Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.
The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.
The NGS-based test, which was approved by the FDA in June, will be now available to the insurers' members, who have non-small cell lung cancer, in four states.
BUPA Global and other private health insurers have approved reimbursement for OncoDNA's test, which is intended to provide a complete genetic profile of a patient's tumor.
Payors say online, automated systems will bring standardization and efficiency to prior authorizations, but doctors and labs are uncertain about the impact on patient care.
