HHS Loosens Reins on Buprenorphine Prescribing

https://www.medpagetoday.com/psychiatry/opioids/90718

WASHINGTON — X will mark the spot for physicians who will be newly able to prescribe buprenorphine for opioid use disorder under guidance announced Thursday by the Department of Health and Human Services (HHS).

The guidance, outlined in a press release, eliminates a requirement known as an “X waiver” for physicians who want to prescribe buprenorphine for opioid use disorder (OUD), as long as they meet certain requirements:

• They only treat patients located in the state in which the physician is authorized to practice

• They will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time

• They cannot prescribe or dispense methadone for OUD

Physicians using the X-waiver exemption must put an “X” on the prescription, clearly state that the prescription is being written for opioid use disorder, and maintain separate charts for patients being treated for OUD, according to the release. HHS will also establish an interagency working group to monitor the implementation and results of the guidance, as well as the impact on diversion.

“Regulation stands in the way of connecting individuals suffering from substance use disorder with this lifesaving care,” Jim Carroll, director of the White House Office of National Drug Control Policy, said on a phone call with reporters. “Improving the X waiver is a major action, and it’s one that has broad support.”

Currently there are numerous bills circulating on Capitol Hill that would remove the X waiver entirely, Carroll continued, adding that the legislation is supported by both Republicans and Democrats. “There is an urgent need to remove it, especially now with COVID and people being cut off,” Carroll said. In the meantime, “we took this strong action, and this will continue to reap benefits for those who need help the most.”

“There’s been an analysis of the barriers that have limited access to buprenorphine for those that need it, and one of them is there are not enough clinicians to provide the buprenorphine; there are not sufficient physicians that are waivered to provide it,” said Nora Volkow, MD, director of the National Institute on Drug Abuse. “And yet we know from research that the healthcare system, whether it’s primary care physicians or specialists in emergency departments, can play a key role in providing this medication to patients.”

The guidelines “will make it much easier to bring buprenorphine and treatment of OUD into the healthcare system that exists through the country,” she added. “It will enable primary care physicians to provide this treatment, which research has already shown they are as able to do as specialized treatment programs.”

Asked by MedPage Today why physicians would only be allowed to treat 30 patients at a time, Adm. Brett Giroir, MD, assistant secretary for health at HHS, said that the normal X waiver process begins by letting physicians treat 30 patients, and then 100 patients, and then 250. “What we’re doing here is creating an exemption so if you have not gone through that process, we’re giving you that limit of 30 to start with.”

“We’re not at all decreasing what can be done through the traditional process; we’re allowing an exemption,” he continued. “And again, we anticipate that this is going to be primary care providers who may be in rural areas that may treat 5 or 10 people within their practice with this. If they’re going to get into the business of 40 or 50 or 80 or 100, right now we think they should go through the X waiver process with all the controls on that, but this is a first step that we’ll evaluate.”

Carroll added that “We’re encouraging more and more providers to be able to provide this; we think as their practice builds naturally, we would want them to get additional training once they start hitting that 30 folks and over.”

“This is a compromise,” said Volkow. “We’re changing a practice, and by doing it in a conservative way, we can ensure that we’re not producing harm by practices of things that we may not know. Initially the X waiver was also starting with 30, and I assume that that’s because there was experience with that; that made a reasonable, justifiable number.”

The guidance comes as deaths from drug overdoses continue to rise. “Beginning in the October-November timeframe in 2019, after a flattening of our mortality, we started to see mortality go up,” Giroir said. “We saw that overdose mortality was going up before the pandemic, but it has actually gone up significantly more since the pandemic.”

Data released Wednesday for the time period ending in June 2020 show that “our mortality has gone up over 21% from overdoses, with over 83,000 Americans dying during that period of time,” he said. “The increase of synthetic overdose mortality from synthetic opioids like fentanyl is up 44.75%. If this rate continues, we could see losses of between 85,00 and 90,000 Americans in 2020 due to overdoses.”

Filed under: General Problems