IB 

Union Calendar No. 435 

114TH CONGRESS 

2D SESSION H. R. 4981 

[Report No. 114–561, Part I] 

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 

MAY 10, 2016 

Additional sponsor: Mr. ROKITA

MAY 10, 2016 

Reported from the Committee on Energy and Commerce with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

MAY 10, 2016 

The Committee on the Judiciary discharged; committed to the Committee of 

the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on April 18, 2016] 


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A BILL 

To amend the Controlled Substances Act to improve access 

to opioid use disorder treatment. 


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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. 

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 become 

8 a public health epidemic that must be addressed by increas9 ing awareness and access to all treatment options for opioid 

10 use disorder, overdose reversal, and relapse prevention. 

11 SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZA12 TION. 

13 (a) IN GENERAL.—Section 303(g)(2) of the Controlled 

14 Substances Act (21 U.S.C. 823(g)(2)) is amended— 

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

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

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

18 (as defined in subparagraph (G)). 

19 ‘‘(ii) With respect to patients to whom the prac20 titioner will provide such drugs or combinations of 

21 drugs, the practitioner has the capacity to provide di22 rectly, by referral, or in such other manner as deter23 mined by the Secretary— 

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

25 well as unscheduled medications approved by the 


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1 Food and Drug Administration, for the treat2 ment of opioid use disorder, including such 

3 drugs and medications for maintenance, detoxi4 fication, overdose reversal, and relapse preven5 tion, as available; and 

6 ‘‘(II) appropriate counseling and other ap7 propriate ancillary services. 

8 ‘‘(iii)(I) The total number of such patients of the 

9 practitioner at any one time will not exceed the ap10 plicable number. Except as provided in subclauses 

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

12 ‘‘(II) The applicable number is 100 if, not sooner 

13 than 1 year after the date on which the practitioner 

14 submitted the initial notification, the practitioner 

15 submits a second notification to the Secretary of the 

16 need and intent of the practitioner to treat up to 100 

17 patients. 

18 ‘‘(III) The applicable number is 250 if the prac19 titioner is a qualifying physician meeting the require20 ment of subclause (VI) and, not sooner than 1 year 

21 after the date on which the physician submitted a sec22 ond notification under subclause (II), the practitioner 

23 submits a third notification to the Secretary of the 

24 need and intent of the physician to treat up to 250 

25 patients. 


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

2 such total number. 

3 ‘‘(V) The Secretary may exclude from the appli4 cable number patients to whom such drugs or com5 binations of drugs are directly administered by the 

6 qualifying practitioner in the office setting. 

7 ‘‘(VI) For purposes of subclause (III), a quali8 fying physician meets the requirement of this sub9 clause if the physician— 

10 ‘‘(aa) holds a special certification in addic11 tion psychiatry or addiction medicine as de12 scribed in clause (ii) from the American Board 

13 of Medical Specialties, the American Board of 

14 Addiction Medicine, the American Osteopathic 

15 Association, the American Society of Addiction 

16 Medicine, or such other organization as the Sec17 retary determines to be appropriate for purposes 

18 of this subclause; or 

19 ‘‘(bb) has completed not fewer than 24 hours 

20 of training, with respect to the treatment and 

21 management of opiate-dependent patients, ad22 dressing the topics listed in subparagraph 

23 (G)(ii)(IV). 

24 The Secretary may review and update the require25 ments of this subclause. 


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

2 clause (iii)(III), the qualifying physician maintains 

3 and implements a diversion control plan that con4 tains specific measures to reduce the likelihood of the 

5 diversion of controlled substances prescribed by the 

6 physician for the treatment of opioid use disorder. 

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

8 clause (iii)(III), the qualifying physician obtains a 

9 written agreement from each patient, including the 

10 patient’s signature, that the patient— 

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

12 treatment plan and periodic assessments and 

13 treatment plans thereafter; 

14 ‘‘(II) will be subject to medication adherence 

15 and substance use monitoring; 

16 ‘‘(III) understands available treatment op17 tions, including all drugs approved by the Food 

18 and Drug Administration for the treatment of 

19 opioid use disorder, including their potential 

20 risks and benefits; and 

21 ‘‘(IV) understands that receiving regular 

22 counseling services is critical to recovery. 

23 ‘‘(vi) The practitioner will comply with the re24 porting requirements of subparagraph (D)(i)(IV).’’; 

25 (2) in subparagraph (D)— 


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

2 following: 

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

4 at such times and in such manner as specified by the 

5 Secretary, such information and assurances as the 

6 Secretary determines necessary to assess whether the 

7 practitioner continues to meet the requirements for a 

8 waiver under this paragraph.’’; 

9 (B) in clause (ii), by striking ‘‘Upon receiv10 ing a notification under subparagraph (B)’’ and 

11 inserting ‘‘Upon receiving a determination from 

12 the Secretary under clause (iii) finding that a 

13 practitioner meets all requirements for a waiver 

14 under subparagraph (B)’’; and 

15 (C) in clause (iii)— 

16 (i) by inserting ‘‘and shall forward 

17 such determination to the Attorney Gen18 eral’’ before the period at the end of the first 

19 sentence; and 

20 (ii) by striking ‘‘physician’’ and in21 serting ‘‘practitioner’’; 

22 (3) in subparagraph (G)— 

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

24 follows: 


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1 ‘‘(IV) The physician has, with respect to the 

2 treatment and management of opiate-dependent 

3 patients, completed not less than eight hours of 

4 training (through classroom situations, seminars 

5 at professional society meetings, electronic com6 munications, or otherwise) that is provided by 

7 the American Society of Addiction Medicine, the 

8 American Academy of Addiction Psychiatry, the 

9 American Medical Association, the American Os10 teopathic Association, the American Psychiatric 

11 Association, or any other organization that the 

12 Secretary determines is appropriate for purposes 

13 of this subclause. Such training shall address— 

14 ‘‘(aa) opioid maintenance and detoxi15 fication; 

16 ‘‘(bb) appropriate clinical use of all 

17 drugs approved by the Food and Drug Ad18 ministration for the treatment of opioid use 

19 disorder; 

20 ‘‘(cc) initial and periodic patient as21 sessments (including substance use moni22 toring); 

23 ‘‘(dd) individualized treatment plan24 ning; overdose reversal; relapse prevention; 


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1 ‘‘(ee) counseling and recovery support 

2 services; 

3 ‘‘(ff) staffing roles and considerations; 

4 ‘‘(gg) diversion control; and 

5 ‘‘(hh) other best practices, as identified 

6 by the Secretary.’’; and 

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

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

9 means— 

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

11 clause (ii); or 

12 ‘‘(II) a qualifying other practitioner, as de13 fined in clause (iv). 

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

15 means a nurse practitioner or physician assistant 

16 who satisfies each of the following: 

17 ‘‘(I) The nurse practitioner or physician as18 sistant is licensed under State law to prescribe 

19 schedule III, IV, or V medications for the treat20 ment of pain. 

21 ‘‘(II) The nurse practitioner or physician 

22 assistant satisfies 1 or more of the following: 

23 ‘‘(aa) Has completed not fewer than 24 

24 hours of initial training addressing each of 

25 the topics listed in clause (ii)(IV) (through 


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1 classroom situations, seminars at profes2 sional society meetings, electronic commu3 nications, or otherwise) provided by the 

4 American Society of Addiction Medicine, 

5 the American Academy of Addiction Psychi6 atry, the American Medical Association, the 

7 American Osteopathic Association, the 

8 American Nurses Credentialing Center, the 

9 American Psychiatric Association, the 

10 American Association of Nurse Practi11 tioners, the American Academy of Physi12 cian Assistants, or any other organization 

13 that the Secretary determines is appro14 priate for purposes of this subclause. 

15 ‘‘(bb) Has such other training or expe16 rience as the Secretary determines will dem17 onstrate the ability of the nurse practitioner 

18 or physician assistant to treat and manage 

19 opiate-dependent patients. 

20 ‘‘(III) The nurse practitioner or physician 

21 assistant is supervised by or works in collabora22 tion with a qualifying physician, if the nurse 

23 practitioner or physician assistant is required by 

24 State law to prescribe medications for the treatVerDate Sep 11 2014 01:18 May 11, 2016 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H4981.RH H4981

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1 ment of opioid use disorder in collaboration with 

2 or under the supervision of a physician. 

3 The Secretary may review and update the require4 ments for being a qualifying other practitioner under 

5 this clause.’’; and 

6 (4) in subparagraph (H)— 

7 (A) in clause (i), by inserting after sub8 clause (II) the following: 

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

10 under this paragraph as the Secretary determines 

11 necessary for purposes of implementing such require12 ments.’’; and 

13 (B) by amending clause (ii) to read as fol14 lows: 

15 ‘‘(ii) Not later than one year after the date of enact16 ment of the Opioid Use Disorder Treatment Expansion and 

17 Modernization Act, the Secretary shall update the treatment 

18 improvement protocol containing best practice guidelines 

19 for the treatment of opioid-dependent patients in office20 based settings. The Secretary shall update such protocol in 

21 consultation with experts in opioid use disorder research 

22 and treatment.’’. 

23 (b) RECOMMENDATION OF REVOCATION OR SUSPEN24 SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON25 COMPLIANCE.—The Secretary of Health and Human ServVerDate Sep 11 2014 01:18 May 11, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H4981.RH H4981

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1 ices may recommend to the Attorney General that the reg2 istration of a practitioner be revoked or suspended if the 

3 Secretary determines, according to such criteria as the Sec4 retary establishes by regulation, that a practitioner who is 

5 registered under section 303(g)(2) of the Controlled Sub6 stances Act (21 U.S.C. 823(g)(2)) is not in substantial com7 pliance with the requirements of such section, as amended 

8 by this Act. 

9 (c) OPIOID DEFINED.—Section 102(18) of the Con10 trolled Substances Act (21 U.S.C. 802(18)) is amended by 

11 inserting ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 

12 (d) REPORTS TO CONGRESS.— 

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

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

15 over every 5 years thereafter, the Secretary of Health 

16 and Human Services, in consultation with the Drug 

17 Enforcement Administration and experts in opioid 

18 use disorder research and treatment, shall— 

19 (A) perform a thorough review of the provi20 sion of opioid use disorder treatment services in 

21 the United States, including services provided in 

22 opioid treatment programs and other specialty 

23 and nonspecialty settings; and 

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

25 findings and conclusions of such review. 


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1 (2) CONTENTS.—Each report under paragraph 

2 (1) shall include an assessment of— 

3 (A) compliance with the requirements of 

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

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

6 Act; 

7 (B) the measures taken by the Secretary of 

8 Health and Human Services to ensure such com9 pliance; 

10 (C) whether there is further need to increase 

11 or decrease the number of patients a waivered 

12 practitioner is permitted to treat, as provided for 

13 by the amendment made by subsection (a)(1); 

14 (D) the extent to which, and proportions 

15 with which, the full range of Food and Drug Ad16 ministration-approved treatments for opioid use 

17 disorder are used in routine health care settings 

18 and specialty substance use disorder treatment 

19 settings; 

20 (E) access to, and use of, counseling and re21 covery support services, including the percentage 

22 of patients receiving such services; 

23 (F) changes in State or local policies and 

24 legislation relating to opioid use disorder treat25 ment; 


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1 (G) the use of prescription drug monitoring 

2 programs by practitioners who are permitted to 

3 dispense narcotic drugs to individuals pursuant 

4 to a waiver under section 303(g)(2) of the Con5 trolled Substances Act (21 U.S.C. 823(g)(2)); 

6 (H) the findings resulting from inspections 

7 by the Drug Enforcement Administration of 

8 practitioners described in subparagraph (G); and 

9 (I) the effectiveness of cross-agency collabo10 ration between Department of Health and 

11 Human Services and the Drug Enforcement Ad12 ministration for expanding effective opioid use 

13 disorder treatment. 


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Union Calendar No. 435 

114TH CONGRESS 

2D SESSION H. R. 4981 

[Report No. 114–561, Part I] 

A BILL 

To amend the Controlled Substances Act to 

improve access to opioid use disorder treatment. 

MAY 10, 2016 

Reported from the Committee on Energy and Commerce 

with an amendment 

MAY 10, 2016 

The Committee on the Judiciary discharged; committed 

the Union and ordered to be printed to the Committee of the Whole House on the State of 


SSpencer on DSK4SPTVN1PROD with BILLS