New Federal Regulations for Improving Quality in Opioid Treatment Programs.

The U.S. Food and Drug Administration (FDA) has enforced federal requirements related to the use of methadone since 1972; regulations essentially have not changed for nearly 30 years. With Congress' recently released federal regulations for opioid treatment programs (OTPs), however, oversight of OTPs has shifted from the FDA to the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA's Center for Substance Abuse Treatment developed guidelines for accreditation agencies such as the Joint Commission on Accreditation of Healthcare Organizations and The Rehabilitation Accreditation Commission...CARF to develop standards for OTPs. Preliminary findings show that OTPs are indeed able to meet these accreditation standards. This article reviews the need for the changes, the history of methadone treatment oversight, the development of accreditation requirements, stakeholders' initial response to the proposed regulations, and performance domains of importance to OTPs.