (NAS)</header> <subsection id="HEE0976DE3EF643F98233320A72357609"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance and the Committee on Health, Education, Labor and Pensions of the Senate a report on neonatal abstinence syndrome (in this section referred to as <quote>NAS</quote>) in the United States.</text></subsection> <subsection id="H435594DDABE849D981D87605F4A97BC1"><enum>(b)</enum><header>Information To be included in report</header><text>Such report shall include information on the following:</text> <paragraph id="HA9354829E4AF4B2CAED8E823F1DA480C"><enum>(1)</enum><text display-inline="yes-display-inline">The prevalence of NAS in the United States, including the proportion of children born in the United States with NAS who are eligible for medical assistance under State Medicaid programs under title XIX of the Social Security Act at birth and the costs associated with NAS through such programs.</text></paragraph> <paragraph id="H41778DFD79F742968330C62A53B140A3"><enum>(2)</enum><text>The services for which coverage is available under State Medicaid programs for treatment of infants with NAS. </text></paragraph> <paragraph id="H7BF49CEF7A2F406EBEE8DA780DDC7991"><enum>(3)</enum><text>The settings (including inpatient, outpatient, hospital-based, and other settings) for the treatment of infants with NAS and the reimbursement methodologies and costs associated with such treatment in such settings.</text></paragraph> <paragraph id="H2BDB82D9902C429482B7E2189D4FF221"><enum>(4)</enum><text>The prevalence of utilization of various care settings under State Medicaid programs for treatment of infants with NAS and any Federal barriers to treating such infants under such programs, particularly in non-hospital-based settings.</text></paragraph> <paragraph id="H6B93EA331C8540778CA8B7C09049D828"><enum>(5)</enum><text display-inline="yes-display-inline">What is known about best practices for treating infants with NAS.</text></paragraph></subsection> <subsection id="H1C74F0D0C66749ADBC42E37F82D535C9"><enum>(c)</enum><header>Recommendations</header><text>Such report also shall include such recommendations as the Comptroller General determines appropriate for improvements that will ensure access to treatment for infants with NAS under State Medicaid programs. </text></subsection></section> <section id="H77BB91FAAE0E4EB9874E551BFDB97A55" section-type="subsequent-section" display-inline="no-display-inline"><enum>803.</enum><header>Excluding abuse-deterrent formulations of prescription drugs from the Medicaid additional rebate requirement for new formulations of prescription drugs</header> <subsection id="H6DED081BE5254DCEB1F392A0CF4F5487" commented="no"><enum>(a)</enum><header>In general</header><text>The last sentence of section 1927(c)(2)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)(2)(C)</external-xref>) is amended by inserting before the period at the end the following: <quote>, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation</quote>.</text></subsection> <subsection id="H450CE9E6494A4B28B7563C96E055D4CC"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to drugs that are paid for by a State in calendar quarters beginning on or after the date of the enactment of this Act.</text></subsection></section> <section id="HB3639F38FBA94C38A4BE2AEBECB20B2A"><enum>804.</enum><header>Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse</header> <subsection id="H9B45E3F725E74FAD8EEBB9263C795D1C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Title XI of the Social Security Act is amended by inserting after section 1128J (<external-xref legal-doc="usc" parsable-cite="usc/42/1320a-7k">42 U.S.C. 1320a–7k</external-xref>) the following new section: </text> <quoted-block style="OLC" id="HF50498DD32E14BBA9686BFE4D7F1C331" display-inline="no-display-inline"> <section id="HA9DDBECF7E4342A19B3285422D506455"><enum>1128K.</enum><header>Disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse</header> <subsection id="H70B4B12115B342AFB44BB418620044B9"><enum>(a)</enum><header>Reference to predictive modeling technologies requirements</header><text display-inline="yes-display-inline">For provisions relating to the use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children’s Health Insurance Program under title XXI, see section 4241 of the Small Business Jobs Act of 2010 (<external-xref legal-doc="usc" parsable-cite="usc/42/1320a-7m">42 U.S.C. 1320a–7m</external-xref>).</text></subsection> <subsection id="H59DB1FB6F47F448F9639EF5D6CF1CDFB"><enum>(b)</enum><header>Limiting disclosure of predictive modeling technologies</header><text display-inline="yes-display-inline">In implementing such provisions under such section 4241 with respect to covered algorithms (as defined in subsection (c)), the following shall apply: </text> <paragraph id="HAC1571E986BE445D8F970CA2BEB52E05"><enum>(1)</enum><header>Nonapplication of FOIA</header><text display-inline="yes-display-inline">The covered algorithms used or developed for purposes of such section (including by the Secretary or a State (or an entity operating under a contract with a State)) shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code.</text></paragraph> <paragraph id="H8227FB9E84AC47709280BF9582BCB43D"><enum>(2)</enum><header>Limitation with respect to use and disclosure of information by State agencies</header> <subparagraph id="HB86559E828C04F53947DC56FD07C59D8"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">A State agency may not use or disclose covered algorithms used or developed for purposes of such section except for purposes of administering the State plan (or a waiver of the plan) under the Medicaid program under title XIX or the State child health plan (or a waiver of the plan) under the Children’s Health Insurance Program under title XXI, including by enabling an entity operating under a contract with a State to assist the State to identify or prevent waste, fraud, and abuse with respect to such programs. </text></subparagraph> <subparagraph id="H49AA877766194926A59AA241EAE751CE"><enum>(B)</enum><header>Information security</header><text>A State agency shall have in effect data security and control policies that the Secretary finds adequate to ensure the security of covered algorithms used or developed for purposes of such section 4241 and to ensure that access to such information is restricted to authorized persons for purposes of authorized uses and disclosures described in subparagraph (A).</text></subparagraph> <subparagraph id="H5EAB7230B4414524AE43B6F4A8E32349"><enum>(C)</enum><header>Procedural requirements</header><text>State agencies to which information is disclosed pursuant to such section 4241 shall adhere to uniform procedures established by the Secretary.</text></subparagraph></paragraph></subsection> <subsection id="HD46326D5453B49F5AA14B3516C54E807"><enum>(c)</enum><header>Covered algorithm defined</header><text display-inline="yes-display-inline">In this section, the term <quote>covered algorithm</quote>—</text> <paragraph id="H0E553453EA9B402F8CB15FFE21EC95A8"><enum>(1)</enum><text>means a predictive modeling or other analytics technology, as used for purposes of section 4241(a) of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a–7m(a)) to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children’s Health Insurance Program under title XXI; and</text></paragraph> <paragraph id="H419E7CC51A5E4DCE9A3D1F79ED45E42C"><enum>(2)</enum><text>includes the mathematical expressions utilized in the application of such technology and the means by which such technology is developed.</text></paragraph></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></subsection> <subsection id="H6E4DBAAA6576481E93D809067D4D1E3B"><enum>(b)</enum><header>Conforming amendments</header> <paragraph id="H5DE839826D794602950DB348ECCDC27E"><enum>(1)</enum><header>Medicaid State plan requirement</header><text display-inline="yes-display-inline">Section 1902(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)</external-xref>) is amended—</text> <subparagraph id="HA615A044ECB94205A51F80F13A8C6BF0"><enum>(A)</enum><text>in paragraph (80), by striking <quote>and</quote> at the end;</text></subparagraph> <subparagraph id="HB504AF63A6F74A65B7A07EEB04F4CDF0"><enum>(B)</enum><text>in paragraph (81), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph> <subparagraph id="H7120025856DC462D9D3E5FB0E1EE874E"><enum>(C)</enum><text>by inserting after paragraph (81) the following new paragraph: </text> <quoted-block style="traditional" display-inline="no-display-inline" id="H3F34F7AE0E6F44209513AD2C62CB7B1A"> <paragraph id="H7B11098BBD2C43008F0897425533286D"><enum>(82)</enum><text display-inline="yes-display-inline">provide that the State agency responsible for administering the State plan under this title provides assurances to the Secretary that the State agency is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2). </text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H92B3F4956D0B4DB9AD2127FEF3E26083"><enum>(2)</enum><header>State child health plan requirement</header><text>Section 2102(a)(7) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397bb">42 U.S.C. 1397bb(a)(7)</external-xref>) is amended—</text> <subparagraph id="HE5E137E722AD4ACEB3AB72604FE4BC7B"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>, and</quote> at the end and inserting a semicolon;</text></subparagraph> <subparagraph id="HC7A1C3F0CB0B4ABCBC8F6ADFD5A5AA3D"><enum>(B)</enum><text>in subparagraph (B), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph> <subparagraph id="HBDE45731F9CA4F0AB5E9D8DEA79B0913"><enum>(C)</enum><text>by adding at the end the following new subparagraph: </text> <quoted-block style="OLC" display-inline="no-display-inline" id="H0B0279A07334460A995B33E45C71A6FD"> <subparagraph id="H9353190E1F7A462785D454604BC54821"><enum>(C)</enum><text display-inline="yes-display-inline">to ensure that the State agency involved is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section> <section id="H34C04A8BBF7B461EA1EF783A49020D6B"><enum>805.</enum><header>Medicaid Improvement Fund</header><text display-inline="no-display-inline">Section 1941(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396w-1">42 U.S.C. 1396w–1(b)(1)</external-xref>) is amended to read as follows: </text> <quoted-block style="OLC" id="HCABA678EEC0C4D959C22FEE23313316F" display-inline="no-display-inline"> <paragraph id="H14422C5DE5E04ED9AF6630E4EC4C31B8"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">There shall be available to the Fund, for expenditures from the Fund for fiscal year 2021 and thereafter, $5,000,000.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>IX</enum><header>Co-Prescribing to Reduce Overdoses Act</header> <section id="H3E730D14291342BD9AC759D97B41BBFF" section-type="subsequent-section"><enum>901.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Co-Prescribing to Reduce Overdoses Act of 2016</short-title></quote>.</text></section> <section id="HAE0AAC399A5049DBB32CC7E15648FCA8"><enum>902.</enum><header>Opioid overdose reversal drugs prescribing grant program</header> <subsection id="HF2D8D5C634DA4B9089796D0EEA384AB5"><enum>(a)</enum><header>Establishment</header> <paragraph id="H83D424DB49C24184921BB03EE34FB1CC"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services may establish, in accordance with this section, a 5-year opioid overdose reversal drugs prescribing grant program (in this Act referred to as the <quote>grant program</quote>).</text></paragraph> <paragraph id="HFD0596ACC23940A09D03390076738F20"><enum>(2)</enum><header>Maximum grant amount</header><text>A grant made under this section may not be for more than $200,000 per grant year.</text></paragraph> <paragraph id="H825CA259066A456B891AEEBF5DAB9316"><enum>(3)</enum><header>Eligible entity</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>eligible entity</term> means a federally qualified health center (as defined in section 1861(aa) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(aa)</external-xref>), an opioid treatment program under part 8 of title 42, Code of Federal Regulations, any practitioner dispensing narcotic drugs pursuant to section 303(g) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)</external-xref>), or any other entity that the Secretary deems appropriate.</text></paragraph> <paragraph id="H2C41D105C2404A28B423E6384E2CBFDD"><enum>(4)</enum><header>Prescribing</header><text display-inline="yes-display-inline">For purposes of this section and section 3, the term <quote>prescribing</quote> means, with respect to an opioid overdose reversal drug, such as naloxone, the practice of prescribing such drug—</text> <subparagraph id="H2B4A43EC9EC44189AAAA75EA96A703F6"><enum>(A)</enum><text>in conjunction with an opioid prescription for patients at an elevated risk of overdose;</text></subparagraph> <subparagraph id="H13E647C843B04B5EB9DC0B520B5B7E27"><enum>(B)</enum><text>in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) for the treatment of opioid abuse disorder;</text></subparagraph> <subparagraph id="H039FBD112CB4421AB60ED20014B7E05B"><enum>(C)</enum><text>to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or</text></subparagraph> <subparagraph id="H7BCCCB432A1142B2A2B7627501BAF155"><enum>(D)</enum><text>in other circumstances, as identified by the Secretary, in which a provider identifies a patient is at an elevated risk for an intentional or unintentional drug overdose from heroin or prescription opioid therapies.</text></subparagraph></paragraph></subsection> <subsection id="HF4E82231EA7143CBB8984CC72D135C1E"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">To be eligible to receive a grant under this section, an eligible entity shall submit to the Secretary of Health and Human Services, in such form and manner as specified by the Secretary, an application that describes—</text> <paragraph id="HD15B3F5F3F3E4E2FA7259E02918F03EB"><enum>(1)</enum><text>the extent to which the area to which the entity will furnish services through use of the grant is experiencing significant morbidity and mortality caused by opioid abuse;</text></paragraph> <paragraph id="H4D0F6519EA1349798CA20D0007F687A9"><enum>(2)</enum><text>the criteria that will be used to identify eligible patients to participate in such program; and</text></paragraph> <paragraph id="H2ED94CE902214B419442CEF7D28B66E6"><enum>(3)</enum><text>how such program will work to try to identify State, local, or private funding to continue the program after expiration of the grant.</text></paragraph></subsection> <subsection id="HFEF2B8B293444300B80CC9413264BFC9"><enum>(c)</enum><header>Use of funds</header><text display-inline="yes-display-inline">An eligible entity receiving a grant under this section may use the grant for any of the following activities, but may use not more than 20 percent of the grant funds for activities described in paragraphs (4) and (5):</text> <paragraph id="H1D87315AA77D4E2686E31A023A5CAD6D"><enum>(1)</enum><text>To establish a program for prescribing opioid overdose reversal drugs, such as naloxone.</text></paragraph> <paragraph id="HB7E0E3418B3A46A48C8E355BB484340C"><enum>(2)</enum><text display-inline="yes-display-inline">To train and provide resources for health care providers and pharmacists on the prescribing of opioid overdose reversal drugs, such as naloxone.</text></paragraph> <paragraph id="H2A331245EFEF4A21BFB599EAF351A068"><enum>(3)</enum><text>To establish mechanisms and processes for tracking patients participating in the program described in paragraph (1) and the health outcomes of such patients.</text></paragraph> <paragraph id="H974D5C227C044EDEBA5A4D8216C4316D"><enum>(4)</enum><text>To purchase opioid overdose reversal drugs, such as naloxone, for distribution under the program described in paragraph (1).</text></paragraph> <paragraph id="H5D5F68CF7A454BC5A21B30ADA5E205FB"><enum>(5)</enum><text>To offset the co-pays and other cost sharing associated with opioid overdose reversal drugs, such as naloxone, to ensure that cost is not a limiting factor for eligible patients.</text></paragraph> <paragraph id="HB3210C7AC86841F89F451D15EC4FA440"><enum>(6)</enum><text display-inline="yes-display-inline">To conduct community outreach, in conjunction with community-based organizations, designed to raise awareness of prescribing practices, and the availability of opioid overdose reversal drugs, such as naloxone.</text></paragraph> <paragraph id="H06A2A42C6E8E456385BB66147C68FD0D"><enum>(7)</enum><text>To establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medication assisted treatment and appropriate counseling and behavioral therapies.</text></paragraph></subsection> <subsection id="HA9A38145DED644BAA25B4E1AFD7F7B46"><enum>(d)</enum><header>Evaluations by recipients</header><text display-inline="yes-display-inline">As a condition of receipt of a grant under this section, an eligible entity shall, for each year for which the grant is received, submit to the Secretary of Health and Human Services information on appropriate outcome measures specified by the Secretary to assess the outcomes of the program funded by the grant, including—</text> <paragraph id="H45B8AD0139F44898B4DC42A0FFEDDFA0"><enum>(1)</enum><text>the number of prescribers trained;</text></paragraph> <paragraph id="H5C67E35BB0D6404C809B9B026C4BDBB2"><enum>(2)</enum><text>the number of prescribers who have co-prescribed an opioid overdose reversal drug, such as naloxone, to at least one patient;</text></paragraph> <paragraph id="H5CB8BCB817DA42B8BA38ECEDDDC1634D"><enum>(3)</enum><text display-inline="yes-display-inline">the total number of prescriptions written for opioid overdose reversal drugs, such as naloxone;</text></paragraph> <paragraph id="H1F8643ED5CB143A5BC4D989CEB715D89"><enum>(4)</enum><text display-inline="yes-display-inline">the percentage of patients at elevated risk who received a prescription for an opioid overdose reversal drug, such as naloxone;</text></paragraph> <paragraph id="H27A1A54750DF4B1294F788944010355D"><enum>(5)</enum><text display-inline="yes-display-inline">the number of patients reporting use of an opioid overdose reversal drug, such as naloxone; and</text></paragraph> <paragraph id="HF11AE194785341038161F570735C706C"><enum>(6)</enum><text>any other outcome measures that the Secretary deems appropriate.</text></paragraph></subsection> <subsection id="HE0B149F2157D474DA84331FBE65A641A"><enum>(e)</enum><header>Reports by Secretary</header><text display-inline="yes-display-inline">For each year of the grant program under this section, the Secretary of Health and Human Services shall submit to the appropriate committees of the House of Representatives and of the Senate a report aggregating the information received from the grant recipients for such year under subsection (d) and evaluating the outcomes achieved by the programs funded by grants made under this section.</text></subsection></section> <section commented="no" display-inline="no-display-inline" id="H5B238D2495BF428DA87A9D049FDD135C" section-type="subsequent-section"><enum>903.</enum><header>Providing information to prescribers in certain Federal health care and medical facilities on best practices for prescribing opioid overdose reversal drugs</header> <subsection id="H7CAB5DCD775449B29BD6460C9C3EEE45"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) may, as appropriate, provide information to prescribers within federally qualified health centers (as defined in paragraph (4) of section 1861(aa) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(aa)</external-xref>)), and the health care facilities of the Indian Health Service, on best practices for prescribing opioid overdose reversal drugs, such as naloxone, for patients receiving chronic opioid therapy, patients being treated for opioid use disorders, and other patients that a provider identifies as having an elevated risk of overdose from heroin or prescription opioid therapies.</text></subsection> <subsection id="HCFBB130483364CFCB25551003DB4840F"><enum>(b)</enum><header>Not establishing a medical standard of care</header><text display-inline="yes-display-inline">The information on best practices provided under this section shall not be construed as constituting or establishing a medical standard of care for prescribing opioid overdose reversal drugs, such as naloxone, for patients described in subsection (a). </text></subsection> <subsection id="H5D80258D20DC43159D6F7703EDC5787E"><enum>(c)</enum><header>Elevated risk of overdose defined</header><text>In this section, the term <term>elevated risk of overdose</term> has the meaning given such term by the Secretary, which—</text> <paragraph id="HFCCEA5FE1045444BA8E62D110A56C283"><enum>(1)</enum><text>may be based on the criteria provided in the Opioid Overdose Toolkit published by the Substance Abuse and Mental Health Services Administration (SAMHSA); and</text></paragraph> <paragraph id="H19626247B1554B4DB4DE474EC1ED22D5" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>may include patients on a first course opioid treatment, patients using extended-release and long-acting opioid analgesics, and patients with a respiratory disease or other co-morbidities.</text></paragraph></subsection></section> <section id="HABF9AD1A5840481194E43291D91AC920"><enum>904.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">There is authorized to be appropriated to carry out this title $5,000,000 for the period of fiscal years 2017 through 2021.</text></section> <section id="HD667CD8D3DCE4405BA52B0715C41DAC2"><enum>905.</enum><header>Cut-Go Compliance</header><text display-inline="no-display-inline">Subsection (f) of section 319D of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended by inserting before the period at the end the following: <quote>(except such dollar amount shall be reduced by $5,000,000 for fiscal year 2018)</quote>. </text></section> <enum>X</enum><header>Improving Treatment for Pregnant and Postpartum Women Act</header> <section id="H23164B6D5C8E453DBBC81DFA2002AB77" section-type="subsequent-section"><enum>1001.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Improving Treatment for Pregnant and Postpartum Women Act of 2016</short-title></quote>.</text></section> <section id="HA1106834CAD54794A1F6B3CCA349D885"><enum>1002.</enum><header>Reauthorization of residential treatment programs for pregnant and postpartum women</header><text display-inline="no-display-inline">Section 508 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-1">42 U.S.C. 290bb–1</external-xref>) is amended—</text> <paragraph id="H2756465443604F5193ED718FC3B4C581"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (p), in the first sentence, by inserting <quote>(other than subsection (r))</quote> after <quote>section</quote>; and</text></paragraph> <paragraph id="HF160F32C1F504821B958A93B0FAA10D2"><enum>(2)</enum><text>in subsection (r), by striking <quote>such sums</quote> and all that follows through <quote>2003</quote> and inserting <quote>$16,900,000 for each of fiscal years 2017 through 2021</quote>.</text></paragraph></section> <section id="H846B1C7D81F94413A92D19991850073F"><enum>1003.</enum><header>Pilot program grants for State substance abuse agencies</header> <subsection id="H314825F373E2477891B28C3FF6F49776"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 508 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-1">42 U.S.C. 290bb–1</external-xref>) is amended—</text> <paragraph id="H81297A8299A5460786B952B46CBDD8E7"><enum>(1)</enum><text>by redesignating subsection (r), as amended by section 2, as subsection (s); and</text></paragraph> <paragraph id="HE25D0D66A23F43F99B7023FEDD1D724D"><enum>(2)</enum><text>by inserting after subsection (q) the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="H15C5610DE2B846AEAA6264FEC3020F3D" style="OLC"> <subsection id="H28192B4FC5334C2FAFE0B4378075579E"><enum>(r)</enum><header>Pilot program for State substance abuse agencies</header> <paragraph id="HA9FB9EAC6B8A4789BDF5E23A9B2AD391"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">From amounts made available under subsection (s), the Director of the Center for Substance Abuse Treatment shall carry out a pilot program under which competitive grants are made by the Director to State substance abuse agencies to—</text> <subparagraph id="H1599B650BADF4107BF341855DD7013B5"><enum>(A)</enum><text>enhance flexibility in the use of funds designed to support family-based services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid use disorders;</text></subparagraph> <subparagraph id="H0FD0415C159A4C109BCDCACF6CC98AC1"><enum>(B)</enum><text>help State substance abuse agencies address identified gaps in services furnished to such women along the continuum of care, including services provided to women in nonresidential based settings; and</text></subparagraph> <subparagraph id="HDABE39BCE3D34E189CE0482903FEE7EF"><enum>(C)</enum><text>promote a coordinated, effective, and efficient State system managed by State substance abuse agencies by encouraging new approaches and models of service delivery.</text></subparagraph></paragraph> <paragraph id="HF7E0A32664E5449E89C6F8B8D3F41E04"><enum>(2)</enum><header>Requirements</header><text display-inline="yes-display-inline">In carrying out the pilot program under this subsection, the Director shall—</text> <subparagraph id="H1261C9C3C7F9420DB1D91C55C79EEAFB"><enum>(A)</enum><text>require State substance abuse agencies to submit to the Director applications, in such form and manner and containing such information as specified by the Director, to be eligible to receive a grant under the program;</text></subparagraph> <subparagraph id="HE6C0B25CAFDC471E85C52C3D3849EF20"><enum>(B)</enum><text>identify, based on such submitted applications, State substance abuse agencies that are eligible for such grants;</text></subparagraph> <subparagraph id="HA9273DCF914D4747A1D89440AB3D9A76"><enum>(C)</enum><text>require services proposed to be furnished through such a grant to support family-based treatment and other services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid use disorders;</text></subparagraph> <subparagraph id="HCF1F8A44A5D142A5A5318B3B77C29763"><enum>(D)</enum><text>not require that services furnished through such a grant be provided solely to women that reside in facilities;</text></subparagraph> <subparagraph id="H24A42725235D471492199B50DB4E178C"><enum>(E)</enum><text>not require that grant recipients under the program make available through use of the grant all services described in subsection (d); and</text></subparagraph> <subparagraph id="H2792069B75B64477A239F92EC95415BB"><enum>(F)</enum><text>consider not applying requirements described in paragraphs (1) and (2) of subsection (f) to applicants, depending on the circumstances of the applicant.</text></subparagraph></paragraph> <paragraph id="HB19B2D7B2A7949B680D35587D2E31199"><enum>(3)</enum><header>Required services</header> <subparagraph id="HF58DC1F1649D4EC3B7769FCED29DB921"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Director shall specify a minimum set of services required to be made available to eligible women through a grant awarded under the pilot program under this subsection. Such minimum set—</text> <clause id="HA7369BB9D18641BF9E718C588AF8D154"><enum>(i)</enum><text>shall include requirements described in subsection (c) and be based on the recommendations submitted under subparagraph (B); and</text></clause> <clause id="HE5A18A0FD31E40609E104D1B180818FB"><enum>(ii)</enum><text>may be selected from among the services described in subsection (d) and include other services as appropriate.</text></clause></subparagraph> <subparagraph id="H42CD953F6E1C4C2CAD417BA2E176068E"><enum>(B)</enum><header>Stakeholder input</header><text>The Director shall convene and solicit recommendations from stakeholders, including State substance abuse agencies, health care providers, persons in recovery from substance abuse, and other appropriate individuals, for the minimum set of services described in subparagraph (A).</text></subparagraph></paragraph> <paragraph id="HFDD325D038BC4908BD094EDAA3701DF3"><enum>(4)</enum><header>Duration</header><text>The pilot program under this subsection shall not exceed 5 years.</text></paragraph> <paragraph id="H8523E085AA91437DA66264F211D1DA11"><enum>(5)</enum><header>Evaluation and Report to Congress</header><text display-inline="yes-display-inline">The Director of the Center for Behavioral Health Statistics and Quality shall fund an evaluation of the pilot program at the conclusion of the first grant cycle funded by the pilot program. The Director of the Center for Behavioral Health Statistics and Quality, in coordination with the Director of the Center for Substance Abuse Treatment shall submit to the relevant committees of jurisdiction of the House of Representatives and the Senate a report on such evaluation. The report shall include at a minimum outcomes information from the pilot program, including any resulting reductions in the use of alcohol and other drugs; engagement in treatment services; retention in the appropriate level and duration of services; increased access to the use of medications approved by the Food and Drug Administration for the treatment of substance use disorders in combination with counseling; and other appropriate measures.</text></paragraph> <paragraph id="H4837ED85DB00404E99A2564671946227"><enum>(6)</enum><header>State substance abuse agencies defined</header><text>For purposes of this subsection, the term <term>State substance abuse agency</term> means, with respect to a State, the agency in such State that manages the Substance Abuse Prevention and Treatment Block Grant under part B of title XIX.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H6C847469CD96418E932754D86B51B8CB"><enum>(b)</enum><header>Funding</header><text display-inline="yes-display-inline">Subsection (s) of section 508 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-1">42 U.S.C. 290bb–1</external-xref>), as amended by section 1002 and redesignated by subsection (a), is further amended by adding at the end the following new sentence: <quote>Of the amounts made available for a year pursuant to the previous sentence to carry out this section, not more than 25 percent of such amounts shall be made available for such year to carry out subsection (r), other than paragraph (5) of such subsection. Notwithstanding the preceding sentence, no funds shall be made available to carry out subsection (r) for a fiscal year unless the amount made available to carry out this section for such fiscal year is more than the amount made available to carry out this section for fiscal year 2016.</quote>.</text></subsection></section> <section id="H88774EDD11B4481DB005060956F5097B"><enum>1004.</enum><header>Cut-Go Compliance</header><text display-inline="no-display-inline">Subsection (f) of section 319D of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended by striking <quote>through 2018</quote> and inserting <quote>through 2016, $133,300,000 for fiscal year 2017, and $138,300,000 for fiscal year 2018</quote>. </text></section> <enum>XI</enum><header>Veteran Emergency Medical Technician Support Act</header> <section id="H33BAC5E40DEB49E2AFCA625CD9F91C8E" section-type="subsequent-section"><enum>1101.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Veteran Emergency Medical Technician Support Act of 2016</short-title></quote>.</text></section> <section id="H81C9075C163A4EBCBD84BFCD651A1F58"><enum>1102.</enum><header>Assisting veterans with military emergency medical training to meet requirements for becoming civilian emergency medical technicians</header><text display-inline="no-display-inline">Part B of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/243">42 U.S.C. 243 et seq.</external-xref>) is amended by inserting after section 314 the following:</text> <quoted-block id="H66EF1D14132D407288C0FF8E5C7CD5AD" style="OLC"> <section id="H18ACC73EAED7410490A92DE7BDA27C6C"><enum>315.</enum><header>Assisting veterans with military emergency medical training to meet requirements for becoming civilian emergency medical technicians</header> <subsection id="H8EBFDB14C62641EEA9FB44C1C931D4F6"><enum>(a)</enum><header>Program</header><text>The Secretary shall establish a program consisting of awarding demonstration grants to States to streamline State requirements and procedures in order to assist veterans who completed military emergency medical technician training while serving in the Armed Forces of the United States to meet certification, licensure, and other requirements applicable to becoming an emergency medical technician in the State.</text></subsection> <subsection id="HD676AC80C1004E07A03394BC62BE30FE"><enum>(b)</enum><header>Use of funds</header><text>Amounts received as a demonstration grant under this section shall be used to prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—</text> <paragraph id="H5CB8A87B46A245EF9BB6F8B0733E4E3F"><enum>(1)</enum><text>determining the extent to which the requirements for the education, training, and skill level of emergency medical technicians in the State are equivalent to requirements for the education, training, and skill level of military emergency medical technicians; and</text></paragraph> <paragraph id="HE82F48E18D3845F9AE9C616CC0287A50"><enum>(2)</enum><text>identifying methods, such as waivers, for military emergency medical technicians to forgo or meet any such equivalent State requirements.</text></paragraph></subsection> <subsection id="H5EA9E3D58CA94879BCDAD0B5875F1FD1"><enum>(c)</enum><header>Eligibility</header><text>To be eligible for a grant under this section, a State shall demonstrate that the State has a shortage of emergency medical technicians.</text></subsection> <subsection id="H122392DD96684A788B1B9D87C312716B"><enum>(d)</enum><header>Report</header><text>The Secretary shall submit to the Congress an annual report on the program under this section.</text></subsection> <subsection id="H29F56BC56468481F9F03EA2D04E1C150"><enum>(e)</enum><header>Funding</header><text display-inline="yes-display-inline">No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>XII</enum><header>John Thomas Decker Act</header> <section id="HEDCC4CEB57F74DE1A667BFC636160DB0" section-type="subsequent-section"><enum>1201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>John Thomas Decker Act of 2016</short-title></quote>. </text></section> <section id="H4D44F1DFB1594779A5C23E2E95857543"><enum>1202.</enum><header>Information materials and resources to prevent addiction related to youth sports injuries</header> <subsection id="HB3C5FC87DE624FDC82A2D3E564F4A52B"><enum>(a)</enum><header>Technical clarification</header><text display-inline="yes-display-inline">Effective as if included in the enactment of the Children’s Health Act of 2000 (<external-xref legal-doc="public-law" parsable-cite="pl/106/310">Public Law 106–310</external-xref>), section 3405(a) of such Act (114 Stat. 1221) is amended by striking <quote>Part E of title III</quote> and inserting <quote>Part E of title III of the Public Health Service Act</quote>.</text></subsection> <subsection id="HD3A1D0512A4D475EA63534E5BB991078"><enum>(b)</enum><header>Amendment</header><text>Title III of the Public Health Service Act is amended by inserting after part D of such title (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b et seq.</external-xref>) the following new part E:</text> <quoted-block style="OLC" id="H3B7E7EFA1C104332B7AEB23244AC4089" display-inline="no-display-inline"> <part id="HFCDD5C9697814F04865D75E1353F7485"><enum>E</enum><header>Opioid Use Disorder</header> <section id="H3CF13A8F0E834FA8BE8F91F889BCCB56"><enum>341.</enum><header>Information materials and resources to prevent addiction related to youth sports injuries</header> <subsection id="H237B08C2574A4252BDF1ED6E7E8D41C2"><enum>(a)</enum><header>Report</header><text display-inline="yes-display-inline">The Secretary shall—</text> <paragraph id="HAE682C8DB97142C3ACB6284A9CAF8C06"><enum>(1)</enum><text display-inline="yes-display-inline">not later than 24 months after the date of the enactment of this section, make publicly available a report determining the extent to which informational materials and resources described in subsection (b) are available to teenagers and adolescents who play youth sports, families of such teenagers and adolescents, nurses, youth sports groups, and relevant health care provider groups; and</text></paragraph> <paragraph id="HBA5587B3E423454B885EC6335F891570"><enum>(2)</enum><text display-inline="yes-display-inline">for purposes of educating and preventing addiction in teenagers and adolescents who are injured playing youth sports and are subsequently prescribed an opioid, not later than 12 months after such report is made publicly available and taking into consideration the findings of such report, develop and, in coordination with youth sports groups, disseminate informational materials and resources described in subsection (b) for teenagers and adolescents who play youth sports, families of such teenagers and adolescents, nurses, youth sports groups, and relevant health care provider groups.</text></paragraph></subsection> <subsection id="H91FF52A8F7D04A48999AEACFEFCD61D3"><enum>(b)</enum><header>Materials and resources described</header><text display-inline="yes-display-inline">For purposes of this section, the informational materials and resources described in this subsection are informational materials and resources with respect to youth sports injuries for which opioids are potentially prescribed and subsequently potentially lead to addiction, including materials and resources focused on the dangers of opioid use and misuse, treatment options for such injuries that do not involve the use of opioids, and how to seek treatment for addiction.</text></subsection> <subsection id="H24AE796178A24486A1B40C88926D3284"><enum>(c)</enum><header>No additional funds</header><text display-inline="yes-display-inline">No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.</text></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <enum>XIII</enum><header>Lali's Law</header> <section id="H7CBE5154F5694E5A9D931EA990BDF97D" section-type="subsequent-section"><enum>1301.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as <quote>Lali’s Law</quote>.</text></section> <section id="H595EAE5DBFA543B48D70CFE09A5AF7A7"><enum>1302.</enum><header>Opioid overdose reversal medication access and education grant programs</header> <subsection id="H7AAD741C81E9472B95F591C026E42D29"><enum>(a)</enum><header>Technical clarification</header><text display-inline="yes-display-inline">Effective as if included in the enactment of the Children’s Health Act of 2000 (<external-xref legal-doc="public-law" parsable-cite="pl/106/310">Public Law 106–310</external-xref>), section 3405(a) of such Act (114 Stat. 1221) is amended by striking <quote>Part E of title III</quote> and inserting <quote>Part E of title III of the Public Health Service Act</quote>.</text></subsection> <subsection id="H0BAAC38FF34743DB87441FC480A47276"><enum>(b)</enum><header>Amendment</header><text>Title III of the Public Health Service Act is amended by inserting after part D of such title (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b et seq.</external-xref>) the following new part E:</text> <quoted-block display-inline="no-display-inline" id="HB59D9D1957564186A59B578EE677EF78" style="OLC"> <part id="H82869E904344411FBEA120884AC6871C"><enum>E</enum><header>Opioid Use Disorder</header> <section id="HA5EF3ED06EBC4BB5B6A2D885F04C2FE2"><enum>341.</enum><header>Opioid overdose reversal medication access and education grant programs</header> <subsection id="H72EC13DA9C594461870111391D89CD09"><enum>(a)</enum><header>Grants to States</header><text>The Secretary may make grants to States for—</text> <paragraph id="H3379BE301FC54223936C25B97584B0AA"><enum>(1)</enum><text display-inline="yes-display-inline">developing standing orders for pharmacies regarding opioid overdose reversal medication;</text></paragraph> <paragraph id="HDA67C08DFA7B4539B72DC584F89E3F5C"><enum>(2)</enum><text display-inline="yes-display-inline">encouraging pharmacies to dispense opioid overdose reversal medication pursuant to a standing order;</text></paragraph> <paragraph id="HA9E53FC0671B4D9AAACC8812A0F3A897"><enum>(3)</enum><text display-inline="yes-display-inline">implementing best practices for persons authorized to prescribe medication regarding—</text> <subparagraph id="H083776118292498BB849266DCD517DF8"><enum>(A)</enum><text display-inline="yes-display-inline">prescribing opioids for the treatment of chronic pain;</text></subparagraph> <subparagraph id="HB1EB1906F0B549BCBA66D24B71A79B89"><enum>(B)</enum><text>co-prescribing opioid overdose reversal medication with opioids; and</text></subparagraph> <subparagraph display-inline="no-display-inline" id="H128C97E34917429A921D177C5CF74147"><enum>(C)</enum><text display-inline="yes-display-inline">discussing the purpose and administration of opioid overdose reversal medication with patients;</text></subparagraph></paragraph> <paragraph id="HC514FBF536CE41C79C38B52A46651926"><enum>(4)</enum><text display-inline="yes-display-inline">developing or adapting training materials and methods for persons authorized to prescribe or dispense medication to use in educating the public regarding—</text> <subparagraph id="H131A8B9B828845A09C19620F1DFC38C5"><enum>(A)</enum><text display-inline="yes-display-inline">when and how to administer opioid overdose reversal medication; and</text></subparagraph> <subparagraph display-inline="no-display-inline" id="H11F247CB978B48D0A922A18057EE29E6"><enum>(B)</enum><text display-inline="yes-display-inline">steps to be taken after administering opioid overdose reversal medication; and</text></subparagraph></paragraph> <paragraph id="H7C7464E9865947FFBE0C8ED35B6AC7B7"><enum>(5)</enum><text display-inline="yes-display-inline">educating the public regarding—</text> <subparagraph id="HB45007A0C8FB46F99B306109BF72A7BB"><enum>(A)</enum><text display-inline="yes-display-inline">the public health benefits of opioid overdose reversal medication; and</text></subparagraph> <subparagraph id="H2AE7B4A0A52641E6B64259C43A55BBE4"><enum>(B)</enum><text display-inline="yes-display-inline">the availability of opioid overdose reversal medication without a person-specific prescription.</text></subparagraph></paragraph></subsection> <subsection id="H4C1979A9A88E42B19EBB6AB071A2A094"><enum>(b)</enum><header>Certain requirement</header><text display-inline="yes-display-inline">A grant may be made under this section only if the State involved has authorized standing orders regarding opioid overdose reversal medication.</text></subsection> <subsection id="H61C376314CDC44D891BC15822E028556"><enum>(c)</enum><header>Preference in making grants</header><text display-inline="yes-display-inline">In making grants under this section, the Secretary shall give preference to States that—</text> <paragraph id="HC19509F62B3F4A64818AEF8051709E8B"><enum>(1)</enum><text display-inline="yes-display-inline">have not issued standing orders regarding opioid overdose reversal medication;</text></paragraph> <paragraph id="HC1BB3B53F70D4CDE97DD5B1D4C7395D2"><enum>(2)</enum><text display-inline="yes-display-inline">authorize standing orders that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer opioid overdose reversal medication;</text></paragraph> <paragraph id="HDF3CA24788A5448990145B3721A5ADB9"><enum>(3)</enum><text display-inline="yes-display-inline">authorize standing orders that permit police, fire, or emergency medical services agencies to acquire and administer opioid overdose reversal medication;</text></paragraph> <paragraph id="H3656B6B2E11740C99D54C07F451AAFD8"><enum>(4)</enum><text display-inline="yes-display-inline">have a higher per capita rate of opioid overdoses than other applicant States; or</text></paragraph> <paragraph id="H0B38E37E4F464673A7EB12237334B4D8"><enum>(5)</enum><text display-inline="yes-display-inline">meet any other criteria deemed appropriate by the Secretary.</text></paragraph></subsection> <subsection id="H65030CE4D7734EAAAAAA2068891F358B"><enum>(d)</enum><header>Grant terms</header> <paragraph id="HAFBCED93AE5243268097C2E7C9DC59CD"><enum>(1)</enum><header>Number</header><text display-inline="yes-display-inline">A State may not receive more than one grant under this section.</text></paragraph> <paragraph id="H6310C5D6944A42D4A9089545CA531B69"><enum>(2)</enum><header>Period</header><text display-inline="yes-display-inline">A grant under this section shall be for a period of 3 years.</text></paragraph> <paragraph id="H74B07AAECE6D495C874F99395C85D199"><enum>(3)</enum><header>Amount</header><text display-inline="yes-display-inline">A grant under this section may not exceed $500,000.</text></paragraph> <paragraph id="HC0409F7C509847AA8E937D47D957CD59"><enum>(4)</enum><header>Limitation</header><text display-inline="yes-display-inline">A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(5).</text></paragraph></subsection> <subsection id="HA9558A6202E64DF095C07FD241A613D5"><enum>(e)</enum><header>Applications</header><text display-inline="yes-display-inline">To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require, including detailed proposed expenditures of grant funds.</text></subsection> <subsection id="HE33C6762C17740A795AFAA72A2D82AAE"><enum>(f)</enum><header>Reporting</header><text display-inline="yes-display-inline">Not later than 3 months after the Secretary disburses the first grant payment to any State under this section and every 6 months thereafter for 3 years, such State shall submit a report to the Secretary that includes the following:</text> <paragraph id="H1E41A7AFFB21465E88F0858FA655BDE7"><enum>(1)</enum><text display-inline="yes-display-inline">The name and ZIP Code of each pharmacy in the State that dispenses opioid overdose reversal medication under a standing order.</text></paragraph> <paragraph id="H14F696C56A5A4A088911A7181E9C6B4F"><enum>(2)</enum><text display-inline="yes-display-inline">The total number of opioid overdose reversal medication doses dispensed by each such pharmacy, specifying how many were dispensed with or without a person-specific prescription.</text></paragraph> <paragraph id="HFAD13086BAF543F08D6CD31B819D6FDB"><enum>(3)</enum><text display-inline="yes-display-inline">The number of pharmacists in the State who have participated in training pursuant to subsection (a)(4).</text></paragraph></subsection> <subsection id="H8235C213D9F741009CFF8B8F21642672"><enum>(g)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text> <paragraph id="H88DAC3DBF9A14E03BB10A86B41E086E5"><enum>(1)</enum><header>Opioid overdose reversal medication</header><text display-inline="yes-display-inline">The term <quote>opioid overdose reversal medication</quote> means any drug, including naloxone, that—</text> <subparagraph id="HD176403DD215413FB9395A70A8413A3D"><enum>(A)</enum><text>blocks opioids from attaching to, but does not itself activate, opioid receptors; or</text></subparagraph> <subparagraph id="H2B7C333514674114B34962FA490E7FA1"><enum>(B)</enum><text display-inline="yes-display-inline">inhibits the effects of opioids on opioid receptors.</text></subparagraph></paragraph> <paragraph id="HEEB2044B980345B4B215B91C9A3764D4"><enum>(2)</enum><header>Standing order</header><text display-inline="yes-display-inline">The term <quote>standing order</quote> means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription.</text></paragraph></subsection> <subsection display-inline="no-display-inline" id="HBC906FD880A04756934BD9E81CF7A17F"><enum>(h)</enum><header>Authorization of appropriations</header> <paragraph id="H0D0F6AA031714F249649FC57DF76CADE"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $5,000,000 for the period of fiscal years 2017 through 2019.</text></paragraph> <paragraph id="HE91EAE76FCF44612B326C912357EB587"><enum>(2)</enum><header>Administrative costs</header><text>Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section.</text></paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="HEB1AD9E02C3549418D5A86BD6CBBC247"><enum>1303.</enum><header>Cut-Go Compliance</header><text display-inline="no-display-inline">Subsection (f) of section 319D of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended by inserting before the period at the end the following: <quote>(except such dollar amount shall be reduced by $5,000,000 for fiscal year 2017)</quote>.</text></section> <enum>XIV</enum><header>Reducing Unused Medications Act</header> <section id="H1D2DF9E2DE3D4C95B17136CFDC2AB2E5" section-type="subsequent-section"><enum>1401.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Reducing Unused Medications Act of 2016</short-title></quote>.</text></section> <section id="HE6397898503B4E70AA93CFB1FD4859BF"><enum>1402.</enum><header>Partial fills of schedule II controlled substances</header> <subsection id="H8BE6CF93E9F74DE1AB1E6394A72068B9"><enum>(a)</enum><header>In general</header><text>Section 309 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/829">21 U.S.C. 829</external-xref>) is amended by adding at the end the following:</text> <quoted-block id="HBACF9044C20443B99BFE7F8DA9D7FC81" style="OLC"> <subsection id="H0FDBB6320D9549BA92D76270A82ABC73"><enum>(f)</enum><header>Partial fills of schedule II controlled substances</header> <paragraph id="HF9E9EEE13F524C929EB2CCE85E3C8363"><enum>(1)</enum><header>Partial fills</header> <subparagraph id="HDEB5EA9004934A208D2888C6758BECA9"><enum>(A)</enum><header>In general</header><text>A prescription for a controlled substance in schedule II may be partially filled if—</text> <clause id="HEE3921015D70482F9F3A93E3DE464D8E"><enum>(i)</enum><text display-inline="yes-display-inline">it is not prohibited by State law;</text></clause> <clause id="H1A5F541D69794FBC972BFC82E39F13B2"><enum>(ii)</enum><text display-inline="yes-display-inline">the prescription is written and filled in accordance with the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/801">21 U.S.C. 801 et seq.</external-xref>), regulations prescribed by the Attorney General, and State law;</text></clause> <clause id="H531410EBE4BD441F91F0204622AB645F"><enum>(iii)</enum><text display-inline="yes-display-inline">the partial fill is requested by the patient or the practitioner that wrote the prescription; and</text></clause> <clause id="HA6A2FDBFDF59469DABBC88405F09BF5B"><enum>(iv)</enum><text display-inline="yes-display-inline">the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.</text></clause></subparagraph> <subparagraph id="HDDB271B96F004AD48D8C640D5B2D2E6E"><enum>(B)</enum><header>Other circumstances</header><text>A prescription for a controlled substance in schedule II may be partially filled in accordance with section 1306.13 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the <short-title>Reducing Unused Medications Act</short-title>).</text></subparagraph></paragraph> <paragraph id="H1B101B9A2529485F97BEF3B894620A3C"><enum>(2)</enum><header>Remaining portions</header> <subparagraph id="H66EF431FF35D47F99E69A8E8C7F7A817"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—</text> <clause id="HFDA893F54D6547DA902D5B8B2D2B1FF6"><enum>(i)</enum><text display-inline="yes-display-inline">may be filled; and</text></clause> <clause id="H2B69FEB6ED964116851BBE725E531CEE"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be filled not later than 30 days after the date on which the prescription is written.</text></clause></subparagraph> <subparagraph id="H9130362CB9B44A469B4A36F15C35896A" display-inline="no-display-inline"><enum>(B)</enum><header>Emergency situations</header><text display-inline="yes-display-inline">In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—</text> <clause id="H8CFBBAF11A324A33AED2503A17FCA38C"><enum>(i)</enum><text display-inline="yes-display-inline">may be filled; and</text></clause> <clause id="H626EF8880F484805BACD839B51CD10BC"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be filled not later than 72 hours after the prescription is issued.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H4EAE18FEFF0749DF904EED00E6E58E0C"><enum>(b)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812(c)</external-xref>) to be partially filled.</text></subsection></section> <enum>XV</enum><header>Opioid Review Modernization Act</header> <section id="HB79A561D2C9A4F27918842A1F9A04ABD" section-type="subsequent-section"><enum>1501.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Opioid Review Modernization Act of 2016</short-title></quote>.</text></section> <section id="H1B27ACDC02A2436BBF245722AA5D591C"><enum>1502.</enum><header>FDA opioid action plan</header><text display-inline="no-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 569 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350bbb-8">21 U.S.C. 350bbb–8</external-xref>) the following:</text> <quoted-block display-inline="no-display-inline" id="H3F93373760344851BC63543C1613781E" style="OLC"> <section id="HA884E167C06B4E668C2399712DF5C8F6"><enum>569–1.</enum><header>Opioid action plan</header> <subsection id="H3023DC94499F491DAFFFA9180F794930"><enum>(a)</enum><header>New drug application</header> <paragraph id="HAB0F77A3B8BC49FB9B895955E83C364E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (2), prior to the approval pursuant to an application under section 505(b) of a new drug that is an opioid and does not have abuse-deterrent properties, the Secretary shall refer the application to an advisory committee of the Food and Drug Administration to seek recommendations from such advisory committee.</text></paragraph> <paragraph id="HF5482A9EC0F44EC393F379E707B47BE8"><enum>(2)</enum><header>Public health exemption</header><text>A referral to an advisory committee under paragraph (1) is not required with respect to a new drug if the Secretary—</text> <subparagraph id="H5337951CD50C4CC8974FD247D8902422"><enum>(A)</enum><text>finds that such a referral is not in the interest of protecting and promoting public health;</text></subparagraph> <subparagraph id="HDBCF9D81D0D04FDEA1F9A4CCB633E148"><enum>(B)</enum><text display-inline="yes-display-inline">finds that such a referral is not necessary based on a review of the relevant scientific information; and</text></subparagraph> <subparagraph id="HAC2648D36BAE491990083A0EAEE73A4D"><enum>(C)</enum><text>submits a notice containing the rationale for such findings to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.</text></subparagraph></paragraph></subsection> <subsection id="H12AF46FBFAF740D3BE09364D1C55D85F"><enum>(b)</enum><header>Pediatric opioid labeling</header><text display-inline="yes-display-inline">The Secretary shall convene the Pediatric Advisory Committee of the Food and Drug Administration to seek recommendations from such Committee regarding a framework for the inclusion of information in the labeling of drugs that are opioids relating to the use of such drugs in pediatric populations before the Secretary approves any labeling or change to labeling for any drug that is an opioid intended for use in a pediatric population.</text></subsection> <subsection id="HB90A5524A403497AA93170CF14A61E64"><enum>(c)</enum><header>Sunset</header><text>The requirements of subsections (a) and (b) shall cease to be effective on October 1, 2022.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H18DD5B6C51D74D3499CFC65DCA4DAE5E"><enum>1503.</enum><header>Prescriber education</header><text display-inline="no-display-inline">Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, as part of the Food and Drug Administration’s evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, and in consultation with relevant stakeholders, shall develop recommendations regarding education programs for prescribers of opioids pursuant to section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>), including recommendations on—</text> <paragraph id="HB1EB2AB6F87C49BA99B564B28719B079"><enum>(1)</enum><text>which prescribers should participate in such programs; and</text></paragraph> <paragraph id="HDF1960A10F8443E6BA8B9424E1EBCFEC"><enum>(2)</enum><text>how often participation in such programs is necessary.</text></paragraph></section> <section id="H0383D78609204F00BC1B209D172303F2"><enum>1504.</enum><header>Guidance on evaluating the abuse deterrence of generic solid oral opioid drug products</header><text display-inline="no-display-inline">Not later than 2 years after the end of the period for public comment on the draft guidance entitled <quote>General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products</quote> issued by the Center for Drug Evaluation and Research of the Food and Drug Administration in March 2016, the Commissioner of Food and Drugs shall publish in the Federal Register a final version of such guidance.</text></section> <enum>XVI</enum><header>Examining Opioid Treatment Infrastructure Act</header> <section id="H57E300BFA5AA45BCB258FE619D69A80C" section-type="subsequent-section"><enum>1601.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Examining Opioid Treatment Infrastructure Act of 2016</short-title></quote>.</text></section> <section id="HAF43AA29FEFB4233B222D9CED8599494"><enum>1602.</enum><header>Study on treatment infrastructure</header><text display-inline="no-display-inline">Not later than 24 months after the date of enactment of this Act, the Comptroller General of the United States shall initiate an evaluation, and submit to Congress a report, of the inpatient and outpatient treatment capacity, availability, and needs of the United States, which shall include, to the extent data are available—</text> <paragraph id="H0ACABDA9359A4A05BC07A36823CF508B"><enum>(1)</enum><text>the capacity of acute residential or inpatient detoxification programs;</text></paragraph> <paragraph id="H461ABBF6588D4403BC68F06084AC8033"><enum>(2)</enum><text>the capacity of inpatient clinical stabilization programs, transitional residential support services, and residential rehabilitation programs;</text></paragraph> <paragraph id="HBA0863C1444040619702D70F30E35D2D"><enum>(3)</enum><text>the capacity of demographic specific residential or inpatient treatment programs, such as those designed for pregnant women or adolescents;</text></paragraph> <paragraph id="H3CBD9E9DB1164C9088135DCA092386B2"><enum>(4)</enum><text>geographical differences of the availability of residential and outpatient treatment and recovery options for substance use disorders across the continuum of care;</text></paragraph> <paragraph id="H52F0F060484741A59FF06E115633B206"><enum>(5)</enum><text>the availability of residential and outpatient treatment programs that offer treatment options based on reliable scientific evidence of efficacy for the treatment of substance use disorders, including the use of Food and Drug Administration-approved medicines and evidence-based nonpharmacological therapies;</text></paragraph> <paragraph id="H0EADA833FB494A15B01AC46639A1F7ED"><enum>(6)</enum><text>the number of patients in residential and specialty outpatient treatment services for substance use disorders;</text></paragraph> <paragraph id="H94E045C9B3ED43BFA3718EA2772325DF"><enum>(7)</enum><text>an assessment of the need for residential and outpatient treatment for substance use disorders across the continuum of care;</text></paragraph> <paragraph id="H5FCF332C92D241AE977AD686D399ECDF"><enum>(8)</enum><text display-inline="yes-display-inline">the availability of residential and outpatient treatment programs to American Indians and Alaska Natives through an Indian health program (as defined by section 4 of the Indian Health Care Improvement Act (<external-xref legal-doc="usc" parsable-cite="usc/25/1603">25 U.S.C. 1603</external-xref>)); and</text></paragraph> <paragraph id="HDF021A2D39804004A2820F701EE448B5"><enum>(9)</enum><text>the barriers (including technological barriers) at the Federal, State, and local levels to real-time reporting of de-identified information on drug overdoses and ways to overcome such barriers.</text></paragraph></section> <enum>XVII</enum><header>Opioid Use Disorder Treatment Expansion and Modernization Act</header> <section id="H7E6192A5372446D681B323281660E5EB" section-type="subsequent-section"><enum>1701.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Opioid Use Disorder Treatment Expansion and Modernization Act</short-title></quote>.</text></section> <section id="H9BC574B84D6C42D0AE5976D1474028B0"><enum>1702.</enum><header>Finding</header><text display-inline="no-display-inline">The Congress finds that opioid use disorder has become a public health epidemic that must be addressed by increasing awareness and access to all treatment options for opioid use disorder, overdose reversal, and relapse prevention.</text></section> <section id="H27618FF3FE1E49419919D607D545746F"><enum>1703.</enum><header>Opioid use disorder treatment modernization</header> <subsection id="H44592083A4324BCC9B4BDAC30E55EBA5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 303(g)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>) is amended—</text> <paragraph id="H76A6172E6CF94355B6947D27F31A00D7"><enum>(1)</enum><text>in subparagraph (B), by striking clauses (i), (ii), and (iii) and inserting the following:</text> <quoted-block style="OLC" id="H204ABE66F7234E5E948DAF90C42D1D63" display-inline="no-display-inline"> <clause id="H85657D71F1D045D29195172539960D62" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">The practitioner is a qualifying practitioner (as defined in subparagraph (G)).</text></clause> <clause id="H257CFD24006B44C082552A3718B30862" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary—</text> <subclause id="H3F74C41021974107B387599A981E0E63"><enum>(I)</enum><text display-inline="yes-display-inline">all schedule III, IV, and V drugs, as well as unscheduled medications approved by the Food and Drug Administration, for the treatment of opioid use disorder, including such drugs and medications for maintenance, detoxification, overdose reversal, and relapse prevention, as available; and</text></subclause> <subclause id="H816DF648E205441FA57C5999C525D5A0"><enum>(II)</enum><text display-inline="yes-display-inline">appropriate counseling and other appropriate ancillary services.</text></subclause></clause> <clause id="H436A3FB2A2124060A96EA47DC9183384" indent="up2" commented="no"><enum>(iii)</enum> <subclause id="H1D55254EE8EB4553B1394237E664C434" display-inline="yes-display-inline" commented="no"><enum>(I)</enum><text>The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. </text></subclause> <subclause id="H5280C499EFBD486C83CE8FD5AF445110" indent="up1" commented="no"><enum>(II)</enum><text>The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.</text></subclause> <subclause id="HDC5A2F38CCC24650893F9ED5711F1B8D" indent="up1"><enum>(III)</enum><text>The Secretary may by regulation change such total number.</text></subclause> <subclause id="H2DFA71C8ED414BCA996595456F1F66D7" indent="up1"><enum>(IV)</enum><text display-inline="yes-display-inline">The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. </text></subclause></clause> <clause id="H62E96287A7194CCEB1DA9C21B6CE4537" indent="up2" commented="no"><enum>(iv)</enum><text display-inline="yes-display-inline">If the Secretary by regulation increases the total number of patients which a qualifying practitioner is permitted to treat pursuant to clause (iii)(II), the Secretary shall require such a practitioner to obtain a written agreement from each patient, including the patient’s signature, that the patient—</text> <subclause id="H6BA0DC465B1C4D8BBE87AD7EF282A192" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">will receive an initial assessment and treatment plan and periodic assessments and treatment plans thereafter;</text></subclause> <subclause id="H59681EB0C5C34CE7A5158F46ECC5F38B" commented="no"><enum>(II)</enum><text>will be subject to medication adherence and substance use monitoring;</text></subclause> <subclause id="H51E33F41867C455C8FC28EC0374BFF3C" commented="no"><enum>(III)</enum><text display-inline="yes-display-inline">understands available treatment options, including all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including their potential risks and benefits; and</text></subclause> <subclause id="H22167A739DCC45E6B293562D28CDA2DF"><enum>(IV)</enum><text display-inline="yes-display-inline">understands that receiving regular counseling services is critical to recovery.</text></subclause></clause> <clause id="HEF47D4AAA9754BC9856616435BD4759E" indent="up2"><enum>(v)</enum><text>The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV).</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H6B7EC123DFE743FDBE1143782339FFF4"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text> <subparagraph id="H16F6583DDD50419898A992424212653B"><enum>(A)</enum><text>in clause (i), by adding at the end the following:</text> <quoted-block style="OLC" id="H5C25B0D26AC048BF82F381535BA1B2C1" display-inline="no-display-inline"> <subclause id="H756647590B934300ABA43F0D9F55CF93" indent="up3"><enum>(IV)</enum><text display-inline="yes-display-inline">The practitioner reports to the Secretary, at such times and in such manner as specified by the Secretary, such information and assurances as the Secretary determines necessary to assess whether the practitioner continues to meet the requirements for a waiver under this paragraph.</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph> <subparagraph id="HB92907550A39472CB50EDC646CEA4CFB"><enum>(B)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>Upon receiving a notification under subparagraph (B)</quote> and inserting <quote>Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)</quote>; and</text></subparagraph> <subparagraph id="HFBEE337BE043404BAE5613C4A0FE84D2"><enum>(C)</enum><text display-inline="yes-display-inline">in clause (iii)—</text> <clause id="H32C906AD864B4CE3B46244B59B7C36B6"><enum>(i)</enum><text>by inserting <quote>and shall forward such determination to the Attorney General</quote> before the period at the end of the first sentence; and</text></clause> <clause id="H41CC5A4B773142C08C5A2EC9E472E41D"><enum>(ii)</enum><text>by striking <quote>physician</quote> and inserting <quote>practitioner</quote>;</text></clause></subparagraph></paragraph> <paragraph id="H48DF51D9BE184B67A9E8E9CD35EEFFDF"><enum>(3)</enum><text>in subparagraph (G)—</text> <subparagraph id="HDB15AB908A5A4ED1BA5976DE9CEEBCF4"><enum>(A)</enum><text>by amending clause (ii)(IV) to read as follows:</text> <quoted-block style="OLC" id="H7EC4FB9AD782407E8B460EAE191C5BD8" display-inline="no-display-inline"> <subclause id="H86C43E4863C1452BA05C1BC7F9879896" indent="up2"><enum>(IV)</enum><text display-inline="yes-display-inline">The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause. Such training shall address—</text> <item id="HA81002AC47B84D869246FCA824ACDA86"><enum>(aa)</enum><text display-inline="yes-display-inline">opioid maintenance and detoxification;</text></item> <item id="HC2EF89BCE0254D3CAEE885F34D7325E9"><enum>(bb)</enum><text>appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder;</text></item> <item id="H59687B8D366A4F88B667DD6B42DEA132"><enum>(cc)</enum><text>initial and periodic patient assessments (including substance use monitoring);</text></item> <item id="HBB2D69DA8A3E4F20860E65D698CE7D7A"><enum>(dd)</enum><text>individualized treatment planning; overdose reversal; relapse prevention;</text></item> <item id="H66371DB092414F1EB8DF9C8DA3D82B83"><enum>(ee)</enum><text>counseling and recovery support services;</text></item> <item id="HDDC9AACE3A904CA3ABB3E61254165C7D"><enum>(ff)</enum><text>staffing roles and considerations;</text></item> <item id="HD1C9A30E73604C2782D29D9CEC6AE844"><enum>(gg)</enum><text>diversion control; and</text></item> <item id="H6935582D1A1E47DDBCB4EB96D1236F52"><enum>(hh)</enum><text>other best practices, as identified by the Secretary.</text></item></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H65BAFAB077EC47E59BCBFAE24C061FED"><enum>(B)</enum><text>by adding at the end the following: </text> <quoted-block style="OLC" id="HEEC3FA1878524261B34D85DA26DADC2B" display-inline="no-display-inline"> <clause id="H7D2C0DAB2F6D4857A7FABC4FCDD20269" indent="up2"><enum>(iii)</enum><text>The term <term>qualifying practitioner</term> means—</text> <subclause id="H5AE5510FB3754AB297E50F3BCE309A83"><enum>(I)</enum><text>a qualifying physician, as defined in clause (ii); or</text></subclause> <subclause id="HF6D83D6C0E674A57959C7265B93294F8"><enum>(II)</enum><text>during the period beginning on the date of the enactment of the <short-title>Opioid Use Disorder Treatment Expansion and Modernization Act</short-title> and ending on the date that is 3 years after such date of enactment, a qualifying other practitioner, as defined in clause (iv).</text></subclause></clause> <clause id="HC19578AABC1A44BFBD66F54375F3F612" indent="up2"><enum>(iv)</enum><text>The term <term>qualifying other practitioner</term> means a nurse practitioner or physician assistant who satisfies each of the following:</text> <subclause id="H19BD174D2E314E59B9F403306639569C"><enum>(I)</enum><text display-inline="yes-display-inline">The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain.</text></subclause> <subclause id="H8161197E6FC1488695EF67424339878A"><enum>(II)</enum><text>The nurse practitioner or physician assistant satisfies one or more of the following:</text> <item id="HDC03BC0239064E1FAE761BD0EEA6589E"><enum>(aa)</enum><text display-inline="yes-display-inline">Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines is appropriate for purposes of this subclause.</text></item> <item id="HE8F8594B36F74D0F90EA959B10DAD662"><enum>(bb)</enum><text>Has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner or physician assistant to treat and manage opiate-dependent patients.</text></item></subclause> <subclause id="H07EF4D0E254C499FABA208E53A83B71A" commented="no"><enum>(III)</enum><text display-inline="yes-display-inline">The nurse practitioner or physician assistant is supervised by or works in collaboration with a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician.</text></subclause><continuation-text continuation-text-level="clause">The Secretary may review and update the requirements for being a qualifying other practitioner under this clause.</continuation-text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H8DBDD0464C5D49C1BACF85E4433895B9"><enum>(4)</enum><text>in subparagraph (H)—</text> <subparagraph id="H59DF0153982A459B9BCDBFAF5EA0BCC8"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (i), by inserting after subclause (II) the following:</text> <quoted-block style="OLC" id="H97D3B821C98147BD834504EC89021739" display-inline="no-display-inline"> <subclause id="H97D43D0CC10A4F55B3D001926F416437" indent="up3"><enum>(III)</enum><text display-inline="yes-display-inline">Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="HFF2C9346C8FB47A78EBBC363E298309A"><enum>(B)</enum><text>by amending clause (ii) to read as follows:</text> <quoted-block style="OLC" id="H0FADA84AFE1746399F382AE0AA54F920" display-inline="no-display-inline"> <clause id="H74D3F1E089FD448BB61EAE27E60F58F6" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the <short-title>Opioid Use Disorder Treatment Expansion and Modernization Act</short-title>, the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="HFB11642D2B27410DBAE070B7D4F3FD4D"><enum>(b)</enum><header>Recommendation of revocation or suspension of registration in case of substantial noncompliance</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services may recommend to the Attorney General that the registration of a practitioner be revoked or suspended if the Secretary determines, according to such criteria as the Secretary establishes by regulation, that a practitioner who is registered under section 303(g)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>) is not in substantial compliance with the requirements of such section, as amended by this Act. </text></subsection> <subsection id="H09E1D776FB3B40DAB3DFE312B5E9E30F"><enum>(c)</enum><header>Opioid defined</header><text>Section 102(18) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802(18)</external-xref>) is amended by inserting <quote>or <quote>opioid</quote></quote> after <quote>The term <term>opiate</term></quote>.</text></subsection> <subsection id="HBF56A769F5324B758C2A6B4AE64ABBBF"><enum>(d)</enum><header>Reports to Congress</header> <paragraph id="HF1DC739CE05046CD9A2961322B3C4537"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act and not less than over every 5 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall—</text> <subparagraph id="H159DE36C73C74ADABE70DC6BFE68E1DE"><enum>(A)</enum><text display-inline="yes-display-inline">perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and</text></subparagraph> <subparagraph id="HB69F637C463C4034BBE6289405A502D4"><enum>(B)</enum><text>submit a report to the Congress on the findings and conclusions of such review.</text></subparagraph></paragraph> <paragraph id="H40E7BA5A1F5144B09C6C06855FB5B730"><enum>(2)</enum><header>Contents</header><text>Each report under paragraph (1) shall include an assessment of—</text> <subparagraph id="H004FEE5722C745FE9D0439D8EDCE3FF7"><enum>(A)</enum><text>compliance with the requirements of section 303(g)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>), as amended by this Act;</text></subparagraph> <subparagraph id="H9F3623DE3BF94391A10FA3F81DE34408"><enum>(B)</enum><text>the measures taken by the Secretary of Health and Human Services to ensure such compliance; </text></subparagraph> <subparagraph id="HE6B2EE8FD2EB4CD9B9B4602F8F94D933"><enum>(C)</enum><text display-inline="yes-display-inline">whether there is further need to increase or decrease the number of patients a waivered practitioner is permitted to treat, as provided for by the amendment made by subsection (a)(1);</text></subparagraph> <subparagraph id="HFC806FED8A7F4AFE8D0055772AD85426"><enum>(D)</enum><text display-inline="yes-display-inline">the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings; </text></subparagraph> <subparagraph id="H5AE387D785224EC28DE85BFF467B560B"><enum>(E)</enum><text display-inline="yes-display-inline">access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services;</text></subparagraph> <subparagraph id="H7618073F997D41A295D3196082FA0E96"><enum>(F)</enum><text display-inline="yes-display-inline">changes in State or local policies and legislation relating to opioid use disorder treatment;</text></subparagraph> <subparagraph id="HA0348823D68F4A1E84DE49FF255D3D18"><enum>(G)</enum><text display-inline="yes-display-inline">the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>);</text></subparagraph> <subparagraph id="H6E0836F30B12422A819C001D25F2F4FA"><enum>(H)</enum><text>the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in subparagraph (G); and</text></subparagraph> <subparagraph id="H86F462DBD4B14E029A30BD9D850A2E99"><enum>(I)</enum><text display-inline="yes-display-inline">the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment.</text></subparagraph></paragraph></subsection></section> <section id="HA4544D7EEFEB4BD494D806C5196A4423"><enum>1704.</enum><header>Sense of Congress</header><text display-inline="no-display-inline">It is the Sense of Congress that, with respect to the total number of patients that a qualifying physician (as defined in subparagraph (G)(iii) of section 303(g)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>) can treat at any one time pursuant to such section, the Secretary of Health and Human Services should consider raising such total number to 250 patients following a third notification to the Secretary of the need and intent of the physician to treat up to 250 patients that is submitted to the Secretary not sooner than 1 year after the date on which the physician submitted to the Secretary a second notification to treat up to 100 patients. </text></section> <section id="HE2132C53635C4514A8ECFC8B9F973A0F"><enum>1705.</enum><header>Partial fills of schedule II controlled substances</header> <subsection id="H4309F5B235454F5194ECC0B8003C16DA"><enum>(a)</enum><header>In general</header><text>Section 309 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/829">21 U.S.C. 829</external-xref>) is amended by adding at the end the following:</text> <quoted-block id="H21A905226BCF46A58FAAD55DCF65747C" style="OLC"> <subsection id="H3A616FBFF5B74FA083802D2D2957C46C"><enum>(f)</enum><header>Partial fills of schedule II controlled substances</header> <paragraph id="H67E829B32FC841E591E409B07D711D83"><enum>(1)</enum><header>Partial fills</header> <subparagraph id="H95FE030871E447ADBCFE4836BA1258FE"><enum>(A)</enum><header>In general</header><text>A prescription for a controlled substance in schedule II may be partially filled if—</text> <clause id="H6A812A3FB16747FD9809F163682C5EAD"><enum>(i)</enum><text display-inline="yes-display-inline">it is not prohibited by State law;</text></clause> <clause id="H2013928ED86C4E678F54BEBD8B82F5DB"><enum>(ii)</enum><text display-inline="yes-display-inline">the prescription is written and filled in accordance with the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/801">21 U.S.C. 801 et seq.</external-xref>), regulations prescribed by the Attorney General, and State law;</text></clause> <clause id="H8F93DE3DAC064B4BAEB7A17804F26510"><enum>(iii)</enum><text display-inline="yes-display-inline">the partial fill is requested by the patient or the practitioner that wrote the prescription; and</text></clause> <clause id="H6D95C182A87E4A768F1C2C8D67425A2A"><enum>(iv)</enum><text display-inline="yes-display-inline">the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.</text></clause></subparagraph> <subparagraph id="HDF294EB459EF4019B895047F8D468DC4"><enum>(B)</enum><header>Other circumstances</header><text>A prescription for a controlled substance in schedule II may be partially filled in accordance with section 1306.13 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the <short-title>Reducing Unused Medications Act of 2016</short-title>).</text></subparagraph></paragraph> <paragraph id="HF6647183EBCF4631B5650114481879C9"><enum>(2)</enum><header>Remaining portions</header> <subparagraph id="H86F13F34B7424E67837C90F8DAFD85D6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—</text> <clause id="HAC207779A68D4CA38260DA4707DB6E98"><enum>(i)</enum><text display-inline="yes-display-inline">may be filled; and</text></clause> <clause id="H0858062AFA994CD699C5A309256810B7"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be filled not later than 30 days after the date on which the prescription is written.</text></clause></subparagraph> <subparagraph id="HBAE8A3CD8EE640F48119C6A7BA35299D" display-inline="no-display-inline"><enum>(B)</enum><header>Emergency situations</header><text display-inline="yes-display-inline">In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—</text> <clause id="H0837EE7777FA481BA6ACE7D40AE3BDC0"><enum>(i)</enum><text display-inline="yes-display-inline">may be filled; and</text></clause> <clause id="H3A215968CCC14492A1108F6D75968DB5"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be filled not later than 72 hours after the prescription is issued.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3CCAE656EE6C4D7291BF130197541198"><enum>(b)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812(c)</external-xref>) to be partially filled.</text></subsection></section> <enum>XVIII</enum><header>National All Schedules Prescription Electronic Reporting Reauthorization Act</header> <section id="H93A5616CA28A46DD852B0DCC26908DD5" section-type="subsequent-section"><enum>1801.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015</short-title></quote>.</text></section> <section id="HC32EF23E9396429494B081DDFB3EDF4B"><enum>1802.</enum><header>Amendment to purpose</header><text display-inline="no-display-inline">Paragraph (1) of section 2 of the National All Schedules Prescription Electronic Reporting Act of 2005 (<external-xref legal-doc="public-law" parsable-cite="pl/109/60">Public Law 109–60</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H4D210630D1B44AC490A43D2EC236CEE6" style="OLC"> <paragraph id="H87EBF1E25DB6423989EE09D6D24AFD7B"><enum>(1)</enum><text display-inline="yes-display-inline">foster the establishment of State-administered controlled substance monitoring systems in order to ensure that—</text> <subparagraph id="HAD033B991C034CD5891FF88CEFD154F2"><enum>(A)</enum><text>health care providers have access to the accurate, timely prescription history information that they may use as a tool for the early identification of patients at risk for addiction in order to initiate appropriate medical interventions and avert the tragic personal, family, and community consequences of untreated addiction; and</text></subparagraph> <subparagraph id="H6A12D6BDC2104BDCA32AB27B4438831E"><enum>(B)</enum><text display-inline="yes-display-inline">appropriate law enforcement, regulatory, and State professional licensing authorities have access to prescription history information for the purposes of investigating drug diversion and prescribing and dispensing practices of errant prescribers or pharmacists; and</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HE2F019F032CD495B9BE5DFF5C7562A49"><enum>1803.</enum><header>Amendments to controlled substance monitoring program</header><text display-inline="no-display-inline">Section 399O of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g-3">42 U.S.C. 280g–3</external-xref>) is amended—</text> <paragraph id="H4D69201A42894962863C76B82B6FAC3D"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="HD90ECB24176340BB95F58954CB8A80F8"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="H0C7213B300E746F5B2A33E23A6000635"><enum>(i)</enum><text>in subparagraph (A), by striking <quote>or</quote>;</text></clause> <clause id="H0070E706768248C18913CABC8954FE6A"><enum>(ii)</enum><text>in subparagraph (B), by striking the period at the end and inserting <quote>; or</quote>; and</text></clause> <clause id="HDABD127A5D554C8C8CBD8FA097B9674D"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HDF0B2176F2104C4996C34A36BB3C5A26" style="OLC"> <subparagraph id="H9DA1C8E41A2543E58AA5C00D045045B3"><enum>(C)</enum><text display-inline="yes-display-inline">to maintain and operate an existing State-controlled substance monitoring program.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="H53A38B1181A54E4299F9CCC220F51407" commented="no"><enum>(B)</enum><text>in paragraph (3), by inserting <quote>by the Secretary</quote> after <quote>Grants awarded</quote>; </text></subparagraph></paragraph> <paragraph id="HB8CC5E07F08649C29C9DCB680347D038"><enum>(2)</enum><text>by amending subsection (b) to read as follows:</text> <quoted-block id="H832ECEDFB46E4084856273A29C733E6F" style="OLC"> <subsection id="H5EAFA7D8E9094186AD808283A1CE526A"><enum>(b)</enum><header>Minimum requirements</header><text>The Secretary shall maintain and, as appropriate, supplement or revise (after publishing proposed additions and revisions in the Federal Register and receiving public comments thereon) minimum requirements for criteria to be used by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A).</text></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="HA13D67CC2A804EACAE18BBEB687C53CA"><enum>(3)</enum><text>in subsection (c)—</text> <subparagraph id="HBC967D165A634D7A8FC5761F4EFF58DB"><enum>(A)</enum><text>in paragraph (1)(B)—</text> <clause id="H36C5CD18C2F34D92993391907008F3E4"><enum>(i)</enum><text>in the matter preceding clause (i), by striking <quote>(a)(1)(B)</quote> and inserting <quote>(a)(1)(B) or (a)(1)(C)</quote>;</text></clause> <clause id="H53628692642147ADBB9E563D604FD93B"><enum>(ii)</enum><text>in clause (i), by striking <quote>program to be improved</quote> and inserting <quote>program to be improved or maintained</quote>;</text></clause> <clause id="H67619B4CC4874A8C8540F21B2795F233" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">by redesignating clauses (iii) and (iv) as clauses (iv) and (v), respectively;</text></clause> <clause id="H812FDF2F9A484C748801EDBAC89B9FE2" commented="no"><enum>(iv)</enum><text>by inserting after clause (ii) the following:</text> <quoted-block style="OLC" id="H5228BE12547F43CE9092063617E9F027" display-inline="no-display-inline"> <clause id="HB715DB47CFE7441EB5D99721948073C2" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">a plan to apply the latest advances in health information technology in order to incorporate prescription drug monitoring program data directly into the workflow of prescribers and dispensers to ensure timely access to patients’ controlled prescription drug history;</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause> <clause id="HC752435583B841888D1C3542B04B7A4C" commented="no"><enum>(v)</enum><text>in clause (iv), as redesignated, by inserting before the semicolon at the end <quote>and at least one health information technology system such as an electronic health records system, a health information exchange, or an e-prescribing system</quote>; and</text></clause> <clause id="H98080B86FAE94486BD4378827F560F3E" commented="no"><enum>(vi)</enum><text>in clause (v), as redesignated, by striking <quote>public health</quote> and inserting <quote>public health or public safety</quote>;</text></clause></subparagraph> <subparagraph id="H04F7A8D0F76F4C0ABA0A748DD1C1D779"><enum>(B)</enum><text>in paragraph (3)—</text> <clause id="HF5D51E7867E34083B12E64D0EB379EEC"><enum>(i)</enum><text>by striking <quote>If a State that submits</quote> and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="HDCDCD6F6E44343FCB3311FDAB88FB4CF" style="OLC"> <subparagraph id="H64C0958EACE9466A9C0C90F6730C3F5F"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">If a State that submits</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause> <clause id="H10B5687A1E12469CBF6ADEC35D45B863" commented="no"><enum>(ii)</enum><text>by striking the period at the end and inserting <quote>and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for implementation of such interoperability.</quote>; and</text></clause> <clause id="HEBF6B0168CDC4C37A50B953B2BCA08AD"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HE7BB65184FBD4DC3BC641B7BB0ACCDEB" style="OLC"> <subparagraph id="H55891A8CB21F4516946A6A393054C878"><enum>(B)</enum><header>Monitoring of efforts</header><text display-inline="yes-display-inline">The Secretary shall monitor State efforts to achieve interoperability, as described in subparagraph (A).</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="HE1A6B6915EA14A839F715CCADF62B379"><enum>(C)</enum><text>in paragraph (5)—</text> <clause id="HECD0B3A835D94B8087F0A9282D2CC243"><enum>(i)</enum><text>by striking <quote>implement or improve</quote> and inserting <quote>establish, improve, or maintain</quote>; and</text></clause> <clause id="H19F90A01DF384909A7B8B881B7FBE9F6"><enum>(ii)</enum><text>by adding at the end the following: <quote>The Secretary shall redistribute any funds that are so returned among the remaining grantees under this section in accordance with the formula described in subsection (a)(2)(B).</quote>;</text></clause></subparagraph></paragraph> <paragraph id="HA9A685AAD1A84358983D07BCFF6F42DA"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (d)—</text> <subparagraph id="H0F7FEEBFA2AD4431888DAA523435FBD6"><enum>(A)</enum><text>in the matter preceding paragraph (1)—</text> <clause id="HB7FDD461BF4B402F8F85986666191D3A"><enum>(i)</enum><text>by striking <quote>In implementing or improving</quote> and all that follows through <quote>(a)(1)(B)</quote> and inserting <quote>In establishing, improving, or maintaining a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subparagraph (B) or (C) of subsection (a)(1)</quote>; and</text></clause> <clause id="H36BC4CFF7E324D32B34F61F862FF6FB5" commented="no"><enum>(ii)</enum><text>by striking <quote>public health</quote> and inserting <quote>public health or public safety</quote>; and</text></clause></subparagraph> <subparagraph id="H61239CAD283F4034B55FEA3CC9E225B7"><enum>(B)</enum><text>by adding at the end the following: </text> <quoted-block style="OLC" id="H02F22E05D37C4E2CA3DE63A24B6DC615" display-inline="no-display-inline"> <paragraph id="H6F1E6452D89C4F0883B303208FD7C0E4"><enum>(5)</enum><text>The State shall report to the Secretary on—</text> <subparagraph id="HA388C3745F6B48C99E4A6FCAEFC8BFB0"><enum>(A)</enum><text>as appropriate, interoperability with the controlled substance monitoring programs of Federal departments and agencies;</text></subparagraph> <subparagraph id="HE4BC080AB29545A8B6CABE092715C6B2"><enum>(B)</enum><text>as appropriate, interoperability with health information technology systems such as electronic health records systems, health information exchanges, and e-prescribing systems; and</text></subparagraph> <subparagraph id="H149BE6B13FAA41579E0DC8D4ECA7D243"><enum>(C)</enum><text>whether or not the State provides automatic, real-time or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="HD938AB44A66246DF89F2496421C016C0"><enum>(5)</enum><text>in subsections (e), (f)(1), and (g), by striking <quote>implementing or improving</quote> each place it appears and inserting <quote>establishing, improving, or maintaining</quote>;</text></paragraph> <paragraph id="H5A8D7B6378514B088A5C3EFE87930269"><enum>(6)</enum><text>in subsection (f)—</text> <subparagraph id="H411375D2833E4A92B6F079533EA79508"><enum>(A)</enum><text>in paragraph (1)—</text> <clause id="H0D49B0C33B754E77AA15CD2A937FDC61"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>misuse of a schedule II, III, or IV substance</quote> and inserting <quote>misuse of a controlled substance included in schedule II, III, or IV of section 202(c) of the Controlled Substance Act</quote>; and</text></clause> <clause id="H90B04AD25CB34A2298B335A82EF61593" commented="no"><enum>(ii)</enum><text>in subparagraph (D), by inserting <quote>a State substance abuse agency,</quote> after <quote>a State health department,</quote>; and</text></clause></subparagraph> <subparagraph id="HF7593636C0304B9488198566F4C72B66"><enum>(B)</enum><text>by adding at the end the following:</text> <quoted-block id="H9863D8E41E6143DC950A0A5A290F2BBB" style="OLC"> <paragraph id="H924A3D1D37604A48B764B368D2E985C2"><enum>(3)</enum><header>Evaluation and reporting</header><text>Subject to subsection (g), a State receiving a grant under subsection (a) shall provide the Secretary with aggregate data and other information determined by the Secretary to be necessary to enable the Secretary—</text> <subparagraph id="H77EEFA2056BF44E2BEB455457D9B802C"><enum>(A)</enum><text>to evaluate the success of the State’s program in achieving its purposes; or</text></subparagraph> <subparagraph id="H43911E28D197402F91B6C6E43B12D8D5"><enum>(B)</enum><text>to prepare and submit the report to Congress required by subsection (l)(2).</text></subparagraph></paragraph> <paragraph id="H8050980AB1E541A5A35741DDCE8D281E"><enum>(4)</enum><header>Research by other entities</header><text>A department, program, or administration receiving nonidentifiable information under paragraph (1)(D) may make such information available to other entities for research purposes.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="HD2266AC810EF48F9A88C65E16540FF43"><enum>(7)</enum><text>by redesignating subsections (h) through (n) as subsections (j) through (p), respectively;</text></paragraph> <paragraph id="HE64F1AC5F0294FAD9F7D9BEDFE1194A3"><enum>(8)</enum><text>in subsections (c)(1)(A)(iv) and (d)(4), by striking <quote>subsection (h)</quote> each place it appears and inserting <quote>subsection (j)</quote>;</text></paragraph> <paragraph id="HE28B40F21B52425484D1D6E322448483"><enum>(9)</enum><text>by inserting after subsection (g) the following:</text> <quoted-block id="H794CD3C6C4E24581A1BFBF63DF1AC0E7" style="OLC"> <subsection id="H78300B99E5DB4B2E928FE2CD2429D076"><enum>(h)</enum><header>Education and access to the monitoring system</header><text>A State receiving a grant under subsection (a) shall take steps to—</text> <paragraph id="H9DDDE8C295584B3C98615337F888CD66"><enum>(1)</enum><text>facilitate prescriber and dispenser use of the State’s controlled substance monitoring system; </text></paragraph> <paragraph id="HBB926AF544724A4CBD1AF356D55C30EC"><enum>(2)</enum><text>educate prescribers and dispensers on the benefits of the system both to them and society; and</text></paragraph> <paragraph id="HF2458B5BF90F401AB7B03BFE400FD900" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">facilitate linkage to the State substance abuse agency and substance abuse disorder services.</text></paragraph></subsection> <subsection id="HD806B1D6C964475DBC2A18E92A65A059"><enum>(i)</enum><header>Consultation with Attorney General</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary shall consult with the Attorney General of the United States and other relevant Federal officials to—</text> <paragraph id="H3550DD047F5F4D8A89C35F3855F37E52"><enum>(1)</enum><text>ensure maximum coordination of controlled substance monitoring programs and related activities; and</text></paragraph> <paragraph id="H2F18352940644E988325CCEC8FB2347C"><enum>(2)</enum><text>minimize duplicative efforts and funding. </text></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H58964D3856EA48F68A375E3A5CBB17CB" commented="no"><enum>(10)</enum><text>in subsection (l)(2)(A), as redesignated by paragraph (7)—</text> <subparagraph id="HC1683A005EA44649BD987D44C512B3CB" commented="no"><enum>(A)</enum><text>in clause (ii), by inserting <quote>; established or strengthened initiatives to ensure linkages to substance use disorder services;</quote> before <quote>or affected patient access</quote>; and</text></subparagraph> <subparagraph id="H7FB6D23AD8594C3DB48E28FEE0CD4479" commented="no"><enum>(B)</enum><text>in clause (iii), by inserting <quote>and between controlled substance monitoring programs and health information technology systems</quote> before <quote>, including an assessment</quote>; </text></subparagraph></paragraph> <paragraph display-inline="no-display-inline" id="H1E6B4CF6221B49E08AB44928A328433B" commented="no"><enum>(11)</enum><text>by striking subsection (m) (relating to preference), as redesignated by paragraph (7);</text></paragraph> <paragraph id="H392CE22EC62F4C449320EC2018DAEF98"><enum>(12)</enum><text>by redesignating subsections (n) through (p), as redesignated by paragraph (7), as subsections (m) through (o), respectively;</text></paragraph> <paragraph id="HF7B6271E7F424BB18652883C7993A1EC"><enum>(13)</enum><text>in subsection (m)(1), as redesignated by paragraph (12), by striking <quote>establishment, implementation, or improvement</quote> and inserting <quote>establishment, improvement, or maintenance</quote>;</text></paragraph> <paragraph id="HCDA9DFA0D78E4BD48605D418F0A360DB"><enum>(14)</enum><text display-inline="yes-display-inline">in subsection (n), as redesignated by paragraph (12)—</text> <subparagraph id="HA9300161CD634257886D282DBA8DB4A9"><enum>(A)</enum><text>in paragraph (5)—</text> <clause id="H4ABC5D5FC6F247D79DEA7230F8866A4A"><enum>(i)</enum><text>by striking <quote>means the ability</quote> and inserting the following:</text> <quoted-block style="OLC" id="HDFA84772E5834FCE8474DC6F09D228D8" display-inline="yes-display-inline"><text display-inline="yes-display-inline">means—</text> <subparagraph id="H7173364270A34F35BB04F11A48D61E13"><enum>(A)</enum><text display-inline="yes-display-inline">the ability</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause> <clause id="HE8E1F320D9AB4152969E2F3AF81B9ABA"><enum>(ii)</enum><text>by striking the period at the end and inserting <quote>; or</quote>; and</text></clause> <clause id="H93430B2DE84B4FA1988BFB6F479A22C2"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" id="HD5D26F8831B74BFA8858C44F3048D193" display-inline="no-display-inline"> <subparagraph id="HEE4E0302B879442FAB7A707048B74910"><enum>(B)</enum><text display-inline="yes-display-inline">sharing of State controlled substance monitoring program information with a health information technology system such as an electronic health records system, a health information exchange, or an e-prescribing system.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="H7417954D98744B60B5B1657866AD9081"><enum>(B)</enum><text>in paragraph (7), by striking <quote>pharmacy</quote> and inserting <quote>pharmacist</quote>; and </text></subparagraph> <subparagraph id="HD0A5A055A9E34A89A221F7F3E8480E0E"><enum>(C)</enum><text>in paragraph (8), by striking <quote>and the District of Columbia</quote> and inserting <quote>, the District of Columbia, and any commonwealth or territory of the United States</quote>; and</text></subparagraph></paragraph> <paragraph id="H40BB94EB2DA0414B900AB02D3DBB16BE" commented="no"><enum>(15)</enum><text>by amending subsection (o), as redesignated by paragraph (12), to read as follows:</text> <quoted-block style="OLC" id="HE0BBF4F1BA964F24B90B05D01F2DD942" display-inline="no-display-inline"> <subsection id="HDBC5251FC2A64C6F86CE1CC49EEAF43A"><enum>(o)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years from 2016 through 2020.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> Amend the title so as to read: An Act to authorize the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes..Karen L. HaasClerk.