Details
On November 30, CMS released a highly impactful proposed National Coverage Determination governing uses of next gene sequencing testing in oncology, with wide-ranging inclusions and exclusions. The original comment closure date of December 30 was extended, on December 20, to January 17, because the FDA had newly (finally) released its evaluation paperwork on the Foundation One CDx test.
On Wednesday, February 28, CMS missed the original final NCD announcement date.
On Tuesday March 6, CMS posted the new final date as Friday March 16. This fits a statutory deadline of 60 days after the extended January 17 comment period. CMS explained: "We are continuing to review and evaluate the high-volume of public comment, and expect to complete the process soon."
The final NCD could appear before the announced deadline of March 16. For my comments a few days ago on the rationale for the extended process, see an earlier blog, here.
