Pressure mounts to deregulate buprenorphine.
Some experts in the medical field are asking the government to deregulate buprenorphine, an addiction treatment drug, arguing that requiring providers to take an eight-hour X-waiver training course before administering the drug and submitting to subsequent audits by the Drug Enforcement Administration (DEA) has limited its availability in the medical community amid the opioid epidemic. On the other side of the camp, however, some opioid addiction treatment providers, are contending that more training is needed. The Biden Administration and Congress are set to make a decision on the future of buprenorphine regulation in the near future.
Dr. Shawn Ryan, an addiction specialist in Cincinnati, Ohio, said, “Buprenorphine diversion has never been connected with significant mortality, while in contrast, increased buprenorphine access has definitely proven to decrease overdose mortality in communities.” Thus, because of the high probability of diversion, he supports eliminating the X-waiver, which is administered by the federal Substance Abuse and Mental Health Services Administration (SAMHSA).
However, Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, does not. He said, “We know what happens when doctors who prescribe opioids don’t have enough training, it’s called an opioid epidemic.” Parrino added, “Instead of removing the guardrails designed to protect patients, the federal government should consider policies that would increase Medicaid and private insurance reimbursement rates for treatment with buprenorphine and remove time-consuming pre-authorization rules that impede access to the medication.”
Research shows that buprenorphine is at least two-times as effective in preventing drug use as addiction treatment without medication, supporting efforts to deregulate it, and DEA data shows Massachusetts has the highest number of physicians per capita who publicly list themselves as registered to prescribe buprenorphine, followed by Maine, Vermont, Alaska, Rhode Island, Connecticut, Maryland, and New Mexico. Nebraska has the lowest number of listed providers, followed by Iowa, Texas and Kansas. Data also shows “only 18% of the 1.6 million Americans with opioid use disorder are receiving any addiction medications” at all, according to the SAMHSA.
A pair of bills sponsored by Democratic U.S. Sen. Maggie Hassan of New Hampshire and Republican Sen. Lisa Murkowski of Alaska have sought to deregulate the treatment medication. “Removing this barrier will massively expand treatment access, making it easier for medical professionals to integrate substance use disorder treatment into primary care settings,” they wrote in the letter to the Biden Administration. According to the proposed legislation, “The training requirement reflects a longstanding stigma around substance use treatment and sends a message to the medical community that they lack the knowledge or ability to effectively treat individuals with substance use disorder.”
In a January 26 statement, the American Society of Addiction Medicine, the National Council for Behavioral Health and other addiction advocacy groups also urged Congress to eliminate the training requirement, stating in a letter, “As clinicians and advocates on the frontlines of the addiction and overdose crisis, we call on congressional leaders to confront this epidemic with the urgency and boldness it requires.” And, the American Medical Association, the American College of Emergency Physicians and the American College of Obstetricians and Gynecologists, wrote the Department of Health and Human Services a day later, stating, “In this case, there’s no time to waste.”
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