BCBSRI multimarker ovarian testing Coverage & Prior Auth

Coverage Criteria & Medical Necessity

Medical necessity for OVA1 (81503)

Covered when ALL of the following are met

Medicare Advantage / Commercial coverage for OVA1: OVA1 (CPT 81503) is considered medically necessary when the medical criteria in the online authorization tool for participating providers is met (effective 9/1/2026).

Prior authorization is recommended for Commercial Products via the online authorization tool for participating providers.

Not medically necessary / Not covered uses

Not covered / Not medically necessary in these settings

Noncovered uses for Overa (0003U) and ROMA (81500): All uses of Overa (CPT 0003U) and ROMA (CPT 81500) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Includes but is not limited to: preoperative evaluation of adnexal masses to triage for malignancy; screening for ovarian cancer; selecting individuals for surgery for an adnexal mass; evaluation of individuals with clinical or radiologic evidence of malignancy; evaluation of individuals with nonspecific signs or symptoms suggesting possible malignancy; and postoperative testing and monitoring to assess surgical outcome or detect recurrent disease.

This policy defines coverage for multimarker serum tests used to assess ovarian malignancy risk. OVA1 (CPT 81503) is considered medically necessary for Medicare Advantage Plans and Commercial Products effective 9/1/2026 when the medical criteria in the online authorization tool for participating providers are met; prior authorization is recommended for Commercial Products via the online tool. All uses of Overa (CPT 0003U) and ROMA (CPT 81500) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products, including but not limited to preoperative triage, screening, selection for surgery, evaluation with clinical or radiologic evidence of malignancy, evaluation of nonspecific signs or symptoms, and postoperative testing/monitoring.

Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or employer agreement, which supersede this medical policy. For member-specific benefits and coverage determinations, providers should contact the provider call center. This policy is informational and is not a guarantee of payment.

Specific test-level coverage statements in this policy: Overa (CPT 0003U) and ROMA (CPT 81500) are explicitly listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. OVA1 (CPT 81503) is listed as medically necessary when authorization criteria are met.

Services determined to be not medically necessary (or medically necessary services that are non-covered benefits) may result in denial of coverage and financial liability implications. Providers may not bill members for such services unless the member has been informed and has agreed in writing in advance to accept financial responsibility, per the subscriber/participation agreements.

Indications Considered Medically Necessary

Aid to assess likelihood of malignancy in women presenting with an ovarian adnexal mass — adjunct to clinical and radiologic assessment

Used as an adjunct to clinical and radiologic assessment

Intended use and role: Multimarker serum tests are intended to aid assessment of the likelihood of malignancy in women presenting with an ovarian adnexal mass and are to be used in conjunction with clinical and radiologic evaluation; they were developed and evaluated only in patients with adnexal masses and planned surgeries.

Results should not be used as a stand-alone diagnostic or for screening asymptomatic women.

Preoperative assessment of adnexal/pelvic masses to evaluate risk of ovarian malignancy — evidence support

Supported by multiple studies and guideline references

Preoperative assessment indication: Preoperative use of serum biomarkers (HE4, CA125) and algorithms (ROMA) to evaluate risk of ovarian malignancy in women with adnexal/pelvic masses is addressed in multiple diagnostic accuracy studies, meta-analyses, and guideline publications cited in this policy.

Uses and Indications Not Covered

Use of multimarker tests to screen asymptomatic women, to serve as a stand-alone diagnostic test to determine whether surgery is needed, or for postoperative monitoring/recurrence detection is not supported by the evidence and is not covered/not medically necessary. The FDA has issued a black box warning highlighting the risks of off-label use for screening, stand-alone diagnosis, or using results to decide surgery.

Portions of the policy reiterate that benefits and coverage are governed by the member's subscriber or employer agreement; these sections do not list additional test-specific exclusions beyond those stated elsewhere in the document.

CPT / Code Guidance

Covered CPT Codes (medically necessary when authorized)CPTCovered

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

Not covered / Not medically necessaryCPTNot Covered

81500

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

Not covered / Not medically necessaryCPTNot 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 a likelihood score (Overa/OVA1 Next Generation)

inv-10: CA-125 referral threshold (postmenopausal)

Postmenopausal CA-125 referral threshold35 U/mL

ContextThreshold cited in ACOG guidance as lower threshold for postmenopausal referral

Use noteUsed with other clinical factors (ultrasound, ascites, nodular/fixed mass) to decide referral

inv-11: CA-125 historical referral threshold (premenopausal, prior guidance)

Historical premenopausal CA-125 referral threshold200 U/mL

ContextDescribed as prior expert-opinion guidance; current guidance favors very elevated CA-125 plus other clinical factors

Prior Authorization & Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for OVA1 (Aspira Labs) — CPT 81503 — for Medicare Advantage and Commercial Products when the medical criteria in the online authorization tool for participating providers are met. For Commercial Products, prior authorization is recommended via the online tool for participating providers.

Affected code: CPT 81503 (OVA1 ™, Aspira Labs)
Authorization method: online authorization tool for participating providers
Coverage condition: medical criteria in the online authorization tool must be met

Note

Contact Provider Call Center for Member-Specific Benefits

For member-specific benefits or to confirm whether a service requires prior authorization for a particular member, contact the BCBSRI provider call center. Benefits and eligibility are determined by the member's subscriber agreement or employer agreement and those documents supersede this policy.

Test Frequency and Re-testing

inv-28: OVA1 (81503) — frequency limit/key identifier for the test

Test / CPTOVA1 (Aspira Labs) — CPT 81503

Frequency/authorizationPrior authorization recommended for Commercial Products via the online tool for participating providers

Effective dateConsidered medically necessary when online authorization criteria are met effective 9/1/2026

inv-29: (unnamed frequency limits item)

Frequency limit — placeholderNo specific limit or period specified in policy (see authorization requirements)

Authorization noteLaboratories are not allowed to obtain authorization on behalf of the ordering physician

Background & Scope

Epithelial ovarian cancer (including high-grade serous ovarian, fallopian tube, and peritoneal carcinomas) commonly presents as an adnexal mass; most adnexal masses are benign and surgical evaluation is required for definitive diagnosis. Multimarker serum tests such as OVA1, Overa, and ROMA are intended as adjuncts to clinical and radiologic assessment to help triage women with adnexal masses for appropriate referral and management, not as stand-alone diagnostic or screening tools.

Definitions and Test Descriptions

inv-22: Epithelial ovarian cancer definition

DefinitionEpithelial ovarian cancer includes high-grade serous epithelial ovarian, fallopian tubal, and peritoneal carcinomas

RationaleGrouped due to shared pathogenesis, clinical presentation, and treatment

Clinical noteNo serum biomarker currently distinguishes between these subtypes

inv-23: Off-label risk / FDA warning

FDA-required warningManufacturers must warn against off-label use such as screening asymptomatic women, stand-alone diagnosis, or using results to determine surgery due to morbidity/mortality risks

Examples of off-label risksFalse-positive screening may lead to unnecessary testing and surgery; false-negative results risk missed malignancy

Additional Coding/Code-specific Notes

As a reminder, benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or employer agreement, which supersede this policy. Providers should verify member-specific coverage through the provider call center before ordering tests; this has implications for coding and billing because plan language ultimately governs whether a service is payable.

OpenPayer

Multimarker Serum Testing Related to Ovarian Cancer