Nixing the X Waiver Hasn't Yet Vastly Expanded Buprenorphine Access

While the elimination of the X waiver increased the number of clinicians prescribing buprenorphine, it hasn't yet had a substantial impact on the number of patients taking the drug, according to an analysis of prescription data.

By December 2023, there were about 11,000 more clinicians prescribing buprenorphine than there were a year earlier, when the X waiver was in effect (it was eliminated in January 2023), Kao-Ping Chua, MD, PhD, of the University of Michigan Medical School, and colleagues reported in a research letter in the New England Journal of Medicine.

However, the monthly number of patients treated with buprenorphine "changed little," hovering around 800,000 patients over 2 years, and the number of patients who initiated buprenorphine rose only modestly, with a jump of about 5,245 new patients in January 2023 but no major increases through the year, they reported.

"There was a very small immediate increase, but that's not a big deal in the grand scheme of everything," Chua told MedPage Today. "What this suggests is that the policy did succeed in reducing barriers to buprenorphine prescribing as evidenced by the increased number of prescribers, but it was insufficient to increase the number of patients with buprenorphine prescriptions at least through the first 12 months of policy implementation."

Chua said that's not a surprise to experts in addiction medicine. As training requirements for the X waiver were eased beginning in 2021, subsequent data suggested that while more clinicians obtained a waiver, there was no paired increase in buprenorphine prescribing.

"The waiver requirement was a burden and a barrier, but it's not the only one," Chua said. "There are so many other factors -- patient-level factors, prescriber-level factors, insurance-related factors, systems factors, pharmacy factors -- so many other barriers that need to be addressed if we're ever really going to make a bump."

Smita Das, MD, PhD, MPH, chair of the Council on Addiction Psychiatry at the American Psychiatric Association, agreed that the problem of access is multi-factorial, ranging from "lack of information, to concerns about stigma, to there not being adequate structural improvements to encourage seeking care."

"When it comes to lack of information, I've had numerous patients who have started on buprenorphine after years of suffering from opioid use disorder, and who were not aware that a life-saving treatment was available," Das told MedPage Today in an email. "So often I hear patients say, 'I feel normal or myself again,' and are in disbelief" that such a treatment existed.

As for stigma, there's "still misinformation, such as the false idea that people should be able to deal with these conditions on their own or not take a medication," she said. And structural barriers can "range from having adequate coverage for treatment for opioid use disorder, experiencing true parity when it comes to coverage, being able to take time from work or family to start medication, and having a prescriber close by," she added.

Lewis Nelson, MD, chair of emergency medicine and an addiction medicine specialist at Rutgers New Jersey Medical School in Newark, agreed that the findings aren't surprising.

"The required 8-hour waiver training made buprenorphine seem dangerous and difficult to use, and reinforced stigma about the disease of opioid addiction," Nelson told MedPage Today in an email. "The waiver was used as an excuse to not prescribe buprenorphine and misinterpreted by those who wanted to eliminate the waiver as a hurdle to prescribing. The reality is that fear, bias, and misunderstanding are preventing physicians from prescribing this life-altering treatment, not the waiver."

Melissa Weimer, DO, an addiction medicine physician at Yale School of Medicine in New Haven, Connecticut, and a spokesperson for the American Society of Addiction Medicine, told MedPage Today in an email that the study's shorter timeframe "likely misses the larger upward trend that was already occurring before the elimination of the X waiver."

Given that the push to improve access to buprenorphine began before the X waiver was eliminated, a longer timeframe may detect a larger increase, she noted. Nonetheless, she said, "we know we need an all-hands-on-deck approach to increase [opioid use disorder] treatment access, so any upward trend is encouraging but not sufficient to dramatically increase access to care."

The X waiver had long been considered a bureaucratic hurdle to improving treatment for opioid use disorder (OUD). Obtaining one required 8 hours of training on prescribing medication-assisted treatment to patients with OUD. The Biden administration scrapped the training requirements in April 2021, and prescribers only had to register for a waiver. But in January 2023, the X waiver was eliminated in its entirety.

In its place came a new policy tied to obtaining or renewing a Drug Enforcement Administration license: prescribers would have to complete a one-time, 8-hour training on managing substance use disorders in general in order to do so. Exemptions were made for those who are board-certified in addiction medicine or addiction psychiatry, or who have some other comprehensive training on treating substance use disorders.

To examine trends in prescribing after the X waiver was lifted, Chua and colleagues analyzed data from the IQVIA Longitudinal Prescription Database, which captures 92% of prescriptions dispensed in U.S. retail pharmacies. They used an interrupted-time-series design to assess whether the number of prescribers, the number of patients, and the number of new patients starting buprenorphine changed after the policy was implemented, compared with expected trends.

They cautioned that one limitation of the database was its lack of information on whether buprenorphine was prescribed for OUD or another indication such as pain.

The number of buprenorphine prescribers rose in 2022, from 38,684 in January to 42,158 in December, and January 2023 saw a "level increase" of 1,938 prescribers, along with a "slope increase" of 595 prescribers per month through the year. By December 2023, there were 53,635 buprenorphine prescribers, they found.

On the other hand, the number of patients taking buprenorphine rose only slightly in 2022, from 810,911 in January to 831,656 in December, and there was no level increase in January 2023 or slope change that year, they found.

Treatment initiations declined in 2022, from 51,692 new patients in January to 46,565 in December, they reported. While there was a level increase of 5,245 new patients in January 2023, there was no substantial slope change, with just 34 new patients per month through the year, ending at 48,247 patients initiating treatment in December 2023.

"We're on the first year of policy maturation and sometimes it takes longer for policies to kick in," Chua said. "Maybe prescribers only have a few patients, and they haven't had time to build their patient panel. It's possible as time goes on, the patient panel will increase and we will eventually see an uptick. As of now, though, the data suggest a lot more needs to be done."

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