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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Opioid Use Disorder 
Treatment Expansion and Modernization Act’’. 
SEC. 2. FINDING. 
The Congress finds that opioid use disorder has be-
come a public health epidemic that must be addressed by 
increasing awareness and access to all treatment options 
for opioid use disorder, overdose reversal, and relapse pre-
vention. 
SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZA-
TION. 
(a) IN GENERAL.—Section 303(g)(2) of the Con-
trolled Substances Act (21 U.S.C. 823(g)(2)) is amend-
ed— 
(1) in subparagraph (B), by striking clauses (i), 
(ii), and (iii) and inserting the following: 
‘‘(i) The practitioner is a qualifying practitioner 
(as defined in subparagraph (G)). 
‘‘(ii) With respect to patients to whom the prac-
titioner will provide such drugs or combinations of 
drugs, the practitioner has the capacity to provide 
directly, by referral, or in such other manner as de-
termined by the Secretary— 
‘‘(I) all schedule III, IV, and V drugs, as 
well as unscheduled medications approved by 
the Food and Drug Administration, for the 
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treatment of opioid use disorder, including such 
drugs and medications for maintenance, detoxi-
fication, overdose reversal, and relapse preven-
tion, as available; and 
‘‘(II) appropriate counseling and other ap-
propriate ancillary services. 
‘‘(iii)(I) The total number of such patients of 
the practitioner at any one time will not exceed the 
applicable number. Except as provided in subclause 
(II), the applicable number is 30. 
‘‘(II) The applicable number is 100 if, not soon-
er than 1 year after the date on which the practi-
tioner submitted the initial notification, the practi-
tioner submits a second notification to the Secretary 
of the need and intent of the practitioner to treat up 
to 100 patients. 
‘‘(III) The Secretary may by regulation change 
such total number. 
‘‘(IV) The Secretary may exclude from the ap-
plicable number patients to whom such drugs or 
combinations of drugs are directly administered by 
the qualifying practitioner in the office setting. 
‘‘(iv) If the Secretary by regulation increases 
the total number of patients which a qualifying prac-
titioner is permitted to treat pursuant to clause 
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(iii)(II), the Secretary shall require such a practi-
tioner to obtain a written agreement from each pa-
tient, including the patient’s signature, that the pa-
tient— 
‘‘(I) will receive an initial assessment and 
treatment plan and periodic assessments and 
treatment plans thereafter; 
‘‘(II) will be subject to medication adher-
ence and substance use monitoring; 
‘‘(III) understands available treatment op-
tions, including all drugs approved by the Food 
and Drug Administration for the treatment of 
opioid use disorder, including their potential 
risks and benefits; and 
‘‘(IV) understands that receiving regular 
counseling services is critical to recovery. 
‘‘(v) The practitioner will comply with the re-
porting requirements of subparagraph (D)(i)(IV).’’; 
(2) in subparagraph (D)— 
(A) in clause (i), by adding at the end the 
following: 
‘‘(IV) The practitioner reports to the Secretary, 
at such times and in such manner as specified by 
the Secretary, such information and assurances as 
the Secretary determines necessary to assess wheth-
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er the practitioner continues to meet the require-
ments for a waiver under this paragraph.’’; 
(B) in clause (ii), by striking ‘‘Upon re-
ceiving a notification under subparagraph (B)’’ 
and inserting ‘‘Upon receiving a determination 
from the Secretary under clause (iii) finding 
that a practitioner meets all requirements for a 
waiver under subparagraph (B)’’; and 
(C) in clause (iii)— 
(i) by inserting ‘‘and shall forward 
such determination to the Attorney Gen-
eral’’ before the period at the end of the 
first sentence; and 
(ii) by striking ‘‘physician’’ and in-
serting ‘‘practitioner’’; 
(3) in subparagraph (G)— 
(A) by amending clause (ii)(IV) to read as 
follows: 
‘‘(IV) The physician has, with respect to 
the treatment and management of opiate-de-
pendent patients, completed not less than 8 
hours of training (through classroom situations, 
seminars at professional society meetings, elec-
tronic communications, or otherwise) that is 
provided by the American Society of Addiction 
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Medicine, the American Academy of Addiction 
Psychiatry, the American Medical Association, 
the American Osteopathic Association, the 
American Psychiatric Association, or any other 
organization that the Secretary determines is 
appropriate for purposes of this subclause. Such 
training shall address— 
‘‘(aa) opioid maintenance and detoxi-
fication; 
‘‘(bb) appropriate clinical use of all 
drugs approved by the Food and Drug Ad-
ministration for the treatment of opioid 
use disorder; 
‘‘(cc) initial and periodic patient as-
sessments (including substance use moni-
toring); 
‘‘(dd) individualized treatment plan-
ning; overdose reversal; relapse prevention; 
‘‘(ee) counseling and recovery support 
services; 
‘‘(ff) staffing roles and considerations; 
‘‘(gg) diversion control; and 
‘‘(hh) other best practices, as identi-
fied by the Secretary.’’; and 
(B) by adding at the end the following: 
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‘‘(iii) 
The 
term 
‘qualifying 
practitioner’ 
means— 
‘‘(I) a qualifying physician, as defined in 
clause (ii); or 
‘‘(II) during the period beginning on the 
date of the enactment of the Opioid Use Dis-
order Treatment Expansion and Modernization 
Act and ending on the date that is 3 years after 
such date of enactment, a qualifying other prac-
titioner, as defined in clause (iv). 
‘‘(iv) The term ‘qualifying other practitioner’ 
means a nurse practitioner or physician assistant 
who satisfies each of the following: 
‘‘(I) The nurse practitioner or physician 
assistant is licensed under State law to pre-
scribe schedule III, IV, or V medications for the 
treatment of pain. 
‘‘(II) The nurse practitioner or physician 
assistant satisfies one or more of the following: 
‘‘(aa) Has completed not fewer than 
24 hours of initial training addressing each 
of the topics listed in clause (ii)(IV) 
(through classroom situations, seminars at 
professional society meetings, electronic 
communications, or otherwise) provided by 
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The Secretary may review and update the require-
ments for being a qualifying other practitioner under 
this clause.’’; and 
(4) in subparagraph (H)— 
(A) in clause (i), by inserting after sub-
clause (II) the following: 
‘‘(III) Such other elements of the requirements 
under this paragraph as the Secretary determines 
necessary for purposes of implementing such re-
quirements.’’; and 
(B) by amending clause (ii) to read as fol-
lows: 
‘‘(ii) Not later than 1 year after the date of enact-
ment of the Opioid Use Disorder Treatment Expansion 
and Modernization Act, the Secretary shall update the 
treatment improvement protocol containing best practice 
guidelines for the treatment of opioid-dependent patients 
in office-based settings. The Secretary shall update such 
protocol in consultation with experts in opioid use disorder 
research and treatment.’’. 
(b) RECOMMENDATION OF REVOCATION OR SUSPEN-
SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON-
COMPLIANCE.—The Secretary of Health and Human 
Services may recommend to the Attorney General that the 
registration of a practitioner be revoked or suspended if 
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the Secretary determines, according to such criteria as the 
Secretary establishes by regulation, that a practitioner 
who is registered under section 303(g)(2) of the Controlled 
Substances Act (21 U.S.C. 823(g)(2)) is not in substantial 
compliance with the requirements of such section, as 
amended by this Act. 
(c) OPIOID DEFINED.—Section 102(18) of the Con-
trolled Substances Act (21 U.S.C. 802(18)) is amended 
by inserting ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 
(d) REPORTS TO CONGRESS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act and not less than 
over every 5 years thereafter, the Secretary of 
Health and Human Services, in consultation with 
the Drug Enforcement Administration and experts 
in opioid use disorder research and treatment, 
shall— 
(A) perform a thorough review of the pro-
vision of opioid use disorder treatment services 
in the United States, including services pro-
vided in opioid treatment programs and other 
specialty and nonspecialty settings; and 
(B) submit a report to the Congress on the 
findings and conclusions of such review. 
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(2) CONTENTS.—Each report under paragraph 
(1) shall include an assessment of— 
(A) compliance with the requirements of 
section 303(g)(2) of the Controlled Substances 
Act (21 U.S.C. 823(g)(2)), as amended by this 
Act; 
(B) the measures taken by the Secretary of 
Health and Human Services to ensure such 
compliance; 
(C) whether there is further need to in-
crease or decrease the number of patients a 
waivered practitioner is permitted to treat, as 
provided for by the amendment made by sub-
section (a)(1); 
(D) the extent to which, and proportions 
with which, the full range of Food and Drug 
Administration-approved treatments for opioid 
use disorder are used in routine health care set-
tings and specialty substance use disorder treat-
ment settings; 
(E) access to, and use of, counseling and 
recovery support services, including the percent-
age of patients receiving such services; 
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(F) changes in State or local policies and 
legislation relating to opioid use disorder treat-
ment; 
(G) the use of prescription drug moni-
toring programs by practitioners who are per-
mitted to dispense narcotic drugs to individuals 
pursuant to a waiver under section 303(g)(2) of 
the Controlled Substances Act (21 U.S.C. 
823(g)(2)); 
(H) the findings resulting from inspections 
by the Drug Enforcement Administration of 
practitioners described in subparagraph (G); 
and 
(I) the effectiveness of cross-agency col-
laboration between Department of Health and 
Human Services and the Drug Enforcement 
Administration for expanding effective opioid 
use disorder treatment. 
SEC. 4. SENSE OF CONGRESS. 
It is the Sense of Congress that, with respect to the 
total number of patients that a qualifying physician (as 
defined in subparagraph (G)(iii) of section 303(g)(2) of 
the Controlled Substances Act (21 U.S.C. 823(g)(2)) can 
treat at any one time pursuant to such section, the Sec-
retary of Health and Human Services should consider 
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raising such total number to 250 patients following a third 
notification to the Secretary of the need and intent of the 
physician to treat up to 250 patients that is submitted 
to the Secretary not sooner than 1 year after the date 
on which the physician submitted to the Secretary a sec-
ond notification to treat up to 100 patients. 
SEC. 5. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUB-
STANCES. 
(a) IN GENERAL.—Section 309 of the Controlled 
Substances Act (21 U.S.C. 829) is amended by adding at 
the end the following: 
‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED 
SUBSTANCES.— 
‘‘(1) PARTIAL FILLS.— 
‘‘(A) IN GENERAL.—A prescription for a 
controlled substance in schedule II may be par-
tially filled if— 
‘‘(i) it is not prohibited by State law; 
‘‘(ii) the prescription is written and 
filled in accordance with the Controlled 
Substances Act (21 U.S.C. 801 et seq.), 
regulations prescribed by the Attorney 
General, and State law; 
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‘‘(iii) the partial fill is requested by 
the patient or the practitioner that wrote 
the prescription; and 
‘‘(iv) the total quantity dispensed in 
all partial fillings does not exceed the total 
quantity prescribed. 
‘‘(B) OTHER
CIRCUMSTANCES.—A pre-
scription for a controlled substance in schedule 
II may be partially filled in accordance with 
section 1306.13 of title 21, Code of Federal 
Regulations (as in effect on the date of enact-
ment of the Reducing Unused Medications Act 
of 2016). 
‘‘(2) REMAINING PORTIONS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), remaining portions of a par-
tially filled prescription for a controlled sub-
stance in schedule II— 
‘‘(i) may be filled; and 
‘‘(ii) shall be filled not later than 30 
days after the date on which the prescrip-
tion is written. 
‘‘(B) EMERGENCY SITUATIONS.—In emer-
gency situations, as described in subsection (a), 
the remaining portions of a partially filled pre-
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scription for a controlled substance in schedule 
II— 
‘‘(i) may be filled; and 
‘‘(ii) shall be filled not later than 72 
hours after the prescription is issued.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to affect the authority of the Attor-
ney General to allow a prescription for a controlled sub-
stance in schedule III, IV, or V of section 202(c) of the 
Controlled Substances Act (21 U.S.C. 812(c)) to be par-
tially filled. 
Passed the House of Representatives May 11, 2016. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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