MolDX: BRCA1 and BRCA2 Genetic Testing LCD – R3
March 5, 2019The MolDX: BRCA1 and BRCA2 Genetic Testing LCD have been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI) and 01312 (NV).
Medicare Coverage Database (MCD) Number: L36161
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.