Monday, July 15, 2013
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.