The “saga” of the buprenorphine practice guidelines came to pleasant conclusion earlier this week. As you may recall, the Trump Administration released draft practice guidelines on January 14. Despite our strong support for them, the Biden Administration issued a statement at the end of January announcing that the guidelines were released prematurely and could not be finalized at that time. However, the Biden Administration did express its commitment to increasing access to buprenorphine for the treatment of opioid use disorder (OUD). To its credit, the administration has now made good on that commitment, as the Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. Department of Health and Human Services (HHS) just finalized a form of the practice guidelines! The practice guidelines became effective on Wednesday, April 28 when they were officially published in the Federal Register.
In order to prescribe buprenorphine, health care practitioners who are licensed under state law and who are registered with the Drug Enforcement Administration (DEA) must apply for an “X waiver” through SAMHSA. To receive the X-waiver, practitioners have to certify that they have satisfied certain requirements related to training (including an 8-hour training course for physicians), counseling, and other ancillary services. In other words, there are prerequisite steps that must be taken, which overall are burdensome and time-consuming.
ACEP has been advocating for years to fully repeal the X-waiver requirement, as we believe that it represents a barrier to treatment and contributes to stigma around OUD. However, we have always understood that eliminating the requirement in its entirety would require Congressional action. As with the draft practice guidelines, the final ones represent a positive first step—and ACEP has put out a press release expressing our support for them. Specifically, the new guidelines create an exemption that allows practitioners, when applying for an X-waiver, to forgo the mandatory certification requirements that represented such a significant barrier. Which means… no more mandated 8-hour training course!
However, there is a catch. The exemption comes with a 30-patient limit, and if practitioners want to treat more than 30 patients “at one time,” they still must complete the training and meet all the other requirements that are in place around counseling and other ancillary services. For primary care providers, the application of the 30-day patient limit is pretty clear. It means that they cannot prescribe buprenorphine to more than 30 patients in their practice without having to undergo training. However, it’s unclear how or if the 30-patient limit would even apply to you as emergency physicians. Working in the emergency department, you rarely, if ever, are treating more than 30 patients at one time. Thus, ACEP believes that once you refer a patient for treatment or stop managing a patient’s buprenorphine prescription, the patient is no longer under your care and would not count towards the 30-patient limit. We are seeking confirmation from HHS lawyers on this interpretation, but if HHS does agree with us, then the 30-patient limit would not actually be a barrier for you and you could qualify for the exemption without any viable restrictions. I will keep you updated as we wait for HHS to get back to us with that legal opinion.
Again, it is important to re-emphasize that the practice guidelines do NOT eliminate the X-waiver. You still have to notify SAMHSA of your intent to prescribe buprenorphine and wait for their approval before being able to do so (which SAMHSA says can take up to 45 days, but the agency is trying to do it quicker). Thus, even eliminating the training requirements doesn’t get rid of all the administrative burden of the X-waiver. It also doesn’t eliminate the stigma and misconceptions that are created by having to receive a separate waiver before being allowed to prescribe a medication. ACEP continues to support legislation—specifically the Mainstreaming Addiction Treatment (MAT) Act —that fully repeals the X-waiver! Our work to “X the X-waiver” continues—but we definitely appreciate the Biden Administration’s intermediary step!
Before concluding, I want to remind you all that there is also still a “Three-day Rule” exception to the X-waiver requirement— which is unaffected by the practice guidelines. As outlined in a previous Regs & Eggs blog, the Three-day Rule exception currently allows you to administer (but not prescribe) buprenorphine to patients in the ED over a three-day period without an X-waiver. Critical changes to the Three-day Rule are going into effect later this year. Once finalized (hopefully in June), these revisions to the Three-day Rule will allow health care practitioners to dispense a three-day supply of buprenorphine to one person at one time (instead of only allowing physicians to administer one-days’ worth of medication to a person at one time over a three-day period). More to come on that important policy change!
Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.