The confusing policy surrounding the buprenorphine X-waiver

In the waning days of the Trump administration, a surprising announcement came down from the Department of Health and Human Services (HHS) that the barrier required to write buprenorphine prescriptions for opioid use disorder would be lifted via reform of the so-called “X-waiver.”

The X-waiver is a rare regulation in American medicine that requires an 8-hour training and documented DEA permission before a medical doctor can prescribe Suboxone to treat opioid use disorder. The Drug Addiction Treatment Act of 2000 (DATA 2000) that implemented the X-waiver also restricts physicians to prescribing Suboxone to thirty, one hundred, or two hundred seventy-five patients depending on their experience level. Nurse practitioners and physician assistants must undergo 24 hours of continuing education to obtain a maximum prescribing limit of 100 patients. These restrictions are oddly out of tune with the regulation of actual opioids, which any practitioner with a DEA license can prescribe without specific limits despite the clear danger opioids pose to individual and public health. While DATA 2000 intended to expand opioid treatment options, two decades later, its limitations are more of a hindrance than a help in mitigating the opioid epidemic.

But the proposed reforms raised alarms among proponents of expanded access to treatment. The HHS press release stated, “Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time.” Taken at face value, this edict could actually reduce current buprenorphine slots and call the viability of focused, high-volume addiction medicine practices into question, as it would take roughly five new prescribers at a maximum volume of 30 patients each to match the volume of one DATA-waived prescriber at the 275 limit, in effect removing 245 slots from current high-volume providers.  A deeper dive into the HHS announcement reveals only half-hearted reassurance that “Prescribers…may continue to seek a DATA waiver per current protocols.”

Aside from this confusing language, the announced policy removed the training component of the X-waiver without addressing its most burdensome aspect: The close patient tracking required to ensure that patient volume remains under the prescriber limit. Neither did the proposed reform mention any change to the DEA practice of visiting X-waived providers at random to review their charts – a process that I have found surprisingly helpful but can be anxiety-provoking at the least. The HHS edict also changed nothing about the stricter limits on nurse practitioners and physician assistants, who are rapidly becoming the addiction medicine workforce’s backbone.

In the end, the incoming Biden administration placed the new regulations on hold pending review; it is unclear if Biden’s intent is to restrict or liberalize those reforms beyond what HHS suggested under Trump.

While addiction medicine proponents largely support liberalizing buprenorphine prescribing regulations, this chaotic process underlines the danger of hastily-written health care policies that fail to take into account the current conditions on the ground. Care and thought will be required to restructure – or put to rest – the X-waiver in a manner that reduces barriers to opioid treatment and increases access to this life-saving treatment.

Julie Craig is an addiction medicine specialist.

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