In an adjacent proposed local coverage decision (LCD) Palmetto (Medicare contractor) suggests the following guidelines for oncological molecular profiling and sign outs.  Some of the analytical requirements are timely but it continue to amaze me how prescriptive these coverage policies are getting.  (Analytical Performance Specifications for Comprehensive Genomic Profiling (M00118, V1))

It includes the following language which is pretty amazing considering they put these codes on the CLFS (clinical lab fee schedule)


Post-Analytical Testing Requirements

  1. The variants identified, clinical interpretations, and therapeutic recommendations must be reported by a physician, board certified in Molecular Genetic Pathology by the American Board of Pathology, or in Molecular Genetics by the American Board of Medical Genetics and Genomics, or has equivalent experience and expertise.  A PhD is not a recognized Medicare provider.
  2. Each sequenced run must include a control to document that quality control metrics for the assay (including at least read depth and sequence quality) have been met for that run for all variant classes reported.
  3. The bioinformatics pipeline must exclude specimen contamination as the source of identified variants for the variant classes and variant allele frequencies (VAFs) reported3,4.