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 and medical necessity determinations for salivary hormone testing (including salivary estriol/SalEst) for predicting preterm labor and for management 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 ActionDo not authorize or provide salivary hormone testing for Medicare Advantage members; for commercial members it is considered not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessaryCoverage stance for salivary testing

S3650, S3652HCPCS not covered

22-36 wksGestational window

1–2 wksRecommended frequency

Coverage determination

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Not medically necessary indications

Covered when ALL of the following are met:

Salivary testing for menopause/aging: Salivary hormone testing to diagnose, treat, or monitor menopause or aging is considered not medically necessary because the scientific validity has not been established and no published studies document validity for these indications

Supported by statements from ACOG, FDA, NAMS, ICSI, AACE

Salivary estriol testing for preterm birth risk: Measurement of salivary estriol (e.g., SalEst) to predict preterm labor is considered not medically necessary because no clinical studies demonstrate that treatment decisions based on salivary testing improve health outcomes

SalEst is FDA-cleared for monitoring between 22 and 36 weeks every 1–2 weeks but evidence of beneficial health outcomes is lacking

For Medicare Advantage Plans and Commercial Products, salivary hormone testing is not covered for Medicare Advantage and not medically necessary for Commercial Products due to insufficient evidence that the technology affects health outcomes. Relevant procedure codes identified as not covered/not medically necessary are S3650 and S3652.

Salivary hormone testing to diagnose, treat, or monitor menopause or aging is considered not medically necessary because the scientific validity of salivary hormone levels for these indications has not been established and no published studies document clinical validity.

Measurement of salivary estriol (for example, the FDA-cleared SalEst system) to predict preterm labor risk is considered not medically necessary because no clinical studies demonstrate that treatment decisions based on salivary testing improve health outcomes.

The following HCPCS codes are listed as not covered / not medically necessary: S3650 (saliva test, hormone level; during menopause) and S3652 (saliva test, hormone level; to assess preterm labor risk).

Coding and testing window

Not covered / Not medically necessary HCPCS codesHCPCSNot Covered

S3650	Saliva test, hormone level; during menopause
S3652	Saliva test, hormone level; to assess preterm labor risk

Gestational testing window and recommended frequency per SalEst labeling

Gestational testing windowPregnant women with singleton pregnancies between 22 and 36 weeks gestation

Recommended frequency per SalEst labelingEvery 1 to 2 weeks

Test populationSingleton pregnancies (SalEst labeling)

Clinical limitation notedNo clinical studies demonstrating that treatment decisions based on salivary testing improve health outcomes

What providers need to know and do

Note

Prior Authorization

Prior authorization is not applicable for this policy.

Note

Coverage Stance

The use of salivary hormone testing is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products due to insufficient evidence of clinical benefit.

Documentation Required

Ordering Physician Responsibility

Only the ordering physician may be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.

Only the ordering physician may complete or sign authorization or appeal documents related to medical necessity.

Denial Risk

Unauthorized Laboratory Actions — Denial and Financial Liability

A laboratory must not obtain authorization, facilitate the authorization process, or participate in appeals on behalf of the ordering physician. If a laboratory provides a service that has not been authorized, BCBSRI will deny the service and the financial liability will be the responsibility of the participating laboratory; the laboratory may not bill the member.

Use of a laboratory representative or any third party to obtain or assist with authorization/appeal is prohibited.
Violations may result in severe action up to and including termination from the BCBSRI provider network.

Background and clinical context

Salivary hormone tests measure hormone levels in saliva and have been marketed for uses including management of menopause/aging and as a predictor of preterm labor. Salivary estriol has been observed to surge several weeks before spontaneous preterm labor, and the FDA-cleared SalEst system is labeled for monitoring salivary estriol in singleton pregnancies between 22 and 36 weeks of gestation at a frequency of every 1 to 2 weeks. However, there are no clinical studies showing that basing treatment decisions on salivary testing leads to improved health outcomes, and major professional organizations have raised concerns about the validity of salivary hormone testing for menopause/aging.