On April 12, 2021, the U.S. Food and Drug Administration (FDA) informed the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine that the FDA will not enforce the in-person dispensing requirements for mifepristone, one of two drugs used to provide medication abortions, for the duration of the COVID-19 public health emergency (PHE). Consistent with many studies, the FDA’s Center for Drug Evaluation and Research found that modifying the in-person dispensing requirements does not impose any serious safety concerns for medication abortion patients. The National Health Law Program calls on state Medicaid agencies and private payers to reimburse abortion providers who mail or deliver mifepristone to their patients.
Thanks to this FDA decision, patients will be able to receive medication abortion pills by mail and not have to travel long distances or enter indoor spaces to access medication abortions. This notice covers both provider-direct mailing as well as mail-order pharmacies, as a previous injunction allowed. In contrast to the injunction, however, the FDA also permits the mailing and delivery of mifepristone for miscarriage management. While the current PHE declaration expires July 15, the U.S. Department of Health and Human Services indicated that it expects the PHE to extend through the end of the year.
FDA’s action is a significant step in the right direction and NHeLP calls on the federal agency to make this long-overdue change permanent. Medication abortions are safe and effective. Ample research and more than 20 years of clinical experience have demonstrated that in-person dispensing is medically unnecessary, particularly when the patient can self-administer the medication at home. Outdated requirements have forced many patients to travel hours from their homes using buses or planes to access medication abortions. In addition to involving health risks, traveling involves costs for lodging, arranging for childcare (sixty percent of abortion patients are already parents) and missing workーharming the economic wellbeing of patients and their families. Like other restrictions on abortion access, in-person dispensing requirements have long harmed and fallen hardest on Black, Indigenous, and other People of Color, people who live in rural areas, and those struggling to make ends meet.
Following the FDA’s decision, Medicaid and private payers should immediately adjust their payment systems to make sure they are covering medication abortion that is mailed or delivered. The manufacturers of mifepristone participate in the Medicaid Drug Rebate Program. Since all states have decided to cover prescription drugs in their Medicaid programs, they must cover mifepristone. (States that only comply with the Hyde Amendment must cover medication abortions that are mailed or delivered under the circumstances of rape, incest, and life endangerment; states that use their own funding to cover abortions must reimburse for all medication abortions that are mailed or delivered). Additionally, states should issue bulletins and update their manuals informing providers and patients that they will cover medication abortion that is delivered or mailed, including through mail-order pharmacies.
NHeLP commends the FDA for taking this action and seeks to ensure that Medicaid enrollees and other low-income and underserved patients also benefit from this flexibility.