OVA1â„¢ is an FDA-cleared qualitative serum test that combines the biomarker values of five immunoassays, using a proprietary algorithm, to further assess the likelihood that an ovarian mass is malignant, in women whose pre-surgical assessment did not indicate malignancy. Highmark Medicare Services will cover OVA1â„¢ in keeping with the FDA-cleared indication until such time that a Local Coverage Determination is developed and implemented. OVA1â„¢ is currently indicated for women who meet the following criteria:
- Over the age of 18, and
- Have an ovarian adnexal mass present for which surgery is planned, and
- Have not been referred to an oncologist, surgical oncologist, or gynecological oncologist.
Until such time that a specific CPT/HCPCS code is issued, the OVA1â„¢ test will be billed to Medicare utilizing the â€œnot otherwise classifiedâ€ (NOC) CPT code, 84999. When billing an NOC code to Medicare, a brief description of the service must be reported in Block 19 of the CMS 1500 paper claim, or the claims note segment of the electronic claim. â€œOVA1â€ will suffice for this brief description. Services billed utilizing an NOC code are individually reviewed and priced accordingly.