NEW FEDERAL RULES PROPOSED TO IMPROVE QUALITY AND OVERSIGHT OF METHADONE TREATMENT

Center for Substance Abuse Treatment

July 22, 1999

Contact:

Jim Michie Phone: 1-800-487-4890

Leah Young Phone: 301-443-3740

Methadone programs will have to be accredited under a

new proposal announced today by the U.S. Department

of Health and Human Services. The new accreditation

program will be managed by the Substance Abuse and

Mental Health Services Administration (SAMHSA) and

replaces a 30-year-old inspection program conducted

by the Food and Drug Administration (FDA). The new

program mirrors the recommendations that have been

made over the last decade by several independent

groups, such as the Institute of Medicine, the

Congressional General Accounting Office, and a

consensus conference of the National Institutes of

Health.

Under the proposed rule, published in the Federal

Register, narcotic treatment programs would be

accredited by independent agencies in accordance

with standards established by SAMHSA’s Center

for Substance Abuse Treatment (CSAT). These

proposed standards emphasize improving the

quality of care, such as individualized treatment

planning, increased medical supervision, and

assessment of patient outcomes. This new

program relies on “best practice guidelines”

developed by CSAT over the past 10 years.

“Treatment, along with research and prevention,

is an essential part of the national strategy to

reduce drug addiction and its consequences,”

HHS Secretary Donna E. Shalala said. “The

regulatory changes we are proposing today

will help improve federal oversight of narcotic

treatment programs that use methadone by

bringing the full force of our medical and

clinical knowledge to bear on treating heroin

addiction. These reforms will help ensure a

treatment system that is good for patients,

practitioners, providers and our communities.”

While the White House Office of National Drug

Control Policy (ONDCP) estimates that there are

810,000 heroin addicts in the United States,

only 138,000 to 170,000 people currently receive

methadone or Levo-Alpha-Acetyl-Methadol

(LAAM), as part of an addiction treatment

program. There are approximately 900

methadone treatment programs in the U.S.,

including programs approved for LAAM

treatment. “These regulations will improve

access to methadone treatment programs

and give doctors more flexibility in designing

treatment plans for their patients,” said

ONDCP Director Barry R. McCaffrey.

“Research provides strong evidence to

support methadone maintenance as the

most effective treatment for heroin

addiction. Methadone therapy helps keep

more than 100,000 addicts off heroin, off

welfare, and on the tax rolls as law-abiding,

productive citizens. Without methadone

programs, these individuals will be back on

the streets, back on drugs, and back on welfare, at an enormous cost to society and to

the safety of all of us.” Accreditation has

been proven over the years to produce

effective outcomes and is a widely adopted

external quality assessment system used by

the federal government, states, managed

care firms, insurers, and others to ensure

accountability for quality treatment. The

reorganization toward accreditation follows

recommendations made by a recent National

Institutes of Health consensus panel. The

panel concluded that existing federal and

state regulations limit the ability of

physicians and other health care professionals to provide methadone maintenance

services to patients and recommended

accreditation in lieu of regulations to

improve the quality of care. The proposed

changes are also consistent with a 1995

report by the Institute of Medicine that

stressed the need to readjust the balance

among regulations, clinical practice

guidelines and quality assurance systems.

The HHS proposal details accreditation

standards and the requirements for

accrediting organizations. When the rule

is final, CSAT will enforce these

regulations. Until the program is transferred, FDA will continue to monitor

programs in accordance with existing

regulations.

The Drug Enforcement Administration is not

proposing any changes to its oversight and

monitoring activities and responsibilities as

a result of this proposal. The proposed rule

provides for a 120-day period for public

comment and a public hearing prior to

adoption of a final rule. The document

specifies a core of federal standards for

treatment that must be incorporated into

accreditation standards. CSAT is conducting

a study on a representative group of

treatment facilities that are implementing

accreditation standards developed by the

Commission on Accreditation of Rehabilitation

Facilities (CARF) and the Joint Commission on

Accreditation of Healthcare Organizations

(JCAHO). Accreditation standards will be

modified, if needed, to insure the best

quality of care for patients. The proposed

rule is available on the web at

NEW FEDERAL RULES PROPOSED TO IMPROVE QUALITY AND OVERSIGHT OF METHADONE TREATMENT

by clicking on Federal Register. Written

comments on the rule may be submitted to

Documents Management Branch (HFA-305)

Food and Drug Administration, 5630 Fishers

Lane, Room 1061, Rockville, MD 20857. The

Center for Substance Abuse Treatment (CSAT)

is part of the Substance Abuse and Mental

Health Services Administration (SAMHSA).

SAMHSA, a public health agency in the U.S.

Department of Health and Human Services,

is the lead Federal agency for improving the

quality and availability of substance abuse

prevention, addiction treatment and mental

health services in the U.S. News media

requests for information on SAMHSA’s

programs should be directed to Media

Services at 1-800-487-4890. This release

may be obtained on the Internet at

www.samhsa.gov.

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