CareDx Announces Draft LCD Supporting Coverage for Transplant Rejection Surveillance Testing
The Transplant Company – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – announced the release of a proposed draft Local Coverage Determination (LCD) related to molecular testing for solid organ allograft rejection. There is no change in current coverage and the draft LCD is open for comment through August 31, 2025.
The draft policy would continue to provide coverage for surveillance testing for kidney, heart, and lung transplant patients without a tie to protocol biopsy, underscoring the value of this important non-invasive molecular testing for solid organ transplant patients.
In addition, the draft policy introduces a bundled payment concept for surveillance testing. The Company is reviewing the draft coverage and payment policy and anticipates providing additional information during its upcoming earnings call on August 6, 2025.
“We believe publication of 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. “We do not expect changes in the use of our testing in response to this draft LCD and remain deeply committed to patient care and providing access to our testing. We look forward to providing feedback on the draft LCD through the public comment process.”
The proposed LCD is available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40059&ver=8&contractorName=all&contractorNumber=all&updatePeriod=1156&sortBy=updated&bc=13
About CareDx – The Transplant Company™
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.
