On September 10, 2008 Dept. of Health (DOH) repealed provisions in 10 NYCRR 80.84 corresponding to provisions of 14 NYCRR 829 requiring practitioners and pharmacies to register with the DOH and OASAS to prescribe and dispense buprenorphine. Both agencies had previously adopted these regulations in response to the passage of the federal Drug Addiction Treatment Act of 2000 (DATA 2000) and a joint task force to implement the provisions and intent the Act.

DATA 2000 permitted certain qualified physicians to treat opioid addiction with schedule III, IV and V narcotics approved by the federal FDA for such purpose outside of an opioid treatment program (OTP; “methadone clinic”). Buprenorphine is the only approved medication in those federal schedules. Physicians were authorized to provide this treatment by the Drug Enforcement Administration (DEA) via a waiver (“DATA 2000 waiver”) from certain provisions of the Narcotic Addiction Treatment Act of 1974 based on documentation of certain required credentials and training. The federal law delegated some regulatory oversight to the individual states so the NY task force established a process for NY physicians authorized by DEA to jointly register with both DOH and OASAS to provide this treatment modality.

However, since 2002 the federal Substance Abuse and Mental Health Services Administration (SAMHSA) has facilitated the waiver process for physicians (extended to physician assistants and nurse practitioners by the Comprehensive Addiction and Recovery Act of 2016) and tracks the number of practitioner waivers nationwide, making the process for registration in New York unnecessary and duplicative. As noted above in 2008 DOH repealed provisions requiring practitioners and pharmacies to register with the Department to prescribe and dispense buprenorphine. This proposal is consistent with both the DOH repeal and the redundancy resulting from federal oversight.

This rule making is filed as a Consensus Rulemaking because its purpose is to repeal obsolete regulations to which no person is likely to object. The Behavioral Health Services Advisory Council approved advancement of this proposal on January 31, 2018.

A Job Impact Statement (JIS) is not being submitted with this notice because it is evident from the subject matter of the regulation that it will have no impact on jobs and employment opportunities.