MolDX: BRCA1 and BRCA2 Genetic Testing LCD - R3

The MolDX: BRCA1 and BRCA2 Genetic Testing LCD 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.

Medicare Coverage Database (MCD) Number: L36163
LCD Title: MolDX: BRCA1 and BRCA2 Genetic Testing
Effective Date: January 1, 2019
Summary of Changes: This LCD has been updated to include and/or remove CPT/HCPCS codes including the updates referenced below.

  • New/Revised CPT/HCPCS codes
    • 81163 BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis
    • 81164 BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (i.e., detection of large gene rearrangements)
    • 81165 BRCA1 (BRCA1, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis
    • 81166 BRCA1 (BRCA1, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (i.e., detection of large gene rearrangements)
    • 81167 BRCA2 (BRCA2, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (i.e., detection of large gene rearrangements)
  • Deleted CPT/HCPCS codes
    • 81211 BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1 (i.e., exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)
    • 81213 BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants
    • 81214 BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants (i.e., exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb)
  • Revisions under Indications and Limitations of Coverage to Criteria for Testing for breast and prostate indications.
  • Added verbiage under Multigene Panels to align with the National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer.
  • Updated Bibliography #20 to update NCCN reference version to Version 2.2019.

View the locally hosted Noridian Active LCD.  

  • Go to Active LCD webpage
    • The End User Agreement for Providers will appear if you have not recently visited the website. Select "Accept" (if necessary)
  • Locate above listed LCD title

Last Updated Feb 08, 2019