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

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 http://www.access.gpo.gov/su_docs 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.

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Note: HHS press releases are available on the World Wide Web at: http://www.dhhs.gov.