Modernizing Opioid Treatment Access Act

[jakeakins]

I

118th CONGRESS

IN THE SENATE

Mr. Jones (for himself; with thanks to Mr. Norcross) 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 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.

1.

Short title

This Act may be cited as the Modernizing Opioid Treatment Access Act.

2.

Expansion of methadone for opioid use disorder through prescribing and pharmacies

(a)

Registration; other care by telehealth

(1)

Definitions

In this subsection:

(A)

Controlled substance; detoxification treatment; dispense; maintenance treatment; opioid

The terms controlled substance, detoxification treatment, dispense, maintenance treatment, and opioid have the meanings given the terms in section 102 of the Controlled Substances Act (21 U.S.C. 802).

(B)

Secretary

The term Secretary means the Secretary of Health and Human Services.

(2)

Waiver

(A)

In general

The requirements of section 303(h) of Controlled Substances Act (21 U.S.C. 823(h)) applicable to methadone medication for opioid use disorder are waived, and the Attorney General, in consultation with the Secretary, shall register persons described in subparagraph (B) to prescribe methadone for opioid use disorder to be dispensed through a pharmacy for individuals for unsupervised use.

(B)

Persons described

Persons described in this subparagraph are persons who—

(i)

are licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which they practice, to prescribe controlled substances in the course of professional practice; and

(ii)

are—

(I)

employees or contractors of an opioid treatment program; or

(II)

addiction medicine physicians or addiction psychiatrists who hold a subspecialty board certification in addiction medicine from the American Board of Preventive Medicine, a board certification in addiction medicine from the American Board of Addiction Medicine, a subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology, or a subspecialty board certification in addiction medicine from the American Osteopathic Association.

(C)

Requirements for prescribing methadone

The prescribing of methadone pursuant to subparagraph (A) shall be—

(i)

exclusively by electronic prescribing and dispensed to the patient treated pursuant to subparagraph (A);

(ii)

for a supply of not more than 30 days pursuant to each prescription; and

(iii)

subject to the restrictions listed in section 8.12(i)(3) of title 42, Code of Federal Regulations, or successor regulation or guidance.

(D)

Requirements for dispensing methadone

The dispensing of methadone to an individual pursuant to subparagraph (A) shall be in addition to the other care that the individual continues to have access to through an opioid treatment program.

(E)

Registration requirements

Persons registered in a State pursuant to subparagraph (A) shall—

(i)

ensure and document, with respect to each patient treated pursuant to subparagraph (A), informed consent to treatment; and

(ii)

include in such informed consent, specific informed consent regarding differences in confidentiality protections applicable when dispensing through an opioid treatment program versus dispensing through a pharmacy pursuant to subparagraph (A).

(F)

Cessation and withdrawal of registration

At the request of a State, the Attorney General, in consultation with the Secretary, shall—

(i)

cease registering persons in the State pursuant to subparagraph (A); and

(ii)

withdraw any such registration in effect for a person in the State.

(G)

Maintenance and detoxification treatment

Maintenance treatment or detoxification treatment provided pursuant to subparagraph (A) and other care provided in conjunction with such treatment, such as counseling and other ancillary services, may be provided by means of telehealth, as determined jointly by the State and the Secretary to be feasible and appropriate.

(b)

Annual reporting

Not later than 180 days after the date of enactment of this Act, and annually thereafter, the Assistant Secretary for Mental Health and Substance Use and the Administrator of the Drug Enforcement Administration shall jointly submit a report to Congress that includes—

(1)

the number of persons registered pursuant to subsection (a);

(2)

the number of patients being prescribed methadone pursuant to subsection (a); and

(3)

a list of the States in which persons are registered pursuant to such subsection (a).

3.

Sense of Congress on need to reduce barriers to patient care through opioid treatment programs

It is the sense of Congress that—

(1)

patients receiving services through opioid treatment programs face barriers to their care; and

(2)

each State should align the regulation of opioid treatment programs in a manner that is consistent with the intent of this Act.

Quote

 

PES

Modernizing Opioid Treatment Access Act

This bill expands access to methadone for an individual's unsupervised use to treat opioid use disorder (OUD). (Typically, methadone must be dispensed to individuals in person through opioid treatment programs.)

The bill (1) waives provisions of the Controlled Substances Act that require qualified practitioners to obtain a separate registration from the Drug Enforcement Administration (DEA) to prescribe and dispense methadone to treat OUD, and (2) requires the Substance Abuse and Mental Health Services Administration and the DEA to jointly report on the waiver.

Additionally, the bill directs the DEA to register certain practitioners to prescribe methadone that is dispensed through a pharmacy for an individual's unsupervised use. Qualified practitioners must be licensed or authorized to prescribe controlled substances, and they must either work for an opioid treatment program or be a physician or psychiatrist with a specialty certification in addiction medicine. A state may request that the DEA stop registering such practitioners in its jurisdiction.

Individuals who receive methadone for unsupervised use must continue to have access to other care through an opioid treatment program.

For purposes of the waiver, the bill also requires the exclusive use of electronic prescribing, establishes prescription limits, and sets out requirements for informed consent. Further, the bill permits the use of telehealth to provide methadone treatment and related services if the state and the Department of Health and Human Services jointly determine the use is feasible and appropriate.