The following Local Coverage Determination (LCD) has completed the Open Public and Contractor Advisory Committee (CAC) comment period and is now finalized under contractor numbers 02102 (AK), 02202 (ID), 02302 (OR), 02402 (WA), 03102 (AZ), 03202 (MT), 03302 (ND), 03402 (SD), 03502 (UT) and 03602 (WY).
Medicare Coverage Database (MCD) Number/Contractor Determination Number: L36374
LCD Title: MolDX: Genetic Testing for Lynch Syndrome
Effective Date: April 16, 2019
Summary of LCD: This policy limits Lynch syndrome (LS) genetic testing to a stepped approach for Microsatellite Instability and Immunohistochemistry (MSI/IHC) screening, BRAF gene mutation, MLH1 gene promoter hypermethylation and targeted mismatch repair (MMR) germ-line gene testing to all patients with colorectal cancer (CRC) and endometrial cancer regardless of age, or a multi-gene NGS or other multi-analyte methodology that is inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genes. MSI/MMR testing is also covered for adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.