Page 1 GAO-25-107911 Medicaid Coverage of Medical Abortions
Outpatient prescription drug coverage is an optional benefit under Medicaid, a
joint federal-state program that finances health care for certain low-income and
medically needy individuals. Medicaid programs that choose to cover prescription
drugs generally must 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).
The MDRP provides significant discounts to Medicaid programs in the form of
rebates for certain outpatient prescription drugs.
Mifepristone is approved by the FDA, in a regimen with the prescription drug
misoprostol, for the medical termination of an intrauterine pregnancy, known as a
medical abortion. In September 2000, FDA approved Mifeprex—the brand name
drug for mifepristone 200 mg—for medical abortions. In April 2019, FDA
approved a generic equivalent, referred to as Mifepristone Tablets, 200 mg, for
the same purpose. Both drugs are approved for medical abortion through 70
days gestation. While not approved for any other indications, both drugs have
been used for “off-label” purposes to treat other conditions, such as uterine
fibroids. Danco Laboratories and GenBioPro are the exclusive manufacturers of
Mifeprex and Mifepristone Tablets, 200 mg, respectively, and both participate in
the MDRP.
Within the Department of Health and Human Services (HHS) the Centers for
Medicare & Medicaid Services (CMS) is responsible for monitoring Medicaid
programs’ compliance with federal requirements, including those related to the
MDRP. In 2019, we reported that CMS was unaware that some state Medicaid
programs did not cover Mifeprex as statutorily required.
We were asked to update our findings on Medicaid programs’ coverage of
mifepristone. This report examines Medicaid programs’ coverage of Mifeprex and
Mifepristone Tablets, 200 mg, and identifies programs that claimed a Medicaid
rebate for them in the last 5 years.
• All 50 states, the District of Columbia, and Puerto Rico have opted to cover
prescription drugs and participate in the MDRP. Thus, they are required to
cover Mifeprex and Mifepristone Tablets, 200 mg for beneficiaries when
prescribed for medical abortion in circumstances eligible for federal funding.
This includes when the pregnancy is the result of rape or incest, or the life of
the pregnant woman is endangered unless an abortion is performed.
• Officials from 35 of the 49 Medicaid programs who responded to our
questions told us their programs covered Mifeprex and Mifepristone Tablets,
U.S. Government Accountability Office
: Action Needed to Ensure
Compliance with Medicaid Drug Rebate
-25-107911
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