MAT Regulatory Flexibilities Led to More X-Waivers, Not More Patients in Treatment

The relaxation of federal medication-assisted treatment (MAT) regulations did not immediately result in more patients accessing care.

However, the numbers of patients accessing naltrexone prescriptions and physicians cleared to prescribe buprenorphine have increased, according to an update and study released by the U.S. Department of Health and Human Services (HHS).

In April 2021, HHS removed two key provisions for obtaining an X waiver, a federal regulation that requires special registration and training for providers to treat people with buprenorphine. Prescribers looking to obtain an X waiver will no longer need to complete a training certification and the requirement to provide counseling and other ancillary services. Since the onset of the pandemic, drug overdose deaths have increased sharply.

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About 19% more providers received X waivers to prescribe buprenorphine to up to 30 patients in the twelve months that ended September 2022 compared to a year ago.

Similarly, 37% more patients received prescriptions for naltrexone, a non-controlled substance used to treat substance use disorder, since the regulation changes, according to the update. 

However, the rate of buprenorphine prescriptions filled decreased in the remaining months of 2021.

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“The rate of increase continued to slow after the release of the [changes], with about 3,880 fewer patients (63% fewer) having buprenorphine fills each month compared to the pre-COVID rate and about 1,960 fewer patients (47% fewer) compared to the first 15 months of COVID-19,” a study conducted by the Office of the Assistant Secretary for Planning and Evaluation, part of HHS, states.

Barriers to MAT listed in the study include stigma, a lack of other health care practitioners knowing about or trusting MAT, low reimbursement and administrative barriers.

Removing the two requirements did not eliminate the X waiver. That would take an act of Congress to amend the Controlled Substances Act.

“Additional time and policy efforts may be necessary for increased provider capacity to result in greater numbers of patients treated,” the study states.

It also points to potential accelerants of MAT use — expanding the type of providers that can obtain an X waiver, expanding patient limits for waivered providers and allowing telehealth buprenorphine initiation under the public health emergency.

Even with the expanded number of providers, the U.S. faces a lack of access to MAT. As many as 9% of Americans live over 10 miles away from an X-waivered provider while a third of rural counties don’t have any such providers, the study states.

While as many as 1 million physicians could receive an X waiver, fewer than 93,000 do, the study states.

The update comes a year after HHS released its Overdose Prevention Strategy. This strategy advances the National Drug Control Strategy the White House released in May. In his state of the union address, President Joe Biden made tackling the opioid epidemic part of his unity agenda.

Looking forward, the X waiver’s days may be numbered as legislators angle to pack provisions into major must-pass bills expected to move before the end of the year and the beginning of a new session of Congress.

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