IIB 

114TH CONGRESS 

2D SESSION H. R. 4981 

IN THE SENATE OF THE UNITED STATES 

MAY 12, 2016 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Opioid Use Disorder 

3 Treatment Expansion and Modernization Act’’. 

4 SEC. 2. FINDING. 

5 The Congress finds that opioid use disorder has be6 come a public health epidemic that must be addressed by 

7 increasing awareness and access to all treatment options 

8 for opioid use disorder, overdose reversal, and relapse pre9 vention. 

10 SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZA11 TION. 

12 (a) IN GENERAL.—Section 303(g)(2) of the Con13 trolled Substances Act (21 U.S.C. 823(g)(2)) is amend14 ed— 

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 

22 directly, by referral, or in such other manner as de23 termined by the Secretary— 

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

25 well as unscheduled medications approved by 

26 the Food and Drug Administration, for the 


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1 treatment of opioid use disorder, including such 

2 drugs and medications for maintenance, detoxi3 fication, overdose reversal, and relapse preven4 tion, as available; and 

5 ‘‘(II) appropriate counseling and other ap6 propriate ancillary services. 

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

8 the practitioner at any one time will not exceed the 

9 applicable number. Except as provided in subclause 

10 (II), the applicable number is 30. 

11 ‘‘(II) The applicable number is 100 if, not soon12 er than 1 year after the date on which the practi13 tioner submitted the initial notification, the practi14 tioner submits a second notification to the Secretary 

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

16 to 100 patients. 

17 ‘‘(III) The Secretary may by regulation change 

18 such total number. 

19 ‘‘(IV) The Secretary may exclude from the ap20 plicable number patients to whom such drugs or 

21 combinations of drugs are directly administered by 

22 the qualifying practitioner in the office setting. 

23 ‘‘(iv) If the Secretary by regulation increases 

24 the total number of patients which a qualifying prac25 titioner is permitted to treat pursuant to clause 


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1 (iii)(II), the Secretary shall require such a practi2 tioner to obtain a written agreement from each pa3 tient, including the patient’s signature, that the pa4 tient— 

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; 

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; and 

15 ‘‘(IV) understands that receiving regular 

16 counseling services is critical to recovery. 

17 ‘‘(v) The practitioner will comply with the re18 porting requirements of subparagraph (D)(i)(IV).’’; 

19 (2) in subparagraph (D)— 

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

21 following: 

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

23 at such times and in such manner as specified by 

24 the Secretary, such information and assurances as 

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1 er the practitioner continues to meet the require2 ments for a waiver under this paragraph.’’; 

3 (B) in clause (ii), by striking ‘‘Upon re4 ceiving a notification under subparagraph (B)’’ 

5 and inserting ‘‘Upon receiving a determination 

6 from the Secretary under clause (iii) finding 

7 that a practitioner meets all requirements for a 

8 waiver under subparagraph (B)’’; and 

9 (C) in clause (iii)— 

10 (i) by inserting ‘‘and shall forward 

11 such determination to the Attorney Gen12 eral’’ before the period at the end of the 

13 first sentence; and 

14 (ii) by striking ‘‘physician’’ and in15 serting ‘‘practitioner’’; 

16 (3) in subparagraph (G)— 

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

18 follows: 

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

20 the treatment and management of opiate-de21 pendent patients, completed not less than 8 

22 hours of training (through classroom situations, 

23 seminars at professional society meetings, elec24 tronic communications, or otherwise) that is 

25 provided by the American Society of Addiction 


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1 Medicine, the American Academy of Addiction 

2 Psychiatry, the American Medical Association, 

3 the American Osteopathic Association, the 

4 American Psychiatric Association, or any other 

5 organization that the Secretary determines is 

6 appropriate for purposes of this subclause. Such 

7 training shall address— 

8 ‘‘(aa) opioid maintenance and detoxi9 fication; 

10 ‘‘(bb) appropriate clinical use of all 

11 drugs approved by the Food and Drug Ad12 ministration for the treatment of opioid 

13 use disorder; 

14 ‘‘(cc) initial and periodic patient as15 sessments (including substance use moni16 toring); 

17 ‘‘(dd) individualized treatment plan18 ning; overdose reversal; relapse prevention; 

19 ‘‘(ee) counseling and recovery support 

20 services; 

21 ‘‘(ff) staffing roles and considerations; 

22 ‘‘(gg) diversion control; and 

23 ‘‘(hh) other best practices, as identi24 fied by the Secretary.’’; and 

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


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

2 means— 

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

4 clause (ii); or 

5 ‘‘(II) during the period beginning on the 

6 date of the enactment of the Opioid Use Dis7 order Treatment Expansion and Modernization 

8 Act and ending on the date that is 3 years after 

9 such date of enactment, a qualifying other prac10 titioner, as defined in clause (iv). 

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

12 means a nurse practitioner or physician assistant 

13 who satisfies each of the following: 

14 ‘‘(I) The nurse practitioner or physician 

15 assistant is licensed under State law to pre16 scribe schedule III, IV, or V medications for the 

17 treatment of pain. 

18 ‘‘(II) The nurse practitioner or physician 

19 assistant satisfies one or more of the following: 

20 ‘‘(aa) Has completed not fewer than 

21 24 hours of initial training addressing each 

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

23 (through classroom situations, seminars at 

24 professional society meetings, electronic 

25 communications, or otherwise) provided by 


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1 the American Society of Addiction Medi2 cine, the American Academy of Addiction 

3 Psychiatry, the American Medical Associa4 tion, the American Osteopathic Associa5 tion, the American Nurses Credentialing 

6 Center, the American Psychiatric Associa7 tion, the American Association of Nurse 

8 Practitioners, the American Academy of 

9 Physician Assistants, or any other organi10 zation that the Secretary determines is ap11 propriate for purposes of this subclause. 

12 ‘‘(bb) Has such other training or ex13 perience as the Secretary determines will 

14 demonstrate the ability of the nurse practi15 tioner or physician assistant to treat and 

16 manage opiate-dependent patients. 

17 ‘‘(III) The nurse practitioner or physician 

18 assistant is supervised by or works in collabora19 tion with a qualifying physician, if the nurse 

20 practitioner or physician assistant is required 

21 by State law to prescribe medications for the 

22 treatment of opioid use disorder in collaboration 

23 with or under the supervision of a physician. 


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1 The Secretary may review and update the require2 ments for being a qualifying other practitioner under 

3 this clause.’’; and 

4 (4) in subparagraph (H)— 

5 (A) in clause (i), by inserting after sub6 clause (II) the following: 

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

8 under this paragraph as the Secretary determines 

9 necessary for purposes of implementing such re10 quirements.’’; and 

11 (B) by amending clause (ii) to read as fol12 lows: 

13 ‘‘(ii) Not later than 1 year after the date of enact14 ment of the Opioid Use Disorder Treatment Expansion 

15 and Modernization Act, the Secretary shall update the 

16 treatment improvement protocol containing best practice 

17 guidelines for the treatment of opioid-dependent patients 

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

19 protocol in consultation with experts in opioid use disorder 

20 research and treatment.’’. 

21 (b) RECOMMENDATION OF REVOCATION OR SUSPEN22 SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON23 COMPLIANCE.—The Secretary of Health and Human 

24 Services may recommend to the Attorney General that the 

25 registration of a practitioner be revoked or suspended if 


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1 the Secretary determines, according to such criteria as the 

2 Secretary establishes by regulation, that a practitioner 

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

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

5 compliance with the requirements of such section, as 

6 amended by this Act. 

7 (c) OPIOID DEFINED.—Section 102(18) of the Con8 trolled Substances Act (21 U.S.C. 802(18)) is amended 

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

10 (d) REPORTS TO CONGRESS.— 

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

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

13 over every 5 years thereafter, the Secretary of 

14 Health and Human Services, in consultation with 

15 the Drug Enforcement Administration and experts 

16 in opioid use disorder research and treatment, 

17 shall— 

18 (A) perform a thorough review of the pro19 vision of opioid use disorder treatment services 

20 in the United States, including services pro21 vided in opioid treatment programs and other 

22 specialty and nonspecialty settings; and 

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

24 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 

9 compliance; 

10 (C) whether there is further need to in11 crease or decrease the number of patients a 

12 waivered practitioner is permitted to treat, as 

13 provided for by the amendment made by sub14 section (a)(1); 

15 (D) the extent to which, and proportions 

16 with which, the full range of Food and Drug 

17 Administration-approved treatments for opioid 

18 use disorder are used in routine health care set19 tings and specialty substance use disorder treat20 ment settings; 

21 (E) access to, and use of, counseling and 

22 recovery support services, including the percent23 age of patients receiving such services; 


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1 (F) changes in State or local policies and 

2 legislation relating to opioid use disorder treat3 ment; 

4 (G) the use of prescription drug moni5 toring programs by practitioners who are per6 mitted to dispense narcotic drugs to individuals 

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

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

9 823(g)(2)); 

10 (H) the findings resulting from inspections 

11 by the Drug Enforcement Administration of 

12 practitioners described in subparagraph (G); 

13 and 

14 (I) the effectiveness of cross-agency col15 laboration between Department of Health and 

16 Human Services and the Drug Enforcement 

17 Administration for expanding effective opioid 

18 use disorder treatment. 

19 SEC. 4. SENSE OF CONGRESS. 

20 It is the Sense of Congress that, with respect to the 

21 total number of patients that a qualifying physician (as 

22 defined in subparagraph (G)(iii) of section 303(g)(2) of 

23 the Controlled Substances Act (21 U.S.C. 823(g)(2)) can 

24 treat at any one time pursuant to such section, the Sec25 retary of Health and Human Services should consider 


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1 raising such total number to 250 patients following a third 

2 notification to the Secretary of the need and intent of the 

3 physician to treat up to 250 patients that is submitted 

4 to the Secretary not sooner than 1 year after the date 

5 on which the physician submitted to the Secretary a sec6 ond notification to treat up to 100 patients. 

7 SEC. 5. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUB8 STANCES. 

9 (a) IN GENERAL.—Section 309 of the Controlled 

10 Substances Act (21 U.S.C. 829) is amended by adding at 

11 the end the following: 

12 ‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED

13 SUBSTANCES.— 

14 ‘‘(1) PARTIAL FILLS.— 

15 ‘‘(A) IN GENERAL.—A prescription for a 

16 controlled substance in schedule II may be par17 tially filled if— 

18 ‘‘(i) it is not prohibited by State law; 

19 ‘‘(ii) the prescription is written and 

20 filled in accordance with the Controlled 

21 Substances Act (21 U.S.C. 801 et seq.), 

22 regulations prescribed by the Attorney 

23 General, and State law; 


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1 ‘‘(iii) the partial fill is requested by 

2 the patient or the practitioner that wrote 

3 the prescription; and 

4 ‘‘(iv) the total quantity dispensed in 

5 all partial fillings does not exceed the total 

6 quantity prescribed. 

7 ‘‘(B) OTHER CIRCUMSTANCES.—A pre8 scription for a controlled substance in schedule 

9 II may be partially filled in accordance with 

10 section 1306.13 of title 21, Code of Federal 

11 Regulations (as in effect on the date of enact12 ment of the Reducing Unused Medications Act 

13 of 2016). 

14 ‘‘(2) REMAINING PORTIONS.— 

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

16 subparagraph (B), remaining portions of a par17 tially filled prescription for a controlled sub18 stance in schedule II— 

19 ‘‘(i) may be filled; and 

20 ‘‘(ii) shall be filled not later than 30 

21 days after the date on which the prescrip22 tion is written. 

23 ‘‘(B) EMERGENCY SITUATIONS.—In emer24 gency situations, as described in subsection (a), 

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1 scription for a controlled substance in schedule 

2 II— 

3 ‘‘(i) may be filled; and 

4 ‘‘(ii) shall be filled not later than 72 

5 hours after the prescription is issued.’’. 

6 (b) RULE OF CONSTRUCTION.—Nothing in this sec7 tion shall be construed to affect the authority of the Attor8 ney General to allow a prescription for a controlled sub9 stance in schedule III, IV, or V of section 202(c) of the 

10 Controlled Substances Act (21 U.S.C. 812(c)) to be par11 tially filled. 

Passed the House of Representatives May 11, 2016. 

Attest: KAREN L. HAAS, 

Clerk. 


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