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Provider Letter 2023-09: RE: Makena® market withdrawal

Oklahoma SoonerCare·OK · OB-GYN, Family Medicine·Provider Letter
Effective date
Apr 10, 2023
We identified it
Jun 20, 2026
Days to comply

Summary

The FDA has withdrawn approval of Makena® (hydroxyprogesterone caproate injection) for preventing preterm birth due to proven ineffectiveness. SoonerCare (Oklahoma Medicaid) has immediately ended coverage for both brand-name Makena® and compounded hydroxyprogesterone caproate injection as of April 10, 2023.

Action Required

Action needed
Immediately: Stop billing Oklahoma Medicaid (SoonerCare) for Makena® and compounded hydroxyprogesterone caproate injection. Billing team must update system to flag these medications as non-covered for SoonerCare members. Providers must discontinue prescribing these medications and consider alternative treatments per ACOG guidelines. Claims submitted for these medications will be denied.