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HHS Loosens Rules for Prescribing Buprenorphine

— Allows for treating up to 30 opioid use disorder patients, includes non-physician practitioners

MedpageToday
A pen hovers above a Medical procedure referral form with an Opiate replacement therapy sticker on it.

WASHINGTON -- Primary care doctors and other health professionals will be able to more easily prescribe buprenorphine for opioid use disorder under by HHS.

"We are seeing a startling rise in opioid addiction and mental health issues during COVID-19, and addressing these underlying issues is critical to moving forward as a country," Assistant Secretary for Health Rachel Levine, MD, said on a phone call with reporters. "We want to incorporate this as a routine part of healthcare, so primary care physicians can more easily take care of a patient who presents in their office with opioid use disorder."

In addition to physicians, the exemption will be available to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

Under the new guidelines, providers will be exempt from requirements under the Controlled Substances Act that they undergo 8 hours of training and make counseling available to patients. Providers will be limited to prescribing buprenorphine to a maximum of 30 patients at a time, and will be required to notify the Substance Abuse and Mental Health Services Administration (SAMHSA) of their intent to prescribe the drug, Levine said.

"The opioid epidemic has ended too many American lives," she continued. "More than 90,000 drug overdose deaths are predicted to have occurred in the U.S. in the 12 months ending in 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, according to provisional data from the CDC."

The new guidelines are similar to those announced by the Trump administration in January, which eliminated some "X waiver" requirements for buprenorphine prescribing. Under those loosened requirements, physicians could prescribe buprenorphine to up to 30 patients, as long as they only treated patients in the state in which they were authorized to practice.

Providers wishing to prescribe buprenorphine to more patients can do so if they , including training, as outlined by SAMHSA.

Physicians using that exemption must put an "X" on the prescription, clearly state that the prescription is being written for opioid use disorder, and maintain separate charts for patients being treated for opioid use disorder, according to a . HHS also said it would establish an interagency working group to monitor the implementation and results of the guidance, as well as the impact on diversion.

On Tuesday's call, Levine noted that the new guidance includes other providers in addition to physicians. "I'm confident this evidence-based and patient-centered step has the potential to save thousands of lives," she said.

The American Medical Association (AMA) praised Tuesday's announcement. "The AMA is pleased that HHS will support physicians to prescribe buprenorphine by removing daunting regulatory barriers and easing stigma facing patients with opioid use disorder," AMA Opioid Task Force Chair Patrice Harris, MD, said in a statement. "Patients are struggling to find physicians who are authorized to prescribe buprenorphine; onerous regulations discourage physicians from being certified to prescribe it."

"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," continued Harris, who is also immediate past president of the AMA.

"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 ... Going forward, the AMA is supporting legislation to remove the waiver requirements altogether and will advocate for that in Congress," she said.

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    Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy.