Recently, the United States Department of Health and Human Services (HHS) released new buprenorphine practice guidelines, Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. These new guidelines remove a long-time requirement tied to training, which some practitioners have historically cited as a barrier to treating more patients.
The new guidelines exempt eligible physicians, physician assistances, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from federal certification requirements related to training, counseling, and other services that are part of the process for obtaining a waiver to treat up to thirty patients with buprenorphine. Practitioners must still have a valid DEA registration and valid state medical license for the state in which they deliver medical care.
Practitioners who use the exemption cannot treat more than 30 patients at any one time and time spent practicing under the exemption will not qualify the provider for a higher patient limit. Additionally, if state law requires the provider to work with a physician when prescribing medications for the treatment of opioid use disorder, the provider must be supervised by, or work in collaboration with, a DEA registered physician.
Practitioners who do not wish to practice under the exemption and be restrained by the 30 patient limit may seek a waiver via established protocols, including submitting a new Notice of Intent that satisfies all existing statutory certification requirements related to training and psychosocial services.
Importantly, practitioners who wish to qualify for the exemption must submit a Notice of Intent with their DEA registration and state medical license attached. These new guidelines do not eliminate the CSA waiver or the Notice of Intent requirements. More information about the application process can be found here.
In its FAQs on the new guidance, SAMHSA seems to indicate the possibility that the 30-patient limit may be expanded in the future, after examining the effects of this policy.
“Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” said Assistant Secretary for Health, Rachel Levine, MD. “These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities.”
“The spike we’ve seen in opioid involved deaths during the COVID-19 pandemic requires us to do all we can to make treatment more accessible,” said Acting Assistant Secretary for Mental Health and Substance Use Tom Coderre, who leads HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA). “Americans with this chronic disease need and deserve readily available access to life-saving, evidence-based treatment options. These new guidelines are an important step forward in reducing barriers to treatment and will ultimately help more people find recovery.”
“Removing barriers to quality treatment is a top policy priority for the Biden-Harris Administration,” said Office of National Drug Control Policy Acting Director Regina LaBelle. “Addiction treatment should be a routine part of healthcare, and this new guideline will make access to quality treatment for opioid use disorder more accessible. The guideline is another important step forward in our efforts to bend the curve of the overdose and addiction epidemic.”