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 subse-
quently 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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 
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‘‘(VI) For purposes of subclause (III), a quali-
fying physician meets the requirement of this sub-
clause if the practitioner or physician— 
‘‘(aa) holds a special certification in addic-
tion psychiatry or addiction medicine as de-
scribed in clause (ii) from the American Board 
of Medical Specialties, the American Board of 
Addiction Medicine, the American Osteopathic 
Association, the American Society of Addiction 
Medicine, or such other organization as the Sec-
retary determines to be appropriate for pur-
poses of this subclause; or 
‘‘(bb) completes at least 24 hours of train-
ing, with respect to the treatment and manage-
ment of opiate-dependent patients, addressing 
the topics listed in subparagraph (G)(ii)(IV). 
The Secretary may review and update the require-
ments of this subclause. 
‘‘(iv) In the case of a third notification under 
clause (iii)(III), the practitioner maintains and im-
plements a diversion control plan that contains spe-
cific measures to reduce the likelihood of the diver-
sion of controlled substances prescribed by the prac-
titioner for the treatment of opioid use disorder. 
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‘‘(v) In the case of a third notification under 
clause (iii)(III), the practitioner obtains a written 
agreement from each patient, including the patient’s 
signature, that the patient— 
‘‘(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; and 
‘‘(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. 
‘‘(vi) 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-
er the practitioner continues to meet the require-
ments for a waiver under this paragraph.’’; 
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(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 eight 
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 
Medicine, the American Academy of Addiction 
Psychiatry, the American Medical Association, 
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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: 
‘‘(iii) 
The 
term 
‘qualifying 
practitioner’ 
means— 
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‘‘(I) a qualifying physician, as defined in 
clause (ii); or 
‘‘(II) a qualifying other practitioner, as de-
fined 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 1 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, seminar at 
professional society meetings, electronic 
communications, or otherwise) provided by 
the American Society of Addiction Medi-
cine, the American Academy of Addiction 
Psychiatry, the American Medical Associa-
tion, the American Osteopathic Associa-
tion, the American Nurses Credentialing 
Center, the American Psychiatric Associa-
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tion, or any other organization that the 
Secretary determines is appropriate for 
purposes of this subclause. 
‘‘(bb) Has such other training or ex-
perience as the Secretary determines will 
demonstrate the ability of the nurse practi-
tioner or physician assistant to treat and 
manage opiate-dependent patients. 
‘‘(III) If required by State law, the nurse 
practitioner or physician assistant prescribes 
medications for the treatment of opioid use dis-
order in collaboration with or under supervision 
of a physician. 
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 adding at the end 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: 
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‘‘(ii) Not later than one 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 
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 (42 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 
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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 non-specialty settings; and 
(B) submit a report to the Congress on the 
findings and conclusions of such review. 
(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 
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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, other behavioral 
health and recovery supports; 
(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 
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Human Services and the Drug Enforcement 
Administration for expanding effective opioid 
use disorder treatment. 
Æ 
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