I 

115TH CONGRESS 

2D SESSION H. R. 5545 

To provide emergency assistance to States, territories, Tribal nations, and 

local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and 

public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient 

systems for the delivery of essential services to individuals with substance 

use disorder and their families. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2018 

Mr. CUMMINGS introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

the Judiciary, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To provide emergency assistance to States, territories, Tribal 

nations, and local areas affected by the opioid epidemic 

and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private 

nonprofit entities to provide for the development, organization, coordination, and operation of more effective and 

cost efficient systems for the delivery of essential services 

to individuals with substance use disorder and their families. 


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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Comprehensive Addiction Resources Emergency Act of 

6 2018’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Purpose. 

Sec. 3. Amendment to the Public Health Service Act. 

‘‘TITLE XXXIV—SUBSTANCE USE AND OPIOID HEALTH 

RESOURCES 

‘‘Subtitle A—Substance Use and Opioid Emergency Relief Grant Program 

‘‘Sec. 3401. Establishment of program of grants. 

‘‘Sec. 3402. Planning council. 

‘‘Sec. 3403. Amount of grant and use of amounts. 

‘‘Sec. 3404. Application. 

‘‘Sec. 3405. Technical assistance. 

‘‘Sec. 3406. Authorization of appropriations. 

‘‘Subtitle B—State and Tribal Substance Use Disorder Prevention and 

Intervention Grant Program 

‘‘Sec. 3411. Establishment of program of grants. 

‘‘Sec. 3412. Amount of grant and use of amounts. 

‘‘Sec. 3413. Application and limitation. 

‘‘Sec. 3414. Technical assistance. 

‘‘Sec. 3415. Authorization of appropriations. 

‘‘Subtitle C—Other Grant Program 

‘‘Sec. 3421. Establishment of grant program. 

‘‘Sec. 3422. Use of amounts. 

‘‘Sec. 3423. Technical assistance. 

‘‘Sec. 3424. Planning and development grants. 

‘‘Sec. 3425. Authorization of appropriations. 

‘‘Subtitle D—Miscellaneous Provisions 

‘‘Sec. 3431. Special projects of national significance. 

‘‘Sec. 3432. Education and training centers. 

‘‘Sec. 3433. Other provisions. 

‘‘Sec. 3434. Standards for substance use disorder treatment and recovery 

facilities. 


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‘‘Sec. 3435. Naloxone distribution program. 

‘‘Sec. 3436. Additional funding for the National Institutes of Health. 

‘‘Sec. 3437. Additional funding for improved data collection and prevention 

of infectious disease transmission. 

‘‘Sec. 3438. Definitions. 

Sec. 4. Amendments to the Controlled Substances Act. 

1 SEC. 2. PURPOSE. 

2 It is the purpose of this Act to provide emergency 

3 assistance to States, territories, Tribal nations, and local 

4 areas that are disproportionately affected by the opioid 

5 epidemic and to make financial assistance available to 

6 States, territories, Tribal nations, local areas, and other 

7 public or private nonprofit entities to provide for the devel8 opment, organization, coordination, and operation of more 

9 effective and cost efficient systems for the delivery of es10 sential services to individuals and families with substance 

11 use disorder. 

12 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

13 ACT. 

14 The Public Health Service Act (42 U.S.C. 201 et 

15 seq.) is amended by adding at the end the following: 


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1 ‘‘TITLE XXXIV—SUBSTANCE USE 

2 AND OPIOID HEALTH RE3 SOURCES 

4 ‘‘Subtitle A—Substance Use and 

5 Opioid Emergency Relief Grant 

6 Program 

7 ‘‘SEC. 3401. ESTABLISHMENT OF PROGRAM OF GRANTS. 

8 ‘‘(a) IN GENERAL.—The Secretary, in coordination 

9 with the Director of the Office of National Drug Control 

10 Policy, shall award grants to eligible localities for the pur11 pose of addressing substance use within such localities. 

12 ‘‘(b) ELIGIBILITY.— 

13 ‘‘(1) IN GENERAL.—To be eligible to receive a 

14 grant under subsection (a) a locality shall— 

15 ‘‘(A) be— 

16 ‘‘(i) a county that can demonstrate 

17 that the rate of drug overdose deaths per 

18 100,000 individuals residing in the county 

19 during the most recent 3-year period for 

20 which such data are available was not less 

21 than the rate of such deaths for the county 

22 that ranked at the 67th percentile of all 

23 counties, as determined by the Secretary; 

24 ‘‘(ii) a county that can demonstrate 

25 that the number of drug overdose deaths 


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1 during the most recent 3-year period for 

2 which such data are available was not less 

3 than the number of such deaths for the 

4 county that ranked at the 90th percentile 

5 of all counties, as determined by the Sec6 retary; or 

7 ‘‘(iii) a city that is located within a 

8 county described in clause (i) or (ii), that 

9 meets the requirements of paragraph (3); 

10 and 

11 ‘‘(B) submit to the Secretary an applica12 tion in accordance with section 3404. 

13 ‘‘(2) MULTIPLE CONTIGUOUS COUNTIES.—In 

14 the case of an eligible county that is contiguous to 

15 one or more other eligible counties within the same 

16 State, the group of counties shall— 

17 ‘‘(A) be considered as a single eligible 

18 county for purposes of a grant under this sec19 tion; 

20 ‘‘(B) submit a single application under sec21 tion 3404; 

22 ‘‘(C) form a joint planning council (for the 

23 purposes of section 3402); and 

24 ‘‘(D) establish, through intergovernmental 

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1 locate funds and substance use disorder treat2 ment services under the grant based on— 

3 ‘‘(i) the number and rate of drug 

4 overdose deaths and nonfatal drug 

5 overdoses in each of the counties that com6 pose the eligible county; 

7 ‘‘(ii) the severity of need for services 

8 in each such county; and 

9 ‘‘(iii) the health and support per10 sonnel needs of each such county. 

11 ‘‘(3) CITIES AND COUNTIES WITHIN MULTIPLE

12 CONTIGUOUS COUNTIES.— 

13 ‘‘(A) IN GENERAL.—A city that is within 

14 an eligible county described in paragraph (1), 

15 or a group of counties that is within a group of 

16 counties determined to be an eligible county 

17 under paragraph (2), shall be eligible to receive 

18 a grant under section 3401 if such city or coun19 ty or group of counties meets the requirements 

20 of subparagraph (B). 

21 ‘‘(B) REQUIREMENTS.—A city or county 

22 meets the requirements of this subparagraph if 

23 such city or county— 


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1 ‘‘(i) except as provided in subpara2 graph (C), has a population of not less 

3 than 50,000 residents; 

4 ‘‘(ii) meets the requirements of para5 graph (1)(A); 

6 ‘‘(iii) submits an application under 

7 section 3404; 

8 ‘‘(iv) establishes a planning council 

9 (for purposes of section 3402); and 

10 ‘‘(v) establishes an administrative 

11 mechanism to allocate funds and services 

12 under the grant based on— 

13 ‘‘(I) the number and rate of drug 

14 overdose deaths and nonfatal drug 

15 overdoses in the city or county; 

16 ‘‘(II) the severity of need for sub17 stance use disorder treatment services 

18 in the city or county; and 

19 ‘‘(III) the health and support 

20 personnel needs of the city or county. 

21 ‘‘(C) POPULATION EXCEPTION.—A city or 

22 county or group of counties that does not meet 

23 the requirements of subparagraph (B)(i) may 

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1 quirement. Such application shall dem2 onstrate— 

3 ‘‘(i) that the needs of the population 

4 to be served are distinct or that addressing 

5 substance use in the service area would be 

6 best served by the formation of an inde7 pendent council; and 

8 ‘‘(ii) that the city or county or group 

9 of counties has the capacity to administer 

10 the funding received under this subtitle. 

11 ‘‘(D) MINIMUM FUNDING.—A city or coun12 ty that meets the requirement of this paragraph 

13 and receives a grant under section 3401 shall 

14 be entitled to an amount of funding under the 

15 grant in an amount that is not less than the 

16 amount determined under section 3403(a) with 

17 respect to such city or county. 

18 ‘‘(4) INDEPENDENT CITY.—Independent cities 

19 that are not located within the territory of a county 

20 shall be treated as eligible counties for purposes of 

21 this subtitle. 

22 ‘‘(5) POLITICAL SUBDIVISIONS.—With respect 

23 to States that do not have a local county system of 

24 governance, the Secretary shall determine the local 

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1 gible to receive a grant under section 3401 and such 

2 subdivisions shall be treated as eligible counties for 

3 purposes of this subtitle. 

4 ‘‘(6) DETERMINATIONS WHERE THERE IS A

5 LACK OF DATA.—The Secretary shall establish eligi6 bility and allocation criteria related to the prevalence 

7 of drug overdose deaths, the mortality rate from 

8 drug overdoses, and that provides an equivalent 

9 measure of need for funding for cities and counties 

10 for which the data described in paragraph (1)(A) or 

11 (2)(D)(i) is not available. 

12 ‘‘(7) STUDY.—Not later than 3 years after the 

13 date of enactment of this title, the Comptroller Gen14 eral shall conduct a study to determine whether the 

15 data utilized for purposes of paragraph (1)(A) pro16 vides the most precise measure of local area need re17 lated to substance use and addiction prevalence and 

18 whether additional data would provide more precise 

19 measures of substance use and addiction prevalence 

20 in local areas. Such study shall identify barriers to 

21 collecting or analyzing such data, and make rec22 ommendations for revising the indicators used under 

23 such paragraph to determine eligibility in order to 

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1 ing to provide assistance related to substance use 

2 and addiction. 

3 ‘‘(8) REFERENCE.—For purposes of this sub4 title, the term ‘eligible local area’ includes— 

5 ‘‘(A) a city or county described in para6 graph (1); 

7 ‘‘(B) multiple contiguous counties de8 scribed in paragraph (2); 

9 ‘‘(C) an independent locality described in 

10 paragraph (3); 

11 ‘‘(D) an independent city described in 

12 paragraph (4); and 

13 ‘‘(E) a political subdivision described in 

14 paragraph (5). 

15 ‘‘(c) ADMINISTRATION.— 

16 ‘‘(1) IN GENERAL.—Assistance made available 

17 under a grant awarded under this section shall be 

18 directed to the chief elected official of the eligible 

19 local area who shall administer the grant funds. 

20 ‘‘(2) MULTIPLE CONTIGUOUS COUNTIES.— 

21 ‘‘(A) IN GENERAL.—Except as provided in 

22 subparagraph (B), in the case of an eligible 

23 county described in subsection (b)(2), assist24 ance made available under a grant awarded 

25 under this section shall be directed to the chief 


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1 elected official of the particular county des2 ignated in the application submitted for the 

3 grant under section 3404. Such chief elected of4 ficial shall be the administrator of the grant. 

5 ‘‘(B) STATE ADMINISTRATION.—Notwith6 standing subparagraph (A), the eligible county 

7 described in subsection (b)(2) may elect to des8 ignate the chief elected State official of the 

9 State in which the eligible county is located as 

10 the administrator of the grant funds. 

11 ‘‘SEC. 3402. PLANNING COUNCIL. 

12 ‘‘(a) ESTABLISHMENT.—To be eligible to receive a 

13 grant under section 3401, the chief elected official of the 

14 eligible local area shall establish or designate a substance 

15 use disorder treatment and services planning council that 

16 shall, to the maximum extent practicable— 

17 ‘‘(1) be representative of the demographics of 

18 the population of individuals with substance use dis19 order in the area; and 

20 ‘‘(2) include representatives of— 

21 ‘‘(A) health care providers, including feder22 ally qualified health centers, rural health clinics, 

23 Indian health programs as defined in section 4 

24 of the Indian Health Care Improvement Act, 

25 urban Indian organizations as defined in section 


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1 4 of the Indian Health Care Improvement Act, 

2 Native Hawaiian organizations as defined in 

3 section 12 of the Native Hawaiian Health Care 

4 Act of 1988, and facilities operated by the De5 partment of Veterans Affairs; 

6 ‘‘(B) community-based health, harm reduc7 tion, or addiction service organizations, includ8 ing, where applicable, representatives of Drug 

9 Free Communities Coalition grantees; 

10 ‘‘(C) social service providers, including pro11 viders of housing and homelessness services and 

12 recovery residence providers; 

13 ‘‘(D) mental health care providers; 

14 ‘‘(E) local public health agencies; 

15 ‘‘(F) law enforcement officials, including 

16 officials from High Intensity Drug Trafficking 

17 Area program, where applicable; 

18 ‘‘(G) affected communities, including indi19 viduals with substance use disorder or a history 

20 of substance use disorder, including individuals 

21 in recovery from substance use disorders; 

22 ‘‘(H) State governments, including the 

23 State Medicaid agency and the Single State 

24 Agency for Substance Abuse Services; 

25 ‘‘(I) local governments; 


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1 ‘‘(J) non-elected community leaders; 

2 ‘‘(K) substance use disorder treatment pro3 viders; 

4 ‘‘(L) Indian tribes and tribal organizations 

5 as defined in section 4 of the Indian Self-Deter6 mination and Education Assistance Act; 

7 ‘‘(M) urban Indians as defined in section 4 

8 of the Indian Health Care Improvement Act; 

9 ‘‘(N) historically underserved groups and 

10 subpopulations; 

11 ‘‘(O) individuals who were formerly incar12 cerated; 

13 ‘‘(P) organizations serving individuals who 

14 are currently or were formerly incarcerated; 

15 ‘‘(Q) representatives of Federal agencies; 

16 ‘‘(R) representatives of organizations that 

17 provide services to youth at risk of substance 

18 use; 

19 ‘‘(S) representatives of medical examiners 

20 or coroners; 

21 ‘‘(T) representatives of labor unions and 

22 the workplace community; and 

23 ‘‘(U) representatives of local fire depart24 ments and emergency medical services. 

25 ‘‘(b) METHOD OF PROVIDING FOR COUNCIL.— 


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1 ‘‘(1) IN GENERAL.—In providing for a council 

2 for purposes of subsection (a), the chief elected offi3 cial of the eligible local area may establish the coun4 cil directly or designate an existing entity to serve as 

5 the council, subject to paragraph (2). 

6 ‘‘(2) CONSIDERATION REGARDING DESIGNATION

7 OF COUNCIL.—In making a determination of wheth8 er to establish or designate a council under para9 graph (1), the chief elected official shall give priority 

10 to the designation of an existing entity that has 

11 demonstrated experience in the provision of health 

12 and support services to individuals with substance 

13 use disorder within the eligible local area, that has 

14 a structure that recognizes the Federal trust respon15 sibility when spending Federal health care dollars, 

16 and that has demonstrated a commitment to re17 specting the obligation of government agencies using 

18 Federal dollars to consult with Indian tribes and 

19 confer with Urban Indian health programs. 

20 ‘‘(3) JOINT COUNCIL.—The Secretary shall es21 tablish a process to permit an eligible local area that 

22 is not contiguous with any other eligible local area 

23 to form a joint planning council with such other eli24 gible local area or areas, as long as such areas are 

25 located in geographical proximity to each other, as 


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1 determined by the Secretary, and submit a joint ap2 plication under section 3404. 

3 ‘‘(4) JOINT COUNCIL ACROSS STATE LINES.— 

4 Eligible local areas may form a joint planning coun5 cil with other eligible local areas across State lines 

6 if such areas are located in geographical proximity 

7 to each other, as determined by the Secretary, sub8 mit a joint application under section 3404, and es9 tablish intergovernmental agreements to allow the 

10 administration of the grant across State lines. 

11 ‘‘(c) MEMBERSHIP.—Members of the planning coun12 cil established or designated under subsection (a) shall— 

13 ‘‘(1) be nominated and selected through an 

14 open process; 

15 ‘‘(2) elect from among their membership a chair 

16 and vice chair; 

17 ‘‘(3) include at least one representative from 

18 Indian tribes located within any eligible local area 

19 that receives funding under the grant program es20 tablished in section 3401; and 

21 ‘‘(4) serve no more than 3 consecutive years on 

22 the planning council. 

23 ‘‘(d) MEMBERSHIP TERMS.—Members of the plan24 ning council established or designated under subsection 


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1 (a) may serve additional terms if nominated and selected 

2 through the process established in subsection (c)(1). 

3 ‘‘(e) DUTIES.—The planning council established or 

4 designated under subsection (a) shall— 

5 ‘‘(1) establish priorities for the allocation of 

6 grant funds within the eligible local area that em7 phasize reducing drug overdose and substance use 

8 disorder through evidence-based interventions in 

9 both community and criminal justice settings and 

10 that are based on— 

11 ‘‘(A) the use by the grantee of substance 

12 use disorder treatment and intervention strate13 gies that comply with best practices identified 

14 by the Secretary; 

15 ‘‘(B) the demonstrated or probable cost-ef16 fectiveness of proposed substance use disorder 

17 treatment services; 

18 ‘‘(C) the health priorities of the commu19 nities within the eligible local area that are af20 fected by substance use; 

21 ‘‘(D) the priorities and needs of individuals 

22 with substance use disorder; and 

23 ‘‘(E) the availability of other governmental 

24 and nongovernmental services; 


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1 ‘‘(2) ensure the use of grant funds are con2 sistent with any existing State or local plan regard3 ing the provision of substance use disorder treat4 ment services to individuals with substance use dis5 order; 

6 ‘‘(3) in the absence of a State or local plan, 

7 work with local public health agencies to develop a 

8 comprehensive plan for the organization and delivery 

9 of substance use disorder treatment services; 

10 ‘‘(4) regularly assess the efficiency of the ad11 ministrative mechanism in rapidly allocating funds 

12 to support evidence-based substance use disorder 

13 treatment services in the areas of greatest need 

14 within the eligible local area; 

15 ‘‘(5) work with local public health agencies to 

16 determine the size and demographics of the popu17 lation of individuals with substance use disorders 

18 and the types of substance use that are most preva19 lent in the eligible local area; 

20 ‘‘(6) work with local public health agencies to 

21 determine the needs of such population, including 

22 the need for substance use disorder treatment serv23 ices; 

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1 fected subpopulations and historically underserved 

2 communities, including infrastructure and capacity 

3 shortcomings of providers that contribute to these 

4 disparities; 

5 ‘‘(8) work with local public agencies to establish 

6 methods for obtaining input on community needs 

7 and priorities, including by partnering with organi8 zations that serve targeted communities experiencing 

9 high opioid related health disparities to gather data 

10 using culturally attuned data collection methodolo11 gies; 

12 ‘‘(9) coordinate with Federal grantees that pro13 vide substance use disorder treatment services within 

14 the eligible local area; and 

15 ‘‘(10) annually assess the effectiveness of the 

16 substance use disorder treatment services being sup17 ported by the grant received by the eligible local 

18 area, including— 

19 ‘‘(A) reductions in the rates of overdose 

20 and death from substance use disorders; 

21 ‘‘(B) rates of discontinuation from sub22 stance use disorder treatment services; 

23 ‘‘(C) long-term outcomes among individ24 uals receiving treatment for substance use dis25 orders; and 


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1 ‘‘(D) the availability of substance use dis2 order treatment services needed by individuals 

3 with substance use disorders over their life4 times. 

5 ‘‘(f) CONFLICTS OF INTEREST.— 

6 ‘‘(1) IN GENERAL.—The planning council under 

7 subsection (a) may not be directly involved in the 

8 administration of a grant under section 3401. 

9 ‘‘(2) REQUIRED AGREEMENTS.—An individual 

10 may serve on the planning council under subsection 

11 (a) only if the individual agrees that if the individual 

12 has a financial interest in an entity, if the individual 

13 is an employee of a public or private entity, or if the 

14 individual is a member of a public or private organi15 zation, and such entity or organization is seeking 

16 amounts from a grant under section 3401, the indi17 vidual will not, with respect to the purpose for which 

18 the entity seeks such amounts, participate (directly 

19 or in an advisory capacity) in the process of select20 ing entities to receive such amounts for such pur21 pose. 

22 ‘‘(g) GRIEVANCE PROCEDURES.—A planning council 

23 under subsection (a) shall develop procedures for address24 ing grievances with respect to funding under this subtitle, 

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1 not be resolved to binding arbitration. Such procedures 

2 shall be described in the by-laws of the planning council. 

3 ‘‘(h) PUBLIC DELIBERATIONS.—With respect to a 

4 planning council under subsection (a), in accordance with 

5 criteria established by the Secretary, the following applies: 

6 ‘‘(1) The meetings of the council shall be open 

7 to the public and shall be held only after adequate 

8 notice to the public. 

9 ‘‘(2) The records, reports, transcripts, minutes, 

10 agenda, or other documents which were made avail11 able to or prepared for or by the council shall be 

12 available for public inspection and copying at a sin13 gle location. 

14 ‘‘(3) Detailed minutes of each meeting of the 

15 council shall be kept. The accuracy of all minutes 

16 shall be certified to by the chair of the council. 

17 ‘‘(4) This subparagraph does not apply to any 

18 disclosure of information of a personal nature that 

19 would constitute a clearly unwarranted invasion of 

20 personal privacy, including any disclosure of medical 

21 information or personnel matters. 

22 ‘‘SEC. 3403. AMOUNT OF GRANT AND USE OF AMOUNTS. 

23 ‘‘(a) AMOUNT OF GRANT.— 

24 ‘‘(1) GRANTS BASED ON RELATIVE NEED OF

25 AREA.— 


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1 ‘‘(A) IN GENERAL.—In carrying out this 

2 subtitle, the Secretary shall make a grant for 

3 each eligible local area for which an application 

4 under section 3404 has been approved. Each 

5 such grant shall be made in an amount deter6 mined in accordance with paragraph (3). 

7 ‘‘(B) EXPEDITED DISTRIBUTION.—Not 

8 later than 90 days after an appropriation be9 comes available to carry out this subtitle for a 

10 fiscal year, the Secretary shall disburse 53 per11 cent of the amount made available under sec12 tion 3406 for carrying out this subtitle for such 

13 fiscal year through grants to eligible local areas 

14 under section 3401, in accordance with sub15 paragraphs (C) and (D). 

16 ‘‘(C) AMOUNT.— 

17 ‘‘(i) IN GENERAL.—Subject to the ex18 tent of amounts made available in appro19 priations Acts, a grant made for purposes 

20 of this subparagraph to an eligible local 

21 area shall be made in an amount equal to 

22 the product of— 

23 ‘‘(I) an amount equal to the 

24 amount available for distribution 


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1 under subparagraph (B) for the fiscal 

2 year involved; and 

3 ‘‘(II) the percentage constituted 

4 by the ratio of the distribution factor 

5 for the eligible local area to the sum 

6 of the respective distribution factors 

7 for all eligible local areas; 

8 which product shall then, as applicable, be 

9 increased under subparagraph (D). 

10 ‘‘(ii) DISTRIBUTION FACTOR.—For 

11 purposes of clause (i)(II), the term ‘dis12 tribution factor’ means— 

13 ‘‘(I) an amount equal to— 

14 ‘‘(aa) the estimated number 

15 of drug overdose deaths in the el16 igible local area, as determined 

17 under clause (iii); or 

18 ‘‘(bb) the estimated number 

19 of non-fatal drug overdoses in the 

20 eligible local area, as determined 

21 under clause (iv); 

22 as determined by the Secretary based 

23 on which distribution factor (item (aa) 

24 or (bb)) will result in the eligible local 


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1 area receiving the greatest amount of 

2 funds; or 

3 ‘‘(II) in the case of an eligible 

4 local area for which the data de5 scribed in subclause (I) is not avail6 able, an amount determined by the 

7 Secretary— 

8 ‘‘(aa) based on other data 

9 the Secretary determines appro10 priate; and 

11 ‘‘(bb) that is related to the 

12 prevalence of non-fatal drug 

13 overdoses, drug overdose deaths, 

14 and the mortality rate from drug 

15 overdoses and provides an equiv16 alent measure of need for fund17 ing. 

18 ‘‘(iii) NUMBER OF DRUG OVERDOSE

19 DEATHS.—The number of drug overdose 

20 deaths determined under this clause for an 

21 eligible county for a fiscal year for pur22 poses of clause (ii) is the number of drug 

23 overdose deaths during the most recent 3- 

24 year period for which such data are avail25 able. 


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1 ‘‘(iv) NUMBER OF NON-FATAL DRUG

2 OVERDOSES.—The number of non-fatal 

3 drug overdose deaths determined under 

4 this clause for an eligible county for a fis5 cal year for purposes of clause (ii) may be 

6 determined by using data including emer7 gency department syndromic data, visits, 

8 or other emergency medical services for 

9 drug-related causes during the most recent 

10 3-year period for which such data are 

11 available. 

12 ‘‘(v) STUDY.—Not later than 3 years 

13 after the date of enactment of this title, 

14 the Comptroller General shall conduct a 

15 study to determine whether the data uti16 lized for purposes of clause (ii) provide the 

17 most precise measure of local area need re18 lated to substance use and addiction preva19 lence in local areas and whether additional 

20 data would provide more precise measures 

21 of substance use and addiction prevalence 

22 in local areas. Such study shall identify 

23 barriers to collecting or analyzing such 

24 data, and make recommendations for revis25 ing the distribution factors used under 


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1 such clause to determine funding levels in 

2 order to direct funds to the local areas in 

3 most need of funding to provide substance 

4 use disorder treatment services. 

5 ‘‘(vi) REDUCTIONS IN AMOUNTS.—If a 

6 local area that is an eligible local area for 

7 a year loses such eligibility in a subsequent 

8 year based on the failure to meet the re9 quirements of section 3401(b)(1)(A), such 

10 area will remain eligible to receive— 

11 ‘‘(I) for such subsequent year, an 

12 amount equal to 80 percent of the 

13 amount received under the grant in 

14 the previous year; and 

15 ‘‘(II) for the second such subse16 quent year, an amount equal to 50 

17 percent of the amount received in the 

18 such previous year. 

19 ‘‘(2) SUPPLEMENTAL GRANTS.— 

20 ‘‘(A) IN GENERAL.—The Secretary shall 

21 disburse the remainder of amounts not dis22 bursed under paragraph (1) for such fiscal year 

23 for the purpose of making grants to cities and 

24 counties whose application under section 

25 3404— 


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1 ‘‘(i) contains a report concerning the 

2 dissemination of emergency relief funds 

3 under paragraph (1) and the plan for utili4 zation of such funds, if applicable; 

5 ‘‘(ii) demonstrates the need in such 

6 local area, on an objective and quantified 

7 basis, for supplemental financial assistance 

8 to combat substance use disorder; 

9 ‘‘(iii) demonstrates the existing com10 mitment of local resources of the area, 

11 both financial and in-kind, to combating 

12 substance use disorder; 

13 ‘‘(iv) demonstrates the ability of the 

14 area to utilize such supplemental financial 

15 resources in a manner that is immediately 

16 responsive and cost effective; 

17 ‘‘(v) demonstrates that resources will 

18 be allocated in accordance with the local 

19 demographic incidence of substance use 

20 disorders and drug overdose mortality; 

21 ‘‘(vi) demonstrates the inclusiveness of 

22 affected communities and individuals with 

23 substance use disorders, including those 

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1 proportionately affected or historically un2 derserved; 

3 ‘‘(vii) demonstrates the manner in 

4 which the proposed services are consistent 

5 with the local needs assessment and the 

6 statewide coordinated statement of need 

7 required in section 3413(e); 

8 ‘‘(viii) demonstrates success in identi9 fying individuals with substance use dis10 orders; and 

11 ‘‘(ix) demonstrates that support for 

12 substance use disorder treatment services 

13 is organized to maximize the value to the 

14 population to be served with an appro15 priate mix of substance use disorder treat16 ment services and attention to transition in 

17 care. 

18 ‘‘(B) AMOUNT.— 

19 ‘‘(i) IN GENERAL.—The amount of 

20 each grant made for purposes of this para21 graph shall be determined by the Sec22 retary. In making such determination, the 

23 Secretary shall consider— 


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1 ‘‘(I) the rate of drug overdose 

2 deaths per 100,000 population in the 

3 eligible local area; and 

4 ‘‘(II) the increasing need for sub5 stance use disorder treatment serv6 ices, including relative rates of in7 crease in the number of drug 

8 overdoses or drug overdose deaths, re9 cent increases in drug overdoses or 

10 drug overdose deaths since data was 

11 provided under section 3401(b), if ap12 plicable. 

13 ‘‘(ii) DEMONSTRATED NEED.—The 

14 factors considered by the Secretary in de15 termining whether a local area has a dem16 onstrated need for purposes of clause 

17 (i)(II) may include any or all of the fol18 lowing: 

19 ‘‘(I) The unmet need for sub20 stance use disorder treatment serv21 ices, including factors identified in 

22 subparagraph (B)(i)(II). 

23 ‘‘(II) Relative rates of increase in 

24 the number of drug overdoses or drug 

25 overdose deaths. 


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1 ‘‘(III) The relative rates of in2 crease in the number of drug 

3 overdoses or drug overdose deaths 

4 within new or emerging subpopula5 tions. 

6 ‘‘(IV) The current prevalence of 

7 substance use disorders. 

8 ‘‘(V) Relevant factors related to 

9 the cost and complexity of delivering 

10 substance use disorder treatment serv11 ices to individuals in the eligible local 

12 area. 

13 ‘‘(VI) The impact of co-morbid 

14 factors, including co-occurring condi15 tions, determined relevant by the Sec16 retary. 

17 ‘‘(VII) The prevalence of home18 lessness among individuals with sub19 stance use disorders. 

20 ‘‘(VIII) The relevant factors that 

21 limit access to health care, including 

22 geographic variation, adequacy of 

23 health insurance coverage, and lan24 guage barriers. 


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1 ‘‘(IX) The impact of a decline in 

2 the amount received pursuant to para3 graph (1) on substance use disorder 

4 treatment services available to all in5 dividuals with substance use disorders 

6 identified and eligible under this sub7 title. 

8 ‘‘(X) The increasing incidence in 

9 conditions related to substance use, 

10 including hepatitis C, human immuno11 deficiency virus, hepatitis B and other 

12 infections associated with injection 

13 drug use. 

14 ‘‘(C) APPLICATION OF PROVISIONS.—A 

15 local area that receives a grant under this para16 graph— 

17 ‘‘(i) shall use amounts received in ac18 cordance with subsection (b); 

19 ‘‘(ii) shall not have to meet the eligi20 ble criteria in section 3401(b); and 

21 ‘‘(iii) shall not have to establish a 

22 planning council under section 3402. 

23 ‘‘(3) AMOUNT OF GRANT TO TRIBAL GOVERN24 MENTS.— 


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1 ‘‘(A) INDIAN TRIBES.—In this section, the 

2 term ‘Indian tribe’ has the meaning given such 

3 term in section 4 of the Indian Self-Determina4 tion and Education Assistance Act. 

5 ‘‘(B) FORMULA GRANTS.—The Secretary, 

6 acting through the Indian Health Service, shall 

7 use 10 percent of the amount available under 

8 section 3406 for each fiscal year to provide for9 mula grants to Indian tribes disproportionately 

10 affected by substance use, in an amount deter11 mined pursuant to a formula and eligibility cri12 teria developed by the Secretary in consultation 

13 with Indian tribes, for the purposes of address14 ing substance use. 

15 ‘‘(C) USE OF AMOUNTS.—Notwithstanding 

16 any requirements in this section, an Indian 

17 tribe may use amounts provided under grants 

18 awarded under this paragraph for the uses 

19 identified in subsection (b) and any other activi20 ties determined appropriate by the Secretary, in 

21 consultation with Indian tribes. 

22 ‘‘(b) USE OF AMOUNTS.— 

23 ‘‘(1) REQUIREMENTS.—The Secretary may not 

24 make a grant under section 3401 to an eligible local 


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1 area unless the chief elected official of the area 

2 agrees that— 

3 ‘‘(A) the allocation of funds and services 

4 within the area under the grant will be made in 

5 accordance with the priorities established by the 

6 substance use disorder treatment services plan7 ning council; and 

8 ‘‘(B) funds provided under this grant will 

9 be expended for— 

10 ‘‘(i) prevention services described in 

11 paragraph (3); 

12 ‘‘(ii) core medical services described in 

13 paragraph (4); 

14 ‘‘(iii) recovery and support services 

15 described in paragraph (5); 

16 ‘‘(iv) early intervention and engage17 ment services described in paragraph (6); 

18 ‘‘(v) harm reduction services described 

19 in paragraph (7); 

20 ‘‘(vi) financial assistance with health 

21 insurance described in paragraph (8); and 

22 ‘‘(vii) administrative expenses de23 scribed in paragraph (10). 

24 ‘‘(2) DIRECT FINANCIAL ASSISTANCE.— 


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1 ‘‘(A) IN GENERAL.—An eligible local area 

2 shall use amounts received under a grant under 

3 section 3401 to provide direct financial assist4 ance to eligible entities for the purpose of pro5 viding prevention services, core medical services, 

6 recovery and support services, harm reduction 

7 services, and early intervention and engagement 

8 services. 

9 ‘‘(B) APPROPRIATE ENTITIES.—Direct fi10 nancial assistance may be provided under sub11 paragraph (A) to public or nonprofit private en12 tities, or private for-profit entities if such enti13 ties are the only available provider of quality 

14 substance use disorder treatment services in the 

15 area. 

16 ‘‘(3) PREVENTION SERVICES.— 

17 ‘‘(A) IN GENERAL.—For purposes of this 

18 subsection, the term ‘prevention services’ means 

19 services, programs, or multi-sector strategies to 

20 prevent substance use disorder (such as evi21 dence-based education campaigns, community22 based prevention programs, opioid diversion, 

23 collection and disposal or unused opioids, and 

24 services to at-risk populations). 


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1 ‘‘(B) LIMIT.—An eligible local area may 

2 use not to exceed 20 percent of the amount of 

3 the grant under section 3401 for prevention 

4 services. An eligible local area may apply to the 

5 Secretary for a waiver of this subparagraph. 

6 ‘‘(4) CORE MEDICAL SERVICES.—For purposes 

7 of this subsection, the term ‘core medical services’ 

8 means the following evidence-based services provided 

9 to individuals with substance use disorder or at risk 

10 for developing substance use disorder: 

11 ‘‘(A) Substance use disorder treatments, 

12 including clinical stabilization services, with13 drawal management and detoxification, inten14 sive inpatient treatment, intensive outpatient 

15 treatment, all forms of Federally-approved 

16 medication-assisted treatment, outpatient treat17 ment, and residential recovery treatment. 

18 ‘‘(B) Outpatient and ambulatory health 

19 services, including those administered by Feder20 ally qualified health centers and rural health 

21 clinics. 

22 ‘‘(C) Hospice services. 

23 ‘‘(D) Mental health services. 

24 ‘‘(E) Naloxone procurement, distribution, 

25 and training. 


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1 ‘‘(F) Pharmaceutical assistance and diag2 nostic testing related to the management of 

3 substance-use disorders a co-morbid conditions. 

4 ‘‘(G) Home and community based health 

5 services. 

6 ‘‘(H) Comprehensive Case Management, 

7 including substance use disorder treatment ad8 herence services. 

9 ‘‘(I) Health insurance enrollment and cost10 sharing assistance in accordance with para11 graph (8). 

12 ‘‘(5) RECOVERY AND SUPPORT SERVICES.—For 

13 purposes of paragraph (1)(B)(ii), the term ‘recovery 

14 and support services’ means services, subject to the 

15 approval of the Secretary, that are provided to indi16 viduals with substance use disorder, including resi17 dential recovery treatment and housing, including 

18 for individuals receiving medication-assisted treat19 ment, long term recovery services, 24/7 hotline crisis 

20 center support, medical transportation services, res21 pite care for persons caring for individuals with sub22 stance use disorder, child care and family services 

23 while an individual is receiving inpatient treatment 

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1 ices, and referrals for job training and career serv2 ices, housing, legal services, and child care and fam3 ily services. 

4 ‘‘(6) EARLY INTERVENTION AND ENGAGEMENT

5 SERVICES.—For purposes of this section, the term 

6 ‘early intervention and engagement services’ means 

7 services to provide rapid access to substance use dis8 order treatment, counseling provided to individuals 

9 who have misused substances, who have experienced 

10 an overdose, or are at risk of developing substance 

11 use disorder, and the provision of referrals to facili12 tate the access of such individuals to core medical 

13 services or recovery and support services. The enti14 ties through which such services may be provided in15 clude emergency rooms, fire departments and emer16 gency medical services, detention facilities, homeless 

17 shelters, law enforcement agencies, health care 

18 points of entry specified by eligible local areas, Fed19 erally qualified health centers, and rural health clin20 ics. 

21 ‘‘(7) HARM REDUCTION SERVICES.—For pur22 poses of this section, the term ‘harm reduction serv23 ices’ means evidence-based services provided to indi24 viduals engaging in substance use that reduce the 


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1 risk of infectious disease transmission, overdose, or 

2 death, including by increasing access to health care. 

3 ‘‘(8) AFFORDABLE HEALTH INSURANCE COV4 ERAGE.—An eligible local area may use amounts 

5 provided under a grant awarded under section 3401 

6 to establish a program of financial assistance to as7 sist eligible individuals with substance use disorder 

8 in— 

9 ‘‘(A) enrolling in health insurance cov10 erage; or 

11 ‘‘(B) affording health care services, includ12 ing assistance paying cost-sharing amounts, in13 cluding premiums. 

14 ‘‘(9) REQUIREMENT OF STATUS AS MEDICAID

15 PROVIDER.— 

16 ‘‘(A) PROVISION OF SERVICE.—Subject to 

17 paragraph (2), the Secretary may not make a 

18 grant under section 3401 for the provision of 

19 substance use disorder treatment services under 

20 this section in an eligible local area unless, in 

21 the case of any such service that is available 

22 pursuant to the State plan approved under title 

23 XIX of the Social Security Act for the State— 

24 ‘‘(i) the political subdivision involved 

25 will provide the service directly, and the 


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1 political subdivision has entered into a par2 ticipation agreement under the State plan 

3 and is qualified to receive payments under 

4 such plan; or 

5 ‘‘(ii) the eligible local area involved 

6 will enter into an agreement with a public 

7 or nonprofit private entity under which the 

8 entity will provide the service, and the enti9 ty has entered into such a participation 

10 agreement and is qualified to receive such 

11 payments. 

12 ‘‘(B) WAIVER.— 

13 ‘‘(i) IN GENERAL.—In the case of an 

14 entity making an agreement pursuant to 

15 subparagraph (A)(ii) regarding the provi16 sion of substance use disorder treatment 

17 services, the requirement established in 

18 such subparagraph shall be waived by the 

19 substance use planning council for the area 

20 involved if the entity does not, in providing 

21 health care services, impose a charge or ac22 cept reimbursement available from any 

23 third-party payor, including reimbursement 

24 under any insurance policy or under any 

25 Federal or State health benefits program. 


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1 ‘‘(ii) DETERMINATION.—A determina2 tion by the substance use planning council 

3 of whether an entity referred to in clause 

4 (i) meets the criteria for a waiver under 

5 such clause shall be made without regard 

6 to whether the entity accepts voluntary do7 nations for the purpose of providing serv8 ices to the public. 

9 ‘‘(10) ADMINISTRATION AND PLANNING.—An 

10 eligible local area shall not use in excess of 10 per11 cent of amounts received under a grant under sec12 tion 3401 for administration, accounting, reporting, 

13 and program oversight functions, including the de14 velopment of systems to improve data collection and 

15 data sharing. 

16 ‘‘(11) INCARCERATED INDIVIDUALS.—Amounts 

17 received under a grant under section 3401 may be 

18 used to provide substance use disorder treatment 

19 services to currently incarcerated individuals. 

20 ‘‘SEC. 3404. APPLICATION. 

21 ‘‘(a) IN GENERAL.—To be eligible to receive a grant 

22 under section 3401, an eligible local area shall prepare and 

23 submit to the Secretary an application in such form, and 

24 containing such information, as the Secretary shall re25 quire, including— 


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1 ‘‘(1) a complete accounting of the disbursement 

2 of any prior grants received under this subtitle by 

3 the applicant and the results achieved through such 

4 disbursements; 

5 ‘‘(2) a demonstration of the extent of local need 

6 for the funds under the grant and a plan for pro7 posed substance use disorder treatment services that 

8 is consistent with local needs, including a com9 prehensive plan for the use of the grant funds devel10 oped by the planning council established under sec11 tion 3402, except that the planning council require12 ment shall not apply with respect to areas receiving 

13 supplemental grant funds under section 3403(a)(2); 

14 ‘‘(3) a demonstration that the area will use 

15 funds in a manner that provides substance use dis16 order treatment services compliant with the evi17 dence-based standards developed in accordance with 

18 section 3434, including all forms of Federally-ap19 proved medication-assisted treatments; 

20 ‘‘(4) information on the number of individuals 

21 likely to be served by the funds sought, including de22 mographic data on the populations to be served; 

23 ‘‘(5) key outcomes that will be measured by all 

24 entities that receive assistance, as well as an expla25 nation of how the outcomes will be measured; 


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1 ‘‘(6) a demonstration that resources provided 

2 under the grant will be allocated in accordance with 

3 the local demographic incidence of substance use, in4 cluding allocations for services for children, youths, 

5 and women; 

6 ‘‘(7) a demonstration that funds received from 

7 a grant under this subtitle in any prior year were ex8 pended in accordance with the priorities established 

9 by the planning council; 

10 ‘‘(8) a demonstration that at least one rep11 resentative from Indian tribes located within any eli12 gible local area are included in the membership of a 

13 planning council; 

14 ‘‘(9) a demonstration that the confidentiality of 

15 individuals receiving substance use disorder treat16 ment services will be maintained in a manner not in17 consistent with applicable law; and 

18 ‘‘(10) an explanation of how income, asset, and 

19 medical expense criteria will be established and ap20 plied to those who qualify for assistance under the 

21 program under this subtitle. 

22 ‘‘(b) ASSURANCES.—To be eligible to receive a grant 

23 under section 3401, the application submitted by the eligi24 ble local area shall include assurances adequate to en25 sure— 


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1 ‘‘(1) that funds received under the grant will be 

2 utilized to supplement not supplant other State or 

3 local funds made available in the year for which the 

4 grant is awarded to provide substance use disorder 

5 treatment services; 

6 ‘‘(2) that the political subdivisions within the el7 igible local area will maintain the level of expendi8 tures by such political subdivisions for substance 

9 use-related services at a level that is equal to the 

10 level of such expenditures by such political subdivi11 sions for the preceding fiscal year; 

12 ‘‘(3) that political subdivisions within the eligi13 ble local area will not use funds received under a 

14 grant awarded under section 3401 in maintaining 

15 the level of substance use disorder treatment services 

16 as required in paragraph (2); 

17 ‘‘(4) that substance use disorder treatment 

18 services provided with assistance made available 

19 under the grant will be provided without regard— 

20 ‘‘(A) to the ability of the individual to pay 

21 for such services; and 

22 ‘‘(B) to the current or past health condi23 tion of the individual to be served; 

24 ‘‘(5) that substance use disorder treatment 

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1 sible to low-income individuals with substance use 

2 disorder, and to individuals with substance use dis3 order residing in rural areas; 

4 ‘‘(6) that a program of outreach will be pro5 vided to low-income individuals with substance use 

6 disorder to inform such individuals of substance use 

7 disorder treatment services, and to individuals with 

8 substance use disorder residing in rural areas; and 

9 ‘‘(7) that funds received under a grant awarded 

10 under this subtitle will not be utilized to make pay11 ments for any item or service to the extent that pay12 ment has been made, or can reasonably be expected 

13 to be made, with respect to that item or service 

14 under any State compensation program, under an 

15 insurance policy, or under any Federal or State 

16 health benefits program (except for a program ad17 ministered by, or providing the services of, the In18 dian Health Service). 

19 ‘‘(c) REQUIREMENTS REGARDING IMPOSITION OF

20 CHARGES FOR SERVICES.— 

21 ‘‘(1) IN GENERAL.—The Secretary may not 

22 make a grant under section 3401 to an eligible local 

23 area unless the eligible local area provides assur24 ances that in the provision of substance use disorder 


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1 treatment services with assistance provided under 

2 the grant— 

3 ‘‘(A) in the case of individuals with an in4 come less than or equal to 138 percent of the 

5 official poverty level, the provider will not im6 pose charges on any such individual for the 

7 services provided under the grant; 

8 ‘‘(B) in the case of individuals with an in9 come greater than 138 percent of the official 

10 poverty level, the provider will impose a charge 

11 on each such individual according to a schedule 

12 of charges made available to the public; 

13 ‘‘(C) in the case of individuals with an in14 come greater than 138 percent of the official 

15 poverty level but not exceeding 200 percent of 

16 such poverty level, the provider will not, for an 

17 calendar year, impose charges in an amount ex18 ceeding 5 percent of the annual gross income of 

19 the individual; 

20 ‘‘(D) in the case of individuals with an in21 come greater than 200 percent of the official 

22 poverty level but not exceeding 300 percent of 

23 such poverty level, the provider will not, for any 

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1 ceeding 7 percent of the annual gross income of 

2 the individual involved; 

3 ‘‘(E) in the case of individuals with an in4 come greater than 300 percent of the official 

5 poverty level, the provider will not, for any cal6 endar year, impose charges in an amount ex7 ceeding 15 percent of the annual gross income 

8 of the individual involved; and 

9 ‘‘(F) in the case of eligible American In10 dian and Alaska Native individuals as defined 

11 by section 447.50 of title 42, Code of Federal 

12 Regulations (as in effect on July 1, 2010), the 

13 provider will not impose any charges for sub14 stance use disorder treatment services, includ15 ing any charges or cost-sharing prohibited by 

16 section 1402(d) of the Patient Protection and 

17 Affordable Care Act. 

18 ‘‘(2) CHARGES.—With respect to compliance 

19 with the assurances made under paragraph (1), an 

20 eligible local area may, in the case of individuals 

21 subject to a charge— 

22 ‘‘(A) assess the amount of the charge in 

23 the discretion of the area, including imposing 

24 only a nominal charge for the provision of sub25 stance use disorder treatment services, subject 


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1 to the provisions of the paragraph regarding 

2 public schedules and regarding limitations on 

3 the maximum amount of charges; and 

4 ‘‘(B) take into consideration the total med5 ical expenses of individuals in assessing the 

6 amount of the charge, subject to such provi7 sions. 

8 ‘‘(3) AGGREGATE CHARGES.—The Secretary 

9 may not make a grant under section 3401 to an eli10 gible local area unless the area agrees that the limi11 tations on charges for substance use disorder treat12 ment services under this subsection applies to the 

13 annual aggregate of charges imposed for such serv14 ices, however the charges are characterized, includes 

15 enrollment fees, premiums, deductibles, cost sharing, 

16 co-payments, co-insurance costs, or any other 

17 charges. 

18 ‘‘(d) INDIAN TRIBES.—Any application requirements 

19 for grants distributed in accordance with section 

20 3403(a)(3) shall be developed by the Secretary in con21 sultation with Indian tribes. 

22 ‘‘SEC. 3405. TECHNICAL ASSISTANCE. 

23 ‘‘The Secretary shall, beginning on the date of enact24 ment of this title, provide technical assistance, including 

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1 tors under this title to assist newly eligible local areas in 

2 the establishment of planning councils and, to assist enti3 ties in complying with the requirements of this subtitle 

4 in order to make such areas eligible to receive a grant 

5 under this subtitle. The Secretary may make planning 

6 grants available to eligible local areas, in an amount not 

7 to exceed $75,000 for any area, that is projected to be 

8 eligible for funding under section 3401 in the following 

9 fiscal year. Such grant amounts shall be deducted from 

10 the first year formula award to eligible local areas accept11 ing such grants. 

12 ‘‘SEC. 3406. AUTHORIZATION OF APPROPRIATIONS. 

13 ‘‘There is authorized to be appropriated to carry out 

14 this subtitle— 

15 ‘‘(1) $2,700,000,000 for fiscal year 2019; 

16 ‘‘(2) $2,700,000,000 for fiscal year 2020; 

17 ‘‘(3) $2,700,000,000 for fiscal year 2021; 

18 ‘‘(4) $2,700,000,000 for fiscal year 2022; 

19 ‘‘(5) $2,700,000,000 for fiscal year 2023; 

20 ‘‘(6) $2,700,000,000 for fiscal year 2024; 

21 ‘‘(7) $2,700,000,000 for fiscal year 2025; 

22 ‘‘(8) $2,700,000,000 for fiscal year 2026; 

23 ‘‘(9) $2,700,000,000 for fiscal year 2027; and 

24 ‘‘(10) $2,700,000,000 for fiscal year 2028. 


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1 ‘‘Subtitle B—State and Tribal Sub2 stance Use Disorder Prevention 

3 and Intervention Grant Pro4 gram 

5 ‘‘SEC. 3411. ESTABLISHMENT OF PROGRAM OF GRANTS. 

6 ‘‘The Secretary, acting in coordination with the Di7 rector of the Office of National Drug Control Policy, shall 

8 award grants to States, territories, and tribal governments 

9 for the purpose of addressing substance use within such 

10 States. 

11 ‘‘SEC. 3412. AMOUNT OF GRANT AND USE OF AMOUNTS. 

12 ‘‘(a) AMOUNT OF GRANT TO STATES AND TERRI13 TORIES.— 

14 ‘‘(1) IN GENERAL.— 

15 ‘‘(A) EXPEDITED DISTRIBUTION.—Not 

16 later than 90 days after an appropriation be17 comes available, the Secretary shall disburse 50 

18 percent of the amount made available under 

19 section 3415 for carrying out this subtitle for 

20 such fiscal year through grants to States under 

21 section 3411, in accordance with subparagraphs 

22 (B) and (C). 

23 ‘‘(B) MINIMUM ALLOTMENT.—Subject to 

24 the amount made available under section 3415, 

25 the amount of a grant under section 3411 for— 


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1 ‘‘(i) each of the 50 States, the District 

2 of Columbia, and Puerto Rico for a fiscal 

3 year shall be the greater of— 

4 ‘‘(I) $2,000,000; or 

5 ‘‘(II) an amount determined 

6 under the subparagraph (C); and 

7 ‘‘(ii) each territory other than Puerto 

8 Rico for a fiscal year shall be the greater 

9 of— 

10 ‘‘(I) $500,000; or 

11 ‘‘(II) an amount determined 

12 under the subparagraph (C). 

13 ‘‘(C) DETERMINATION.— 

14 ‘‘(i) FORMULA.—For purposes of sub15 paragraph (B), the amount referred to in 

16 this subparagraph for a State (including a 

17 territory) for a fiscal year is— 

18 ‘‘(I) an amount equal to the 

19 amount made available under section 

20 3415 for the fiscal year involved for 

21 grants pursuant to subparagraph (B); 

22 and 

23 ‘‘(II) the percentage constituted 

24 by the sum of— 


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1 ‘‘(aa) the product of 0.85 

2 and the ratio of the State dis3 tribution factor for the State or 

4 territory to the sum of the re5 spective distribution factors for 

6 all States; and 

7 ‘‘(bb) the product of 0.15 

8 and the ratio of the non-local dis9 tribution factor for the State or 

10 territory (as determined under 

11 clause (iv)) to the sum of the re12 spective non-local distribution 

13 factors for all States or terri14 tories. 

15 ‘‘(ii) STATE DISTRIBUTION FACTOR.— 

16 For purposes of clause (i)(II)(aa), the term 

17 ‘State distribution factor’ means an 

18 amount equal to— 

19 ‘‘(I) the estimated number of 

20 drug overdose deaths in the State, as 

21 determined under clause (iii); or 

22 ‘‘(II) the number of non-fatal 

23 drug overdoses in the State, as deter24 mined under clause (iv); 


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1 as determined by the Secretary based on 

2 which distribution factor (subclause (I) or 

3 (II)) will result in the State receiving the 

4 greatest amount of funds. 

5 ‘‘(iii) NUMBER OF DRUG

6 OVERDOSES.—For purposes of clause (ii), 

7 the number of drug overdose deaths deter8 mined under this clause for a State for a 

9 fiscal year is the number of drug overdose 

10 deaths during the most recent 3-year pe11 riod for which such data are available. 

12 ‘‘(iv) NUMBER OF NON-FATAL DRUG

13 OVERDOSES.—For purposes of clause (ii), 

14 the number of non-fatal drug overdose 

15 deaths determined under this clause for 

16 State for a fiscal year for purposes of 

17 clause (ii) may be determined by using 

18 data including emergency department 

19 syndromic data, visits, or other emergency 

20 medical services for drug-related causes 

21 during the most recent 3-year period for 

22 which such data are available. 

23 ‘‘(v) NON-LOCAL DISTRIBUTION FAC24 TORS.—For purposes of clause (i)(II)(bb), 


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1 the term ‘non-local distribution factor’ 

2 means an amount equal to the sum of— 

3 ‘‘(I) the number of drug 

4 overdoses deaths in the State involved, 

5 as determined under clause (iii), or 

6 the number of non-fatal drug 

7 overdoses in the State, based on the 

8 criteria used by the State under 

9 clause (ii); less 

10 ‘‘(II) the total number of drug 

11 overdose deaths or non-fatal drug 

12 overdoses that are within areas in 

13 such State or territory that are eligi14 ble counties under section 3401. 

15 ‘‘(vi) STUDY.—Not later than 3 years 

16 after the date of enactment of this title, 

17 the Comptroller General shall conduct a 

18 study to determine whether the data uti19 lized for purposes of clause (ii) provides 

20 the most precise measure of State need re21 lated to substance use and addiction preva22 lence and whether additional data would 

23 provide more precise measures the levels of 

24 substance use and addiction prevalent in 

25 States. Such study shall identify barriers 


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1 to collecting or analyzing such data, and 

2 make recommendations for revising the 

3 distribution factors used under such clause 

4 to determine funding levels in order to di5 rect funds to the States in most need of 

6 funding to provide substance use disorder 

7 treatment services. 

8 ‘‘(2) SUPPLEMENTAL GRANTS.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (C), the Secretary shall disburse the re11 mainder of amounts not disbursed under para12 graph (1) for such fiscal year for the purpose 

13 of making grants to States whose application— 

14 ‘‘(i) contains a report concerning the 

15 dissemination of emergency relief funds 

16 under paragraph (1) and the plan for utili17 zation of such funds; 

18 ‘‘(ii) demonstrates the need in such 

19 State, on an objective and quantified basis, 

20 for supplemental financial assistance to 

21 combat substance use disorder; 

22 ‘‘(iii) demonstrates the existing com23 mitment of local resources of the State, 

24 both financial and in-kind, to combating 

25 substance use disorder; 


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1 ‘‘(iv) demonstrates the ability of the 

2 State to utilize such supplemental financial 

3 resources in a manner that is immediately 

4 responsive and cost effective; 

5 ‘‘(v) demonstrates that resources will 

6 be allocated in accordance with the local 

7 demographic incidence of substances use 

8 disorders and drug overdose mortality; 

9 ‘‘(vi) demonstrates the inclusiveness of 

10 affected communities and individuals with 

11 substance use disorders, including those 

12 communities and individuals that are dis13 proportionately affected or historically un14 derserved; 

15 ‘‘(vii) demonstrates the manner in 

16 which the proposed services are consistent 

17 with the local needs assessment and the 

18 statewide coordinated statement of need 

19 required under section 3413(e); 

20 ‘‘(viii) demonstrates success in identi21 fying individuals with substance use dis22 orders; and 

23 ‘‘(ix) demonstrates that support for 

24 substance use disorder treatment services 

25 is organized to maximize the value to the 


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1 population to be served with an appro2 priate mix of substance use disorder treat3 ment services and attention to transition in 

4 care. 

5 ‘‘(B) AMOUNT.— 

6 ‘‘(i) IN GENERAL.—The amount of 

7 each grant made for purposes of this para8 graph shall be determined by the Sec9 retary. In making such determination, the 

10 Secretary shall consider: 

11 ‘‘(I) the rate of drug overdose 

12 deaths per 100,000 population in the 

13 State; and 

14 ‘‘(II) the increasing need for sub15 stance use disorder treatment serv16 ices, including relative rates of in17 crease in the number of drug 

18 overdoses or drug overdose deaths, or 

19 recent increases in drug overdoses or 

20 drug overdose deaths since the data 

21 was reported under section 3413. 

22 ‘‘(ii) DEMONSTRATED NEED.—The 

23 factors considered by the Secretary in de24 termining whether a State has a dem25 onstrated need for purposes of subparaVerDate Sep 11 2014 01:45 Apr 21, 2018 Jkt 079200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6201 E:\BILLS\H5545.IH H5545

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1 graph (A)(ii) may include any or all of the 

2 following: 

3 ‘‘(I) The unmet need for such 

4 services, including the factors identi5 fied in clause (i)(II). 

6 ‘‘(II) Relative rates of increase in 

7 the number of drug overdoses or drug 

8 overdose deaths. 

9 ‘‘(III) The relative rates of in10 crease in the number of drug deaths 

11 within new or emerging subpopula12 tions. 

13 ‘‘(IV) The current prevalence of 

14 substance use disorders. 

15 ‘‘(V) Relevant factors related to 

16 the cost and complexity of delivering 

17 substance use disorder treatment serv18 ices to individuals in the State. 

19 ‘‘(VI) The impact of co-morbid 

20 factors, including co-occurring condi21 tions, determined relevant by the Sec22 retary. 

23 ‘‘(VII) The prevalence of home24 lessness among individuals with sub25 stance use disorder. 


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1 ‘‘(VIII) The relevant factors that 

2 limit access to health care, including 

3 geographic variation, adequacy of 

4 health insurance coverage, and lan5 guage barriers. 

6 ‘‘(IX) The impact of a decline in 

7 the amount received pursuant to para8 graph (1) on substance use disorder 

9 treatment services available to all in10 dividuals with substance use disorders 

11 identified and eligible under this sub12 title. 

13 ‘‘(X) The increasing incidence in 

14 conditions related to substance use, 

15 including hepatitis C, human immuno16 deficiency virus, hepatitis B and other 

17 infections associated with injection 

18 drug use. 

19 ‘‘(C) MODEL STANDARDS.— 

20 ‘‘(i) PREFERENCE.—In determining 

21 whether a State will receive funds under 

22 this paragraph, except as provided in 

23 clause (ii), the Secretary shall give pref24 erence to States that have adopted the 


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1 model standards developed in accordance 

2 with section 3434. 

3 ‘‘(ii) REQUIREMENT.—Effective begin4 ning in fiscal year 2025, the Secretary 

5 shall not award a grant under this para6 graph to a State unless that State has 

7 adopted the model standards developed in 

8 accordance with section 3434. 

9 ‘‘(3) AMOUNT OF GRANT TO TRIBAL GOVERN10 MENTS.— 

11 ‘‘(A) INDIAN TRIBES.—In this section, the 

12 term ‘Indian tribe’ has the meaning given such 

13 term in section 4 of the Indian Self-Determina14 tion and Education Assistance Act. 

15 ‘‘(B) FORMULA GRANTS.—The Secretary, 

16 acting through the Indian Health Service, shall 

17 use 10 percent of the amount available under 

18 section 3415 for each fiscal year to provide for19 mula grants to Indian tribes in an amount de20 termined pursuant to a formula and eligibility 

21 criteria developed by the Secretary in consulta22 tion with Indian tribes, for the purposes of ad23 dressing substance use. 

24 ‘‘(C) USE OF AMOUNTS.—Notwithstanding 

25 any requirements in this section, an Indian 


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1 tribe may use amounts provided under grants 

2 awarded under this paragraph for the uses 

3 identified in subsection (b) and any other activi4 ties determined appropriate by the Secretary, in 

5 consultation with Indian tribes. 

6 ‘‘(b) USE OF AMOUNTS.— 

7 ‘‘(1) IN GENERAL.—A State may use amounts 

8 provided under grants awarded under section 3411 

9 for— 

10 ‘‘(A) prevention services described in para11 graph (2); 

12 ‘‘(B) core medical services described in 

13 paragraph (3); 

14 ‘‘(C) recovery and support services de15 scribed in paragraph (4); 

16 ‘‘(D) early intervention and engagement 

17 services described in paragraph (5); 

18 ‘‘(E) harm reduction services described in 

19 paragraph (6); and 

20 ‘‘(F) administrative expenses described in 

21 paragraph (8). 

22 ‘‘(2) PREVENTION SERVICES.— 

23 ‘‘(A) IN GENERAL.—For purposes of this 

24 subsection, the term ‘prevention services’ means 

25 services, programs, or multi-sector strategies to 


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1 prevent substance use disorder (including evi2 dence-based education campaigns, community3 based prevention programs, opioid diversion, 

4 collection and disposal of unused opioids, and 

5 services to at-risk populations). 

6 ‘‘(B) LIMIT.—A State may use not to ex7 ceed 20 percent of the amount of the grant 

8 under section 3411 for prevention services. A 

9 State may apply to the Secretary for a waiver 

10 of this subparagraph. 

11 ‘‘(3) CORE MEDICAL SERVICES.—For purposes 

12 of this subsection, the term ‘core medical services’ 

13 means the following evidence-based services when 

14 provided to individuals with substance use disorder 

15 or at risk for developing substance use disorder: 

16 ‘‘(A) Substance use disorder treatments, 

17 including clinical stabilization services, with18 drawal management and detoxification, inten19 sive inpatient treatment, intensive outpatient 

20 treatment, all forms of Federally-approved 

21 medication-assisted treatment, outpatient treat22 ment, and residential recovery treatment. 

23 ‘‘(B) Outpatient and ambulatory health 

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1 ally qualified health centers and rural health 

2 clinics. 

3 ‘‘(C) Hospice services. 

4 ‘‘(D) Mental health services. 

5 ‘‘(E) Naloxone procurement, distribution, 

6 and training. 

7 ‘‘(F) Pharmaceutical assistance related to 

8 the management of substance-use disorders and 

9 co-morbid conditions. 

10 ‘‘(G) Home and community based health 

11 services. 

12 ‘‘(H) Comprehensive Case Management 

13 and care coordination, including treatment ad14 herence services. 

15 ‘‘(I) Health insurance enrollment and cost16 sharing assistance in accordance with sub17 section (e). 

18 ‘‘(4) RECOVERY AND SUPPORT SERVICES.—For 

19 purposes of paragraph (1)(C), the term ‘recovery 

20 and support services’ means services, subject to the 

21 approval of the Secretary, that are provided to indi22 viduals with substance use disorder, including resi23 dential recovery treatment and housing, including 

24 for individuals receiving medication-assisted treat25 ment, long term recovery services, 24/7 hotline crisis 


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1 center services, medical transportation services, res2 pite care for persons caring for individuals with sub3 stance use disorder, child care and family services 

4 while an individual is receiving inpatient treatment 

5 services or at the time of outpatient services, out6 reach services, peer recovery services, nutrition serv7 ices, and referrals for job training and career serv8 ices, housing, legal services, and child care and fam9 ily services. 

10 ‘‘(5) EARLY INTERVENTION AND ENGAGEMENT

11 SERVICES.—For purposes of this subsection, the 

12 term ‘early intervention and engagement services’ 

13 means services to provide rapid access to substance 

14 use disorder treatment services, counseling provided 

15 to individuals who have misused substances, who 

16 have experienced an overdose, or are at risk of devel17 oping substance use disorder, and the provision of 

18 referrals to facilitate the access of such individuals 

19 to core medical services or recovery and support 

20 services. The entities through which such services 

21 may be provided include emergency rooms, fire de22 partments and emergency medical services, detention 

23 facilities, homeless shelters, law enforcement agen24 cies, health care points of entry specified by eligible 


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1 areas, Federally qualified health centers, and rural 

2 health clinics. 

3 ‘‘(6) HARM REDUCTION SERVICES.—For pur4 poses of this subsection, the term ‘harm reduction 

5 services’ means evidence-based services provided to 

6 individuals engaging in substance use disorder that 

7 reduce the risk of infectious disease transmission, 

8 overdose, or death, including by increasing access to 

9 health care. 

10 ‘‘(7) AFFORDABLE HEALTH INSURANCE COV11 ERAGE.—A State may use amounts provided under 

12 a grant awarded under section 3411 to establish a 

13 program of financial assistance to assist eligible indi14 viduals with substance use disorder in— 

15 ‘‘(A) enrolling in health insurance cov16 erage; or 

17 ‘‘(B) affording health care services, includ18 ing assistance paying cost-sharing amounts, in19 cluding premiums. 

20 ‘‘(8) ADMINISTRATION AND PLANNING.—A 

21 State shall not use in excess of 10 percent of 

22 amounts received under a grant under section 3411 

23 for administration, accounting, reporting, and pro24 gram oversight functions, including the development 


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1 of systems to improve data collection and data shar2 ing. 

3 ‘‘(9) INCARCERATED INDIVIDUALS.—Amounts 

4 received under a grant under section 3411 may be 

5 used to provide substance use disorder treatment 

6 services to currently incarcerated individuals. 

7 ‘‘SEC. 3413. APPLICATION AND LIMITATION. 

8 ‘‘(a) APPLICATION.—To be eligible to receive a grant 

9 under section 3411, a State shall prepare and submit to 

10 the Secretary an application in such form, and containing 

11 such information, as the Secretary shall require, includ12 ing— 

13 ‘‘(1) a complete accounting of the disbursement 

14 of any prior grants received under this subtitle by 

15 the applicant and the results achieved by these ex16 penditures; 

17 ‘‘(2) a comprehensive plan for the use of the 

18 grant, including a demonstration of the extent of 

19 local need for the funds sought and a plan for pro20 posed substance use disorder treatment services that 

21 is consistent with local needs; 

22 ‘‘(3) a demonstration that the State will use 

23 funds in a manner that provides substance use dis24 order treatment services compliant with the evi25 dence-based standards developed in accordance with 


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1 section 3434, including all Federally-approved medi2 cation-assisted treatments; 

3 ‘‘(4) information on the number of individuals 

4 likely to be served by the funds sought, including de5 mographic data on the populations to be served; 

6 ‘‘(5) an identification of key outcomes that will 

7 be measured by all entities that receive assistance, 

8 as well as an explanation of how the outcomes will 

9 be measured; 

10 ‘‘(6) a demonstration that resources provided 

11 under the grant will be allocated in accordance with 

12 the local demographic incidence of substance use, in13 cluding allocations for services for children, youths, 

14 and women; 

15 ‘‘(7) a demonstration that funds received from 

16 a grant under this subtitle in any prior year were ex17 pended in accordance with State priorities; 

18 ‘‘(8) a demonstration that the confidentiality of 

19 individuals receiving substance use disorder treat20 ment services will be maintained in a manner not in21 consistent with applicable law; and 

22 ‘‘(9) an explanation of how income, asset, and 

23 medical expense criteria will be established and ap24 plied to those who qualify for assistance under the 

25 program. 


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1 ‘‘(b) ASSURANCES.—To be eligible to receive a grant 

2 under section 3401, the application submitted by an eligi3 ble State shall include assurances adequate to ensure— 

4 ‘‘(1) that funds received under the grant will be 

5 utilized to supplement not supplant other State or 

6 local funds made available in the year for which the 

7 grant is awarded to provide substance use disorder 

8 treatment services to individuals with substance use 

9 disorder; 

10 ‘‘(2) that the political subdivisions within the 

11 State will maintain the level of expenditures by such 

12 political subdivisions for substance use disorder 

13 treatment services at a level that is equal to the level 

14 of such expenditures by such political subdivisions 

15 for the preceding fiscal year; 

16 ‘‘(3) that political subdivisions within the State 

17 will not use funds received under a grant awarded 

18 under section 3411 in maintaining the level of sub19 stance use disorder treatment services as required in 

20 paragraph (2); 

21 ‘‘(4) that substance use disorder treatment 

22 services provided with assistance made available 

23 under the grant will be provided without regard— 

24 ‘‘(A) to the ability of the individual to pay 

25 for such services; and 


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1 ‘‘(B) to the current or past health condi2 tion of the individual to be served; 

3 ‘‘(5) that substance use disorder treatment 

4 services will be provided in a setting that is acces5 sible to low-income individuals with substance use 

6 disorders and to individuals with substance use dis7 orders residing in rural areas; 

8 ‘‘(6) that a program of outreach will be pro9 vided to low-income individuals with substance use 

10 disorders to inform such individuals of substance use 

11 disorder treatment services and to individuals with 

12 substance use disorders residing in rural areas; 

13 ‘‘(7) that Indian tribes are included in planning 

14 for the use of grant funds and that the Federal 

15 trust responsibility is upheld at all levels of program 

16 administration; and 

17 ‘‘(8) that funds received under a grant awarded 

18 under this section will not be utilized to make pay19 ments for any item or service to the extent that pay20 ment has been made, or can reasonably be expected 

21 to be made, with respect to that item or service 

22 under a State compensation program, under an in23 surance policy, or under any Federal or State health 

24 benefits program (except for a program administered 


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1 by or providing the services of the Indian Health 

2 Service). 

3 ‘‘(c) MEDICAID IMD WAIVER APPLICATION RE4 QUIREMENT.—A State shall not be eligible to receive a 

5 grant under this subtitle for a fiscal year unless the 

6 State— 

7 ‘‘(1) has in effect for the year a waiver under 

8 section 1115 of the Social Security Act (42 U.S.C. 

9 1315) to provide medical assistance under the State 

10 plan under title XIX of such Act to individuals 

11 who— 

12 ‘‘(A) have not attained age 65 (or, if the 

13 State provides the medical assistance described 

14 in section 1905(a)(16) of such Act, have at15 tained age 21 but have not attained age 65); 

16 ‘‘(B) are patients in an institution for 

17 mental diseases; and 

18 ‘‘(C) are eligible for medical assistance 

19 under the State plan; or 

20 ‘‘(2) has submitted an application for the year 

21 for such a waiver. 

22 ‘‘(d) REQUIREMENTS REGARDING IMPOSITION OF

23 CHARGES FOR SERVICES.— 

24 ‘‘(1) IN GENERAL.—The Secretary may not 

25 make a grant under section 3411 to a State unless 


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1 the State provides assurances that in the provision 

2 of services with assistance provided under the 

3 grant— 

4 ‘‘(A) in the case of individuals with an in5 come less than or equal to 138 percent of the 

6 official poverty level, the provider will not im7 pose charges on any such individual for the 

8 services provided under the grant; 

9 ‘‘(B) in the case of individuals with an in10 come greater than 138 percent of the official 

11 poverty level, the provider will impose a charge 

12 on each such individual according to a schedule 

13 of charges made available to the public; 

14 ‘‘(C) in the case of individuals with an in15 come greater than 138 percent of the official 

16 poverty level but not exceeding 200 percent of 

17 such poverty level, the provider will not, for an 

18 calendar year, impose charges in an amount ex19 ceeding 5 percent of the annual gross income of 

20 the individual; 

21 ‘‘(D) in the case of individuals with an in22 come greater than 200 percent of the official 

23 poverty level but not exceeding 300 percent of 

24 such poverty level, the provider will not, for any 

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1 ceeding 7 percent of the annual gross income of 

2 the individual involved; 

3 ‘‘(E) in the case of individuals with an in4 come greater than 300 percent of the official 

5 poverty level, the provider will not, for any cal6 endar year, impose charges in an amount ex7 ceeding 15 percent of the annual gross income 

8 of the individual involved; and 

9 ‘‘(F) in the case of eligible American In10 dian and Alaska Native individuals as defined 

11 by section 447.50 of title 42, Code of Federal 

12 Regulations (as in effect on July 1, 2010), the 

13 provider will not impose any charges for sub14 stance use disorder treatment services, includ15 ing any charges or cost-sharing prohibited by 

16 section 1402(d) of the Patient Protection and 

17 Affordable Care Act. 

18 ‘‘(2) CHARGES.—With respect to compliance 

19 with the assurances made under paragraph (1), a 

20 State may, in the case of individuals subject to a 

21 charge— 

22 ‘‘(A) assess the amount of the charge in 

23 the discretion of the State, including imposing 

24 only a nominal charge for the provision of serv25 ices, subject to the provisions of the paragraph 


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1 regarding public schedules and regarding limi2 tations on the maximum amount of charges; 

3 and 

4 ‘‘(B) take into consideration the total med5 ical expenses of individuals in assessing the 

6 amount of the charge, subject to such provi7 sions. 

8 ‘‘(3) AGGREGATE CHARGES.—The Secretary 

9 may not make a grant under section 3411 to a State 

10 unless the State agrees that the limitations on 

11 charges for substance use disorder treatment serv12 ices under this subsection applies to the annual ag13 gregate of charges imposed for such services, how14 ever the charges are characterized, includes enroll15 ment fees, premiums, deductibles, cost sharing, co16 payments, co-insurance costs, or any other charges. 

17 ‘‘(e) STATEWIDE COORDINATED STATEMENT OF

18 NEED.—A State shall not be eligible to receive a grant 

19 under this subtitle for a fiscal year unless the State devel20 ops and publishes a statewide coordinated statement of 

21 need, including a demonstration of the extent of State 

22 need for assistance in addressing addiction and substance 

23 use disorder in the State and identifying priorities for the 

24 delivery of essential services to individuals with substance 

25 use disorder and their families. 


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1 ‘‘(f) INDIAN TRIBES.—Any application requirements 

2 applying to grants distributed in accordance with section 

3 3412(c) shall be developed by the Secretary in consulta4 tion with Indian tribes. 

5 ‘‘SEC. 3414. TECHNICAL ASSISTANCE. 

6 ‘‘The Secretary shall provide technical assistance in 

7 administering and coordinating the activities authorized 

8 under section 3412, including technical assistance for the 

9 development of State applications for supplementary 

10 grants authorized in section 3212(a)(2). 

11 ‘‘SEC. 3415. AUTHORIZATION OF APPROPRIATIONS. 

12 ‘‘There is authorized to be appropriated to carry out 

13 this subtitle— 

14 ‘‘(1) $4,000,000,000 for fiscal year 2019; 

15 ‘‘(2) $4,000,000,000 for fiscal year 2020; 

16 ‘‘(3) $4,000,000,000 for fiscal year 2021; 

17 ‘‘(4) $4,000,000,000 for fiscal year 2022; 

18 ‘‘(5) $4,000,000,000 for fiscal year 2023; 

19 ‘‘(6) $4,000,000,000 for fiscal year 2024; 

20 ‘‘(7) $4,000,000,000 for fiscal year 2025; 

21 ‘‘(8) $4,000,000,000 for fiscal year 2026; 

22 ‘‘(9) $4,000,000,000 for fiscal year 2027; and 

23 ‘‘(10) $4,000,000,000 for fiscal year 2028. 


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1 ‘‘Subtitle C—Other Grant Program 

2 ‘‘SEC. 3421. ESTABLISHMENT OF GRANT PROGRAM. 

3 ‘‘(a) IN GENERAL.—The Secretary shall award 

4 grants to public, nonprofit, and Native entities for the 

5 purpose of funding core medical services, recovery and 

6 support services, harm reduction services, administrative 

7 expenses, and early intervention and engagement services 

8 in accordance with this section. 

9 ‘‘(b) ELIGIBILITY.— 

10 ‘‘(1) ENTITIES.—Public, nonprofit, or Native 

11 entities eligible to receive a grant under subsection 

12 (a) may include— 

13 ‘‘(A) federally qualified health centers 

14 under section 1905(l)(2)(B) of the Social Secu15 rity Act; 

16 ‘‘(B) family planning clinics; 

17 ‘‘(C) rural health clinics; 

18 ‘‘(D) Native entities, including Indian 

19 health programs as defined in section 4 of the 

20 Indian Health Care Improvement Act, urban 

21 Indian organizations as defined in section 4 of 

22 the Indian Health Care Improvement Act, and 

23 Native Hawaiian organizations as defined in 

24 section 12 of the Native Hawaiian Health Care 

25 Act of 1988; 


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1 ‘‘(E) community-based organizations, clin2 ics, hospitals, and other health facilities that 

3 provide substance use disorder treatment serv4 ices; 

5 ‘‘(F) other nonprofit entities that provide 

6 substance use disorder treatment services; and 

7 ‘‘(G) faith based organizations that provide 

8 substance use disorder treatment services. 

9 ‘‘(2) UNDERSERVED POPULATIONS.—Entities 

10 described in paragraph (1) shall serve underserved 

11 populations which may include minority populations 

12 and Indian populations, ex-offenders, individuals 

13 with comorbidities including HIV/AIDS, hepatitis B 

14 or C, mental illness, or other behavioral health dis15 orders, low-income populations, inner city popu16 lations, and rural populations. 

17 ‘‘(3) APPLICATION.—To be eligible to receive a 

18 grant under this section, a public or nonprofit entity 

19 described in this subsection shall prepare and submit 

20 to the Secretary an application in such form, and 

21 containing such information, as the Secretary shall 

22 require, including— 

23 ‘‘(A) a complete accounting of the dis24 bursement of any prior grants received under 


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1 this subtitle by the applicant and the results 

2 achieved by these expenditures; 

3 ‘‘(B) a comprehensive plan for the use of 

4 the grant, including a demonstration of the ex5 tent of local need for the funds sought and a 

6 plan for proposed substance use disorder treat7 ment services that is consistent with local 

8 needs; 

9 ‘‘(C) a demonstration that the grantee will 

10 use funds in a manner that provides substance 

11 use disorder treatment services compliant with 

12 the evidence-based standards developed in ac13 cordance with section 3434, including all Feder14 ally-approved medication-assisted treatments; 

15 ‘‘(D) information on the number of individ16 uals likely to be served by the funds sought, in17 cluding demographic data on the populations to 

18 be served; 

19 ‘‘(E) an identification of key outcomes that 

20 will be measured by all entities that receive as21 sistance, as well as an explanation of how the 

22 outcomes will be measured; 

23 ‘‘(F) a demonstration that resources pro24 vided under the grant will be allocated in ac25 cordance with the local demographic incidence 


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1 of substance use, including allocations for serv2 ices for children, youths, and women; 

3 ‘‘(G) a demonstration that the confiden4 tiality of individuals receiving substance use dis5 order treatment services will be maintained in a 

6 manner not inconsistent with applicable law; 

7 and 

8 ‘‘(H) an explanation of how income, asset, 

9 and medical expense criteria will be established 

10 and applied to those who qualify for assistance 

11 under the program. 

12 ‘‘(c) REQUIREMENT OF STATUS AS MEDICAID PRO13 VIDER.— 

14 ‘‘(1) PROVISION OF SERVICE.—Subject to para15 graph (2), the Secretary may not make a grant 

16 under this section for the provision of substance use 

17 disorder treatment services under this section in a 

18 State unless, in the case of any such service that is 

19 available pursuant to the State plan approved under 

20 title XIX of the Social Security Act for the State— 

21 ‘‘(A) the political subdivision involved will 

22 provide the substance use disorder treatment 

23 service directly, and the political subdivision has 

24 entered into a participation agreement under 


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1 the State plan and is qualified to receive pay2 ments under such plan; or 

3 ‘‘(B) the political subdivision involved will 

4 enter into an agreement with a public or non5 profit private entity under which the entity will 

6 provide the substance use disorder treatment 

7 service, and the entity has entered into such a 

8 participation agreement and is qualified to re9 ceive such payments. 

10 ‘‘(2) WAIVER.— 

11 ‘‘(A) IN GENERAL.—In the case of an enti12 ty making an agreement pursuant to paragraph 

13 (1)(B) regarding the provision of substance use 

14 disorder treatment services, the requirement es15 tablished in such paragraph shall be waived by 

16 the State if the entity does not, in providing 

17 such services, impose a charge or accept reim18 bursement available from any third-party payor, 

19 including reimbursement under any insurance 

20 policy or under any Federal or State health 

21 benefits program. 

22 ‘‘(B) DETERMINATION.—A determination 

23 by the State of whether an entity referred to in 

24 subparagraph (A) meets the criteria for a waiv25 er under such subparagraph shall be made 


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1 without regard to whether the entity accepts 

2 voluntary donations for the purpose of pro3 viding services to the public. 

4 ‘‘(d) AMOUNT OF GRANT TO NATIVE ENTITIES.— 

5 ‘‘(1) INDIAN TRIBES.—In this section, the term 

6 ‘Indian tribe’ has the meaning given such term in 

7 section 4 of the Indian Self-Determination and Edu8 cation Assistance Act. 

9 ‘‘(2) FORMULA GRANTS.—The Secretary, acting 

10 through the Indian Health Service, shall use 10 per11 cent of the amount available under section 3425 for 

12 each fiscal year to provide grants to Native entities 

13 in an amount determined pursuant to criteria devel14 oped by the Secretary in consultation with Indian 

15 tribes, for the purposes of addressing substance use. 

16 ‘‘(3) USE OF AMOUNTS.—Notwithstanding any 

17 requirements in this section, Native entities may use 

18 amounts provided under grants awarded under this 

19 section for the uses identified in section 3422 and 

20 any other activities determined appropriate by the 

21 Secretary, in consultation with Indian tribes. 

22 ‘‘SEC. 3422. USE OF AMOUNTS. 

23 ‘‘(a) USE OF FUNDS.—An entity shall use amounts 

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1 rect financial assistance to eligible entities for the purpose 

2 of delivering or enhancing— 

3 ‘‘(1) prevention services described in subsection 

4 (b); 

5 ‘‘(2) core medical services described in sub6 section (c); 

7 ‘‘(3) recovery and support services described in 

8 subsection (d); 

9 ‘‘(4) early intervention and engagement services 

10 described in subsection (e); 

11 ‘‘(5) harm reduction services described in sub12 section (f); and 

13 ‘‘(6) administrative expenses described in sub14 section (g). 

15 ‘‘(b) PREVENTION SERVICES.—For purposes of this 

16 subsection, the term ‘prevention services’ means services, 

17 programs, or multi-sector strategies to prevent substance 

18 use disorder, including evidence-based education cam19 paigns, community-based prevention programs, opioid di20 version, collection and disposal of unused opioids, and 

21 services to at-risk populations. 

22 ‘‘(c) CORE MEDICAL SERVICES.—For purposes of 

23 this section, the term ‘core medical services’ means the 

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1 stance use disorder or at risk for developing substance use 

2 disorder: 

3 ‘‘(1) Substance use disorder treatments, includ4 ing clinical stabilization services, withdrawal man5 agement and detoxification, intensive inpatient treat6 ment, intensive outpatient treatment, all forms of 

7 Federally-approved medication-assisted treatment, 

8 and residential recovery treatment. 

9 ‘‘(2) Outpatient and ambulatory health services, 

10 including those administered by federally qualified 

11 health centers and rural health clinics. 

12 ‘‘(3) Hospice services. 

13 ‘‘(4) Mental health services. 

14 ‘‘(5) Naloxone procurement, distribution, and 

15 training. 

16 ‘‘(6) Pharmaceutical assistance and diagnostic 

17 testing related to the management of substance-use 

18 disorder and co-morbid conditions. 

19 ‘‘(7) Home and community based health serv20 ices. 

21 ‘‘(8) Comprehensive Case Management and care 

22 coordination, including treatment adherence services. 

23 ‘‘(9) Health insurance enrollment and cost24 sharing assistance in accordance with section 3412. 


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1 ‘‘(d) RECOVERY AND SUPPORT SERVICES.—For pur2 poses of subsection (a)(3), the term ‘recovery and support 

3 services’ means services, subject to the approval of the 

4 Secretary, that are provided to individuals with substance 

5 use disorder, including residential recovery treatment and 

6 housing, including for individuals receiving medication-as7 sisted treatment, long term recovery services, 24/7 hotline 

8 services, medical transportation services, respite care for 

9 persons caring for individuals with substance use disorder, 

10 child care and family services while an individual is receiv11 ing inpatient treatment services or at the time of out12 patient services, outreach services, peer recovery services, 

13 nutrition services, and referrals for job training and career 

14 services, housing, legal services, and child care and family 

15 services. 

16 ‘‘(e) EARLY INTERVENTION AND ENGAGEMENT

17 SERVICES.—For purposes of this section, the term ‘early 

18 intervention and engagement services’ means services to 

19 provide rapid access to substance use disorder treatment 

20 services, counseling provided to individuals who have mis21 used substances, who have experienced an overdose, or are 

22 at risk of developing substance use disorder and the provi23 sion of referrals to facilitate the access of such individuals 

24 to core medical services or recovery and support services. 

25 The entities through which such services may be provided 


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1 include emergency rooms, fire departments and emergency 

2 medical services, detention facilities, homeless shelters, 

3 law enforcement agencies, health care points of entry spec4 ified by eligible areas, Federally qualified health centers, 

5 and rural health clinics. 

6 ‘‘(f) HARM REDUCTION SERVICES.—For purposes of 

7 this subsection, the term ‘harm reduction services’ means 

8 evidence-based services provided to individuals engaging in 

9 substance use that reduce the risk of infectious disease 

10 transmission, overdose, or death, including by increasing 

11 access to health care. 

12 ‘‘(g) ADMINISTRATION AND PLANNING.—An entity 

13 shall not use in excess of 10 percent of amounts received 

14 under a grant under section 3421 for administration, ac15 counting, reporting, and program oversight functions, in16 cluding for the purposes of developing systems to improve 

17 data collection and data sharing. 

18 ‘‘SEC. 3423. TECHNICAL ASSISTANCE. 

19 ‘‘The Secretary may, directly or through grants or 

20 contracts, provide technical assistance to nonprofit private 

21 entities and Native entities regarding the process of sub22 mitting to the Secretary applications for grants under sec23 tion 3421, and may provide technical assistance with re24 spect to the planning, development, and operation of any 

25 program or service carried out pursuant to such section. 


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1 ‘‘SEC. 3424. PLANNING AND DEVELOPMENT GRANTS. 

2 ‘‘(a) IN GENERAL.—The Secretary may provide plan3 ning grants to public, nonprofit private, and Native enti4 ties for purposes of assisting such entities in expanding 

5 their capacity to provide substance use disorder treatment 

6 services in low-income communities and affected sub7 populations that are underserviced with respect to such 

8 services. 

9 ‘‘(b) AMOUNT.—A grant under this section may be 

10 made in an amount not to exceed $150,000. 

11 ‘‘SEC. 3425. AUTHORIZATION OF APPROPRIATIONS. 

12 ‘‘There is authorized to be appropriated to carry out 

13 this subtitle— 

14 ‘‘(1) $500,000,000 for fiscal year 2019; 

15 ‘‘(2) $500,000,000 for fiscal year 2020; 

16 ‘‘(3) $500,000,000 for fiscal year 2021; 

17 ‘‘(4) $500,000,000 for fiscal year 2022; 

18 ‘‘(5) $500,000,000 for fiscal year 2023; 

19 ‘‘(6) $500,000,000 for fiscal year 2024; 

20 ‘‘(7) $500,000,000 for fiscal year 2025; 

21 ‘‘(8) $500,000,000 for fiscal year 2026; 

22 ‘‘(9) $500,000,000 for fiscal year 2027; and 

23 ‘‘(10) $500,000,000 for fiscal year 2028. 


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1 ‘‘Subtitle D—Miscellaneous 

2 Provisions 

3 ‘‘SEC. 3431. SPECIAL PROJECTS OF NATIONAL SIGNIFI4 CANCE. 

5 ‘‘(a) IN GENERAL.—The Secretary, acting in con6 sultation with the Director of the Office of National Drug 

7 Control Policy, shall award grants to entities to administer 

8 special projects of national significance to support the de9 velopment of innovative and original models for the deliv10 ery of substance use disorder treatment services. 

11 ‘‘(b) GRANTS.—The Secretary shall award grants 

12 under a project under subsection (a) to entities eligible 

13 for grants under subtitles A, B, and C based on newly 

14 emerging needs of individuals receiving assistance under 

15 this title. 

16 ‘‘(c) REPLICATION.—The Secretary shall make infor17 mation concerning successful models or programs devel18 oped under this section available to grantees under this 

19 title for the purpose of coordination, replication, and inte20 gration. To facilitate efforts under this subsection, the 

21 Secretary may provide for peer-based technical assistance 

22 for grantees funded under this section. 

23 ‘‘(d) GRANTS TO TRIBAL GOVERNMENTS.— 

24 ‘‘(1) INDIAN TRIBES.—In this section, the term 

25 ‘Indian tribe’ has the meaning given such term in 


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1 section 4 of the Indian Self-Determination and Edu2 cation Assistance Act. 

3 ‘‘(2) USE OF FUNDS.—The Secretary, acting 

4 through the Indian Health Service, shall use 10 per5 cent of the amount available under this section for 

6 each fiscal year to provide grants to Indian tribes 

7 for the purposes of supporting the development of 

8 innovative and original models for the delivery of 

9 substance use disorder treatment and services, in10 cluding the development of culturally-informed care 

11 models. 

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

13 is authorized to be appropriated to carry out this section— 

14 ‘‘(1) $500,000,000 for fiscal year 2019; 

15 ‘‘(2) $500,000,000 for fiscal year 2020; 

16 ‘‘(3) $500,000,000 for fiscal year 2021; 

17 ‘‘(4) $500,000,000 for fiscal year 2022; 

18 ‘‘(5) $500,000,000 for fiscal year 2023; 

19 ‘‘(6) $500,000,000 for fiscal year 2024; 

20 ‘‘(7) $500,000,000 for fiscal year 2025; 

21 ‘‘(8) $500,000,000 for fiscal year 2026; 

22 ‘‘(9) $500,000,000 for fiscal year 2027; and 

23 ‘‘(10) $500,000,000 for fiscal year 2028. 


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1 ‘‘SEC. 3432. EDUCATION AND TRAINING CENTERS. 

2 ‘‘(a) IN GENERAL.—The Secretary may make grants 

3 and enter into contracts to assist public and nonprofit pri4 vate entities, and schools, and academic health centers in 

5 meeting the cost of projects— 

6 ‘‘(1) to train health personnel, including practi7 tioners in programs under this title and other com8 munity providers, including counselors, case man9 agers, social workers, peer recovery coaches, and 

10 harm reduction workers, in the diagnosis, treatment, 

11 and prevention of substance use disorders, including 

12 measures for the prevention and treatment of co-oc13 curring infectious diseases and other conditions, and 

14 including (as applicable to the type of health profes15 sional involved), care for women, pregnant women, 

16 and children; 

17 ‘‘(2) to train the faculty of schools of medicine, 

18 nursing, public health, osteopathic medicine, den19 tistry, allied health, and mental health practice to 

20 teach health professions students to screen for and 

21 provide for the needs of individuals with substance 

22 use disorders or at risk of substance use; and 

23 ‘‘(3) to develop and disseminate curricula and 

24 resource materials relating to evidence-based prac25 tices for the screening, prevention, and treatment of 

26 substance use disorders, including information about 


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1 prescribing best practices, alternative pain therapies, 

2 and Federally-approved medication-assisted treat3 ment options. 

4 ‘‘(b) PREFERENCE IN MAKING GRANTS.—In making 

5 grants under subsection (a), the Secretary shall give pref6 erence to qualified projects that will— 

7 ‘‘(1) train, or result in the training of, health 

8 professionals, including counselors, case managers, 

9 social workers, peer recovery coaches, and harm re10 duction workers, who will provide substance use dis11 order treatments for underserved groups, including 

12 minority individuals and Indians with substance use 

13 disorder and other individuals who are at a high risk 

14 of substance use; 

15 ‘‘(2) train, or result in the training of, minority 

16 health professionals and minority allied health pro17 fessionals, including counselors, case managers, so18 cial workers, peer recovery coaches, and harm reduc19 tion workers, to provide substance use disorder 

20 treatment for individuals with such disease; 

21 ‘‘(3) train or result in the training of individ22 uals, including counselors, case managers, social 

23 workers, peer recovery coaches, and harm reduction 

24 workers, who will provide substance use disorder 


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1 treatment in rural or other areas that are under2 served by current treatment structures; and 

3 ‘‘(4) train or result in the training of health 

4 professionals and allied health professionals, includ5 ing counselors, case managers, social workers, peer 

6 recovery coaches, and harm reduction workers, to 

7 provide treatment for infectious diseases and mental 

8 health conditions co-occurring with substance use 

9 disorder. 

10 ‘‘(c) NATIVE EDUCATION AND TRAINING CEN11 TERS.—The Secretary shall use 10 percent of the amount 

12 available under subsection (d) for each fiscal year to pro13 vide grants authorized under this subtitle to— 

14 ‘‘(1) tribal colleges and universities; 

15 ‘‘(2) Indian Health Service grant funded insti16 tutions; and 

17 ‘‘(3) Native partner institutions, including insti18 tutions of higher education with medical training 

19 programs that partner with one or more Indian 

20 tribes, tribal organizations, Native Hawaiian organi21 zations, or tribal colleges and universities to train 

22 Native health professionals that will provide sub23 stance use disorder treatment services in Native 

24 communities. 


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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

2 is authorized to be appropriated to carry out this section— 

3 ‘‘(1) $400,000,000 for fiscal year 2019; 

4 ‘‘(2) $400,000,000 for fiscal year 2020; 

5 ‘‘(3) $400,000,000 for fiscal year 2021; 

6 ‘‘(4) $400,000,000 for fiscal year 2022; 

7 ‘‘(5) $400,000,000 for fiscal year 2023; 

8 ‘‘(6) $400,000,000 for fiscal year 2024; 

9 ‘‘(7) $400,000,000 for fiscal year 2025; 

10 ‘‘(8) $400,000,000 for fiscal year 2026; 

11 ‘‘(9) $400,000,000 for fiscal year 2027; and 

12 ‘‘(10) $400,000,000 for fiscal year 2028. 

13 ‘‘SEC. 3433. OTHER PROVISIONS. 

14 ‘‘(a) MEDICATION-ASSISTED TREATMENT.—The Sec15 retary may not make a grant under this title unless the 

16 applicant for the grant agrees to require all entities offer17 ing substance use disorder treatment services under the 

18 grant to offer all Federally-approved forms of medication19 assisted substance use treatment for the substance use 

20 disorders for which the applicant offers treatment. 

21 ‘‘(b) WAIVER.—The Secretary may grant a waiver 

22 with respect to any requirement of this title if the grant 

23 applicant involved— 


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1 ‘‘(1) submits to the Secretary a justification 

2 containing such information as the Secretary shall 

3 require; and 

4 ‘‘(2) agrees to require all entities offering sub5 stance use disorder treatment services under the 

6 grant— 

7 ‘‘(A) to offer at least two Federally-ap8 proved forms of medication-assisted treatment 

9 on site; 

10 ‘‘(B) provide counseling to patients on the 

11 benefits and risks of all forms of Federally-ap12 proved medication-assisted treatments; and 

13 ‘‘(C) maintain an affiliation with a pro14 vider that can prescribe or otherwise dispense 

15 all other forms of Federally-approved medica16 tion-assisted treatment. 

17 ‘‘(c) GAO STUDY.—Not later than 1 year after the 

18 date of enactment of this title, the Comptroller General 

19 of the United States shall submit to Congress a com20 prehensive report describing any relationship between sub21 stance use rates, pain management practices of the Indian 

22 Health Service, and patient request denials through the 

23 purchased/referred care program of the Indian Health 

24 Service. 


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1 ‘‘SEC. 3434. STANDARDS FOR SUBSTANCE USE DISORDER 

2 TREATMENT AND RECOVERY FACILITIES. 

3 ‘‘(a) IN GENERAL.—Not later than 3 years after the 

4 date of enactment of this title, the Secretary, in consulta5 tion with the American Society of Addiction Medicine, 

6 shall promulgate model standards for the regulation of 

7 substance use disorder treatment services. 

8 ‘‘(b) CONTENTS.—The model standards promulgated 

9 under subsection (a) shall— 

10 ‘‘(1) identify the types of providers intended to 

11 be covered without regard to whether such providers 

12 participate in any Federal health care program (as 

13 defined in section 1128B(f) of the Social Security 

14 Act (42 U.S.C. 1320a–7b(f))) and shall not include 

15 a private practitioner who is already licensed by a 

16 State medical licensing board and whose practice is 

17 limited to outpatient care; 

18 ‘‘(2) require that all substance use disorder 

19 treatment services be licensed by the respective 

20 States for the levels of care which they provide; 

21 ‘‘(3) identify the professional credentials needed 

22 by each type of substance use disorder treatment 

23 professional; 

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1 cluding health care providers and physicians, for in2 patient and outpatient care; 

3 ‘‘(5) identify and develop strategies for States 

4 to ensure that all substance use disorder patients re5 ceive a medical assessment, including for co-occur6 ring mental health issues and infectious diseases; 

7 ‘‘(6) require States to implement a process to 

8 ensure that residential treatment provider qualifica9 tions are verified by the single State agency serving 

10 as the primary regulator in the State for substance 

11 use disorder treatment services (as required in para12 graph (13)) or by an independent third party with 

13 the necessary competencies to use evidence-based pa14 tient placement assessment tools and nationally-rec15 ognized program standards, as applicable; 

16 ‘‘(7) ensure that patients receiving substance 

17 use disorder treatment have access directly, by refer18 ral, or in such other manner as determined by the 

19 Secretary, to all Federally-approved medication-as20 sisted treatments for substance use disorder; 

21 ‘‘(8) develop standards for data reporting and 

22 require compilation of Statewide reports; 

23 ‘‘(9) develop standards for licensed providers to 

24 ensure all patients receive an outpatient treatment 

25 and discharge plan; 


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1 ‘‘(10) develop standards for the certification of 

2 recovery residences that have an ongoing economic 

3 relationship with any commercial substance use dis4 order treatment service, including any relationship 

5 with any such service that includes receiving or mak6 ing referrals for substance use disorder treatment, 

7 including— 

8 ‘‘(A) application, inspection, and renewal 

9 procedures for recovery residences; 

10 ‘‘(B) fire, safety, and health standards; 

11 ‘‘(C) standards for equipping residences 

12 with naloxone and training residence owners, 

13 operators, and employees in the administration 

14 of naloxone; 

15 ‘‘(D) standards for recovery residence own16 ers and operators; and 

17 ‘‘(E) standards to identify, disqualify from 

18 grant funding, and refer to the appropriate reg19 ulatory authority any entity engaged in the so20 liciting or receiving of a commission, benefit, 

21 bonus, rebate, kickback, or bribe, directly or in22 directly, in cash or in kind, or engaging in any 

23 split-fee arrangement, aimed at inducing the re24 ferral of a patient to or from a substance use 

25 disorder treatment service; 


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1 ‘‘(11) establish a toll-free telephone number to 

2 handle complaints about recovery residences; 

3 ‘‘(12) establish and maintain on a publicly ac4 cessible internet website a list of all recovery resi5 dences in the State that have a certification in effect 

6 in accordance with this section; 

7 ‘‘(13) require the designation of a single State 

8 agency to serve as the primary regulator in the 

9 State for substance use disorder treatment services; 

10 ‘‘(14) require a single State agency to imple11 ment a process to ensure that treatment provider as12 sessments for all substance use disorder treatment 

13 services, including levels of care and length-of-stay 

14 recommendations, are verified by an independent 

15 third party that has the necessary competencies to 

16 use evidence-based patient placement assessment 

17 tools and nationally-recognized program standards, 

18 as applicable; and 

19 ‘‘(15) consider existing barriers to substance 

20 use disorder treatment and service access, including 

21 capacity and infrastructure needs, as well as access 

22 to culturally attuned services. 

23 ‘‘(c) ANNUAL ASSESSMENT.—Beginning with respect 

24 to fiscal year 2021, the Secretary shall make a determina25 tion with respect to each State on whether the State has 


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1 adopted the model standards promulgated in accordance 

2 with this section. 

3 ‘‘(d) QUALITY MEASURES.—The Secretary shall en4 gage a nonprofit, non-partisan standards development and 

5 quality measurement organization to convene government 

6 regulators, State representatives, consumer representa7 tives, substance use disorder treatment providers, recovery 

8 residence owners and operators, and purchasers of sub9 stance use disorder treatments exercising leadership in 

10 quality-based purchasing to develop and annually revise 

11 a set of health care quality measures for substance use 

12 disorder treatment providers and owners and operators of 

13 recovery residences. 

14 ‘‘SEC. 3435. NALOXONE DISTRIBUTION PROGRAM. 

15 ‘‘(a) ESTABLISHMENT OF PROGRAM.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall provide 

17 for the purchase and delivery of Federally-approved 

18 opioid overdose reversal drug products on behalf of 

19 each State (or Indian tribe as defined in section 4 

20 of the Indian Health Care Improvement Act) that 

21 receives a grant under subtitle B. This paragraph 

22 constitutes budget authority in advance of appro23 priations Acts, and represents the obligation of the 

24 Federal Government to provide for the purchase and 


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1 delivery to States of the opioid overdose reversal 

2 drug products in accordance with this paragraph. 

3 ‘‘(2) SPECIAL RULES WHERE OPIOID OVERDOSE

4 REVERSAL DRUG PRODUCTS ARE UNAVAILABLE.—To 

5 the extent that a sufficient quantity of opioid over6 dose reversal drug products are not available for 

7 purchase or delivery under paragraph (1), the Sec8 retary shall provide for the purchase and delivery of 

9 the available opioid overdose reversal drug products 

10 in accordance with priorities established by the Sec11 retary, with priority given to States with at least one 

12 local area eligible for funding under section 3401(a). 

13 ‘‘(b) NEGOTIATION OF CONTRACTS WITH MANUFAC14 TURERS.— 

15 ‘‘(1) IN GENERAL.—For the purpose of car16 rying out this section, the Secretary shall negotiate 

17 and enter into contracts with manufacturers of 

18 opioid overdose reversal drug products consistent 

19 with the requirements of this subsection and, to the 

20 maximum extent practicable, consolidate such con21 tracting with any other contracting activities con22 ducted by the Secretary to purchase opioid overdose 

23 reversal drug products. The Secretary may enter 

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1 thority for which is not provided for in advance in 

2 appropriations Acts, for the purchase and delivery of 

3 opioid overdose reversal drug products under sub4 section (a). 

5 ‘‘(2) AUTHORITY TO DECLINE CONTRACTS.— 

6 The Secretary may decline to enter into contracts 

7 under this subsection and may modify or extend 

8 such contracts. 

9 ‘‘(3) CONTRACT PRICE.— 

10 ‘‘(A) IN GENERAL.—The Secretary, in ne11 gotiating the prices at which opioid overdose re12 versal drug products will be purchased and de13 livered from a manufacturer under this sub14 section, shall take into account quantities of 

15 opioid overdose reversal drug products to be 

16 purchased by States under the option under 

17 paragraph (4)(B). 

18 ‘‘(B) NEGOTIATION OF DISCOUNTED PRICE

19 FOR OPIOID OVERDOSE REVERSAL DRUG PROD20 UCTS.—With respect to contracts entered into 

21 for the purchase of opioid overdose reversal 

22 drug products on behalf of States under this 

23 subsection, the price for the purchase of such 

24 drug product shall be a discounted price nego25 tiated by the Secretary. 


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1 ‘‘(4) PRODUCT DOSAGE.—All opioid overdose 

2 reversal products purchased under this section shall 

3 contain— 

4 ‘‘(A) for each dose, the maximum amount 

5 of active pharmaceutical ingredient that acts as 

6 an opioid receptor antagonist as recommended 

7 by the Food and Drug Administration as an 

8 initial dose when administered by one of the ap9 proved, labeled routes of administration in 

10 adults; and 

11 ‘‘(B) a minimum of two doses packaged to12 gether. 

13 ‘‘(5) QUANTITIES AND TERMS OF DELIVERY.— 

14 Under contracts under this subsection— 

15 ‘‘(A) the Secretary shall provide, consistent 

16 with paragraph (6), for the purchase and deliv17 ery on behalf of States and Indian tribes of 

18 quantities of opioid overdose reversal drug 

19 products; and 

20 ‘‘(B) each State and Indian tribe, at the 

21 option of the State or tribe, shall be permitted 

22 to obtain additional quantities of opioid over23 dose reversal drug products (subject to amounts 

24 specified to the Secretary by the State or tribe 

25 in advance of negotiations) through purchasing 


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1 the opioid overdose reversal drug products from 

2 the manufacturers at the applicable price nego3 tiated by the Secretary consistent with para4 graph (3), if the State or tribe provides to the 

5 Secretary such information (at a time and man6 ner specified by the Secretary, including in ad7 vance of negotiations under paragraph (1)) as 

8 the Secretary determines to be necessary, to 

9 provide for quantities of opioid overdose rever10 sal drug products for the State or tribe to pur11 chase pursuant to this subsection and to deter12 mine annually the percentage of the opioid over13 dose reversal drug market that is purchased 

14 pursuant to this section and this subparagraph. 

15 The Secretary shall enter into the initial negotia16 tions not later than 180 days after the date of the 

17 enactment of this title. 

18 ‘‘(6) CHARGES FOR SHIPPING AND HAN19 DLING.—The Secretary may enter into a contract 

20 referred to in paragraph (1) only if the manufac21 turer involved agrees to submit to the Secretary 

22 such reports as the Secretary determines to be ap23 propriate to assure compliance with the contract and 

24 if, with respect to a State program under this sec25 tion that does not provide for the direct delivery of 


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1 qualified opioid overdose reversal drug products, the 

2 manufacturer involved agrees that the manufacturer 

3 will provide for the delivery of the opioid overdose 

4 reversal drug products on behalf of the State in ac5 cordance with such program and will not impose any 

6 charges for the costs of such delivery (except to the 

7 extent such costs are provided for in the price estab8 lished under paragraph (3)). 

9 ‘‘(7) MULTIPLE SUPPLIERS.—In the case of the 

10 opioid overdose reversal drug product involved, the 

11 Secretary may, as appropriate, enter into a contract 

12 referred to in paragraph (1) with each manufacturer 

13 of the opioid overdose reversal drug product that 

14 meets the terms and conditions of the Secretary for 

15 an award of such a contract (including terms and 

16 conditions regarding safety and quality). With re17 spect to multiple contracts entered into pursuant to 

18 this paragraph, the Secretary may have in effect dif19 ferent prices under each of such contracts and, with 

20 respect to a purchase by States pursuant to para21 graph (4)(B), each eligible State may choose which 

22 of such contracts will be applicable to the purchase. 

23 ‘‘(c) USE OF OPIOID OVERDOSE REVERSAL DRUG

24 PRODUCT LIST.—Beginning not later than one year after 

25 the first contract has been entered into under this section, 


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1 the Secretary shall use, for the purpose of the purchase, 

2 delivery, and administration of opioid overdose reversal 

3 drug products under this section, the list established (and 

4 periodically reviewed and, as appropriate, revised) by an 

5 advisory committee, established by the Secretary and lo6 cated within the Centers for Disease Control and Preven7 tion, which considers the cost effectiveness of each opioid 

8 overdose reversal drug product. 

9 ‘‘(d) STATE DISTRIBUTION OF OPIOID OVERDOSE

10 REVERSAL DRUG PRODUCTS.—States shall distribute 

11 opioid overdose reversal drug products received under this 

12 section to the following: 

13 ‘‘(1) First Responders, including— 

14 ‘‘(A) all State, county, and local law en15 forcement departments; 

16 ‘‘(B) all Tribal police departments; 

17 ‘‘(C) all local fire departments, including 

18 career fire departments, combination fire de19 partments, and volunteer fire departments; and 

20 ‘‘(D) all local emergency medical services 

21 organizations, including volunteer emergency 

22 medical services organizations. 

23 ‘‘(2) Public entities with authority to administer 

24 local public health services, including all local health 


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1 departments, for the purposes of making opioid over2 dose reversal drug products available to— 

3 ‘‘(A) public and nonprofit entities, includ4 ing— 

5 ‘‘(i) community-based organizations 

6 that provide substance use disorder treat7 ments or harm reduction services; 

8 ‘‘(ii) nonprofit entities that provide 

9 substance use disorder treatments or harm 

10 reduction services; and 

11 ‘‘(iii) faith based organizations that 

12 provide substance use disorder treatments 

13 or harm reduction services; and 

14 ‘‘(B) the general public. 

15 ‘‘(e) STATE REQUIREMENTS.—To be eligible to re16 ceive opioid overdose reversal drugs under this section, 

17 each State shall— 

18 ‘‘(1) establish a program for distributing opioid 

19 overdose reversal drug products to first responders 

20 and entities with authority to administer local public 

21 health services, including local health departments; 

22 ‘‘(2) beginning in the second year of the pro23 gram, demonstrate a distribution rate of a minimum 

24 of 90 percent of the opioid overdose reversal drug 

25 products received under this program; and 


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1 ‘‘(3) certify to the Secretary that the State has 

2 in place measures that enhance access to opioid 

3 overdose reversal drug products, such as laws that 

4 provide civil or disciplinary immunity for medical 

5 personnel who prescribe an opioid overdose reversal 

6 drug product, Good Samaritan Laws, Third Party 

7 Prescription Laws, Collaborative Practice Agree8 ments, and Standing Orders. 

9 ‘‘(f) INDIAN TRIBE REQUIREMENTS.—The Indian 

10 Health Service, in consultation with Indian tribes, shall 

11 determine any requirements that shall apply to Indian 

12 tribes receiving opioid overdose reversal drug products 

13 made available under this section. 

14 ‘‘(g) DEFINITIONS.—For purposes of this section: 

15 ‘‘(1) CAREER FIRE DEPARTMENT.—The term 

16 ‘career fire department’ means a fire department 

17 that has an all-paid force of firefighting personnel 

18 other than paid-on-call firefighters. 

19 ‘‘(2) COLLABORATIVE PRACTICE AGREEMENT.— 

20 The term ‘Collaborative Practice Agreement’ means 

21 an agreement under which a pharmacist operates 

22 under authority delegated by another licensed practi23 tioner with prescribing authority. 

24 ‘‘(3) COMBINATION FIRE DEPARTMENT.—The 

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1 partment that has paid firefighting personnel and 

2 volunteer firefighting personnel. 

3 ‘‘(4) EMERGENCY MEDICAL SERVICE.—The 

4 term ‘emergency medical service’ means resources 

5 used by a public or private nonprofit licensed entity 

6 to deliver medical care outside of a medical facility 

7 under emergency conditions that occur as a result of 

8 the condition of the patient and includes services de9 livered (either on a compensated or volunteer basis) 

10 by an emergency medical services provider or other 

11 provider that is licensed or certified by the State in12 volved as an emergency medical technician, a para13 medic, or an equivalent professional (as determined 

14 by the State). 

15 ‘‘(5) GOOD SAMARITAN LAW.—The term ‘Good 

16 Samaritan Law’ means a law that provides criminal 

17 immunity for a person who administers an opioid 

18 overdose reversal drug product, a person who, in 

19 good faith, seeks medical assistance for someone ex20 periencing a drug-related overdose, or a person who 

21 experiences a drug-related overdose and is in need of 

22 medical assistance and, in good faith, seeks such 

23 medical assistance, or is the subject of such a good 

24 faith request for medical assistance. 


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1 ‘‘(6) INDIANS.—The terms ‘Indian’, ‘Indian 

2 tribe’, ‘tribal organization’, and ‘Urban Indian 

3 Health Program’ have the meanings given such 

4 terms in section 4 of the Indian Health Care Im5 provement Act. 

6 ‘‘(7) MANUFACTURER.—The term ‘manufac7 turer’ means any corporation, organization, or insti8 tution, whether public or private (including Federal, 

9 State, and local departments, agencies, and instru10 mentalities), which manufactures, imports, proc11 esses, or distributes under its label any opioid over12 dose reversal drug product. The term ‘manufacture’ 

13 means to manufacture, import, process, or distribute 

14 an opioid overdose reversal drug. 

15 ‘‘(8) OPIOID OVERDOSE REVERSAL DRUG PROD16 UCT.—The term ‘opioid overdose reversal drug prod17 uct’ means a finished dosage form that has been ap18 proved by the Food and Drug Administration and 

19 that contains an active pharmaceutical ingredient 

20 that acts as an opioid receptor antagonist. The term 

21 ‘opioid overdose reversal drug product’ includes a 

22 combination product, as defined in section 3.2(e) of 

23 title 21, Code of Federal Regulations. 

24 ‘‘(9) STANDING ORDER.—The term ‘standing 

25 order’ means a non-patient-specific order covering 


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1 administration of medication by others to a patient 

2 who may be unknown to the prescriber at the time 

3 of the order. 

4 ‘‘(10) THIRD PARTY PRESCRIPTION.—The term 

5 ‘third party prescription’ means an order written for 

6 medication dispensed to one person with the inten7 tion that it will be administered to another person. 

8 ‘‘(11) VOLUNTEER FIRE DEPARTMENT.—The 

9 term ‘volunteer fire department’ means a fire de10 partment that has an all-volunteer force of fire11 fighting personnel. 

12 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

13 is authorized to be appropriated to carry out this suc14 tion— 

15 ‘‘(1) $500,000,000 for fiscal year 2019; 

16 ‘‘(2) $500,000,000 for fiscal year 2020; 

17 ‘‘(3) $500,000,000 for fiscal year 2021; 

18 ‘‘(4) $500,000,000 for fiscal year 2022; 

19 ‘‘(5) $500,000,000 for fiscal year 2023; 

20 ‘‘(6) $500,000,000 for fiscal year 2024; 

21 ‘‘(7) $500,000,000 for fiscal year 2025; 

22 ‘‘(8) $500,000,000 for fiscal year 2026; 

23 ‘‘(9) $500,000,000 for fiscal year 2027; and 

24 ‘‘(10) $500,000,000 for fiscal year 2028. 


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1 ‘‘SEC. 3436. ADDITIONAL FUNDING FOR THE NATIONAL IN2 STITUTES OF HEALTH. 

3 ‘‘There is authorized to be appropriated to the Na4 tional Institute of Health for the purpose of conducting 

5 research on addiction and pain related to substance mis6 use, including research to develop overdose reversal drug 

7 products, non-addictive drug products for treating pain, 

8 and drug products used to treat substance use disorder— 

9 ‘‘(1) $1,000,000,000 for fiscal year 2019; 

10 ‘‘(2) $1,000,000,000 for fiscal year 2020; 

11 ‘‘(3) $1,000,000,000 for fiscal year 2021; 

12 ‘‘(4) $1,000,000,000 for fiscal year 2022; 

13 ‘‘(5) $1,000,000,000 for fiscal year 2023; 

14 ‘‘(6) $1,000,000,000 for fiscal year 2024; 

15 ‘‘(7) $1,000,000,000 for fiscal year 2025; 

16 ‘‘(8) $1,000,000,000 for fiscal year 2026; 

17 ‘‘(9) $1,000,000,000 for fiscal year 2027; and 

18 ‘‘(10) $1,000,000,000 for fiscal year 2028. 

19 ‘‘SEC. 3437. ADDITIONAL FUNDING FOR IMPROVED DATA 

20 COLLECTION AND PREVENTION OF INFEC21 TIOUS DISEASE TRANSMISSION. 

22 ‘‘(a) DATA COLLECTION.—The Centers for Disease 

23 Control and Prevention shall use a portion of the funding 

24 appropriated under this section to ensure that all States 

25 participate in the Enhanced State Opioid Overdose Sur26 veillance program and to provide technical assistance to 


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1 medical examiners and coroners to facilitate improved 

2 data collection on fatal overdoses through such program. 

3 ‘‘(b) CENTERS FOR DISEASE CONTROL AND PREVEN4 TION.—The Centers for Disease Control and Prevention 

5 shall use amounts appropriated under this section for the 

6 purpose of improving data on drug overdose deaths and 

7 non-fatal drug overdoses, surveillance related to addiction 

8 and substance use disorder, and the prevention of trans9 mission of infectious diseases related to substance use. 

10 ‘‘(c) TRIBAL EPIDEMIOLOGY CENTERS.—There shall 

11 be made available to the Indian Health Service for the 

12 purpose of funding efforts by tribal epidemiology centers 

13 to improve data on drug overdose deaths and non-fatal 

14 drug overdoses and surveillance related to addiction and 

15 substance use disorder, not less than 1.5 percent of the 

16 total amount appropriated under this section for each fis17 cal year. 

18 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

19 is authorized to be appropriated to carry out this section— 

20 ‘‘(1) $400,000,000 for fiscal year 2019; 

21 ‘‘(2) $400,000,000 for fiscal year 2020; 

22 ‘‘(3) $400,000,000 for fiscal year 2021; 

23 ‘‘(4) $400,000,000 for fiscal year 2022; 

24 ‘‘(5) $400,000,000 for fiscal year 2023; 

25 ‘‘(6) $400,000,000 for fiscal year 2024; 


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1 ‘‘(7) $400,000,000 for fiscal year 2025; 

2 ‘‘(8) $400,000,000 for fiscal year 2026; 

3 ‘‘(9) $400,000,000 for fiscal year 2027; and 

4 ‘‘(10) $400,000,000 for fiscal year 2028. 

5 ‘‘SEC. 3438. DEFINITIONS. 

6 ‘‘In this title: 

7 ‘‘(1) PLANNING COUNCIL.—The term ‘planning 

8 council’ means the substance use planning council 

9 established under section 3402. 

10 ‘‘(2) RECOVERY RESIDENCE.—The term ‘recov11 ery residence’ means a residential dwelling unit, or 

12 other form of group housing, that is offered or ad13 vertised through any means, including oral, written, 

14 electronic, or printed means, by any individual or en15 tity as a residence that provides an evidence-based, 

16 peer-supported living environment for individuals un17 dergoing any type of substance use disorder treat18 ment or who have received any type of substance use 

19 disorder treatment in the past 3 years, including 

20 medication-assisted treatment. 

21 ‘‘(3) STATE.— 

22 ‘‘(A) IN GENERAL.—The term ‘State’ 

23 means each of the 50 States, the District of Co24 lumbia, and each of the territories. 


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1 ‘‘(B) TERRITORIES.—The term ‘territory’ 

2 means each of American Samoa, Guam, the 

3 Commonwealth of Puerto Rico, the Common4 wealth of the Northern Mariana Islands, the 

5 Virgin Islands, the Republic of the Marshall Is6 lands, the Federated States of Micronesia, and 

7 Palau. 

8 ‘‘(4) SUBSTANCE USE DISORDER TREAT9 MENT.— 

10 ‘‘(A) IN GENERAL.—The term ‘substance 

11 use disorder treatment’ means an evidence12 based, professionally directed, deliberate, and 

13 planned regimen including evaluation, observa14 tion, medical monitoring, and rehabilitative 

15 services and interventions such as 

16 pharmacotherapy, behavioral therapy, and indi17 vidual and group counseling, on an inpatient or 

18 outpatient basis, to help patients with substance 

19 use disorder reach recovery. 

20 ‘‘(B) TYPES OF TREATMENT.—Substance 

21 use disorder treatments shall include the fol22 lowing: 

23 ‘‘(i) Clinical stabilization services, 

24 which are evidence-based services provided 

25 in secure, acute care facilities (which may 


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1 be referred to as ‘addictions receiving fa2 cilities’) that, at a minimum— 

3 ‘‘(I) provide detoxification and 

4 stabilization services; 

5 ‘‘(II) are operated 24 hours per 

6 day, 7 days per week; and 

7 ‘‘(III) that serve individuals 

8 found to be substance use impaired. 

9 These can also be referred to as ‘Ad10 dictions receiving facilities’. 

11 ‘‘(ii) Withdrawal management and de12 toxification, which is a service that is pro13 vided on an inpatient or an outpatient 

14 basis to assist individuals manage the 

15 process of withdrawing from the physio16 logical and psychological effects of sub17 stance use disorder. 

18 ‘‘(iii) Intensive inpatient treatment, 

19 which is a service that provides a planned 

20 regimen of evidence-based evaluation, ob21 servation, medical monitoring, and evi22 dence-based rehabilitative services and 

23 interventions such as pharmacotherapy, be24 havioral therapy, and counseling, 24 hours 


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1 per day, 7 days per week, in a highly 

2 structured, residential environment. 

3 ‘‘(iv) Intensive outpatient treatment, 

4 which is a service that provides a planned 

5 regimen of evidence-based evaluation, ob6 servation, medical monitoring, and evi7 dence-based rehabilitative services and 

8 interventions such as pharmacotherapy, be9 havioral therapy, and counseling, in a 

10 structured, nonresidential environment at a 

11 higher level of intensity and duration than 

12 outpatient treatment. 

13 ‘‘(v) Medication-assisted treatment, 

14 which is a service that uses Federally-ap15 proved medication as authorized by Fed16 eral and State law, in combination with 

17 evidence-based medical, rehabilitative, and 

18 counseling services, in the treatment of in19 dividuals who suffer from substance use 

20 disorder. 

21 ‘‘(vi) Outpatient treatment, which is a 

22 service that provides a planned regimen of 

23 evidence-based evaluation, observation, 

24 medical monitoring, and evidence-based re25 habilitative services and interventions such 


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1 as pharmacotherapy, behavioral therapy, 

2 and counseling in a structured, nonresiden3 tial environment by appointment during 

4 scheduled operating hours. 

5 ‘‘(vii) Residential recovery treatment, 

6 which is a service that provides a planned 

7 regimen of evidence-based evaluation, ob8 servation, medical monitoring, and evi9 dence-based rehabilitative services and 

10 interventions such as pharmacotherapy, be11 havioral therapy, and counseling provided 

12 in a structured, live-in environment within 

13 a nonhospital setting on a 24-hours-per14 day, 7-days-per-week basis. 

15 ‘‘(C) LIMITATION.—Substance use disorder 

16 treatment providers shall not include— 

17 ‘‘(i) prevention only providers; and 

18 ‘‘(ii) a private practitioner who is li19 censed by a State medical licensing board 

20 and whose practice is limited to outpatient 

21 care. 

22 ‘‘(5) SUBSTANCE USE DISORDER TREATMENT

23 SERVICES.—The term ‘substance use disorder treat24 ment services’ means any prevention services, core 

25 medical services, recovery and support services, early 


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1 intervention and engagement services, and harm re2 duction services authorized under this title.’’. 

3 SEC. 4. AMENDMENTS TO THE CONTROLLED SUBSTANCES 

4 ACT. 

5 (a) CERTIFICATIONS.—Part C of the Controlled Sub6 stances Act (21 U.S.C. 821 et seq.) is amended by adding 

7 at the end the following: 

8 ‘‘CERTIFICATIONS RELATING TO DIVERSION CONTROLS

9 AND MISBRANDING

10 ‘‘SEC. 312. (a) DEFINITIONS.—In this section— 

11 ‘‘(1) the term ‘covered dispenser’— 

12 ‘‘(A) means a dispenser— 

13 ‘‘(i) that is required to register under 

14 section 302(a)(2); and 

15 ‘‘(ii) dispenses a controlled substance 

16 in schedule II; and 

17 ‘‘(B) does not include a dispenser that is— 

18 ‘‘(i) registered to dispense opioid 

19 agonist treatment medication under section 

20 303(g)(1); and 

21 ‘‘(ii) operating in that capacity; 

22 ‘‘(2) the term ‘covered distributor’ means a dis23 tributor— 

24 ‘‘(A) that is required to register under sec25 tion 302(a)(1); and 


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1 ‘‘(B) distributes a controlled substance in 

2 schedule II; 

3 ‘‘(3) the term ‘covered manufacturer’ means a 

4 manufacturer— 

5 ‘‘(A) that is required to register under sec6 tion 302(a)(1); and 

7 ‘‘(B) manufactures a controlled substance 

8 in schedule II; 

9 ‘‘(4) the term ‘covered officer’, with respect to 

10 a covered person means— 

11 ‘‘(A) in the case of a covered person that 

12 is not an individual— 

13 ‘‘(i) the chief executive officer of the 

14 covered person; 

15 ‘‘(ii) the president of the covered per16 son; 

17 ‘‘(iii) the chief medical officer of the 

18 covered person; and 

19 ‘‘(iv) the chief counsel of the covered 

20 person; and 

21 ‘‘(B) in the case of a covered person that 

22 is an individual, that individual; and 

23 ‘‘(5) the term ‘covered person’ means a covered 

24 dispenser, a covered distributor, or a covered manu25 facturer. 


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1 ‘‘(b) CERTIFICATIONS RELATING TO DIVERSION

2 CONTROLS.—Not later than 180 days after the date of 

3 enactment of this section, and each year thereafter, each 

4 covered officer of a covered person shall submit to the At5 torney General, for each controlled substance in schedule 

6 II dispensed, distributed, or manufactured by the covered 

7 person, a certification— 

8 ‘‘(1) signed by the covered officer; and 

9 ‘‘(2) certifying that— 

10 ‘‘(A) the covered person maintains effective 

11 controls against diversion of the controlled sub12 stance into channels other than legitimate med13 ical, scientific, research, or industrial channels; 

14 ‘‘(B) all information contained in any 

15 record, inventory, or report required to be kept 

16 or submitted to the Attorney General by the 

17 covered person under section 307, or under any 

18 regulation issued under that section, is accu19 rate; and 

20 ‘‘(C) the covered person is in compliance 

21 with all applicable requirements under Federal 

22 law relating to reporting suspicious orders for 

23 controlled substances. 

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1 actment of this section, and each year thereafter, each cov2 ered officer of a covered manufacturer shall submit to the 

3 Attorney General, for each controlled substance in sched4 ule II manufactured by the covered manufacturer, a cer5 tification— 

6 ‘‘(1) signed by the covered officer; and 

7 ‘‘(2) certifying that the controlled substance is 

8 not misbranded, as described in section 502 of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 352).’’. 

11 (b) OFFENSES.—Part D of title II of the Controlled 

12 Substances Act (21 U.S.C. 841 et seq.) is amended by 

13 adding at the end the following: 

14 ‘‘CERTIFICATIONS BY COVERED OFFICERS

15 ‘‘SEC. 424. (a) DEFINITIONS.—In this section, the 

16 terms ‘covered dispenser’, ‘covered distributor’, ‘covered 

17 manufacturer’, ‘covered officer’, and ‘covered person’ have 

18 the meanings given those terms in section 312. 

19 ‘‘(b) OFFENSES.— 

20 ‘‘(1) FAILURE TO SUBMIT CERTIFICATIONS.— 

21 ‘‘(A) CERTIFICATIONS RELATING TO DI22 VERSION CONTROLS.—It shall be unlawful for a 

23 covered officer of a covered person to fail to 

24 submit a certification required under section 

25 312(b), without regard to the state of mind of 

26 the covered officer. 


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1 ‘‘(B) CERTIFICATIONS RELATING TO MIS2 BRANDING.—It shall be unlawful for a covered 

3 officer of a covered manufacturer to fail to sub4 mit a certification required under section 

5 312(c), without regard to the state of mind of 

6 the covered officer. 

7 ‘‘(2) SUBMISSION OF FALSE CERTIFICATIONS.— 

8 ‘‘(A) FALSE CERTIFICATIONS RELATING TO

9 DIVERSION CONTROLS.—It shall be unlawful for 

10 a covered officer of a covered person to submit 

11 a certification required under section 312(b), 

12 without regard to the state of mind of the cov13 ered officer, that contains a materially false 

14 statement or representation relating to the in15 formation required to be certified under that 

16 section for the year for which the certification 

17 is submitted. 

18 ‘‘(B) FALSE CERTIFICATIONS RELATING

19 TO MISBRANDING.—It shall be unlawful for a 

20 covered officer of a covered manufacturer to 

21 submit a certification required under section 

22 312(c), without regard to the state of mind of 

23 the covered officer, that contains a materially 

24 false statement or representation relating to the 

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1 spect to the year for which the certification is 

2 submitted. 

3 ‘‘(c) PENALTIES.— 

4 ‘‘(1) CIVIL PENALTIES.—Except as provided in 

5 paragraph (2), a covered officer who violates sub6 section (b) shall be subject to a civil penalty of not 

7 more than $25,000. 

8 ‘‘(2) CRIMINAL PENALTIES.—A covered officer 

9 who knowingly violates subsection (b)(2) shall be 

10 subject to criminal penalties under section 403(d). 

11 ‘‘(d) COMPREHENSIVE ADDICTION RESOURCES

12 FUND.— 

13 ‘‘(1) ESTABLISHMENT.—There is established in 

14 the Treasury a fund to be known as the ‘Com15 prehensive Addiction Resources Fund’. 

16 ‘‘(2) TRANSFER OF AMOUNTS.—There shall be 

17 transferred to the Comprehensive Addiction Re18 sources Fund 100 percent of— 

19 ‘‘(A) any civil penalty paid to the United 

20 States under this section; and 

21 ‘‘(B) any fine paid to the United States 

22 under section 403(d) for a knowing violation of 

23 subsection (b)(2) of this section. 


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1 ‘‘(3) AVAILABILITY AND USE OF FUNDS.— 

2 Amounts transferred to the Comprehensive Addic3 tion Fund under paragraph (2) shall— 

4 ‘‘(A) remain available until expended; and 

5 ‘‘(B) be made available to supplement 

6 amounts appropriated to carry out title XXXIV 

7 of the Public Health Service Act.’’. 

8 (c) CRIMINAL PENALTIES.—Section 403 of the Con9 trolled Substances Act (21 U.S.C. 843) is amended— 

10 (1) in subsection (d)(1)— 

11 (A) by inserting ‘‘or knowingly violates sec12 tion 424(b)(2)’’ after ‘‘any person who violates 

13 this section’’; and 

14 (B) by striking ‘‘violation of this section’’ 

15 and inserting ‘‘such a violation’’; and 

16 (2) in subsection (f)— 

17 (A) in paragraph (1), by striking ‘‘or 416’’ 

18 and inserting ‘‘or section 416, or knowing viola19 tions of section 424(b)(2)’’; and 

20 (B) in paragraph (3), by inserting ‘‘or 

21 knowing violations of section 424(b)(2)’’ before 

22 the period at the end. 

23 (d) TECHNICAL AND CONFORMING AMENDMENTS.— 

24 The table of contents for the Comprehensive Drug Abuse 


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1 Prevention and Control Act of 1970 (Public Law 91–513; 

2 84 Stat. 1236) is amended— 

3 (1) by inserting after the item relating to sec4 tion 311 the following: 

‘‘Sec. 312. Certifications relating to diversion controls and misbranding.’’; 

5 and 

6 (2) by inserting after the item relating to sec7 tion 423 the following: 

‘‘Sec. 424. Certifications by covered officers.’’. 

8 (e) EFFECTIVE DATE.—The amendments made by 

9 subsections (b) and (c) of this section shall take effect on 

10 the date that is 180 days after the date of enactment of 

11 this Act. 

Æ 


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