Politics over Precedent? How the Court Limited Telemedicine in FDA v. American College of Obstetricians and Gynecologists

Photo by Kari Shea on Unsplash

Sarah Simon, Associate Member, University of Cincinnati Law Review

I. Introduction

“Telemedicine” or “telehealth” is the use of technology to provide remote medical care.[1] In 2020, doctors saw “between 50 and 175 times more patients” via telemedicine than they did before COVID.[2] Telemedicine is here to stay: 83% of patients plan to use it post-COVID.[3] The U.S. Department of Health and Human Services removed barriers to telemedicine by allowing Medicare and Medicaid recipients to receive virtual care regardless of their location and waiving HIPAA violations for providers using private technology and “good faith delivery.”[4] The Supreme Court has not weighed in on these regulatory changes, but a recent decision addresses telemedicine—in the dissent.

FDA v. American College of Obstetricians and Gynecologists (“FDA”) is the first Supreme Court decision to reference “telemedicine.”[5] Only Justice Sotomayor and Justice Kagan discuss telemedicine in their dissent.[6] This article will analyze the Court’s decision in FDA and argue that the Court ignored the importance of telemedicine by choosing politics over precedent. Part II explains the Court’s decision in FDA. Part III describes a standard that the Court could have used to evaluate the case. Part IV discusses two ways that the Court could have approached the case along with telemedicine implications of the Court’s decision. Part V concludes by recommending that the Biden administration reverse the decision.

II. FDA v. American College of Obstetricians and Gynecologists

Mifepristone (or Mifeprex) is a medicine used to end pregnancy during the first trimester.[7] The U.S. Food and Drug Administration approved the pill 21 years ago but stipulated that it be given in a clinical setting.[8] The ACLU, on behalf of the American College of Obstetricians and Gynecologists (“ACOG”), sued to prevent the in-person requirement from being enforced, citing the dangers of COVID.[9] In 2020, three federal courts sided with the ACLU and granted a preliminary injunction that waived the in-person requirement.[10] This allowed providers to mail or deliver the drug directly to patients.[11] In one decision, U.S. District Judge Theodore Chuang emphasized, “in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm.”[12]

The Trump administration demanded the Supreme Court overrule the preliminary injunction and reinstate the in-person criteria for mifepristone.[13] In FDA, the Court sided with the Trump administration and restored the criteria for the pill.[14] However, the majority failed to provide any reasoning for this decision.[15] Chief Justice Roberts concurred, adding the issue is “not whether the requirements for dispensing mifepristone impose an undue burden on a woman’s right to an abortion.”[16] Instead, he interpreted the issue as whether the federal courts were correct to override the in-person requirement.[17] Relying on the separation of powers notion, he concluded that courts should not overstep “politically accountable entities…[in] public health.”[18]

Justice Sotomayor and Justice Kagan dissented, pointing out that the FDA had waived in-person requirements for some controlled substances due to COVID, but singled out mifepristone for political reasons.[19] The justices also argued that the Trump administration failed to show “irreparable harm” to justify reversing the injunction.[20]

III. Undue Burden Standard

Stare decisis is a Latin term which means “let the decision stand.” This imposes a duty on the Court to follow its past decisions.[21] In Planned Parenthood v. Casey, the Court created the undue burden standard.[22] Under this standard, if a regulation’s “purpose or effect is to place substantial obstacles in the path of a woman seeking an abortion,” the regulation is void as an undue burden.[23] The Casey precedent applies to future abortion regulations and requires the Court to ask if the regulation creates an “undue burden.”[24]

IV. Discussion

In FDA, the Court missed an opportunity to discuss the benefits of telemedicine during COVID. The Court viewed abortion as a political issue and voted along party lines.[25] The six justices appointed by Republican presidents made up the majority and the three justices appointed by Democrat presidents dissented.[26] The Court should have used the case to discuss the benefits of telemedicine during COVID.

There are two routes the Court could have taken, and both would have allowed the Court to appreciate telemedicine. First, the Court could have applied the Casey precedent by asking if the in-person requirement created an “undue burden” on seeking an abortion. Requiring patients to see their doctor in person significantly increases the risk of COVID, not only for the patient and doctor, but also for other healthcare workers and patients. This likely rises to an undue burden for the patient, especially for those with risk factors that predispose them to COVID.

As of 2019, six states only have one abortion clinic.[27] In these states, the in-person requirement brings in patients from all over the state, facilitating the spread of COVID, whereas telemedicine allows the patient to meet with their doctor, obtain their medicine, and stops the spread of COVID. [28] By ignoring the Casey precedent, the Court unnecessarily restricted telemedicine when it was crucial. The Court should have concluded that the totality of the circumstances with COVID constitute an undue burden.

Second, the Court could have focused on the literal meaning of the FDA’s “by or under the supervision of a certified prescriber” requirement and reasoned that video calls achieve this.[29] Video calls have replaced in-person interactions for the majority of Americans due to COVID. Things that we would have never thought could be done virtually are now commonly occurring via video calls. At a virtual appointment, a provider can closely observe the patient taking the medicine, then monitor them for side effects. Even for in-person visits, the provider cannot watch the patient for the entirety of the time that side effects may occur. Thus, virtual visits could have satisfied the FDA’s stipulation for mifepristone in light of COVID.

Misinformation from the government contributed to the spread of COVID in the U.S.[30] The Supreme Court could have helped counteract the spread of COVID by discussing the benefits of telemedicine. The Court could have also quelled fears of advancing technology by emphasizing that telemedicine provides safe and effective medical care. As a well-respected institution, the Court should have done its part to legitimize telemedicine. Instead, the Court failed to appreciate the potential implications of its decision on telemedicine.

V. Conclusion

The Court should have recognized the importance of telemedicine during COVID and upheld the federal court’s preliminary injunction waiving the in-person requirement for mifepristone. Now, the Biden administration should nullify the Court’s decision by getting rid of the in-person requirement for mifepristone and allow patients to obtain the medicine after a virtual visit with their doctor. As of now, COVID still poses a threat that telemedicine is best equipped to eliminate.  

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[1] Ctrs. for Disease Control & Prevention, Trends in the Use of Telehealth During the Emergence of the COVID-19 Pandemic, Centers for Disease Control and Prevention (Oct. 30, 2020) https://www.cdc.gov/mmwr/volumes/69/wr/mm6943a3.htm.

[2] Marc Zarefsky, 5 Huge Ways the Pandemic has Changed Telemedicine, American Medical Association (Aug. 26, 2020), https://www.ama-assn.org/practice-management/digital/5-huge-ways-pandemic-has-changed-telemedicine?gclid=Cj0KCQiA34OBBhCcARIsAG32uvM52Rm7oIYwv6W-_FWyxegJTXaxNbDxF6_3fivIvwOICZ_CBpiIsnEaAuYZEALw_wcB.

[3] Andrei Zimiles, Four New Statistics that Prove that Telemedicine isn’t just a Pandemic Fad, Medical Economics (July 8, 2020), https://www.medicaleconomics.com/view/four-new-statistics-that-prove-that-telemedicine-isn-t-just-a-pandemic-fad.

[4] U.S. Dep’t of Health & Human Servs., HHS Issues New Report Highlighting Dramatic Trends in Medicare Beneficiary Telehealth Utilization amid COVID-19, U.S. Department of Health & Human Services (July 28, 2020), https://www.hhs.gov/about/news/2020/07/28/hhs-issues-new-report-highlighting-dramatic-trends-in-medicare-beneficiary-telehealth-utilization-amid-covid-19.html.

[5] Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 580 (2021).

[6] Id. at 579.

[7] Food & Drug Admin., Questions and Answers on Mifeprex, Food and Drug Administration (Apr. 12, 2019) https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex.

[8] Id.

[9] Am. Civil Liberties Union, ACOG Led Coalition of Medical Experts and Reproductive Justice Advocates as Plaintiffs in the Lawsuit, American Civil Liberties Union (July 13, 2020) https://www.aclu.org/press-releases/federal-court-blocks-fda-restriction-unnecessarily-imposes-covid-19-risks-patients.

[10] Jaclyn Diaz, Supreme Court OKs White House Request to Limit Abortion Pill Access During Pandemic, National Public Radio (Jan. 13, 2021) https://www.npr.org/2021/01/13/956279232/supreme-court-oks-white-house-request-to-limit-abortion-pill-access-during-pande.

[11] Michael Kunzelman, Federal Judge Rules Women Can Get Abortion Pill Without Doctor Visits, Public Broadcasting Station (July 13, 2020) https://www.pbs.org/newshour/health/federal-judge-rules-women-can-get-abortion-pill-without-doctor-visits.

[12] Id.

[13] Diaz, supra note 9.

[14] Id.

[15] Food & Drug Admin. v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 579 (2021).

[16] Id. at 578-579.

[17] Id. at 579.

[18] Id.

[19] Id.

[20] Id.

[21] Planned Parenthood of Se. Pennsylvania v. Casey, 505 U.S. 833, 854 (1992).

[22] Id. at 837.

[23] Id.

[24] Id.

[25] Food & Drug Admin., 141 S. Ct. at 578.

[26] Id.

[27] Holly Yan, These 6 States Have Only 1 Abortion Clinic Left, CNN (June 21, 2019) https://www.cnn.com/2019/05/29/health/six-states-with-1-abortion-clinic-map-trnd/index.html.

[28] Ctrs. for Disease Control & Prevention, Telemedicine – What Does it Mean and Why Should You Care?, Centers for Disease Control and Prevention (Sept. 15, 2020) https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/telemedicine.html. 

[29] Food & Drug Admin., supra note 7.

[30] Rem Rieder, Trump’s Statements About the Coronavirus, Fact Check (Mar. 18, 2020) https://www.factcheck.org/2020/03/trumps-statements-about-the-coronavirus/.