CurrentAetnaPolicy N/A

Makena (hydroxyprogesterone caproate) Precertification Request — Coverage Criteria

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.

Policy Summary

PayerAetna

PolicyMakena (hydroxyprogesterone caproate) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification request with required clinical information to Aetna via the provided phone or fax for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1primary medication covered by this form

requiredclinical documentation

1-866-752-7021phone

1-888-267-3277fax

Medical Necessity & Exclusions

Medical necessity criteria (information requested)

Covered when ALL of the following are met (form collects these data to support coverage determination):

Indication and pregnancy status: Medication is prescribed to reduce risk of preterm birth; patient is currently pregnant with gestational age provided; intended gestational age to start therapy provided and consistent with label/practice

Form asks if medication is being prescribed to reduce risk of preterm birth and for current and start gestational ages.

History of prior spontaneous preterm birth: Documentation of prior spontaneous preterm birth (delivery <37 weeks) is provided, including gestational age of prior event and whether prior was a singleton pregnancy

Form specifically asks whether patient had prior spontaneous preterm birth and the gestational age.

No contraindications: No listed contraindications to hydroxyprogesterone caproate are present (e.g., current/history of thrombosis or thromboembolic disorders; known or suspected breast cancer; other hormone-sensitive cancer; cholestatic jaundice of pregnancy; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; uncontrolled hypertension; liver tumors or active liver disease)

Policy Summary

PayerAetna

PolicyMakena (hydroxyprogesterone caproate) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification request with required clinical information to Aetna via the provided phone or fax for prior authorization.

SourceLink

On This Page

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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 CPT codes (requested)CPT

Administration code(s) (CPT)

Administration CPT codes — form requests provider to indicate applicable CPT administration codes

Diagnosis codes (requested)ICD-10

Primary ICD Code

Form requests primary ICD diagnosis code relevant to the indication

Precertification & Submission Requirements

Prior Authorization

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

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)

Documentation Required

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

Denial Risk

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

Previous spontaneous preterm birth — Definition

DefinitionDelivery at less than 37 weeks gestation following preterm labor, preterm rupture of membranes, or cervical insufficiency.

Question on formForm asks: 'Has the patient had a previous spontaneous preterm birth (defined as delivery at less than 37 weeks gestation following preterm labor, preterm rupture of membranes, and cervical insufficiency)?' with checkboxes for Yes/No and space to provide gestational age of prior event.

Gestational age captureForm requests gestational age of prior preterm birth in weeks.

Singleton status of prior eventForm asks whether the previous preterm birth was a singleton pregnancy (Yes/No).

Use in coverage criteriaDocumentation of prior spontaneous preterm birth (<37 weeks) is required as part of the medical necessity information collected for coverage determination.