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

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

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