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CareDx Announces Transplant Community Secures Win Reaffirming Longstanding Medicare Coverage for AlloSure and AlloMap Testing
CMS Recognizes the Importance of Surveillance Testing for Early Detection of Allograft Rejection CMS to Retire Proposed Draft Policy that Would Have
About this update from Caredx, Inc.
[{"type":"text","content":"\nCMS Recognizes the Importance of Surveillance Testing for Early Detection of Allograft Rejection\n\n\nCMS to Retire Proposed Draft Policy that Would Have Restricted Coverage\n\n\n BRISBANE, Calif.--(BUSINESS WIRE)--\nCareDx, Inc. (Nasdaq: CDNA) - The Transplant Company™ – today announced that the Centers for Medicare and Medicaid Services (CMS) has announced its plan to retire a draft LCD that would have restricted coverage for non-invasive blood-based surveillance testing for allograft rejection. Combined with the February 2024 removal of restrictive language in the accompanying Billing Article and based on discussions with CMS, CareDx believes that longstanding coverage for AlloSure®, AlloMap® and HeartCare® has effectively been restored.\n\n\n“We appreciate the Agency and its local contractors for listening to the voices of thousands of patients and clinicians who tirelessly advocated for access to non-invasive surveillance testing based on its clinical utility in detecting early signs of rejection. We believe their efforts were instrumental in restoring longstanding Medicare coverage,” said John W. Hanna, CareDx President and CEO.\n\n\nThe longstanding Medicare coverage for AlloSure and AlloMap testing includes surveillance monitoring of organ transplant rejection, without requiring ties to invasive biopsies. In March 2023, Medicare issued a Billing Article that, among other restrictions, required clinicians to indicate that the surveillance testing was being performed instead of a surveillance biopsy. This resulted in a decrease in testing as not all transplant centers perform surveillance biopsies, particularly for kidney transplant monitoring.\n\n\nAlloSure donor-derived cell-free DNA (dd-cfDNA) and AlloMap gene-expression profiling (GEP) are non-invasive blood tests that assess allograft injury and immune quiescence respectively, both important indicators of transplanted organ health. The clinical utility of AlloSure Kidney, AlloSure Heart, AlloSure Lung, AlloMap Heart and HeartCare have been widely demonstrated in peer-reviewed clinical studies.\n\n\nCareDx has been a longstanding proponent for improving access to the latest transplantation innovations and supported the Honor the Gift and Health Equity in Transplantation coalitions in their recent efforts to restore Medicare coverage for non-invasive surveillance test...