In the Senate of the United States, 
September 17, 2018. 
Resolved, That the bill from the House of Representa-
tives (H.R. 6) entitled ‘‘An Act to provide for opioid use dis-
order prevention, recovery, and treatment, and for other pur-
poses.’’, do pass with the following 
AMENDMENT: 
Strike all after the enacting clause and insert the 
following: 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Opioid Crisis Response Act of 2018’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—OPIOID CRISIS RESPONSE ACT 
Sec. 1001. Definitions. 
Subtitle A—Reauthorization of Cures Funding 
Sec. 1101. State response to the opioid abuse crisis. 
Subtitle B—Research and Innovation 
Sec. 1201. Advancing cutting-edge research.
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Sec. 1202. Pain research. 
Sec. 1203. Report on synthetic drug use. 
Subtitle C—Medical Products and Controlled Substances Safety 
Sec. 1301. Clarifying FDA regulation of non-addictive pain products. 
Sec. 1302. Clarifying FDA packaging authorities. 
Sec. 1303. Strengthening FDA and CBP coordination and capacity. 
Sec. 1304. Clarifying FDA post-market authorities. 
Sec. 1305. Restricting entrance of illicit drugs. 
Sec. 1306. First responder training. 
Sec. 1307. Disposal of controlled substances of hospice patients. 
Sec. 1308. GAO study and report on hospice safe drug management. 
Sec. 1309. Delivery of a controlled substance by a pharmacy to be administered 
by injection or implantation. 
Subtitle D—Treatment and Recovery 
Sec. 1401. Comprehensive opioid recovery centers. 
Sec. 1402. Program to support coordination and continuation of care for drug 
overdose patients. 
Sec. 1403. Alternatives to opioids. 
Sec. 1404. Building communities of recovery. 
Sec. 1405. Peer support technical assistance center. 
Sec. 1406. Medication-assisted treatment for recovery from addiction. 
Sec. 1407. Grant program. 
Sec. 1408. Allowing for more flexibility with respect to medication-assisted treat-
ment for opioid use disorders. 
Sec. 1409. National recovery housing best practices. 
Sec. 1410. Addressing economic and workforce impacts of the opioid crisis. 
Sec. 1411. Career Act. 
Sec. 1412. Pilot program to help individuals in recovery from a substance use 
disorder become stably housed. 
Sec. 1413. Youth prevention and recovery. 
Sec. 1414. Plans of safe care. 
Sec. 1415. Regulations relating to special registration for telemedicine. 
Sec. 1416. National Health Service Corps behavioral and mental health profes-
sionals providing obligated service in schools and other commu-
nity-based settings. 
Sec. 1417. Loan repayment for substance use disorder treatment providers. 
Sec. 1418. Protecting moms and infants. 
Sec. 1419. Early interventions for pregnant women and infants. 
Sec. 1420. Report on investigations regarding parity in mental health and sub-
stance use disorder benefits. 
Subtitle E—Prevention 
Sec. 1501. Study on prescribing limits. 
Sec. 1502. Programs for health care workforce. 
Sec. 1503. Education and awareness campaigns. 
Sec. 1504. Enhanced controlled substance overdoses data collection, analysis, and 
dissemination. 
Sec. 1505. Preventing overdoses of controlled substances. 
Sec. 1506. CDC surveillance and data collection for child, youth, and adult trau-
ma. 
Sec. 1507. Reauthorization of NASPER.
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Sec. 1508. Jessie’s law. 
Sec. 1509. Development and dissemination of model training programs for sub-
stance use disorder patient records. 
Sec. 1510. Communication with families during emergencies. 
Sec. 1511. Prenatal and postnatal health. 
Sec. 1512. Surveillance and education regarding infections associated with illicit 
drug use and other risk factors. 
Sec. 1513. Task force to develop best practices for trauma-informed identification, 
referral, and support. 
Sec. 1514. Grants to improve trauma support services and mental health care for 
children and youth in educational settings. 
Sec. 1515. National Child Traumatic Stress Initiative. 
Sec. 1516. National milestones to measure success in curtailing the opioid crisis. 
TITLE II—FINANCE 
Sec. 2001. Short title. 
Subtitle A—Medicare 
Sec. 2101. Medicare opioid safety education. 
Sec. 2102. Expanding the use of telehealth services for the treatment of opioid use 
disorder and other substance use disorders. 
Sec. 2103. Comprehensive screenings for seniors. 
Sec. 2104. Every prescription conveyed securely. 
Sec. 2105. Standardizing electronic prior authorization for safe prescribing. 
Sec. 2106. Strengthening partnerships to prevent opioid abuse. 
Sec. 2107. Commit to opioid medical prescriber accountability and safety for sen-
iors. 
Sec. 2108. Fighting the opioid epidemic with sunshine. 
Sec. 2109. Demonstration testing coverage of certain services furnished by opioid 
treatment programs. 
Sec. 2110. Encouraging appropriate prescribing under Medicare for victims of 
opioid overdose. 
Sec. 2111. Automatic escalation to external review under a Medicare part D drug 
management program for at-risk beneficiaries. 
Sec. 2112. Testing of incentive payments for behavioral health providers for adop-
tion and use of certified electronic health record technology. 
Sec. 2113. Medicare Improvement Fund. 
Subtitle B—Medicaid 
Sec. 2201. Caring recovery for infants and babies. 
Sec. 2202. Peer support enhancement and evaluation review. 
Sec. 2203. Medicaid substance use disorder treatment via telehealth. 
Sec. 2204. Enhancing patient access to non-opioid treatment options. 
Sec. 2205. Assessing barriers to opioid use disorder treatment. 
Sec. 2206. Help for moms and babies. 
Sec. 2207. Securing flexibility to treat substance use disorders. 
Sec. 2208. MACPAC study and report on MAT utilization controls under State 
Medicaid programs. 
Sec. 2209. Opioid addiction treatment programs enhancement. 
Sec. 2210. Better data sharing to combat the opioid crisis. 
Sec. 2211. Mandatory reporting with respect to adult behavioral health measures.
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Sec. 2212. Report on innovative State initiatives and strategies to provide hous-
ing-related services and supports to individuals struggling with 
substance use disorders under Medicaid. 
Sec. 2213. Technical assistance and support for innovative State strategies to 
provide housing-related supports under Medicaid. 
Subtitle C—Human Services 
Sec. 2301. Supporting family-focused residential treatment. 
Sec. 2302. Improving recovery and reunifying families. 
Sec. 2303. Building capacity for family-focused residential treatment. 
Subtitle D—Synthetics Trafficking and Overdose Prevention 
Sec. 2401. Short title. 
Sec. 2402. Customs fees. 
Sec. 2403. Mandatory advance electronic information for postal shipments. 
Sec. 2404. International postal agreements. 
Sec. 2405. Cost recoupment. 
Sec. 2406. Development of technology to detect illicit narcotics. 
Sec. 2407. Civil penalties for postal shipments. 
Sec. 2408. Report on violations of arrival, reporting, entry, and clearance re-
quirements and falsity or lack of manifest. 
Sec. 2409. Effective date; regulations. 
TITLE III—JUDICIARY 
Subtitle A—Access to Increased Drug Disposal 
Sec. 3101. Short title. 
Sec. 3102. Definitions. 
Sec. 3103. Authority to make grants. 
Sec. 3104. Application. 
Sec. 3105. Use of grant funds. 
Sec. 3106. Eligibility for grant. 
Sec. 3107. Duration of grants. 
Sec. 3108. Accountability and oversight. 
Sec. 3109. Duration of program. 
Sec. 3110. Authorization of appropriations. 
Subtitle B—Using Data To Prevent Opioid Diversion 
Sec. 3201. Short title. 
Sec. 3202. Purpose. 
Sec. 3203. Amendments. 
Sec. 3204. Report. 
Subtitle C—Substance Abuse Prevention 
Sec. 3301. Short title. 
Sec. 3302. Reauthorization of the Office of National Drug Control Policy. 
Sec. 3303. Reauthorization of the Drug-Free Communities Program. 
Sec. 3304. Reauthorization of the National Community Anti-Drug Coalition In-
stitute. 
Sec. 3305. Reauthorization of the High-Intensity Drug Trafficking Area Pro-
gram. 
Sec. 3306. Reauthorization of drug court program. 
Sec. 3307. Drug court training and technical assistance.
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Sec. 3308. Drug overdose response strategy. 
Sec. 3309. Protecting law enforcement officers from accidental exposure. 
Sec. 3310. COPS Anti-Meth Program. 
Sec. 3311. COPS anti-heroin task force program. 
Sec. 3312. Comprehensive Addiction and Recovery Act education and awareness. 
Sec. 3313. Protecting children with addicted parents. 
Sec. 3314. Reimbursement of substance use disorder treatment professionals. 
Sec. 3315. Sobriety Treatment and Recovery Teams (START). 
Sec. 3316. Provider education. 
Sec. 3317. Demand reduction. 
Sec. 3318. Anti-drug media campaign. 
Sec. 3319. Technical corrections to the office of national drug control policy reau-
thorization act of 1998. 
Subtitle D—Synthetic Abuse and Labeling of Toxic Substances 
Sec. 3401. Short title. 
Sec. 3402. Controlled substance analogues. 
Subtitle E—Opioid Quota Reform 
Sec. 3501. Short title. 
Sec. 3502. Strengthening considerations for DEA opioid quotas. 
Subtitle F—Preventing Drug Diversion 
Sec. 3601. Short title. 
Sec. 3602. Improvements to prevent drug diversion. 
Subtitle G—Sense of Congress 
Sec. 3701. Sense of Congress. 
TITLE IV—COMMERCE 
Subtitle A—Fighting Opioid Abuse in Transportation 
Sec. 4101. Short title. 
Sec. 4102. Rail mechanical employee controlled substances and alcohol testing. 
Sec. 4103. Rail yardmaster controlled substances and alcohol testing. 
Sec. 4104. Department of Transportation public drug and alcohol testing data-
base. 
Sec. 4105. GAO report on Department of Transportation’s collection and use of 
drug and alcohol testing data. 
Sec. 4106. Transportation Workplace Drug and Alcohol Testing Program; addi-
tion of fentanyl. 
Sec. 4107. Status reports on hair testing guidelines. 
Sec. 4108. Mandatory Guidelines for Federal Workplace Drug Testing Programs 
Using Oral Fluid. 
Sec. 4109. Electronic recordkeeping. 
Sec. 4110. Status reports on Commercial Driver’s License Drug and Alcohol 
Clearinghouse. 
Subtitle B—Opioid Addiction Recovery Fraud Prevention 
Sec. 4201. Short title. 
Sec. 4202. Definitions.
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Sec. 4203. False or misleading representations with respect to opioid treatment 
programs and products. 
TITLE I—OPIOID CRISIS 
RESPONSE ACT 
SEC. 1001. DEFINITIONS. 
In this title— 
(1) the terms ‘‘Indian Tribe’’ and ‘‘tribal organi-
zation’’ have the meanings given the terms ‘‘Indian 
tribe’’ and ‘‘tribal organization’’ in section 4 of the 
Indian Self-Determination and Education Assistance 
Act (25 U.S.C. 5304); and 
(2) the term ‘‘Secretary’’ means the Secretary of 
Health and Human Services, unless otherwise speci-
fied. 
Subtitle A—Reauthorization of 
Cures Funding 
SEC. 1101. STATE RESPONSE TO THE OPIOID ABUSE CRISIS. 
(a) IN GENERAL.—Section 1003 of the 21st Century 
Cures Act (Public Law 114–255) is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘the authorization of appro-
priations under subsection (b) to carry out the 
grant program described in subsection (c)’’ and 
inserting ‘‘subsection (h) to carry out the grant 
program described in subsection (b)’’; and
† HR 6 EAS 
(B) by inserting ‘‘and Indian Tribes’’ after 
‘‘States’’; 
(2) by striking subsection (b); 
(3) by redesignating subsections (c) through (e) 
as subsections (b) through (d), respectively; 
(4) by redesignating subsection (f) as subsection 
(j); 
(5) in subsection (b), as so redesignated— 
(A) in paragraph (1)— 
(i) in the paragraph heading, by in-
serting ‘‘AND INDIAN TRIBE’’ after ‘‘STATE’’; 
(ii) by striking ‘‘States for the purpose 
of addressing the opioid abuse crisis within 
such States’’ and inserting ‘‘States and In-
dian Tribes for the purpose of addressing 
the opioid abuse crisis within such States 
and Indian Tribes’’; 
(iii) by inserting ‘‘or Indian Tribes’’ 
after ‘‘preference to States’’; and 
(iv) by inserting before the period of 
the second sentence ‘‘or other Indian Tribes, 
as applicable’’; 
(B) in paragraph (2)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘to a State’’;
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(ii) in subparagraph (A), by striking 
‘‘State’’; 
(iii) in subparagraph (C), by inserting 
‘‘preventing diversion of controlled sub-
stances,’’ after ‘‘treatment programs,’’; and 
(iv) in subparagraph (E), by striking 
‘‘as the State determines appropriate, re-
lated to addressing the opioid abuse crisis 
within the State’’ and inserting ‘‘as the 
State or Indian Tribe determines appro-
priate, related to addressing the opioid 
abuse crisis within the State, including di-
recting resources in accordance with local 
needs related to substance use disorders’’; 
(6) in subsection (c), as so redesignated, by strik-
ing ‘‘subsection (c)’’ and inserting ‘‘subsection (b)’’; 
(7) in subsection (d), as so redesignated— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘the authorization of appropriations 
under subsection (b)’’ and inserting ‘‘subsection 
(h)’’; and 
(B) in paragraph (1), by striking ‘‘sub-
section (c)’’ and inserting ‘‘subsection (b)’’; and 
(8) by inserting after subsection (d), as so redes-
ignated, the following:
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‘‘(e) INDIAN TRIBES.— 
‘‘(1) DEFINITION.—For purposes of this section, 
the term ‘Indian Tribe’ has the meaning given the 
term ‘Indian tribe’ in section 4 of the Indian Self-De-
termination and Education Assistance Act (25 U.S.C. 
5304). 
‘‘(2) 
APPROPRIATE
MECHANISMS.—The 
Sec-
retary, in consultation with Indian Tribes, shall 
identify and establish appropriate mechanisms for 
Tribes to demonstrate or report the information as re-
quired under subsections (b), (c), and (d). 
‘‘(f) REPORT TO CONGRESS.—Not later than 1 year 
after the date on which amounts are first awarded after 
the date of enactment of the Opioid Crisis Response Act 
of 2018, pursuant to subsection (b), and annually there-
after, the Secretary shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of 
Representatives a report summarizing the information pro-
vided to the Secretary in reports made pursuant to sub-
section (c), including the purposes for which grant funds 
are awarded under this section and the activities of such 
grant recipients. 
‘‘(g) TECHNICAL ASSISTANCE.—The Secretary, includ-
ing through the Tribal Training and Technical Assistance
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Center of the Substance Abuse and Mental Health Services 
Administration, shall provide State agencies and Indian 
Tribes, as applicable, with technical assistance concerning 
grant application and submission procedures under this 
section, award management activities, and enhancing out-
reach and direct support to rural and underserved commu-
nities and providers in addressing the opioid crisis. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For pur-
poses of carrying out the grant program under subsection 
(b), there is authorized to be appropriated $500,000,000 for 
each of fiscal years 2019 through 2021, to remain available 
until expended. 
‘‘(i) SET ASIDE.—Of the amounts made available for 
each fiscal year to award grants under subsection (b) for 
a fiscal year, 5 percent of such amount for such fiscal year 
shall be made available to Indian Tribes, and up to 15 per-
cent of such amount for such fiscal year may be set aside 
for States with the highest age-adjusted rate of drug over-
dose death based on the ordinal ranking of States according 
to the Director of the Centers for Disease Control and Pre-
vention.’’. 
(b) CONFORMING AMENDMENT.—Section 1004(c) of the 
21st Century Cures Act (Public Law 114–255) is amended 
by striking ‘‘, the FDA Innovation Account, or the Account
† HR 6 EAS 
For the State Response to the Opioid Abuse Crisis’’ and 
inserting ‘‘or the FDA Innovation Account’’. 
Subtitle B—Research and 
Innovation 
SEC. 1201. ADVANCING CUTTING-EDGE RESEARCH. 
Section 402(n)(1) of the Public Health Service Act (42 
U.S.C. 282(n)(1)) is amended— 
(1) in subparagraph (A), by striking ‘‘or’’; 
(2) in subparagraph (B), by striking the period 
and inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(C) high impact cutting-edge research that 
fosters scientific creativity and increases funda-
mental biological understanding leading to the 
prevention, diagnosis, or treatment of diseases 
and disorders, or research urgently required to 
respond to a public health threat.’’. 
SEC. 1202. PAIN RESEARCH. 
Section 409J(b) of the Public Health Service Act (42 
U.S.C. 284q(b)) is amended— 
(1) in paragraph (5)— 
(A) in subparagraph (A), by striking ‘‘and 
treatment of pain and diseases and disorders as-
sociated with pain’’ and inserting ‘‘treatment, 
and management of pain and diseases and dis-
† HR 6 EAS 
orders associated with pain, including informa-
tion on best practices for utilization of non-phar-
macologic treatments, non-addictive medical 
products, and other drugs or devices approved or 
cleared by the Food and Drug Administration’’; 
(B) in subparagraph (B), by striking ‘‘on 
the symptoms and causes of pain;’’ and inserting 
the following: ‘‘on— 
‘‘(i) the symptoms and causes of pain, 
including the identification of relevant bio-
markers and screening models and the epi-
demiology of acute and chronic pain; 
‘‘(ii) the diagnosis, prevention, treat-
ment, and management of acute or chronic 
pain, including with respect to non-phar-
macologic treatments, non-addictive medical 
products, and other drugs or devices ap-
proved or cleared by the Food and Drug Ad-
ministration; and 
‘‘(iii) risk factors for, and early warn-
ing signs of, substance use disorders; and’’; 
and 
(C) by striking subparagraphs (C) through 
(E) and inserting the following:
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‘‘(C) make recommendations to the Director 
of NIH— 
‘‘(i) to ensure that the activities of the 
National Institutes of Health and other 
Federal agencies are free of unnecessary du-
plication of effort; 
‘‘(ii) on how best to disseminate infor-
mation on pain care and epidemiological 
data related to acute and chronic pain; and 
‘‘(iii) on how to expand partnerships 
between public entities and private entities 
to expand collaborative, cross-cutting re-
search.’’; 
(2) by redesignating paragraph (6) as para-
graph (7); and 
(3) by inserting after paragraph (5) the fol-
lowing: 
‘‘(6) REPORT.—The Director of NIH shall ensure 
that recommendations and actions taken by the Direc-
tor with respect to the topics discussed at the meetings 
described in paragraph (4) are included in appro-
priate reports to Congress.’’. 
SEC. 1203. REPORT ON SYNTHETIC DRUG USE. 
(a) IN GENERAL.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary shall submit
† HR 6 EAS 
to the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and Com-
merce of the House of Representatives a report on the health 
effects of new psychoactive substances, including synthetic 
drugs, by adolescents and young adults. 
(b) NEW PSYCHOACTIVE SUBSTANCE DEFINED.—For 
purposes of subsection (a), the term ‘‘new psychoactive sub-
stance’’ means a controlled substance analogue (as defined 
in section 102(32) of the Controlled Substances Act (21 
U.S.C. 802(32))). 
Subtitle C—Medical Products and 
Controlled Substances Safety 
SEC. 1301. CLARIFYING FDA REGULATION OF NON-ADDICT-
IVE PAIN PRODUCTS. 
(a) PUBLIC MEETINGS.—Not later than one year after 
the date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs, shall hold 
not less than one public meeting to address the challenges 
and barriers of developing non-addictive medical products 
intended to treat pain or addiction, which may include— 
(1) the manner by which the Secretary may in-
corporate the risks of misuse and abuse of a controlled 
substance (as defined in section 102 of the Controlled 
Substances Act (21 U.S.C. 802) into the risk benefit 
assessments under subsections (d) and (e) of section
† HR 6 EAS 
505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), section 510(k) of such Act (21 U.S.C. 
360(k)), or section 515(c) of such Act (21 U.S.C. 
360e(c)), as applicable; 
(2) the application of novel clinical trial designs 
(consistent with section 3021 of the 21st Century 
Cures Act (Public Law 114–255)), use of real world 
evidence (consistent with section 505F of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and 
use of patient experience data (consistent with section 
569C of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–8c)) for the development of non- 
addictive medical products intended to treat pain or 
addiction; 
(3) the evidentiary standards and the develop-
ment of opioid sparing data for inclusion in the label-
ing of medical products; and 
(4) the application of eligibility criteria under 
sections 506 and 515B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356, 360e–3) for non- 
addictive medical products intended to treat pain or 
addiction. 
(b) GUIDANCE.—Not less than one year after the public 
meetings are conducted under subsection (a) the Secretary 
shall issue one or more final guidance documents, or update
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existing guidance documents, to help address challenges to 
developing non-addictive medical products to treat pain or 
addiction. Such guidance documents shall include informa-
tion regarding— 
(1) how the Food and Drug Administration may 
apply sections 506 and 515B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to 
non-addictive medical products intended to treat pain 
or addiction, including the circumstances under 
which the Secretary— 
(A) may apply the eligibility criteria under 
such sections 506 and 515B to non-addictive 
medical products intended to treat pain or ad-
diction; 
(B) considers the risk of addiction of con-
trolled substances approved to treat pain when 
establishing unmet medical need; and 
(C) considers pain, pain control, or pain 
management in assessing whether a disease or 
condition is a serious or life-threatening disease 
or condition; 
(2) the methods by which sponsors may evaluate 
acute and chronic pain, endpoints for non-addictive 
medical products intended to treat pain, the manner 
in which endpoints and evaluations of efficacy will be
† HR 6 EAS 
applied across and within review divisions, taking 
into consideration the etiology of the underlying dis-
ease, and the manner in which sponsors may use sur-
rogate endpoints, intermediate endpoints, and real 
world evidence; 
(3) the manner in which the Food and Drug Ad-
ministration will assess evidence to support the inclu-
sion of opioid sparing data in the labeling of non-ad-
dictive medical products intended to treat pain, in-
cluding— 
(A) data collection methodologies, including 
the use of novel clinical trial designs (consistent 
with section 3021 of the 21st Century Cures Act 
(Public Law 114–255)) and real world evidence 
(consistent with section 505F of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), 
as appropriate, to support product labeling; 
(B) ethical considerations of exposing sub-
jects to controlled substances in clinical trials to 
develop opioid sparing data and considerations 
on data collection methods that reduce harm, 
which may include the reduction of opioid use as 
a clinical benefit;
† HR 6 EAS 
(C) endpoints, including primary, sec-
ondary, and surrogate endpoints, to evaluate the 
reduction of opioid use; 
(D) best practices for communication be-
tween sponsors and the agency on the develop-
ment of data collection methods, including the 
initiation of data collection; and 
(E) the appropriate format in which to sub-
mit such data results to the Secretary; and 
(4) the circumstances under which the Food and 
Drug Administration considers misuse and abuse of a 
controlled substance (as defined in section 102 of the 
Controlled Substances Act (21 U.S.C. 802) in making 
the risk benefit assessment under paragraphs (2) and 
(4) of subsection (d) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 
in finding that a drug is unsafe under paragraph (1) 
or (2) of subsection (e) of such section. 
(c) DEFINITIONS.—In this section— 
(1) the term ‘‘medical product’’ means a drug 
(as defined in section 201(g)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), bio-
logical product (as defined in section 351(i) of the 
Public Health Service Act (42 U.S.C. 262(i))), or de-
† HR 6 EAS 
vice (as defined in section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h))); and 
(2) the term ‘‘opioid sparing’’ means reducing, 
replacing, or avoiding the use of opioids or other con-
trolled substances. 
SEC. 1302. CLARIFYING FDA PACKAGING AUTHORITIES. 
(a) ADDITIONAL POTENTIAL ELEMENTS OF STRAT-
EGY.—Section 505–1(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding 
at the end the following: 
‘‘(4) PACKAGING AND DISPOSAL.—The Secretary 
may require a risk evaluation mitigation strategy for 
a drug for which there is a serious risk of an adverse 
drug experience described in subparagraph (B) or (C) 
of subsection (b)(1), taking into consideration the fac-
tors described in subparagraphs (C) and (D) of sub-
section (f)(2) and in consultation with other relevant 
Federal agencies with authorities over drug pack-
aging, which may include requiring that— 
‘‘(A) the drug be made available for dis-
pensing to certain patients in unit dose pack-
aging, packaging that provides a set duration, or 
another packaging system that the Secretary de-
termines may mitigate such serious risk; or
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‘‘(B) the drug be dispensed to certain pa-
tients with a safe disposal packaging or safe dis-
posal system for purposes of rendering drugs 
non-retrievable (as defined in section 1300.05 of 
title 21, Code of Federal Regulations (or any 
successor regulation)) if the Secretary has deter-
mines that such safe disposal packaging or sys-
tem may mitigate such serious risk and exists in 
sufficient quantities.’’. 
(b) ASSURING ACCESS AND MINIMIZING BURDEN.— 
Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1(f)(2)(C)) is amended— 
(1) in clause (i) by striking ‘‘and’’ at the end; 
and 
(2) by adding at the end the following: 
‘‘(iii) patients with functional needs; 
and’’. 
(c) APPLICATION TO ABBREVIATED NEW DRUG APPLI-
CATIONS.—Section 505–1(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(i)) is amended— 
(1) in paragraph (1)— 
(A) by redesignating subparagraph (B) as 
subparagraph (C); and 
(B) inserting after subparagraph (A) the 
following:
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‘‘(B) A packaging or disposal requirement, 
if required under subsection (e)(4) for the appli-
cable listed drug.’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘and’’ 
at the end; 
(B) by redesignating subparagraph (B) as 
subparagraph (C); and 
(C) by inserting after subparagraph (A) the 
following: 
‘‘(B) shall permit packaging systems and 
safe disposal packaging or safe disposal systems 
that are different from those required for the ap-
plicable listed drug under subsection (e)(4); 
and’’. 
SEC. 1303. STRENGTHENING FDA AND CBP COORDINATION 
AND CAPACITY. 
(a) IN GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall coordinate with the 
Secretary of Homeland Security to carry out activities re-
lated to customs and border protection and response to ille-
gal controlled substances and drug imports, including at 
sites of import (such as international mail facilities). Such 
Secretaries may carry out such activities through a memo-
† HR 6 EAS 
randum of understanding between the Food and Drug Ad-
ministration and the U.S. Customs and Border Protection. 
(b) FDA IMPORT FACILITIES AND INSPECTION CAPAC-
ITY.— 
(1) IN GENERAL.—In carrying out this section, 
the Secretary shall, in collaboration with the Sec-
retary of Homeland Security and the Postmaster 
General of the United States Postal Service, provide 
that import facilities in which the Food and Drug 
Administration operates or carries out activities re-
lated to drug imports within the international mail 
facilities include— 
(A) facility upgrades and improved capac-
ity in order to increase and improve inspection 
and detection capabilities, which may include, as 
the Secretary determines appropriate— 
(i) improvements to facilities, such as 
upgrades or renovations, and support for 
the maintenance of existing import facilities 
and sites to improve coordination between 
Federal agencies; 
(ii) the construction of, or upgrades to, 
laboratory capacity for purposes of detec-
tion and testing of imported goods;
† HR 6 EAS 
(iii) upgrades to the security of import 
facilities; and 
(iv) innovative technology and equip-
ment to facilitate improved and near-real- 
time information sharing between the Food 
and Drug Administration, the Department 
of Homeland Security, and the United 
States Postal Service; and 
(B) innovative technology, including con-
trolled substance detection and testing equipment 
and other applicable technology, in order to col-
laborate with the U.S. Customs and Border Pro-
tection to share near-real-time information, in-
cluding information about test results, as appro-
priate. 
(2) INNOVATIVE TECHNOLOGY.—Any technology 
used in accordance with paragraph (1)(B) shall be 
interoperable with technology used by other relevant 
Federal agencies, including the U.S. Customs and 
Border Protection, as the Secretary determines appro-
priate. 
(c) REPORT.—Not later than 6 months after the date 
of enactment of this Act, the Secretary, in consultation with 
the Secretary of Homeland Security and the Postmaster 
General of the United States Postal Service, shall report
† HR 6 EAS 
to the relevant committees of Congress on the implementa-
tion of this section, including a summary of progress made 
towards near-real-time information sharing and the inter-
operability of such technologies. 
(d) AUTHORIZATION
OF APPROPRIATIONS.—Out of 
amounts otherwise available to the Secretary, the Secretary 
may allocate such sums as may be necessary for purposes 
of carrying out this section. 
SEC. 1304. CLARIFYING FDA POST-MARKET AUTHORITIES. 
Section 505–1(b)(1)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by 
striking ‘‘of the drug’’ and inserting ‘‘of the drug, which 
may include reduced effectiveness under the conditions of 
use prescribed in the labeling of such drug, but which may 
not include reduced effectiveness that is in accordance with 
such labeling’’. 
SEC. 1305. RESTRICTING ENTRANCE OF ILLICIT DRUGS. 
(a) IN GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, upon discovering or re-
ceiving, in a package being offered for import, a controlled 
substance that is offered for import in violation of any re-
quirement of the Controlled Substances Act (21 U.S.C. 801 
et seq.), the Controlled Substances Import and Export Act 
(21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.), or any other applicable
† HR 6 EAS 
law, shall transfer such package to the U.S. Customs and 
Border Protection. If the Secretary identifies additional 
packages that appear to be the same as such package con-
taining a controlled substance, such additional packages 
may also be transferred to U.S. Customs and Border Protec-
tion. The U.S. Customs and Border Protection shall receive 
such packages consistent with the requirements of the Con-
trolled Substances Act (21 U.S.C. 801 et seq.). 
(b) DEBARMENT, TEMPORARY DENIAL OF APPROVAL, 
AND SUSPENSION.— 
(1) IN GENERAL.—Section 306(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(A) in paragraph (1)— 
(i) in the matter preceding subpara-
graph (A), by inserting ‘‘or (3)’’ after 
‘‘paragraph (2)’’; 
(ii) in subparagraph (A), by striking 
the comma at the end and inserting a semi-
colon; 
(iii) in subparagraph (B), by striking 
‘‘, or’’ and inserting a semicolon; 
(iv) in subparagraph (C), by striking 
the period and inserting ‘‘; or’’; and 
(v) by adding at the end the following:
† HR 6 EAS 
‘‘(D) a person from importing or offering 
for import into the United States a drug.’’; and 
(B) in paragraph (3)— 
(i) in the heading, by striking ‘‘FOOD’’; 
(ii) in subparagraph (A), by striking 
‘‘; or’’ and inserting a semicolon; 
(iii) in subparagraph (B), by striking 
the period and inserting a semicolon; and 
(iv) by adding at the end the following: 
‘‘(C) the person has been convicted of a fel-
ony for conduct relating to the importation into 
the United States of any drug or controlled sub-
stance (as defined in section 102 of the Con-
trolled Substances Act); 
‘‘(D) the person has engaged in a pattern of 
importing or offering for import— 
‘‘(i) controlled substances that are pro-
hibited from importation under section 
401(m) of the Tariff Act of 1930 (19 U.S.C. 
1401(m)); or 
‘‘(ii) adulterated or misbranded drugs 
that are— 
‘‘(I) not designated in an author-
ized electronic data interchange system
† HR 6 EAS 
as a product that is regulated by the 
Secretary; or 
‘‘(II) knowingly or intentionally 
falsely designated in an authorized 
electronic data interchange system as a 
product that is regulated by the Sec-
retary.’’. 
(2) PROHIBITED
ACT.—Section 301(cc) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331(cc)) is amended by inserting ‘‘or a drug’’ after 
‘‘food’’. 
(c) IMPORTS AND EXPORTS.—Section 801(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) 
is amended— 
(1) by striking the second sentence; 
(2) by striking ‘‘If it appears’’ and inserting 
‘‘Subject to subsection (b), if it appears’’; 
(3) by striking ‘‘regarding such article, then such 
article shall be refused’’ and inserting the following: 
‘‘regarding such article, or (5) such article is being 
imported or offered for import in violation of section 
301(cc), then any such article described in any of 
clauses (1) through (5) may be refused admission. If 
it appears from the examination of such samples or
† HR 6 EAS 
otherwise that the article is a counterfeit drug, such 
article shall be refused admission.’’; 
(4) by striking ‘‘this Act, then such article shall 
be refused admission’’ and inserting ‘‘this Act, then 
such article may be refused admission’’; and 
(5) by striking ‘‘Clause (2) of the third sentence’’ 
and all that follows through the period at the end and 
inserting the following: ‘‘Neither clause (2) nor clause 
(5) of the second sentence of this subsection shall be 
construed to prohibit the admission of narcotic drugs, 
the importation of which is permitted under the Con-
trolled Substances Import and Export Act.’’. 
(d) CERTAIN ILLICIT ARTICLES.—Section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 
amended by adding at the end the following— 
‘‘(t) ILLICIT ARTICLES CONTAINING ACTIVE PHARMA-
CEUTICAL INGREDIENTS.— 
‘‘(1) IN GENERAL.—For purposes of this section, 
an article that is being imported or offered for import 
into the United States may be treated by the Sec-
retary as a drug if the article— 
‘‘(A) is not— 
‘‘(i) accompanied by an electronic im-
port entry for such article submitted using
† HR 6 EAS 
an authorized electronic data interchange 
system; and 
‘‘(ii) designated in such a system as an 
article regulated by the Secretary (which 
may include regulation as a drug, a device, 
or a dietary supplement; and 
‘‘(B) is an ingredient that presents signifi-
cant public health concern and is, or contains— 
‘‘(i) an active ingredient in a drug— 
‘‘(I) that is approved under sec-
tion 505 or licensed under section 351 
of the Public Health Service Act; or 
‘‘(II) for which— 
‘‘(aa) an investigational use 
exemption is in effect under sec-
tion 505(i) of this Act or section 
351(a) of the Public Health Serv-
ice Act; and 
‘‘(bb) a substantial clinical 
investigation has been instituted, 
and such investigation has been 
made public; or 
‘‘(ii) a substance that has a chemical 
structure that is substantially similar to the 
chemical structure of an active ingredient
† HR 6 EAS 
in a drug or biological product described in 
subclause (I) or (II) of clause (i). 
‘‘(2) EFFECT.—This subsection shall not be con-
strued to bear upon any determination of whether an 
article is a drug within the meaning of section 
201(g), other than for the purposes described in para-
graph (1).’’. 
SEC. 1306. FIRST RESPONDER TRAINING. 
Section 546 of the Public Health Service Act (42 
U.S.C. 290ee–1) is amended— 
(1) in subsection (c)— 
(A) in paragraph (2), by striking ‘‘and’’ at 
the end; 
(B) in paragraph (3), by striking the period 
and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(4) train and provide resources for first re-
sponders and members of other key community sectors 
on safety around fentanyl, carfentanil, and other dan-
gerous licit and illicit drugs to protect themselves 
from exposure to such drugs and respond appro-
priately when exposure occurs.’’; 
(2) in subsection (d), by striking ‘‘and mecha-
nisms for referral to appropriate treatment for an en-
tity receiving a grant under this section’’ and insert-
† HR 6 EAS 
ing ‘‘mechanisms for referral to appropriate treat-
ment, and safety around fentanyl, carfentanil, and 
other dangerous licit and illicit drugs’’; 
(3) in subsection (f)— 
(A) in paragraph (3), by striking ‘‘and’’ at 
the end; 
(B) in paragraph (4), by striking the period 
and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(5) the number of first responders and members 
of other key community sectors trained on safety 
around fentanyl, carfentanil, and other dangerous 
licit and illicit drugs.’’; 
(4) by redesignating subsection (g) as subsection 
(h); 
(5) by inserting after subsection (f) the following: 
‘‘(g) OTHER KEY COMMUNITY SECTORS.—In this sec-
tion, the term ‘other key community sectors’ includes sub-
stance abuse treatment providers, emergency medical serv-
ices agencies, agencies and organizations working with 
prison and jail populations and offender reentry programs, 
health care providers, harm reduction groups, pharmacies, 
community health centers, tribal health facilities, and men-
tal health providers.’’; and
† HR 6 EAS 
(6) in subsection (h), as so redesignated, by 
striking ‘‘$12,000,000 for each of fiscal years 2017 
through 2021’’ and inserting ‘‘$36,000,000 for each of 
fiscal years 2019 through 2023’’. 
SEC. 1307. DISPOSAL OF CONTROLLED SUBSTANCES OF 
HOSPICE PATIENTS. 
(a) IN GENERAL.—Section 302(g) of the Controlled 
Substances Act (21 U.S.C. 822(g)) is amended by adding 
at the end the following: 
‘‘(5)(A) An employee of a qualified hospice program 
acting within the scope of employment may handle, in the 
place of residence of a hospice patient, any controlled sub-
stance that was lawfully dispensed to the hospice patient, 
for the purpose of assisting in the disposal of the controlled 
substance— 
‘‘(i) after the hospice patient’s death; 
‘‘(ii) if the controlled substance is expired; or 
‘‘(iii) if— 
‘‘(I) the employee is— 
‘‘(aa) the physician of the hospice pa-
tient; and 
‘‘(bb) registered under section 303(f); 
and
† HR 6 EAS 
‘‘(II) the hospice patient no longer requires 
the controlled substance because the plan of care 
of the hospice patient has been modified. 
‘‘(B) In this paragraph: 
‘‘(i) The term ‘employee of a qualified hospice 
program’ means a physician, physician assistant, 
registered nurse, or nurse practitioner who— 
‘‘(I) is employed by, or is acting pursuant 
to arrangements made with, a qualified hospice 
program; and 
‘‘(II) is licensed or certified to perform such 
employment, or such activities arranged by the 
qualified hospice program, in accordance with 
applicable State law. 
‘‘(ii) The terms ‘hospice care’ and ‘hospice pro-
gram’ have the meanings given those terms in section 
1861(dd) of the Social Security Act (42 U.S.C. 
1395x(dd)). 
‘‘(iii) The term ‘hospice patient’ means an indi-
vidual receiving hospice care. 
‘‘(iv) The term ‘qualified hospice program’ 
means a hospice program that— 
‘‘(I) has written policies and procedures for 
employees of the hospice program to use when as-
sisting in the disposal of the controlled sub-
† HR 6 EAS 
stances of a hospice patient in a circumstance 
described in clause (i), (ii), or (iii) of subpara-
graph (A); 
‘‘(II) at the time when the controlled sub-
stances are first ordered— 
‘‘(aa) provides a copy of the written 
policies and procedures to the hospice pa-
tient or hospice patient representative and 
the family of the hospice patient; 
‘‘(bb) discusses the policies and proce-
dures with the hospice patient or hospice 
patient’s representative and the hospice pa-
tient’s family in a language and manner 
that such individuals understand to ensure 
that such individuals are informed regard-
ing the safe disposal of controlled sub-
stances; and 
‘‘(cc) documents in the clinical record 
of the hospice patient that the written poli-
cies and procedures were provided and dis-
cussed with the hospice patient or hospice 
patient’s representative; and 
‘‘(III) at the time when an employee of the 
hospice program assists in the disposal of con-
trolled substances of a hospice patient, documents
† HR 6 EAS 
in the clinical record of the hospice patient a list 
of all controlled substances disposed of. 
‘‘(C) The Attorney General may, by regulation, include 
additional types of licensed medical professionals in the def-
inition of the term ‘employee of a qualified hospice pro-
gram’ under subparagraph (B).’’. 
(b) NO REGISTRATION REQUIRED.—Section 302(c) of 
the Controlled Substances Act (21 U.S.C. 822(c)) is amend-
ed by adding at the end the following: 
‘‘(4) An employee of a qualified hospice program 
for the purpose of assisting in the disposal of a con-
trolled substance in accordance with subsection (g)(5), 
except as provided in subparagraph (A)(iii) of that 
subsection.’’. 
(c) GUIDANCE.—The Attorney General may issue 
guidance to qualified hospice programs to assist the pro-
grams in satisfying the requirements under paragraph (5) 
of section 302(g) of the Controlled Substances Act (21 
U.S.C. 822(g)), as added by subsection (a). 
(d) STATE AND LOCAL AUTHORITY.—Nothing in this 
section or the amendments made by this section shall be 
construed to prevent a State or local government from im-
posing additional controls or restrictions relating to the reg-
ulation of the disposal of controlled substances in hospice 
care or hospice programs.
† HR 6 EAS 
SEC. 1308. GAO STUDY AND REPORT ON HOSPICE SAFE 
DRUG MANAGEMENT. 
(a) STUDY.— 
(1) IN GENERAL.—The Comptroller General of 
the United States (in this section referred to as the 
‘‘Comptroller General’’) shall conduct a study on the 
requirements applicable to and challenges of hospice 
programs with regard to the management and dis-
posal of controlled substances in the home of an indi-
vidual. 
(2) CONTENTS.—In conducting the study under 
paragraph (1), the Comptroller General shall in-
clude— 
(A) an overview of challenges encountered 
by hospice programs regarding the disposal of 
controlled substances, such as opioids, in a home 
setting, including any key changes in policies, 
procedures, or best practices for the disposal of 
controlled substances over time; and 
(B) a description of Federal requirements, 
including requirements under the Medicare pro-
gram, for hospice programs regarding the dis-
posal of controlled substances in a home setting, 
and oversight of compliance with those require-
ments.
† HR 6 EAS 
(b) REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Comptroller General shall sub-
mit to Congress a report containing the results of the study 
conducted under subsection (a), together with recommenda-
tions, if any, for such legislation and administrative action 
as the Comptroller General determines appropriate. 
SEC. 1309. DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY TO BE ADMINISTERED BY INJEC-
TION OR IMPLANTATION. 
(a) IN GENERAL.—The Controlled Substances Act is 
amended by inserting after section 309 (21 U.S.C. 829) the 
following: 
‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY 
TO AN ADMINISTERING PRACTITIONER 
‘‘SEC. 309A. (a) IN GENERAL.—Notwithstanding sec-
tion 102(10), a pharmacy may deliver a controlled sub-
stance to a practitioner in accordance with a prescription 
that meets the requirements of this title and the regulations 
issued by the Attorney General under this title, for the pur-
pose of administering the controlled substance by the practi-
tioner if— 
‘‘(1) the controlled substance is delivered by the 
pharmacy to the prescribing practitioner or the prac-
titioner administering the controlled substance, as ap-
plicable, at the location listed on the practitioner’s 
certificate of registration issued under this title;
† HR 6 EAS 
‘‘(2) in the case of administering of the con-
trolled substance for the purpose of maintenance or 
detoxification treatment under section 303(g)(2)— 
‘‘(A) the practitioner who issued the pre-
scription is a qualifying practitioner authorized 
under, and acting within the scope of that sec-
tion; and 
‘‘(B) the controlled substance is to be ad-
ministered by injection or implantation; 
‘‘(3) the pharmacy and the practitioner are au-
thorized to conduct the activities specified in this sec-
tion under the law of the State in which such activi-
ties take place; 
‘‘(4) the prescription is not issued to supply any 
practitioner with a stock of controlled substances for 
the purpose of general dispensing to patients; 
‘‘(5) except as provided in subsection (b), the 
controlled substance is to be administered only to the 
patient named on the prescription not later than 14 
days after the date of receipt of the controlled sub-
stance by the practitioner; and 
‘‘(6) notwithstanding any exceptions under sec-
tion 307, the prescribing practitioner, and the practi-
tioner administering the controlled substance, as ap-
plicable, maintain complete and accurate records of
† HR 6 EAS 
(b) STUDY AND REPORT.—Not later than 2 years after 
the date of enactment of this section, the Comptroller Gen-
eral of the United States shall conduct a study and submit 
to Congress a report on access to and potential diversion 
of controlled substances administered by injection or im-
plantation. 
(c) TECHNICAL AND CONFORMING AMENDMENT.—The 
table of contents for the Comprehensive Drug Abuse Preven-
tion and Control Act of 1970 is amended by inserting after 
the item relating to section 309 the following: 
‘‘Sec. 309A. Delivery of a controlled substance by a pharmacy to an admin-
istering practitioner.’’. 
Subtitle D—Treatment and 
Recovery 
SEC. 1401. COMPREHENSIVE OPIOID RECOVERY CENTERS. 
(a) IN GENERAL.—The Secretary shall award grants 
on a competitive basis to eligible entities to establish or op-
erate a comprehensive opioid recovery center (referred to in 
this section as a ‘‘Center’’). A Center may be a single entity 
or an integrated delivery network. 
(b) GRANT PERIOD.— 
(1) IN GENERAL.—A grant awarded under sub-
section (a) shall be for a period not more than 5 
years. 
(2) RENEWAL.—A grant awarded under sub-
section (a) may be renewed, on a competitive basis,
† HR 6 EAS 
for additional periods of time, as determined by the 
Secretary. In determining whether to renew a grant 
under this paragraph, the Secretary shall consider the 
data submitted under subsection (h). 
(c) MINIMUM NUMBER OF GRANTS.—The Secretary 
shall allocate the amounts made available under subsection 
(j) such that not fewer than 10 grants may be awarded. 
Not more than one grant shall be made to entities in a sin-
gle State for any one period. 
(d) APPLICATION.— 
(1) ELIGIBLE ENTITY.—An entity is eligible for 
a grant under this section if the entity offers treat-
ment and other services for individuals with a sub-
stance use disorder. 
(2) SUBMISSION OF APPLICATION.—In order to 
be eligible for a grant under subsection (a), an entity 
shall submit an application to the Secretary at such 
time and in such manner as the Secretary may re-
quire. Such application shall include— 
(A) evidence that such entity carries out, or 
is capable of coordinating with other entities to 
carry out, the activities described in subsection 
(g); and 
(B) such other information as the Secretary 
may require.
† HR 6 EAS 
(e) PRIORITY.—In awarding grants under subsection 
(a), the Secretary shall give priority to eligible entities lo-
cated in a State or Indian Tribe with an age-adjusted rate 
of drug overdose deaths that is above the national overdose 
mortality rate, as determined by the Director of the Centers 
for Disease Control and Prevention. 
(f) PREFERENCE.—In awarding grants under sub-
section (a), the Secretary may give preference to eligible en-
tities utilizing technology-enabled collaborative learning 
and capacity building models, including such models as de-
fined in section 2 of the Expanding Capacity for Health 
Outcomes Act (Public Law 114–270; 130 Stat. 1395), to 
conduct the activities described in this section. 
(g) CENTER ACTIVITIES.—Each Center shall, at a 
minimum, carry out the following activities directly, 
through referral, or through contractual arrangements, 
which may include carrying out such activities through 
technology-enabled collaborative learning and capacity 
building models described in subsection (f): 
(1) TREATMENT
AND
RECOVERY
SERVICES.— 
Each Center shall— 
(A) ensure that intake and evaluations meet 
the individualized clinical needs of patients, in-
cluding by offering assessments for services and 
care recommendations through independent, evi-
† HR 6 EAS 
dence-based verification processes for reviewing 
patient placement in treatment settings; 
(B) provide the full continuum of treatment 
services, including— 
(i) all drugs approved by the Food and 
Drug Administration to treat substance use 
disorders, pursuant to Federal and State 
law; 
(ii) medically supervised withdrawal 
management that includes patient evalua-
tion, stabilization, and readiness for and 
entry into treatment; 
(iii) counseling provided by a program 
counselor or other certified professional who 
is licensed and qualified by education, 
training, or experience to assess the psycho-
logical and sociological background of pa-
tients, to contribute to the appropriate 
treatment plan for the patient, and to mon-
itor patient progress; 
(iv) treatment, as appropriate, for pa-
tients with co-occurring substance use and 
mental disorders;
† HR 6 EAS 
(v) testing, as appropriate, for infec-
tions commonly associated with illicit drug 
use; 
(vi) residential rehabilitation, and out-
patient and intensive outpatient programs; 
(vii) recovery housing; 
(viii) community-based and peer recov-
ery support services; 
(ix) job training, job placement assist-
ance, and continuing education assistance 
to support reintegration into the workforce; 
and 
(x) other best practices to provide the 
full continuum of treatment and services, as 
determined by the Secretary; 
(C) ensure that all programs covered by the 
Center include medication-assisted treatment, as 
appropriate, and do not exclude individuals re-
ceiving medication-assisted treatment from any 
service; 
(D) periodically conduct patient assess-
ments to support sustained and clinically sig-
nificant recovery, as defined by the Assistant 
Secretary for Mental Health and Substance Use;
† HR 6 EAS 
(E) administer an onsite pharmacy and 
provide toxicology services, for purposes of car-
rying out this section; and 
(F) operate a secure, confidential, and 
interoperable electronic health information sys-
tem. 
(2) OUTREACH.—Each Center shall carry out 
outreach activities to publicize the services offered 
through the Centers, which may include— 
(A) training and supervising outreach staff, 
as appropriate, to work with State and local 
health departments, health care providers, the 
Indian Health Service, State and local edu-
cational agencies, schools funded by the Indian 
Bureau of Education, institutions of higher edu-
cation, State and local workforce development 
boards, State and local community action agen-
cies, public safety officials, first responders, In-
dian Tribes, child welfare agencies, as appro-
priate, and other community partners and the 
public, including patients, to identify and re-
spond to community needs; 
(B) ensuring that the entities described in 
subparagraph (A) are aware of the services of the 
Center; and
† HR 6 EAS 
(C) disseminating and making publicly 
available, including through the internet, evi-
dence-based resources that educate professionals 
and the public on opioid use disorder and other 
substance use disorders, including co-occurring 
substance use and mental disorders. 
(h) DATA REPORTING AND PROGRAM OVERSIGHT.— 
With respect to a grant awarded under subsection (a), not 
later than 90 days after the end of the first year of the grant 
period, and annually thereafter for the duration of the 
grant period (including the duration of any renewal period 
for such grant), the entity shall submit data, as appro-
priate, to the Secretary regarding— 
(1) the programs and activities funded by the 
grant; 
(2) health outcomes of the population of individ-
uals with a substance use disorder who received serv-
ices from the Center, evaluated by an independent 
program evaluator through the use of outcomes meas-
ures, as determined by the Secretary; 
(3) the retention rate of program participants; 
and 
(4) any other information that the Secretary 
may require for the purpose of ensuring that the Cen-
ter is complying with all the requirements of the
† HR 6 EAS 
grant, including providing the full continuum of serv-
ices described in subsection (g)(1)(B). 
(i) PRIVACY.—The provisions of this section, including 
with respect to data reporting and program oversight, shall 
be subject to all applicable Federal and State privacy laws. 
(j) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $10,000,000 for each of fiscal 
years 2019 through 2023 for purposes of carrying out this 
section. 
(k) REPORTS TO CONGRESS.— 
(1) PRELIMINARY
REPORT.—Not later than 3 
years after the date of the enactment of this Act, the 
Secretary shall submit to Congress a preliminary re-
port that analyzes data submitted under subsection 
(h). 
(2) FINAL REPORT.—Not later than 2 years after 
submitting the preliminary report required under 
paragraph (1), the Secretary shall submit to Congress 
a final report that includes— 
(A) an evaluation of the effectiveness of the 
comprehensive services provided by the Centers 
established or operated pursuant to this section 
with respect to health outcomes of the population 
of individuals with substance use disorder who 
receive services from the Center, which shall in-
† HR 6 EAS 
clude an evaluation of the effectiveness of services 
for treatment and recovery support and to reduce 
relapse, recidivism, and overdose; and 
(B) recommendations, as appropriate, re-
garding ways to improve Federal programs re-
lated to substance use disorders, which may in-
clude dissemination of best practices for the 
treatment of substance use disorders to health 
care professionals. 
SEC. 1402. PROGRAM TO SUPPORT COORDINATION AND 
CONTINUATION OF CARE FOR DRUG OVER-
DOSE PATIENTS. 
(a) IN GENERAL.—The Secretary shall identify or fa-
cilitate the development of best practices for— 
(1) emergency treatment of known or suspected 
drug overdose; 
(2) the use of recovery coaches, as appropriate, 
to encourage individuals who experience a non-fatal 
overdose to seek treatment for substance use disorder 
and to support coordination and continuation of care; 
(3) coordination and continuation of care and 
treatment, including, as appropriate, through refer-
rals, of individuals after an opioid overdose; and 
(4) the provision of overdose reversal medication, 
as appropriate.
† HR 6 EAS 
(b) GRANT ESTABLISHMENT AND PARTICIPATION.— 
(1) IN
GENERAL.—The Secretary shall award 
grants on a competitive basis to eligible entities to 
support implementation of voluntary programs for 
care and treatment of individuals after an opioid 
overdose, as appropriate, which may include imple-
mentation of the best practices described in subsection 
(a). 
(2) ELIGIBLE ENTITY.—In this section, the term 
‘‘eligible entity’’ means— 
(A) a State alcohol or drug agency; 
(B) an Indian Tribe or tribal organization; 
or 
(C) an entity that offers treatment or other 
services for individuals in response to, or fol-
lowing, drug overdoses or a drug overdose, in 
consultation with a State alcohol and drug agen-
cy. 
(3) APPLICATION.—An eligible entity desiring a 
grant under this section shall submit an application 
to the Secretary, at such time and in such manner as 
the Secretary may require, that includes— 
(A) evidence that such eligible entity carries 
out, or is capable of contracting and coordi-
† HR 6 EAS 
nating with other community entities to carry 
out, the activities described in paragraph (4); 
(B) evidence that such eligible entity will 
work with a recovery community organization to 
recruit, train, hire, mentor, and supervise recov-
ery coaches and fulfill the requirements described 
in paragraph (4)(A); and 
(C) such additional information as the Sec-
retary may require. 
(4) USE OF GRANT FUNDS.—An eligible entity 
awarded a grant under this section shall use such 
grant funds to— 
(A) hire or utilize recovery coaches to help 
support recovery, including by— 
(i) connecting patients to a continuum 
of care services, such as— 
(I) treatment and recovery sup-
port programs; 
(II) programs that provide non- 
clinical recovery support services; 
(III) peer support networks; 
(IV) recovery community organi-
zations;
† HR 6 EAS 
(V) health care providers, includ-
ing physicians and other providers of 
behavioral health and primary care; 
(VI) education and training pro-
viders; 
(VII) employers; 
(VIII) housing services; and 
(IX) child welfare agencies; 
(ii) providing education on overdose 
prevention and overdose reversal to patients 
and families, as appropriate; 
(iii) providing follow-up services for 
patients after an overdose to ensure contin-
ued recovery and connection to support 
services; 
(iv) collecting and evaluating outcome 
data for patients receiving recovery coach-
ing services; and 
(v) providing other services the Sec-
retary determines necessary to help ensure 
continued connection with recovery support 
services, including culturally appropriate 
services, as applicable; 
(B) establish policies and procedures, pur-
suant to Federal and State law, that address the