MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer (L38972) Final LCD - Effective August 08, 2022

This Local Coverage Determination (LCD) has completed the Open Public Meeting and is now finalized under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV). Responses to comments received may be found as a link at the bottom of the final LCD.

Medicare Coverage Database (MCD) Number/Contractor Determination Number: L38972

LCD Title: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer

Effective Date: August 08, 2022

Summary of LCD: This policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Federal Drug Administration (FDA)-cleared, and FDA-approved clinical laboratory tests in hereditary cancer tests including Next Generation Sequencing (NGS) tests as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage.

This policy’s scope is specific for hereditary germline testing, and is exclusive of polygenic risk scores, solid tumor, hematologic malignancies, circulating tumor deoxyribonucleic acid (DNA) testing (ctDNA), and other acquired cancer-related tests

Visit the Proposed LCDs webpage to access this LCD.

 

Last Updated Jun 22 , 2022