Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder
On Jan. 27, 2021, the Office of National Drug Control Policy issued a statement regarding the announcement from the Department of Health and Human Services (DHHS) about forthcoming Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. The initial DHHS announcement generated a lot of discussion in the field around the pros and cons of the X waiver for buprenorphine prescribers. To provide clarity, the ATTC Network Coordinating Office (NCO) asked H. Westley Clark, MD, JD, MPH to write a summary of the proposal and the field’s reaction. The article below was written prior to ONDCP’s Jan. 27 statement, which postponed the new Guidelines indefinitely. Nevertheless, the ATTC NCO felt it was important to publish Dr. Clark’s article to provide context to a conversation which will undoubtedly be ongoing.
By Westley Clark, MD, JD, MPH
Dean's Executive Professor of Public Health
Santa Clara University
Santa Clara, California
On Jan. 12, 2021, a week before the Trump Administration left office, the U.S. Department of Health and Human Services (DHHS) submitted to the Federal Register for publication new Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. In a questionable interpretation of the Drug Addiction Treatment Acts of 2000 (DATA 2000), the Comprehensive Addiction and Recovery Act (CARA) and the Substance Use Disorder Prevention Opioid Recovery and Treatment For Patients and Communities (SUPPORT) Act, DHHS concluded that Practice Guidelines could eliminate the requirement that physicians with a Drug Enforcement Administration (DEA) registration number apply for a separate waiver to prescribe buprenorphine for opioid use disorder treatment.
The Office of the Assistant Secretary for Health (OASH) in DHHS determined that the need for physicians to make all of the certifications under DATA 2000 represented a significant perceived barrier to prescribing buprenorphine in the United States and removing the certification requirements would
dramatically improve access to buprenorphine and save lives.
The proposed guidelines applied only to licensed physicians who possess a DEA registration and only to buprenorphine, not methadone. They required physicians who use the exemption to place an ‘X’ on the prescription, clearly identifying the prescription as being written for opioid use disorders. They required that charts for patients being treated for OUD be maintained separately from other patients to ensure confidentiality and required physicians to maintain and retain records of prescriptions issued. Physicians became limited to no more than 30 patients; however, they exempted hospital-based physicians, such as emergency department (ED) physicians who initiated treatment in the ED, from the 30-patient limit if they did not engage in a long-term treatment relationship. Finally, the guidelines restricted the exemption to patients in the states where physicians have a license.
The proposal included information about implementation of the guidelines. DHHS would establish an interagency working group to monitor the implementation and results of the guidelines, as well as the impact on diversion. The working group would be chaired by a representative from the Immediate Office of the Secretary of HHS. To read the full article, click on View Resource.
