In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that treats opioid use disorder. On a side note, it has always been a “head scratcher” that it was actually much easier to prescribe highly addictive opioids (like schedule II or schedule III narcotic controlled substances) than buprenorphine, which is used for the much-needed treatment for abuse of opioids. Until HHS’s recent announcement any physician seeking to treat opioid use disorder with buprenorphine was required to obtain an “X” DEA number (i.e., “X waiver” or “Data 2000 waiver”). Unless appropriately board certified, this required an 8-hour training; advanced practitioners including physician assistants and nurse practitioners need 24 hours of training. Prescribers were also limited to 30 patients at a time within their first waiver year, and 100 patients thereafter (after meeting additional notification requirements).
The attached Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempts from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) those physicians licensed under State law and who possess a DEA registration. Note the following important limitations on the new HHS exemption:
- The exemption only applies to physicians who may only treat patients who are located in the state or states in which they are authorized to practice medicine.
- Physicians will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (but note: the 30-patient cap does not apply to hospital-based physicians, such as emergency department physicians).
- The exemption applies only to the prescribing of drugs or formulations covered under the X waiver, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD (which – appropriately used — must be administered in a SAMHSA-certified program).
- Physicians utilizing this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (and separately maintain information in the chart used for the patient being treated for OUD).
- An interagency working group will be established to monitor the implementation and results of these new practice guidelines, as well as the impact on diversion.
The new guidelines state the date on which they will take effect will be added after publication in the Federal Register.