NEW YORK (1010 WINS) — A DEA rule that allows clinicians to prescribe controlled drugs over telehealth video calls without first meeting the patient is set to expire in November. The implementation of the rule at the start of the COVID-19 pandemic unintentionally gave trans people unprecedented access to hormone therapy, and trans New Yorkers and medical providers are unclear on whether that level of access will persist with the rule in limbo.
Remote prescription of testosterone is especially important for trans masculine people living in rural areas who often live great distances from endocrinology clinics that provide gender affirming care. Estradiol, the hormone most commonly prescribed for trans femme people, is not a controlled substance, and is therefore unaffected by this rule.
Dr. Carolyn Wolf-Gould, the medical director of the Gender Wellness Center in Oneonta, the only rural-based interdisciplinary center of its kind in Upstate New York, said her patients often live hours away. Before telehealth prescription was an option, many people couldn’t make the trip.
“For some people that one visit would be impossible,” Wolf-Gould told 1010 WINS. “Not all trans people have cars. Many have been marginalized and find it hard to get work, buy gas money, take a day off from work. All of those things would be significant barriers to care.”
The GWC pivoted to telehealth during the pandemic and saw the increase in access manifest in real time as new patients started signing up for appointments from across the state.
“When telehealth happened, we had a huge surge in the number of patients,” said Wolf-Gould. “People who previously couldn’t get to us were suddenly able to access care, and people who were traveling long distances for care no longer had to do that. It put us right in the living rooms of our patients. It was a very profound improvement in access to care.”
Many practices integrated telehealth for the first time at the start of the pandemic. If the DEA rule is allowed to expire, clinics will still be able to prescribe hormones for returning patients, but new patients won’t be able to get their initial prescription remotely.
The agency first moved to scrap the rule in February, two months before President Joe Biden signed a congressional resolution officially ending the COVID-19 emergency.
The DEA never intended its “telemedicine flexibilities” to impact trans health care. The rule was designed to allow prescribers to remain socially distanced while treating patients.
During a public comment period following the DEA’s announcement that the rule would end, though, trans healthcare advocates submitted a record 38,000 comments demanding the rule remain in place.
“We take those comments seriously and are considering them carefully,” said DEA Administrator Anne Milgram in a statement. “We recognize the importance of telemedicine in providing Americans with access to needed medications.”
On May 11, the DEA issued a six month extension of the rule, which is now scheduled to expire on November 11.
The Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA said they’re now “actively reviewing input” on making the rule permanent.
New York State legislators said there’s potential for the DEA to be undermined if the rule is allowed to expire.
Assemblymember MaryJane Shimsky, co-sponsor of a recently-passed bill making New York a sanctuary state for trans people who might be targeted by laws restricting their health care or participation in public life in other states, told 1010 WINS the fight to legalize cannabis could be a model for states looking to protect trans healthcare.
“I know with medical marijuana there were lots of concerns when states started legalizing it, because the federal government still had it listed as I believe it was a level one [sic] controlled substance, and states did what states wanted to do on it, and as far as I can tell there have been no repercussions,” she said. “I assume that there is the same potential if we did the same thing with testosterone, but I cannot say 100% at this point.”
If the rule does expire, Wolf-Gould worries the limitation to access will compound other barriers to care that keep trans people from receiving medical treatment.
“Transgender people face all kinds of barriers to care,” said Wolf-Gould. “Barriers to care for transgender people include stigma, minority stress, institutionalized discrimination… and then of course lack of access to care.”
Dr. Joshua Safer, the director of the Center for Transgender Medicine and Surgery at Mount Sinai New York, advocated for rescheduling testosterone as a way to improve access to care for trans people.
“The hurdles with regard to gender affirming hormone treatment, for adults at least, are heavily logistical,” said Safer. “Testosterone, for reasons relating to fears of abuse in the past, is more tightly regulated than our other hormones. I don’t know if I see as a practitioner real logic for that, but the net result is that patients are obliged to get new prescriptions on a more frequent basis and there’s a little more complexity there.”
The DEA classifies controlled drugs as schedules one through five, with one being the most restrictive and five being the least restrictive. Scheduling is subjective, and doesn’t always align with popular or scientific opinion on a narcotic’s potential for harm.
For example, cannabis is a schedule one drug alongside heroin, bath salts and many hallucinogens. Xanax, a drug that is commonly used recreationally and can be highly addictive, is a schedule four drug — a category that indicates a low risk for developing a substance use disorder.
The logic for regulating testosterone comes from its potential to be used alongside steroids for enhancing sports performance and muscle gain.
Testosterone is a schedule three drug federally, but a schedule two drug in New York State. Pharmacies, as a rule, always adhere to the stricter law in cases where there is a disparity, so it’s therefore treated as a schedule two drug in New York, according to Safer.
“Testosterone is schedule 3 in most states… In New York it’s actually schedule two, which creates a real burden for patients, because schedule two requires a new prescription every time, it doesn’t allow refills,” said Safer. “It’s the tier that’s used for narcotics where there’s a real fear of abuse potential. So it’s a very, very tight leash.”
“There are two problems with that. One is there’s much more effort on the part of the patient just to maintain their prescriptions,” Safer continued. “The second is there’s more effort required on the part of the provider getting the bureaucracy addressed on a regular basis, which means that sometimes prescribing is more limited to practices that see more transgender patients or are more specialized.”
Assemblymember Shimsky supports rescheduling testosterone.
“Rescheduling testosterone just from two to three, that could be done by New York, at the state level, and that would be a major improvement for transmasculine folks, for transgender guys here in New York State,” said Shimsky. “This is a major barrier to care delivery, and it’s a shame, and the state could fix it.”
She also suggested a carveout for trans health care to bring the schedule down even further on a federal level.
“I do support allowing trans masc people to have access to testosterone through telehealth. What a blanket declassification could do, is it could result in the increase of steroid abuse, especially among our young athletes,” she said. “But there is a middle path for the DEA to take, which is to make an exception for the drug when it’s being used by licensed doctors to treat gender dysphoria.”
The DEA did not respond to 1010 WINS’ request for comment on the potential for rescheduling testosterone.
Whether through rescheduling, a DEA extension or state intervention, Wolf-Gould emphasized that protecting gender affirming care is crucial to the state’s health goals.
“All across the board, our crediting agencies, the New York State Department of Health, everyone is asking us to focus on health equity, and if this ends, it will be a huge impediment to health equity for transgender people,” she said. “My hope is that our legislators, our Department of Health, the DEA, all these people will recognize that in order to get health equity for trans people, they have to recognize that there aren’t places for people to get care. That people may not be able to travel for care, that there are not trained clinicians in every part of the world, and that we need to keep this in place to ensure health equity.”
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