CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Multimarker serum tests for ovarian adnexal mass assessment (OVA1, Overa, ROMA)

This policy governs coverage and medical necessity determinations for the OVA1, Overa (OVA1 Next Generation), and ROMA multimarker serum tests used to assess likelihood of malignancy in women with ovarian adnexal masses for Commercial Products with Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultimarker serum tests for ovarian adnexal mass assessment (OVA1, Overa, ROMA)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not use OVA1, Overa, or ROMA for Commercial Products — these tests are considered not medically necessary for the listed indications and will be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-cleared multimarker tests addressed

92-94% / 42-65%Reported sensitivity / specificity

68%Estimated benign probability

Commercial onlyPolicy applicability

40+

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Coverage Criteria — Commercial Products

Commercial Products - General Coverage Stance

All uses of the OVA1, Overa, and ROMA tests are considered not medically necessary for Commercial Products when used for the following indications because evidence is insufficient to determine improvement in net health outcome.

Not medically necessary indications: Preoperative evaluation of adnexal masses to assess for malignancy or for triage; selecting individuals for surgery for an adnexal mass; screening for ovarian cancer; evaluation of individuals with clinical or radiologic evidence of malignancy; postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment; evaluation of individuals with nonspecific signs or symptoms suggesting possible malignancy.

Evidence is insufficient to show that use of these tests improves net health outcomes; tests are intended to be used with clinical assessment and not as standalone tests.

This policy applies to Commercial Products only. For Medicare Advantage plans, providers should consult the Related Policies section for applicable guidance.

This medical policy is provided for informational purposes and is not a guarantee of payment. Coverage, benefits, and member eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement; those documents take precedence over this policy. Providers should verify member-specific benefits and eligibility and obtain any required authorizations per plan documents and participation agreements.

For Commercial Products, the following multimarker serum tests and associated CPT codes are considered not medically necessary for the listed clinical uses: ROMA (CPT 81500), OVA1 (CPT 81503), and Overa / OVA1 Next Generation (CPT 0003U). These tests are not covered when used for preoperative evaluation or triage of adnexal masses, selection of individuals for surgery, screening for ovarian cancer, evaluation when clinical or radiologic evidence of malignancy exists, postoperative monitoring for surgical outcome or recurrent disease, or evaluation of nonspecific signs or symptoms suggesting possible malignancy.

Coding — Test Codes and Coverage Status

Not medically necessary - ROMACPTNot Covered

81500

Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score

Not medically necessary - OVA1CPTNot Covered

81503

Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein Al, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score

Not medically necessary - Overa (OVA1 Next Generation)CPTNot Covered

0003U

Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as likelihood score

Provider Actions, Prior Authorization & Billing Guidance

Prior Authorization

Prior Authorization Determined by Plan

Prior authorization requirements are determined by the member's plan documents and participation agreements. Providers must verify member-specific benefits and eligibility before ordering services.

Prior authorization determined by member plan documents and participation agreements
Providers should verify member-specific benefits and eligibility prior to ordering

Denial Risk

Denial Triggers for Commercial Products

Use of OVA1/Overa and ROMA tests for Commercial Products is considered not medically necessary and will be denied for the listed indications.

Preoperative evaluation of adnexal masses to assess for malignancy or triage
Selecting individuals for surgery for an adnexal mass

Background and Clinical Context

Epithelial ovarian cancer encompasses high-grade serous epithelial ovarian, fallopian tube, and peritoneal carcinomas; definitive diagnosis requires surgical evaluation and pathologic assessment. Most adnexal masses in adult women are benign (estimated ~68% benign), with a smaller proportion representing invasive malignancy. Multimarker serum tests such as OVA1, Overa, and ROMA were developed to assist in assessing the likelihood of malignancy in women presenting with an adnexal mass who have not been referred to an oncologist, to be used alongside clinical and radiologic evaluation rather than as standalone diagnostic or screening tests. Evidence has not demonstrated that use of these tests improves net health outcomes for the commercial populations and indications addressed in this policy.

Definitions and Intended Use

Epithelial ovarian cancer — Group term including high-grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas

DefinitionGroup term that collectively includes high-grade serous epithelial ovarian, fallopian tubal, and primary peritoneal carcinomas which share pathogenesis, clinical presentation, and treatment.

Diagnostic noteThere is currently no serum biomarker that can distinguish between these carcinoma types; definitive diagnosis requires surgery.

EpidemiologyEstimated 19,710 expected U.S. diagnoses in 2023 with approximately 13,270 expected deaths; adnexal masses are benign in ~68% of adult women presenting with a mass.

Clinical implicationPatients with masses that have a high likelihood of malignancy should be referred for surgical staging by a gynecologic oncologist; clearly benign masses do not require specialist referral.

Intended use of tests — Aid in assessing likelihood of malignancy in women with adnexal masses who have not been referred to an oncologist

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultimarker serum tests for ovarian adnexal mass assessment (OVA1, Overa, ROMA)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not use OVA1, Overa, or ROMA for Commercial Products — these tests are considered not medically necessary for the listed indications and will be denied.

SourceLink

On This Page

Screening for ovarian cancer

Evaluation of individuals with clinical or radiologic evidence of malignancy

Postoperative testing/monitoring to assess surgical outcome or detect recurrent disease

Evaluation of individuals with nonspecific signs or symptoms suggesting possible malignancy

Documentation Required

Authorization Process Violations

Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in authorization, appeals, or other administrative processes related to authorization and medical necessity.

Only the ordering physician may pursue authorization, appeals, or administrative processes related to medical necessity
Laboratories, their representatives, or third parties with relationships to laboratories may not obtain authorization on behalf of the ordering physician

Billing Rule

Billing and Coverage Risk

If a laboratory provides a service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member. Benefits and eligibility are determined by the member's subscriber agreement; services determined not to be medically necessary may be denied.

Unauthorized laboratory services may be denied and billed to the laboratory, not the member
Services determined not to be medically necessary may be denied per the subscriber/employer agreement

Primary intended useAid, in conjunction with clinical and radiologic assessment, to assess likelihood of malignancy in women with adnexal masses who have not been referred to an oncologist.

Not intended usesNot intended for screening asymptomatic women, as a standalone diagnostic test, or for selecting patients for surgery except as part of overall clinical assessment.

Population studiedDeveloped and evaluated only in patients with adnexal masses and planned surgeries; manufacturers warn against off-label use (eg, screening).

Regulatory cautionFDA requires boxed warnings to mitigate off-label risks when used for screening, standalone diagnosis, or to determine need for surgery.

Biomarker-based ovarian malignancy risk algorithms — ROMA, RMI, OVA1, MIA and similar names referenced in studies and FDA documents

Examples of algorithms/testsROMA (Risk of Ovarian Malignancy Algorithm), OVA1, Overa (OVA1 Next Generation), RMI, and MIA are biomarker-based ovarian malignancy risk algorithms referenced in the literature and regulatory materials.

Regulatory statusThree multimarker serum-based tests (including OVA1 and ROMA) have received FDA 510(k) clearance for triaging patients with adnexal masses.

Evidence baseMultiple clinical studies and systematic reviews (see Moore et al., Terlikowska et al., meta-analyses) have evaluated diagnostic performance of these algorithms.

Performance reportingPublished reports document sensitivities and specificities for OVA1/Overa in the literature (reported ranges in the brief).