CareDx Comments on Issuance of Proposed LCD for Molecular Testing for Solid Allograft Rejection

CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today commented on the issuance of proposed changes to the Local Coverage Determination (LCD) MolDX Molecular Testing for Solid Organ Allograft Rejection that covers AlloSure®, AlloMap® and HeartCare.

CareDx is pleased that MolDX is providing the public with the opportunity to participate in an open and transparent process, as advocated by CareDx and many others across the transplant community. In the proposed LCD (DL38568) MolDX continues to recognize the value of surveillance testing in certain scenarios, as well as other uses for these tests in transplant; however, the proposed LCD would change the existing LCD to inappropriately restrict coverage in a manner similar to the restrictions that CareDx believes were impermissibly introduced in the Medicare Billing Article revisions issued on March 2 and May 4, 2023.

MolDX and Noridian have opened a public comment period that extends through September 23, 2023, to solicit feedback from clinicians, patients, and the transplant community for consideration in drafting a final LCD. CareDx will continue to review the proposed LCD and looks forward to providing comments on the draft policy. CareDx believes that broad coverage of these tests based upon the clinicians’ assessment of need for their transplant patients is both appropriate and also consistent with MolDX’s longstanding coverage policies.

“While CareDx welcomes an open process for gaining public feedback on the proposed LCD as required by CMS rules, we are disappointed in the way the coverage policy was changed with two Billing Articles issued in the six months prior to this proposed LCD. This has created unnecessary clinician confusion, chaos, and disruption to patient care,” said Reg Seeto, CEO and President of CareDx. “CareDx will continue to fight for access to transplant innovation for these highly vulnerable patients.”

CareDx is the only company covered under this LCD that is 100 percent focused on serving transplant patients. CareDx has invested hundreds of millions of dollars and over two decades to support the transplant community, leading with innovation. CareDx is the first and only company approved by MolDX for gene expression profiling in heart with AlloMap Heart, the first and only approved for donor-derived cell-free DNA (dd-cfDNA) in lung with AlloSure Lung and the first dd-cfDNA approved in kidney with AlloSure Kidney. CareDx is also the first and only approved in multimodality with HeartCare.


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