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CareDx Comments on MolDX Publication of New B****** and Coding Article

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

CareDx, – The Transplant Company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers –  commented on the release of a B****** Article related to MolDX Molecular Testing for Solid Organ Allograft Rejection that covers AlloSure and AlloMap. The B****** Article is effective March 31, 2023.

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“After discussions with MolDX regarding yesterday’s B****** Article release, it is now our understanding that MolDX does not plan to modify the foundational LCD but instead issued this B****** Article revision for clarification purposes”

“After discussions with MolDX regarding yesterday’s B****** Article release, it is now our understanding that MolDX does not plan to modify the foundational LCD but instead issued this B****** Article revision for clarification purposes,” said Reg Seeto, CEO and President of CareDx.

This revised B****** Article applies across covered solid organ transplantation tests for kidney and heart (“Testing Services”).

The B****** Article addresses Testing Services coverage under the foundational LCD in three main areas:

1. The foundational LCD covers patients utilizing the Testing Services for cause and for surveillance:

  • Testing Services are covered for cause in lieu of biopsy or to further inform on the need for or results of a biopsy.
  • Testing Services are covered for surveillance, where the physician would have otherwise ordered a surveillance biopsy.

For 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.

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2. 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.

Notably,

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  • Most of CareDx’s heart transplant patients are covered by commercial payers, while the B****** Article is limited to Medicare patients. Furthermore, approximately 50 percent of 2022 AlloSure Heart revenues were from non-Medicare reimbursement.
  • CareDx has a new source of reimbursement as 19 percent of AlloSure Heart volume year-to-date was ordered alone, independent of AlloMap Heart. This represents a new opportunity for reimbursement in the Medicare population.

3. Pathway for Multimodality: In the B****** Article revision, two billed tests in a single patient encounter will not be covered. MolDX has indicated that this coverage would be considered with additional data supporting this use. This provides a path for multimodality with sufficient data.

Notably,

  • CareDx plans to update its HeartCare® submission to MolDX. The Company does not expect that this will require a new LCD.
  • CareDx’s AlloMap Kidney Test was submitted as a standalone test to MolDX, as well as the planned UroMap® submission. Future plans include submitting for multimodal use with additional data.

As next steps, CareDx plans to have follow-up discussions with MolDX, submit additional data for HeartCare, and update its procedures in line with the revised B****** Article.

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients

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