CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Policy governing 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 DateN/A

Key ActionDo not submit claims for OVA1, Overa, or ROMA for Commercial Products—these services are considered not medically necessary and are subject to denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-cleared tests

92-94%Sensitivity

42-67%Specificity

81500,81503,0003UNot MN codes

CommercialApplicability

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.

Coverage Determination

Commercial Products — Coverage Determination

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

Not medically necessary uses: Includes 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; postoperative testing and monitoring to assess surgical outcome and/or to detect recurrent malignant disease following treatment.

Services listed in policy are considered not medically necessary for Commercial Products.

Per FDA guidance, women without adnexal masses (screening) are outside the intended use population for ovarian adnexal mass assessment score tests and carry recognized public health risks related to false-positive and false-negative results. The FDA requires labeling to warn against use of these tests for screening in women without adnexal pelvic masses and for use as a standalone screening modality. (See FDA black box warning.)

Accordingly, the policy does not support use of OVA1, Overa, or ROMA for screening in women without adnexal masses; such uses are considered not medically necessary for Commercial Products.

For Commercial Products, all uses of OVA1, Overa, and ROMA are considered not medically necessary because peer-reviewed evidence does not demonstrate that these services are effective. Examples of clinical scenarios specifically listed as not medically necessary include: 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 or monitoring to assess surgical outcome or detect recurrence.

Claims for the proprietary test codes listed in this policy (including 81500, 81503, and 0003U) are considered not medically necessary for Commercial Products and are subject to denial.

Coding

Not Medically Necessary / Proprietary Lab CodesCPT | PLANot 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, algorithm reported as a likelihood score

Not Medically Necessary / Proprietary Lab Codes (alternate view)mixedNot 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, algorithm reported as a likelihood score

Provider Actions and Billing Rules

Prior Authorization

Prior authorization is not applicable for these services.

Denial Risk

Not Medically Necessary — Denial Risk

All uses of OVA1, Overa, ROMA tests and the listed assay codes are considered not medically necessary. Claims for these services are subject to denial.

Not medically necessary for preoperative evaluation of adnexal masses to triage for malignancy
Not medically necessary for screening for ovarian cancer
Not medically necessary for selecting patients for surgery for an adnexal mass
Not medically necessary for evaluation of patients with clinical or radiologic evidence of malignancy
Not medically necessary for evaluation of patients with nonspecific signs or symptoms suggesting possible malignancy

Background

Epithelial ovarian cancer refers collectively to high-grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas. These tumors share common pathogenesis, clinical presentation, and therapeutic approaches.

Definitive diagnosis of adnexal masses typically requires surgical evaluation; the majority of adnexal masses are benign. Multimarker serum tests (OVA1, Overa, ROMA) were developed as adjunctive tools to help estimate the likelihood that an adnexal mass is malignant and to assist clinicians in triage decisions, including possible referral to a gynecologic oncologist.

Regulatory history and the FDA’s labeling emphasize that these tests are intended to be used as an adjunct to clinical and radiologic assessment rather than as standalone diagnostic or screening tests. Given insufficient evidence linking use of these multimarker tests to improved patient outcomes, this policy considers their use for the listed indications not medically necessary for Commercial Products.

Definitions

inv-10: Epithelial ovarian cancer — definition and grouping

DefinitionEpithelial ovarian cancer collectively includes high‑grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas due to shared pathogenesis, clinical presentation, and treatment.

Clinical implicationThese malignancies are managed similarly (surgery and oncologic care) and outcomes are improved when treated by gynecologic oncologists.

Biomarker limitationThere is currently no serum biomarker that can distinguish between these carcinoma types.

Policy use of termThe policy uses the term 'epithelial ovarian cancer' to refer to this grouped set of malignancies throughout the document.

inv-11: Intended use of OVA1/Overa/ROMA — adjunctive aid, not standalone

Intended use