CMS has a special pricing category, created in 2016, for "Advanced Diagnostic Laboratory Tests," or ADLTs. Guardant SHIELD, FDA-approved for colorectal cancer screening, is now an ADLT test. The price, effective April 1, 2025, is $1495.
See the Guardant press release here:
See the CMS ADLT listing page here:
https://www.cms.gov/files/document/advanced-diagnostic-laboratory-tests-under-medicare-clfs.pdf
Coding will be via PLA code 0537U, released by AMA on December 30, 2024, and effective for use on April 1, 2025.
