The Comments Are In: Stakeholders Categorize Genomic Tests
September 25, 2012
From the first widespread clinical use of genetic sequencing tests in the early 1990s up to the present, Medicare, CLIA, and the FDA have classified these tests as clinical laboratory tests. Accordingly, a section of the Medicare statute instructs CMS how it is to reimburse clinical laboratory tests, via a statutory mechanism called the Clinical Laboratory Fee Schedule. With the most complex arguments being introduced by the College of American Pathologists, four major and well-respected stakeholder groups submitted public comments to CMS requesting that genetic tests be transferred to the Physician Fee Schedule, a different payment and policy system. This white paper discusses those comments in the light of existing CMS policy and precedents, and in the light of CMS data described by other stakeholders who believe the tests are best classified as clinical laboratory tests.