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.
H. 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. The proposal also 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 the 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. The working group would include representatives from the Office of National Drug Control Policy; Drug Enforcement Administration; Department of Justice; National Institute on Drug Abuse; Substance Abuse and Mental Health Services Administration; Food and Drug Administration; and the Centers for Disease Control and Prevention. The working group would meet at least twice yearly and would make formal recommendations to the DHHS Secretary on whether the guidelines should be continued, discontinued or modified.
The proposed guidelines were announced in a press release on Jan. 14, 2021, and were met with a mixed reaction. The American Medical Association (AMA) strongly endorsed the proposed new guidelines contending that office-based physicians and physician-led teams working with patients to manage other medical conditions could also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime. Those in the harm reduction community agreed with the AMA, contending that buprenorphine on demand saves lives.
However, not all physicians greeted the proposed guidelines favorably. One physician commenting in Medscape Psychiatry argued that the existing waiver was not an obstacle, as it only required eight hours of continuing medical education (CME) on proper prescribing and treatment. The author noted that CME hours are already required to maintain a license and that if a physician has no interest in applying some of their mandated CME into learning about buprenorphine and addiction, then those physicians should not be prescribing buprenorphine. Others worried about promoting buprenorphine “pill mills” driven by cash only providers.
A number of other issues surfaced about the guidelines. The first was whether the Trump Administration’s interpretation of DATA 2000 and its amendments was correct. Other legal authorities found no justification for guidelines being used to eliminate the X-waiver. Others noted that while the formal X-waiver would be eliminated, the new guidelines still required an ‘X’ to be placed on a prescription and that the prescription was for the treatment of an opioid use disorder. Thus, the new guidelines would do little to diminish stigma or discrimination.
The new guidelines relied heavily on the following assumptions: that they would (1) have a positive impact on overdose deaths, (2) increase access to treatment, and (3) reduce stigma. However, no data were offered to support these assumptions. Furthermore, there were no provisions for an evaluation or data collection to determine the impact of the new guidelines.
On Jan. 25, 2021, the Washington Post reported that the new guidelines were not going to be published, preventing them from taking effect. The rationale for halting the publication was that DHHS lacked the authority to issue the guidelines, given that the waiver was mandated by Congress. It should be noted that the Biden Administration is committed to ensuring that any undue restrictions on prescribing drugs like buprenorphine are lifted.