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Coverage criteria policies

Hydroxyprogesterone caproate (Makena®) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Hydroxyprogesterone caproate (Makena) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

All requests for doses exceeding the FDA-approved regimen will not be covered.

Authorization criteria:
  1. Patient is female and at least 16 years old; and,
  2. 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); and,
  3. The request is from OBGYN specialty; and,
  4. 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.

Quantity limit:

No more than 21 doses (16 weeks gestation to 36 weeks gestation) will be approved

Definitions

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena 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.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS Codes

Codes

Description

J1726

Injection, hydroxyprogesterone caproate, (Makena), 10 mg

NDC Codes

Codes

Description

64011024301

Makena 250 MG/ML OIL

64011024702

Makena 250 MG/ML OIL

64011030103

Makena 275 MG/1.1ML SOAJ

66993003901

Hydroxyprogesterone Caproate 250 MG/ML OIL

66993003883

Hydroxyprogesterone Caproate 250 MG/ML OIL

00517176701

Hydroxyprogesterone Caproate 250 MG/ML OIL

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/makena.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date
Revision date
  • 11/05/2018

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