BRISBANE, Calif. — CareDx, Inc. (Nasdaq: CDNA), a precision medicine company specializing in transplant care, announced the release of a proposed draft Local Coverage Determination (LCD) that affirms Medicare coverage for molecular surveillance testing to detect organ transplant rejection.
The draft policy, issued for public comment and open through August 31, 2025, maintains current coverage for non-invasive testing in kidney, heart, and lung transplant patients. Notably, the proposed policy does not require testing to be tied to protocol biopsies, reinforcing the importance of regular molecular monitoring in transplant care.
“This draft policy solidifies coverage for surveillance testing and supports our longstanding position that our tests improve health outcomes for transplant patients,” said John W. Hanna, President and CEO of CareDx.
The draft LCD also introduces a bundled payment model for surveillance testing. CareDx stated it is currently reviewing the proposal and will provide further insights during its next earnings call scheduled for August 6, 2025.
CareDx emphasized that the policy does not impact current usage of its testing services and reiterated its commitment to patient access and outcomes.
“We do not expect changes in the use of our testing in response to this draft LCD and remain deeply committed to patient care,” Hanna added. “We look forward to providing feedback on the draft LCD through the public comment process.”
