What GAO Found

Medicaid programs that choose to cover outpatient prescription drugs are required to cover all Food and Drug Administration (FDA) approved drugs for their medically accepted indications when those drugs are made by a manufacturer that participates in the Medicaid Drug Rebate Program (MDRP), except as outlined in federal law. The FDA has approved two drugs—Mifeprex in 2000 and its generic equivalent in 2019, referred to as Mifepristone Tablets, 200 mg—for the medical termination of an intrauterine pregnancy, known as a medical abortion. Danco Laboratories and GenBioPro are the exclusive manufacturers of Mifeprex and Mifepristone Tablets, 200 mg, respectively, and both manufacturers participate in the MDRP.

Medicaid programs in all 50 states, the District of Columbia, and Puerto Rico cover prescription drugs and participate in the MDRP. According to officials from the Centers for Medicare & Medicaid Services (CMS)—the federal agency within the Department of Health and Human Services (HHS) responsible for ensuring Medicaid programs’ compliance—none of the MDRP’s statutory exceptions apply to Mifeprex or Mifepristone Tablets, 200 mg. Thus, these 52 Medicaid programs must cover these drugs when prescribed for medical abortion in circumstances eligible for federal funding, such as when the pregnancy is the result of rape or incest.

GAO identified gaps in Medicaid programs’ coverage of Mifeprex and Mifepristone Tablets, 200 mg. Officials from 35 of the 49 programs who responded to GAO questions said their programs covered Mifeprex and Mifepristone Tablets, 200 mg for medical abortion, as of December 31, 2024. In contrast, officials from 13 programs told GAO their programs did not cover either drug for medical abortion. An official from the remaining program did not specify the medical indications for which its program covered the drugs.

Medicaid Programs’ Coverage of Danco Laboratories’ Mifeprex and GenBioPro’s Mifepristone Tablets, 200 mg, as of December 31, 2024

Note: For more details, see fig. 1 in GAO-25-107911.

State officials’ responses to GAO’s questions indicated that some states may not be complying with the MDRP requirements for covering Mifeprex and Mifepristone Tablets, 200 mg. However, CMS has not determined the extent to which states comply with the MDRP requirements for these drugs. CMS officials told GAO they were not aware of the following:

• Nine programs did not cover Mifeprex and Mifepristone Tablets, 200 mg for any medical indication, as of December 31, 2024; GAO reported four of these programs did not cover Mifeprex in 2019. Mifepristone Tablets, 200 mg was not available at the time of GAO’s 2019 report.
• Four additional Medicaid programs did not cover either drug when prescribed for medical abortion, as of December 31, 2024.

CMS was not aware of these coverage gaps, in part, because it had not implemented GAO’s 2019 recommendation to take actions to ensure Medicaid programs comply with MDRP requirements to cover Mifeprex. CMS also has not taken actions related to the coverage of Mifepristone Tablets, 200 mg, as of August 2025. Without such actions, CMS lacks assurance that Medicaid programs comply with MDRP requirements and Medicaid beneficiaries may lack access to these drugs when appropriate.

Why GAO Did This Study

GAO was asked to describe Medicaid programs’ coverage of mifepristone. This report examines Medicaid programs’ coverage of Mifeprex and Mifepristone Tablets, 200 mg, among other things.

GAO reviewed laws and CMS guidance on the MDRP, and coverage of Mifeprex and Mifepristone Tablets, 200 mg. GAO also sent written questions to officials from the 52 Medicaid programs that participate in the MDRP regarding their coverage of these drugs, and reviewed officials’ responses from the 49 programs that provided GAO information.