I 

114TH CONGRESS 

2D SESSION H. R. 4981 

To amend the Controlled Substances Act to improve access to opioid use 

disorder treatment. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2016 

Mr. BUCSHON (for himself and Mr. TONKO) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on the Judiciary, 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 amend the Controlled Substances Act to improve access 

to opioid use disorder treatment. 

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 ‘‘Opioid Use Disorder 

5 Treatment Expansion and Modernization Act’’. 

6 SEC. 2. FINDING. 

7 The Congress finds that opioid use disorder has be8 come a public health epidemic that must be addressed by 

9 increasing awareness and access to all treatment options 


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1 for opioid use disorder, overdose reversal, and relapse pre2 vention. 

3 SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZA4 TION. 

5 (a) IN GENERAL.—Section 303(g)(2) of the Con6 trolled Substances Act (21 U.S.C. 823(g)(2)) is amend7 ed— 

8 (1) in subparagraph (B), by striking clauses (i), 

9 (ii), and (iii) and inserting the following: 

10 ‘‘(i) The practitioner is a qualifying practitioner 

11 (as defined in subparagraph (G)). 

12 ‘‘(ii) With respect to patients to whom the prac13 titioner will provide such drugs or combinations of 

14 drugs, the practitioner has the capacity to provide 

15 directly, by referral, or by providing the contact in16 formation for the nearest applicable practitioner— 

17 ‘‘(I) all schedule III, IV, and V drugs, as 

18 well as unscheduled medications approved by 

19 the Food and Drug Administration, for the 

20 treatment of opioid use disorder, including such 

21 drugs and medications for maintenance, detoxi22 fication, overdose reversal, and relapse preven23 tion, as available; and 

24 ‘‘(II) appropriate counseling and other ap25 propriate ancillary services. 


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1 ‘‘(iii)(I) The total number of such patients of 

2 the practitioner at any one time will not exceed the 

3 applicable number. Except as provided in subclauses 

4 (II) and (III), the applicable number is 30. 

5 ‘‘(II) The applicable number is 100 if, not soon6 er than 1 year after the date on which the practi7 tioner submitted the initial notification, the practi8 tioner submits a second notification to the Secretary 

9 of the need and intent of the practitioner to treat up 

10 to 100 patients. 

11 ‘‘(III) The applicable number is 250 if the prac12 titioner is a qualifying physician meeting the re13 quirement of subclause (VI) and, not sooner than 1 

14 year after the date on which the practitioner sub15 mitted a second notification under subclause (II), 

16 the practitioner submits a third notification to the 

17 Secretary of the need and intent of the practitioner 

18 to treat up to 250 patients. 

19 ‘‘(IV) The Secretary may by regulation change 

20 such total number. 

21 ‘‘(V) The Secretary may exclude from the appli22 cable number patients to whom such drugs or com23 binations of drugs are directly administered by the 

24 qualifying practitioner in the office setting. 


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1 ‘‘(VI) For purposes of subclause (III), a quali2 fying physician meets the requirement of this sub3 clause if the practitioner or physician— 

4 ‘‘(aa) holds a special certification in addic5 tion psychiatry or addiction medicine as de6 scribed in clause (ii) from the American Board 

7 of Medical Specialties, the American Board of 

8 Addiction Medicine, the American Osteopathic 

9 Association, the American Society of Addiction 

10 Medicine, or such other organization as the Sec11 retary determines to be appropriate for pur12 poses of this subclause; or 

13 ‘‘(bb) completes at least 24 hours of train14 ing, with respect to the treatment and manage15 ment of opiate-dependent patients, addressing 

16 the topics listed in subparagraph (G)(ii)(IV). 

17 The Secretary may review and update the require18 ments of this subclause. 

19 ‘‘(iv) In the case of a third notification under 

20 clause (iii)(III), the practitioner maintains and im21 plements a diversion control plan that contains spe22 cific measures to reduce the likelihood of the diver23 sion of controlled substances prescribed by the prac24 titioner for the treatment of opioid use disorder. 


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1 ‘‘(v) In the case of a third notification under 

2 clause (iii)(III), the practitioner obtains a written 

3 agreement from each patient, including the patient’s 

4 signature, that the patient— 

5 ‘‘(I) will receive an initial assessment and 

6 treatment plan and periodic assessments and 

7 treatment plans thereafter; 

8 ‘‘(II) will be subject to medication adher9 ence and substance use monitoring; and 

10 ‘‘(III) understands available treatment op11 tions, including all drugs approved by the Food 

12 and Drug Administration for the treatment of 

13 opioid use disorder, including their potential 

14 risks and benefits. 

15 ‘‘(vi) The practitioner will comply with the re16 porting requirements of subparagraph (D)(i)(IV).’’; 

17 (2) in subparagraph (D)— 

18 (A) in clause (i), by adding at the end the 

19 following: 

20 ‘‘(IV) The practitioner reports to the Secretary, 

21 at such times and in such manner as specified by 

22 the Secretary, such information and assurances as 

23 the Secretary determines necessary to assess wheth24 er the practitioner continues to meet the require25 ments for a waiver under this paragraph.’’; 


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1 (B) in clause (ii), by striking ‘‘Upon re2 ceiving a notification under subparagraph (B)’’ 

3 and inserting ‘‘Upon receiving a determination 

4 from the Secretary under clause (iii) finding 

5 that a practitioner meets all requirements for a 

6 waiver under subparagraph (B)’’; and 

7 (C) in clause (iii)— 

8 (i) by inserting ‘‘and shall forward 

9 such determination to the Attorney Gen10 eral’’ before the period at the end of the 

11 first sentence; and 

12 (ii) by striking ‘‘physician’’ and in13 serting ‘‘practitioner’’; 

14 (3) in subparagraph (G)— 

15 (A) by amending clause (ii)(IV) to read as 

16 follows: 

17 ‘‘(IV) The physician has, with respect to 

18 the treatment and management of opiate-de19 pendent patients, completed not less than eight 

20 hours of training (through classroom situations, 

21 seminars at professional society meetings, elec22 tronic communications, or otherwise) that is 

23 provided by the American Society of Addiction 

24 Medicine, the American Academy of Addiction 

25 Psychiatry, the American Medical Association, 


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1 the American Osteopathic Association, the 

2 American Psychiatric Association, or any other 

3 organization that the Secretary determines is 

4 appropriate for purposes of this subclause. Such 

5 training shall address— 

6 ‘‘(aa) opioid maintenance and detoxi7 fication; 

8 ‘‘(bb) appropriate clinical use of all 

9 drugs approved by the Food and Drug Ad10 ministration for the treatment of opioid 

11 use disorder; 

12 ‘‘(cc) initial and periodic patient as13 sessments (including substance use moni14 toring); 

15 ‘‘(dd) individualized treatment plan16 ning; overdose reversal; relapse prevention; 

17 ‘‘(ee) counseling and recovery support 

18 services; 

19 ‘‘(ff) staffing roles and considerations; 

20 ‘‘(gg) diversion control; and 

21 ‘‘(hh) other best practices, as identi22 fied by the Secretary.’’; and 

23 (B) by adding at the end the following: 

24 ‘‘(iii) The term ‘qualifying practitioner’ 

25 means— 


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1 ‘‘(I) a qualifying physician, as defined in 

2 clause (ii); or 

3 ‘‘(II) a qualifying other practitioner, as de4 fined in clause (iv). 

5 ‘‘(iv) The term ‘qualifying other practitioner’ 

6 means a nurse practitioner or physician assistant 

7 who satisfies each of the following: 

8 ‘‘(I) The nurse practitioner or physician 

9 assistant is licensed under State law to pre10 scribe schedule III, IV, or V medications for the 

11 treatment of pain. 

12 ‘‘(II) The nurse practitioner or physician 

13 assistant satisfies 1 or more of the following: 

14 ‘‘(aa) Has completed not fewer than 

15 24 hours of initial training addressing each 

16 of the topics listed in clause (ii)(IV) 

17 (through classroom situations, seminar at 

18 professional society meetings, electronic 

19 communications, or otherwise) provided by 

20 the American Society of Addiction Medi21 cine, the American Academy of Addiction 

22 Psychiatry, the American Medical Associa23 tion, the American Osteopathic Associa24 tion, the American Nurses Credentialing 

25 Center, the American Psychiatric AssociaVerDate Sep 11 2014 02:26 Apr 23, 2016 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4981.IH H4981

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1 tion, or any other organization that the 

2 Secretary determines is appropriate for 

3 purposes of this subclause. 

4 ‘‘(bb) Has such other training or ex5 perience as the Secretary determines will 

6 demonstrate the ability of the nurse practi7 tioner or physician assistant to treat and 

8 manage opiate-dependent patients. 

9 ‘‘(III) If required by State law, the nurse 

10 practitioner or physician assistant prescribes 

11 medications for the treatment of opioid use dis12 order in collaboration with or under supervision 

13 of a physician. 

14 The Secretary may review and update the require15 ments for being a qualifying other practitioner under 

16 this clause.’’; and 

17 (4) in subparagraph (H)— 

18 (A) in clause (i), by adding at the end the 

19 following: 

20 ‘‘(III) Such other elements of the requirements 

21 under this paragraph as the Secretary determines 

22 necessary for purposes of implementing such re23 quirements.’’; and 

24 (B) by amending clause (ii) to read as fol25 lows: 


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1 ‘‘(ii) Not later than one year after the date of enact2 ment of the Opioid Use Disorder Treatment Expansion 

3 and Modernization Act, the Secretary shall update the 

4 treatment improvement protocol containing best practice 

5 guidelines for the treatment of opioid-dependent patients 

6 in office-based settings. The Secretary shall update such 

7 protocol in consultation with experts in opioid use disorder 

8 research and treatment.’’. 

9 (b) RECOMMENDATION OF REVOCATION OR SUSPEN10 SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON11 COMPLIANCE.—The Secretary of Health and Human 

12 Services may recommend to the Attorney General that the 

13 registration of a practitioner be revoked or suspended if 

14 the Secretary determines, according to such criteria as the 

15 Secretary establishes by regulation, that a practitioner 

16 who is registered under section 303(g)(2) of the Controlled 

17 Substances Act (21 U.S.C. 823(g)(2)) is not in substantial 

18 compliance with the requirements of such section, as 

19 amended by this Act. 

20 (c) OPIOID DEFINED.—Section 102(18) of the Con21 trolled Substances Act (42 U.S.C. 802(18)) is amended 

22 by inserting ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 

23 (d) REPORTS TO CONGRESS.— 

24 (1) IN GENERAL.—Not later than 2 years after 

25 the date of enactment of this Act and not less than 


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1 over every 5 years thereafter, the Secretary of 

2 Health and Human Services, in consultation with 

3 the Drug Enforcement Administration and experts 

4 in opioid use disorder research and treatment, 

5 shall— 

6 (A) perform a thorough review of the pro7 vision of opioid use disorder treatment services 

8 in the United States, including services pro9 vided in opioid treatment programs and other 

10 specialty and non-specialty settings; and 

11 (B) submit a report to the Congress on the 

12 findings and conclusions of such review. 

13 (2) CONTENTS.—Each report under paragraph 

14 (1) shall include an assessment of— 

15 (A) compliance with the requirements of 

16 section 303(g)(2) of the Controlled Substances 

17 Act (21 U.S.C. 823(g)(2)), as amended by this 

18 Act; 

19 (B) the measures taken by the Secretary of 

20 Health and Human Services to ensure such 

21 compliance; 

22 (C) whether there is further need to in23 crease or decrease the number of patients a 

24 waivered practitioner is permitted to treat, as 


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1 provided for by the amendment made by sub2 section (a)(1); 

3 (D) the extent to which, and proportions 

4 with which, the full range of Food and Drug 

5 Administration-approved treatments for opioid 

6 use disorder are used in routine health care set7 tings and specialty substance use disorder treat8 ment settings; 

9 (E) access to, and use of, other behavioral 

10 health and recovery supports; 

11 (F) changes in State or local policies and 

12 legislation relating to opioid use disorder treat13 ment; 

14 (G) the use of prescription drug moni15 toring programs by practitioners who are per16 mitted to dispense narcotic drugs to individuals 

17 pursuant to a waiver under section 303(g)(2) of 

18 the Controlled Substances Act (21 U.S.C. 

19 823(g)(2)); 

20 (H) the findings resulting from inspections 

21 by the Drug Enforcement Administration of 

22 practitioners described in subparagraph (G); 

23 and 

24 (I) the effectiveness of cross-agency col25 laboration between Department of Health and 


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1 Human Services and the Drug Enforcement 

2 Administration for expanding effective opioid 

3 use disorder treatment. 

Æ 


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