Telemedicine Prescribing of Controlled Substances- DEA Docket 407 Advocacy Resources

Learn more about proposed upcoming changes to telemedicine prescribing and find resources to help you adovcate for continued access to life-saving gender affirming medical care.

The ASK: for the DEA to allow for telemedicine access to the “maximum extent legally permissible without an in-person evaluation.”

Overview and History Resources

Alliance for Connected Care Summary of the History of Telemedicine Prescribing Regulation and Proposed Changes

Foley and Lardner White Paper

Attorney’s Summary of Proposed Changes and Concerns

• DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends– Nathaniel M. Lacktman, Foley & Lardner, February 23, 2023
• What the latest DEA Proposed Rule Means for Telemedicine Prescribing of Controlled Substances– Rebecca Gwilt, Nixon Gwilt Law, February 27, 2023

American Telemedicine Association’s Press Release and Suggested Actions

• ATA ACTION SUBMITS COMPREHENSIVE RECOMMENDATIONS TO DEA ON PROPOSED RULES REGARDING REMOTE PRESCRIBING OF CONTROLLED SUBSTANCES
• ATA AND ATA ACTION CALL DEA’S PROPOSED RULE ON CONTROLLED SUBSTANCES OVERLY RESTRICTIVE, FEAR CONSEQUENCES IN PATIENT CARE– Press Release
• Restrictions in DEA’s Telehealth Proposed Rules Put Vulnerable Patients at Risk– actions to be taken

Information on Testosterone’s Controlled Status

• Letter on Expanding Access to Gender-Affirming Hormone Therapy
• The Substance of Borders: Transgender Politics, Mobility, and US State Regulation of Testosterone
• Increasing Access to Testosterone to improve the lives of Transmasculine People

Effects on Trans Patients

• Dr. Crystal Beal’s blog with lots of great analysis and references can be found here: DEA Docket 407 – QueerDoc – Curing LGBTQ+ Healthcare Discrimination.

Telemedicine Prescribing Talking Points credit to MiQuel Davies, Physicians for Reproductive Health

• We appreciate the Department of Health and Human Services (HHS) and Drug Enforcement Agency’s (DEA) recent  announcement of the proposed rules for prescribing controlled substances via telehealth.  During the pandemic millions of Americans relied on telehealth as an important tool in the delivery of medical and behavioral health services.  The waiving of the face-to-face requirement under the Ryan Haight Act for controlled substances III-V during the COVID-19 Public Health Emergency (PHE) helped break down barriers for underserved populations. This is especially true for the transgender and gender-nonconforming (TGNC) community who were able to access testosterone via telehealth for gender-affirming care.  
• Testosterone for gender-affirming hormone therapy is safe, effective, and endorsed as medically necessary, evidence-based care by many professional organizations including the World Professional Association of Transgender Health, the Endocrine Society, the American Academy of Family Physicians, the American Medical Association, and the American Psychological Association.[1]  Upwards of 80 percent of TGNC people in the United States seek hormone therapy, including testosterone, as part of their overall health care and well-being.[2]
• The proposed rules revert to DEA’s prior requirement that the patient have an in-person evaluation. We strongly urge you to finalize a rule that would ensure that TGNC individuals can continue to access testosterone therapy via telemedicine prescription with minimal additional conditions or requirements.[3] 
• The flexibility to prescribe testosterone therapy via telemedicine without an in-person visit during the COVID-19 PHE has meaningfully increased access to lifesaving care for TGNC individuals.  LGBTQ+- focused clinics are clustered in only a few major cities across the U.S. and typically have months-long waiting periods to secure an appointment. A recent study found a demonstrable increase in new TGNC patient visits specifically for gender-affirming hormone therapy with the adoption of telehealth during the pandemic.[4] 
• Further, research also shows that TGNC individuals are more than twice as likely to use telehealth compared to the general population and 85 percent of TGNC people delayed medically necessary care due to fear of discrimination in physical settings.10 Given the clear benefits to TGNC patients of having access to medically necessary testosterone therapy via telemedicine prescription, we are very concerned that the provisions in the proposed regulations on prescribing controlled substances are overly restrictive and could have serious adverse impacts on the overall health and well-being of individuals in this under-served community. 
• The COVID-19 experience clearly has demonstrated that an in-person physical exam is not required to safely prescribe testosterone for gender-affirming care as supported by the standards of care.[5]  Limiting a telemedicine prescription without an in-person visit to only 30 days for testosterone therapy as put forward in the proposed rule is unduly burdensome for TGNC individuals, who often take testosterone as part of gender-affirming care for their entire lives.  Moreover, the proposed qualified telemedicine referral process in the proposed rule does not address the care challenges that many TGNC individuals often experience when seeing general practitioners and clinics who do not have familiarity with their specific care needs and do not have relationships with providers in LGBTQ+- focused clinics.  We are also concerned that the telemedicine referral process as proposed in the proposed rule is overly burdensome and will likely create confusion, which will limit practitioner buy-in and result in prescription denials at the point of pharmacy where TGNC individuals already face rampant discrimination and delays in care.[6] 

References:

[1] Transgender Legal Defense & Education Fund. TDLEF’s Trans Health Project. Accessed March 1, 2023.

[2] National Center for Transgender Equality. The Report of the 2015 U.S. Transgender Survey. December 2016.

[3] 88 FR 12875 Drug Enforcement Administration. Telemedicine prescribing of controlled substances when the practitioner and the patient have not had a prior in-person medical evaluation. 4410-09-P.

[4] Lock et al. “Transgender Care and the COVID-19 Pandemic: Exploring the Initiation and Continuation of Transgender Care In-Person and Through Telehealth.” Transgender Health. Vol. 7, No. 2. April 11, 2022

¹⁰DeSilva et al. “Startup innovation for underserved groups: 2021 digital health consumer adoption insights.” Rock Health and the Stanford Center of Digital Health. May 16, 2022.

[5] World Professional Association for Transgender Health. Standards of Care Version 8. Accessed March 2, 2023.

[6] Abrams et al. The importance of providing gender-affirming care in pharmacy practice. Explo Res Clin Soc Pharm. 2022 Jun; 6: 100135.