What This Bill Does
This bill allows certain doctors and addiction specialists to prescribe methadone for opioid use disorder (an addiction to pain medicines or heroin) through regular pharmacies instead of only through specialized treatment programs. Patients would be able to pick up methadone prescriptions at pharmacies for unsupervised use at home. The bill also requires annual reports to Congress about how many people are prescribing and using methadone under these new rules.
Who It Affects
- Doctors and psychiatrists who specialize in addiction medicine and work at opioid treatment programs or hold specific board certifications
- Patients with opioid use disorder who want to take methadone at home
- The Attorney General and Secretary of Health and Human Services
- States that choose to participate in the program
- Pharmacies that dispense methadone
- Congress (receiving annual reports)
Key Provisions
- Doctors who work at opioid treatment programs or have addiction medicine board certifications can register with the Attorney General to prescribe methadone through pharmacies for patients to use at home (Sec. 2(a)(2)(A))
- Methadone prescriptions can only be written electronically and limited to 30-day supplies at a time (Sec. 2(a)(2)(C))
- Doctors must obtain informed consent from patients, including explaining differences in privacy protections between pharmacy and treatment program dispensing (Sec. 2(a)(2)(E))
- Patients receiving methadone through pharmacies must continue to have access to other support services from opioid treatment programs (Sec. 2(a)(2)(D))
- The Assistant Secretary for Mental Health and the Drug Enforcement Administration must report to Congress annually on registrations, patients, and participating states (Sec. 2(b))
What Changes
Current federal law requires all methadone for opioid use disorder to be dispensed through specialized opioid treatment programs where patients must come in regularly. This bill eliminates that requirement for certain qualified doctors, allowing them to prescribe methadone through regular pharmacies so patients can pick it up and use it at home.
Important Definitions
- Controlled substance: a drug regulated by federal law
- Methadone: a medication used to treat opioid addiction
- Opioid use disorder: addiction to opioid drugs
- Maintenance treatment: long-term medication to prevent withdrawal symptoms
- Detoxification treatment: medication to help someone stop using opioids
- Dispense: to hand out medicine
- Opioid: pain-relieving drugs (including heroin)
- Telehealth: medical care provided remotely using technology
- Informed consent: when a patient agrees to treatment after being told the risks and benefits
Effective Date
Not specified in bill text
I
118TH CONGRESS
1ST SESSION H. R. 1359
To expand the take-home prescribing of methadone through pharmacies.
IN THE HOUSE OF REPRESENTATIVES
MARCH 3, 2023
Mr. NORCROSS (for himself, Mr. BACON, Ms. KUSTER, Mr. TRONE, Mr.
FITZPATRICK, Mr. TONKO, Ms. PETTERSEN, and Mr. KIM of New Jer-
sey) introduced the following bill; which was referred to the Committee
on Energy and Commerce, and in addition to the Committee on the Judi-
ciary, 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
A BILL
To expand the take-home prescribing of methadone through
pharmacies.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Modernizing Opioid
4
Treatment Access Act’’.
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•HR 1359 IH
SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS-
1
ORDER THROUGH PRESCRIBING AND PHAR-
2
MACIES.
3
(a)
REGISTRATION;
OTHER
CARE
BY
TELE-
4
HEALTH.—
5
(1) DEFINITIONS.—In this subsection:
6
(A) CONTROLLED
SUBSTANCE; DETOXI-
7
FICATION
TREATMENT;
DISPENSE;
MAINTE-
8
NANCE TREATMENT; OPIOID.—The terms ‘‘con-
9
trolled substance’’, ‘‘detoxification treatment’’,
10
‘‘dispense’’,
‘‘maintenance
treatment’’,
and
11
‘‘opioid’’ have the meanings given the terms in
12
section 102 of the Controlled Substances Act
13
(21 U.S.C. 802).
14
(B) SECRETARY.—The term ‘‘Secretary’’
15
means the Secretary of Health and Human
16
Services.
17
(2) WAIVER.—
18
(A) IN
GENERAL.—The requirements of
19
section 303(h) of Controlled Substances Act (21
20
U.S.C. 823(h)) applicable to methadone medica-
21
tion for opioid use disorder are waived, and the
22
Attorney General, in consultation with the Sec-
23
retary, shall register persons described in sub-
24
paragraph (B) to prescribe methadone for
25
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•HR 1359 IH
opioid use disorder to be dispensed through a
1
pharmacy for individuals for unsupervised use.
2
(B) PERSONS
DESCRIBED.—Persons de-
3
scribed in this subparagraph are persons who—
4
(i) are licensed, registered, or other-
5
wise permitted, by the United States or the
6
jurisdiction in which they practice, to pre-
7
scribe controlled substances in the course
8
of professional practice; and
9
(ii) are—
10
(I) employees or contractors of
11
an opioid treatment program; or
12
(II) addiction medicine physi-
13
cians or addiction psychiatrists who
14
hold a subspecialty board certification
15
in addiction medicine from the Amer-
16
ican Board of Preventive Medicine, a
17
board certification in addiction medi-
18
cine from the American Board of Ad-
19
diction Medicine, a subspecialty board
20
certification in addiction psychiatry
21
from the American Board of Psychi-
22
atry and Neurology, or a subspecialty
23
board certification in addiction medi-
24
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•HR 1359 IH
cine from the American Osteopathic
1
Association.
2
(C) REQUIREMENTS
FOR
PRESCRIBING
3
METHADONE.—The prescribing of methadone
4
pursuant to subparagraph (A) shall be—
5
(i) exclusively by electronic prescribing
6
and dispensed to the patient treated pursu-
7
ant to subparagraph (A);
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(ii) for a supply of not more than 30
9
days pursuant to each prescription; and
10
(iii) subject to the restrictions listed
11
in section 8.12(i)(3) of title 42, Code of
12
Federal Regulations, or successor regula-
13
tion or guidance.
14
(D)
REQUIREMENTS
FOR
DISPENSING
15
METHADONE.—The dispensing of methadone to
16
an individual pursuant to subparagraph (A)
17
shall be in addition to the other care that the
18
individual continues to have access to through
19
an opioid treatment program.
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(E) REGISTRATION REQUIREMENTS.—Per-
21
sons registered in a State pursuant to subpara-
22
graph (A) shall—
23
(i) ensure and document, with respect
24
to each patient treated pursuant to sub-
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•HR 1359 IH
paragraph (A), informed consent to treat-
1
ment; and
2
(ii) include in such informed consent,
3
specific informed consent regarding dif-
4
ferences in confidentiality protections ap-
5
plicable when dispensing through an opioid
6
treatment
program
versus
dispensing
7
through a pharmacy pursuant to subpara-
8
graph (A).
9
(F) CESSATION
AND
WITHDRAWAL
OF
10
REGISTRATION.—At the request of a State, the
11
Attorney General, in consultation with the Sec-
12
retary, shall—
13
(i) cease registering persons in the
14
State pursuant to subparagraph (A); and
15
(ii) withdraw any such registration in
16
effect for a person in the State.
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(G) MAINTENANCE AND DETOXIFICATION
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TREATMENT.—Maintenance treatment or de-
19
toxification treatment provided pursuant to sub-
20
paragraph (A) and other care provided in con-
21
junction with such treatment, such as coun-
22
seling and other ancillary services, may be pro-
23
vided by means of telehealth, as determined
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•HR 1359 IH
jointly by the State and the Secretary to be fea-
1
sible and appropriate.
2
(b) ANNUAL REPORTING.—Not later than 180 days
3
after the date of enactment of this Act, and annually
4
thereafter, the Assistant Secretary for Mental Health and
5
Substance Use and the Administrator of the Drug En-
6
forcement Administration shall jointly submit a report to
7
Congress that includes—
8
(1) the number of persons registered pursuant
9
to subsection (a);
10
(2) the number of patients being prescribed
11
methadone pursuant to subsection (a); and
12
(3) a list of the States in which persons are
13
registered pursuant to such subsection (a).
14
SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BAR-
15
RIERS TO PATIENT CARE THROUGH OPIOID
16
TREATMENT PROGRAMS.
17
It is the sense of Congress that—
18
(1) patients receiving services through opioid
19
treatment programs face barriers to their care; and
20
(2) each State should align the regulation of
21
opioid treatment programs in a manner that is con-
22
sistent with the intent of this Act.
23
Æ
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