The federal government now allows any appropriately registered prescribers to use buprenorphine to treat patients with opioid use disorder (OUD) after years of loosening restrictions on the drug.
Several behavioral health insiders see the move as having clear benefits for the industry. However, the benefit of deregulating buprenorphine may underwhelm in the short-term and even open lanes for subpar care.
But the long-term impact of the move could help address a fundamental challenge in addiction treatment: encouraging prescribers to treat patients in addiction or to consider the field of addiction treatment as a career.
Before the recent change, the Drug Enforcement Administration required prescribers to obtain a special certification, the so-called X-waiver, and abide by several restrictions to be able to prescribe buprenorphine, a common drug used in medication-assisted treatment (MAT) for OUD.
“This is not some practical and tactical thing that, like magic, is going to increase the number of people in treatment by 400%,” Steve Priest, CEO and founder of Spero Health, told Behavioral Health Business. “I think it provides the opportunity for a physician or nurse practitioner to have a real practice [in addiction medicine] and to not be restrained.
“To put it bluntly, getting rid of the X-waiver helps reduce stigma in the medical community.”
Spero Health, headquartered in Brentwood, Tennessee, operates 99 integrated outpatient health care locations in Indiana, Kentucky, Ohio, Tennessee, Virginia and West Virginia. It’s backed by the Heritage Group, Health Velocity Capital, South Central Inc.
While not likely to cause an overnight transformation, the final elimination of the X-waiver is a reality that behavioral health organizations will have to grapple with as it suddenly eliminates a long-time barrier to the use of buprenorphine in addiction treatment.
What happened to the X-waiver
The Consolidated Appropriations Act of 2023, the most recent congressional omnibus funding bill, eliminated the X-waiver.
On Jan. 12, the DEA informed providers registered to prescribe controlled substances that the need for X-waiver ended with signing the omnibus bill in a letter. The letter also told registrants that new training requirements related to treating OUD would go into effect on June 21.
Initially conceived in 2000, the X-waiver acted as an administrative hurdle for providers. It also restricted the number of patients a provider could prescribe to at one time. Providers within their first year of obtaining the waiver could only have 30 patients and could only have 100 patients following a second approval process.
In 2016, the Substance Abuse and Mental Health Administration (SAMHSA) finalized a rule that increased the prescribing count to 275 patients.
During this time, overdose deaths generally rocketed in number. Opioid-specific overdose deaths increased over eightfold from 2001 to 2021 and totaled over 80,000 in 2021, according to the Centers for Disease Control and Prevention.
The pandemic worsened matters: Estimated opioid overdose deaths in the trailing 12 months ended in March 2020 totaled 53,900. That increased by 54% by March 2022 with an estimated 83,300 opioid-related overdose deaths, according to other CDC data.
Calls to increase and ease access to care grew and efforts to loosen prescribing restrictions spanned multiple administrations.
Like other parts of health care, added flexibilities tied to the federal public health emergency (PHE) revealed promising new ways of offering care. This happened with buprenorphine prescribing as well.
“We’d gotten some level of experience and comfort and feel that it’s time to eliminate some rules or barriers to get more [providers] to be able to prescribe,” Dr. Nasser Khan, operations group president of comprehensive treatment centers for Acadia Healthcare Co. Inc. (Nasdaq: ACHC), told BHB. “Even though I think it was time and it was necessary to eliminate the waiver, I don’t expect you’re going to see a dramatic increase in the number of people that are in practice, at scale, prescribing buprenorphine.”
What more prescribers mean for addiction care
In effect, the elimination throws the doors wide open to buprenorphine access. But the reality is much more complicated.
In 2022, about 1.73 million providers were registered with the DEA to prescribe controlled substances. About 6%, or 101,500, held X-waiver, according to one study.
Even though roughly 17 times more providers may now prescribe buprenorphine, other data imply wide hesitancy to use or maximize the use of X-waiver.
About half of the waivered physicians actively prescribed buprenorphine. The median monthly census for those active prescribers was about eight from April 2017 to January 2019, according to one data review. The review also found that only about half of waivered providers with the highest capacity allowed (275 patients) had concurrent patient counts over 100.
“For 20-something years, the government has been twisting the arms of primary care doctors and other docs to try to get them to treat the population,” Jason Kletter, president of BayMark Health Services, told BHB. “They just don’t want to — they don’t want to work with that population for whatever reason.”
Some of those reasons include stigma — not wanting to have “those patients” in waiting rooms — hesitancy to treat a complicated disease such as substance use disorder (SUD), and/or worries about the intensive support needed to ensure recovery.
“Getting rid of the rule won’t change doctors’ minds about treating these patients,” Kletter added.
Kletter also remains skeptical of the impact of the removal of the X-waiver on the addiction treatment field. He worries eliminating the X-waiver will “dilute” the expectation that therapy and other supports will accompany buprenorphine prescriptions. The pairing of buprenorphine and the psychosocial interventions that make up MAT represents the gold standard for OUD treatment.
He also worries that removing caps will darkly lessen the need for prescribing practitioners within an addiction treatment organization, leading to too-large of addiction treatment panels without other strong behavioral health supports.
“If you had a practice of 300 or 400, you would need three or four docs,” Kletter said, referring to the time before the elimination of the X-waiver. “Now, you can go recruit a retired neurologist and that person can have 1,000 patients on day one.”
Still, he remains optimistic that fewer administrative hurdles will, over time, lead to more “well-trained, competent people who are willing to engage and we think that’s a win for patients and for providers” in addiction treatment.
Addressing workforce challenges around addiction treatment prescribers requires changes to the fundamental systems that produce health care providers.
Khan said physicians “as an industry and as a professional society” need to push for OUD patient management in medical schools and residencies so that OUD management starts to fall within the scope of primary care.
“That takes a number of years starting with students and trainees, seeing that flow through,” Khan said. “So I do believe that there will be, in the long term, a benefit. I just think it’s going to take time.”
The real power of the move
Several sources state the immediate impact of the X-waiver will be minimal but that it’s a necessary step to deal with an overwhelming need for care and demand for services.
Some sources also take a better-late-than-never view of eliminating the X-waiver, viewing it and other opioid overdose measures as slow in coming.
However, the move is a powerful symbolic move by the government to show that it, as the ultimate regulatory body over buprenorphine, no longer attaches skepticism and stigma to using MAT in primary care settings. That signal may prompt additional changes in the future.
“Had these changes happened 10 years ago, maybe it would have made a huge impact, but we’re behind the eight ball already,” Dr. Charles Peterson, addiction medicine specialist at Vituity Family Medicine Center, told BHB. “A lot of [patients] don’t know that they can have access to this.”
Peterson is hopeful that more access to buprenorphine will encourage patients to seek addiction treatment in the same places they would otherwise seek care including urgent care offices and emergency rooms.
Jovive Health, the primary care and urgent care arm of Emeryville, California-based Vituity, a large multispecialty practice, launched MAT services for OUD at six of its clinics in February. It plans to roll out more throughout the year.
The addition of MAT was contemplated before the elimination of the X-waiver, Petersons said.
The move to remove the X-waiver may set OUD on a similar track as other chronic diseases. Peterson hopes that eliminating the X-waiver and other regulatory changes will lead to a cultural change in medical education.
“Diabetes used to be treated only by an endocrinologist and now a family medicine doctor, a nurse practitioner treats it. Hypertension, and abnormal heartbeats used to be treated only by the cardiologist and can be managed by anyone initially if they’re not complicated,” Peterson said. “I don’t think this is going to be any different.”