I 

115TH CONGRESS 

2D SESSION H. R. 4938 

To address the opioid epidemic, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 6, 2018 

Ms. KUSTER of New Hampshire introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to 

the Committees on the Judiciary, Ways and Means, Education and the 

Workforce, and the Budget, 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 address the opioid epidemic, and for other purposes. 

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. 

4 This Act may be cited as the ‘‘Respond to the Needs 

5 in the Opioid War Act’’ or the ‘‘Respond NOW Act’’. 

6 TITLE I—OPIOID EPIDEMIC 

7 RESPONSE FUND 

8 SEC. 101. OPIOID EPIDEMIC RESPONSE FUND. 

9 (a) IN GENERAL.—The Secretary of Health and 

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1 retary’’) shall use any funds appropriated pursuant to the 

2 authorization of appropriations under subsection (c) to 

3 carry out the programs and activities described in sub4 section (d) to address the opioid and substance use epi5 demic. Such funds shall be in addition to any funds which 

6 are otherwise available to carry out such programs and 

7 activities. 

8 (b) OPIOID EPIDEMIC RESPONSE FUND.— 

9 (1) ESTABLISHMENT OF ACCOUNT.—There is 

10 established in the Treasury an account, to be known 

11 as the Opioid Epidemic Response Fund (referred to 

12 in this subsection as the ‘‘Funds’’), for purposes of 

13 funding the programs and activities described in 

14 subsection (d). 

15 (2) TRANSFER.—For each of fiscal years 2018 

16 through 2022, $5,000,000,000 shall be transferred 

17 to the Fund from the general fund of the Treasury. 

18 (3) AMOUNTS DEPOSITED.—Any amounts 

19 transferred under paragraph (2) shall remain un20 available in the Fund until such amounts are appro21 priated pursuant to subsection (c). 

22 (c) APPROPRIATIONS.— 

23 (1) AUTHORIZATION OF APPROPRIATIONS.—For 

24 the period of fiscal years 2018 through 2022, there 

25 is authorized to be appropriated from the Fund to 


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1 the Department of Health and Human Services, for 

2 the purpose of carrying out the programs and activi3 ties described in subsection (d), an amount not to 

4 exceed the total amount transferred to the Fund 

5 under subsection (b)(2), to remain available until ex6 pended. 

7 (2) OFFSETTING FUTURE APPROPRIATIONS.— 

8 For any of fiscal years 2018 through 2022, for any 

9 discretionary appropriation to the Department of 

10 Health and Human Services (or any agency therein) 

11 pursuant to the authorization of appropriations 

12 under paragraph (1) for the purpose of carrying out 

13 the programs and activities described in subsection 

14 (d), the total amount of such appropriations for the 

15 applicable fiscal year (not to exceed the total amount 

16 remaining in the Account) shall be subtracted from 

17 the estimate of discretionary budget authority and 

18 the resulting outlays for any estimate under the 

19 Congressional Budget and Impoundment Control 

20 Act of 1974 or the Balanced Budget and Emergency 

21 Deficit Control Act of 1985, and the amount trans22 ferred to the Fund shall be reduced by the same 

23 amount. 

24 (d) PROGRAMS AND ACTIVITIES.—Of the total 

25 amount authorized to be appropriated from the Fund to 


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1 the Department of Health and Human Services by sub2 section (c)(1), such amount shall be allocated as follows: 

3 (1) SAMHSA.—For the Substance Abuse and 

4 Mental Health Services Administration to carry out 

5 programs and activities pursuant to section 102, 

6 $3,650,000,000 for each of fiscal years 2018 

7 through 2022. 

8 (2) CDC.—For the Centers for Disease Control 

9 and Prevention to carry out programs and activities 

10 pursuant to section 103, $500,000,000 for each of 

11 fiscal years 2018 through 2022. 

12 (3) FDA.—For the Food and Drug Adminis13 tration to carry out programs and activities pursu14 ant to section 104, $65,000,000 for each of fiscal 

15 years 2018 through 2022. 

16 (4) NIH.—For the National Institutes of 

17 Health to carry out programs and activities pursu18 ant to section 105, $500,000,000 for each of fiscal 

19 years 2018 through 2022. 

20 (5) HRSA.—For the Health Resources and 

21 Services Administration to carry out programs and 

22 activities pursuant to section 106, $235,000,000 for 

23 each of fiscal years 2018 through 2022. 

24 (6) ACF.—For the Administration for Children 

25 and Families to carry out programs and activities 


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1 pursuant to section 107, $50,000,000 for each of 

2 fiscal years 2018 through 2022. 

3 (e) ACCOUNTABILITY AND OVERSIGHT.— 

4 (1) WORK PLAN.— 

5 (A) IN GENERAL.—Not later than 180 

6 days after the date of enactment of this Act, 

7 the Secretary of Health and Human Services 

8 shall submit to the Committee on Health, Edu9 cation, Labor, and Pensions and the Committee 

10 on Appropriations of the Senate and the Com11 mittee on Energy and Commerce and the Com12 mittee on Appropriations of the House of Rep13 resentatives, a work plan including the proposed 

14 allocation of funds appropriated pursuant to the 

15 authorization of appropriations under sub16 section (c) for each of fiscal years 2018 through 

17 2022 and the contents described in subpara18 graph (B). 

19 (B) CONTENTS.—The work plan submitted 

20 under subparagraph (A) shall include— 

21 (i) the amount of money to be obli22 gated or expended out of the Fund in each 

23 fiscal year for each program and activity 

24 described in subsection (d); and 


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1 (ii) a description and justification of 

2 each such program and activity. 

3 (2) REPORTS.— 

4 (A) ANNUAL REPORTS.—Not later than 

5 October 1 of each of fiscal years 2019 through 

6 2023, the Secretary of Health and Human 

7 Services shall submit to the Committee on 

8 Health, Education, Labor, and Pensions and 

9 the Committee on Appropriations of the Senate 

10 and the Committee on Energy and Commerce 

11 and the Committee on Appropriations of the 

12 House of Representatives, a report including— 

13 (i) the amount of money obligated or 

14 expended out of the Fund in the prior fis15 cal year for each program and activity de16 scribed in subsection (d); 

17 (ii) a description of all programs and 

18 activities using funds provided pursuant to 

19 the authorization of appropriations under 

20 subsection (c); and 

21 (iii) how the programs and activities 

22 are responding to the opioid epidemic. 

23 (B) ADDITIONAL REPORTS.—At the re24 quest of the Committee on Health, Education, 

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1 propriations of the Senate, or the Committee on 

2 Energy and Commerce or the Committee on 

3 Appropriations of the House of Representatives, 

4 the Commissioner shall provide an update in 

5 the form of testimony and any additional re6 ports to the respective congressional committee 

7 regarding the allocation of funding under this 

8 section or the description of the programs and 

9 activities undertaken with such funding. 

10 (f) LIMITATIONS.—Notwithstanding any transfer au11 thority authorized by this Act or any appropriations Act, 

12 any funds made available pursuant to the authorization 

13 of appropriations under subsection (c) may not be used 

14 for any purpose other than the programs and activities 

15 described in subsection (d) to address the opioid and sub16 stance use epidemic. 

17 (g) SUNSET.—This section shall expire at the end of 

18 fiscal year 2027. 

19 SEC. 102. SUBSTANCE ABUSE AND MENTAL HEALTH SERV20 ICES ADMINISTRATION. 

21 The entirety of the funds made available pursuant to 

22 section 101(d)(1) shall be for carrying out subsections (c) 

23 and (d) of section 1003 of the 21st Century Cures Act, 

24 as amended by section 203. 


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1 SEC. 103. CENTERS FOR DISEASE CONTROL AND PREVEN2 TION. 

3 (a) ADDRESSING OPIOID USE DISORDER.—The en4 tirety of the funds made available pursuant to section 

5 101(d)(2) shall be for the Director of the Centers for Dis6 ease Control and Prevention, pursuant to applicable au7 thorities in the Public Health Service Act (42 U.S.C. 201 

8 et seq.), to continue and expand programs of the Centers 

9 for Disease Control and Prevention to address opioid use 

10 disorder, including by— 

11 (1) improving the timeliness and quality of data 

12 on the opioid epidemic, including improvement of— 

13 (A) data on fatal and nonfatal overdoses; 

14 (B) syndromic surveillance; 

15 (C) data on long-term sequelae (including 

16 neonatal abstinence syndrome); and 

17 (D) cause of death reporting related to 

18 substance abuse or opioid overdose; 

19 (2) expanding and strengthening evidence-based 

20 prevention and education strategies; 

21 (3) supporting responsible prescribing practices, 

22 including through development and dissemination of 

23 prescriber guidelines; 

24 (4) improving access to and use of effective pre25 vention, treatment, and recovery support, including 


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1 through grants and the provision of technical assist2 ance to States and localities; 

3 (5) strengthening partnerships with first re4 sponders, including to protect their safety; 

5 (6) considering the needs of vulnerable popu6 lations; 

7 (7) addressing infectious diseases linked to the 

8 opioid crisis; and 

9 (8) strengthening prescription drug monitoring 

10 programs. 

11 (b) LIMITATION.—Of the funds made available pur12 suant to section 101(d)(2) for carrying out this section, 

13 not more than 20 percent may be used for intramural pur14 poses. 

15 SEC. 104. FOOD AND DRUG ADMINISTRATION. 

16 The entirety of the funds made available pursuant to 

17 section 101(d)(3) shall be for the Commissioner of Food 

18 and Drugs, pursuant to applicable authorities in the Pub19 lic Health Service Act (42 U.S.C. 201 et seq.) or the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

21 seq.) and other applicable law, to support widespread inno22 vation in non-opioid and non-addictive medical products 

23 for pain treatment, access to opioid addiction treatments, 

24 appropriate use of approved opioids, and efforts to reduce 


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1 illicit importation of opioids. Such support may include the 

2 following: 

3 (1) Facilitating the development of non-opioid 

4 and non-addictive pain treatments. 

5 (2) Advancing guidance documents for sponsors 

6 of non-opioid pain products. 

7 (3) Developing evidence to inform the potential 

8 for nonprescription overdose therapies. 

9 (4) Examining expanded labeling indications for 

10 medication-assisted treatment. 

11 (5) Conducting public education and outreach, 

12 including public workshops or public meetings, re13 garding the benefits of medication-assisted treat14 ment, and approved non-opioid drug and device 

15 treatment options. 

16 (6) Exploring the expansion and possible man17 datory nature of prescriber education regarding pain 

18 management and appropriate opioid prescribing 

19 through authorities under section 505–1 of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

21 1). 

22 (7) Examining options to limit the duration of 

23 opioid prescriptions for acute pain, including 

24 through packaging options. 


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1 (8) Increasing staff and infrastructure capacity 

2 to inspect and analyze packages at international 

3 mail facilities and pursue criminal investigations. 

4 SEC. 105. NATIONAL INSTITUTES OF HEALTH. 

5 The entirety of the funds made available pursuant to 

6 section 101(d)(4) shall be for the Director of the National 

7 Institutes of Health, pursuant to applicable authorities in 

8 the Public Health Service Act (42 U.S.C. 201 et seq.), 

9 to carry out activities related to— 

10 (1) accelerating research for addressing the 

11 opioid epidemic, including developing non-opioid 

12 medications and interventions, including non-addict13 ive medications, to manage pain, as well as to treat 

14 and to prevent substance use disorders; 

15 (2) conducting and supporting research on 

16 which treatments (in terms of pain management as 

17 well as treating and preventing substance use dis18 orders) are optimal for which patients; and 

19 (3) conducting and supporting research on cre20 ating longer-lasting or faster-acting antidotes for 

21 opioid overdose, particularly in response to the prev22 alence of fentanyl and carfentanyl overdoses. 


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1 SEC. 106. HEALTH RESOURCES AND SERVICES ADMINIS2 TRATION. 

3 The entirety of the funds made available pursuant to 

4 section 101(d)(5) shall be for the Administrator of the 

5 Health Resources and Services Administration, pursuant 

6 to applicable authorities in titles III, VII, and VIII of the 

7 Public Health Service Act (42 U.S.C. 241 et seq.), to 

8 carry out activities that increase the availability and ca9 pacity of the behavioral health workforce. Such activities 

10 may include providing loan repayment assistance for sub11 stance abuse treatment providers. 

12 SEC. 107. ADMINISTRATION FOR CHILDREN AND FAMILIES. 

13 Of the funds made available pursuant to section 

14 101(d)(6) for each of fiscal years 2018 through 2022— 

15 (1) $25,000,000 for each such fiscal year shall 

16 be for the Secretary of Health and Human Services 

17 to carry out title I of the Child Abuse Prevention 

18 and Treatment Act (42 U.S.C. 5101 et seq.); and 

19 (2) $25,000,000 for each such fiscal year shall 

20 be for the Secretary of Health and Human Services 

21 to carry out title II of such Act (42 U.S.C. 5116 et 

22 seq.). 


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1 TITLE II—ADDITIONAL INVEST2 MENTS IN EXISTING PRO3 GRAMS TO RESPOND TO THE 

4 OPIOID EPIDEMIC 

5 SEC. 201. INCREASE IN FUNDING FOR REGIONAL PARTNER6 SHIP GRANTS. 

7 Section 436 of the Social Security Act (42 U.S.C. 

8 629f) is amended— 

9 (1) in subsection (a), by striking 

10 ‘‘$345,000,000 for each of fiscal years 2012 through 

11 2016’’ and inserting ‘‘$385,000,000 for each of fis12 cal years 2018 through 2023’’; and 

13 (2) in subsection (b)— 

14 (A) in paragraph (4)(A), by striking ‘‘2012 

15 through 2016’’ and inserting ‘‘2018 through 

16 2023’’; and 

17 (B) in paragraph (5), by striking 

18 ‘‘$20,000,000 for each of fiscal years 2012 

19 through 2016’’ and inserting ‘‘$60,000,000 for 

20 each of fiscal years 2018 through 2023’’. 

21 SEC. 202. ACCOUNT FOR THE STATE AND TRIBAL RE22 SPONSE TO THE OPIOID ABUSE CRISIS. 

23 Section 1003 of the 21st Century Cures Act (42 

24 U.S.C. 290ee–3 note) is amended— 


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1 (1) in subsection (b)(2), by amending subpara2 graph (A) to read as follows: 

3 ‘‘(A) IN GENERAL.—The following 

4 amounts shall be transferred to the Account 

5 from the general fund of the Treasury: 

6 ‘‘(i) For fiscal year 2017, 

7 $500,000,000. 

8 ‘‘(ii) For each of fiscal years 2018 

9 through 2022, $3,750,000,000.’’; 

10 (2) in subsection (b)(2), by adding at the end 

11 the following: 

12 ‘‘(C) SET ASIDE.—Of the amount trans13 ferred pursuant to subparagraph (A) for each 

14 of fiscal years 2018 through 2022, 3 percent 

15 shall be set aside for Indian tribes, tribal orga16 nizations, and Urban Indian organizations (as 

17 such terms are defined in section 4 of the In18 dian Health Care Improvement Act).’’; 

19 (3) in subsection (c)(1), by striking the second 

20 sentence and inserting the following: ‘‘In awarding 

21 such grants and allocating funds pursuant to such 

22 grants among the States, the Secretary shall account 

23 for the prevalence of opioid use disorders and deaths 

24 from overdose, including taking into account which 

25 States are hardest hit by the opioid epidemic.’’; 


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1 (4) by redesignating subsection (f) as sub2 section (g); and 

3 (5) by inserting after subsection (e) the fol4 lowing: 

5 ‘‘(f) DEFINITION.—In this section, the term ‘State’ 

6 includes an Indian tribe, tribal organization, and Urban 

7 Indian organization (as such terms are defined in section 

8 4 of the Indian Health Care Improvement Act).’’. 

9 TITLE III—EXPANDING ACCESS 

10 TO TREATMENT SERVICES 

11 SEC. 301. ALLOWING FOR MORE FLEXIBILITY WITH RE12 SPECT TO MEDICATION-ASSISTED TREAT13 MENT FOR OPIOID USE DISORDERS. 

14 (a) CONFORMING APPLICABLE NUMBER.—Subclause 

15 (II) of section 303(g)(2)(B)(iii) of the Controlled Sub16 stances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to 

17 read as follows: 

18 ‘‘(II) The applicable number is— 

19 ‘‘(aa) 100 if, not sooner 

20 than 1 year after the date on 

21 which the practitioner submitted 

22 the initial notification, the practi23 tioner submits a second notifica24 tion to the Secretary of the need 


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1 and intent of the practitioner to 

2 treat up to 100 patients; 

3 ‘‘(bb) 100 if the practitioner 

4 holds additional credentialing, as 

5 defined in section 8.2 of title 42, 

6 Code of Federal Regulations (or 

7 successor regulations); 

8 ‘‘(cc) 100 if the practitioner 

9 provides medication-assisted 

10 treatment (MAT) using covered 

11 medications (as defined in section 

12 8.2 of title 42, Code of Federal 

13 Regulations (or successor regula14 tions)) in a qualified practice set15 ting (as described in section 

16 8.615 of title 42, Code of Federal 

17 Regulations (or successor regula18 tions)); or 

19 ‘‘(dd) 275 if the practitioner 

20 meets the requirements specified 

21 in section 8.610 of title 42, Code 

22 of Federal Regulations (or suc23 cessor regulations).’’. 

24 (b) ELIMINATING ANY TIME LIMITATION FOR NURSE

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1 TIFIED REGISTERED NURSE ANESTHETISTS, CERTIFIED

2 NURSE MIDWIVES, AND PHYSICIAN ASSISTANTS TO BE3 COME QUALIFYING PRACTITIONERS.—Section 

4 303(g)(2)(G)(iii)(II) of the Controlled Substances Act (21 

5 U.S.C. 823(g)(2)(G)(iii)(II)) is amended by striking ‘‘dur6 ing the period beginning on the date of enactment of the 

7 Comprehensive Addiction and Recovery Act of 2016 and 

8 ending on October 1, 2021’’ and inserting ‘‘beginning on 

9 the date of enactment of the Comprehensive Addiction and 

10 Recovery Act of 2016’’. 

11 (c) DEFINITION OF QUALIFYING OTHER PRACTI12 TIONER.—Clause (iv) of section 303(g)(2)(G) of the Con13 trolled Substances Act (21 U.S.C. 823(g)(2)(G)) is 

14 amended by striking ‘‘nurse practitioner or physician as15 sistant’’ each place it appears and inserting ‘‘nurse practi16 tioner, clinical nurse specialist, certified registered nurse 

17 anesthetist, certified nurse midwife, or physician assist18 ant’’. 

19 SEC. 302. COVERAGE OF METHADONE UNDER MEDICARE 

20 PART B. 

21 (a) COVERAGE.—Section 1861(s)(2) of the Social Se22 curity Act (42 U.S.C. 1395x(s)(2)) is amended— 

23 (1) by striking ‘‘and’’ at the end of subpara24 graph (FF); 


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1 (2) by adding ‘‘and’’ at the end of subpara2 graph (GG); and 

3 (3) by inserting after subparagraph (GG) the 

4 following new subparagraph: 

5 ‘‘(HH) methadone, if furnished or dis6 pensed (including by prescription) in an oral 

7 form on or after January 1, 2018, to an indi8 vidual for the purpose of maintenance or detoxi9 fication treatment by a physician or other prac10 titioner who has in effect a registration or waiv11 er under section 303(g) of such Act (21 U.S.C. 

12 823(g)) to dispense methadone for such pur13 pose;’’. 

14 (b) PAYMENT.— 

15 (1) IN CONNECTION WITH PHYSICIAN AND SUP16 PLIER SERVICE.—Section 1842(o)(1) of the Social 

17 Security Act (42 U.S.C. 1395u(o)(1)) is amended by 

18 adding at the end the following new subparagraph: 

19 ‘‘(H) In the case of methadone (as de20 scribed in section 1861(s)(2)(HH)), the amount 

21 provided under section 1847A for such drug.’’. 

22 (2) COVERED OPD SERVICE.—Section 

23 1833(t)(1)(B)(iii) of the Social Security Act (42 

24 U.S.C. 1395l(t)(1)(B)(iii)) is amended by inserting 


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1 ‘‘and methadone described in paragraph (2)(HH) of 

2 such section’’ after ‘‘section 1861(s)’’. 

3 (c) BUDGET NEUTRALITY.—The Secretary of Health 

4 and Human Services shall implement the amendments 

5 made by this section in a manner such that— 

6 (1) estimated expenditures under the physician 

7 fee schedule under section 1848 of the Social Secu8 rity Act (42 U.S.C. 1395w–4) with application of 

9 such amendments are equal to estimated expendi10 tures under such schedule without application of 

11 such amendments; and 

12 (2) estimated expenditures under the prospec13 tive payment system under section 1833(t) of the 

14 Social Security Act (42 U.S.C. 1395l(t)) with appli15 cation of such amendments made by this section are 

16 equal to estimated expenditures under such system 

17 without application of such amendments. 

Æ 


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