From HHS:
HHS is releasing new buprenorphine practice guidelines that among other things, remove a longtime requirement tied to training, which some practitioners have cited as a barrier to treating more people.
The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (available on the Federal Register beginning April 28th) exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives from federal certification requirements related to training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine.
The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder provide an exemption from certain certification requirements under 21 U.S.C. § 823(g)(2)(B)(i)-(ii) of the Controlled Substances Act (CSA). Specifically, the Practice Guidelines provide that:
- With respect to the prescription of certain medications that are covered under applicable provisions of the CSA, such as buprenorphine, practitioners, defined as physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are licensed under state law, and who possesses a valid DEA registration, may be exempt from the certification requirements related to training, counseling and other ancillary services.
- Practitioners utilizing the exemption are limited to treating no more than 30 patients at any one time. Time spent practicing under the exemption will not qualify the practitioner for a higher patient limit.
- Under the exemption, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives are required to be supervised by, or work in collaboration with, a DEA registered physician if required by state law to work in collaboration with, or under the supervision of, a physician when prescribing medications for the treatment of opioid use disorder. This requirement does not apply to practitioners who are employees or contractors of a department or agency of the United States acting within the scope of such employment or contract.
- Practitioners who do not wish to practice under the exemption and its attendant 30 patient limit may seek a waiver per established protocols.
- The exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine. It does not apply to the prescribing, dispensing, or the use of Schedule II medications such as methadone for the treatment of opioid use disorders.
- Before treating patients with buprenorphine for opioid use disorder, practitioners are required to obtain a waiver under the CSA by submitting a Notice of Intent to SAMHSA under established protocols.
Practitioners may find more information about the exemption at Quick Start Guide – PDF and FAQs.