Medicare Recommends Crosswalking 2nd Generation OvaWatch Test from Aspira Labs to Original Ova1 Rate
11-9-23 (by: Scott Gleason) The Centers for Medicare & Medicaid Services (CMS) has proposed to crosswalk the reimbursement rate for Aspira Lab’s next generation ovarian cancer test OvaWatch to that of Ova1 during the 2024 Clinical Laboratory Fee Schedule (CLFS) rate setting process. If finalized later this month, as preliminarily approved in September, the reimbursement rate for OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements would be set at $897 maintaining the company’s current reimbursement rate for the new service. Crosswalking, in this context, involves setting the Medicare reimbursement rate for a new laboratory test by assigning it the same rate as a comparable existing test. Aspira supports this proposal, citing the similarities in pre-analytical, analytical, and post-analytical characteristics of OvaWatch and Ova1 assays.
OvaWatch uses seven biomarkers and patient clinical features to provide a more accurate assessment of adnexal masses to allow physicians to confidently recommend conservative medical management instead or surgery to perform pathology on the mass. In a validation published in the spring of 2023, on a large cohort of 2,000 specimens the test demonstrated a sensitivity of 89.8% and a specificity of 84.02%. The positive predictive value was 22.45%, and the negative predictive value was 99.38%. Stratifying by cancer type and stage, the test achieved sensitivities of 94.94% for epithelial ovarian cancer, 76.92% for early-stage cancer, and 98.04% for late-stage cancer. The >99% negative predictive value allows patients and physicians to comfortably know that a negative result carries a very low risk of cancer.
Nicole Sandford, President and CEO of Aspira, expressed enthusiasm about CMS’s proposal, emphasizing its importance in the company’s broader mission of securing comprehensive reimbursement coverage for OvaSuiteSM tests. These tests, known for their non-invasive nature, play a crucial role in identifying ovarian cancer in women with pelvic masses. The move towards aligning reimbursement rates is seen as a significant stride toward making groundbreaking diagnostic technologies accessible to all women facing an ovarian cancer diagnosis.