TAM18431 S.L.C. 115TH CONGRESS 2D SESSION S. ll øTo be supplied¿ IN THE SENATE OF THE UNITED STATES llllllllll llllllllll introduced the following bill; which was read twice and referred to the Committee on llllllllll A BILL øTo be supplied¿ 1 Be it enacted by the Senate and House of Representa- 2 tives of the United States of America in Congress assembled, 3 4 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) SHORT TITLE.—This Act may be cited as the 5 ‘‘Opioid Crisis Response Act of 2018’’. 6 (b) TABLE OF CONTENTS.—The table of contents of 7 this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—REAUTHORIZATION OF CURES FUNDING Sec. 101. Reauthorization and improvement of State targeted response grants. TITLE II—RESEARCH AND INNOVATION Sec. 201. Advancing cutting-edge research. TAM18431 S.L.C. 2 TITLE III—MEDICAL PRODUCTS AND CONTROLLED SUBSTANCES SAFETY Sec. Sec. Sec. Sec. Sec. Sec. Sec. Sec. 301. 302. 303. 304. 305. 306. 307. 308. Clarifying FDA regulation for non-addictive and non-opioid products. Clarifying FDA packaging authorities. Strengthening FDA and CBP coordination and capacity. Long term efficacy. Strengthening FDA import authorities. First responder training. Disposal of controlled substances by hospice programs. GAO study and report on hospice safe drug management. TITLE IV—TREATMENT AND RECOVERY Sec. Sec. Sec. Sec. Sec. Sec. Sec. 401. 402. 403. 404. 405. 406. 407. Comprehensive opioid recovery centers. Medication-assisted treatment for recovery from addiction. National recovery housing best practices. Addressing economic and workforce impacts of the opioid crisis. Youth prevention and recovery. Plans of safe care. Registration of community addiction treatment facilities and community mental health facilities. Sec. 408. Regulations relating to special registration for telemedicine. Sec. 409. National Health Service Corps behavioral and mental health professionals providing obligated service in schools and other community-based settings. Sec. 410. Loan repayment for substance use disorder treatment providers. TITLE V—PREVENTION Sec. Sec. Sec. Sec. 501. 502. 503. 504. Sec. Sec. Sec. Sec. 505. 506. 507. 508. Sec. 509. Sec. 510. Sec. 511. Sec. 512. Study on prescribing limits. Program for education and training in pain care. Education and awareness campaigns. Enhanced controlled substance overdoses data collection, analysis, and dissemination. Preventing overdoses of controlled substances. Reauthorization of NASPER. Jessie’s law. Development and dissemination of model training programs for substance use disorder patient records. Prenatal and postnatal health. Surveillance and education regarding infections associated with injection drug use and other risk factors. Task force to develop best practices for trauma-informed identification, referral, and support. Grants to improve trauma support services and mental health care for children and youth in educational settings. TAM18431 S.L.C. 3 1 2 3 TITLE I—REAUTHORIZATION OF CURES FUNDING SEC. 101. 4 5 REAUTHORIZATION AND IMPROVEMENT OF STATE TARGETED RESPONSE GRANTS. øReauthorization and modification of State-targeted 6 response grants authorized in the 21st Century Cures 7 Act.¿ 8 9 10 11 TITLE II—RESEARCH AND INNOVATION SEC. 201. ADVANCING CUTTING-EDGE RESEARCH. Section 402(n)(1) of the Public Health Service Act 12 (42 U.S.C. 282(n)(1)) is amended— 13 (1) in subparagraph (A), by striking ‘‘or’’; 14 (2) in subparagraph (B), by striking the period 15 16 and inserting ‘‘; or’’; and (3) by adding at the end the following: 17 ‘‘(C) high impact cutting-edge research 18 that fosters scientific creativity and increases 19 fundamental biological understanding leading to 20 the prevention, diagnosis, or treatment of dis- 21 eases and disorders, or research urgently re- 22 quired to respond to a public health threat.’’. TAM18431 S.L.C. 4 3 TITLE III—MEDICAL PRODUCTS AND CONTROLLED SUBSTANCES SAFETY 4 SEC. 301. CLARIFYING FDA REGULATION FOR NON-ADDICT- 5 IVE AND NON-OPIOID PRODUCTS. 1 2 6 (a) PUBLIC MEETINGS.—Not later than 1 year after 7 the date of enactment of this Act, the Secretary of Health 8 and Human Services (referred to in this section as the 9 ‘‘Secretary’’), acting through the Commissioner of Food 10 and Drugs, shall hold not less than one public meeting 11 to address— 12 (1) challenges and barriers to developing non- 13 opioid or non-addictive medical products intended to 14 treat pain, including chronic pain, and addiction; 15 (2) the manner by which the Secretary may in- 16 corporate the risks of misuse and abuse by the indi- 17 cated patient population of a controlled substance 18 (as defined in section 102 of the Controlled Sub- 19 stances Act (21 U.S.C. 802) or other medical prod- 20 uct into the risk benefit assessment under section 21 505(e) of the Federal Food, Drug, and Cosmetic Act 22 (21 U.S.C. 355(e)); 23 (3) the application of novel clinical trial designs 24 (consistent with section 3021 of the 21st Century 25 Cures Act (Public Law 114–255)), use of real world TAM18431 S.L.C. 5 1 evidence (as defined in section 505F(b) of the Fed- 2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 3 355g(b))), and use of patient experience data (as de- 4 fined in 569C of the Federal Food, Drug, and Cos- 5 metic Act (21 U.S.C. 360bbb–8c)) for the develop- 6 ment of non-opioid or non-addictive medical prod- 7 ucts intended to treat pain or addiction; 8 (4) the evidentiary standards and the develop- 9 ment of data to support opioid sparing indications 10 for medical products; and 11 (5) the application of eligibility criteria under 12 sections 506 and 515B of the Federal Food, Drug, 13 and Cosmetic Act (21 U.S.C. 356, 360e–3) for non- 14 opioid or non-addictive medical products intended to 15 treat pain. 16 (b) GUIDANCE.— 17 (1) USE 18 OF EXPEDITED PATHWAYS.— (A) DRAFT GUIDANCE.—Not later than 1 19 year after the date of enactment of this Act, the 20 Secretary, acting through the Commissioner of 21 Food and Drugs, shall issue draft guidance to 22 clarify how the Food and Drug Administration 23 may apply sections 506 and 515B of the Fed- 24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 25 356, 360e–3) to non-opioid or non-addictive TAM18431 S.L.C. 6 1 medical products intended to treat pain or ad- 2 diction. Such guidance shall include— 3 (i) the circumstances under which the 4 Secretary may apply the eligibility criteria 5 under such sections 506 and 515B to non- 6 opioid or non-addictive medical products 7 intended to treat pain or addiction; 8 (ii) the circumstances under which the 9 Secretary considers the risk of addiction of 10 controlled substances approved to treat 11 pain when establishing unmet medical 12 need; 13 (iii) the circumstances under which 14 the Secretary considers pain, pain control, 15 or pain management in assessing øwhether 16 a disease or condition is a¿ serious or life- 17 threatening disease or condition; and 18 (iv) the manner in which the Sec- 19 retary may apply the requirements under 20 subsection (c)(2)(A) of such section 506 to 21 assess the efficacy of drugs intended to 22 treat chronic pain. 23 (B) FINAL GUIDANCE.—Not later than 6 24 months after the close of the period for public 25 comment on the draft guidance under subpara- TAM18431 S.L.C. 7 1 graph (A), the Secretary shall finalize such 2 guidance. 3 (2) ENDPOINTS 4 FOR PRODUCTS INTENDED TO TREAT PAIN.— 5 (A) DRAFT GUIDANCE.—Not later than 1 6 year after the date of enactment of this Act, the 7 Secretary, acting through the Commissioner of 8 Food and Drugs, shall issue draft guidance that 9 clarifies the methods by which sponsors may 10 evaluate acute and chronic pain, endpoints for 11 non-opioid or non-addictive medical products in- 12 tended to treat pain, and steps the Secretary 13 will take to improve consistency in the use of 14 endpoints and evaluations of efficacy across re- 15 view divisions, taking into consideration the eti- 16 ology of the underlying disease, the use of sur- 17 rogate or intermediate endpoints, and real 18 world evidence. 19 (B) FINAL GUIDANCE.—Not later than 6 20 months after the close of the period for public 21 comment on the draft guidance under subpara- 22 graph (A), the Secretary shall finalize such 23 guidance. 24 (3) OPIOID 25 TIONS.— SPARING CLAIMS AND INDICA- TAM18431 S.L.C. 8 1 (A) DRAFT GUIDANCE.—Not later than 1 2 year after the date of enactment of this Act, the 3 Secretary, acting through the Commissioner of 4 Food and Drugs, shall issue draft guidance to 5 clarify how the Food and Drug Administration 6 will assess evidence to support claims of opioid 7 sparing for non-opioid or øother¿ non-addictive 8 medical products øintended to treat pain¿. 9 Such guidance shall include— 10 (i) data collection methodologies, in- 11 cluding the use of innovative clinical trial 12 designs (consistent with section 3021 of 13 the 21st Century Cures Act (Public Law 14 114–255)), and real world evidence (as de- 15 fined in section 505F(b) of the Federal 16 Food, Drug, and Cosmetic Act (21 U.S.C. 17 355g(b))), as appropriate, to support prod- 18 uct labeling; 19 (ii) ethical implications of exposure to 20 controlled substances in clinical trials to 21 support opioid sparing claims and consid- 22 erations on methods to reduce harm; 23 (iii) endpoints, including primary, sec- 24 ondary, and surrogate endpoints, to evalu- 25 ate the reduction in opioid use; TAM18431 S.L.C. 9 1 (iv) best practices for communication 2 between sponsors and the agency on the 3 development of such data collection meth- 4 ods, including the initiation of data collec- 5 tion; and 6 (v) the appropriate format to submit 7 such data results to the Secretary. 8 (B) FINAL GUIDANCE.—Not later than 6 9 months after the close of the period for public 10 comment on the draft guidance under subpara- 11 graph (A), the Secretary shall finalize such 12 guidance. 13 (4) RISK 14 OF ABUSE AND MISUSE.— (A) DRAFT GUIDANCE.—Not later than 1 15 year after the date of enactment of this Act, the 16 Secretary, acting through the Commissioner of 17 Food and Drugs, shall issue draft guidance to 18 clarify the circumstances under which the Food 19 and Drug Administration considers misuse and 20 abuse of drugs in making determinations of 21 safety under paragraphs (2) and (4) of sub- 22 section (d) of section 505 of the Federal Food, 23 Drug, and Cosmetic Act (21 U.S.C. 355) and 24 in finding that a drug is unsafe under para- TAM18431 S.L.C. 10 1 graph (1) or (2) of subsection (e) of such sec- 2 tion. 3 (B) FINAL GUIDANCE.—Not later than 6 4 months after the close of the period for public 5 comment on the draft guidance under subpara- 6 graph (A), the Secretary shall finalize such 7 guidance. 8 (c) DEFINITIONS.—In this section— 9 (1) the term ‘‘medical product’’ means a drug 10 (as that term is defined by section 201(g)(1) of the 11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 321(g)(1))), biological product (as that term is de- 13 fined by section 351(i) of this Act (42 U.S.C. 14 262(i))), or device (as that term is defined by sec- 15 tion 201(h) of the Federal Food, Drug, and Cos- 16 metic Act (21 U.S.C. 321(h))); and 17 (2) the term ‘‘opioid sparing’’ means reducing 18 the use of opioids øor other controlled substances¿. 19 20 SEC. 302. CLARIFYING FDA PACKAGING AUTHORITIES. Section 505–1(f)(3) of the Federal Food, Drug, and 21 Cosmetic Act (21 U.S.C. 355–1(f)(3)) is amended— 22 23 24 25 (1) in subparagraph (E), by striking ‘‘or’’ at the end; (2) in subparagraph (F), by striking the period and inserting a semicolon; and TAM18431 S.L.C. 11 1 (3) by adding at the end the following: 2 ‘‘(G) the drug be made available for dis- 3 pensing to patients in unit dose packaging or 4 another packaging system that the Secretary 5 determines appropriate; or 6 ‘‘(H) the drug be dispensed to patients 7 with a safe disposal packaging or safe disposal 8 system that the Secretary determines appro- 9 priate for purposes of disposing of any unused 10 11 dose of the dispensed drug.’’. SEC. 303. STRENGTHENING FDA AND CBP COORDINATION 12 13 AND CAPACITY. (a) IN GENERAL.—The Secretary of Health and 14 Human Services (referred to in this section as the ‘‘Sec15 retary’’), acting through the Commissioner of Food and 16 Drugs, shall coordinate with the Secretary of Homeland 17 Security to carry out activities related to customs and bor18 der protection and response to illegal controlled substances 19 and drug imports, including at sites of import (such as 20 international mail facilities). Such Secretaries may estab21 lish a memorandum of understanding between the Food 22 and Drug Administration and the United States Customs 23 and Border Protection for purposes of carrying out such 24 activities. TAM18431 S.L.C. 12 1 2 (b) FDA IMPORT FACILITIES PACITY.—In AND INSPECTION CA- carrying out this section, the Secretary shall 3 provide import facilities operated by the Food and Drug 4 Administration with— 5 (1) innovative technology, including controlled 6 substance detection and testing equipment and other 7 applicable technology, that is interoperable with 8 technology used by United States Customs and Bor- 9 der Protection, and includes capabilities for near- 10 real-time information sharing, as appropriate; 11 (2) access to canine units, including trained ca- 12 nine officers, for purposes of detecting controlled 13 substances and counterfeit opioids, or counterfeit 14 products containing opioids, at sites of import; and 15 (3) facility upgrades and improved capacity in 16 order to increase and improve inspection and detec- 17 tion capabilities, which may include, as the Secretary 18 determines appropriate— 19 (A) improvements to facilities, such as up- 20 grades or renovations, and support for the 21 maintenance of existing import facilities and 22 sites to improve coordination between Federal 23 agencies; TAM18431 S.L.C. 13 1 (B) the construction of, or upgrades to lab- 2 oratory capacity for purposes of detection and 3 testing of imported goods; 4 5 (C) upgrades to the security of such facilities; and 6 (D) innovative technology and equipment 7 consistent with paragraph (1) to facilitate im- 8 proved coordination and information sharing. 9 (c) REPORT.—Not later than 6 months after the date 10 of enactment of this Act, the Secretary, in consultation 11 with the Secretary of Homeland Security, shall report to 12 the relevant committees of Congress on the implementa13 tion of this section, including a summary of progress made 14 towards near-real-time information sharing and the inter15 operability of such technologies. 16 (d) AUTHORIZATION OF APPROPRIATIONS.—Out of 17 amounts otherwise available to the Secretary, the Sec18 retary may allocate such sums as may be necessary for 19 purposes of carrying out this section. 20 21 22 23 SEC. 304. LONG TERM EFFICACY. øTo be supplied.¿ SEC. 305. STRENGTHENING FDA IMPORT AUTHORITIES. øTo be supplied.¿ TAM18431 S.L.C. 14 1 2 SEC. 306. FIRST RESPONDER TRAINING. Section 546 of the Public Health Service Act (42 3 U.S.C. 290ee–1) is amended— 4 (1) in subsection (c)— 5 6 (A) in paragraph (2), by striking ‘‘and’’ at the end; 7 8 (B) in paragraph (3), by striking the period and inserting ‘‘; and’’; and 9 (C) by adding at the end the following: 10 ‘‘(4) train and provide resources for first re- 11 sponders and members of other key community sec- 12 tors on safety around fentanyl and other dangerous 13 illicit drugs to protect themselves from exposure to 14 fentanyl and respond appropriately when exposure 15 occurs.’’; 16 (2) in subsection (d), by inserting ‘‘, and safety 17 around fentanyl and other dangerous illicit drugs’’ 18 before the period; and 19 20 21 22 23 (3) in subsection (f)— (A) in paragraph (3), by striking ‘‘and’’ at the end; (B) in paragraph (4), by striking the period and inserting a semicolon; and 24 (C) by adding at the end the following: 25 ‘‘(5) the number of first responders and mem- 26 bers of other key community sectors trained on safe- TAM18431 S.L.C. 15 1 ty around fentanyl and other dangerous illicit 2 drugs.’’. 3 SEC. 307. DISPOSAL OF CONTROLLED SUBSTANCES BY HOS- 4 5 PICE PROGRAMS. (a) IN GENERAL.—Section 302(g)(3) of the Con- 6 trolled Substances Act (21 U.S.C. 822(g)(3)) is amend7 ed— 8 9 (1) by inserting ‘‘(A)’’ before ‘‘The Attorney General’’; and 10 11 (2) by adding at the end the following: ‘‘(B) Not later than 1 year after the date of enact- 12 ment of this subparagraph, the Attorney General øshall¿, 13 by regulation, authorize hospice programs (as defined in 14 section 1861 of the Social Security Act (42 U.S.C. 15 1395x)) to dispose of controlled substances on behalf of 16 deceased ultimate users in a manner that the Attorney 17 General determines will provide effective controls against 18 diversion and be consistent with the public health and 19 safety.’’. 20 (b) CONFORMING AMENDMENT.—Section 308(b)(3) 21 of the Controlled Substances Act (21 U.S.C. 828(b)(3)) 22 is amended by inserting ‘‘hospice program,’’ after ‘‘facil23 ity,’’. TAM18431 S.L.C. 16 1 2 3 SEC. 308. GAO STUDY AND REPORT ON HOSPICE SAFE DRUG MANAGEMENT. (a) STUDY.—The Comptroller General of the United 4 States (in this section referred to as the ‘‘Comptroller 5 General’’) shall conduct a study on compliance by hospice 6 programs with requirements under the Medicare program 7 under section 418.106 of title 42, Code of Federal Regula8 tions (or any successor regulations), that hospice pro9 grams develop written policies and procedures on the man10 agement and disposal of controlled substances in the home 11 of an individual. Such study shall include— 12 (1) an overview of challenges encountered by 13 hospice programs regarding the disposal of con- 14 trolled substances, such as opioids, including an as- 15 sessment of the number of hospice programs nation- 16 wide encountering those challenges; 17 (2) a description of Federal requirements, as in 18 effect on the day before the date of enactment of 19 this Act, for hospice programs regarding the dis- 20 posal of controlled substances; 21 (3) an assessment of the number of hospice 22 programs that are complying with the requirements 23 described under paragraph (2); and 24 (4) a description of the enforcement mecha- 25 nisms available to the Centers for Medicare & Med- 26 icaid Services to ensure that hospice programs are TAM18431 S.L.C. 17 1 complying with such requirements and an assess- 2 ment of whether the Centers for Medicare & Med- 3 icaid Services has adequately used the enforcement 4 mechanisms. 5 (b) REPORT.—Not later than 1 year after the date 6 of enactment of this Act, the Comptroller General shall 7 submit to Congress a report containing the results of the 8 study conducted under subsection (a), together with rec9 ommendations for such legislation and administrative ac10 tion as the Comptroller General determines appropriate. 11 12 13 14 TITLE IV—TREATMENT AND RECOVERY SEC. 401. COMPREHENSIVE OPIOID RECOVERY CENTERS. (a) IN GENERAL.—Part D of title V of the Public 15 Health Service Act is amended by adding at the end the 16 following new section: 17 18 ‘‘SEC. 550. COMPREHENSIVE OPIOID RECOVERY CENTERS. ‘‘(a) IN GENERAL.—The Secretary, acting through 19 the Assistant Secretary for Mental Health and Substance 20 Use, shall award grants on a competitive basis to eligible 21 entities to establish or operate a comprehensive opioid re22 covery center (referred to in this section as a ‘Center’). 23 A Center may be a single entity or an integrated delivery 24 network. 25 ‘‘(b) GRANT PERIOD.— TAM18431 S.L.C. 18 1 ‘‘(1) IN GENERAL.—A grant awarded under 2 subsection (a) shall be for a period not more than 3 5 years. 4 ‘‘(2) RENEWAL.—A grant awarded under sub- 5 section (a) may be renewed, on a competitive basis, 6 for additional periods of time, as determined by the 7 Secretary. In determining whether to renew a grant 8 under this paragraph, the Secretary shall consider 9 the data submitted under subsection (h). 10 ‘‘(c) MINIMUM NUMBER OF GRANTS.—The Secretary 11 shall allocate the amounts made available under sub12 section (j) such that not fewer than 10 grants may be 13 awarded. Not more than one grant shall be made to enti14 ties in a single State for any one period. 15 ‘‘(d) APPLICATION.—In order to be eligible for a 16 grant under subsection (a), an entity shall submit an ap17 plication to the Secretary at such time and in such manner 18 as the Secretary may require. Such application shall in19 clude— 20 ‘‘(1) evidence that such entity carries out, or is 21 capable of coordinating with other entities to carry 22 out, the activities described in subsection (g); and 23 24 ‘‘(2) such other information as the Secretary may require. TAM18431 S.L.C. 19 1 ‘‘(e) PRIORITY.—In awarding grants under sub- 2 section (a), the Secretary shall give priority to— 3 ‘‘(1) eligible entities located in a State with a 4 per capita drug overdose mortality rate that is above 5 the national average, as determined by the Director 6 of the Centers for Disease Control and Prevention; 7 and 8 ‘‘(2) eligible entities utilizing technology-enabled 9 collaborative learning and capacity building models, 10 as defined in section 2 of the Expanding Capacity 11 for Health Outcomes Act (Public Law 114–270; 130 12 Stat. 1395), to conduct the activities described in 13 this section. 14 ‘‘(f) USE OF GRANT FUNDS.—An eligible entity 15 awarded a grant under subsection (a) shall use the grant 16 funds to establish or operate a Center to carry out the 17 activities described in this section. 18 ‘‘(g) CENTER ACTIVITIES.—Each Center shall, at a 19 minimum, carry out the following activities directly, 20 through referral, or through contractual arrangements, in21 cluding through technology-enabled collaborative learning 22 and capacity building models, as defined in section 2 of 23 the Expanding Capacity for Health Outcomes Act (Public 24 Law 114-270, 130 Stat. 1395): TAM18431 S.L.C. 20 1 2 ‘‘(1) TREATMENT AND RECOVERY SERVICES.— Each Center shall— 3 ‘‘(A) ensure that intake and evaluations 4 meet the individualized clinical needs of pa- 5 tients, including by offering assessments for 6 services and care recommendations through 7 independent, evidence-based verification proc- 8 esses for reviewing patient placement in treat- 9 ment settings; 10 11 ‘‘(B) provide the full continuum of treatment services, including— 12 ‘‘(i) all drugs approved by the Food 13 and Drug Administration to treat sub- 14 stance use disorders; 15 ‘‘(ii) medically supervised withdrawal 16 management that includes patient evalua- 17 tion, stabilization, and readiness for and 18 entry into treatment; 19 ‘‘(iii) counseling provided by a pro- 20 gram counselor or other certified profes- 21 sional who is licensed and qualified by edu- 22 cation, training, or experience to assess the 23 psychological and sociological background 24 of patients, to contribute to the appro- TAM18431 S.L.C. 21 1 priate treatment plan for the patient, and 2 to monitor patient progress; 3 ‘‘(iv) treatment, as appropriate, for 4 patients with co-occurring substance use 5 and mental health disorders; 6 ‘‘(v) residential rehabilitation, and 7 outpatient and intensive outpatient pro- 8 grams; 9 10 11 ‘‘(vi) recovery housing; ‘‘(vii) community-based and peer recovery support services; 12 ‘‘(viii) job training, job placement as- 13 sistance, and continuing education assist- 14 ance to support reintegration into the 15 workforce; and 16 ‘‘(ix) other best practices to provide 17 the full continuum of treatment and serv- 18 ices, as determined by the Secretary; 19 ‘‘(C) periodically conduct patient assess- 20 ments to ensure sustained and clinically signifi- 21 cant recovery, as defined by the Assistant Sec- 22 retary for Mental Health and Substance Use; 23 ‘‘(D) administer an onsite pharmacy and 24 provide toxicology services, for purposes of car- 25 rying out this section; and TAM18431 S.L.C. 22 1 ‘‘(E) operate a secure, confidential, and 2 interoperable electronic health information sys- 3 tem. 4 ‘‘(2) OUTREACH.—Each Center shall carry out 5 outreach activities to publicize the services offered 6 through the Centers, which may include— 7 ‘‘(A) training and supervising outreach 8 staff, as appropriate, to work with State and 9 local health departments, health care providers, 10 State and local education agencies, institutions 11 of higher education, State and local workforce 12 development boards, State and local community 13 action agencies, public safety officials, first re- 14 sponders, and other community partners as de- 15 termined by the Secretary, to identify and re- 16 spond to community needs, and ensuring that 17 such entities are aware of the services of the 18 Center; and 19 ‘‘(B) disseminating and making publicly 20 available, including through the internet, evi- 21 dence-based resources that educate profes- 22 sionals and the public on opioid use disorder 23 and other substance use disorders, including co- 24 occurring substance use and mental health dis- 25 orders. TAM18431 S.L.C. 23 1 2 ‘‘(h) DATA REPORTING SIGHT.—With AND PROGRAM OVER- respect to a grant awarded under sub- 3 section (a) to an eligible entity for a Center, not later than 4 90 days after the end of the first year of the grant period, 5 and annually thereafter for the duration of the grant pe6 riod (including the duration of any renewal period for such 7 grant), the entity shall submit data, as appropriate, to the 8 Secretary regarding— 9 10 ‘‘(1) the programs and activities funded by the grant; 11 ‘‘(2) health outcomes of the population of indi- 12 viduals with a substance use disorder who received 13 services from the Center, evaluated by an inde- 14 pendent program evaluator through the use of out- 15 comes measures, as determined by the Secretary; 16 17 ‘‘(3) the retention rate of program participants; and 18 ‘‘(4) any other information that the Secretary 19 may require for the purpose of ensuring that the 20 Center is complying with all the requirements of the 21 grant, including providing the full continuum of 22 services described in subsection (g)(1)(B). 23 ‘‘(i) PRIVACY.—The provisions of this section, includ- 24 ing with respect to data reporting and program oversight, TAM18431 S.L.C. 24 1 shall be subject to all applicable Federal and State privacy 2 laws. 3 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There 4 is authorized to be appropriated $10,000,000 for each of 5 fiscal years 2019 through 2023 for purposes of carrying 6 out this section.’’. 7 8 (b) REPORTS TO CONGRESS.— (1) PRELIMINARY REPORT.—Not later than 3 9 years after the date of the enactment of this Act, the 10 Secretary of Health and Human Services shall sub- 11 mit to Congress a preliminary report that analyzes 12 data submitted under section 550(h) of the Public 13 Health Service Act, as added by subsection (a). 14 (2) FINAL REPORT.—Not later than 2 year 15 after submitting the preliminary report required 16 under paragraph (1), the Secretary of Health and 17 Human Services shall submit to Congress a final re- 18 port that includes— 19 (A) an evaluation of the effectiveness of 20 the comprehensive services provided by the Cen- 21 ters established or operated pursuant to section 22 550 of the Public Health Service Act, as added 23 by subsection (a), on health outcomes of the 24 population of individuals with substance use 25 disorder who receive services from the Center, TAM18431 S.L.C. 25 1 which shall include an evaluation of the effec- 2 tiveness of services for treatment and recovery 3 support and to prevent relapse, recidivism, and 4 overdose; and 5 (B) recommendations, as appropriate, re- 6 garding ways to improve Federal programs re- 7 lated to substance use disorders, which may in- 8 clude dissemination of best practices for the 9 treatment of substance use disorders to health 10 11 care professionals. øSEC. 402. MEDICATION-ASSISTED TREATMENT FOR RE- 12 13 COVERY FROM ADDICTION. ø(a) MAKING NURSE PRACTITIONER 14 ASSISTANT AUTHORITY AND PHYSICIAN PERMANENT.—Section 15 303(g)(2)(G)(iii)(II) of the Controlled Substances Act (21 16 U.S.C. 823(g)(2)(G)(iii)(II)) is amended by striking ‘‘dur17 ing the period beginning on the date of enactment of the 18 Comprehensive Addiction and Recovery Act of 2016 and 19 ending on October 1, 2021,’’.¿ 20 21 ø(b) REPEAL LATIONS.—Section OF REQUIREMENT TO UPDATE REGU- 303 of the Comprehensive Addiction 22 and Recovery Act of 2016 (Public Law 114–198; 130 23 Stat. 720) is amended by striking subsection (c).¿ 24 ø(c) CODIFICATION 25 NUMBER OF PATIENTS OF EXPANSION FOR OF MAXIMUM MEDICATION-ASSISTED TAM18431 S.L.C. 26 1 TREATMENT.—Section 303(g)(2)(B)(iii)(II) of the Con2 trolled Substances Act (21 U.S.C. (g)(2)(B)(iii)(II)) is 3 amended by striking ‘‘100’’ each place it appears and in4 serting ‘‘275’’.¿ 5 øThe language in subsection (a) is contingent upon a to6 be-decided pay-for.¿ 7 8 9 SEC. 403. NATIONAL RECOVERY HOUSING BEST PRACTICES. (a) BEST PRACTICES.—The Secretary of Health and 10 Human Services, in consultation with the Secretary for 11 Housing and Urban Development, patients with a history 12 of opioid use disorder, and other stakeholders, which may 13 include State accrediting entities and reputable providers 14 of, and analysts of, recovery housing services, shall iden15 tify or facilitate the development of best practices, which 16 may include model laws for implementing suggested min17 imum standards, for operating recovery housing. 18 (b) DISSEMINATION.—The Secretary shall dissemi- 19 nate the best practices identified or developed under sub20 section (a) to— 21 (1) State agencies, which may include the provi- 22 sion of technical assistance to State agencies seeking 23 to adopt or implement such best practices; 24 (2) recovery housing entities; and 25 (3) the public, as appropriate. TAM18431 S.L.C. 27 1 (c) REQUIREMENTS.—In identifying or facilitating 2 the development of best practices under subsection (a), the 3 Secretary of Health and Human Services, in consultation 4 with appropriate stakeholders, shall consider how recovery 5 housing is able to (including by improving access and ad6 herence to treatment) support recovery and prevent re7 lapse, recidivism, or overdose, including overdose death. 8 (d) RULE OF CONSTRUCTION.—Nothing in this sec- 9 tion shall be construed to provide the Secretary with the 10 ability to require States to adhere to minimum standards 11 in the State oversight of recovery housing. 12 (e) DEFINITION.—In this section, the term ‘‘recovery 13 housing’’ means a shared living environment free from al14 cohol and illicit drug use and centered on peer support 15 and connection to services that promote sustained recovery 16 from substance use disorders. 17 18 19 SEC. 404. ADDRESSING ECONOMIC AND WORKFORCE IMPACTS OF THE OPIOID CRISIS. (a) DEFINITIONS.—Except as otherwise expressly 20 provided, in this section: 21 (1) EDUCATION 22 cation provider’’ means— PROVIDER.—The term ‘‘edu- 23 (A) an institution of higher education, as 24 defined in section 101 of the Higher Education 25 Act of 1965 (20 U.S.C. 1001); or TAM18431 S.L.C. 28 1 (B) a postsecondary vocational institution, 2 as defined in section 102(c) of such Act (20 3 U.S.C. 1002(c)). 4 (2) ELIGIBLE 5 ENTITY.—The term ‘‘eligible enti- ty’’ means— 6 (A) a State board; 7 (B) an outlying area, as defined in section 8 3 of the Workforce Innovation and Opportunity 9 Act (29 U.S.C. 3102); or 10 11 (C) a Tribal entity. (3) LOCAL AREA; LOCAL BOARD; ONE-STOP OP- 12 ERATOR.—The 13 and ‘‘one-stop operator’’ have the meanings given 14 such terms in section 3 of the Workforce Innovation 15 and Opportunity Act (29 U.S.C. 3102). 16 17 18 terms ‘‘local area’’, ‘‘local board’’, (4) LOCAL ENTITY.—The term ‘‘local entity’’ means a local board or one-stop operator. (5) PARTICIPATING PARTNERSHIP.—The term 19 ‘‘participating partnership’’ means a partnership es- 20 tablished under subsection (e)(1) by a local entity 21 receiving a subgrant under subsection (d). 22 ø(6) PEER RECOVERY SUPPORT SERVICES.— 23 The term ‘‘peer recovery support services’’ means a 24 collection of community services that—¿ TAM18431 S.L.C. 29 1 ø(A) are designed and delivered by individ- 2 uals who have experienced both substance use 3 disorder and recovery;¿ 4 5 ø(B) are delivered to individuals with a substance use disorder; and¿ 6 ø(C) include peer-to-peer programs, job 7 and life-skills training, øassistance in obtain- 8 ing¿ supportive housing or recovery housing, 9 and other services that contribute to better 10 overall health and well-being.¿ 11 (7) PROGRAM 12 PARTICIPANT.—The term ‘‘pro- gram participant’’ means an individual who— 13 (A) is a member of a population of workers 14 described in subsection (e)(2) that is served by 15 a participating partnership through the pilot 16 program under this section; and 17 (B) enrolls with the applicable partici- 18 pating partnership to receive any of the services 19 described in subsection (e)(3). 20 (8) SECRETARY.—The term ‘‘Secretary’’ means 21 22 the Secretary of Labor. (9) STATE BOARD.—The term ‘‘State board’’ 23 means a State workforce development board estab- 24 lished under section 101 of the Workforce Innova- 25 tion and Opportunity Act (29 U.S.C. 3111). TAM18431 S.L.C. 30 1 (10) SUBSTANCE USE DISORDER.—The term 2 ‘‘substance use disorder’’ means such a disorder 3 within the meaning of title V of the Public Health 4 Service Act (42 U.S.C. 290aa et seq.). 5 (11) SUPPORTIVE SERVICES.—The term ‘‘sup- 6 portive services’’ has the meaning given such term in 7 section 3 of the Workforce Innovation and Oppor- 8 tunity Act (29 U.S.C. 3102). 9 10 ø(12) TREATMENT PROVIDER.—The term ‘‘treatment provider’’—¿ 11 ø(A) means a health care provider that of- 12 fers services for treating substance use dis- 13 orders; and¿ 14 ø(B) may include—¿ ø(i) a nonprofit provider of peer re- 15 16 covery support services;¿ ø(ii) a community health care pro- 17 18 vider;¿ 19 ø(iii) a Federally qualified health cen- 20 ter (as defined in section 1861(aa) of the 21 Social Security Act (42 U.S.C. 1395x)); 22 or¿ 23 ø(iv) any other health care provider or 24 health-related organization øthat treats a 25 substance use disorder¿, including a pro- TAM18431 S.L.C. 31 1 vider that offers medication-assisted ther- 2 apy or providers listed on the Behavioral 3 Health Treatment Services Locator of the 4 Substance Abuse and Mental Health Serv- 5 ices Administration.¿ 6 (13) TRIBAL ENTITY.—The term ‘‘Tribal enti- 7 ty’’ includes any Indian tribe, tribal organization, 8 Indian-controlled organization serving Indians, Na- 9 tive Hawaiian organization, or Alaska Native entity, 10 as such terms are defined or used in section 166 of 11 the Workforce Innovation and Opportunity Act (29 12 U.S.C. 3221). 13 (b) PILOT PROGRAM 14 (1) IN AND GRANTS AUTHORIZED.— GENERAL.—The Secretary, in consulta- 15 tion with the Secretary of Health and Human Serv- 16 ices, shall carry out a pilot program to address eco- 17 nomic and workforce impacts associated with the 18 øopioid crisis¿. In carrying out the pilot program, 19 the Secretary shall make grants, on a competitive 20 basis, to eligible entities to enable such entities to 21 make subgrants to local boards and one-stop opera- 22 tors to address the economic and workforce impacts 23 associated with the øopioid crisis¿. 24 25 (2) GRANT AMOUNTS.—The Secretary shall make each such grant in an amount that is not less TAM18431 S.L.C. 32 1 than $500,000, and not more than $5,000,000, for 2 a fiscal year. 3 (c) GRANT APPLICATIONS.— 4 (1) IN GENERAL.—An eligible entity applying 5 for a grant under this section shall submit an appli- 6 cation to the Secretary at such time and in such 7 form and manner as the Secretary may reasonably 8 require, including the information described in this 9 subsection. 10 11 (2) SIGNIFICANT IMPACT ON COMMUNITY BY OPIOID-RELATED PROBLEMS.— 12 (A) DEMONSTRATION.—An eligible entity 13 shall include in the application information that 14 demonstrates significant impact on the commu- 15 nity by opioid-related problems by— 16 (i) identifying the communities, re- 17 gions, or local areas that will be served 18 through the grant (each referred to in this 19 section as a ‘‘service area’’); and 20 (ii) showing, for each such service 21 area, an increase equal to or greater than 22 the national increase in opioid-related 23 problems, between— 24 (I) 1999; and TAM18431 S.L.C. 33 1 (II) 2016 or the latest year for 2 which data are available. 3 (B) INFORMATION.—In making the show- 4 ing described in subparagraph (A)(ii), the eligi- 5 ble entity may use information including data 6 on— 7 (i) an incidence or prevalence of 8 opioid use disorders that is substantially 9 higher than the national average; 10 (ii) a per capita drug overdose mor- 11 tality rate that is above the national aver- 12 age, as determined by the Director of the 13 Centers for Disease Control and Preven- 14 tion; 15 (iii) rates of non-fatal hospitalizations 16 related to opioid and illegal substance 17 abuse; or 18 (iv) number of arrests, convictions, or 19 relevant law enforcement statistics that 20 reasonably show an increase in opioid and 21 illegal substance abuse. 22 (3) ECONOMIC 23 DEMONSTRATE 24 NEEDED.— AND EMPLOYMENT CONDITIONS ADDITIONAL FEDERAL SUPPORT TAM18431 S.L.C. 34 1 (A) DEMONSTRATION.—An eligible entity 2 shall include in the application information that 3 demonstrates that the øopioid crisis¿ has 4 caused, or is coincident to, an economic or em- 5 ployment downturn in the service area. 6 (B) INFORMATION.—In making the dem- 7 onstration described in subparagraph (A), the 8 eligible entity may use information including— 9 (i) documentation of any layoff, an- 10 nounced future layoff, legacy industry de- 11 cline, decrease in an employment or labor 12 market participation rate, or economic im- 13 pact, whether or not the result described in 14 this clause is overtly related to the opioid 15 epidemic; 16 (ii) documentation showing decreased 17 economic activity related to, caused by, or 18 contributing to the opioid epidemic, includ- 19 ing a description of how the service area 20 has been impacted, or will be impacted, by 21 such a decrease; 22 (iii) in particular, information on eco- 23 nomic indicators, labor market analyses, 24 information from public announcements, 25 and demographic and industry data; TAM18431 S.L.C. 35 1 (iv) information on rapid response ac- 2 tivities (as defined in section 3 of the 3 Workforce Innovation and Opportunity Act 4 (29 U.S.C. 3102)) that have been or will 5 be conducted, including demographic data 6 gathered by employer or worker surveys or 7 through other methods; 8 (v) data or documentation, beyond an- 9 ecdotal evidence, showing that employers 10 face challenges filling job vacancies due to 11 a lack of skilled workers able to pass a 12 drug test; or 13 (vi) any additional relevant data or in- 14 formation on the economy, workforce, or 15 another aspect of the service area to sup- 16 port the application. 17 18 19 (4) WORKFORCE SHORTAGE RELATED TO TREATMENT WORKFORCE.— (A) IN GENERAL.—An eligible entity may 20 include in the application a demonstration of 21 the workforce shortage in a professional area to 22 be addressed under the grant. Such professional 23 areas may include— 24 25 (i) substance use disorder treatment and related services; TAM18431 S.L.C. 36 1 (ii) non-opioid pain therapy and pain 2 management services; or 3 (iii) mental health care treatment 4 services. 5 (B) INFORMATION TO BE INCLUDED.—An 6 eligible entity demonstrating a workforce short- 7 age under subparagraph (A) shall demonstrate 8 the workforce shortage through information 9 that includes— 10 (i) the distance between opioid-af- 11 fected communities and facilities or profes- 12 sionals offering services in the professional 13 area; or 14 (ii) the maximum capacity of facilities 15 or professionals to serve individuals in an 16 affected community, increases in opioid-re- 17 lated arrests, overdose deaths, or nonfatal 18 overdose emergencies in the community. 19 (d) SUBGRANT AUTHORIZATION AND APPLICATION 20 PROCESS.— 21 (1) SUBGRANTS 22 (A) IN 23 AUTHORIZED.— GENERAL.—An eligible entity re- ceiving a grant under subsection (b)— TAM18431 S.L.C. 37 1 (i) may use not more than 5 percent 2 of the grant funds for the administrative 3 costs of carrying out the grant; and 4 (ii) shall use the remaining grant 5 funds to make subgrants to local entities 6 in the area served by the eligible entity to 7 carry out the services and activities de- 8 scribed in subsection (e). 9 (B) GEOGRAPHIC DISTRIBUTION.—In mak- 10 ing subgrants under this subsection, an eligible 11 entity shall ensure, to the extent practicable, 12 the equitable geographic distribution (such as 13 urban and rural distribution) of areas receiving 14 subgrant funds. 15 (2) SUBGRANT 16 (A) IN APPLICATION.— GENERAL.—A local entity desiring 17 to receive a subgrant under this subsection shall 18 submit an application at such time and in such 19 manner as the eligible entity may reasonably re- 20 quire, including the information described in 21 this paragraph. 22 (B) CONTENTS.—Each application de- 23 scribed in subparagraph (A) shall include an 24 analysis of the estimated performance of the TAM18431 S.L.C. 38 1 local entity in carrying out the proposed serv- 2 ices and activities of the subgrant that— 3 (i) uses key performance indicators to 4 assess estimated effectiveness of the pro- 5 posed activities, including the estimated 6 number of individuals with a substance use 7 disorder who may be served by the pro- 8 posed activities and services; 9 (ii) analyzes the record of the local 10 entity in serving individuals with a barrier 11 to employment; and 12 (iii) analyzes the ability of the local 13 entity to establish the partnership de- 14 scribed in subsection (e)(1). 15 (C) ANALYSIS.—The analysis described in 16 subparagraph (B) may include or utilize— 17 (i) data from the National Center for 18 Health Statistics of the Centers for Dis- 19 ease Control and Prevention; 20 (ii) data from the Center for Behav- 21 ioral Health Statistics and Quality of the 22 Substance Abuse and Mental Health Serv- 23 ices Administration; 24 (iii) State vital statistics; TAM18431 S.L.C. 39 1 (iv) 2 records; municipal police department 3 (v) reports from local coroners; or 4 (vi) other relevant data. 5 (e) SUBGRANT SERVICES AND ACTIVITIES.— 6 (1) FORMATION 7 (A) IN OF PARTNERSHIP.— GENERAL.—Each local entity that 8 receives a subgrant under subsection (d) shall 9 form a partnership, established through a writ- 10 ten contract or other agreement, with members 11 described in subparagraph (B), and shall carry 12 out the services and activities described in this 13 subsection through the partnership. 14 ø(B) MEMBERS OF THE PARTNERSHIP.—A 15 partnership described in subparagraph (A) shall 16 include 1 or more of each of the following:¿ 17 ø(i) A treatment provider.¿ 18 ø(ii) An employer or industry organi- 19 zation.¿ 20 ø(iii) An education provider.¿ 21 ø(iv) A legal service or law enforce- 22 23 24 ment organization.¿ ø(v) A faith-based or communitybased organization.¿ TAM18431 S.L.C. 40 1 (2) 2 SERVED.—A 3 provide services and activities under the subgrant to 4 one or both of the following populations of workers: 5 (A) Workers, including dislocated workers, 6 new entrants in the workforce, or incumbent 7 workers (employed or underemployed), who are 8 directly or indirectly affected by the øopioid cri- 9 sis¿ and each of whom is— SELECTION OF POPULATION TO BE participating partnership shall elect to 10 (i) an individual who voluntarily con- 11 firms that the individual, or a friend or 12 family member of the individual, has a his- 13 tory of opioid use; or 14 (ii) an individual who works or resides 15 in a community substantially impacted by 16 the øopioid crisis¿ or can otherwise dem- 17 onstrate job loss as a result of the øopioid 18 crisis¿. 19 (B) Workers, including dislocated workers, 20 new entrants in the workforce, or incumbent 21 workers (employed or underemployed), who— 22 (i) seek to transition to professions 23 that support individuals struggling with 24 opioid use disorder or at risk for devel- TAM18431 S.L.C. 41 1 oping such disorder, such as professions 2 that provide— 3 (I) substance use disorder treat- 4 ment and related services; 5 (II) peer recovery support serv- 6 ices; 7 (III) non-opioid pain therapy and 8 pain management services; or 9 (IV) mental health care; and 10 (ii) need new or upgraded skills to 11 better serve such a population of strug- 12 gling or at-risk individuals. 13 (3) SERVICES AND ACTIVITIES.—Each partici- 14 pating partnership shall use funds available through 15 a subgrant under this subsection to carry out the 16 following: 17 18 19 20 (A) ENGAGING EMPLOYERS.—Engaging with employers to— (i) learn about the skill and hiring requirements of employers; 21 (ii) learn about the support needed by 22 employers to hire and retain program par- 23 ticipants, and other individuals with a sub- 24 stance use disorder, and the support need- 25 ed by such employers to obtain their com- TAM18431 S.L.C. 42 1 mitment to testing creative solutions to 2 employing program participants and indi- 3 viduals; 4 (iii) connect employers and workers to 5 on-the-job or customized training programs 6 before or after layoff to help facilitate re- 7 employment; 8 (iv) connect employers with an edu- 9 cation provider to develop classroom in- 10 struction to complement on-the-job learn- 11 ing for program participants and individ- 12 uals; 13 (v) help employers develop the cur- 14 riculum design of a work-based learning 15 program for program participants and in- 16 dividuals; or 17 (vi) help employers employ program 18 participants or individuals engaging in a 19 work-based learning program for a transi- 20 tional period before hiring the program 21 participant or individual for full-time em- 22 ployment of not less than 30 hours a week. 23 (B) 24 SCREENING SERVICES.—Providing screening services, including— TAM18431 S.L.C. 43 1 (i) using an evidence-based screening 2 method to screen each individual seeking 3 participation in the pilot program to deter- 4 mine whether the individual has a sub- 5 stance use disorder; 6 (ii) conducting an assessment of each 7 such individual to determine the services 8 needed for such individual to obtain or re- 9 tain employment, including an assessment 10 of strengths and general work readiness; 11 and 12 (iii) accepting walk-ins or referrals 13 from employers, labor organizations, or 14 other entities recommending individuals to 15 participate in such program. 16 (C) INDIVIDUAL TREATMENT AND EM- 17 PLOYMENT 18 treatment and employment plan for each pro- 19 gram participant, which shall include providing 20 a case manager to work with each participant 21 to— 22 23 PLAN.—Developing an individual (i) identify employment and career goals; 24 (ii) explore career pathways that lead 25 to high-demand industries and sectors as TAM18431 S.L.C. 44 1 determined by the State workforce board 2 and State commissioner of workforce devel- 3 opment; 4 (iii) set appropriate achievement ob- 5 jectives to attain the employment and ca- 6 reer goals identified under clause (i); and 7 (iv) develop the appropriate combina- 8 tion of services to enable the participant to 9 achieve the employment and career goals 10 identified under clause (i). 11 (D) OUTPATIENT TREATMENT AND RECOV- 12 ERY CARE.—In 13 nership serving program participants ødescribed 14 in paragraph (2)(A)(i) with a substance use dis- 15 order¿, providing individualized and group out- 16 patient treatment and recovery services for such 17 program participants that are offered during 18 the day and evening, and on weekends. Such 19 treatment and recovery services shall— 20 the case of a participating part- (i) be based on a model that utilizes 21 combined 22 other evidence-based or evidence-informed 23 interventions; and 24 25 behavioral interventions and (ii) may include additional services such as— TAM18431 S.L.C. 45 1 (I) health, mental health, addic- 2 tion, or other forms of outpatient 3 treatment that may impact opioid use 4 disorder and co-occurring conditions; 5 (II) drug testing for current il- 6 licit drug use prior to enrollment in 7 career or training services or prior to 8 employment; 9 (III) linkages to community serv- 10 ices, including services offered by 11 partner organizations designed to sup- 12 port program participants; and 13 (IV) referrals to health care, in- 14 cluding referrals to substance use dis- 15 order treatment and mental health 16 services. 17 18 (E) SUPPORTIVE SERVICES.—Providing supportive services, which shall include— 19 (i) coordinated wraparound services to 20 provide maximum support for program 21 participants to ensure that the program 22 participants maintain employment and re- 23 covery for at least 12 months; 24 (ii) assistance in establishing eligi- 25 bility for assistance under Federal, State, TAM18431 S.L.C. 46 1 and local programs providing health serv- 2 ices, mental health services, housing serv- 3 ices, transportation services, or social serv- 4 ices; 5 (iii) peer recovery support services; 6 (iv) networking and mentorship op- 7 8 9 10 portunities; and (v) any supportive services determined necessary by the local entity. (F) CAREER AND JOB TRAINING SERV- 11 ICES.—Offering 12 concurrently or sequentially with the services 13 provided under subparagraphs (B) through (E). 14 Such services shall include the following: career and job training services 15 (i) Services provided to program par- 16 ticipants who are in a pre-employment 17 stage of the program. Such services may 18 include— 19 20 (I) initial education and skills assessments; 21 (II) traditional classroom train- 22 ing funded through individual training 23 accounts under chapter 3 of subtitle B 24 of title I of the Workforce Innovation TAM18431 S.L.C. 47 1 and Opportunity Act (29 U.S.C. 3171 2 et seq.); 3 (III) employability skills such as 4 punctuality, 5 skills, and professional conduct; personal maintenance 6 (IV) in-depth interviewing and 7 evaluation to identify employment bar- 8 riers and to develop individual em- 9 ployment plans; 10 11 (V) career planning that includes— 12 (aa) career pathways leading 13 to high-demand, high-wage jobs; 14 and 15 (bb) job coaching, and job job 16 matching, 17 services; 18 (VI) payments and fees for em- 19 ployment and training-related applica- 20 tions, tests, and certifications; or placement 21 (VII) any other appropriate ca- 22 reer or training service described in 23 section 134(c) of the Workforce Inno- 24 vation 25 U.S.C. 3174). and Opportunity Act (29 TAM18431 S.L.C. 48 1 (ii) Services provided to program par- 2 ticipants during their first 6 months of 3 employment to ensure job retention, which 4 may include— 5 (I) case management and support 6 services, including a continuation of 7 the services described in clause (i); 8 (II) a continuation of skills train- 9 ing, and career and technical edu- 10 cation, described in clause (i) that is 11 conducted in collaboration with the 12 employers of such participants; 13 (III) mentorship services and job 14 retention support for such partici- 15 pants; or 16 (IV) targeted training for man- 17 agers and workers working with such 18 participants (such as mentors), and 19 human resource representatives in the 20 business in which such participants 21 are employed. 22 (iii) Services to ensure program par- 23 ticipant maintain employment for at least 24 12 months. TAM18431 S.L.C. 49 1 (G) PROVEN AND PROMISING PRAC- 2 TICES.—Leading 3 identify and promote proven and promising 4 strategies and initiatives for meeting the needs 5 of employers and program participants. 6 (4) LIMITATIONS.—A participating partnership 7 efforts in the service area to may not use— 8 (A) more than 5 percent of the funds re- 9 ceived under a subgrant under subsection (d) 10 for the administrative costs of the partnership; 11 (B) more than 10 percent of the funds re- 12 ceived under such subgrant for the provision of 13 treatment and recovery services, as described in 14 paragraph (3)(D); or 15 (C) more than 10 percent of the funds re- 16 ceived under such subgrant for the provision of 17 supportive services described in paragraph 18 (3)(E) to program participants. 19 (f) PERFORMANCE ACCOUNTABILITY.— 20 (1) REPORTS.—The Secretary shall establish 21 quarterly reporting requirements for recipients of 22 grants and subgrants under this section that, to the 23 extent practicable, are based on the performance ac- 24 countability system under section 116 of the Work- 25 force Innovation and Opportunity Act (29 U.S.C. TAM18431 S.L.C. 50 1 3141), including the indicators described in sub- 2 section (c)(1)(A) of such section and the require- 3 ments for local area performance reports under sub- 4 section (d) of such section. 5 (2) EVALUATIONS.— 6 (A) AUTHORITY TO ENTER INTO AGREE- 7 MENTS.—The 8 independent evaluation is conducted on the pilot 9 program carried out under this section to deter- 10 mine the impact of the program on employment 11 of individuals with substance use disorders. The 12 Secretary shall enter into an agreement with el- 13 igible entities receiving grants under this sec- 14 tion to pay for all or part of such evaluation. 15 Secretary shall ensure that an (B) METHODOLOGIES TO BE USED.—The 16 independent evaluation required under this 17 paragraph shall use experimental designs using 18 random assignment or, when random assign- 19 ment is not feasible, other reliable, evidence- 20 based research methodologies that allow for the 21 strongest possible causal inferences. 22 23 ø(g) FUNDING.—¿ ø(1) USING FUNDING FOR NATIONAL DIS- 24 LOCATED WORKER GRANTS.—Notwithstanding 25 tion 132(a)(2)(A) of the Workforce Innovation and sec- TAM18431 S.L.C. 51 1 Opportunity Act (29 U.S.C. 3172 (a)(2)(A)), the 2 Secretary may use funds available under such sec- 3 tion for national dislocated worker grants under sec- 4 tion 170 of such Act to carry out the pilot program 5 under this section for fiscal years 2018 through 6 2023, subject to paragraph (2).¿ 7 ø(2) LIMITATION.—The Secretary may not use 8 more than $100,000,000 of the funds described in 9 paragraph (1) for any fiscal year of the pilot pro- 10 11 12 gram under this section.¿ SEC. 405. YOUTH PREVENTION AND RECOVERY. (a) SUBSTANCE ABUSE TREATMENT SERVICES 13 CHILDREN, ADOLESCENTS, AND FOR YOUNG ADULTS.—Sec- 14 tion 514 of the Public Health Service Act (42 U.S.C. 15 290bb–7) is amended— 16 (1) in the section heading, by striking ‘‘CHILand inserting ‘‘CHIL- 17 DREN AND ADOLESCENTS’’ 18 DREN, ADOLESCENTS, AND YOUNG ADULTS’’; 19 (2) in subsection (a)(2), by striking ‘‘children, 20 including’’ and inserting ‘‘children, adolescents, and 21 young adults, including’’; and 22 (3) by striking ‘‘children and adolescents’’ each 23 place it appears and inserting ‘‘children, adolescents, 24 and young adults’’. TAM18431 S.L.C. 52 1 2 3 4 5 (b) YOUTH PREVENTION AND RECOVERY INITIA- TIVE.— (1) DEFINITIONS.—In this subsection: (A) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means— 6 (i) a local educational agency that is 7 seeking to establish or expand substance 8 use prevention and recovery support serv- 9 ices at one or more high schools; 10 (ii) an institution of higher education; 11 (iii) a recovery program at an institu- 12 tion of higher education; 13 14 (iv) a local board or one-stop operator; or 15 (v) a nonprofit organization, excluding 16 a school. 17 (B) HIGH SCHOOL.—The term ‘‘high 18 school’’ has the meaning given such term in 19 section 8101 of the Elementary and Secondary 20 Education Act of 1965 (20 U.S.C. 7801). 21 (C) INSTITUTION OF HIGHER EDU- 22 CATION.—The 23 cation’’ has the meaning given such term in 24 section 101 of the Higher Education Act of 25 1965 (20 U.S.C. 1001) and includes a ‘‘post- term ‘‘institution of higher edu- TAM18431 S.L.C. 53 1 secondary vocational institution’’ as defined in 2 section 102(c) of such Act (20 U.S.C. 1002(c)). 3 (D) LOCAL EDUCATION AGENCY.—The 4 term ‘‘local educational agency’’ has the mean- 5 ing given the term in section 8101 of the Ele- 6 mentary and Secondary Education Act of 1965. 7 (E) 8 ATOR.—The 9 operator’’ have the meanings given such terms 10 in section 3 of the Workforce Innovation and 11 Opportunity Act (29 U.S.C. 3102). 12 13 LOCAL BOARD; ONE-STOP OPER- terms ‘‘local board’’ and ‘‘one-stop (F) RECOVERY PROGRAM.—The term ‘‘re- covery program’’ means a program— 14 (i) to help youth or young adults who 15 are recovering from substance use dis- 16 orders to initiate, stabilize, and maintain 17 healthy and productive lives in the commu- 18 nity; and 19 (ii) that includes peer-to-peer support 20 delivered by individuals with lived experi- 21 ence in recovery, and communal activities 22 to build recovery skills and supportive so- 23 cial networks. TAM18431 S.L.C. 54 1 (G) SECRETARY.—The term ‘‘Secretary’’ 2 means the Secretary of Health and Human 3 Services. 4 (2) BEST 5 PRACTICES.—The Secretary, in con- sultation with the Secretary of Education, shall— 6 (A) identify or facilitate the development of 7 evidence-based best practices for prevention of 8 substance misuse and abuse by children, adoles- 9 cents, and young adults, for appropriate recov- 10 ery support services, and for appropriate use of 11 medication-assisted treatment for such individ- 12 uals, if applicable; 13 (B) disseminate such best practices to local 14 educational agencies, institutions of higher edu- 15 cation, recovery programs at institutions of 16 higher education, local boards, one-stop opera- 17 tors, and nonprofit organizations, as appro- 18 priate; 19 (C) conduct a rigorous, independent eval- 20 uation of each grant funded under this sub- 21 section, particularly its impact on the indicators 22 described in paragraph (5)(B); and 23 24 (D) provide technical assistance for grantees under this subsection. TAM18431 S.L.C. 55 1 (3) GRANTS AUTHORIZED.—The Secretary, in 2 consultation with the Secretary of Education, shall 3 award 3-year grants, on a competitive basis, to eligi- 4 ble entities to enable such entities, in coordination 5 with State agencies responsible for carrying out sub- 6 stance use disorder prevention and treatment pro- 7 grams, to carry out evidence-based or promising pro- 8 grams for— 9 (A) prevention of substance abuse and mis- 10 use by children, adolescents, and young adults; 11 (B) recovery support services for children, 12 adolescents, and young adults, which may in- 13 clude counseling, job training, linkages to com- 14 munity-based services, family support groups, 15 and recovery coaching; and 16 (C) treatment or referrals for treatment of 17 substance use disorders, as appropriate. 18 (4) APPLICATION.—To be eligible for a grant 19 under this subsection, an entity shall submit to the 20 Secretary an application at such time, in such man- 21 ner, and containing such information as the Sec- 22 retary may require. Such application shall include— 23 (A) a description of the impact of sub- 24 stance use disorders on students and youth en- 25 rolled in the local educational agency, one-stop TAM18431 S.L.C. 56 1 operator, local board, or institution of higher 2 education; 3 (B) a description of how the eligible entity 4 has solicited input from faculty, teachers, staff, 5 families, students, and experts in substance use 6 prevention and treatment in developing such 7 application; 8 (C) how the eligible entity plans to use 9 grant funds for evidence-based or promising ac- 10 tivities, in accordance with this subsection to 11 prevent, provide recovery support for, and treat 12 substance use disorders amongst such individ- 13 uals; 14 (D) an assurance that the eligible entity 15 will participate in the evaluation described in 16 paragraph (2)(C); and 17 (E) a description of how the eligible entity 18 will collaborate with local service providers, in- 19 cluding substance use disorder treatment pro- 20 grams, providers of mental health services, and 21 primary care providers, in carrying out the 22 grant program. 23 (5) REPORT.—Each eligible entity awarded a 24 grant under this section shall submit to the appro- 25 priate committees of Congress, a report at such time TAM18431 S.L.C. 57 1 and in such manner as the Secretary may require. 2 Such report shall include— 3 (A) a description of how the eligible entity 4 used grant funds, in accordance with this sub- 5 section, including the number of students 6 reached through programming; and 7 8 (B) a description of how the grant program has made an impact on— 9 (i) indicators of student success, in- 10 cluding student well-being and academic 11 achievement; and 12 (ii) substance use disorders amongst 13 students, 14 overdoses and deaths amongst students 15 during the grant period. 16 including (6) AUTHORIZATION OF the number of APPROPRIATIONS.— 17 There is authorized to be appropriated, such sums 18 as may be necessary to carry out this section. 19 20 SEC. 406. PLANS OF SAFE CARE. (a) IN GENERAL.—Title I of the Child Abuse Preven- 21 tion and Treatment Act (42 U.S.C. 5101 et seq.) is 22 amended by inserting after section 107 the following: TAM18431 S.L.C. 58 1 ‘‘SEC. 107A. GRANTS TO STATES TO IMPROVE AND COORDI- 2 NATE THEIR RESPONSE TO ENSURE THE 3 SAFETY, PERMANENCY, AND WELL-BEING OF 4 INFANTS AFFECTED BY SUBSTANCE USE. 5 ‘‘(a) PROGRAM AUTHORIZED.—The Secretary shall 6 make grants to States for the purpose of assisting child 7 welfare agencies, social services agencies, substance use 8 disorder treatment agencies, public health agencies, and 9 maternal and child health agencies to facilitate collabora10 tion in developing, updating, and implementing plans of 11 safe care described in section 106(b)(2)(B)(iii). 12 ‘‘(b) DISTRIBUTION OF FUNDS.— 13 ‘‘(1) RESERVATIONS.—Of the amounts appro- 14 priated under subsection (h), the Secretary shall re- 15 serve— 16 17 ‘‘(A) no more than 3 percent for the purposes described in subsection (g); and 18 ‘‘(B) up to 2 percent for grants to Indian 19 Tribes and tribal organizations for purposes 20 consistent with this section, as the Secretary 21 determines appropriate. 22 ‘‘(2) ALLOTMENTS TO STATES AND TERRI- 23 TORIES.—The 24 propriated under subsection (h) that remains after 25 application of paragraph (1) øon a competitive Secretary shall allot the amount ap- TAM18431 S.L.C. 59 1 basis¿ to øeach State¿/øStates¿ that appløies¿ for 2 such a grant øon a competitive basis¿. 3 ø‘‘(3) RATABLE REDUCTION.—If the amount 4 appropriated under subsection (h) is insufficient to 5 satisfy the requirements of paragraph (2), the Sec- 6 retary shall ratably reduce each allotment to a 7 State.¿ 8 ‘‘(c) APPLICATION.—A State desiring a grant under 9 this section shall submit an application to the Secretary 10 at such time and in such manner as the Secretary may 11 require. Such application shall include— 12 ‘‘(1) a description of— 13 ‘‘(A) the impact of substance use disorder 14 in such State, including with respect to the sub- 15 stance or class of substances with the highest 16 incidence of abuse in the previous year in such 17 State, including— 18 19 ‘‘(i) the prevalence of substance use disorder in such State; 20 ø‘‘(ii) the aggregate rate of births in 21 the State of infants with prenatal sub- 22 stance exposure (as determined by hos- 23 pitals, insurance claims, claims submitted 24 to the State Medicaid program, or other 25 records), if available; and¿ TAM18431 S.L.C. 60 1 ø‘‘(iii) the number of infants identi- 2 fied, for whom a plan of safe care was de- 3 veloped, and for whom a referral was made 4 for appropriate services, as reported under 5 section 106(d)(18);¿ 6 ‘‘(B) the challenges the State faces in de- 7 veloping and implementing plans of safe care in 8 accordance with section 106(b)(2)(B)(iii); 9 ‘‘(C) the State’s lead agency for the grant 10 program and how that agency will coordinate 11 with relevant State entities and programs, in- 12 cluding the child welfare agency, the substance 13 use disorder treatment agency, and the public 14 health agency, programs funded by the Residen- 15 tial Treatment for Pregnant and Postpartum 16 Women grant program of the Substance Abuse 17 and Mental Health Services Administration, the 18 State Medicaid program, the maternal, infant, 19 and early childhood home visiting program 20 under section 511 of the Social Security Act, 21 the State judicial system, and other agencies, as 22 determined by the Secretary; 23 ‘‘(D) how the State will monitor local im- 24 plementation of plans of safe care, in accord- 25 ance with section 106(b)(2)(B)(iii)(II); TAM18431 S.L.C. 61 1 ‘‘(E) how the State meets the requirements 2 of section 1927 of the Public Health Service 3 Act (42 U.S.C. 300x–27); 4 ‘‘(F) how the State plans to utilize funding 5 authorized under part E, of title IV of the So- 6 cial Security Act (42 U.S.C. 670 et seq.) to as- 7 sist in carrying out any plan of safe care, in- 8 cluding such funding authorized under section 9 471(e) of such Act (as in effect on October 1, 10 2018) for mental health and substance abuse 11 prevention and treatment services and in-home 12 parent skill-based programs and funding au- 13 thorized under such section 472(j) (as in effect 14 on October 1, 2018) for children with a parent 15 in a licensed residential family-based treatment 16 facility for substance abuse; and 17 ‘‘(G) an assessment of the treatment and 18 other services and programs available in the 19 State, to effectively carry out any plan of safe 20 care developed, including identification of need- 21 ed treatment, other services and programs to 22 ensure the wellbeing of young children and their 23 families affected by substance used disorder; 24 ‘‘(2) a description of how the State plans to use 25 funds for activities described in subsection (d) for TAM18431 S.L.C. 62 1 the purposes of ensuring State compliance with re- 2 quirements under clauses (ii) and (iii) of section 3 106(b)(2)(B); and 4 ‘‘(3) an assurance that the State will— 5 ‘‘(A) comply with this Act and parts B and 6 E of title IV of the Social Security Act (42 7 U.S.C. 621 et seq., 670 et seq.); and 8 ‘‘(B) comply with requirements to refer a 9 child identified as substance-exposed to early 10 intervention services as required pursuant to a 11 grant under part C of the Individuals with Dis- 12 abilities Education Act (20 U.S.C. 1431 et 13 seq.). 14 ‘‘(d) USES OF FUNDS.—Funds awarded to a State 15 under this section may be used for the following activities, 16 which may be carried out by the State directly, or through 17 grants or subgrants, contracts, or cooperative agreements: 18 ‘‘(1) Improving State and local systems with re- 19 spect to the development and implementation of 20 plans of safe care, which— 21 ‘‘(A) shall include parent and caregiver en- 22 gagement, 23 106(b)(2)(B)(iii)(I), regarding available treat- 24 ment and service options, which may include re- as required under section TAM18431 S.L.C. 63 1 sources available for pregnant, perinatal, and 2 postnatal women; and 3 ‘‘(B) may include activities such as— 4 ‘‘(i) developing policies, procedures, or 5 protocols for the administration of evi- 6 dence-based and validated screening tools 7 for infants who may be affected by sub- 8 stance use withdrawal symptoms or a fetal 9 alcohol spectrum disorder and pregnant, 10 perinatal, and postnatal women whose in- 11 fants may be affected by substance use 12 withdrawal symptoms or a fetal alcohol 13 spectrum disorder; 14 ‘‘(ii) improving assessments used to 15 determine the needs of the infant and fam- 16 ily; 17 18 ‘‘(iii) improving ongoing case management services; and 19 ‘‘(iv) improving access to treatment 20 services, which may be prior to the preg- 21 nant woman’s due date. 22 ‘‘(2) Developing policies, procedures, or proto- 23 cols in consultation and coordination with health 24 professionals, public and private health facilities, TAM18431 S.L.C. 64 1 and substance use disorder treatment agencies to en- 2 sure that— 3 4 ‘‘(A) appropriate notification to child protective services is made in a timely manner; 5 ‘‘(B) a plan of safe care is in place, where 6 needed, before the infant is discharged from the 7 birth or health care facility; and 8 ‘‘(C) such health and related agency pro- 9 fessionals are trained on how to follow such 10 protocols and are aware of the supports that 11 may be provided under a plan of safe care. 12 ‘‘(3) Training health professionals and health 13 system leaders, child welfare workers, substance use 14 disorder treatment agencies, and other related pro- 15 fessionals such as home visiting agency staff and law 16 enforcement in relevant topics including— 17 18 19 20 21 ‘‘(A) State mandatory reporting laws and the referral and notification process; ‘‘(B) the co-occurrence of pregnancy and substance use disorder; ‘‘(C) the clinical guidance about treating 22 substance 23 postpartum women; and use disorder in pregnant and 24 ‘‘(D) appropriate screening and interven- 25 tions for infants affected by substance use dis- TAM18431 S.L.C. 65 1 order, withdrawal symptoms, or a fetal alcohol 2 spectrum disorder and the requirements under 3 section 106(b)(2)(B)(iii). 4 ‘‘(4) Establishing partnerships, agreements, or 5 memoranda of understanding between the lead agen- 6 cy and health professionals, health facilities, child 7 welfare professionals, substance use disorder and 8 mental health disorder treatment programs, and ma- 9 ternal and child health and early intervention profes- 10 sionals, including home visiting providers, peer re- 11 covery specialists, and housing agencies to facilitate 12 the implementation of, and compliance with section 13 106(b)(2) and paragraph (2) of this subsection, in 14 areas which may include— 15 ‘‘(A) developing a comprehensive, multi- 16 disciplinary assessment and intervention process 17 for infants and their families who are affected 18 by substance use disorder, withdrawal symp- 19 toms, or a fetal alcohol spectrum disorder, that 20 takes into account the unique needs of each 21 family and addresses differences between legal, 22 medically supervised substance use, and sub- 23 stance use disorder; 24 ‘‘(B) ensuring that treatment approaches 25 for serving infants, pregnant women, and TAM18431 S.L.C. 66 1 perinatal and postnatal women whose infants 2 may be affected by substance use, withdrawal 3 symptoms, or a fetal alcohol spectrum disorder, 4 are designed to, where appropriate, keep infants 5 with their mothers during both inpatient and 6 outpatient treatment; and 7 ‘‘(C) increasing access to appropriate evi- 8 dence-based medication assisted treatment serv- 9 ices for substance use disorders approved by the 10 Food and Drug Administration and behavioral 11 therapy, as appropriate, and counseling serv- 12 ices. 13 ‘‘(5) Developing and updating systems of tech- 14 nology for improved data collection and monitoring 15 under section 106(b)(2)(B)(iii), including existing 16 electronic medical records, to measure the outcomes 17 achieved through the plans of safe care, including 18 monitoring systems to meet the requirements of this 19 Act and submission of performance measures. 20 ‘‘(e) REPORTING.—Each State that receives funds 21 under this section, for each year such funds are received, 22 shall submit a report to the Secretary, disaggregated by 23 geographic location, economic status, and major racial and 24 ethnic groups øas determined by the State¿, on the fol25 lowing: TAM18431 S.L.C. 67 1 ‘‘(1) The number of the infants identified under 2 section 106(b)(2)(B)(ii) who experienced removal 3 due to parental substance use concerns who are re- 4 unified with parents, and the length of time between 5 such removal and reunification. 6 ‘‘(2) The number of the infants identified under 7 section 106(b)(2)(B)(ii) who experienced substan- 8 tiated reports of child abuse or neglect, received dif- 9 ferential response while in the care of their birth 10 parents or within 1 year after a reunification has oc- 11 curred. 12 ‘‘(3) The number of the infants identified under 13 section 106(b)(2)(B)(ii) who experienced a return to 14 out-of-home care within one year after reunification. 15 ‘‘(f) SECRETARY’S REPORT TO CONGRESS.—The Sec- 16 retary shall submit an annual report to the Committee on 17 Health, Education, Labor, and Pensions and the Com18 mittee on Appropriations of the Senate and the Committee 19 on Education and the Workforce and the Committee on 20 Appropriations of the House of Representatives that in21 cludes the information described in subsection (e) and rec22 ommendations or observations on the challenges, suc23 cesses, and lessons derived from implementation of the 24 grant program. TAM18431 S.L.C. 68 1 ‘‘(g) RESERVATION OF FUNDS.—The Secretary shall 2 use the amount reserved under subsection (b)(1)(A) for 3 the purposes of— 4 ‘‘(1) providing technical assistance, including 5 programs of in-depth technical assistance, to addi- 6 tional States, territories, and Indian tribes in ac- 7 cordance with the substance-exposed infant initiative 8 developed by the National Center on Substance 9 Abuse and Child Welfare; 10 ‘‘(2) issuing guidance on the requirements of 11 this Act with respect to infants born with and identi- 12 fied as being affected by substance abuse or with- 13 drawal symptoms or fetal alcohol spectrum disorder, 14 as described in clauses (ii) and (iii) of section 15 106(b)(2)(B), including by— 16 ‘‘(A) clarifying key terms; and 17 ‘‘(B) disseminating best practices on im- 18 plementation of plans of safe care, on such top- 19 ics as differential response, collaboration and 20 coordination, and identification and delivery of 21 services, for different populations; 22 ‘‘(3) supporting State efforts to develop infor- 23 mation technology systems to manage plans of safe 24 care; and TAM18431 S.L.C. 69 1 ‘‘(4) preparing the Secretary’s report to Con- 2 gress described in subsection (f). 3 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—To 4 carry out the program under this section, there are au5 thorized to be appropriated $60,000,000 for each of fiscal 6 years 2018 through 2024.’’. 7 (b) DEFINITION.—Section 3 of the Child Abuse Pre- 8 vention and Treatment Act (42 U.S.C. 5101 note) is 9 amended— 10 (1) in paragraph (7), by striking ‘‘; and’’ and 11 inserting a semicolon; 12 (2) by redesignating paragraph (8) as para- 13 graph (9); and 14 (3) by inserting after paragraph (7) the fol- 15 lowing: 16 ‘‘(8) the term ‘substance use disorder’ means 17 18 the abuse of alcohol or other drugs; and’’. SEC. 407. REGISTRATION OF COMMUNITY ADDICTION 19 TREATMENT FACILITIES AND COMMUNITY 20 MENTAL HEALTH FACILITIES. 21 (a) DEFINITIONS.—Section 102 of the Controlled 22 Substances Act (21 U.S.C. 802) is amended— 23 24 (1) by striking paragraph (54)(A)(i) and inserting the following: TAM18431 S.L.C. 70 1 ‘‘(i) while the patient is being treated by, 2 and physically located in— 3 ‘‘(I) a hospital or clinic registered 4 under section 303(f); or 5 ‘‘(II) a community addiction treat- 6 ment facility or community mental health 7 facility registered under section 303(l); 8 and’’; and 9 10 (2) by adding at the end the following: ‘‘(57) The term ‘community addiction treatment fa- 11 cility’ means an addiction treatment facility that, for the 12 purpose of operating as an addiction treatment facility, 13 is licensed, operated, authorized, or otherwise recognized 14 by a State government. 15 ‘‘(58) The term ‘community mental health facility’ 16 means a mental health facility that, for the purpose of 17 operating as a mental health facility, is licensed, operated, 18 authorized, or otherwise recognized by a State govern19 ment.’’. 20 (b) REGISTRATION.—Section 303 of the Controlled 21 Substances Act (21 U.S.C. 823) is amended by adding at 22 the end the following: 23 24 ‘‘(l) COMMUNITY ADDICTION TREATMENT FACILITIES AND COMMUNITY MENTAL HEALTH FACILITIES.— TAM18431 S.L.C. 71 1 ‘‘(1) REGISTRATION.—The Attorney General 2 may register community addiction treatment facili- 3 ties and community mental health facilities to ad- 4 minister controlled substances through the practice 5 of telemedicine. 6 ‘‘(2) DENIAL OF APPLICATIONS.—The Attorney 7 General may deny an application for registration 8 under paragraph (1) if the Attorney General deter- 9 mines that the registration would be inconsistent 10 with the public interest after considering— 11 ‘‘(A) any recommendation by the licensing 12 board or professional disciplinary authority of 13 the State in which the applicant is located; 14 15 ‘‘(B) the experience of the applicant in treating patients; 16 ‘‘(C) any conviction of an employee of the 17 applicant under Federal or State law relating to 18 treatment of patients; 19 ‘‘(D) the compliance of the applicant with 20 applicable Federal, State, or local laws relating 21 to treatment of patients; and 22 ‘‘(E) any other conduct by the applicant 23 that may threaten the public’s health and safe- 24 ty.’’. TAM18431 S.L.C. 72 1 (c) IMPLEMENTATION PLAN.—Not later than 6 2 months after the date of enactment of this Act, the Attor3 ney General shall notify Congress of the plan for the De4 partment of Justice to implement the amendments made 5 by this section. 6 (d) EFFECTIVE DATE.—The amendments made by 7 this section shall take effect on the date that is 6 months 8 after the date on which the Attorney General notifies Con9 gress under subsection (c). 10 11 12 SEC. 408. REGULATIONS RELATING TO SPECIAL REGISTRATION FOR TELEMEDICINE. Section 311(h) of the Controlled Substances Act (21 13 U.S.C. 831(h)) is amended by striking paragraph (2) and 14 inserting the following: 15 16 ‘‘(2) REGULATIONS.— ‘‘(A) IN GENERAL.—Not later than 1 year 17 after the date of enactment of the Opioid Crisis 18 Response Act of 2018, in consultation with the 19 Secretary, and in accordance with the procedure 20 described in subparagraph (B), the Attorney 21 General shall promulgate final regulations 22 specifying— 23 ‘‘(i) the limited circumstances in 24 which a special registration under this sub- 25 section may be issued; and TAM18431 S.L.C. 73 1 ‘‘(ii) the procedure for obtaining a 2 special registration under this subsection. 3 ‘‘(B) PROCEDURE.—In promulgating final 4 regulations under subparagraph (A), the Attor- 5 ney General shall— 6 ‘‘(i) issue a notice of proposed rule- 7 making that includes a copy of the pro- 8 posed regulations; 9 ‘‘(ii) provide a period of not less than 10 60 days for comments on the proposed reg- 11 ulations; 12 ‘‘(iii) finalize the proposed regulation 13 not later than 6 months after the close of 14 the comment period; and 15 ‘‘(iv) publish the final regulations not 16 later than 30 days before the effective date 17 of the final regulations.’’. 18 SEC. 409. NATIONAL HEALTH SERVICE CORPS BEHAVIORAL 19 AND MENTAL HEALTH PROFESSIONALS PRO- 20 VIDING OBLIGATED SERVICE IN SCHOOLS 21 AND OTHER COMMUNITY-BASED SETTINGS. 22 Subpart III of part D of title III of the Public Health 23 Service Act (42 U.S.C. 254l et seq.) is amended by adding 24 at the end the following: TAM18431 S.L.C. 74 1 ‘‘SEC. 338N. BEHAVIORAL AND MENTAL HEALTH PROFES- 2 SIONALS PROVIDING OBLIGATED SERVICE IN 3 SCHOOLS AND OTHER COMMUNITY-BASED 4 SETTINGS. 5 ‘‘(a) SCHOOLS AND COMMUNITY-BASED SETTINGS.— 6 An entity to which a Corps member is assigned under sec7 tion 333 may direct such Corps member to provide service 8 as a behavioral and mental health professional at a school 9 øor other community-based setting located in a mental 10 health professional shortage area or a health professional 11 shortage area in a State with an incidence or prevalence 12 of opioid use disorder, or an opioid overdose mortality 13 rate, that is above the national average¿. 14 ‘‘(b) OBLIGATED SERVICE.—Any service described in 15 subsection (a) that a Corps member provides may count 16 towards such Corps member’s completion of any obligated 17 service requirements under the Scholarship Program or 18 the Loan Repayment Program. The Secretary shall not 19 impose any maximum limitation on the number of hours 20 of service described in subsection (a) that a Corps member 21 may count towards completing such obligated service re22 quirements. 23 ‘‘(c) RULE OF CONSTRUCTION.—The authorization 24 under subsection (a) shall be notwithstanding any other 25 provision of this subpart or subpart II.’’. TAM18431 S.L.C. 75 1 SEC. 410. LOAN REPAYMENT FOR SUBSTANCE USE DIS- 2 ORDER TREATMENT PROVIDERS. 3 4 (a) LOAN REPAYMENT MENT FOR SUBSTANCE USE TREAT- PROVIDERS.—The Secretary of Health and Human 5 Services (referred to in this section as the ‘‘Secretary’’) 6 shall enter into contracts under section 338B of the Public 7 Health Service Act (42 U.S.C. 254l-1) with eligible health 8 professionals providing substance use disorder treatment 9 services in substance use disorder treatment facilities, as 10 defined by the Secretary. 11 (b) PROVISION OF SUBSTANCE USE DISORDER 12 TREATMENT.—In carrying out the activities described in 13 subsection (a)— 14 (1) such facilities shall be located in mental 15 health professional shortage areas designated under 16 section 332 of the Public Health Service Act (42 17 U.S.C. 254e); 18 (2) section 331(a)(3)(D) of such Act (42 U.S.C. 19 254d(a)(3)(D)) shall be applied as if the term ‘‘pri- 20 mary health services’’ includes health services re- 21 garding substance use disorder treatment; 22 (3) section 331(a)(3)(E)(i) of such Act (42 23 U.S.C. 254d(a)(3)(E)(i)) shall be applied as if the 24 term ‘‘behavioral and mental health professionals’’ 25 includes masters level, licensed substance use dis- 26 order treatment counselors; and TAM18431 S.L.C. 76 1 2 (4) such professionals and facilities shall provide— 3 (A) counseling by a program counselor or 4 other certified professional who is licensed and 5 qualified by education, training, or experience 6 to assess the psychological and sociological 7 background of patients, to contribute to the ap- 8 propriate treatment plan for the patient, and to 9 monitor progress; and 10 (B) all drugs approved by the Food and 11 Drug Administration to treat substance use dis- 12 orders. 13 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 14 authorized to be appropriated to carry out this section, 15 øsuch sums as may be necessary¿ for each of fiscal years 16 2019 through 2023. 17 18 19 TITLE V—PREVENTION SEC. 501. STUDY ON PRESCRIBING LIMITS. Not later than 2 years after the date of enactment 20 of this Act, the Secretary of Health and Human Services, 21 in consultation with the Attorney General, shall submit to 22 the Committee on Health, Education, Labor, and Pen23 sions of the Senate and the Committee on Energy and 24 Commerce of the House of Representatives a report on 25 the impact of Federal and State laws and regulations that TAM18431 S.L.C. 77 1 limit the length, quantity, or dosage of opioid prescrip2 tions. Such report shall address— 3 4 5 6 7 (1) the impact of such limits on— (A) the incidence and prevalence of overdose related to prescription opioids; (B) the incidence and prevalence of overdose related to illicit opioids; 8 (C) the prevalence of opioid use disorders; 9 (D) medically appropriate use of, and ac- 10 cess to, opioids, including any impact on travel 11 expenses and pain management outcomes for 12 patients, and whether such limits are associated 13 with significantly higher rates of negative 14 health outcomes, including suicide; 15 (2) whether such limits lead to a significant in- 16 crease in burden for prescribers of opioids or pre- 17 scribers of treatments for opioid use disorder, in- 18 cluding any impact on patient access to treatment, 19 and whether such burden is mitigated by any factors 20 such as electronic prescribing; and 21 (3) the impact of such limits on diversion or 22 misuse of any controlled substance in schedule II, 23 III, or IV of section 202(c) of the Controlled Sub- 24 stances Act (21 U.S.C. 812(c)). TAM18431 S.L.C. 78 1 2 3 SEC. 502. PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE. Section 759 of the Public Health Service Act (42 4 U.S.C. 294i) is amended— 5 6 7 (1) in subsection (a), by inserting ‘‘nonprofit’’ after ‘‘private’’; (2) in subsection (b)— 8 (A) in the matter preceding paragraph (1), 9 by striking ‘‘award may be made under sub- 10 section (a) only if the applicant for the award 11 agrees that the program carried out with the 12 award will include’’ and inserting ‘‘entity receiv- 13 ing an award under this section shall develop a 14 comprehensive education and training plan that 15 includes’’; 16 17 18 (B) in paragraph (1)— (i) by inserting ‘‘preventing,’’ after ‘‘diagnosing,’’; and 19 (ii) by inserting ‘‘non-addictive med- 20 ical products and non-pharmacologic treat- 21 ments and’’ after ‘‘including’’; 22 (C) in paragraph (2)— 23 24 (i) by inserting ‘‘Federal, State, and local’’ after ‘‘applicable’’; and TAM18431 S.L.C. 79 1 (ii) by striking ‘‘the degree to which’’ 2 and all that follows through ‘‘effective pain 3 care’’ and inserting ‘‘opioids’’; 4 (D) in paragraph (3), by inserting ‘‘and, 5 as appropriate, non-pharmacotherapy’’ before 6 the semicolon; 7 (E) in paragraph (4)— 8 9 (i) by inserting ‘‘any’’ before ‘‘cultural’’; and 10 (ii) by striking ‘‘; and’’ and inserting 11 ‘‘;’’; 12 (F) in paragraph (5), by striking ‘‘provi- 13 sion of pain care.’’ and inserting ‘‘scientific 14 basis of pain and the provision of pain care, in- 15 cluding through non-addictive medical products 16 and non-pharmacologic treatments; and’’; and 17 (G) by adding at the end the following: 18 ‘‘(6) the dangers of opioid abuse, detection of 19 early warning signs of opioid use disorders, and safe 20 disposal options for prescription medications, includ- 21 ing such options provided by law enforcement, or 22 other innovative deactivation mechanisms.’’; 23 24 (3) in subsection (d), by inserting ‘‘prevention,’’ after ‘‘diagnosis,’’; and TAM18431 S.L.C. 80 1 2 3 4 (4) in subsection (e), by striking ‘‘2010 through 2012’’ and inserting ‘‘2019 through 2023’’. SEC. 503. EDUCATION AND AWARENESS CAMPAIGNS. Section 102 of the Comprehensive Addiction and Re- 5 covery Act of 2016 (Public Law 114–198) is amended— 6 (1) by amending subsection (a) to read as fol- 7 lows: 8 ‘‘(a) IN GENERAL.—The Secretary of Health and 9 Human Services, acting through the Director of the Cen10 ters for Disease Control and Prevention and in coordina11 tion with the heads of other departments and agencies, 12 shall advance education and awareness regarding the risks 13 related to misuse and abuse of opioids, as appropriate, 14 which may include developing or improving existing pro15 grams, conducting activities, and awarding grants that ad16 vance the education and awareness of— 17 18 19 20 21 ‘‘(1) the public, including patients and consumers; ‘‘(2) providers, which may include— ‘‘(A) providing for continuing education on appropriate prescribing practices; 22 ‘‘(B) education related to applicable State 23 or local prescriber limit laws, information on 24 the use of non-addictive or non-opioid alter- TAM18431 S.L.C. 81 1 natives for pain management, and the use of 2 overdose reversal drugs, as appropriate; 3 ‘‘(C) disseminating and improving the use 4 of evidence-based opioid prescribing guidelines 5 across relevant health care settings, as appro- 6 priate, and updating guidelines as necessary; 7 and 8 ‘‘(D) implementing strategies, such as best 9 practices, to encourage and facilitate the use of 10 prescriber guidelines, in accordance with State 11 and local law; and 12 ‘‘(3) other appropriate entities.’’; and 13 (2) in subsection (b)— 14 (A) by striking ‘‘opioid abuse’’ each place 15 such term appears and inserting ‘‘opioid misuse 16 and abuse’’; and 17 (B) in paragraph (2), by striking ‘‘safe dis- 18 posal of prescription medications and other’’ 19 and inserting ‘‘non-addictive or non-opioid 20 treatment options, safe disposal options for pre- 21 scription medications, and other applicable’’. TAM18431 S.L.C. 82 1 SEC. 504. ENHANCED CONTROLLED SUBSTANCE 2 OVERDOSES DATA COLLECTION, ANALYSIS, 3 AND DISSEMINATION. 4 Part J of title III of the Public Health Service Act 5 is amended by inserting after section 392 (42 U.S.C. 6 280b-1) the following: 7 ‘‘SEC. 392A. ENHANCED CONTROLLED SUBSTANCE 8 OVERDOSES DATA COLLECTION, ANALYSIS, 9 AND DISSEMINATION. 10 ‘‘(a) IN GENERAL.—The Director of the Centers for 11 Disease Control and Prevention, using the authority pro12 vided to the Director under section 392, may— 13 ‘‘(1) to the extent practicable, carry out and ex- 14 pand any controlled substance overdose data collec- 15 tion, analysis, and dissemination activity described 16 in subsection (b); 17 ‘‘(2) provide training and technical assistance 18 to States, localities, and Indian tribes for the pur- 19 pose of carrying out any such activity; and 20 ‘‘(3) award grants to States, localities, and In- 21 dian tribes for the purpose of carrying out any such 22 activity. 23 ‘‘(b) CONTROLLED SUBSTANCE OVERDOSE DATA 24 COLLECTION AND ANALYSIS ACTIVITIES.—A controlled 25 substance overdose data collection, analysis, and dissemi- TAM18431 S.L.C. 83 1 nation activity described in this subsection is any of the 2 following activities: 3 ‘‘(1) Improving the timeliness of reporting ag- 4 gregate data to the public, including data on fatal 5 and nonfatal controlled substance overdoses. 6 ‘‘(2) Enhancing the comprehensiveness of con- 7 trolled substance overdose data by collecting infor- 8 mation on such overdoses from appropriate sources 9 such as toxicology reports, death scene investiga- 10 tions, and emergency department services. 11 ‘‘(3) Modernizing the system for coding causes 12 of death related to controlled substance overdoses to 13 use an electronic-based system. 14 ‘‘(4) Using data to help identify risk factors as- 15 sociated with controlled substance overdoses, includ- 16 ing the delivery of certain health care services. 17 ‘‘(5) Supporting entities involved in reporting 18 information on controlled substance overdoses, such 19 as coroners and medical examiners, to improve accu- 20 rate testing and reporting of causes and contributing 21 factors of such overdoses, and analysis of various 22 opioid analogues to controlled substances overdoses. 23 ‘‘(6) Working to enable and encourage the ac- 24 cess, exchange, and use of data regarding controlled TAM18431 S.L.C. 84 1 substances overdoses among data sources and enti- 2 ties. 3 ‘‘(c) CONTROLLED SUBSTANCE DEFINED.—In this 4 section, the term ‘controlled substance’ has the meaning 5 given that term in section 102 of the Controlled Sub6 stances Act.’’. 7 SEC. 505. PREVENTING OVERDOSES OF CONTROLLED SUB- 8 9 STANCES. Part J of title III of the Public Health Service Act 10 (42 U.S.C. 280b et seq.), as amended by section 504, is 11 further amended by inserting after section 392A the fol12 lowing: 13 14 15 16 ‘‘SEC. 392B. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES. ‘‘(a) PREVENTION ACTIVITIES.— ‘‘(1) IN GENERAL.—The Director of the Cen- 17 ters for Disease Control and Prevention (referred to 18 in this section as the ‘Director’), using the authority 19 provided to the Director under section 392, may— 20 ‘‘(A) to the extent practicable, carry out 21 and expand any prevention activity described in 22 paragraph (2); 23 ‘‘(B) provide training and technical assist- 24 ance to States, localities, and Indian tribes to 25 carrying out any such activity; and TAM18431 S.L.C. 85 1 ‘‘(C) award grants to States, localities, and 2 tribes for the purpose of carrying out any such 3 activity. 4 ‘‘(2) PREVENTION ACTIVITIES.—A prevention 5 activity described in this paragraph is an activity to 6 improve the efficiency and use of a new or currently 7 operating prescription drug monitoring program— 8 ‘‘(A) encouraging all authorized users (as 9 specified by the State or other entity) to reg- 10 ister with and use the program; 11 ‘‘(B) enabling such users to access any 12 data updates in as close to real-time as prac- 13 ticable; 14 ‘‘(C) providing for a mechanism for the 15 program to notify authorized users of any po- 16 tential misuse or abuse of controlled substances 17 and any detection of inappropriate prescribing 18 practices relating to such substances; 19 ‘‘(D) encouraging the analysis of prescrip- 20 tion drug monitoring data for purposes of pro- 21 viding reports based on such analysis to State 22 public health agencies and State licensing 23 boards, as allowed under applicable Federal and 24 State law, to prevent inappropriate prescribing, 25 drug diversion, or abuse and misuse of con- TAM18431 S.L.C. 86 1 trolled substances, provided such agencies and 2 boards maintain data use agreements with pro- 3 grams; 4 ‘‘(E) enhancing interoperability between 5 the program and any health information tech- 6 nology (including certified health information 7 technology), including by integrating program 8 data into such technology; 9 ‘‘(F) updating program capabilities to re- 10 spond to technological innovation for purposes 11 of appropriately addressing the occurrence and 12 evolution of controlled substance overdoses; and 13 ‘‘(G) facilitating and encouraging data ex- 14 change between the program and the prescrip- 15 tion drug monitoring programs of other States. 16 ‘‘(b) ADDITIONAL GRANTS.—The Director may 17 award grants to States, localities, and Indian tribes— 18 ‘‘(1) to carry out innovative projects for grant- 19 ees to rapidly respond to controlled substance mis- 20 use, abuse, and overdoses, including changes in pat- 21 terns of controlled substance use; and 22 ‘‘(2) for any other evidence-based activity for 23 preventing controlled substance misuse, abuse, and 24 overdoses as the Director determines appropriate. TAM18431 S.L.C. 87 1 ‘‘(c) RESEARCH.—The Director may conduct studies 2 and evaluations to address substance use disorders, in3 cluding preventing substance use disorders or other re4 lated topics the Director determines appropriate. 5 ‘‘(d) PUBLIC AND PRESCRIBER EDUCATION.—Pursu- 6 ant to section 102 of the Comprehensive Addiction and 7 Recovery Act of 2016, the Director may advance the edu8 cation and awareness of prescribers and the public regard9 ing the risk of abuse of prescription opioids. 10 ‘‘(e) CONTROLLED SUBSTANCE DEFINED.—In this 11 section, the term ‘controlled substance’ has the meaning 12 given that term in section 102 of the Controlled Sub13 stances Act. 14 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For 15 purposes of carrying out this section, section ø392A¿ of 16 this Act, and section 102 of the Comprehensive Addiction 17 and Recovery Act of 2016, there is authorized to be appro18 priated øsuch sums as may be necessary¿ for each of fiscal 19 years 2019 through 2024.’’. 20 SEC. 506. REAUTHORIZATION OF NASPER. 21 øTo be supplied.¿ 22 SEC. 507. JESSIE’S LAW. 23 24 25 (a) BEST PRACTICES.— (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of TAM18431 S.L.C. 88 1 Health and Human Services (referred to in this sec- 2 tion as the ‘‘Secretary’’), in consultation with appro- 3 priate stakeholders, including a patient with a his- 4 tory of opioid use disorder, an expert in electronic 5 health records, an expert in the confidentiality of pa- 6 tient health information and records, and a health 7 care provider, shall identify or facilitate the develop- 8 ment of best practices regarding— 9 (A) the circumstances under which infor- 10 mation that a patient has provided to a health 11 care provider regarding such patient’s history of 12 opioid use disorder should, only at the patient’s 13 request, be prominently displayed in the med- 14 ical records (including electronic health records) 15 of such patient; 16 (B) what constitutes the patient’s request 17 for the purpose described in subparagraph (A); 18 and 19 (C) the process and methods by which the 20 information should be so displayed. 21 (2) DISSEMINATION.—The Secretary shall dis- 22 seminate the best practices developed under para- 23 graph (1) to health care providers and State agen- 24 cies. TAM18431 S.L.C. 89 1 (b) REQUIREMENTS.—In identifying or facilitating 2 the development of best practices under subsection (a), as 3 applicable, the Secretary, in consultation with appropriate 4 stakeholders, shall consider the following: 5 (1) The potential for addiction relapse or over- 6 dose, including overdose death, when opioid medica- 7 tions are prescribed to a patient recovering from 8 opioid use disorder. 9 (2) The benefits of displaying information 10 about a patient’s opioid use disorder history in a 11 manner similar to other potentially lethal medical 12 concerns, including drug allergies and contraindica- 13 tions. 14 (3) The importance of prominently displaying 15 information about a patient’s opioid use disorder 16 when a physician or medical professional is pre- 17 scribing medication, including methods for avoiding 18 alert fatigue in providers. 19 (4) The importance of a variety of appropriate 20 medical professionals, including physicians, nurses, 21 and pharmacists, to have access to information de- 22 scribed in this section when prescribing or dis- 23 pensing opioid medication, consistent with Federal 24 and State laws and regulations. TAM18431 S.L.C. 90 1 (5) The importance of protecting patient pri- 2 vacy, including the requirements related to consent 3 for disclosure of substance use disorder information 4 under all applicable laws and regulations. 5 6 (6) All applicable Federal and State laws and regulations. 7 SEC. 508. DEVELOPMENT AND DISSEMINATION OF MODEL 8 TRAINING PROGRAMS FOR SUBSTANCE USE 9 DISORDER PATIENT RECORDS. 10 (a) INITIAL PROGRAMS AND MATERIALS.—Not later 11 than 1 year after the date of the enactment of this Act, 12 the Secretary of Health and Human Services (referred to 13 in this section as the ‘‘Secretary’’), in consultation with 14 appropriate experts, shall identify the following model pro15 grams and materials (or if no such programs or materials 16 exist, recognize private or public entities to develop and 17 disseminate such programs and materials): 18 (1) Model programs and materials for training 19 health care providers (including physicians, emer- 20 gency medical personnel, psychiatrists, psychologists, 21 counselors, therapists, nurse practitioners, physician 22 assistants, behavioral health facilities and clinics, 23 care managers, and hospitals, including individuals 24 such as general counsels or regulatory compliance 25 staff who are responsible for establishing provider TAM18431 S.L.C. 91 1 privacy policies) concerning the permitted uses and 2 disclosures, consistent with the standards and regu- 3 lations governing the privacy and security of sub- 4 stance use disorder patient records promulgated by 5 the Secretary under section 543 of the Public 6 Health Service Act (42 U.S.C. 290dd-2) for the con- 7 fidentiality of patient records. 8 (2) Model programs and materials for training 9 patients and their families regarding their rights to 10 protect and obtain information under the standards 11 and regulations described in paragraph (1). 12 (b) REQUIREMENTS.—The model programs and ma- 13 terials described in paragraphs (1) and (2) of subsection 14 (a) shall address circumstances under which disclosure of 15 substance use disorder patient records is needed to— 16 (1) facilitate communication between substance 17 use disorder treatment providers and other health 18 care providers to promote and provide the best pos- 19 sible integrated care; 20 (2) avoid inappropriate prescribing that can 21 lead to dangerous drug interactions, overdose, or re- 22 lapse; and 23 (3) notify and involve families and caregivers 24 when individuals experience an overdose. 25 (c) PERIODIC UPDATES.—The Secretary shall— TAM18431 S.L.C. 92 1 (1) periodically review and update the model 2 program and materials identified or developed under 3 subsection (a); and 4 (2) disseminate such updated programs and 5 materials to the individuals described in subsection 6 (a)(1). 7 (d) INPUT OF CERTAIN ENTITIES.—In identifying, 8 reviewing, or updating the model programs and materials 9 under this section, the Secretary shall solicit the input of 10 relevant stakeholders. 11 (e) AUTHORIZATION OF APPROPRIATIONS.—There is 12 authorized to be appropriated to carry out this section, 13 øsuch sums¿ as may be necessary for each of fiscal years 14 2019 through 2023. 15 16 SEC. 509. PRENATAL AND POSTNATAL HEALTH. Section 317L of the Public Health Service Act (42 17 U.S.C. 247b–13) is amended— 18 19 (1) in subsection (a)— (A) by amending paragraph (1) to read as 20 follows: 21 ‘‘(1) to collect, analyze, and make available data 22 on prenatal smoking, alcohol and substance abuse 23 and misuse, including— 24 ‘‘(A) data on— TAM18431 S.L.C. 93 1 2 ‘‘(i) the incidence, prevalence, and implications of such activities; and 3 ‘‘(ii) the incidence and prevalence of 4 implications and outcomes, including neo- 5 natal abstinence syndrome and other out- 6 comes associated with such activities; and 7 ‘‘(B) to inform such analysis, additional in- 8 formation or data on family health history, 9 medication exposures during pregnancy, demo- 10 graphic information, such as race, ethnicity, ge- 11 ographic location, and family history, and other 12 relevant information, as appropriate;’’; 13 (B) in paragraph (2)— 14 (i) by striking ‘‘prevention of’’ and in- 15 serting ‘‘prevention and long-term out- 16 comes associated with’’; and 17 (ii) by striking ‘‘illegal drug use’’ and 18 inserting ‘‘substance abuse and misuse’’; 19 (C) in paragraph (3), by striking ‘‘and ces- 20 sation programs; and’’ and inserting ‘‘, treat- 21 ment, and cessation programs;’’; 22 (D) in paragraph (4), by striking ‘‘illegal 23 drug use.’’ and inserting ‘‘substance abuse and 24 misuse; and’’; and 25 (E) by adding at the end the following: TAM18431 S.L.C. 94 1 ‘‘(5) to issue public reports on the analysis of 2 data described in paragraph (1), including analysis 3 of— 4 ‘‘(A) long-term outcomes of children af- 5 fected by neonatal abstinence syndrome; 6 ‘‘(B) health outcomes associated with pre- 7 natal smoking, alcohol, and substance abuse 8 and misuse; and 9 ‘‘(C) relevant studies, evaluations, or infor- 10 mation the Secretary determines to be appro- 11 priate.’’; 12 (2) in subsection (b), by inserting ‘‘tribal enti- 13 ties,’’ after ‘‘local governments,’’; 14 15 (3) by redesignating subsection (c) as subsection (d); 16 (4) by inserting after subsection (b) the fol- 17 lowing: 18 ‘‘(c) COORDINATING ACTIVITIES.—To carry out this 19 section, the Secretary may— 20 ‘‘(1) provide technical and consultative assist- 21 ance to entities receiving grants under subsection 22 (b); 23 ‘‘(2) ensure a pathway for data sharing between 24 States, tribal entities, and the Centers for Disease 25 Control and Prevention; TAM18431 S.L.C. 95 1 ‘‘(3) ensure data collection under this section is 2 consistent with applicable State, Federal, and Tribal 3 privacy laws; and 4 ‘‘(4) coordinate with the National Coordinator 5 for Health Information Technology, as appropriate, 6 to assist States and tribes in implementing systems 7 that use standards recognized by such National Co- 8 ordinator, as such recognized standards are avail- 9 able, in order to facilitate interoperability between 10 such systems and health information technology sys- 11 tems, including certified health information tech- 12 nology.’’; and 13 (5) in subsection (d), as so redesignated, by 14 striking ‘‘2001 through 2005’’ and inserting ‘‘2019 15 through 2023’’. 16 SEC. 510. SURVEILLANCE AND EDUCATION REGARDING IN- 17 FECTIONS 18 DRUG USE AND OTHER RISK FACTORS. 19 ASSOCIATED WITH INJECTION Section 317N of the Public Health Service Act (42 20 U.S.C. 247b–15) is amended— 21 (1) by amending the section heading to read as AND EDUCATION RE- 22 follows: ‘‘SURVEILLANCE 23 GARDING INFECTIONS ASSOCIATED WITH IN- 24 JECTION DRUG USE AND OTHER RISK FAC- 25 TORS’’; TAM18431 S.L.C. 96 1 2 3 4 (2) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting ‘‘activities’’ before the colon; (B) in paragraph (1)— 5 6 (i) by inserting ‘‘or maintaining’’ after ‘‘implementing’’; 7 (ii) by striking ‘‘hepatitis C virus in- 8 fection (in this section referred to as ‘HCV 9 infection’)’’ and inserting ‘‘infections com- 10 monly associated with injection drug use, 11 including viral hepatitis and human im- 12 munodeficiency virus,’’; and 13 (iii) by striking ‘‘such infection’’ and 14 all that follows through the period at the 15 end and inserting ‘‘such infections, which 16 may include the reporting of cases of such 17 infections.’’; 18 (C) in paragraph (2), by striking ‘‘HCV 19 infection’’ and all that follows through the pe- 20 riod at the end and inserting ‘‘infections as a 21 result of injection drug use, receiving blood 22 transfusions prior to July 1992, or other risk 23 factors.’’; 24 (D) in paragraphs (4) and (5), by striking 25 ‘‘HCV infection’’ each place such term appears TAM18431 S.L.C. 97 1 and inserting ‘‘infections described in para- 2 graph (1)’’; and 3 (E) in paragraph (5), by striking ‘‘pedia- 4 tricians and other primary care physicians, and 5 obstetricians and gynecologists’’ and inserting 6 ‘‘substance use disorder treatment providers, 7 pediatricians, other primary care providers, and 8 obstetrician-gynecologists’’; 9 (3) in subsection (b)— 10 11 (A) by striking ‘‘directly and’’ and inserting ‘‘directly or’’; and 12 (B) by striking ‘‘hepatitis C,’’ and all that 13 follows through the period at the end and in- 14 serting ‘‘infections described in subsection 15 (a)(1).’’; 16 (4) by redesignating subsection (c) as sub- 17 18 section (d); (5) by inserting after subsection (b) the fol- 19 lowing: 20 ‘‘(c) DEFINITION.—In this section, the term ‘injec- 21 tion drug use’ means— 22 ‘‘(1) intravenous administration of a substance 23 in schedule I of section 202(c) of the Controlled 24 Substances Act; TAM18431 S.L.C. 98 1 ‘‘(2) intravenous administration of a substance 2 in schedule II, III, IV, or V of section 202(c) of the 3 Controlled Substances Act that has not been ap- 4 proved for intravenous use under section 505 of the 5 Federal Food, Drug and Cosmetic Act or section 6 351 of the Public Health Service Act; or 7 ‘‘(3) intravenous administration of a substance 8 in schedule II, III, IV, or V of section 202(c) of the 9 Controlled Substances Act that has not been pre- 10 scribed to the person using the substance.’’; and 11 (6) in subsection (d), as so redesignated, by 12 striking ‘‘such sums as may be necessary for each of 13 the fiscal years 2001 through 2005’’ and inserting 14 ‘‘$40,000,000 for each of fiscal years 2019 through 15 2023’’. 16 SEC. 511. TASK FORCE TO DEVELOP BEST PRACTICES FOR 17 TRAUMA-INFORMED 18 FERRAL, AND SUPPORT. 19 IDENTIFICATION, RE- (a) ESTABLISHMENT.—There is established a task 20 force, to be known as the Interagency Task Force on 21 Trauma-Informed Care (in this section referred to as the 22 ‘‘task force’’) that shall identify, evaluate, and make rec23 ommendations regarding best practices with respect to 24 children and youth, and their families as appropriate, who 25 have experienced or are at risk of experiencing trauma. TAM18431 S.L.C. 99 1 (b) MEMBERSHIP.— 2 ø(1) COMPOSITION.—The task force shall be 3 composed of the heads of the following Federal de- 4 partments and agencies, or their designees:¿ 5 6 7 8 9 10 11 12 ø(A) The Centers for Medicare & Medicaid Services.¿ ø(B) The Substance Abuse and Mental Health Services Administration.¿ ø(C) The Agency for Healthcare Research and Quality.¿ ø(D) The Centers for Disease Control and Prevention.¿ 13 ø(E) The Indian Health Service.¿ 14 ø(F) The Department of Veterans Af- 15 fairs.¿ 16 ø(G) The National Institutes of Health.¿ 17 ø(H) The Food and Drug Administra- 18 19 20 tion.¿ ø(I) The Health Resources and Services Administration.¿ 21 ø(J) The Department of Defense.¿ 22 ø(K) The Office of Minority Health.¿ 23 ø(L) The Administration for Children and 24 Families.¿ TAM18431 S.L.C. 100 1 2 3 4 ø(M) The Office of the Assistant Secretary for Planning and Evaluation.¿ ø(N) The Office for Civil Rights at the Department of Health and Human Services.¿ 5 ø(O) The Office of Juvenile Justice and 6 Delinquency Prevention of the Department of 7 Justice.¿ 8 ø(P) The Office of Community Oriented 9 Policing Services of the Department of Jus- 10 11 12 tice.¿ ø(Q) The Office on Violence Against Women of the Department of Justice.¿ 13 ø(R) The National Center for Education 14 Evaluation and Regional Assistance of the De- 15 partment of Education.¿ 16 ø(S) The National Center for Special Edu- 17 cation Research of the Institute of Education 18 Science.¿ 19 ø(T) The Office of Elementary and Sec- 20 ondary Education of the Department of Edu- 21 cation.¿ 22 23 ø(U) The Office for Civil Rights at the Department of Education.¿ TAM18431 S.L.C. 101 1 ø(V) The Office of Special Education and 2 the Rehabilitative Services of the Department 3 of Education.¿ ø(W) the Bureau of Indian Affairs of the 4 5 Department of the Interior.¿ ø(X) The Veterans Health Administration 6 7 of the Department of Veterans Affairs.¿ 8 ø(Y) The Office of Special Needs Assist- 9 ance Programs of the Department of Housing 10 and Urban Development.¿ ø(Z) Such other Federal agencies as the 11 12 Secretaries determine to be appropriate.¿ 13 (2) DATE OF APPOINTMENTS.—The heads of 14 Federal departments and agencies shall appoint the 15 corresponding members of the task force not later 16 than 6 months after the date of enactment of this 17 Act. 18 (3) CHAIRPERSON.—The task force shall be 19 chaired by the Assistant Secretary for Mental 20 Health and Substance Use. 21 (c) TASK FORCE DUTIES.—The task force shall iden- 22 tify, evaluate, make recommendations, and update such 23 recommendations not less than annually, to the general 24 public, the Secretary of Education, the Secretary of 25 Health and Human Services, the Secretary of Labor, the TAM18431 S.L.C. 102 1 Secretary of the Interior, the Attorney General, and other 2 relevant cabinet Secretaries, and Congress regarding— 3 4 (1) a set of evidence-based, evidence-informed, and promising best practices with respect to— 5 (A) the identification of infants, children 6 and youth, and their families as appropriate, 7 who have experienced or are at risk of experi- 8 encing trauma; and 9 (B) the expeditious referral to and imple- 10 mentation of trauma-informed practices and 11 supports that prevent and mitigate the effects 12 of trauma; 13 (2) a national strategy on how the task force 14 and member agencies will collaborate, prioritize op- 15 tions for, and implement a coordinated approach 16 which may include data sharing and the awarding of 17 grants that support children and their families as 18 appropriate, who have experienced or are at risk of 19 experiencing trauma; and 20 (3) existing Federal authorities at the Depart- 21 ment of Education, Department of Health and 22 Human Services, Department of Justice, Depart- 23 ment of Labor, Department of Interior, and other 24 relevant agencies authorized under existing Federal 25 law and specific Federal grant programs to dissemi- TAM18431 S.L.C. 103 1 nate best practices on, provide training in, or deliver 2 services through, trauma-informed practices, and 3 disseminate such information— 4 (A) in writing to relevant program offices 5 at such agencies to encourage grant applicants 6 in writing to use such funds, where appropriate, 7 for trauma-informed practices; and 8 9 10 (B) to the general public through the internet website of the task force. (d) BEST PRACTICES.—In identifying, evaluating, 11 and recommending the set of best practices under sub12 section (c), the task force shall— 13 (1) include guidelines for providing professional 14 development for front-line services providers, includ- 15 ing school personnel, providers from child- or youth- 16 serving organizations, primary and behavioral health 17 care providers, child welfare and social services pro- 18 viders, family and juvenile court judges and attor- 19 neys, health care providers, individuals who are 20 mandatory reporters of child abuse or neglect, 21 trained nonclinical providers (including peer mentors 22 and clergy), and first responders, in— 23 (A) understanding and identifying early 24 signs and risk factors of trauma in children and TAM18431 S.L.C. 104 1 youth, and their families as appropriate, includ- 2 ing through screening processes; 3 (B) providing practices to prevent and 4 mitigate the impact of trauma, including by fos- 5 tering safe and stable environments and rela- 6 tionships; and 7 8 (C) developing and implementing procedures or systems that— 9 (i) are designed to quickly refer in- 10 fants, children, youth, and their families as 11 appropriate, who have experienced or are 12 at risk of experiencing trauma to the ap- 13 propriate trauma-informed screening and 14 support, including treatment appropriate 15 to the age of the child, and ensure the in- 16 fants, children, youth, and appropriate 17 family members receive, the appropriate 18 trauma-informed screening and support, 19 including treatment appropriate to the age 20 of the child; and 21 (ii) utilize and develop partnerships 22 with local social services organizations and 23 clinical mental health or health care service 24 providers with expertise in providing sup- 25 port services (including trauma-informed TAM18431 S.L.C. 105 1 and evidence-based treatment appropriate 2 to the age of the child) aimed at pre- 3 venting or mitigating the effects of trauma 4 (iii) educate children and youth to— 5 (I) understand and identify the 6 signs, effects, or symptoms of trauma; 7 and 8 (II) build the resilience and cop- 9 ing skills to mitigate the effects of ex- 10 periencing trauma; 11 (iv) promote and support multi- 12 generational practices that assist parents, 13 foster parents, and caregivers in accessing 14 resources related to, and developing envi- 15 ronments conducive to, the prevention and 16 mitigation of trauma; and 17 (v) collect and utilize data from 18 screenings, referrals, or the provision of 19 services and supports, conducted in the 20 covered settings, to evaluate and improve 21 processes for trauma-informed support and 22 outcomes that are culturally sensitive, lin- 23 guistically appropriate, and specific to age 24 ranges and sex, as applicable; and TAM18431 S.L.C. 106 1 (2) recommend best practices that are designed 2 to avoid unwarranted custody loss or criminal pen- 3 alties for parents or guardians in connection with in- 4 fants, children, and youth who have experienced or 5 are at risk of experiencing trauma. 6 (e) OPERATING PLAN.—Not later than 1 year after 7 the date of enactment of this Act, the task force shall hold 8 the first meeting. Not later than 2 years after such date 9 of enactment, the task force shall submit to the Secretary 10 of Education, Secretary of Health and Human Services, 11 Secretary of Labor, Secretary of the Interior, the Attorney 12 General, and Congress an operating plan for carrying out 13 the activities of the task force described in subsection 14 (c)(2) and (3). Such operating plan shall include— 15 (1) a list of specific activities that the task 16 force plans to carry out for purposes of carrying out 17 duties described in subsection (c)(2), which may in- 18 clude public engagement; 19 20 (2) a plan for carrying out the activities under subsection (c)(2) and (3); 21 (3) a list of members of the task force and 22 other individuals who are not members of the task 23 force that may be consulted to carry out such activi- 24 ties; TAM18431 S.L.C. 107 1 (4) an explanation of Federal agency involve- 2 ment and coordination needed to carry out such ac- 3 tivities, including any statutory or regulatory bar- 4 riers to such coordination; 5 6 7 (5) a budget for carrying out such activities; and (6) other information that the task force deter- 8 mines appropriate. 9 (f) FINAL REPORT.—Not later than 3 years after the 10 date of the first meeting of the task force, the task force 11 shall submit to the general public, Secretary of Education, 12 Secretary of Health and Human Services, Secretary of 13 Labor, Secretary of the Interior, the Attorney General, 14 and other relevant cabinet Secretaries, and Congress, a 15 final report containing all of the findings and rec16 ommendations required under this section. 17 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 18 out this section, there are authorized to be appropriated 19 such sums as may be necessary for each of fiscal years 20 2019 through 2022. 21 (h) SUNSET.—The task force shall on the date that 22 is 60 days after the submission of the final report under 23 subsection (g), but not later than September 30, 2022. TAM18431 S.L.C. 108 1 SEC. 512. GRANTS TO IMPROVE TRAUMA SUPPORT SERV- 2 ICES AND MENTAL HEALTH CARE FOR CHIL- 3 DREN AND YOUTH IN EDUCATIONAL SET- 4 TINGS. 5 (a) GRANTS, CONTRACTS, AND COOPERATIVE 6 AGREEMENTS AUTHORIZED.—The Secretary, in coordina7 tion with the Director of Substance Abuse and Mental 8 Health Services Administration, is authorized to award 9 grants to, or enter into contracts or cooperative agree10 ments with, State educational agencies, local educational 11 agencies, Indian tribes or their tribal educational agencies, 12 a school operated by the Bureau of Indian Education, or 13 a Regional Corporation (as defined in section 3 of the 14 Alaska Native Claims Settlement Act (43 U.S.C. 1602)) 15 for the purpose of increasing student access to evidence16 based or promising trauma support services and mental 17 health care by developing innovative programs to link local 18 school systems with local trauma-informed support and 19 mental health systems, including those under the Indian 20 Health Service. 21 (b) DURATION.—With respect to a grant, contract, 22 or cooperative agreement awarded or entered into under 23 this section, the period during which payments under such 24 grant, contract or agreement are made to the recipient 25 ømay not exceed 5 years¿. TAM18431 S.L.C. 109 1 (c) USE OF FUNDS.—An entity that receives a grant, 2 contract, or cooperative agreement under this section shall 3 use amounts made available through such grant, contract, 4 or cooperative agreement for øevidence-based or prom5 ising¿ activities, which shall include any of the following: 6 (1) Collaborative efforts between school-based 7 service systems and trauma-informed support and 8 mental health service systems to provide, develop, or 9 improve prevention, screening, referral, and treat- 10 ment services to students, such as by providing uni- 11 versal trauma screenings to identify students in need 12 of specialized support. 13 (2) To implement multi-tiered positive behav- 14 ioral interventions and supports, or other trauma-in- 15 formed models of support. 16 (3) To provide professional development to 17 teachers, teacher assistants, school leaders, special- 18 ized instructional support personnel, and mental 19 health professionals that— 20 (A) fosters safe and stable learning envi- 21 ronments that prevent and mitigate the effects 22 of trauma, including through social and emo- 23 tional learning; or 24 (B) improves school capacity to, as appro- 25 priate, identify, refer, and provide services to TAM18431 S.L.C. 110 1 students in need of trauma support or behav- 2 ioral health services. 3 (4) To provide technical assistance to school 4 systems and mental health agencies. 5 (5) To evaluate the effectiveness of the program 6 carried out under this section in increasing student 7 access to evidence-based and promising trauma sup- 8 port services and mental health care, and make rec- 9 ommendations to the Secretary about the sustain- 10 ability of the program. 11 (6) To provide professional development and 12 implement procedures pursuant to the relevant best 13 practices developed and recommended by the task 14 force described in section øllll¿. 15 (d) APPLICATIONS.—To be eligible to receive a grant, 16 contract, or cooperative agreement under this section, an 17 entity described in subsection (a) shall submit an applica18 tion to the Secretary at such time, in such manner, and 19 containing such information as the Secretary may reason20 ably require, such as the following: 21 (1) A description of the program to be funded 22 under the grant, contract, or cooperative agreement, 23 including how such program will increase access to 24 evidence-based or promising trauma support services 25 and mental health care for students. TAM18431 S.L.C. 111 1 (2) A description of how the program will pro- 2 vide linguistically appropriate and culturally com- 3 petent services. 4 (3) A description of how the program will sup- 5 port students and the school in improving the school 6 climate in order to support an environment condu- 7 cive to learning. 8 (4) An assurance that— 9 (A) persons providing services under the 10 grant, contract, or cooperative agreement are 11 adequately trained to provide such services; and 12 (B) teachers, school leaders, administra- 13 tors, specialized instructional support personnel, 14 representatives of local Indian tribes as appro- 15 priate, other school personnel, and parents or 16 guardians of students participating in services 17 under this section will be engaged and involved 18 in the design and implementation of the serv- 19 ices. 20 (5) A description of how the applicant will sup- 21 port and integrate existing school-based services 22 with the program in order to provide mental health 23 services for students, as appropriate. 24 (e) INTERAGENCY AGREEMENTS.— TAM18431 S.L.C. 112 1 (1) DESIGNATION OF LEAD AGENCY.—A recipi- 2 ent of a grant, contract, or cooperative agreement 3 under this section shall designate a lead agency to 4 direct the establishment of an interagency agreement 5 among local educational agencies, juvenile justice au- 6 thorities, mental health agencies, child welfare agen- 7 cies, and other relevant entities in the State, in col- 8 laboration with local entities, such as Indian tribes. 9 (2) CONTENTS.—The interagency agreement 10 shall ensure the provision of the services described 11 in subsection (c), specifying with respect to each 12 agency, authority, or entity— 13 14 (A) the financial responsibility for the services; 15 (B) the conditions and terms of responsi- 16 bility for the services, including quality, ac- 17 countability, and coordination of the services; 18 and 19 (C) the conditions and terms of reimburse- 20 ment among the agencies, authorities, or enti- 21 ties that are parties to the interagency agree- 22 ment, including procedures for dispute resolu- 23 tion. TAM18431 S.L.C. 113 1 (f) EVALUATION.—The Secretary shall reserve not to 2 exceed 3 percent of the funds made available under sub3 section (l) for each fiscal year to— 4 5 (1) conduct a rigorous, independent evaluation of the activities funded under this section; and 6 (2) disseminate and promote the utilization of 7 evidence-based or promising practices regarding 8 trauma support services and mental health care. 9 (g) DISTRIBUTION OF AWARDS.—The Secretary may 10 ensure that grants, contracts, and cooperative agreements 11 awarded or entered into under this section are equitably 12 distributed among the geographical regions of the United 13 States and among tribal, urban, suburban, and rural pop14 ulations. 15 (h) RULE OF CONSTRUCTION.—Nothing in this sec- 16 tion shall be construed— 17 (1) to prohibit an entity involved with a pro- 18 gram carried out under this section from reporting 19 a crime that is committed by a student to appro- 20 priate authorities; or 21 (2) to prevent State and tribal law enforcement 22 and judicial authorities from exercising their respon- 23 sibilities with regard to the application of Federal, 24 tribal, and State law to crimes committed by a stu- 25 dent. TAM18431 S.L.C. 114 1 (i) SUPPLEMENT, NOT SUPPLANT.—Any services 2 provided through programs carried out under this section 3 shall supplement, and not supplant, existing mental health 4 services, including any special education and related serv5 ices provided under the Individuals with Disabilities Edu6 cation Act. 7 (j) CONSULTATION WITH INDIAN TRIBES.—In car- 8 rying out subsection (a), the Secretary shall, in a timely 9 manner, meaningfully consult, engage, and cooperate with 10 Indian tribes and their representatives to ensure notice of 11 eligibility. 12 13 (k) DEFINITIONS.—In this section: (1) ELEMENTARY OR SECONDARY SCHOOL.— 14 The term ‘‘elementary or secondary school’’ means a 15 public elementary and secondary school as such term 16 is defined in section 8101 of the Elementary and 17 Secondary Education Act of 1965 (20 U.S.C. 7801). 18 ø(2) EVIDENCE-BASED.—The term‘‘ evidence- 19 based’’, when used with respect to a program or 20 practice, means a program or practice that—¿ 21 22 23 24 ø(A) is demonstrated to be effective when implemented with fidelity;¿ ø(B) is based on a clearly articulated and empirically supported theory;¿ TAM18431 S.L.C. 115 1 ø(C) has measurable outcomes relevant to 2 substance use disorder prevention, treatment, 3 and recovery, including a detailed description of 4 the outcomes produced in a particular popu- 5 lation;¿ 6 ø(D) has been scientifically tested and 7 proven effective through randomized control 8 studies or comparison group studies; and¿ 9 ø(E) has the ability to replicate and 10 scale.¿ 11 ø(3) PROMISING.—The term ‘‘promising’’, when 12 used with respect to a program or practice, means 13 a program or practice that—¿ 14 ø(A) is demonstrated to be effective based 15 on positive outcomes relevant to one or more 16 objective, independent, and scientifically valid 17 evaluations, as documented in writing to the 18 Secretary involved; and¿ 19 ø(B) will be evaluated through a well-de- 20 signed and rigorous study, as described in sub- 21 section ø(ll)¿.¿ 22 (4) SCHOOL LEADER.—The term ‘‘school lead- 23 er’’ has the same meaning given such term in sec- 24 tion 8101 of the Elementary and Secondary Edu- 25 cation Act of 1965 (20 U.S.C. 7801). TAM18431 S.L.C. 116 1 (5) SECRETARY.—The term ‘‘Secretary’’ mens 2 the Secretary of Education. 3 ø(l) AUTHORIZATION OF APPROPRIATIONS.—There 4 is authorized to be appropriated to carry out this section, 5 such sums as may be necessary for each of fiscal years 6 2019 through 2023.¿