Biden Is Opposing a Promising Step Toward Buprenorphine Deregulation

    In the final week of former President Trump’s term, the US Department of Health and Human services (HHS) announced a practice guideline that would exempt physicians from the “X-waiver” requirement for prescribing buprenorphine to treat opioid use disorder (OUD). While imperfect—it applied only to physicians and had a treatment cap of 30 patients—this would have been a step in the right direction. Around 2 million Americans need treatment for OUD, yet few actually receive it. Increasing the number of eligible buprenorphine prescribers would be welcome progress.

    Yet, on January 25, it was revealed that President Biden’s administration is planning to obstruct this move toward expanded access. This is a mistake. As the opioid-involved overdose crisis worsens and is exacerbated by the COVID-19 pandemic, we must expand, rather than limit, access to this effective, life-saving treatment.

    Ultimately, Congress needs to eliminate the X-waiver. All US clinicians should be eligible to prescribe buprenorphine and be equipped with the knowledge and skills to treat OUD. Buprenorphine deregulation, coupled with better education, training and technical assistance in addiction treatment, will help close the treatment gap and save lives.


    Barriers to Access and Increasing Demand

    Despite research showing that buprenorphine saves lives and is generally safe to take, it remains underutilized, and many health disparities and racial inequities plague access. Under 7 percent of all US physicians have an X-waiver; most of these are psychiatrists rather than primary care providers, and most practice in urban settings rather than rural ones.

    One study showed that only half of waivered clinicians in the US actually prescribed buprenorphine, and most prescribe well under their patient limit. Additionally, most buprenorphine treatment is provided to patients with private insurance or who use self-pay. And Black patients are less likely than white patients to receive buprenorphine treatment, despite similar OUD prevalence in OUD

    In New York City where I practice, buprenorphine prescribing is increasing—but not at a fast enough rate to keep up with the needs of our population. Recent national and New York City data show that overdose deaths continue to rise, driven by synthetic opioids before and during the COVID-19 pandemic. And as the pandemic continues to exacerbate social isolation and disrupt treatment services, there are concerns that buprenorphine access may have decreased. 

    Our hospital-based clinic has close to 40 attending physicians and nurse practitioners (NPs), and more than 130 internal medicine residents who provide care to 16,000 patients annually. Most of these patients are insured by Medicaid or Medicare. Fewer than 25 percent of our physicians and NPs have an X-waiver, and only 10 percent prescribe buprenorphine to more than one patient at a time. Residents can only prescribe if their supervising attending physician is waivered.

    I regularly hear about patients who requested buprenorphine treatment, but whose provider did not have a waiver. Instead of receiving a same-day prescription, they received a referral to treatment, creating a delay that could increase their risk of overdose-related mortality and reduce treatment retention.

    If clinicians do not need a waiver to prescribe oxycodone, requiring one to prescribe OUD treatment is not good public health.

    Removing the X-waiver could help to address many of these barriers. It provides an opportunity to engage more frontline clinicians, such as primary care providers, in the care of patients with OUD—including those who practice in rural and low-income communities. Those with OUD seeking treatment would likely have an easier time finding a prescriber, as every physician with a Drug Enforcement Administration registration would be eligible. This would also increase the likelihood of patients finding a physician that takes insurance, including Medicaid.

    Increased buprenorphine prescribing in these underserved communities may additionally allow us to meaningfully tackle racial inequities in buprenorphine access and increase the number of Black Americans receiving treatment. Finally, waiver removal could help reduce the stigma associated with buprenorphine for OUD treatment by normalizing it as something any US clinician can prescribe (like insulin for diabetes).

    There who argue against removing the X-waiver point to concerns around diversion or the risks of overprescribing another opioid. However, studies show that people largely use non-prescribed buprenorphine to self-treat OUD rather than to “get high.” And while buprenorphine is an opioid, it has a better safety profile than other opioid pain medications such as oxycodone. If clinicians do not need a waiver to prescribe oxycodone, requiring them to undergo special training to prescribe OUD treatment is not good public health.


    A Bigger Vision for Deregulation

    Although the HHS guideline would help expand access, it stops short of broader deregulation that would remove the X-waiver not only for physicians, but also physician assistants, NPs and other advanced practice nurses, in addition to removing a patient limit.

    Such deregulation can be achieved with legislative change. The bipartisan Mainstreaming Addiction Treatment Act of 2019, currently pending in Congress, would eliminate the X-waiver entirely and begin a national education campaign to encourage clinicians to integrate substance use into clinical practice and develop relevant training modules to build capacity.

    When France deregulated buprenorphine in 1995, allowing all physicians to prescribe it without additional training or licensing, opioid overdoses declined by 79 percent within three years. Their experience suggests that buprenorphine deregulation in the US can have a substantial impact on reducing overdose deaths.

    In addition to removing the waiver, we also need to train our current and future clinicians on how to identify and treat addiction. Medical, nursing and pharmacy schools need to integrate this education into their existing curricula for all trainees. Education about buprenorphine prescribing, but also drug-user health and harm reduction, needs to be packaged into practical toolkits to engage new or reluctant prescribers and pharmacists. Trainings to address stigma, racism and discrimination must be reinforced. We also need to fund more innovative models of care to increase the capacity of existing prescribers to treat more patients and increase access in underserved communities. 

    Treatment for OUD with buprenorphine can and should be provided by all US clinicians, with specialty referrals when needed, just like diabetes, hypertension and any other chronic condition. The HHS guideline, however limited in scope, is progress toward buprenorphine expansion. And at a time when the collision of the overdose epidemic with the COVID-19 pandemic continues to devastate US communities, more people receiving buprenorphine means fewer people dying. The Biden administration must not stand in the way of that progress, and Congress must endeavor to pass legislation that eliminates the X-waiver.



    Photograph via Pixabay

    • Linda is assistant professor in the Division of General Internal Medicine at the Icahn School of Medicine at Mount Sinai. She is a general internist and provides primary care to people who use drugs at the REACH Program, where she also directs the buprenorphine treatment program. She is an active clinician educator who is interested in expanding access to substance use disorder treatment, stigma-free care for people who use drugs and training current and future clinicians in drug-user health.

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