Opioid use disorder (OUD) is a dangerous disorder, killing over 100,000 people per year in the United States alone. Part of what makes OUD so deadly is that many people lack access to reliable treatment.
Medication-assisted treatment (MAT) is a form of high-quality care that can change the lives of people with OUD. Before being able to prescribe MAT, medical professionals must get their X-waiver certification. And here’s where the problem becomes most apparent: despite being considered the gold standard of care, less than 5% of clinicians have the necessary waiver to prescribe the life-saving medication. The consequence is that almost half of U.S. counties are without a single certified healthcare provider, creating massive treatment deserts. With over 3 million people suffering from an opioid addiction, we at Ophelia do not accept that reality.
It’s important to understand why this shortage exists and what can be done to correct it. The good news is that Ophelia is playing an active role in expanding access to X-waiver certification so medical professionals can help the people who need it the most.
What is an X-waivered clinician?
An X-waivered clinician is a medical professional who has received an X-waiver to be able to prescribe several medications for OUD, including buprenorphine. Buprenorphine is the active ingredient in Suboxone®—a drug used to treat OUD—so you might also hear this document called a buprenorphine waiver or Suboxone waiver.
The X-waiver comes from the Drug Addiction Treatment Act of 2000. This act authorized buprenorphine for outpatient use. Previously, clinicians could only administer buprenorphine to OUD patients in the hospital.
What qualifications do X-waivered clinicians need?
Initially, qualified practitioners had to go through specialized training before applying for the X-waiver:
- Physicians were required to undergo 8 hours of training
- Advanced practice providers (APPs) were required to undergo 24 hours of training
The Department of Health and Human Services (HHS) released new guidelines in 2021 that changed the longtime training requirement as part of the process of obtaining an X-waiver. Physicians and AAPs, including nurse practitioners (NPs) and physician assistants (PAs), can now obtain the X-waiver without completing the training. However, this fast track limits the practitioner’s patient maximum to 30 at any given time. By contrast, practitioners who undergo the training can take on more patients over time. The individual’s career goals and work requirements will determine which process is best for them. Since the full training gives providers opportunities to expand their patient intake, it’s still a widely recommended approach, even though it’s not a requirement.
To qualify for the waiver, medical professionals first have to fill out the Buprenorphine Waiver Notification from the Substance Abuse and Mental Health Services Administration (SAMHSA). The application goes to the Drug Enforcement Agency (DEA), which assigns the medical provider a special designation. This number starts with the prefix “X” and must be included on all the buprenorphine prescriptions that the medical provider issues for OUD treatment.
Verifying the application for the X-waiver can take up to 45 days. Once approved, clinicians are allowed to treat 30 patients with buprenorphine. After one year, the clinicians who completed the training can apply to increase their patient limit to 100.
Shortage of X-waivered clinicians
Many roles in the medical field are experiencing personnel shortages, and X-waivered clinicians are no exception. With so few certified providers relative to the number of OUD patients who could benefit from the treatment these clinicians provide, not enough people have access to treatment. Modifying the guidelines to obtain an X-waiver would make MAT more accessible, but there’s still a long way to go before everyone who needs buprenorphine for OUD can receive it.
During the pandemic, the growth in the number of X-waiver clinicians slowed down. Part of this is because medical practitioners were responding to an emergency, but part of it is because of some structural barriers to receiving an X-waiver:
- The complexity of the X-Waiver application process
- Difficulty getting started
- Inadequate training
- A perceived lack of support and mentorship from experienced clinicians
Even among clinicians who do have the X-waiver, there were still concerns about starting to offer MAT and receiving insurance reimbursement for this treatment. In one survey of X-waivered clinicians, only 36% were currently prescribing buprenorphine, while 64% were not. More clinicians need to be actively prescribing buprenorphine as part of MAT to address the OUD crisis.
In Pennsylvania, for example, only 3% of practitioners are X-waiver certified. The vast majority of medical providers in the state do not have an X-waiver certification and, as a result, cannot prescribe lifesaving Suboxone as part of MAT. More than 5,100 Pennsylvanians died from opioid overdoses in 2021. Who knows how many of those deaths could have been prevented if more practitioners in the state were able to offer buprenorphine and MAT?
Pennsylvania isn’t unusual in this regard: 40% of U.S. counties don’t have a single X-waiver clinician, and fewer than 5% of eligible clinicians across the country have this certification. Without enough Suboxone-certified providers, patients with OUD have limited options for receiving care.
Proposed reforms to address the X-waivered clinician shortage
Addressing the lack of medical providers who can prescribe Suboxone is key to expanding access to MAT. Experts have proposed a variety of reforms to address the X-waivered clinician shortage, one of which is eliminating the waiver entirely. In theory, this would allow more practitioners to prescribe Suboxone to OUD patients who need it. The truth is that changing the requirements to prescribe Suboxone, like the X-waiver, might not be the most effective option.
Non-waivered clinicians cite regulations like the X-waiver as the least common barrier to prescribing buprenorphine. Half of X-waivered clinicians don’t prescribe at all anyway. Both waivered and non-waivered clinicians list stigma, limited access to experienced addiction experts, and inadequate training among the barriers they face to prescribing buprenorphine.
Increasing infrastructure, training, and support around buprenorphine and MAT is potentially a much more effective reform to ensure greater access to the highest-quality care.
How Ophelia is helping expand access to MAT
We’re partnering with UPenn School of Nursing and Yale School of Nursing to get more practitioners certified and into the field to help people. These programs aim to expand the eight-hour MAT training for OUD and X-waiver certifications for clinical students, addressing some of the frequently cited barriers to prescribing buprenorphine.
Our emphasis on the eight-hour program means those who complete the course will be able to expand their patient intake as their careers progress.
We’re helping the schools focus on immersive observational rotations and live training with experienced clinicians. With more programs like these—and more X-waivered clinicians available to provide care—more Americans with OUD will be able to access the care they need.