Opinion | Will the Demise of the X Waiver Save Lives?

The email came as a surprise.

The Drug Enforcement Agency (DEA) message read: “Going forward, all prescriptions for buprenorphine only require a standard DEA registration number” and that “there are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.” The DEA further indicated that mandated training requirements for all clinicians holding DEA licenses will begin June 21, 2023.

I had waited years for this news. My colleagues and I had advocated for these reforms, but I was not optimistic that Congress would change the law. Yet, it passed and will undoubtedly save lives by expanding access to buprenorphine (Suboxone) to treat opioid use disorder (OUD). The number of lives saved will depend on how many clinicians start prescribing.

Despite intensive efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to expand access to buprenorphine to treat OUD, the number of prescribers never came close to matching the treatment need. In 2022, more than 100,000 people died of drug overdoses, with more than two-thirds of these deaths involving opioids, primarily fentanyl. Even among recent family medicine graduates, only 7% reported prescribing buprenorphine for OUD. The expansion of waivers to nurse practitioners and physician assistants helped but has not been sufficient. Only 13% of people with OUD receive evidence-based OUD treatment, much less a prescription of buprenorphine.

My career paralleled the evolution of OUD treatment. When I completed my family medicine fellowship in 1995, a new opioid treatment program (OTP) was recruiting for a medical director. I was intrigued but apprehensive. I had limited experience with people living with OUD and my head was full of misconceptions and stereotypes. I sought mentorship from an experienced physician, Jack, the medical director of another OTP. He introduced me to staff and patients, shared his protocols, and allowed me to observe one-one and group counseling. He beamed when sharing his fulfillment from caring for people living with OUD.

I was ready to start. Quickly my own fears, biases, and misconceptions were dispelled. I couldn’t distinguish people living with OUD from my own patients. There was no profile. I saw all ages, genders, races, socioeconomic backgrounds, and personalities. Many patients felt stigmatized entering an OTP and expressed reluctance about starting methadone. These views changed as people learned that OUD is a chronic condition affecting the brain, characterized by craving and compulsion for opioids. Like other chronic conditions, it is optimally treated with compassion, medication, education, and support for patient self-management.

What struck me was how dramatically treatment transformed the lives of many people living with OUD. People who were desperate and barely surviving began to manage their condition, take responsibility for their recovery, reconnect with families, and rebuild their lives.

I became a physician to help people optimize their health. I found treating OUD both inspiring and personally meaningful.

Until 2000, there were only two FDA-approved medications to treat people with OUD, methadone and LAAM (a similar, longer-acting opioid agonist). In 2002 buprenorphine was approved by the FDA. Buprenorphine is a partial opioid agonist with a higher safety profile than methadone and other full agonist opioids. At the same time, Congress passed the Drug Addiction Treatment Act of 2000 (DATA 2000), permitting trained physicians to be waivered to prescribe buprenorphine.

I became waivered and began prescribing buprenorphine in the family medicine practice where I also worked. I was surprised at how well patients responded. Patients appreciated receiving their treatment in a family medicine practice without the stigma of standing in dosing lines in an OTP. I fully expected that most primary care physicians would soon become waivered and begin treating OUD as another chronic condition.

I was wrong. Even many of my practice colleagues did not obtain waivers despite how smoothly the buprenorphine program functioned. Numerous studies have documented barriers cited by clinicians to prescribing buprenorphine for OUD. These include stigma and logistical issues such as lack of time, knowledge gaps, and fear of being inundated with patients.

Current reforms will address many of these barriers. An X on prescribers’ licenses will no longer stigmatize prescribers writing prescriptions or patients obtaining prescriptions. All clinicians holding DEA licenses will be able to prescribe buprenorphine. Clinicians will no longer be able to tell patients: “I am very sorry, but I am not licensed to prescribe that medication.” The requirement for 8 hours of training in identifying and treating substance use disorders will ensure minimum education in managing OUD and it will likely be supplemented by training provided in medical school and residency. Increasing the number of potential prescribers by tenfold or more and eliminating limits on the number of patients per clinician will reduce the risk of most prescribers being “inundated.” Clinicians will no longer have to search for other waivered clinicians to cross-cover them during weekends and vacations.

Will this new law be enough to encourage most clinicians to prescribe buprenorphine for OUD? I’m not sure. There is conflicting evidence. While clinicians endorse the need for treatment of OUD, including the prescription of buprenorphine, as recently as 2019 only 38% indicated support for eliminating buprenorphine waivers. Yet, relaxation of waiver requirements under practice guidelines was associated with a 116% improvement in waivered prescribers. Further, the new law ensures universal training while allowing clinicians to pilot prescribing with a few patients. These facts make me optimistic.

Healthcare systems can help by operationalizing peer mentoring, clinician support, and sponsor ECHO training. SAMHSA should expand its Provider Clinical Support System (PCSS). Governments can help by expanding Medicaid coverage and/or ensuring insurance treatment coverage, banning prior-authorization requirements, enhancing professional fees, paying for peer support and addiction counselors in primary care, and ensuring adequate access to OUD specialists and higher levels of care. States and courts should ensure access to treatment in nursing homes and correctional facilities.

Effective treatment of OUD requires mainstreaming treatment. Clinicians can help by venturing out of their comfort zones, committing to learning about OUD management, seeking mentors, and beginning to treat people living with OUD. Doing so will save lives and potentially transform the lives of countless patients and clinicians.

Kevin Fiscella, MD, MPH, is a family physician, HIV physician, and addiction medicine physician in Rochester, New York, and co-director of the Research Division in the Department of Family Medicine at the University of Rochester Medical Center.