CurrentNorth Carolina MedicaidPolicy N/A

Crinone 8% Gel (progesterone) Coverage Criteria

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This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Crinone 8% Gel (progesterone), subject to beneficiary enrollment and eligibility-related service restrictions.

Policy Summary

PayerNorth Carolina Medicaid

PolicyCrinone 8% Gel (progesterone) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative reviewno material clinical or coverage changes

Effective DateNovember 1, 2014

Last ReviewJan 5, 2026

Next Review DateN/A

Key ActionSubmit Crinone 8% Gel requests through outpatient pharmacy prior approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8%Crinone gel strength covered by this policy

2 boxesMaximum quantity approved per 30 days

15Single-use applicators per box

≤25 mmTransvaginal cervical length threshold

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CurrentNorth Carolina MedicaidPolicy N/A

Crinone 8% Gel (progesterone) Coverage Criteria

Customize your policy alerts

Sign up for all North Carolina Medicaid policy alerts

Know when North Carolina Medicaid releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs North Carolina Medicaid outpatient pharmacy prior approval for Crinone 8% Gel (progesterone), subject to beneficiary enrollment and eligibility-related service restrictions.

Policy Summary

PayerNorth Carolina Medicaid

PolicyCrinone 8% Gel (progesterone) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative reviewno material clinical or coverage changes

Effective DateNovember 1, 2014

Last ReviewJan 5, 2026

Next Review DateN/A

Key ActionSubmit Crinone 8% Gel requests through outpatient pharmacy prior approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8%Crinone gel strength covered by this policy

2 boxesMaximum quantity approved per 30 days

15Single-use applicators per box

≤25 mmTransvaginal cervical length threshold

Gestational age window

No changesResult of January 5, 2026 review

Coverage Criteria

Initial coverage criteria

Covered when all of the following are met:

Coverage requirements

Qualifying indication
- Short cervix: Documented ultrasound shows a transvaginal cervical length (TVCL) of 25 mm or less between weeks 17 and 24 of gestation.TVCL ≤ 25 mm; gestational weeks 17–24
- Secondary amenorrhea: The patient has a diagnosis of secondary amenorrhea and has failed Crinone 4% gel.
Permitted use: Crinone 8% is not being used for infertility.

Crinone 8% Gel is not covered under these criteria when it is used for infertility.

Clinical Measurement Requirement

Transvaginal cervical length

Qualifying measurementTransvaginal cervical length (TVCL) of ≤ 25 mm

Gestational-age windowBetween weeks 17 and 24 of gestation

Provider Requirements and Request Documentation

Prior Authorization

Prior Approval Required

Obtain outpatient pharmacy prior approval before dispensing Crinone 8% Gel when prior approval is required. Beneficiaries under 21 are not exempt from the prior approval requirement.

Refer to the NCTracks Provider Claims and Billing Assistance Guide and the EPSDT provider page for additional prior approval information.

Step Therapy

Crinone 4% Failure Required

For secondary amenorrhea, document that the patient has failed Crinone 4% gel before requesting coverage of Crinone 8% Gel.

Documentation Required

Document Short Cervix by TVCL

Product and Policy Background

Crinone 8% Gel contains vaginal progesterone and is covered under this policy for specified obstetric and gynecologic indications, including a documented short cervix or secondary amenorrhea after failure of Crinone 4% gel. The quantity limit is 2 boxes per 30 days, with 15 single-use applicators per box.

Definitions

Transvaginal cervical length (TVCL)

MeasurementUltrasound measurement of cervical length performed through the vagina.

Qualifying short cervix

Cervical-length threshold25 mm or less

Gestational-age intervalBetween 17 and 24 weeks of gestation

Initial Therapy Requirements

Initial therapy requirements

Initial approval requires one qualifying indication, documentation of the applicable clinical criteria, and confirmation that Crinone 8% is not being used for infertility.

Indication pathway
- Short cervix pathway: Provide documented ultrasound measurement of transvaginal cervical length (TVCL) of 25 mm or less obtained between 17 and 24 weeks of gestation.TVCL ≤ 25 mm; gestational weeks 17–24
  Documentation must include the qualifying ultrasound measurement.
- Secondary amenorrhea pathway: Document a diagnosis of secondary amenorrhea and failure of Crinone 4% gel before Crinone 8% gel is approved.
  Crinone 4% gel must be tried and failed for this indication.

Step Therapy

Step	Medication	Requirement
1	Crinone 4% gel	For secondary amenorrhea, try and fail Crinone 4% gel before Crinone 8% gel is approved.

Quantity Limits

Crinone 8% Gel quantity limit

Maximum approved quantity2 boxes per 30 days

Applicators per box15 single-use applicators per box

Policy Summary

PayerNorth Carolina Medicaid

PolicyCrinone 8% Gel (progesterone) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative reviewno material clinical or coverage changes

Effective DateNovember 1, 2014

Last ReviewJan 5, 2026

Next Review DateN/A

Key ActionSubmit Crinone 8% Gel requests through outpatient pharmacy prior approval.

SourceLink

On This Page

Document an ultrasound measurement of transvaginal cervical length (TVCL) of ≤ 25 mm obtained between weeks 17 and 24 of gestation for the short-cervix indication.

Required documentation: ultrasound-confirmed TVCL ≤ 25 mm.
Applicable gestational-age window: 17–24 weeks.

Documentation Required

Document Secondary Amenorrhea

For secondary amenorrhea, submit documentation of the diagnosis and prior failure of Crinone 4% gel.

Document the secondary amenorrhea diagnosis.
Document failed Crinone 4% gel therapy.

Denial Risk

Exclude Infertility Use

Confirm and document that Crinone 8% Gel is not being requested or used for infertility treatment.

Denial Risk

Infertility Use Is Not Covered

Use of Crinone 8% Gel for infertility is a noncovered indication.

Do not submit requests for infertility treatment.
Requests must meet a covered indication: qualifying short cervix or secondary amenorrhea after Crinone 4% failure.

Documentation Required

Criteria Not Met

If the initial criterion is not met, document the qualifying alternative indication and its required evidence for approval.

Alternative 1: ultrasound-documented TVCL ≤ 25 mm between weeks 17 and 24 of gestation.
Alternative 2: documented secondary amenorrhea with prior failure of Crinone 4% gel.
Also document that treatment is not for infertility.

Billing Rule

Verify Beneficiary Eligibility

Verify that the beneficiary is enrolled in NC Medicaid on the date of service and is not subject to eligibility-category service restrictions that would make the service ineligible.

Confirm enrollment on the date of service.
Check for service restrictions associated with the beneficiary’s eligibility category.

Use restriction: Document that Crinone 8% is not being used for infertility.