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OPINION

Remove the waiver requirement for buprenorphine prescribing

As specialists caring for patients with addictive disorders, we have seen first-hand the disastrous consequences of limiting prescribing access.

A man holds his prescription for buprenorphine, a medicine that helps treat substance use disorder, as he prepares to take a dose in a clinic in Olympia, Wash. in November, 2019.
A man holds his prescription for buprenorphine, a medicine that helps treat substance use disorder, as he prepares to take a dose in a clinic in Olympia, Wash. in November, 2019.Ted S. Warren/Associated Press

Buprenorphine, otherwise known by its brand name, Suboxone, is an essential medication in the treatment of opioid addiction. Access to this therapy remains limited by a unique requirement that prescribing physicians must obtain a special waiver from the US Drug Enforcement Agency after eight hours of certified education. The original legislation, cosponsored by then-Senator Joe Biden in 2000, was focused on increasing access to opioid addiction treatment. The historical basis for this additional training rested in concerns about effectiveness, availability, and adverse health consequences of patients during the transition of opioid use disorder treatment from a methadone clinic to a doctor’s office. Now, after two decades of successful office-based use in the United States, these dated and unnecessary restrictions on prescribing are obstructing access to lifesaving essential care for opioid dependence.

As specialists caring for patients with addictive disorders at the University of Massachusetts School of Medicine, we have seen first-hand the disastrous consequences of limiting buprenorphine prescribing capacity through the additional training requirement. For many of our colleagues, the federal regulations on prescribing this vital treatment, which include the cost and time commitment associated with the additional training, are too great a hurdle among competing priorities. UMass Medical School and other schools in the Commonwealth have done extensive work in providing core training to medical students in opioid prescribing and in buprenorphine therapy for addiction. Sadly, we still lack sufficient numbers of prescribers able to offer equitable and easy access to buprenorphine in Massachusetts and the rest of the country.

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Opioid use disorder is a complex disease requiring a multidisciplinary approach to treatment involving medications, counseling, and other psychosocial supports. The medications themselves, however, are not abnormally complex for someone who has completed medical school. Buprenorphine’s long duration of action and partial agonist effect offer unique and significant safety advantages over other opioid medications, treating opioid withdrawal and cravings while decreasing the overall likelihood of overdose. Yet prescribers are not required to undergo additional training prior to writing their first prescription for opioid painkillers like Percocet, Vicodin, or OxyContin.

The opioid crisis has never been more pressing. Preliminary data from the Centers for Disease Control and Prevention indicate that there were more than 81,000 overdose deaths in the United States between June 2019 and May 2020, the highest number of overdose deaths recorded in a 12-month period in US history. Initial data reports suggest synthetic opioids (like fentanyl) are responsible for this increase. The coronavirus pandemic has created additional stressors for individuals with opioid use disorders, leading to financial stressors, interruptions in treatment, and loss of social connectedness.

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In 2020, more than 2,000 people in Massachusetts died from an opioid-related overdose. The role of buprenorphine in preventing deaths is clear. Among people in Massachusetts who were seen in an emergency department after an opioid overdose, buprenorphine treatment decreased their risk of death from overdose and their all-cause mortality by almost 40 percent.

In the closing days of the Trump administration, the US Department of Health and Human Services moved to remove the special waiver requirement for physicians to prescribe buprenorphine. The Biden administration then determined that it could not eliminate the regulation through executive action alone and halted the effort. Legislative action would be the way to permanently address this issue.

The Mainstreaming Addiction Treatment Act of 2019, introduced in the House by Representative Paul Tonko of New York and in the Senate by Democratic Senator Maggie Hassan of New Hampshire and Republican Senator Lisa Murkowski of Alaska, would have eliminated the requirement for additional training in order to be able to prescribe buprenorphine. Even though this bill was endorsed by Attorney General Maura Healy, there were no Massachusetts congressional cosponsors.

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We acknowledge that while the removal of the eight hours of extra training requirement for buprenorphine prescribing is necessary to mainstream the care of patients impacted by opioid use disorder, this change alone will not ensure sufficient availability of treatment. More work will be required to reduce the stigma associated with the care of these patients and to incentivize physicians to provide evidence-based care to those they serve.

In the meantime, we ask that our legislators continue to be leaders on the forefront of addiction treatment and preventing overdose deaths by supporting legislation that leads to the removal of the waiver requirement for buprenorphine prescribing. Doing away with the waiver won’t just save lives; it will save lives immediately.

The authors are professors at the University of Massachusetts School of Medicine, where Dr. Amy L. Harrington is assistant professor in the department of psychiatry; Dr. Kavita Babu is a professor in the department of emergency medicine; Dr. James J. Ledwith Jr. is assistant professor of family medicine and community health; Dr. Caridad Ponce Martinez is assistant professor the department of psychiatry; Dr. Katherine Callaghan is assistant professor in the department of obstetrics and gynecology; and Daniel Mullin is associate professor in the department of family medicine and community health.

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