CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Measurement of Human epididymis protein 4 (HE4)

Defines coverage position for measurement of serum HE4 for monitoring ovarian cancer, evaluation of adnexal/ovarian masses, and screening; applies to Medicare Advantage and Commercial products of Blue Cross & Blue Shield of Rhode Island. Describes prior authorization restrictions for laboratories and overall benefit variability by contract.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMeasurement of Human epididymis protein 4 (HE4)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether HE4 testing is covered for the member's specific plan/contract.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this update.

1CPT code listed as not covered/not medically necessary

Medicare & CommercialProducts with negative coverage stance

MultipleFDA-cleared HE4 test kits exist

Coverage Summary

Human epididymis protein 4 (HE4) is a serum biomarker that has been cleared by the FDA for use as an aid in monitoring disease progression or recurrence in individuals with epithelial ovarian cancer, and it has been proposed for evaluation of adnexal/ovarian masses and screening of asymptomatic women.

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Coverage determinations / Medical Necessity

Coverage determinations

Coverage and medical necessity statements provided by product type:

ALL of the following

Medicare Advantage Plans
- Measurement of Human epididymis protein 4 (HE4) is not covered for all indications as the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial Products
- Measurement of Human epididymis protein 4 (HE4) is not medically necessary for all indications as the evidence is insufficient to determine the effects of the technology on health outcomes.
Benefits may vary between groups and contracts; refer to the Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered laboratory testing benefits/coverage.
Some self-funded groups may have contract exclusions related to the Biomarker Testing Mandate (R.I.G.L. §27-19-81); coverage for genetic/biomarker testing for those groups is determined by contract and is detailed in related Genetic Testing Services or Proprietary Laboratory Analyses policies.

Provider Actions and Administrative Requirements

Documentation Required

Benefit verification and member contract check

Providers must refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether HE4 testing is covered for the member's specific plan/contract.

Check the member's Benefit Booklet
Review the Evidence of Coverage
Confirm specifics in the Subscriber Agreement

Prior Authorization

Prior authorization - ordering physician only

Prior authorization is Not applicable per policy, but laboratories are prohibited from obtaining authorization or participating in the authorization process on behalf of the ordering physician; only the ordering physician may be involved in authorization, appeals, or administrative processes related to prior authorization/medical necessity.

Laboratories cannot obtain authorization on behalf of ordering physicians

Denial Risk

Billing risk if unauthorized lab obtains authorization

If a laboratory provides a laboratory service that has not been authorized or is found to have supported the authorization process improperly, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member; BCBSRI may take severe actions up to termination from the provider network.

Unauthorized services may result in termination from the provider network
Unauthorized services become the laboratory's financial liability and cannot be billed to the member

Background and Evidence Summary

HE4 is intended primarily as a serum biomarker to aid in monitoring patients with epithelial ovarian cancer, and it has also been proposed for use in evaluating women with adnexal or ovarian masses and for screening asymptomatic women for ovarian cancer.

Limitations noted in the evidence include that HE4 generally shows diagnostic accuracy similar to CA-125 (with some studies reporting higher specificity but not sensitivity), cutoffs for HE4 are not established and varied across studies, and there are no prospective controlled trials demonstrating that HE4-directed testing or management changes lead to improved health outcomes. The Risk of Ovarian Malignancy Algorithm (ROMA), which combines HE4 with CA-125 and menopausal status, is explicitly not addressed in this policy.

Regulatory & Diagnostic Evidence

Unsupported block type: paragraph

Clinical Outcome Evidence

Unsupported block type: paragraph

Definitions

HE4Human epididymis protein 4, a serum biomarker proposed for monitoring epithelial ovarian cancer, evaluating adnexal masses, and screening.

ROMARisk of Ovarian Malignancy Algorithm combining HE4, CA125, and menopausal status into a numeric score (not addressed in this policy).

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMeasurement of Human epididymis protein 4 (HE4)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether HE4 testing is covered for the member's specific plan/contract.

SourceLink

On This Page

OpenPayer

Measurement of Human epididymis protein 4 (HE4)

Coverage Summary

Coverage determinations / Medical Necessity

Coding — Not Covered

Provider Actions and Administrative Requirements

Background and Evidence Summary

Revision History

Measurement of Human epididymis protein 4 (HE4)

Coverage Summary

Coverage determinations / Medical Necessity

Coding — Not Covered

Provider Actions and Administrative Requirements

Background and Evidence Summary

Related Policies

Revision History