Billing and Coding: MolDX: Pharmacogenomics Testing - R2 - Effective August 23, 2021

This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV).

Effective Date: August 23, 2021
Summary of Article Changes:
08.23.2021: Under Article Text subheading Billing instructions added the verbiage, “The use of the generic name is strongly preferred.” to the end of the second paragraph. Under the third and fourth paragraph deleted the verbiage, “Multigene panels can be performed when (as defined in the policy):

1. More than one gene is reasonable and necessary for the safe use of the drug being considered or in use; or

2. More than one drug is in consideration or use that is associated with a gene-drug interaction

A multigene panel must include all relevant genes and variants for its intended use to be reasonable and necessary. If, after the initial test is completed and additional testing is warranted and is reasonable and necessary as stated in the associated policy and as defined in the Repeat Germline Testing policy, an additional test may be subsequently performed.” Under subheading Gene/CPT coding/Drug information revised the first sentence to read, “Table 1 represents relevant gene/drug associations from CPIC and FDA sources”. Table 1 and Table 2 were deleted and a new Table 1 was added. Under subheading Covered multigene panels the verbiage, “with intended uses” was added to the subheading. Table 3 was renamed Table 2 and added the verbiage, “Table 2 represents covered multigene panels with specified uses that have successfully completed a TA. These tests must fulfill all the criteria above and may be further limited to specific indications listed by ICD-10 codes, when applicable”. Rows 3 and 5 were added to the table. Under CPT/HCPCS Codes Group 1: Codes added 0029U. This revision is retroactive effective for dates of service on or after 8/23/2021.

01.01.2021: Under Article Text subheading Billing instructions: added registered mark after CPT and added the verbiage, “If multiple drugs are being used/considered for the specified beneficiary on the claim, they should be added to the comment line separated by a "/" (example Drug 1/Drug 2). Do not list the same drug more than once”. Under subheading Gene/CPT coding/Drug information revised the two tables to include CPT® code 81479 where N/A was previously listed. Under subheading Covered multigene panels revised table to update the intended use of each test. Under subheading ICD-10 codes associated with intended uses revised table to update intended use, added additional ICD-10 codes, and deleted unspecified codes. Under CPT/HCPCS Codes Group 1: Paragraph added the verbiage, “CPT® code 81479 is used to describe multi-gene panels and single genes not otherwise classified”. Under CPT/HCPCS Codes Group 1: Codes added 81479. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added F20.0, F20.1, F20.2, F20.3, F20.5, F20.81, F20.89, F31.0, F31.11, F31.12, F31.13, F31.2, F31.31, F31.32, F31.4, F31.5, F31.61, F31.62, F31.63, F31.64, F31.71, F31.73, F31.75, F31.77, F40.11, F41.0, F41.1, F41.3, F41.8, F43.11, F43.12, F60.5, F90.0, F90.1, F90.2, F90.8 and deleted F32.9, F33.40, F33.9. This revision is retroactive effective for dates of service on or after 1/1/2021.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

            Last Updated Mon, 27 Dec 2021 16:56:48 +0000