The Department of Health and Human Services has issued Practice Guidelines that will allow all physicians to prescribe buprenorphine for opioid use disorder.

For the first time since buprenorphine was FDA-approved for opioid use disorder nearly twenty years ago, physicians will be able to prescribe this medication to people with opioid use disorder without undergoing redundant, unnecessary training and separate DEA registration requirements.

Summary of Regulatory Changes on Buprenorphine Waiver

These changes were enacted via Practice Guidelines issued by the Department of Health and Human Services today. See HHS’s news release on the change here

  • When it goes into effect: The changes will go into effect when the Practice Guidelines are published in the Federal Register, which will likely occur within 3 business days. I will update you as I learn more about the timeline.  
  • Who it applies to: All physicians with a DEA license can prescribe buprenorphine under these guidelines. Other qualifying practitioners (such as nurse practitioners and physician assistants) will still need to adhere to the normal DATA 2000 waiver protocols.
  • Training or special certification requirements: Under this exemption, physicians no longer have to undertake the 8-hour waiver training or prove they hold an applicable certification from a designated professional body.
  • Counseling and ancillary services referrals: Physicians will also no longer have to have the capacity to provide or refer patients to counseling and ancillary services.
  • How to use the exemption Physicians who utilize this exemption just need to place an “X” on the buprenorphine prescription and note that the prescription is being written for opioid use disorder. Charts for patients being treated for opioid use disorder must be maintained separately from other charts to ensure their confidentiality under Title 42 Part 2.  Physicians can treat only patients who are located in the states where they are authorized to practice.
  • Patient limits: Physicians who utilize this exemption will be limited to treating no more than 30 patients at one time and must maintain records of the prescriptions issued. Hospital-based physicians, including Emergency Department physicians who initiate treatment but do not engage in a long-term treatment relationship with the patient, are exempt from these patient limits.
  • DATA 2000 Waiver: The normal waiver requirements are still in place for all other qualifying practitioners (e.g., nurse practitioners and physician assistants). Physicians who wish to prescribe above the 30-patient limit may continue to seek the DATA 2000 waiver under the normal protocols and would not be subject to the above rules.
  • Regulatory Authority: DATA 2000 allows the Secretary of Health and Human Services to create exemptions from the certification requirements by issuing practice guidelines.