Medicare Coverage

April 21, 2016 BACK TO RESOURCES

OBJECTIVE:

To articulate a persuasive coverage claim for a diagnostic test, based on current Medicare statute and regulation, precedent, and clinical evidence.

APPROACH:

Conduct evidence review to identify the magnitude and direction of available published evidence on the index technology and similar tests used for compatible indications. Assess the impact of FDA labeling or the absence of FDA review for LDTs. Identify thought leaders among the Medicare contractor medical directors.

OUTPUT:

  • Develop realistic implementable options
  • Develop appropriate applications for coverage requests, pricing and coding
  • Attend public meetings, answer CMS questions
  • Create private meeting opportunity as necessary
  • Develop stakeholder engagement plan, as applicable

AUDIENCE:

Senior executives, physicians

USE BY CLIENT:

Determine the most favorable local or national coverage Medicare strategy in light of CMS authorities and precedents.

DURATION:

Nine – twelve months