On July 6, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the Department of Health and Human Services (HHS), published a final rule implementing changes to the Controlled Substances Act (CSA), as amended by the Drug Addiction Treatment Act of 2000 (DATA 2000). The final rule will go into effect August 8, with perhaps the most significant modification being the increase in the number of patients that a physician can treat with buprenorphine, a medication which is prescribed as part of medication-assisted treatment (MAT) for opioid addiction.
Under the CSA buprenorphine is a Schedule III drug, which is defined by the Drug Enforcement Administration (DEA) as a drug with “a moderate to low potential for physical and psychological dependence.” DATA 2000 allows for qualified physicians to obtain a waiver to prescribe buprenorphine without needing to register as an opioid treatment center. Prior to the passage of the final rule, a physician whose waiver request was approved could initially prescribe buprenorphine to only 30 patients at a time, with this cap rising to 100 after the physician has complied with the program for one year and filed a request for the patient increase. This final rule will significantly raise the maximum number of patients allowed, from 100 to 275.
For a practitioner to be qualified to treat any patients with buprenorphine, they must: be a physician; possess a valid license to practice medicine; be registered with the DEA; have the ability to refer patients to addiction counseling and other ancillary services; and have completed a required training regime. In order to be eligible to treat 275 patients with buprenorphine, a physician needs to be currently authorized to treat 100 patients, and must hold “additional credentialing.” Additional credentialing is defined within the final rule as “board certification in addiction medicine or addiction psychiatry by the American Board of Addiction Medicine or the American Board of Medical Specialties or certification by the American Osteopathic Academy of Addiction Medicine, the American Board of Addiction Medicine, or the American Society of Addiction Medicine.”