A judge has ordered the state to provide Medicaid coverage for a pricey drug that prevents premature births.
U.S. District Judge Charles Pannell granted a victory to K-V Pharmaceutical Co., which had accused the Department of Community Health of preventing pregnant women from getting its drug, Makena.
State officials had argued that a readily available custom-compounded drug costs far less and has no major safety issues. They accused K-V of seeking a court order that would let the company gouge taxpayers and consumers.
The compounded drug costs up to $20 per injection. K-V has said it has agreements for Makena's use in other states for rebated rates of less than $300 per injection.
Makena is prescribed to women who have high-risk pregnancies because they previously had at least one premature birth. About 20 doses are prescribed over the course of a pregnancy.
Pannell said the key difference is that Makena has Food and Drug Administration approval and the compounded drug does not.
"Because the court finds that the FDA drug approval process means something," Pannell wrote, the state has an "upside-down policy" because it is covering a drug that is not FDA-approved and not covering one that is.
Pannell ordered the state to discontinue its policy that favors the compounded drug over Makena and to stop denying Medicaid coverage for Makena. The Department of Community Health also must provide written notice to eligible women that its prior policy is no longer in effect and that it will provide coverage for the compounded drug only when a physician finds a patient has a specific medical need for it.
Pannell also ordered K-V to post a bond to cover the cost difference between Medicaid coverage of Makena and the compounded drug, in case his ruling is overturned on appeal.
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