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CareDx Comments on MolDX Publication of New Billing and Coding Article

Article Addresses Coverage of Molecular Testing for Solid Organ Allograft Rejection Following Contractor Advisory Committee Meetings BRISBANE,

articleCaredx, Inc.March 3, 20233/company/caredx-inc/news/caredx-comments-on-moldx-publication-of-new-billing-and-coding-article-2023-03-03
CareDx Comments on MolDX Publication of New Billing and Coding Article

About this update from Caredx, Inc.

[{"type":"text","content":"\nArticle Addresses Coverage of Molecular Testing for Solid Organ Allograft Rejection Following Contractor Advisory Committee Meetings\n\n BRISBANE, Calif.--(BUSINESS WIRE)--\nCareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today commented on the release of a Billing Article related to MolDX Molecular Testing for Solid Organ Allograft Rejection that covers AlloSure® and AlloMap®. The Billing Article is effective March 31, 2023.\n\n“After discussions with MolDX regarding yesterday’s Billing Article release, it is now our understanding that MolDX does not plan to modify the foundational LCD but instead issued this Billing Article revision for clarification purposes,” said Reg Seeto, CEO and President of CareDx.\n\nThis revised Billing Article applies across covered solid organ transplantation tests for kidney and heart (“Testing Services”).\n\nThe Billing Article addresses Testing Services coverage under the foundational LCD in three main areas:\n\n1. The foundational LCD covers patients utilizing the Testing Services for cause and for surveillance:\n\n\nTesting Services are covered for cause in lieu of biopsy or to further inform on the need for or results of a biopsy.\n\n\nTesting Services are covered for surveillance, where the physician would have otherwise ordered a surveillance biopsy.\n\n\nFor Testing Services reimbursement, the ordering physician needs to clarify that they would have otherwise considered a biopsy – either a protocol surveillance or for cause biopsy. Notably, reimbursement is not necessarily limited to centers that have surveillance biopsy protocols.\n\n2. AlloSure Heart Standalone Reimbursement: In heart transplantation, both AlloSure Heart and AlloMap Heart can now be billed individually to Medicare, whereas in the past AlloSure Heart could only be billed with AlloMap Heart. This change will now enable AlloSure Heart to be reimbursed independently.\n\nNotably,\n\n\nMost of CareDx’s heart transplant patients are covered by commercial payers, while the Billing Article is limited to Medicare patients. Furthermore, approximately 50 percent of 2022 AlloSure Heart revenues were from non-Medicare reimbursement.\n\n\nCareDx has a new source of re...

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