The United States “drug czar” James Carrol released a report on May 3 announcing a goal to nearly double the number of medical practitioners certified to prescribe the currently-restricted “gold standard” opioid use disorder medication, buprenorphine. But just a day before, a bipartisan team of US Representatives unveiled their own plan to axe the bureaucratic obstacles faced by prescribers, which could yield results far surpassing Carrol’s goal.
The Office of National Drug Control Policy (ONDCP) announced its goal to raise the proportion of doctors, nurse practitioners and physician assistants legally able to prescribe buprenorphine to 10 percent. Currently, the proportion of practitioners who have successfully completed the “X waivers” required under the Drug Addiction Treatment Act of 2000 is 5.4 percent—a number that is “unacceptably low,” according to the Performance Reporting System, the ONDCP document that quantifies its two- and five-year goals as outlined in the National Drug Control Strategy.
The ONDCP’s report arrives after it was taken to task by the Government Accountability Office, the federal watchdog agency, in March for failing to provide legally-required numbers to enable assessment of success.
“More than doubling the percent of US prescribers waivered to prescribe bupe would be significant progress, moving us from a completely abysmal to a slightly less abysmal state of affairs when it comes to buprenorphine access,” Leo Beletsky, associate professor of law and health sciences at Northeastern University School of Law, told Filter.
Doctors and other prescribers currently face a number of hurdles to being certified: time-consuming training, at eight hours for physicians and 24 hours for nurse practitioners and physician assistants; maintaining thorough records required by federal law; Drug Enforcement Administration office inspections; and stigma.
For doctors Sarah Wakeman and Kevin Fiscella, deregulating buprenorphine prescribing practices could boost access by eliminating the burdensome bureaucratic procedure that many medical practitioners—especially those in under-resourced rural areas—find financially or practically difficult to navigate. A 2017 Journal of Substance Abuse Treatment study found that 36 percent of surveyed doctors who were already waivered simply did not have time to prescribe buprenorphine to more patients, suggesting that hard-pressed unwaivered physicians would be even more overwhelmed by taking on buprenorphine clients.
“We have set out to achieve an aggressive set of specific objectives, and accomplish our overarching goal, which is to save more Americans from losing their lives to drug use,” ONDCP Director James Carroll said. But for Beletsky, the ONDCP’s goal is not “nearly sufficient or bold enough” and Harm Reduction Coalition’s medical director Dr. Kimberly Sue characterized it as a “far too conservative goal if we actually care about addressing the opioid overdose crisis.”
“We needed major scale-up in access to this medication years ago, and every passing day that it isn’t available results in lost lives,” Beletsky believes. Currently, 65,773 practitioners are certified, and the number of patients receiving buprenorphine did increase 23 percent since President Donald Trump took office, according to a May 8 ONDCP Opioid Commission report.
Regardless of the total headcount of practitioners authorized to prescribe the partial opioid agonist, federal data shows that the majority are only permitted to see 30 patients at a time. In the 2017 study, 48 percent of 558 surveyed physicians reported that they were waivered but were not prescribing at capacity. Sue also pointed out that “There is no other medication that doctors have caps on prescribing.”
Democratic Representative Paul Tonko of New York is pushing for one of the latest efforts to expand access. On May 2, he, along with two other Democrats and three Republicans, unveiled H.R. 2482 – The Mainstreaming Addiction Treatment Act, a bill to eliminate the waiver administered by the DEA.
“For nearly two decades, buprenorphine has provided the cornerstone for safe, effective and life-saving treatment for Americans with a diagnosed substance use disorder,” said Rep. Tonko. “We need to unbind the hands of our medical professionals on the front lines of this epidemic and make this proven, safe addiction treatment available to every American working to overcome addiction and find or follow the path of recovery. And we need to do it now.”
Although there is limited research on the exact results that deregulation would have on buprenorphine prescribing patterns, France saw a “rapidly increasing number” of people with opioid use disorders receiving buprenorphine treatment after special training requirements were eliminated in 1995—resulting in an 80 percent drop in overdose deaths.
The imperative to “X the X waiver,” as Wakeman and Fiscella described it, is to remove stigma. That’s because, as Sue explained, “Stigma is baked into the X waiver” itself. The buprenorphine waiver is founded in the logic that treating addiction is a choice, and that the health of the people with opioid use disorders should be decided according to a medical professional’s politics.
“Doctors should not be able to opt out of such care as we do not opt out of learning or providing diabetes care,” said Sue. “It is far easier to start someone on buprenorphine and achieve a therapeutic dose than it is to titrate insulin dosages for initiation of insulin therapy in a diabetic patient.”
“We need to do far more to rapidly reduce barriers to access and integrate addiction treatment into primary care settings,” said Beletesky, “including by nixing the X waiver.”