Sunday, October 30, 2016

MolDX Updates General Q&A on the MolDX Program (V10, M00086, 10/24/2016)

On October 24, 2016, MolDX updated its general Q&A, which is its Document M00086, to Version 10.   The MolDX link is here.

I don't have an archive of Version 9 to list the most recent updates.  I did have an archive of Version 7, from February 2016.   Updates that occurred at some point from February 2016 to October include:

  • WPS:  WPS MAC added to the program (J5, J8).
  • AMA HAS ITS RULES...:  Continues to affirm, "The effort to publish CPT codes for molecular diagnostic techniques...and the MolDX program are NOT related or interdependent."
  • WHAT CPT CODE?  [Q.34] What resources are available to help me determine the CPT code to bill?   Applications are reviewed for CPT code mapping by the MolDX team....the Team will notify the test provider with final coding, billing, coaverage, and if applicable, fee for the test.
  • G0452 Interpretation:  Molecular interpretation G0452 must be submitted with a Z code for the test.
  • NGS MUST USE SPECIAL CODES:  [Billing Q.10] A test was registered on an NGS platform that is a gene on the MolDX  approved gene list.  Why was the claim denied?  A:  MolDX does NOT consider the T1 and T2 descriptions appropriate for genes interrogated on an NGS platform.  Please reference the coding and billing guidelines in reference article M00130.

Note that the following tests "may not require a TA":

  • NYS certified tests that are industry accepted and have established clinical utility.
  • FDA kit used in unmodified form.
  • PMA-approved tests, and stacking codes, a unique identifier is required, but a TA is not.
  • Tests that use existing or novel technology for targets with established clinical utility.

A cloud copy of V10 is here.