Testosterone Access Could Be Limited as COVID-19 Public Health Emergency Ends

COVID’s closure of clinics and doctors’ offices opened new doors online, and some trans and nonbinary patients were able to receive gender-affirming care for the first time thanks to new telehealth providers and online clinics. The looming end of the official COVID Public Health Emergency means some of those doors could be closing.

“Many people in this country live in care deserts,” said Kate Steinle, chief clinical officer at FOLX Health, an LGBTQ+ startup that launched during the pandemic. “That’s care deserts from any provider, and specifically care deserts from an affirming provider, somebody who knows how to address the health concerns of the LGBT population.”

Companies like FOLX and its competitor Plume, which ship hormones directly to patients, have rapidly expanded in the past three years. But easily accessible testosterone prescriptions over the platforms could be coming to an end.

On May 11, the federal government’s COVID-19 Public Health Emergency will expire, ending a number of pandemic-relief rules, including a waiver that allowed doctors practicing medicine online to prescribe testosterone to patients without meeting in person. On Wednesday, the DEA announced it would extend telemedicine waivers in response to an unprecedented 38,000 comments about the expiration. It remains unclear if or when the rule will expire, but LGBTQ+ health advocates say the extension will be life-saving for many who are dependent on telemedicine for testosterone.

“Any rule that requires any type of evaluation in person of trans and gender-diverse individuals will result in significant harm, because we’ll see access to gender-affirming care decline,” said Dallas Ducar, CEO of TransHealth, a Massachusetts-based transgender clinic. “And any physical requirement also increases [the] risk of potential violence or even discrimination.”

Under the current proposed rule by the Drug Enforcement Administration (DEA), patients taking testosterone will need to meet with a licensed DEA doctor in person within six months if they want to stay on testosterone through telehealth. New testosterone prescriptions will also require in-person visits. The expiration does not affect the hormone estrogen.

Historically used by athletes in the late 80s and early 90s to enhance performance, testosterone has been classified as a controlled substance by the federal government. Controlled substances are medications that are tightly monitored by the DEA because they are more likely than other drugs to be abused or cause addiction.

The classification of testosterone has long been a subject of ire for transgender health experts. Today, some say it makes getting the hormone to people who need it for transgender care particularly tricky. Ducar said many have pushed for testosterone to be declassified as a controlled substance for gender-affirming care.

In September 2022, Sens. Ed Markey and Elizabeth Warren asked the Biden administration to reconsider the classification of testosterone. A spokesperson for Markey said his office has yet to get a response on that request.

“As the public health emergency declaration winds down, we cannot allow the critical tools that were developed to connect patients to care to sunset along with it,” Markey said in a statement to The 19th. “I have repeatedly urged the administration to expand, not roll back, gender and life-affirming care for trans people.”

The DEA did not respond to a request from The 19th to comment for this story.

It’s unclear just how many people could lose access to testosterone if the waiver expires. Current data on transgender and nonbinary people is scarce, but the 2015 transgender survey conducted by the National Center for Transgender Equality found that while 78 percent of transgender people wanted hormone therapy, just 49 percent had received it. A third of those surveyed — 33 percent — said they had experienced discrimination from a health care provider in the last year.

Companies like FOLX and Plume aimed to open up access to the more than half of gender-diverse people looking for other options. Plume currently serves 13,000 people, according to the company. FOLX has 12,000 patients. Both companies estimate that fewer than half of their members use the platforms to get testosterone. An untold number of doctors and companies also moved their gender-affirming practices online during the pandemic.

Those providers are scrambling to find in-person appointments for patients before November of this year when the six-month grace period ends. FOLX Health sent an email to its members instructing them to trek to the closest Planned Parenthood clinic for in-person appointments. Plume has instructed its clients to lobby the federal government to change the proposed rules before May 11.

Advocacy organizations like the National Center for Transgender Equality (NCTE) and the Human Rights Campaign have been pushing the Biden administration to allow those companies to continue seeing patients online or allow lab visits, which are required for hormone prescriptions to count as in-person appointments. TransHealth had also sent staff members to Washington D.C., to meet with lawmakers, hoping that the final rules ease restrictions on testosterone.

“We’re particularly concerned about people in rural areas and states where we’ve seen attempts to prohibit access to care,” C.P. Hoffman, senior policy counsel at NCTE, said.

The expiration of the waiver raises alarm bells about the future of transgender health companies that built their business models on temporary pandemic health rules. Both FOLX and Plume were conceived before COVID hit, but former employees and health care experts at the companies say both startups anticipated the public health expiration and declined to plan for it.

On March 17, FOLX laid off 15 staffers out of 100 contract and full-time employees in anticipation of the rule. Steinle said the company is not at risk of folding but needed to downsize in anticipation of a cooler climate for venture startups as the economy begins to drag.

Three former FOLX employees, who were unwilling to be named due to non-disclosure agreements with the company, said that as early as 2020, transgender employees pitched the idea of mobile clinics so that testosterone users would not lose access when the public health emergency ended.

“It was mind-boggling for me to witness the company be like, ‘OK, it’s temporary, but we’re gonna go ahead and expand our services for this,’ knowing that it was a risk in the long term that we could lose half of our, you know, our members,” said one former employee.

Steinle said the company hoped that in providing critical care to transgender people, it would also be able to present irrefutable data that might make the temporary waiver permanent.

“The government then allowing us to do this through telehealth now that we can have many years of use cases showing that it is good, and safe and literally clinically the same as doing it in person could then influence the continuation of that afterwards.” Steinle said.

Dr. Jerrica Kirkley, co-founder and chief medical officer at Plume, acknowledged that the decision to expand access to testosterone under a temporary rule was tricky. She doesn’t necessarily regret it.

“When we get into marginalized communities, who face significant limitations and access to basic civil rights and health care, we often talk about a risk-reduction model,” Kirkley said. “And so there I would say that maximizing the opportunities that we have to provide life-saving care is critical, and we’ve got to take every opportunity we can. At the same time . . . be responsible in that sense of contingency planning.”