Buprenorphine is widely seen as one of the most effective medications for treating opioid use disorder. But physicians trying to prescribe it have faced a big obstacle: The U.S. government required they first take a special eight-hour training course.
Last week, the U.S. Department of Health and Human Services (HHS) did away with that obstacle when it released new buprenorphine practice guidelines.
“This is a great move forward in removing barriers to care,” said Blair Walker, MD, chief of psychiatry at Dell Seton Medical Center at The University of Texas at Austin.
The requirement discouraged physicians from prescribing buprenorphine because of the time commitment required to take the eight-hour course, she says. Other health care professionals had to take 24 hours of training in order to prescribe the medication.
It also added stigma to an already stigmatized area of care by giving the impression the medication is not safe or is difficult to use, and removing the requirement should help more physicians incorporate buprenorphine into their practices.
“It’s just the opposite with buprenorphine. It’s one of the safest opioids we have and highly effective for opioid use disorder,” Dr. Walker said.
Buprenorphine is a partial opioid receptor agonist that partly activates opioid receptors in the brain (compared with full agonists like methadone and heroin, which activate receptors completely). The medication is designed to stop cravings for opioids.
The training requirement was mandated by the Drug Addiction Treatment Act of 2000. Physicians and other health care professionals had to take the course to obtain a special license called an “X-waiver” that allowed them to prescribe buprenorphine.
Physicians and health care professionals still must obtain an X-waiver, but now they can opt out of the course requirement. If they do, they can treat only up to 30 patients at a time with buprenorphine.
The U.S. government has not required physicians and other health care professionals to take a course before prescribing any other opioid, including medications like hydrocodone or fentanyl that can cause opioid use disorder, said Carlos Tirado, MD, an addiction psychiatrist who is founder and chief medical officer at CARMAhealth in Austin and a member of TMA’s Subcommittee on Behavioral Health.
Lifting the course requirement is welcome and should improve physician use of buprenorphine, he said. But it does not address another important obstacle preventing wider use of the medication.
Prescribing buprenorphine still automatically triggers law enforcement audits of physician practices, Dr. Tirado said. As with the course requirement, these audits apply only to the prescription of buprenorphine – not to the prescription of any other opioids.
The Drug Enforcement Administration will inspect a physician’s practice every 15 years from the date he or she is approved to prescribe buprenorphine. The first inspection usually takes place within the first three years after being waivered, according to the website for the American Society of Addiction Medicine.
A bill pending before Congress called the Mainstreaming Addiction Treatment Act would eliminate both the X-waiver and the law enforcement audit for prescribing buprenorphine, Dr. Tirado said. The Texas Medical Association has not taken a position on the bill, but the American Medical Association has endorsed it.
Ending the course requirement “is a good step in the right direction but it still falls short of what really needed to happen, which is ending this threat of law enforcement action against medical practices,” Dr. Tirado said.