In April 2021, the U.S. Department of Health and Human Services (HHS) made a significant regulatory change aimed at increasing access to medication-assisted treatment (MAT) for opioid use disorder. Two key provisions for obtaining an X waiver—a federal certification required for providers to prescribe buprenorphine—were removed. Providers seeking the X waiver no longer needed to complete a training certification, nor were they required to provide counseling or other ancillary services as part of their practice. This regulatory shift came amid an alarming rise in drug overdose deaths during the COVID-19 pandemic, highlighting the urgent need for broader treatment availability. The goal of this policy change was to expand buprenorphine access across the United States, enabling more physicians to provide care for patients struggling with opioid use disorder. Buprenorphine and naltrexone—two cornerstone medications in MAT—are proven to reduce opioid cravings, prevent relapse, and save lives. However, early evidence indicates that increased provider capacity alone was not enough to immediately improve patient access.
Early Increases in Provider Capacity
Since the regulatory updates, there has been measurable growth in the number of healthcare providers able to prescribe MAT. According to HHS data, about 19% more providers received X waivers to prescribe buprenorphine to up to 30 patients in the twelve months ending September 2022, compared to the prior year. This increase represents a significant step toward expanding buprenorphine access, as more prescribers are entering the field and potentially reaching patients who previously had limited treatment options.
Similarly, naltrexone prescriptions—a non-controlled substance used to treat substance use disorder—have risen by 37% since the X waiver changes, demonstrating that regulatory changes can positively impact MAT availability, though the effect on buprenorphine use has been more complex.
Declining Buprenorphine Prescriptions
Despite the increase in waivered providers, the rate of buprenorphine prescriptions filled declined during the latter months of 2021. A study conducted by the Office of the Assistant Secretary for Planning and Evaluation, part of HHS, reported that roughly 3,880 fewer patients—a 63% drop—filled buprenorphine prescriptions each month compared to pre-COVID levels, and about 1,960 fewer patients (47% fewer) compared to the first 15 months of the pandemic.
These trends suggest that while increasing provider capacity is necessary, it does not automatically translate to broader buprenorphine access. Persistent barriers, including stigma, administrative challenges, and lack of provider knowledge, continue to limit the impact of regulatory changes.
Persistent Barriers to Buprenorphine Access
The HHS study identifies several ongoing obstacles to MAT adoption. Stigma surrounding MAT remains a significant barrier for patients and healthcare providers alike. Many practitioners are not fully informed about MAT, may not trust its effectiveness, or face low reimbursement rates that make offering buprenorphine less feasible. Administrative and logistical challenges also hinder buprenorphine access, particularly in smaller clinics and rural healthcare settings.
It’s important to note that removing training and counseling requirements did not eliminate the X waiver entirely—doing so would require Congressional action to amend the Controlled Substances Act. This means that providers must still navigate regulatory hurdles, limiting how quickly buprenorphine access can expand nationwide.
Potential Accelerants for MAT Expansion
The study highlights strategies that could further enhance buprenorphine access. Expanding the types of providers eligible for X waivers, such as nurse practitioners and physician assistants, could dramatically increase the number of treatment points nationwide. Increasing patient limits for waivered providers would allow more patients to receive care from the same prescriber. Telehealth also represents a promising opportunity for MAT expansion, as public health emergency provisions now permit virtual initiation of buprenorphine therapy.
Combined with efforts to reduce stigma, improve provider education, and simplify administrative processes, these measures could help translate increased provider capacity into meaningful improvements in buprenorphine access across the U.S.
Access Gaps Persist
Even with more providers entering the field, geographic and structural gaps remain significant. Around 9% of Americans live more than 10 miles from an X-waivered provider, and one-third of rural counties do not have any providers authorized to prescribe buprenorphine. Although an estimated 1 million physicians could potentially receive an X waiver, fewer than 93,000 currently hold one. These gaps underscore the continued challenges to expanding buprenorphine access nationwide.
Policy Context and Future Outlook
This update from HHS follows the release of its Overdose Prevention Strategy, which aligns with the National Drug Control Strategy and President Joe Biden’s focus on combating the opioid crisis. Legislative efforts are ongoing, and the X waiver itself may face significant changes as provisions could be included in upcoming must-pass bills. Such changes could further expand buprenorphine access and help address the persistent barriers preventing patients from receiving life-saving treatment.
Conclusion
The relaxation of federal MAT regulations marked an important step toward expanding access to effective treatments for opioid use disorder. While more providers are now able to prescribe buprenorphine and naltrexone prescriptions have increased, the full potential of these changes has yet to be realized. Persistent barriers—including stigma, administrative hurdles, provider knowledge gaps, and geographic disparities—continue to limit buprenorphine access for many Americans.
Ongoing policy efforts, provider education, telehealth expansion, and legislative reforms will be critical to ensuring that increased provider capacity translates into real-world improvements in buprenorphine access, giving more patients the opportunity to recover and thrive.
