Description
Methadone hydrochloride is a synthetic narcotic analgesic with multiple actions quantitatively similar to those of morphine. Its principal use is detoxification or maintenance in opiate addiction (heroin or other morphine-like drugs).

Policy
Methadone treatment is MEDICALLY NECESSARY for opiate addiction in patients who, by history, physical examination and urinalysis, demonstrate a current state of physiologic dependence on opiates.

Methadone treatment is NOT MEDICALLY NECESSARY for treatment of addiction to other types of drugs. 

Policy Guidelines
Treatment must be rendered in a program approved by the U.S. Food and Drug Administration (FDA). Maintenance programs must be approved by the FDA and the designated state authority (usually the Department of Public Health).

• These programs must dispense and use methadone in oral form only. A methadone product used as an analgesic, and not for the treatment of opiate addiction, may be dispensed in any licensed pharmacy.
• Methadone products, when used for the treatment of narcotic addiction in detoxification or maintenance programs, must be provided by approved hospital pharmacies or approved community pharmacies.
• These programs may admit patients under the age of 18 to be detoxified using methadone only under special circumstances, since the safety and effectiveness of methadone in the treatment of adolescents has not been approved by adequate clinical study. The FDA requires that such patients must have a documented history of two or more unsuccessful attempts at detoxification and a documented history of dependence on heroin or other morphine-like drugs beginning two years prior to application for treatment. Under such conditions, a parent, legal guardian or responsible adult designated by the state authority must complete and sign an FDA "Consent for Methadone Treatment" form.

The FDA further states that "if methadone is administered for treatment of heroin dependence for more than three weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his stay or whose enrollment has been verified in a program which has been approved for maintenance treatment with methadone."

• Programs shall include, under FDA requirements, a detoxification treatment not to exceed 21 days and not to be repeated earlier than four weeks after completion of the proceeding course. Treatment with methadone over 21 days is considered maintenance treatment.

Attention should be directed to women of childbearing age for the potential of addicted babies.

Rationale
A search of literature was completed through the MEDLINE database for the period of January 1995 through October 1996. The search strategy focused on references containing the following medical subject heading:

• Methadone and Program

See Also:

Physicians’ Desk Reference, 1996

References

1. Consultation Report: Morbidity and Mortality Following Rapid Opiate Detoxification: Submitted by Steffanie A. Strathdee, PhD, Associate Professor, Johns Hopkins School of Public Health. 
2. The Methadone Site, Changing the Recipients Behavior.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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