Header: CMS adds "colorectal cancer screening" as an update to its "waitlist" for National Coverage Decisions. Relevant to several products, "Colosense" (approved by FDA 5/2024) and "Cologuard Plus" (FDA approval pending soon).
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A few weeks ago I wrote about CMS's notorious backlist or waitlist for NCD revisions, including new information I obtained by FOIA - here.
John Leppard at Washington Analysis has been one of the first to pick up, that CMS has updated its "NCD Wait List," dated as 8/15/2024, by adding Colorectal Cancer Screening to the top of the list (no other changes.) The document was posted later, as the 5/15/2024 version was online when I wrote my blog on August 26.
Here's a screen shot of May versus August:
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| click to enlarge |
Different Parts of NCD in Different Styles
Here's NCD 210.3 for CRC screening. Different parts are written in different styles.
- Part 1 covers fecal occult blood tests, immunoassays that superceded previous "guaiac" tests. This part simply says FOBT tests are covered annually, and doesn't refer to FDA, although the tests couldn't be sold without FDA approval. No names or branding.
- Part 2 is for the Cologuard test, effective October 9, 2014 and refers to "Cologuard" as a "proprietary" test. Whether CMS could automatically cover a successor Cologuard test ("Cologuard II, Cologuard Plus, Cologuard New, etc") is a question I'll leave to attorneys expert in the art.
- Part 3 is for blood-based biomarker tests, January 19, 2021. This one clearly anticipates successor tests, predicating CMS coverage on FDA approval and certain performance standards.
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CMS could have written Part 2 in a broader way; for example, at about the same time, a non-coverage decision blocked coverage of amyloid PET testing in Alzheimer's disease, and applied both to all current FDA amyloid PET biomarkers and even to future ones not yet approved by FDA (and even if they had better performance). CMS's more recent NCD for amyloid-altering drugs in Alzheimer's also applies to the whole class of drugs, including future ones, with coverage not varying by product.
All We Know is the Topic
All we know for sure about the pending CRC NCD is the name of the topic - preventive screening in colorectal cancer. But note in a parallel track, in Physician Fee Schedule rulemaking this summer, CMS proposed to add a benefit for CT colonography and remove a (antique) benefit for barium enema.
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The CMS NCD against amyloid PET scans (though now deleted) did not apply to coverage of tau PET scans, where FDA approvals began in 2020.
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"Cologuard Plus" had a publication in NEJM in March 2024, and is currently undergoing pricing by CMS (the annual crosswalk/gapfill process for all new tests).
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The August 2024 NCD dashboard shows 3 NCDs completed in the rolling 12 months, including merely deleting the amyloid PET one. Under the TCET plan, CMS would add 10 NCD decisions per year to the 3-4 it does now. It would add 5 new TCET decisions, and over time, that requires a re-evaluation of 5 per year to achieve steady state.
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CMS posts the new August list with a new link, while leaving the May list posted concurrently under a different link.
August 2024 https://www.cms.gov/files/document/ncddashboard2024.pdf
Old May 2024 https://www.cms.gov/files/document/ncd-dashboard.pdf
