MolDX: AlloSure or Equivalent Cell-Free DNA Final LCD - Effective December 06, 2020

This Local Coverage Determination (LCD) has completed the Open Public Meeting and 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). 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: L38380
LCD Title: MolDX: AlloSure® or Equivalent Cell-Free DNA
FORMERLY: MolDX: Allosure® Cell-Free DNA Testing
Effective Date: December 06, 2020
Summary of LCD: Provides limited coverage for tests performed using the AlloSure® donor-derived cell-free DNA assay (CareDx, Inc., Brisbane, CA) for AlloSure® Kidney and AlloSure® Heart is covered when used in conjunction with AlloMap® with clinical suspicion of rejection and to inform clinical decision-making about the necessity of heart and renal biopsy.

Visit the Future LCDs webpage to access this LCD.

            Last Updated Thu, 22 Oct 2020 17:50:15 +0000