After the GAO report was published, the FDA commissioned the Institute of Medicine (IOM) to conduct a comprehensive review of the federal regulations for methadone treatment programs. In its 1995 published findings, IOM recommended that the federal oversight of methadone treatment programs change from a process-oriented mechanism to a more patient-outcome mechanism. The IOM also concluded “that a need exists to maintain certain enforceable requirements in order to prevent substandard or unethical practices that have socially undesirable consequences.” ⁽⁵⁾

Lessons Learned from Regulatory Oversight

Following the release of the 1995 IOM report, the Department of Health and Human Services (DHHS) implemented a strategy to transition federal oversight from the FDA to SAMHSA. After years of strategic development, this transition occurred in 2001.

SAMHSA decided to use an accreditation oversight mechanism to monitor quality assurance in the OTPs primarily through the Joint Commission on Accountability of Healthcare Organizations (now the Joint Commission) and the Commission on Accreditation of Rehabilitation Facilities (CARF). Other accreditation entities such as the Council on Accreditation (COA) and the states of Washington and Missouri also became certified accreditation entities under the aegis of SAMHSA. The National Commission on Correctional Heath Care implemented similar accreditation procedures for treatment in correctional settings.

While the federal government has provided guidelines and resources for evidence-based medication assisted treatment for OUD, it is important to note that the term “assisted treatment” reflects the view that medication alone is not generally thought to be sufficient to treat this complex disorder.

An article by Dr. Dole in the Journal of the American Medical Association in 1988 provides context for this view. In the article, Dr. Dole postulated that the high rate of relapse among addicts after detoxification from heroin use is due to persistent derangement of the endogenous ligand-narcotic receptor system and that methadone in an adequate daily dose compensates for this defect. Some patients with long histories of heroin use and subsequent rehabilitation on a maintenance program do well when the treatment is terminated. The majority, unfortunately, experience a return of symptoms after maintenance is stopped. The treatment, therefore, is corrective but not curative for severely addicted individuals. A major challenge for future research is to identify the specific defect in receptor function and to repair it. Meanwhile, methadone maintenance provides a safe and effective way to normalize the functioning of otherwise intractable narcotic addicts.⁽⁶⁾