HHS announced Tuesday it will make it easier for providers to prescribe buprenorphine, potentially expanding access to the addiction treatment and better integrating it with primary care.
Under new practice guidelines, several types of providers, including physicians, physician assistants, nurse practitioners and others, will no longer have to complete an eight-hour training before prescribing buprenorphine for opioid use disorder to up to 30 patients.
The training is part of the requirements for obtaining an "X-waiver" from the federal government, part of a law passed in the 2000s intended to prevent possible abuse of buprenorphine and other drugs.
Advocates and lawmakers have long argued the waiver is a barrier to MAT access, with providers not wanting to go through the steps of completing training and meeting other requirements, like being able to refer patients for counseling.
Under the practice guidelines issued Tuesday, providers must still obtain a waiver by notifying HHS, but the associated training requirements are waived for providers treating 30 or fewer patients. Providers treating more than 30 patients will still need to meet the requirements of obtaining an X-waiver, including the training.
"These practice guidelines are intended to help expand access to treatment and reduce stigma by integrating opioid use disorder care with primary care," Dr. Rachel Levine, assistant HHS health secretary, told reporters Tuesday.
More than 90,000 drug overdose deaths occurred in the 12-month period ended in September 2020, a record-high for the U.S. that was in part triggered by the stresses and challenges of living through the pandemic.
"This alarming increase in overdose deaths underlines the need for more accessible treatment services," Levine said.
Studies show buprenorphine leads to fewer overdose deaths and aids long-term recovery, but access is spotty throughout the country due to addiction workforce shortages, the small number of providers who are able to prescribe it, and stigma.
While nearly 2 million people had opioid use disorder in 2019, only 100,000 physicians have waivers to prescribe buprenorphine, according to the Substance Abuse and Mental Health Services Administration. Forty percent of counties have no providers that can prescribe buprenorphine.
The changes announced Tuesday aim to address that by expanding the types of providers who can prescribe buprenorphine. Physicians assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives will also be allowed to prescribe buprenorphine without training under the practice guidelines, potentially helping expand access to addiction care, especially in rural areas.
A 2018 report from the Government Accountability Office also cited the need to get a special waiver and its associated training requirements as a barrier that dissuaded some providers from offering buprenorphine, "thereby limiting MAT availability."
Eliminating the waiver requirement altogether would require action from Congress, where both Democratic and Republican lawmakers have expressed interest in doing so.
The Trump administration tried to remove the requirement that providers get an X-waiver before prescribing buprenorphine, but the Biden administration canceled the guidance, arguing it was not allowable under the law.
The new guidance released Tuesday replaces the Trump administration's guidance, allowing providers to prescribe buprenorphine without training but keeping the need for obtaining an X-waiver in place.
"In terms of how we can offer this exemption, we've gone as far as we can," said Tom Coderre, acting assistant secretary for mental health and substance use. "If we want to go further, Congress would have to pass a law."
The American Medical Association called the announcement Tuesday a "critically important step" in treating patients with opioid use disorder.
"Patients are struggling to find physicians who are authorized to prescribe buprenorphine. Onerous regulations discourage physicians from being certified to prescribe it," said Dr. Patrice Harris, chair of the AMA Opioid Task Force. "Going forward, the AMA is supporting legislation to remove the waiver requirements altogether and will advocate for that in Congress."
