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 subse-
quently 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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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 become 
a public health epidemic that must be addressed by increas-
ing awareness and access to all treatment options for opioid 
use disorder, overdose reversal, and relapse prevention. 
SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZA-
TION. 
(a) IN GENERAL.—Section 303(g)(2) of the Controlled 
Substances Act (21 U.S.C. 823(g)(2)) is amended— 
(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 di-
rectly, by referral, or in such other manner as deter-
mined by the Secretary— 
‘‘(I) all schedule III, IV, and V drugs, as 
well as unscheduled medications approved by the 
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Food and Drug Administration, for the treat-
ment 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 ap-
plicable number. Except as provided in subclauses 
(II) and (III), the applicable number is 30. 
‘‘(II) The applicable number is 100 if, not sooner 
than 1 year after the date on which the practitioner 
submitted the initial notification, the practitioner 
submits a second notification to the Secretary of the 
need and intent of the practitioner to treat up to 100 
patients. 
‘‘(III) The applicable number is 250 if the prac-
titioner is a qualifying physician meeting the require-
ment of subclause (VI) and, not sooner than 1 year 
after the date on which the physician submitted a sec-
ond notification under subclause (II), the practitioner 
submits a third notification to the Secretary of the 
need and intent of the physician to treat up to 250 
patients. 
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‘‘(IV) The Secretary may by regulation change 
such total number. 
‘‘(V) The Secretary may exclude from the appli-
cable number patients to whom such drugs or com-
binations of drugs are directly administered by the 
qualifying practitioner in the office setting. 
‘‘(VI) For purposes of subclause (III), a quali-
fying physician meets the requirement of this sub-
clause if the 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 purposes 
of this subclause; or 
‘‘(bb) has completed not fewer than 24 hours 
of training, with respect to the treatment and 
management of opiate-dependent patients, ad-
dressing the topics listed in subparagraph 
(G)(ii)(IV). 
The Secretary may review and update the require-
ments of this subclause. 
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‘‘(iv) In the case of a third notification under 
clause (iii)(III), the qualifying physician maintains 
and implements a diversion control plan that con-
tains specific measures to reduce the likelihood of the 
diversion of controlled substances prescribed by the 
physician for the treatment of opioid use disorder. 
‘‘(v) In the case of a third notification under 
clause (iii)(III), the qualifying physician 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 adherence 
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. 
‘‘(vi) The practitioner will comply with the re-
porting requirements of subparagraph (D)(i)(IV).’’; 
(2) in subparagraph (D)— 
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(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 whether the 
practitioner continues to meet the requirements for a 
waiver under this paragraph.’’; 
(B) in clause (ii), by striking ‘‘Upon receiv-
ing 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: 
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‘‘(IV) The physician has, with respect to the 
treatment and management of opiate-dependent 
patients, completed not less than eight hours of 
training (through classroom situations, seminars 
at professional society meetings, electronic com-
munications, or otherwise) that is provided by 
the American Society of Addiction Medicine, the 
American Academy of Addiction Psychiatry, the 
American Medical Association, the American Os-
teopathic 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; 
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classroom situations, seminars at profes-
sional society meetings, electronic commu-
nications, or otherwise) provided by the 
American Society of Addiction Medicine, 
the American Academy of Addiction Psychi-
atry, the American Medical Association, the 
American 
Osteopathic 
Association, 
the 
American Nurses Credentialing Center, the 
American 
Psychiatric 
Association, 
the 
American Association of Nurse Practi-
tioners, the American Academy of Physi-
cian Assistants, or any other organization 
that the Secretary determines is appro-
priate for purposes of this subclause. 
‘‘(bb) Has such other training or expe-
rience as the Secretary determines will dem-
onstrate the ability of the nurse practitioner 
or physician assistant to treat and manage 
opiate-dependent patients. 
‘‘(III) The nurse practitioner or physician 
assistant is supervised by or works in collabora-
tion with a qualifying physician, if the nurse 
practitioner or physician assistant is required by 
State law to prescribe medications for the treat-
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ment of opioid use disorder in collaboration with 
or under the 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 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 require-
ments.’’; and 
(B) by amending clause (ii) to read as fol-
lows: 
‘‘(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 Serv-
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ices may recommend to the Attorney General that the reg-
istration of a practitioner be revoked or suspended if the 
Secretary determines, according to such criteria as the Sec-
retary establishes by regulation, that a practitioner who is 
registered under section 303(g)(2) of the Controlled Sub-
stances Act (21 U.S.C. 823(g)(2)) is not in substantial com-
pliance 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 provi-
sion of opioid use disorder treatment services in 
the United States, including services provided 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 com-
pliance; 
(C) whether there is further need to increase 
or decrease the number of patients a waivered 
practitioner is permitted to treat, as provided for 
by the amendment made by subsection (a)(1); 
(D) the extent to which, and proportions 
with which, the full range of Food and Drug Ad-
ministration-approved treatments for opioid use 
disorder are used in routine health care settings 
and specialty substance use disorder treatment 
settings; 
(E) access to, and use of, counseling and re-
covery support services, including the percentage 
of patients receiving such services; 
(F) changes in State or local policies and 
legislation relating to opioid use disorder treat-
ment; 
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(G) the use of prescription drug monitoring 
programs by practitioners who are permitted to 
dispense narcotic drugs to individuals pursuant 
to a waiver under section 303(g)(2) of the Con-
trolled 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 collabo-
ration between Department of Health and 
Human Services and the Drug Enforcement Ad-
ministration for expanding effective opioid use 
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 
to the Committee of the Whole House on the State of 
the Union and ordered to be printed 
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