CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Salivary Estriol as Risk Predictor for Preterm Labor and Management of Menopause and/or Aging

This policy governs coverage of salivary hormone testing (including salivary estriol/SalEst) for predicting preterm labor and for the management/monitoring of menopause or aging for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySalivary Estriol as Risk Predictor for Preterm Labor and Management of Menopause and/or Aging

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionVerify member benefits and refer to the Evidence of Coverage or Subscriber Agreement to determine prior authorization requirements or non-covered benefits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessaryCoverage stance (commercial)

S3650, S3652HCPCS codes listed

22-36 wksSalEst gestational window

~11%US preterm birth rate cited

Coverage Determinations

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Not Medically Necessary indications

Coverage determination

Salivary testing for management of menopause/aging: Salivary hormone testing for diagnosis, treatment, or monitoring of menopause or aging is considered not medically necessary due to insufficient evidence of validity and lack of published studies demonstrating clinical utility.

Supported by professional statements and insufficient evidence

Salivary estriol (SalEst) for preterm labor risk: Measurement of salivary estriol (SalEst) as a risk predictor for preterm labor is considered not medically necessary because no clinical studies demonstrate that treatment decisions based on salivary testing result in beneficial health outcomes, despite FDA clearance of the SalEst system for measuring salivary estriol between 22 and 36 weeks in singleton pregnancies.gestational age 22-36 weeks noted in source

SalEst is FDA-approved for measurement but clinical utility unproven

Salivary hormone testing, including assays used to assess menopausal status or aging, is not medically necessary for diagnosis, treatment, or monitoring in commercial products. This determination is based on insufficient evidence demonstrating validity and a lack of studies showing improved health outcomes from management guided by salivary hormone results.

Measurement of salivary estriol (SalEst) for the purpose of predicting preterm labor is also considered not medically necessary. Although salivary estriol levels have been observed to rise prior to spontaneous preterm labor and the SalEst system is FDA-cleared for use between 22 and 36 weeks in singleton pregnancies, there are no clinical studies demonstrating that treatment decisions based on salivary testing lead to beneficial health outcomes.

The use of salivary hormone testing is considered not medically necessary for commercial products. In addition, the following HCPCS code is specifically listed as not medically necessary: S3652 (Saliva test; hormone level; to assess preterm labor risk).

HCPCS code S3650 (Saliva test, hormone level; during menopause) is also listed in the policy coding section and the policy notes that salivary hormone testing is not medically necessary for menopausal management.

Provider Responsibilities and Billing Guidance

Prior Authorization

Verify Member Benefits

Check member benefits before ordering — coverage depends on the member's group contract. Refer to the Evidence of Coverage, Subscriber Agreement, or Benefit Booklet for applicable coverage, Not Covered, or Not Medically Necessary provisions.

Verify benefits and medical necessity with the member's plan prior to testing.
For Medicare and Commercial Products, note specific HCPCS guidance below.

Denial Risk

Not Medically Necessary — Salivary Hormone Testing

Salivary hormone testing (including saliva assays for menopause and other hormone level assessments) is considered not medically necessary for Commercial products; evidence is insufficient to demonstrate clinical benefit. Document clinical rationale if requesting coverage exceptions.

Salivary hormone testing is generally Not Medically Necessary for Commercial Products.
If submitting an exception request, include supporting clinical documentation that addresses why alternative, accepted testing modalities are not appropriate.

Billing Rule

Denial Triggers and Coding

The following HCPCS code is considered not medically necessary and is a likely denial trigger when billed: S3652 (Saliva test; hormone level; to assess preterm labor risk). Use caution when billing and include documentation if clinical circumstances warrant review.

HCPCS S3652 — not medically necessary (denial risk).
HCPCS S3650 noted in source as "Saliva test, hormone level; during menopause" — verify benefits; policy does not support routine salivary testing.

Documentation Required

Provider Responsibilities

Provider actions: verify eligibility and benefits, obtain any required prior authorization per the member's plan, and document medical necessity and rationale in the medical record. When requesting coverage or filing an appeal, include test indication, prior tests and results, and why saliva-based testing is clinically necessary over accepted methods.

Verify member benefits and prior authorization requirements before ordering.
Document clinical indication, prior testing, and rationale in the medical record to support any exception or appeal.
If billing, use appropriate HCPCS/CPT codes and expect denial for S3652 unless exceptional documentation is provided.

Background and Rationale

Salivary hormone assays have been proposed for two primary clinical applications: evaluation of hormone status in menopause/aging and assessment of preterm birth risk. For preterm birth, salivary estriol has been observed to surge several weeks before spontaneous preterm labor, and the SalEst system is FDA-approved as a laboratory method to measure salivary estriol as a risk assessment marker. SalEst is indicated for use every 1 to 2 weeks in singleton pregnancies between 22 and 36 weeks. However, no clinical studies demonstrate that making treatment decisions based on salivary hormone results improves health outcomes, and therefore these applications are considered investigational or not medically necessary in this policy.

Definitions

SalEst (salivary estriol) — description and monitoring

FDA-cleared techniqueSalEst — an FDA‑approved laboratory technique for measuring salivary estriol as a risk‑assessment marker for preterm labor

Indicated gestational windowSingleton pregnancies between 22 and 36 weeks of gestation

Monitoring frequencyTest indicated for use every 1 to 2 weeks

Clinical purposeRisk assessment for preterm labor and delivery based on observed surges in salivary estriol prior to spontaneous preterm labor

Evidence summaryNo clinical studies demonstrate that treatment decisions guided by salivary testing improve health outcomes; therefore salivary testing is considered not medically necessary