Sequencing groups prompt US pricing reversal's reversal
Lobbying by more than 60 organisations including the genetic testing groups Illumina, Thermo Fisher Scientific and Myriad Genetics has scored its first victory in the shape of the Centers for Medicare & Medicaid Services agreeing to reconsider a coverage decision for certain DNA tests for early cancer. In March 2018 CMS made a ruling that was interpreted by many Medicare contractors as restricting coverage for next-generation sequencing tests for inherited – rather than spontaneous – mutations to patients with advanced cancer. Specifically, the ruling meant that tests could only be used in patients with recurrent, relapsed, refractory, metastatic or advanced breast, ovarian and colon cancers. Coverage of testing in patients with early disease, which had previously been reimbursed, was thus denied. CMS is now reopening this coverage determination to reconsider the evidence for tests used to identify those with early hereditary cancer who might benefit from targeted treatments. Whether the CMS will in fact decide to cover the tests once again is another question, though the reopening is probably a positive sign for the testing companies. The verdict is due in October.