HHS removes barriers to buprenorphine for opioid use disorder
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HHS has released new practice guidelines to expand access to buprenorphine for opioid use disorder.
The agency said eligible practitioners — including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives — will be exempt from training and other federal certification requirements for obtaining a waiver to prescribe buprenorphine. Previously, the waiver — also known as the “X waiver” — only applied to physicians, according to Rachel Levine, MD, assistant secretary for health at HHS.
“These practice guidelines are intended to help expand access to treatment and reduce stigma through integrating opioid use disorder care in primary care,” she said during a conference call with reporters. “This evidence-based and patient-centered step has the potential to save thousands of lives over the coming months and years.”
All health care professionals interested in utilizing the waiver must be licensed under state law, possess a valid Drug Enforcement Administration registration and submit a notice of their intent with the Substance Abuse and Mental Health Administration (SAMSHA), according to an HHS press release. Those who utilize the waiver are limited to treating no more than 30 patients for opioid use disorder at any one time.
HHS also said the waiver only applies to Schedule III, IV and V drugs or combinations of these drugs. It does not apply to Schedule II medications such as methadone for the treatment of opioid use disorders.
The expanded eligibility is in response to recent data that indicated a record-high number of Americans died from drug overdoses during a recent 12-month period, Levine said during the call. Tom Coderre, director of SAMSHA, said only 18% of Americans reported receiving medication-based treatment for opioid use disorder in the past year.
“We need to do better, we need to increase that,” Coderre said during the conference call. “This is an all-hands-on-deck moment and a huge expansion of the number of people [buprenorphine] will be made available to.”
AMA said in a statement that it was “pleased” with HHS’ decision.
“Patients are struggling to find physicians who are authorized to prescribe buprenorphine; onerous regulations discourage physicians from being certified to prescribe it,” Patrice Harris, MD, MA, chair of the AMA Opioid Task Force and the organization’s immediate past president, also said.
"With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to separate, burdensome and stigmatizing requirements.”
More details on the waiver can be found within The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.
References:
AMA. AMA statement on HHS decision to remove addiction treatment barriers. https://www.ama-assn.org/press-center/ama-statements/ama-statement-hhs-decision-remove-addiction-treatment-barriers. Accessed April 28, 2021.
HHS. HHS releases new buprenorphine practice guidelines, expanding access to treatment for opioid use disorder. https://www.hhs.gov/about/news/2021/04/27/hhs-releases-new-buprenorphine-practice-guidelines-expanding-access-to-treatment-for-opioid-use-disorder.html. Accessed April 28, 2021.
Perspective
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Anita Gupta, DO, PharmD, MPP, GMP, FASA
The rising drug overdose crisis amid the COVID-19 pandemic has led to more than 87,000 Americans deaths in a 12-month period in 2020, requiring swift action to improve patient lives. The policy action taken by the Biden-Harris administration is one step towards improving and expanding much needed equitable access to evidence-based treatments; however, more work is necessary ahead. The future challenges and opportunities will be to educate, mitigate harm, reduce adverse events, and improve awareness of safe, responsible use of buprenorphine and appropriate opioid therapy, as these will continue to be a priority as the likelihood of the death toll related to the drug crisis increases as reported by the CDC.
Adjunct assistant professor, Johns Hopkins School of Medicine
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