While praising some aspects of the NCD, the authors refer to a "regulatory disconnect" and devotes some attention to the different treatment of FDA certified companion diagnostics and 510(k) NGS tests that are required to show high accuracy. Since the tests authorized by CMS may release large numbers of off-label gene reports for off-label drugs, as I read it, the authors think that CMS missed an opportunity by not including a "more flexible and less burdensome" level of CED.
See also a critique that preceded the final NCD. On November 30, Rebecca Eisenberg of U Michigan, authoring a SCIENCE Op Ed with Nobel laureate Harold Varmus, praised the use of CED with cancer genomics and was cleared prepped to be released with the NCD (here, here). On January 10, Eisenberg submitted comment to CMS that the NCD "undermined the benefits of important steps [take by] the FDA." Eisenberg noted that
"The MSK-IMPACT test uses nearly identical methods to analyze the genes categorized as critical components of companion diagnostics in the F1CDx test. Both tests provide very similar or identical information about variants in very similar sets of genes, with similar implications for clinical care. The MSK-IMPACT test has some notable advantages, including more rigorous validation of the existence of somatic mutations because both tumor and germ line DNA are analyzed. Both tests have been used in tens of thousands of patients and validated by stringent criteria, such as those of the NYSDOH."
