Billing and Coding: MolDX: BRCA1 and BRCA2 Genetic Testing - R2

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.

Effective Date: January 01, 2020
Summary of Article Changes: The following revisions were made:

  • Under ICD-10 Codes that Support Medical Necessity Group 1, the following codes were added:
    • Z85.44 - personal history of malignant neoplasm of other female genital organs
    • Z85.89 - personal history of malignant neoplasm of other organs and systems
    • Z86.000 - personal history of in-situ neoplasm of breast

    This revision is retroactive effective for dates of service on or after 04/02/19.
  • Under CPT/HCPCS Codes Group 1: the description changed for:
    • 0102U - hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, sanger, MLPA, and array CGH, with MMRNA analytics to resolve variants of unknown significance when indicated (17 genes [sequencing and deletion/duplication])
    • 0103U - hereditary ovarian cancer (e.g., hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, sanger, MLPA, and array CGH, with MMRNA analytics to resolve variants of unknown significance when indicated (24 genes [sequencing and deletion/duplication], EPCAM [deletion/duplication only])
  • Under CPT/HCPCS Codes Group 2: the following codes were added:
    • 0157U - APC (APC regulator of WNT signaling pathway) (e.g., familial adenomatosis polyposis [FAP]) MRNA sequence analysis (list separately in addition to code for primary procedure)
    • 0158U - MLH1 (MUTL homolog 1) (e.g., hereditary non-polyposis colorectal cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)
    • 0159U - MSH2 (MUTS homolog 2) (e.g., hereditary colon cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)
    • 0160U - MSH6 (MUTS homolog 6) (e.g., hereditary colon cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)
    • 0161U - PMS2 (PMS1 homolog 2, mismatch repair system component) (e.g., hereditary nonpolyposis colorectal cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)
    • 0162U - hereditary colon cancer (lynch syndrome), targeted MRNA sequence analysis panel (MLH1, MSH2, MSH6, PMS2) (list separately in addition to code for primary procedure)

    This revision is compliant with the 2020 Annual CPT/HCPCS Code Update and is effective on 01/01/20.

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 Fri, 10 Jul 2020 14:49:37 +0000