Biden Administration Nixes Buprenorphine Waiver, Docs Disappointed

Kerry Dooley Young

January 29, 2021

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration's plan, many doctors would be exempt from taking a day's training before they could prescribe buprenorphine for OUD.

On January 25, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health and Human Services (HHS) had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently announced the derailment of the buprenorphine proposal on its website.

The initial waiver plan was was unveiled January 14 in the final days of the Trump administration. In SAMHSA's view, the proposal was made "prematurely." The SAMHSA statement did not detail the reasons for abandoning the January 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to "increase access to buprenorphine, reduce overdose rates and save lives."

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated January 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration (DEA), the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association (AMA), and other organizations.

Treatment Barrier

After taking the training course, it can take 60 to 90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

"Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD]," the letter said.

The Trump administration's proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would only have applied to physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization's Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

"It is estimated that more than two million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment," Harris said in statement. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention (CDC) data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21% compared to the previous year.

A "Disappointment"

Harris said the decision to drop the plan was a disappointment.

"We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication," she said in a statement sent to Medscape Medical News.

The American Society of Addiction Medicine also urged Congress to eliminate the X waiver and called for more education and training in the treatment of patients who struggle with opioids.

Before the last session of Congress, which ended on January 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors.

A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-NH). On January 25, Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

"Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it," she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag "Xthexwaiver."

Among them was the official who put forward the January 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

https://twitter.com/DrGiroir/status/1354812697225744389

 

Objections

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes McCance-Katz as saying the Trump buprenorphine proposal was "unfair to the incoming administration."

"The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble — it's heinous," she said in the article.

McCance-Katz had resigned before the Trump administration proposal was unveiled. On January 7, she issued a public notice announcing she would resign, citing concerns about the previous day's attack on the US Capitol.

"It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building," she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to "XtheXwaiver" and questioned their arguments about the burden of the current rules.

"I think 'all this red tape' is a little bit of an exaggeration ― it's an 8 hour online course, and an application," Flores tweeted in one exchange. "But #XtheXwaiver is fine ― it's probably rooted in stigma. It's unlikely to make much difference tho. The waiver wasn't the thing keeping docs from prescribing."

Kerry Dooley Young is a freelance journalist based in Washington, D.C. She earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.

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