Last week, the Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. Department of Health and Human Services (HHS) took a significant step to helping to increase access to medications for the treatment of opioid use disorder (MOUD). Specifically, SAMHSA issued a proposed regulation, that, among other policies, proposes to make permanent certain flexibilities that were granted to opioid treatment programs (OTPs) during the COVID-19 pandemic, including the provision of unsupervised doses of methadone and the use of telehealth to initiate buprenorphine. Comments on the proposed reg are due on February 14, 2023—and ACEP plans on responding.
ACEP has long believed that buprenorphine is an extremely valuable tool in the emergency department (ED) to help start patients on the path towards recovery. Initiating MOUD in the ED helps individuals stay in treatment longer, reduces illicit opioid use and infectious disease transmission, and decreases overdose deaths. However, as noted in previous Regs and Eggs blog posts, despite the effectiveness of utilizing buprenorphine for treatment purposes, there are many regulatory barriers to its use. I often discussed policies such as the X-waiver and the “three-day rule” which have presented the largest barriers—but another impediment has been the inability to provide MOUD via telehealth (note that the X-waiver will be repealed by the end of the week when Congress passes the big omnibus bill, the Consolidated Appropriations Act of 2023!—more on that next week!!).
From a regulatory perspective, SAMHSA and the Drug Enforcement Administration (DEA) have the ability to make changes to MOUD requirements. Soon after the COVID-19 pandemic began in 2020, SAMHSA issued a waiver allowing physicians and other practitioners within OTPs to have more flexibility to treat patients via telehealth. In the reg that was just released, SAMHSA states that the use of telehealth has improved access to necessary and life-saving treatment—and therefore believes that the waiver should be made permanent.
This is great, but unfortunately, SAMHSA does not have the power to regulate physicians and other practitioners outside of OTPs—that responsibility falls on the DEA. This distinction is critically important for two major reasons: 1) you as emergency physicians mainly practice outside of OTPs in EDs; and 2) the DEA is notoriously slow at making changes to regulatory requirements (even when mandated by Congress!)
To the DEA’s credit, it did issued waivers at the start of the pandemic to allow DEA-registered practitioners (i.e., those with X-waivers) to prescribe controlled substances without having to interact in-person with their patients. Under the DEA’s policy (which became effective on March 31, 2020), authorized practitioners can prescribe buprenorphine over the telephone to new or existing patients with OUD without having to first conduct an examination of the patient in person or via telehealth. However, these waivers are set to expire at the end of the COVID-19 public health emergency (expected mostly like next April) and, unlike SAMHSA, the DEA has yet to release regulations to make the waivers permanent.
The DEA does “plan” to issue two regs regarding the use of telehealth to prescribe controlled substances. One reg relates to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The Act required an in-person medical evaluation as a prerequisite to prescribing or dispensing controlled substances, except in the case of practitioners engaged in the practice of telemedicine. The Act’s definition of the ‘‘practice of telemedicine’’ includes a practitioner who has obtained a special registration from the DEA. However, the DEA must issue regulations to effectuate this special registration provision—and this proposed reg would do so. The other reg would clarify the ability of clinicians with X-waivers to prescribe buprenorphine to patients with OUD via an audio-only encounter (i.e., by telephone).
However, both regs are still being cleared by the Office of Management and Budget (OMB) and have been there for a while. And both are just proposed regs that would need to be finalized at some later point in time. In all, if the PHE is expected to end next April, there is really no way that regulations could be finalized by then!
There is some hope though. I recently was in a meeting with the Director of the Office of National Drug Control Policy (ONDCP) at the White House, Dr. Rahul Gupta, where he mentioned that extending the telehealth waivers for MOUD was a top Administration priority and that he hoped that the DEA regs would be released soon!
All in all, there is some extremely positive momentum towards reducing all the barriers associated with MOUD, but more work needs to be done (including from the DEA) to truly expand access to this crucial treatment!
Before concluding, I wanted to note that you may have seen or heard that Congress released the long-awaited omnibus appropriations package and is expected to pass the bill by the end of the day or tomorrow, wrapping up business for the 117th Congress. Our legislative team is in the process of reviewing the bill and we'll have a special year-end legislative update ready for you next week.
Until then, this is Jeffrey saying, enjoy reading regs with your eggs!