CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Multimarker Serum Testing Related to Ovarian Cancer (OVA1, Overa, ROMA)

Defines coverage determination for multimarker serum tests (OVA1, Overa, ROMA) used to assess ovarian malignancy risk in patients with adnexal masses for Commercial products of Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultimarker Serum Testing Related to Ovarian Cancer (OVA1, Overa, ROMA)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 10, 2015

Next Review Date

Key ActionDo not use OVA1, Overa, or ROMA for Commercial members — these tests are considered not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-cleared multimarker tests discussed

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

Commercial onlyApplies to

Not medically necessaryCoverage stance

Coverage Criteria

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 — Commercial Products

All uses of OVA1, Overa, and ROMA are considered not medically necessary for Commercial products because evidence is insufficient to demonstrate clinical benefit.

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

Diagnostic accuracy data (e.g., reported sensitivities 90–94% and specificities 42–67% for OVA1/Overa/ROMA) exist, but the chain of evidence linking use of these tests to improved patient outcomes is incomplete; therefore services are considered not medically necessary for Commercial products.

For Commercial Products, all uses of the OVA1, Overa, and ROMA tests are considered not medically necessary because the peer‑reviewed literature is insufficient to demonstrate clinical effectiveness. Not medically necessary indications include, but are not limited to: preoperative evaluation of adnexal masses to triage for malignancy, screening for ovarian cancer, selecting patients for surgery for an adnexal mass, evaluation of patients with clinical or radiologic evidence of malignancy, evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy, and postoperative testing and monitoring to assess surgical outcome or detect recurrent disease. The following procedure codes associated with these multimarker tests are listed as not covered: 81500, 81503, 0003U.

Coding

Not medically necessary - specific procedure codesCPT|PLA|HCPCSNot Covered

81500	Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
81503	Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score
0003U	Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum

Provider Actions

Note

Prior Authorization

Not applicable

Note

(Provider Action)

Note

Benefit Verification

Benefits may vary between groups and contracts. Refer to the member's Benefit Booklet, Evidence of Coverage (EOC), or Subscriber Agreement for benefit-specific determinations and member-specific eligibility. For questions about member benefits, contact the provider call center.

Denial Risk

Denial Triggers

Denial triggers — The following are considered not medically necessary and may result in claim denial: use of OVA1, Overa, ROMA tests for all indications (including preoperative evaluation of adnexal masses to triage for malignancy; screening for ovarian cancer; selecting patients for surgery for an adnexal mass; evaluation of patients with clinical or radiologic evidence of malignancy; evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy; and postoperative testing/monitoring to assess surgical outcome or detect recurrent disease). Additionally, the listed multianalyte biochemical assays and related CPT/PLA codes (including but not limited to 81500, 81503, and PLA code 0003U) for ovarian cancer risk scoring are considered not medically necessary.

All uses of OVA1, Overa, ROMA are not medically necessary
81500, 81503, 0003U and similar multianalyte ovarian risk assays are not medically necessary

Background

Epithelial ovarian cancer refers collectively to high‑grade serous epithelial ovarian, fallopian tube, and peritoneal carcinomas. Diagnosis requires surgical evaluation, and outcomes are improved when patients are managed by gynecologic oncologists. Multimarker serum tests such as OVA1, Overa, and ROMA were developed as adjunctive aids to help triage adnexal masses in conjunction with clinical and radiologic assessment, but they are not intended as standalone screening tests or as definitive tests to determine surgical management.

Definitions

Epithelial ovarian cancer — key facts

DefinitionEpithelial ovarian cancer: collective term for high‑grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas that share pathogenesis, clinical presentation, and treatment.

DiagnosisDefinitive diagnosis requires surgery and pathologic evaluation; tumor staging and completeness of resection impact outcomes.

Epidemiology (example year)Estimated 22,440 women in the U.S. were expected to be diagnosed in 2017 with ovarian cancer, with ~14,080 deaths.

Clinical impactOutcomes are improved when patients are managed by gynecologic oncologists, particularly for advanced‑stage disease.

Limitations of biomarkersNo serum biomarker can currently distinguish among these carcinoma types.

Intended use of OVA1/Overa/ROMA — adjunctive aid, not diagnostic alone

Intended useMultimarker tests (OVA1, Overa, ROMA) are intended as adjunctive aids, used in conjunction with clinical and radiologic assessment to help assess likelihood of malignancy in women with adnexal masses.

Not for screeningThese tests are not intended for screening asymptomatic women or for use in women without adnexal pelvic masses (off‑label screening poses patient harm risks).

Not standalone diagnosticTests are not intended to be used as standalone diagnostics to determine surgery or replace clinical judgment; they were developed and evaluated only in patients with adnexal masses and planned surgeries.

Risk communicationsFDA requires labeling (black box) to warn against off‑label use (screening, standalone diagnostic, or use to determine need for surgery) because of risks from false‑positive and false‑negative results.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMultimarker Serum Testing Related to Ovarian Cancer (OVA1, Overa, ROMA)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 10, 2015

Next Review Date

Key ActionDo not use OVA1, Overa, or ROMA for Commercial members — these tests are considered not medically necessary.

SourceLink

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