What This Bill Does
This bill expands access to methadone (a medication used to treat opioid addiction) by allowing certain doctors to prescribe it through regular pharmacies for patients to take home unsupervised. Currently, patients typically must visit opioid treatment programs to receive methadone under supervision. The bill waives certain federal registration requirements to make this expansion possible.
##
Who It Affects
- Patients with opioid use disorder (addiction to opioid drugs)
- Addiction medicine doctors and addiction psychiatrists with specific board certifications
- Employees or contractors of opioid treatment programs who are authorized to prescribe controlled substances
- Pharmacies that dispense methadone
- The Attorney General and the Secretary of Health and Human Services
- State governments and their drug enforcement agencies
##
Key Provisions
- Certain qualified doctors can register to prescribe methadone through pharmacies for patients to use at home without supervision, waiving normal federal registration requirements (Sec. 2(a)(2))
- Doctors who prescribe methadone this way must use electronic prescribing and can prescribe no more than 30 days of medication per prescription (Sec. 2(a)(2)(C))
- Patients must receive informed consent explaining the differences in privacy protections between pharmacy dispensing and opioid treatment program dispensing (Sec. 2(a)(2)(E))
- Patients continue to access other care through opioid treatment programs in addition to receiving methadone through pharmacies (Sec. 2(a)(2)(D))
- Addiction medicine and addiction psychiatry treatment, including counseling, can be provided through telehealth (video or phone appointments) (Sec. 2(a)(2)(G))
- The Attorney General and Secretary of Health and Human Services must report annually to Congress on how many doctors are registered and how many patients receive methadone this way (Sec. 2(b))
- States can request that the Attorney General stop registering doctors in their state or withdraw existing registrations (Sec. 2(a)(2)(F))
##
What Changes
If this bill becomes law, doctors with addiction medicine or addiction psychiatry board certification can legally prescribe methadone through pharmacies for patients to take at home. This is currently not allowed under federal law. Patients with opioid addiction will have the option to receive their medication from a pharmacy instead of only from opioid treatment programs. States will have the power to opt out of this program if they choose.
##
Important Definitions
The bill uses these terms from the Controlled Substances Act (another federal law):
- **Controlled substance**: A drug whose manufacture, possession or use is regulated by the federal government
- **Opioid**: A class of drugs that includes prescription painkillers and illegal drugs like heroin
- **Maintenance treatment**: Long-term medication to prevent withdrawal symptoms and reduce cravings in people with addiction
- **Detoxification treatment**: Short-term medication to help people safely stop using drugs
- **Dispense**: To give out medication to a patient
##
Effective Date
Not specified in bill text
II
Calendar No. 318
118TH CONGRESS
2D SESSION
S. 644
To expand the take-home prescribing of methadone through pharmacies.
IN THE SENATE OF THE UNITED STATES
MARCH 2, 2023
Mr. MARKEY (for himself, Mr. PAUL, Mr. SANDERS, Mr. BRAUN, Mr. BOOK-
ER, Ms. HASSAN, Mr. LUJA´N, Mr. WELCH, Mr. LEE, Ms. WARREN, Mr.
CASEY, and Mr. HEINRICH) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
FEBRUARY 1, 2024
Reported by Mr. SANDERS, with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
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’’.
5
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
2
•S 644 RS
SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS-
1
ORDER THROUGH PRESCRIBING AND PHAR-
2
MACIES.
3
(a)
REGISTRATION;
OTHER
CARE
BY
TELE-
4
HEALTH.—
5
(1) DEFINITIONS.—In this subsection:
6
(A)
CONTROLLED
SUBSTANCE;
DETOXI-
7
FICATION
TREATMENT;
DISPENSE;
MAINTE-
8
NANCE TREATMENT; OPIOID.—The terms ‘‘con-
9
trolled substance’’, ‘‘detoxification treatment’’,
10
‘‘dispense’’,
‘‘maintenance
treatment’’,
and
11
‘‘opioid’’ have the meanings given the terms in
12
section 102 of the Controlled Substances Act
13
(21 U.S.C. 802).
14
(B) SECRETARY.—The term ‘‘Secretary’’
15
means the Secretary of Health and Human
16
Services.
17
(2) WAIVER.—
18
(A) IN
GENERAL.—The requirements of
19
section 303(h) of Controlled Substances Act (21
20
U.S.C. 823(h)) applicable to methadone medica-
21
tion for opioid use disorder are waived, and the
22
Attorney General, in consultation with the Sec-
23
retary, shall register persons described in sub-
24
paragraph
(B)
to
prescribe
methadone
for
25
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
3
•S 644 RS
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
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
4
•S 644 RS
cine from the American Osteopathic
1
Association.
2
(C)
REQUIREMENTS
FOR
PRESCRIBING
3
METHADONE.—The prescribing of methadone
4
pursuant to subparagraph (A) shall be—
5
(i) exclusively by electronic prescribing
6
and dispensed to the patient treated pursu-
7
ant to subparagraph (A);
8
(ii) for a supply of not more than 30
9
days pursuant to each prescription; and
10
(iii) subject to the restrictions listed
11
in section 8.12(i)(3) of title 42, Code of
12
Federal Regulations, or successor regula-
13
tion or guidance.
14
(D)
REQUIREMENTS
FOR
DISPENSING
15
METHADONE.—The dispensing of methadone to
16
an individual pursuant to subparagraph (A)
17
shall be in addition to the other care that the
18
individual continues to have access to through
19
an opioid treatment program.
20
(E) REGISTRATION REQUIREMENTS.—Per-
21
sons registered in a State pursuant to subpara-
22
graph (A) shall—
23
(i) ensure and document, with respect
24
to each patient treated pursuant to sub-
25
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
5
•S 644 RS
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.
17
(G) MAINTENANCE AND DETOXIFICATION
18
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
24
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
6
•S 644 RS
jointly by the State and the Secretary to be fea-
1
sible and appropriate.
2
(b) ANNUAL REPORTING.—Not later than 180 days
3
after the date of enactment of this Act, and annually
4
thereafter, the Assistant Secretary for Mental Health and
5
Substance Use and the Administrator of the Drug En-
6
forcement Administration shall jointly submit a report to
7
Congress that includes—
8
(1) the number of persons registered pursuant
9
to subsection (a);
10
(2) the number of patients being prescribed
11
methadone pursuant to subsection (a); and
12
(3) a list of the States in which persons are
13
registered pursuant to such subsection (a).
14
SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BAR-
15
RIERS TO PATIENT CARE THROUGH OPIOID
16
TREATMENT PROGRAMS.
17
It is the sense of Congress that—
18
(1) patients receiving services through opioid
19
treatment programs face barriers to their care; and
20
(2) each State should align the regulation of
21
opioid treatment programs in a manner that is con-
22
sistent with the intent of this Act.
23
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6401
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
7
•S 644 RS
SECTION 1. SHORT TITLE.
1
This Act may be cited as the ‘‘Modernizing Opioid
2
Treatment Access Act’’.
3
SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS-
4
ORDER THROUGH PRESCRIBING AND PHAR-
5
MACIES.
6
Section 303(h) of the Controlled Substances Act (21
7
U.S.C. 823(h)), is amended—
8
(1) in paragraph (1)—
9
(A) in the matter preceding subparagraph
10
(A), in the first sentence, by inserting ‘‘(other
11
than narcotic drugs in schedule III, IV, or V)’’
12
after ‘‘drugs’’; and
13
(B) by striking subparagraph (B) and in-
14
serting the following:
15
‘‘(B) if the Attorney General determines that the
16
applicant will comply with standards established by
17
the Attorney General respecting—
18
‘‘(i) security of stocks of narcotic drugs for
19
such treatment; and
20
‘‘(ii) the maintenance of records (in accord-
21
ance with section 307) on such drugs; and’’; and
22
(2) by striking paragraph (2) and inserting the
23
following:
24
‘‘(2)(A) The requirements of paragraph (1) applicable
25
to methadone medication for opioid use disorder are
26
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6203
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
8
•S 644 RS
waived, and the Attorney General, in consultation with the
1
Secretary, shall separately register persons described in sub-
2
paragraph (B) to prescribe methadone for opioid use dis-
3
order to be dispensed through a pharmacy for individuals
4
for unsupervised use.
5
‘‘(B) Persons described in this subparagraph are per-
6
sons who—
7
‘‘(i) are licensed, registered, or otherwise per-
8
mitted, by the United States or the jurisdiction in
9
which they practice, to prescribe controlled substances
10
in the course of professional practice; and
11
‘‘(ii) are addiction medicine physicians or ad-
12
diction psychiatrists who hold a subspecialty board
13
certification in addiction medicine from the Amer-
14
ican Board of Preventive Medicine, a board certifi-
15
cation in addiction medicine from the American
16
Board of Addiction Medicine, a subspecialty board
17
certification in addiction psychiatry from the Amer-
18
ican Board of Psychiatry and Neurology, or a sub-
19
specialty board certification in addiction medicine
20
from the American Osteopathic Association.
21
‘‘(C) The prescribing of methadone pursuant to sub-
22
paragraph (A) shall be—
23
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6203
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
9
•S 644 RS
‘‘(i) exclusively by electronic prescribing and dis-
1
pensed to the patient treated pursuant to subpara-
2
graph (A);
3
‘‘(ii) for a supply of not more than 30 days pur-
4
suant to each prescription; and
5
‘‘(iii) subject to the restrictions listed in section
6
8.12(i)(3) of title 42, Code of Federal Regulations, or
7
successor regulation or guidance.
8
‘‘(D) The dispensing of methadone to an individual
9
pursuant to subparagraph (A) shall be in addition to the
10
other care that the individual continues to have access to
11
through an opioid treatment program.
12
‘‘(E) Persons registered pursuant to subparagraph (A)
13
shall—
14
‘‘(i) ensure and document, with respect to each
15
patient treated pursuant to subparagraph (A), in-
16
formed consent to treatment; and
17
‘‘(ii) include in such informed consent, specific
18
informed consent regarding differences in confiden-
19
tiality
protections
applicable
when
dispensing
20
through an opioid treatment program versus dis-
21
pensing through a pharmacy pursuant to subpara-
22
graph (A).
23
‘‘(F) At the request of a State, the Attorney General
24
shall—
25
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6203
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
10
•S 644 RS
‘‘(i) cease registering persons in the State pursu-
1
ant to subparagraph (A); and
2
‘‘(ii) withdraw any such registration in effect for
3
a person in the State.
4
‘‘(G) Maintenance treatment or detoxification treat-
5
ment provided pursuant to subparagraph (A) and other
6
care provided in conjunction with such treatment, such as
7
counseling and other ancillary services, may be provided
8
by means of telehealth.
9
‘‘(3) Not later than 180 days after the date of enact-
10
ment of this paragraph, and annually thereafter, the Assist-
11
ant Secretary for Mental Health and Substance Use and
12
the Administrator of the Drug Enforcement Administration
13
shall jointly submit to Congress a report that includes—
14
‘‘(A) the number of persons registered pursuant
15
to paragraph (2);
16
‘‘(B) a list of States in which persons are reg-
17
istered pursuant to paragraph (2).’’.
18
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6203
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6203
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB
Calendar No. 318
118TH CONGRESS
2D SESSION
S. 644
A BILL
To expand the take-home prescribing of methadone
through pharmacies.
FEBRUARY 1, 2024
Reported with an amendment
VerDate Sep 11 2014
23:21 Feb 01, 2024
Jkt 049200
PO 00000
Frm 00012
Fmt 6651
Sfmt 6651
E:\BILLS\S644.RS
S644
kjohnson on DSK7ZCZBW3PROD with $$_JOB