Wednesday, March 12, 2025

Guardant SHIELD CRC Test Becomes 18th "ADLT" Test

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:

https://investors.guardanthealth.com/press-releases/press-releases/2025/Guardant-Health-Receives-ADLT-Status-From-CMS-for-Shield-Blood-Test/default.aspx

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.