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Makena (hydroxyprogesterone caproate) Precertification Request — Coverage Criteria
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Precertification form and requirements for authorization of Makena (hydroxyprogesterone caproate) injectable therapy to reduce risk of recurrent spontaneous preterm birth; affects Aetna members and their prescribing providers seeking coverage.
No material clinical or coverage changes in this revision.
Medical Necessity & Exclusions
Medical necessity criteria (information requested)
Covered when ALL of the following are met (form collects these data to support coverage determination):
Form asks if medication is being prescribed to reduce risk of preterm birth and for current and start gestational ages.
Form specifically asks whether patient had prior spontaneous preterm birth and the gestational age.
Form provides checklist of contraindications to be selected if present.
The form lists specific contraindications that, if present, would exclude use of hydroxyprogesterone caproate. Explicit exclusions include current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer or other hormone-sensitive cancers (including a history of hormone-sensitive cancer); cholestatic jaundice of pregnancy; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; uncontrolled hypertension; and liver tumors (benign or malignant) or active liver disease.
All clinical information requested on the precertification form must be completed for review. Requests that do not document the required elements — including current gestational age, the intended gestational age to start therapy, confirmation that the medication is being prescribed to reduce risk of preterm birth, singleton pregnancy status, and documentation of prior spontaneous preterm birth (with prior gestational age and whether it was a singleton) — lack the information needed to determine medical necessity. Absent these details or if contraindications listed on the form are present, the request may not meet criteria and may be returned for additional information or denied.
Requested Billing & Diagnosis Codes
| Administration code(s) (CPT) | Administration CPT codes — form requests provider to indicate applicable CPT administration codes |
| Primary ICD Code | Form requests primary ICD diagnosis code relevant to the indication |
Precertification & Submission Requirements
Prior Authorization Required
Prior authorization is required for Makena (hydroxyprogesterone caproate). Submit the completed precertification request to Aetna using the contact details below. Treatment start or continuation dates must be provided on the form.
- Indicate start of treatment date or date of last treatment for continuation
- Provide prescriber contact and license/NPI/DEA information
- Use Medicare request form for Medicare Advantage Part B members
Step Therapy Not Specified
No step therapy requirements are specified on the precertification form. The form explicitly asks whether the medication is being prescribed to reduce the risk of preterm birth and whether the pregnancy is a singleton.
- Form question: "Is the requested medication being prescribed to reduce the risk of preterm birth?" (Yes/No)
- Form question: "Is this a singleton pregnancy?" (Yes/No)
Required Documentation for Review
Complete clinical and administrative documentation is required for review. All required fields on the Makena precertification request must be completed and legible; include supporting clinical records as noted below.
- Patient demographics: name, DOB, address, contact information, weight, height, allergies
- Prescriber information: name, specialty, address, phone, fax, state license, NPI, DEA, UPIN, office contact
- Treatment details: start date or date of last treatment, requested product (brand or generic), dose, frequency
- Pregnancy clinical information: current gestational age (weeks/days) and date recorded; gestational age at intended treatment start
- Risk/indication details: whether prescribed to reduce risk of preterm birth; singleton pregnancy status; history of prior spontaneous preterm birth and gestational age of prior preterm birth; whether prior preterm birth was singleton
- Contraindications: documentation of any contraindications (thrombosis/thromboembolic history, known or suspected breast cancer, other hormone-sensitive cancer, cholestatic jaundice of pregnancy, undiagnosed abnormal vaginal bleeding, uncontrolled hypertension, liver tumors/active liver disease)
- Signature and date: request completed by (signature required) and date
Requests May Be Denied for Incomplete or False Information
The plan may request additional information or clarification if needed to evaluate requests. Providing materially false or fraudulent information may result in denial of the request and could subject the filer to criminal and civil penalties.
- Aetna may request additional information to evaluate the precertification
- Fraudulent or materially false information can lead to denial and legal penalties
Clinical Background
Hydroxyprogesterone caproate (Makena) is an injectable progestin used in pregnancy to reduce the risk of recurrent spontaneous preterm birth in patients with a prior spontaneous preterm delivery. The precertification form collects current pregnancy details, intended start gestational age, confirmation that the drug is being prescribed to reduce the risk of preterm birth, singleton pregnancy status, and information about prior spontaneous preterm birth (delivery at less than 37 weeks gestation) to support a coverage determination.
Key Definitions
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