Big barrier to buprenorphine removed

The U.S. government no longer requires an X waiver to treat patients with buprenorphine for opioid use disorder.

Buprenorphine has been notoriously difficult to prescribe to treat patients with opioid use disorder (OUD)—not because of its pharmacokinetic properties, but because of the special training required for prescribers.

As noted in a September 2018 ACP Internist cover story, the U.S. Drug Enforcement Agency (DEA) waiver program to prescribe buprenorphine (a Schedule III narcotic analgesic) comes from the Drug Addiction Treatment Act (DATA) of 2000, and “Perhaps intimidatingly, this waiver is commonly called an ‘X’ number or license.”

New this year Congress eliminated the X waiver to treat patients with buprenorphine so federal regulations now require only a standard DEA registration number to prescribe it Image by luchschenF
New this year, Congress eliminated the X waiver to treat patients with buprenorphine, so federal regulations now require only a standard DEA registration number to prescribe it. Image by luchschenF

In one study, clinicians cited the complexity of the X-waiver process as a barrier to prescribing buprenorphine and frequently offered structural changes to the waiver training or shortening the training time as potential facilitators, according to results published in May 2022 by JAMA Network Open.

The study noted that some have even argued that it's time to “X the X waiver.” At the end of 2022, they got their wish. With the signing of the Consolidated Appropriations Act of 2023, Congress eliminated the DATA waiver program, and an X waiver is no longer required to treat patients with buprenorphine for OUD, the DEA announced to registrants in January.

That means all prescriptions for buprenorphine now require only a standard DEA registration number. And that in turn means more internal medicine physicians will be able to prescribe it, said ACP Member Laura C. Fanucchi, MD, MPH, an associate professor of medicine and director of the inpatient addiction consult service at the University of Kentucky College of Medicine in Lexington.

“You need a DEA registration to prescribe a scheduled drug, and it's fairly typical that internal medicine physicians will have a DEA license,” she said. “The change immediately removed some barriers, for sure.”

ACP is among the organizations that have advocated for removal of the X waiver, according to a Feb. 10 article in the ACP Advocate. “This is a big step in the right direction to reduce barriers to clinicians prescribing buprenorphine with the hope that more patients who would benefit from this medication will be prescribed it,” said Eileen Barrett, MD, MPH, MACP, Chair-elect of ACP's Board of Regents.

The opioid overdose crisis remains a key reason to increase access to buprenorphine, said Jeanette M. Tetrault, MD, FACP, a professor of medicine and public health and fellowship director for addiction medicine at Yale School of Medicine in New Haven, Conn.

In the U.S., 106,699 drug overdose deaths occurred in 2021, most of them involving opioids, and the age-adjusted rate of drug overdose deaths climbed more than 14% from 2020 through 2021, according to CDC data published in December 2022.

“We're in the midst of an overdose crisis. Patients are dying at exponential rates, and we need to get evidence-based treatment to them in whatever way we can,” Dr. Tetrault said. “This breaks down a barrier that has been in place to really allow us to get more evidence-based treatment to people in need.”

The details

Not long ago, getting an X waiver required eight hours of training for physicians and 24 hours of training for nurse practitioners and physician assistants. There were also limits on how many patients each individual clinician could prescribe to, capped at 30, 100, or 275, depending on the clinician.

“There's really no other medication in the armamentarium of any clinician where these levels of extra steps are required, and many other medications have narrow therapeutic windows or potential adverse effects,” said Dr. Tetrault. “We don't have mandates on eight hours of training to prescribe insulin.”

The requirements eased considerably in April 2021, when a new exemption allowed eligible clinicians to treat up to 30 patients with OUD at one time using buprenorphine without having to meet certain training-related requirements. Now, elimination of the X waiver has completely removed the restrictions on the number of patients a prescriber may treat with buprenorphine for OUD.

But many prescribers never met those patient caps in the first place. A study of nearly 56,000 waivered clinicians found that only about half wrote at least one buprenorphine prescription from February 2017 to April 2019. The median monthly patient census was 101.5 for the 275-patient clinicians (36.9% of their patient limit), 23.9 for the 100-patient clinicians (23.9%), and 3.4 for the 30-patient clinicians (11.3%), according to results published as a research letter in August 2020 by JAMA Network Open.

Still, “There certainly are clinicians for whom that [removal of patient caps] will make a difference,” noted Honora Englander, MD, principal investigator and director of the Improving Addiction Care Team and a professor of medicine at Oregon Health and Science University School of Medicine in Portland.

Details on some other implications of the changes are less clear. For instance, removal of the X waiver does not impact existing state laws or regulations that may apply.

With the DATA program, there was variability among states about whether there were additional state regulations in place, said Dr. Fanucchi. “I practice in Kentucky, where there were separate regulations that govern buprenorphine prescribing,” she said.

When the exemption was allowed at the federal level in April 2021, Kentucky did not change its regulations accordingly, Dr. Fanucchi said. “There were a number of states that did that,” she said. “So I think that the issue going forward is how states will handle this change.”

Separate from the X-waiver changes, the Consolidated Appropriations Act introduced new training requirements for all DEA-registered prescribers, which are scheduled to go into effect on June 21, 2023. This is another area where details are slim.

“It sounds like the DEA and SAMSHA are working together and that we will get more information about what the training requirements are,” said Dr. Fanucchi, a trainer for the Substance Abuse and Mental Health Services Administration (SAMHSA)-approved X-waiver training through the Provider Clinical Support System (PCSS).

As of January, it wasn't clear how the new training requirement would affect physicians who already have an active DEA license or whether some might be exempt from the requirement due to previous training. “We do see that happen a lot of times with regulatory changes, that there are previous trainings or qualifications that apply going forward,” Dr. Fanucchi said. “But we don't know what they'll do.”

She said she is also unsure how or whether the trainings currently available through the PCSS and other organizations will change under the new rules. “I hope that the platforms that we're currently able to [use to] train people to treat opioid use disorder and prescribe buprenorphine are able to continue to exist,” she said. “I think that we still need that education and those resources. Right now, we're kind of in a limbo period.”

While some may point to the new training requirements as an added barrier, Dr. Tetrault said clinician education and training around substance use disorders remain essential.

“Education is not a bad thing,” she said. “People are dying, and one medication alone isn't going to fix everything, so we really do need to pair this with education. I think it's incredibly important that our medical students, health professions students, residents, fellows all do have some training in how to screen for and treat substance use and substance use disorder.”

Dr. Fanucchi agreed. “It's absolutely important that all prescribers receive training in substance use disorders and treatment,” she said. “So I think generally, that's good. The eight-hour training was a barrier to buprenorphine prescribing, but now a training will apply to prescribing of all controlled substances.”

Going forward, that may mean training could then be incorporated in residency training programs, Dr. Fanucchi said. “You could imagine that as residents are going through training and don't yet have their DEA license, that can be incorporated in standard training,” she said.

Impacts and next steps

Removing the X waiver will help more patients get lifesaving OUD treatment, particularly in primary care, Dr. Tetrault said.

Prior to the change, a non-X-waivered primary care clinician would have to turn away a patient who was actively using heroin tainted with fentanyl, had a history of overdose, and was interested in trying buprenorphine for OUD.

That clinician would have to say, “I can't help you; go to somebody else,” Dr. Tetrault said. “Those were unnecessary barriers that we were putting up against the patient in the midst of a pressing public health crisis.”

She acknowledged that primary care clinicians are already stretched thin; however, they will be integral to the effort to increase access to buprenorphine. “It's hard to ask a clinician to do extra things unless there is a clear, pressing need for it,” Dr. Tetrault said. “[But] I think primary care will be a main driver of opening up access.”

An unintended consequence of the X waiver was communicating that treatment of OUD was somehow different than other treatments provided in primary care, said Dr. Fanucchi, who provides outpatient primary care and treatment of OUD.

“That is not accurate. It is not harder or more complicated than other complex things that we manage in primary care,” she said. “It can be taught and can be learned, and it certainly can be integrated in primary care.”

The new rules will have an impact not only in primary care, but in EDs and hospitals as well, said Dr. Englander. Her work involves supporting hospital teams to offer buprenorphine and methadone to treat OUD in the hospital.

“With the old rules, hospitalists could offer medication in the hospital but would need an X waiver to prescribe at discharge or to prescribe in the community,” she said. “So the shift toward ‘This is a medication that anybody can prescribe’ is so important, both because it should increase medication access and because it removes the cloak of ‘This is different.’”

Removing the X waiver may also reduce some of the barriers seen in other health care settings, Dr. Fanucchi noted. “Sometimes, for example, nursing homes are reluctant to accept patients on buprenorphine because their physician isn't X waivered, and now that's not an issue in those states” that adhere to the federal change, she said.

The change may also lead to more office-based OUD care for adolescent patients, who often do not receive timely treatment. “There are enormous access gaps in buprenorphine access for teens, an emerging and high-risk population,” Dr. Englander noted.

One study of nearly 5,000 youths with OUD found that only 1 in 21 adolescents younger than age 18 years and 1 in 4 young adults ages 18 to 22 years received medication for OUD within three months of diagnosis, according to results published in November 2018 by JAMA Pediatrics.

Despite all the impacts of removing the X waiver, barriers to buprenorphine prescribing remain, Dr. Englander said. “What we've addressed is a piece of the puzzle that means that everybody is able to [prescribe],” she said. “But actually doing it and having the training and the confidence and willingness to do it is another really important piece that Xing the X waiver does not necessarily change.”

Stigma has stymied medicine from embracing evidence-based OUD treatment for a long time, with virtually no education requirements outside of the X waiver until recently, Dr. Tetrault noted. Since July 2019, the Accreditation Council for Graduate Medical Education requires that all programs provide instruction and experience in pain management, including recognizing the signs of addiction.

“My hope is that these efforts will dovetail with other efforts to make sure that our health care workforce is primed and ready to care for patients in a nonjudgmental, patient-centered way,” Dr. Tetrault said.

Like anything in health care, the stigma around substance use disorder treatment will take time to change, said Dr. Fanucchi. “I think over time, hopefully we'll see less variation across states and opioid use disorder will be one of many chronic conditions that we manage in general medical settings,” she said.

That doesn't mean general internal medicine physicians have to do it all alone. Complicated or severe cases of OUD in the setting of severe comorbid psychiatric illness may well prompt a referral, Dr. Fanucchi noted.

“But similarly, we manage diabetes and hypertension and heart disease in the primary care setting, and in collaboration with our subspecialty colleagues, we provide comprehensive chronic care management,” she said. “So I think, hopefully, that that will be more and more standard going forward.”