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Drug - Makena (hydroxyprogesterone caproate ) 250 mg/mL [Amag Pharmaceuticals, Inc.]

September 2017

Therapeutic area - Progestational Agents

Approval criteria

  • Patient is female and at least 16 years old
  • Makena is a drug administered by a physician. The NDC for Makena is prior authorized only to allow payment when billed via a medical claim (see below)
  • The request is from OBGYN specialty
  • Providers must verify that the recipient's history includes a singleton spontaneous preterm birth (prior to 37 weeks gestation). The recipient must be pregnant with a single fetus. Treatment should begin between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Treatment must end before week 37 (through 36 weeks, 6 days). It may be appropriate to start a recipient at a later gestational age if she presented for prenatal care at that time
  • No more than 20 doses (16 weeks gestation to 36 weeks gestation) will be approved

For Medicaid billing

  • The ICD diagnosis code required for billing Makena is V23.41 (supervision of pregnancy with history of pre-term labor)
  • Diagnosis codes must be supported with adequate documentation in the medical record. Documentation must also follow the criteria indicated above.
  • Providers must bill Makena with HCPCS code Q9986 AND supply the NDC code 
  • One Medicaid unit of coverage is 10 mg. Coverage is limited to 25 units (one 250-mg dose) per week
  • Providers must supply 11-digit National Drug Codes (NDCs) and appropriate NDC units. If the drug was purchased under the 340-B drug pricing program, place a “UD” modifier in the modifier field for that drug detail


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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