Molecular Test Panel Edit Alert (M00101, V5)

The guidance below only applies to MolDX jurisdictions for which the article "Billing and Coding: MolDX: Testing of Multiple Genes" has not been published by the local MAC to whom a provider or supplier submits claims. Palmetto GBA has published the article "Billing and Coding: MolDX: Testing of Multiple Genes" for Jurisdictions J and M on the Medicare Coverage Database.

MolDX CPT code range affected: 81161-81408

Test Panel Definition: A predetermined set of medical tests composed of individual laboratory tests, related by medical condition, specimen type, frequency ordered, methodology or types of components to aid in the diagnosis/treatment of disease.

Palmetto considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a "panel" of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier. Based on data analysis of MolDX claims, labs are submitting multiple biomarker 'panels' as individual tests similar to the submission of the previous stacking codes.

Example: A lab receives a patient specimen and performs the following tests:

• CPT code 81225-CYP2C19, cv
• CPT code 81240-F2, 20210G>A
• CPT code 81241-F5, Leiden

The panel of three tests listed above should be registered and claims submitted with CPT code 81479 and a single MolDX ID. If the lab also performs one of the three panel’s biomarkers on patient specimens, each biomarker must also be registered and receive a unique ID to submit on claims when only that biomarker is performed. Again, a single CPT code should be billed with a unique ID.

To correct this example, the lab must register four tests and receive identifiers for MolDX claim submission:

Labs should register all panels and obtain a unique MolDX identifier for each panel. If a lab does not perform single biomarker tests, they must notify the registry of this registration error.