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Multimarker Serum Testing Related to Ovarian Cancer
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Policy governs coverage and prior authorization for FDA-cleared multimarker serum tests (OVA1, Overa, ROMA) used to assess malignancy risk in women with ovarian adnexal masses for Blue Cross Blue Shield - Rhode Island members.
Effective 9/1/2026, OVA1 (CPT 81503) is considered medically necessary when online authorization criteria are met for Medicare Advantage and Commercial Products.
Overa (0003U) and ROMA (81500) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products for all uses.
Prior authorization is recommended for Commercial Products via the online tool for OVA1.
Coverage Criteria
Medically Necessary: OVA1
Covered when ALL of the following are met
Authorization via the online tool required for participating providers
Not Medically Necessary / Not Covered: Overa and ROMA
All uses of Overa and ROMA are not covered/not medically necessary, including but not limited to:
Evidence insufficient to demonstrate improvement in net health outcome
For some self-funded employer groups that have contractually excluded expanded coverage of biomarker testing under the state mandate (R.I.G.L. §27-19-81), certain genetic testing services related to biomarker testing may be subject to a contractual exclusion. Providers should refer to the member's Benefit Booklet and related Genetic Testing Services or Proprietary Laboratory Analyses policies to determine whether a specific service is covered, not medically necessary, or excluded for that member's plan.
If a service is determined to be not medically necessary or is a non‑covered benefit, the provider may not bill the member for that service unless the member has been informed in advance and has agreed in writing to assume financial responsibility.
Available evidence does not demonstrate that FDA‑cleared multimarker serum tests (including Overa and ROMA) improve net health outcomes by guiding referral to gynecologic oncology or changing management to improve survival or other patient‑centered outcomes. OVA1 is the only test in this policy designated as potentially medically necessary (when authorization criteria are met); by contrast, Overa (0003U) and ROMA (81500) are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because the evidence is insufficient to show improvement in net health outcome.
The policy reiterates that services found to be not medically necessary or non‑covered benefits may not be charged to the member unless the member has provided prior written agreement to accept financial responsibility.
Covered Indications
Coding
| 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 |
| 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 |
Provider Actions and Authorization
Prior authorization recommended for OVA1 (CPT 81503)
Prior authorization is recommended for OVA1 (CPT 81503) for Commercial Products via the online tool for participating providers; effective 9/1/2026 OVA1 is considered medically necessary when the medical criteria in the online authorization tool are met.
- Test: OVA1 (Aspira Labs) — CPT 81503
- Commercial Products: prior authorization recommended via online tool
- Effective date for medical necessity when authorized: 9/1/2026
Verify member benefits and eligibility
Verify the member's benefits and eligibility prior to performing testing; benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement—contact the provider call center for member-specific details.
- Check subscriber/member certificate and employer agreement for covered benefits
- Contact BCBSRI provider call center for member-specific benefit details
Ordering physician must own authorization and appeals
Ordering physicians must be directly involved in the authorization, appeal, and other administrative processes related to prior authorization/medical necessity; laboratories or third parties must not obtain authorizations on the physician’s behalf.
- Laboratories and third parties are prohibited from obtaining or participating in authorization on behalf of the ordering physician
- Violations may result in severe action, up to termination from the BCBSRI provider network
Labs/third parties cannot obtain or facilitate authorization
Do not allow laboratories or their representatives to facilitate any portion of the authorization process or any appeal; if a laboratory or third party supports the authorization process improperly, BCBSRI will deem it a policy violation and take severe action.
- Prohibition includes preparation of documentation of clinical appropriateness or facilitating appeals
- Noncompliant actions may lead to termination from the BCBSRI provider network
Authorization ownership — ordering physician responsibility
Only the ordering physician shall be involved in authorization, appeal, or other administrative processes related to prior authorization/medical necessity; laboratories or third parties must not obtain authorization on the physician’s behalf.
- Ordering physician responsibility includes initiation and management of authorization and appeals
- Laboratories may not act as the ordering physician’s representative in these processes
Check member-specific benefits and eligibility
Providers must check the member's subscriber agreement or member certificate and/or employer agreement to determine member-specific benefits and eligibility; contact the provider call center for benefit specifics.
- Verify coverage specifics before ordering tests
- Member agreements supersede policy language for benefit determinations
Unauthorized laboratory services will be denied and not billable to member
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and will be the financial liability of the participating laboratory; such services may not be billed to the member.
- Unauthorized lab-performed services will be denied as the lab’s financial liability
- Do not attempt to bill the member for unauthorized lab services
Risk of provider financial liability for non‑covered or not medically necessary services
Services determined to be not medically necessary or that are non-covered benefits may not be charged to the member unless the member has been informed and has agreed in writing in advance to continue at their own expense; verify participation agreement provisions.
- Obtain prior written agreement from the member before charging for non-covered or not medically necessary services
- Refer to provider participation agreements for applicable provisions
Ordering physician must manage authorization and appeals — labs/third parties prohibited
The ordering physician must be involved in authorization and appeals; laboratories or third parties cannot obtain authorization on the physician’s behalf and must not participate in the authorization or appeal processes.
- Ordering physician responsible for authorization and subsequent appeals
- Laboratories/third parties are prohibited from obtaining or facilitating authorizations
Not Covered / Not Medically Necessary
All uses of Overa (CPT 0003U) and ROMA (CPT 81500) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products for any indication, including but not limited to preoperative triage of adnexal masses, screening, selection for surgery, evaluation of suspected malignancy, evaluation of nonspecific symptoms, and postoperative monitoring.
This document portion does not list additional specific molecular or genetic tests as not covered beyond those named (Overa and ROMA). Providers should consult the applicable Benefit Booklet and related policies for any plan‑specific exclusions or additional noncovered tests.
Background
Epithelial ovarian cancer refers to high‑grade serous epithelial ovarian, fallopian tube, and peritoneal carcinomas grouped together because of shared pathogenesis and clinical features. Most adnexal masses are benign, and definitive diagnosis requires surgical evaluation. Multimarker serum tests (OVA1, Overa, ROMA) are intended as adjuncts to clinical assessment to help triage adnexal masses, but they are not a substitute for surgical diagnosis or for evaluation by a gynecologic oncologist when malignancy is suspected.
Definitions
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