Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers (A58456) - R4 - Effective July 06, 2023

This coverage article has been revised and published for notice under contract numbers: 02101 (AK), 02201 (ID), 02301 (OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601 (WY).

Effective Date: July 06, 2023

Summary of Article Changes: Under Article Text revised table one to add "Guardant360 Response". This revision is effective on 4/6/2023.

Under Article Text below the table first subsection deleted first and second paragraphs. Added verbiage, "Intended uses that have met clinical validity (CV) criteria under the policy include: (1) the diagnosis of disease progression, recurrence, or relapse for advanced colorectal, bladder and breast cancers and (2) the monitoring of response to immune-checkpoint inhibitor therapy for any solid tumor. However, the tests listed in the table may have only been approved for one or more (but not necessarily all) of these indications". Under subsection heading "Additional process requirements for coverage" third paragraph added "NOTE: Prophylactic therapeutic interventions in patients with a history of cancer are excluded from the definition of a patient "with cancer"". This revision is effective on 7/6/2023.

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Last Updated Jul 07 , 2023