Saturday, November 15, 2014

Medicare MolDX Program Issues "Molecular Test Panel Alert"

On Friday, November 14, Medicare's program for molecular test coding, pricing, and coverage - MolDX - issued an "Alert" for molecular test coding when a laboratory performs a "set of medical tests composed of individual laboratory tests" that is completed "on a single sample."  Labs performing such tests should start to register such tests as panels beginning on Monday, November 17, 2014, to obtain a "unique MolDX identifier" for each panel.

Effective in six weeks, January 1, 2015, MolDX will "reject tests" submitted with a single biomarker CPT code for each biomarker.

Full text after the break.

The weblink for this article is: here (link accessed on 11/15/2014).  A cloud archive based on the 11/15/2015 version is here.  

For those who have subscription access, Genomeweb published an article on this topic on November 21, 2014, here.

The full text of the new Medicare announcement is below.


Molecular Test Panel Edit Alert (M00101)
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 ordered together, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample as 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 3 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 4 tests and receive identifiers for MolDX claim submission:

Test #
Test Name
CPT Code
Clotting Test Panel
CYP2C19, cv
F2, 20210G>A
F5, Leiden
CYP2C19, cv
F2, 20210G>A
F2, 20210G>A
F5, Leiden
F5, Leiden

Effective November 17, 2014 labs should start to 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.

MolDX Panel Plan Timeline:
  • Effective November 17, 2014, Palmetto GBA will start lab notification. Labs that have submitted panel test claims will receive a list of MolDX IDs that require panel registration
  • Each lab will be given 30 days from the receipt of the list to correct test registration
  • Effective 01/01/15, MolDX will set edits to reject tests performed as panels and registered and submitted with a CPT code for each biomarker in the panel
  • During this period, Palmetto will continue to interrogate the claims data for incorrect submission

last updated on 11/14/2014