The public health emergency declared by the Department of Health and Human Services due to the COVID-19 outbreak is set to end on May 11, 2023.[1] This change will have significant implications for healthcare in the United States—government mandates requiring reporting of COVID test results will be relaxed and certain insurance plans will end coverage for both over-the-counter and laboratory COVID tests, among other changes.[2] One of the most notable changes could affect access to prescription medications via telehealth.
Because of the public health emergency, healthcare providers have been able to prescribe medications classified as controlled substances after only meeting a patient over a videocall appointment. This includes drugs that are considered high risk for abuse, like Adderall and oxycodone. On February 24, the Biden administration moved to reinstate in-person appointment requirements for these kinds of prescriptions after May 11.[3] On March 1, the Drug Enforcement Administration responded with two Notices of Proposed Rulemaking, which would extend telehealth access to some of these drugs indefinitely.[4] The first, titled “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation,” would allow for an initial 30-day supply of non-narcotic schedule III-V controlled substance medications to be prescribed via telemedicine. To have the prescription refilled after this initial supply, patients would generally have to attend an in-person visit.[5] The second, titled “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” would do the same for buprenorphine, which is the only schedule III-V narcotic approved for treatment of opioid use disorder.[6]
Many concerns about the proposed rules center on the risk for abuse that is associated with these medications. Buprenorphine, in particular, has been proven effective for treating opioid use disorder. As an opioid itself, though, it comes with a possibility of physical or psychological dependence if misused.[7] Some of the medications that would be affected by the rules, like Xanax and ketamine, may be prescribed to patients who don’t really need them or who intend to sell them to others. Passage of these rules would increase access to drugs that are frequently sold, misused, or overprescribed.
On the opposite side of this issue, hundreds of people have already left public comments on the DEA’s notices expressing frustration that the rules do not extend far enough. Telehealth has allowed millions of people access to healthcare that they would otherwise not have. This accessibility has tremendously benefitted people living in rural areas far from the nearest doctor’s office and people with disabilities for whom getting to an in-person doctor’s appointment is especially challenging. The rules do not contain exemptions for people with special circumstances, so these people would still be required to attend an in-person appointment for any refills beyond an initial 30-day supply of the medications affected. Furthermore, these rules do not cover many common prescription medications, so telehealth prescriptions would remain unavailable for these after May 11. This includes the majority of ADHD medications—including Adderall, Vyvanse, and Ritalin—because these drugs are categorized as schedule II.[8]
Both Notices of Proposed Rulemaking remain open for public comment until March 31, 2023. After the end of the comment period, the DEA will have a chance to respond to these comments and/or amend their proposed rules.
[1] https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html#:~:text=Based%20on%20current%20COVID%2D19,day%20on%20May%2011%2C%202023.
[2] Id.
[3] https://www.nytimes.com/2023/02/25/science/dea-telemedicine-opioids-prescription.html.
[4] A Notice of Proposed Rulemaking (NPRM) is a publication of a proposed rule along with the proposing agency’s justification for this rule. Once an NPRM is posted, the public has a chance to leave comments about the proposed rule for the agency to consider prior to passage of the official rule; https://www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had; https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter.
[5] https://www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had.
[6] https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter.
[7]https://www.ncbi.nlm.nih.gov/books/NBK459126/#:~:text=Buprenorphine%20is%20FDA%2Dapproved%20for,opioid%20(such%20as%20heroin).