Thursday, March 20, 2025

CMS Updates NCD Coverage for Cologuard, Guardant Shield, Illumina Trusight, Caris

CMS regularly publishes updates to its coding and coverage instructions for NCDs.   Find them here:

https://www.cms.gov/medicare/regulations-guidance/transmittals/2025-transmittals

On March 20, 2025, CMS released CR 13939 (T13097) updating its colorectal screening NCD and its NGS-tumor NCD.

https://www.cms.gov/medicare/regulations-guidance/transmittals/2025-transmittals/r13097otn

Bonus

At least when this PDF was released, the CMS reference to a cloud instructions file was a "dead link." ("Please follow the link below for the NCD spreadsheets ...")  This is a cloud copy I received (note it has many tabs).

https://docs.google.com/spreadsheets/d/1iYzETIFix-HfzHYxaTlU7QTdqNm9hTGc/edit?usp=sharing&ouid=110053226805181888143&rtpof=true&sd=true

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NCD 90.2 (NGS in Cancer) is updated for:

0448U, Pillar Oncoreveal Lung/Colon (Delete)
0523U, Pillar Oncoreveal CDx. (Start)

These are a little quirky because a recent AMA PLA update (Jan 1 2025) deleted 0448U effective January 1.  That AMA PLA update also made 0523U (22 genes FFPE) effective January 1, 2025.

ILMN Trusight Comprehensive, under code 81455 from August 21 2024 and under code 0543U effective April 1, 2025.    

Caris MI Cancer Seek 0211U, effective November 5, 2024.

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NCD 210.3 CRC Screening is also updated.

Add 74263, screening CT colonography.
Add Cologuard Plus 0464U (October 3, 2024)
Add 0537U CRC Guardant SHIELD (July 26, 2024)

There is also a comment, "remove stool-based language from policy to all for all non invasive CRC screening tests" (e.g. apparently stool or other media).  There is also a comment, "Subsequent omnibus CR with additional editing for expansion of colorectal cancer screening policy."  To me, these dangling comments are just cryptic.  NCD 210.3 actual text would be updated here.

There is a link to what I suspect should be a giant excel file, but for me today it's a dead link.

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/CR13939.zip