Extract to table

A test must first fall within a recognized benefit category before the "reasonable and necessary" coverage analysis is applied

This means that a favorable LCD issued by one MAC does not automatically extend to other MAC jurisdictions, and a laboratory seeking nationwide Medicare coverage must either obtain favorable LCDs from multiple MACs or pursue a National Coverage Determination

When an NCD is issued, it supersedes any inconsistent LCD, and MACs must conform their local coverage policies to the NCD

MolDx Technical Assessment Process Laboratories seeking Medicare coverage for a new molecular diagnostic test must submit a Technical Assessment ("TA") dossier to Ridgeline for evaluation

The dossier must comprehensively address the test's analytical validity, clinical validity, clinical utility, and health economic impact

The dossier must include comprehensive evidence demonstrating the test's analytical performance characteristics