skip to content
Primary navigation

Hydroxyprogesterone caproate

Drugs – Hydroxyprogesterone caproate vial

Makena vial

Makena autoinjector 

September 2019

Therapeutic area - Progestational Agents

Approval criteria

  • Patient is female and at least 16 years old AND
  • The requested drug must be billed as a medical claim AND
  • The request is from OBGYN specialty AND
  • Providers must verify that the recipient's history includes a singleton spontaneous preterm birth (prior to 37 weeks gestation) AND
  • 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.


  • The ICD-10 diagnosis codes accepted for billing are:
    • O09.211 OR
    • O09.212 OR
    • O09.213 OR
    • O09.219 OR
    • Z87.51
  • Diagnosis code must be supported with adequate documentation in the medical record. Documentation must also follow the criteria indicated above
  • Providers must bill for requested drug using HCPCS code J1726 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

Quantity Limit

  • No more than 20 doses (16 weeks gestation to 36 weeks gestation) will be approved

Background Information

  • All formulations of hydroxyprogesterone caproate must be administered by a healthcare provider
  • While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth


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

back to top