Skip to main content

New HHS Guidelines Exempt Nearly All Prescribers from X-Waiver Requirement

April 27, 2021

The Department of Health and Human Services announced on Tuesday it is releasing a new version of its Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder that will allow nearly all prescribers to treat opioid use disorder with buprenorphine.

The new guidelines, signed by HHS Secretary Xavier Becerra, exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives from federal certification requirements to obtain a waiver that allows them to treat up to 30 patients with buprenorphine. Although they will now be exempt from the training requirements, providers will still be required to give notice to SAMHSA that they intend to prescribe buprenorphine.

BHE PODCAST: Shatterproof CEO Gary Mendell explains why the X-waiver requirement should be eliminated

The decision comes as more than 90,000 drug overdose deaths were reported for the 12 months ending in September 2020, the highest recorded 12-month total on record, according to CDC data.

“Removing barriers to quality treatment is a top policy priority for the Biden-Harris administration,” Office of National Drug Control Policy Acting Director Regina LaBelle said in a statement. “Addiction treatment should be a routine part of healthcare, and this new guideline will make access to quality treatment for opioid use disorder more accessible. The guideline is another important step forward in our efforts to bend the curve of the overdose and addiction epidemic.”

During its final week in office in January, the Trump administration had announced it would remove the X-waiver requirement for DEA-licensed physicians, but those plans were halted by the incoming Biden administration later in the month amid “significant legal and clinical concerns.”

In a statement issued Tuesday, the American Medical Association lauded the move by HHS.

“Patients are struggling to find physicians who are authorized to prescribe buprenorphine; onerous regulations discourage physicians from being certified to prescribe it,” said Patrice Harris, MD, MA, AMA Opioid Task Force chair and immediate past president of the AMA. “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. Physicians should become educated about managing patients with opioid use disorder to help stem the nationwide overdose epidemic and ease the persistent health disparities facing these patients.”

The American Society of Addiction Medicine called the HHS decision “an important step” toward improving access to medication-assisted treatment, but encouraged federal legislators to go further.

“We now look to Congress to take critical and necessary next steps, including securing a permanent elimination of buprenorphine-specific training requirements, patient limits, and DEA audits, as well as the separate X-waiver application, for DEA-registered prescribers, while ensuring these clinicians receive baseline training on treating patients with substance use disorder,” ASAM president William Haning, MD, DLFAPA, DFASAM, said in a statement.

In an email to AP, American Addiction Centers chief medical officer Lawrence Weinstein, MD, ABHM, FASAM, FAMA, added: “Eliminating the cumbersome regulations and expanding the number of providers who can prescribe buprenorphine—an evidence-based medication that has been proven to effectively treat opioid use disorder—can lead to a significant shift in the way opioid addiction is addressed. Last year saw the highest recorded number of overdose deaths; if we allow more providers to prescribe this medication and we can reach more patients with OUD, we can begin to curb this distressing trend.”

Back to Top