The Imperative of Telemedicine Prescribing for Testosterone
“Requiring even a single in-person visit to access testosterone could mean that many patients will be prevented from accessing gender-affirming hormone therapy entirely – a potentially catastrophic result for their health and lives.”
Soon after the declaration of the COVID-19 Public Health Emergency (COVID-19 PHE), the U.S. Drug Enforcement Administration (DEA) relaxed some long-standing requirements so that providers could prescribe — and patients could access — certain controlled substances safely. The end of the COVID-19 PHE necessitated new rulemaking from the DEA and the agency released a proposed rule in March 2023.
Now, as the DEA determines new telemedicine prescription regulations for certain controlled substances, Planned Parenthood Federation of America (PPFA), along with with other gender-affirming care providers, patients, and other health care organizations, have come forward in historic numbers to urge the continued availability of telemedicine prescriptions, without burdens that would constrain patients’ access to essential medications.
The outpouring of comments critical of the DEA’s initial proposed limits on access led to a joint temporary rule with the Substance Abuse and Mental Health Services Administration (SAMHSA) that continued the pandemic-era flexibilities. In late August, the DEA announced another opportunity for stakeholder feedback: two days of Listening Sessions at their Virginia headquarters. During these sessions, the DEA demonstrated a keen interest – in the words of DEA Deputy Assistant Administrator Matthew Strait – in making sure, “we get it right.”
To get the eventual final rule right, one thing is clear: There must not be an in-person evaluation requirement, and particularly not for testosterone prescriptions.
Dr. Halley Crissman, Associate Medical Director and the Director of Gender Affirming Care at Planned Parenthood of Michigan, explained why at the DEA’s Listening Sessions. Dr. Crissman’s testimony is below.
DEA Administrator Anne Milgram and Deputy Assistant Administrator Tom Prevoznik, thank you for the opportunity to testify today.
My name is Dr. Halley Crissman, and I serve as the Associate Medical Director and the Director of Gender Affirming Care at Planned Parenthood of Michigan, an affiliate of Planned Parenthood Federation of America. Planned Parenthood is the nation’s leading advocate of high-quality, affordable sexual and reproductive health care for all people. As health care providers, Planned Parenthood’s nearly 600 affiliate health centers prescribe patients medications as medically necessary and appropriate, which includes controlled substances like testosterone, my focus today.
I am a board certified obstetrician gynecologist and have a masters degree in public health. In my role at Planned Parenthood, I oversee gender affirming hormone care for more than 2,200 patients across 13 health centers and via telemedicine. My clinical work focuses on reproductive and sexual health care for gender diverse people. I have published numerous peer reviewed research articles related to gender diversity and gender affirming reproductive health care and have trained more than 20 advanced practice providers in gender affirming hormone care. I also serve as an Adjunct Clinical Assistant Professor in Obstetrics and Gynecology at the University of Michigan where I see patients both in-person and via telemedicine for gender affirming hormone care.
Today, I am proud to testify about the critical need for testosterone to remain available through a telemedicine prescription and without an in-person evaluation requirement.
Gender affirming care refers to a range of services provided to support transgender, gender diverse, and nonbinary people. It includes care related to physical, mental, and social health needs and well-being, all affirming patients’ gender identity. Medically necessary gender affirming care includes mental health counseling, non-medical social transition, and–most relevant for the DEA’s work–gender affirming hormone therapy. Gender affirming hormone therapy, as well as other forms of gender affirming care, is the evidence-based standard of care. Appropriate recipients of this necessary form of treatment are identified on a case by case basis with a health care provider. Gender affirming care is lifesaving care, with significant implications for mental health and well-being.
My clinical experience has made clear that testosterone can safely and effectively be prescribed via telemedicine and that this path is essential for patient access. Since the DEA waived the in-person evaluation requirement, providers have developed thorough standards and protocols for attuned and high-quality medical care, via telemedicine. Everyday, via telemedicine, both patients and providers expect and build full patient-provider relationships.
Telemedicine has proven essential for my patients’ access to gender affirming care, many of whom began treatment during the COVID pandemic because telemedicine made it possible for them to access care. In Michigan, where I practice, telemedicine has played a crucial role in expanding access to gender affirming care – allowing the concentration of health care providers in the Southern portion of the lower peninsula to extend the reach of their care to the more rural and remote reaches of the state. Requiring even a single in-person visit to access testosterone could mean that many patients will be prevented from accessing gender affirming hormone therapy entirely – a potentially catastrophic result for their health and lives. In the months since the declaration of the end of the COVID-19 Public Health Emergency, I have fielded countless calls and messages from patients worried they won’t be able to travel for an in-person visit – terrified they will lose access to the care that has been a literal lifeline.
Gender affirming hormone care with testosterone is incredibly well suited to telemedicine care.
Testosterone is a non-narcotic schedule III substance, for which the safety and diversionary concerns are notably low. Testosterone is not an addictive substance. In my years as a clinician I have not seen a patient abuse or intentionally misuse prescribed testosterone. I understand DEA’s interest in ensuring that there is a diversionary framework in place. But an in-person evaluation is neither the only nor best solution. Moreover, the DEA’s interest in diversion is advanced by providers’ reviewing recent prescription drug monitoring program data.
For testosterone, blood labs are typically the only important information needed to safely initiate and monitor testosterone therapy that cannot be obtained during a telemedicine visit. Thankfully, health care providers are well accustomed with protocols for having patients’ obtain labs locally and are not reliant on labs obtained concurrently with in-person visits. Instead of an in-person visit requirement, health care providers can order blood labs – which can be obtained at a health care facility or commercial lab local to the patient, and then faxed to the ordering health care provider for review. These avenues for obtaining lab results allow the health care provider prescribing testosterone to make their own assessment of the patient while being equipped with information about the patient’s physical state via review of pertinent lab results.
An in-person evaluation for testosterone care is a medically unnecessary burden to patient access that would disproportionately impact communities most harmed by systemic and institutional forms of oppression. Planned Parenthood health centers, including those I oversee, provide inclusive care. But many members of LGBTQ+ communities — particularly trans and nonbinary individuals — face discrimination and forms of violence when seeking health care, including misgendering, invasive questioning, unwanted touching, and abusive language. A recent survey found that “approximately half (51 percent) of transgender or nonbinary respondents reported having at least one of these kinds of negative experiences with doctors or other health care providers in the past year.”
And a particularly vitriolic discourse now runs rampant in some state governments and local jurisdictions, compounding longstanding access issues. Gender affirming care is health care. It has clear support from all major American medical professional organizations including the American Medical Association and American Pediatric Association. But numerous states have severely restricted access to gender affirming care. In 2022, state legislatures across the country introduced more than 100 anti-trans bills. In 2023 there has been a dramatic expansion in anti-trans legislation. Almost 500 anti-LGBTQ bills have been introduced in state legislatures this session, roughly 130 of which target trans health care. These bills are extremely harmful — people of all gender identities deserve civil and human rights, including the right to high-quality, affordable, and nonjudgmental health care. These bans actively impede access to care and stigmatize those seeking it.
In this climate, telemedicine access for testosterone is essential. An in-person evaluation — or referral for one — is, for many people, simply unattainable. A return to an in-person evaluation requirement would interrupt patient care and, for some, present insurmountable barriers to accessing the prescription for testosterone that they need. Particularly for patients who are young, live in rural areas, are working to make ends meet, or live at the intersection of multiple of these.
With respect to practitioner record keeping: Providers’ record-keeping obligations and practices are already robust. For provider privacy and personal security, and because records could be misused by hostile lawmakers to target individuals who have obtained gender affirming hormone therapy, providers should be required to document only their city and state during a telemedicine appointment and maintain any records at the registered location of their dispensing registration.
Planned Parenthood’s concerns about the risk of entities hostile to gender-affirming hormone therapy misusing prescribing records to criminalize patients and/or providers who receive or provide this necessary medical care, extends to all data-keeping requirements — as well as to the DEA’s consideration of a Special Registration. Planned Parenthood strongly urges the DEA to exercise caution in deciding how to implement such a registration. It is imperative that it be maximally protective of patient and provider safety and privacy, and does not burden access to care.
In sum: Because testosterone prescriptions made via telemedicine are safe and effective; because an in-person evaluation requirement would severely interrupt care for patients who need access to testosterone; and because there are alternatives that the DEA could utilize to ensure a satisfactory diversionary framework, Planned Parenthood strongly advocates for the DEA to permit telemedicine prescription of testosterone without burdening patients with an in-person evaluation.
Thank you for the opportunity to testify today.