Coding for utility

New, tougher requirements for obtaining Medicare coverage are increasing the cost and time needed to get laboratory-developed molecular diagnostics onto the market and decreasing the certainty that they will be covered.

Empowered by a new CMS coding system that for the first time gives payers information about the molecular diagnostic tests they are being asked to cover, Medicare contractors are increasingly making coverage contingent on evidence of clinical utility - evidence that in many cases labs do not possess...