When the COVID-19 federal Public Health Emergency (PHE) ended on May 11th, the Drug Enforcement Administration (DEA) planned to roll-back PHE flexibility related to pre-pandemic restrictions on several prescribing practices. The roll-back was intended to include waivers allowing prescription of controlled substances via telemedicine, which was discussed in the March 2023 edition of Health Policy News. Controlled medications include drugs used to treat opioid use disorders (OUDs) as well as some drugs utilized for gender affirming hormone therapy (GAHT), such as testosterone.
After the releasing the proposed rule changes in March 2023, the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) received a record 38,000 public comments. As a result, both agencies issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” The temporary rule, issued pursuant to 21 U.S.C. §802(54)(G), took effect on May 11, 2023, and extends the full set of telemedicine flexibilities adopted during the COVID-19 PHE through November 11, 2023. Additionally, for any individual who is already established as a telemedicine patient with a practitioner that can prescribe controlled substances before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications established during the COVID-19 PHE will be extended for one-year, through November 11, 2024.
The temporary rule does not indicate whether anything other than a full roll-back will occur when it expires. Thus, the question remains on what will happen once the temporary extension expires in November, and the potential future impacts on gender-affirming care for those individuals who would have been receiving care since early pandemic days.
Permanent Changes in Telehealth & Gender Affirming Care
At the end of the COVID-19 PHE, additional telehealth flexibilities that were adopted during the PHE remained permanent, and others were extended until December 31, 2024. These changes include increased telehealth access to behavioral health services, and the ability to provide prescriptions such as pre-exposure prophylaxis (PrEP) and other GHAT medications that do not fall under the Schedule III classification, such as estrogen. The US Department of Health and Human Services also provided resources for utilizing telehealth services specifically for LGBTQIA+ individuals.
Permanent Medicare Changes
- Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) can serve as a distant site provider for behavioral/mental telehealth services
- Medicare patients can receive telehealth services for behavioral/mental health care in their home
- There are no geographic restrictions for originating site for behavioral/mental telehealth services
- Rural Emergency Hospitals (REHs) are eligible originating sites for telehealth
- Behavioral and mental telehealth services can be delivered using audio-only communication platforms
Temporary Medicare changes through December 31, 2024
- An in-person visit within six months of an initial behavioral/mental telehealth service, and annually thereafter, is not required
- Telehealth services can be provided by all eligible Medicare providers
DEA’s Initial Proposed Rule
Prior to the issued extension, the DEA’s proposed rule would have returned telehealth prescribing practices of controlled substances to pre-pandemic regulations under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Providers would have the ability to prescribe a 30-day supply of Schedule III-V non-narcotics without having to see a patient in person. After the initial 30-day supply, patients would be required to have an in-person visit with their provider. The DEA reasons that requiring in-person medical evaluations within 30 days of virtual buprenorphine induction will better allow providers to confirm the prescribed medication is the best form of treatment for the patient, and that 67,458 patients annually will be affected by this rule change. Schedule III-v non-narcotics include testosterone for GAHT.
Potential Patient Impact
The uncertain future of telehealth prescribing of GAHT medications like testosterone comes at a particularly volatile time for the transgender and gender nonconforming community. Additionally, providers are concerned that the proposed rule change will negatively impact individuals who live in rural areas, specifically those with safety concerns relating to their identity, experiencing a disability or homelessness, or with transportation barriers. Buprenorphine, a treatment for OUD, is also a Schedule III controlled substance and is also a drug for which access is also important to the LGBTQIA community. There is evidence that suggests members of the LGBTQIA+ community are at a higher risk for OUDs. Recent research also indicates that transgender and gender nonconforming patients are more likely to utilize telehealth services, citing the risk of being refused care in person based on their gender identity, and lack of GAHT-informed providers in their area.
In the past year, some lawmakers have called on the Biden administration to reschedule or deschedule testosterone, which would improve access and remove the stringent prescribing restrictions present for Schedule III substances.
As more unfolds on this issue and the deadlines ahead, updates can be found on the HPN blog from our policy experts!