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Transgender adults are commonly denied insurance coverage for gender-affirming hormone therapy, and substantial numbers thus turn to unlicensed, nonprescription options that carry potential health risks, researchers reported.

A cross-sectional analysis of 27,715 transgender adults from a national survey found that approximately 21% reported having their insurance claims denied, said Daphna Stroumsa, MD, of the University of Michigan in Ann Arbor, and colleagues.

As shown in their study online in , use of nonprescription hormones was more common among those whose claims were denied (OR 2.53, 95% CI 1.61-3.97, P<0.001) as well as among the uninsured (OR 2.64, 95% CI 1.88-3.71, P<0.0001).

Overall, 9.17% of transgender adults who said they were taking hormone therapy indicated they were using non-prescription sources, such as getting the medication from friends or online, a percentage that translates to approximately 75,000 individuals.

"Lack of insurance coverage for gender-affirming hormones is associated with lower overall odds of hormone use and higher odds of use of nonprescription hormones; such barriers may thus be linked to unmonitored and unsafe medication use and increase the risks for adverse health outcomes," Stroumsa and colleagues wrote. "Ensuring access to hormones can decrease the economic burden transgender people face, and is an important part of harm-reduction strategies."

In addition to not being monitored for content or quality, hormones obtained from unlicensed sources may differ in formulation and dose from the recommended therapy, raising health risks for those who take them, the researchers noted. For example, transgender women may be at increased risk for thromboembolic complications when using ethinyl estradiol instead of the recommended 17β-estradiol.

"Additionally, use of nonprescription hormones likely entails decreased monitoring of hormone levels and less opportunity for mitigating risks or other forms of harm reduction, preventive care, and health improvement," the team noted.

National guidelines, such as those from the American Psychological Association and the Endocrine Society, support the provision of gender-affirming hormones for transgender people who seek them, the study authors said, adding that research has shown that hormone therapy is associated with better mental health outcomes.

"Many of the major medical societies and associations in the United States, including the American Academy of Family Physicians, have issued statements in support of insurance coverage for gender-affirming care," the team wrote.

Stroumsa and co-authors analyzed data from the , a national sample of 27,715 transgender adults, collected from August to September 2015. Respondents were 18 or older who self-identified as transgender. The majority were white (64%), and they tended to be younger (mean age 42) and more highly educated (31% had some college and 27% had a Bachelor's degree or higher). They also tended to have lower incomes compared with the general population, with approximately 30% at or near the poverty level.

The study's primary outcome was use of hormones obtained from a source other than a licensed professional. A secondary outcome was the rate of hormone use, determined by those who answered yes to the question "Are you currently taking hormones for your gender identity or gender transition?"

Overall 12,037 respondents (55%), indicated they were currently using hormone therapy, and more than 21,000 (83%) said they were interested in hormone therapy.

Other notable findings:

• When respondents were asked about the most pressing issues affecting transgender people in the United States, insurance coverage was one of the most important (selected by 44% of respondents); this issue ranked second only to violence against transgender people

• The odds of using nonprescription hormones were highest among respondents who were assigned male gender at birth (OR 3.95, 95% CI 2.86-5.46, P<0.001)

• Use of non-prescription hormones decreased with age (OR 0.986 per year, 95% CI 0.975-0.996, P=0.008), but was not meaningfully associated with educational level or income

• Among respondents who indicated an interest in hormone therapy, those who were uninsured were less likely to be taking hormones compared with their insured counterparts (OR 0.37, 95% CI 0.24-0.56, P<0.001)

Limitations of the study, the researchers said, included a lack of information on the specifics of insurance plans and the reasons for claims denial for gender-affirming hormone therapy. In addition, the survey was a non-random sample and unlikely to be completely representative of the transgender population in the United States.

"In understanding these processes, health care clinicians can develop mechanisms for harm reduction, including institutional-level programs to ensure access to medications," Stroumsa and co-authors wrote. "Primary care physicians are ideally positioned to spearhead such efforts. As they address the practice and clinician-level barriers to caring for transgender people, clinicians also need to be aware of the substantial cost barrier for patients without insurance or those who might have their claims denied."

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