The two-drug combination of mifepristone and misoprostol is the most common medication abortion regimen in the U.S. and can be safely used until up to 10 weeks of pregnancy according to the U.S. Food and Drug Administration (FDA). The FDA first approved mifepristone, the primary drug used in medication abortion, in 2000; since that time, reliance on the mifepristone and misoprostol regimen has increased steadily as it has become more accessible through telemedicine. In 2023, medication abortion accounted for more than 63% of all abortions nationwide, up from 53% in 2020.
Since 2000, the FDA has repeatedly expanded the availability of medication abortion and broadened the use of telemedicine dispensing. For instance, in December 2021, the FDA removed the in-person dispensing requirement for mifepristone, and in January 2023 it approved a rule to expand the certification program to allow retail and mail-order pharmacies to fill prescriptions for the drug. Before that latest rule change, a pregnant person had to receive mifepristone directly from a physician or by mail via a telemedicine appointment.
The FDA has approved mifepristone as safe and effective, but the availability of medication abortion is largely dependent on state law. Following the Dobbs decision, some states have attempted to restrict access to medication abortion via telemedicine either by mandating an in-person visit with a physician, requiring a state-mandated in-person counseling session or ultrasound, imposing a requirement for in-person dispensing, or requiring medication abortion to be provided by a physician. For example, in addition to the 14 states currently enforcing a near-total ban on all abortion, five states where abortion is permitted until at least six weeks of pregnancy restrict access to medication abortion via telemedicine—Arizona, Nebraska, North Carolina, South Carolina and Wisconsin require that a patient being prescribed medication abortion have an in-person visit with a physician, and Arizona and North Carolina also ban mailing abortion-inducing drugs to a patient.
The expansion in access to and use of medication abortion via telemedicine has been the subject of recent litigation in federal court. Shortly after the Dobbs decision, an anti-abortion group sued in the Northern District of Texas challenging the FDA’s approach to regulating mifepristone. The case, Alliance for Hippocratic Medicine (AHM) v. FDA, went all the way to the U.S. Supreme Court, which ultimately found that the original plaintiffs lacked standing to sue, and therefore, unanimously agreed to maintain the FDA’s eased access to the drug. Despite the Supreme Court’s ruling, however, the case has recently re-emerged in the same federal district court in Texas. The revised lawsuit was filed in October by three intervenor states – Idaho, Kansas and Missouri – attempting to circumvent the standing hurdle, and if successful, could reverse the ability of a nurse practitioner or other health care provider to prescribe mifepristone, remove the ability for a retail pharmacy to dispense the medication, and require an in-person visit with a prescriber.
Unlike the original lawsuit, Idaho, Kansas and Missouri take aim at the growth of “shield laws” that have been increasingly enacted in abortion-friendly states to preserve abortion access and protect those who provide or assist abortion care from out-of-state prosecution. In the revised lawsuit, they argue that the FDA’s decision to remove the in-person dispensing requirement “enabled a 50-state mail-order abortion drug economy” and led to the proliferation of shield laws, which they claim violate their state sovereignty by allowing abortion medication to be prescribed through telemedicine and then mailed into states that ban or sharply restrict abortion.
Regardless of the immediate outcome of the revised AHM v. FDA case, other disputes and efforts to restrict access to medication abortion via telemedicine will likely continue to escalate, especially given the uncertainty of the change in administration. Further, while the revised lawsuit references the role of shield laws with respect to telemedicine, there has been no known instance of states directly challenging the constitutionality of such laws in court. Accordingly, a potentially significant area to watch going forward will be whether other states proceed with challenging shield laws in light of that case, and importantly, whether such challenges are successful. If so, that result would not only have a direct impact on states that have enacted shield laws but would also drastically curtail access to mifepristone in abortion-hostile states. In fact, the Texas attorney general recently filed a lawsuit, alleging that a New York physician violated Texas’ abortion ban by providing abortion medication to a Texas resident via telemedicine. The lawsuit, State of Texas v. Carpenter, is likely to be the first test of shield laws, as New York has a statute protecting physicians from out-of-state prosecution.
While the constitutionality of shield laws is currently uncertain, MCOs should stay apprised of the positions of the new administration and states’ attorney generals on medication abortion and mifepristone in particular. For instance, the FDA may move to restrict access to or remove mifepristone from the market, making any legal challenge to the FDA’s regulatory approval of the drug moot. Accordingly, MCOs should monitor litigation regarding mifepristone, as well as whether more states decide to challenge the use of telemedicine in prescribing and mailing medication abortion and the role of shield laws in that area. Finally, MCOs should consider reviewing contracts and benefit plans to ensure that their terms comply with coverage requirements with respect to abortion, especially medication abortion, and continue to carefully administer benefits for abortion-related care for members residing in states with abortion restrictions and bans, particularly as they relate to the use of telemedicine.
Reed Smith’s proprietary Post-Dobbs Tracker provides a solution to monitoring abortion law updates relevant to MCOs. Please contact the authors for more information or a demonstration of this tool.