DEA Docket 407

The DEA has proposed changes, Docket 407, to the 2008 Ryan Haight Act to allow more flexibility in telemedicine prescribing once the Public Health Emergency ends May 11. You can see the DEA’s announcement about Docket 407 here and a summary from a telehealth attorney here. Unfortunately, these proposed changes are going to do signficant harm to the trans and gender diverse community if they are not modified. This is a copy of a draft of the letter Dr. Beal plans to submit to the DEA during its public commentary period regarding Docket 407. We encourage EVERYONE to share this news widely- make public comment yourself starting March 1, write your legislatures and ask them to comment, ask your providers to advocate for you. We need to let the DEA know that our community deserves access to medically necessary and life-saving care.

February 27, 2023

RE: DEA Docket 407

To Whom It May Concern:

I am Crystal Beal. I am Board Certified in Family Medicine. Additionally, I am Board Eligible in Addiction Medicine. I am writing regarding DEA Docket 407 and imploring you to help save lives by creating a special exemption for transgender patients.

The primary focus of my practice is gender affirming healthcare for transgender and gender diverse (TGD) patients. When I opened my practice in 2018, I implemented a telemedicine-based model because data from the 2015 US Trans Survey indicated that trans people were three times more likely to have to travel more than 50 miles to access gender affirming care versus general healthcare¹. Less than half of the respondents to the survey received gender affirming care within 10 miles of their home¹.

The suspension of Ryan Haight during the public health emergency was life-saving for TGD people who had not previously been able to access care. Access to gender affirming hormone therapy (GAHT) decreases moderate or severe depression rates by 60% and decreases odds of suicidality by 73%².

The proposed changes to CFR 1300, 1304, and 1306 in DEA Docket 407 are a positive step towards increasing access to medically necessary and life-saving healthcare for many marginalized and underserved patients. However, they fall short of meeting the needs of trans and gender diverse patients.

Access to gender affirming care will decline due to the requirement of an in-person examination or qualifying telemedicine referral. This requirement will also increase the risk of violence to trans patients and increase the rates of attempted and completed suicides in trans patients. Studies in TGD populations and the providers who care for them support this assertion.

Existing data indicate that TGD patients are more likely to experience healthcare discrimination:

• One in three trans patients reports an episode of healthcare discrimination in the past year¹. 
• One in four trans patients reports delays in seeking healthcare due to fear of discrimination¹. 
• Two out of three primary care physicians^3-7 and three out of four endocrinologists⁸ report that they don’t have enough training or expertise to diagnose or treat transgender patients. 
• Further, malpractice insurers, like Norcal, are refusing to insure clinicians who provide GAHT. 

Given that trans patients need to travel farther for care,  and face limited physician availability, trans patients have significant barriers to finding local clinicians who could or would provide the required telemedicine referral to specialists like me. Additionally, local clinicians will likely want to reduce their liability risk and may feel they don’t have appropriate training to provide these referrals. Even worse, patients may experience actual transphobia and hate when seeking these referrals.

Trans and gender diverse people are four times more likely to experience physical harm than their cis peers⁹. Rates of violence against trans people increase with increasing rates of anti-LGBTQ legislation. 2023 has had more than 320 pieces of anti-LGBTQ legislation proposed in the first two months, as tracked by the ACLU. According to the HRC, this is more than in the entire year of 2022, which had seen the most PASSED anti-LGBTQ laws in recent history. In 2018, the Transgender Day of Remembrance Project recorded forty known murders of trans people in hate crimes. In 2022, seventy trans lives were lost to hate crimes. If this year’s trends continue, more than one hundred trans lives will be lost to violence in 2023 in the United States. By requiring a trans or nonbinary person to seek a referral locally, especially in hostile communities,  you forcibly out them and risk their personal safety in their home communities. Hate is not bound by HIPAA. 

With additional restrictions imposed by insurers and legislated, clinicians willing to refer will be few and far between. Over 90 trans health care bans have been proposed in this legislative session. We have seen many clinics stop providing care before the bans are even enacted¹⁰. At least one malpractice insurance carrier has refused to cover clinicians offering GAHT. In many states where multiple barriers to access exist, anti-trans bathroom legislation is also in place. This further increases the burden on the patient and decreases their ability to get care: imagine traveling hours to see one of the few providers willing to see you and not being able to use public bathrooms on your journey. This is already a reality for many transgender patients and puts their health at further risk.

The requirement to seek an in-person examination or qualifying telemedicine referral will also add discriminatory and significant financial burdens to trans patients compared to cis patients. A study in 2021 found that only 34 of 50 states’ Medicaid programs covered GAHT¹¹. Recent anti-trans actions removing funding from institutions that bill Medicaid for GAHT have included states like Oklahoma, Florida, and Texas. This is ILLEGAL based on section 1557 of the 2008 Affordable Care Act and the Biden Administration’s actions. However, the cost of this referral will be placed squarely on the shoulders of the trans patient in many states. One in three TGD people already delay seeking healthcare due to costs of care¹. 

All of these barriers for TGD patients seeking in-person examinations or qualifying telemedicine referrals to comply with the proposed changes to CFR 1300, 1304, and 1306 will decrease access to care and thus increase completed suicides among TGD people. Those lives will be on your hands unless you take action.

The best course of action would be to remove testosterone and other anabolic steroids form the Controlled Substance schedule which is in accordance with the original opposition to the Anabolic Steroid Act from the FDA, DEA, and the AMA. Alternatively, creation of the Telemedicine Registry defined by the Ryan Haight Act would allow gender affirming clinics and clinicians ability to prescribe testosterone without an in-person evaluation.

As neither of these processes seem likely or possible by May 11, I propose that the DEA consider a special exemption from the required qualifying telemedicine referral and in-person examination for patients diagnosed with gender dysphoria (ICD10 F64.0-F64.9) or gender incongruence (ICD11 Z77.0-Z77.9) being treated with testosterone or other androgen therapies. Clinicians like myself, who are well-trained and highly experienced, agree that the standard of care for evaluating, diagnosing, and treating gender dysphoria can be met through telemedicine encounters. My clinic uses two-way synchronous audio and video encounters. Rarely, when bandwidth is poor, we will use a synchronous audio-only encounter (less than 1% of encounters). The DEA could consider an exemption that allows for an initial 30-day prescription for testosterone or other androgens (as allowed by applicable state and federal laws) after an initial telemedicine evaluation with a second required telemedicine visit with the initial prescriber prior to renewing the prescription for a 90-day supply forgoing the in-person examination or telemedicine referral requirements. This very narrow exemption will save trans lives without significantly increasing the risk of diversion or abuse of controlled substances. This action would be consistent with Senator Markey and Senator Warren’s request to reschedule testosterone to Schedule V.

This exemption would allow continued life-saving, medically necessary GAHT for TGD patients who are twice as likely as their cis peers to utilize telehealth¹². Research from Rock Health and the Stanford Center of Digital Health indicates that 85% of TGD respondents delayed medically necessary care in 2021 and that some of the sharpest rises in accessing telemedicine are in marginalized communities. 98% of TGD respondents utilized telemedicine services in 2022¹⁴.

I urge you to consider my proposal or some alternative which will allow trans and gender diverse people to continue to access testosterone therapy without in-person examination or qualifying telemedicine referral. I also urge you NOT to implement a rule where only FDA indications are approved as all prescriptions used in gender affirming medical care are off-label use. Additional clinicians have signed on in support of my statement. I have included all of my references after the signatures. I am happy to be available to the DEA to answer questions or provide further clinical insight. I may be reached via email at drcrystalbeal@queerdoc.com.

Sincerely,

Crystal Beal, MD

Board Certified Family Medicine Physician

Board Eligible Addiction Medicine Physician

Founder & CEO QueerDoc

References

1. James, Sandy E., Herman, Jody, Keisling, Mara, Mottet, Lisa, and Anafi, Ma’ayan. 2015 U.S. Transgender Survey (USTS). Inter-university Consortium for Political and Social Research [distributor], 2019-05-22. https://doi.org/10.3886/ICPSR37229.v1
2. Tordoff DM, Wanta JW, Collin A, Stepney C, Inwards-Breland DJ, Ahrens K. Mental Health Outcomes in Transgender and Nonbinary Youths Receiving Gender-Affirming Care. JAMA Netw Open. 2022;5(2):e220978. doi:10.1001/jamanetworkopen.2022.0978
3. Johnston CD, Shearer LS. Internal medicine resident attitudes, prior education, comfort, and knowledge regarding delivering comprehensive primary care to transgender patients. Transgend Health. 2017;2(1):91-95. https://doi.org/10.1089/trgh.2017.0007
4. Shires DA, Stroumsa D, Jaffee KD, Woodford MR. Primary Care Clinicians’ Willingness to Care for Transgender Patients. Ann Fam Med. 2018;16(6):555-558. https://doi.org/10.1370/afm.2298
5. Deirdre A Shires, Daphna Stroumsa, Kim D Jaffee, Michael R Woodford, Primary care providers’ willingness to continue gender-affirming hormone therapy for transgender patients, Family Practice, Volume 35, Issue 5, October 2018, Pages 576–581, https://doi.org/10.1093/fampra/cmx119
6. Coutin A, Wright S, Li C, Fung R. Missed opportunities: are residents prepared to care for transgender patients? A study of family medicine, psychiatry, endocrinology, and urology residents. Can Med Educ J. 2018;9(3):e41-e55. Published 2018 Jul 27.
7. McPhail D, Rountree-James M, Whetter I. Addressing gaps in physician knowledge regarding transgender health and healthcare through medical education. Can Med Educ J. 2016;7(2):e70-e78. Published 2016 Oct 18.
8. Irwig, Michael. (2016). Transgender Care by Endocrinologists in the United States. Endocrine Practice. 22. 832-836. 10.4158/EP151185.OR. 
9. Flores AR, Meyer IH, Langton L, Herman JL. Gender Identity Disparities in Criminal Victimization: National Crime Victimization Survey, 2017-2018. Am J Public Health. 2021 Apr;111(4):726-729. doi: 10.2105/AJPH.2020.306099. Epub 2021 Feb 18. PMID: 33600251; PMCID: PMC7958056.
10. https://www.tampabay.com/news/health/2023/02/15/transgender-care-minors-florida-gender-affirming-treatment-ban/ 
11. Zaliznyak M, Jung EE, Bresee C, Garcia MM. Which U.S. States’ Medicaid Programs Provide Coverage for Gender-Affirming Hormone Therapy and Gender-Affirming Genital Surgery for Transgender Patients?: A State-by-State Review, and a Study Detailing the Patient Experience to Confirm Coverage of Services. J Sex Med. 2021 Feb;18(2):410-422. doi: 10.1016/j.jsxm.2020.11.016. Epub 2021 Jan 7. PMID: 33422448.
12. https://rockhealth.com/insights/startup-innovation-for-underserved-groups-2021-digital-health-consumer-adoption-insights/ 
13. https://www.rand.org/news/press/2022/11/07/index1.html 
14. https://rockhealth.com/insights/consumer-adoption-of-digital-health-in-2022-moving-at-the-speed-of-trust/?mc_cid=4eb2bcee0a&mc_eid=bd247e782c