Medicare Proposes to Maintain Current Reimbursement Process for AlloMap

Rhea-AI Summary

CareDx announces that the Centers for Medicare and Medicaid Services (CMS) has recommended continued coverage of AlloMap for heart transplant patients via local Medicare Administrative Contractors (MACs). This follows a memo acknowledging multiple studies demonstrating AlloMap's clinical utility since its initial request for a national coverage determination in 2013. AlloMap, adopted by over 90% of U.S. transplant centers and supported by ISHLT guidelines, continues to receive reimbursement, affirming its status as the standard of care in transplant medicine.

Positive

• CMS supports continued reimbursement for AlloMap, enhancing CareDx's market position.
• AlloMap is utilized in over 90% of transplant centers in the U.S.
• The memo reinforces AlloMap's clinical utility and adherence to ISHLT guidelines.

Negative

• None.

CMS believes AlloMap reimbursement process is clinically appropriate for heart transplant patients

SOUTH SAN FRANCISCO, Calif., Oct. 19, 2020 (GLOBE NEWSWIRE) -- 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, announced today that the Centers for Medicare and Medicaid Services (CMS) recently issued a memo recommending continued coverage of AlloMap through local Medicare Administrative Contractors (MACs).

AlloMap is widely adopted by physician providers in over 90% of transplant centers across the US, has been the standard of care and incorporated into guidelines by the International Society for Heart and Lung Transplantation (ISHLT) since 2010, and is covered by a CPT code which is reimbursed by Noridian, the local MAC in California.

The recently issued CMS memo was in response to a request made by a pathologist in January 2013 to make a national coverage determination to non-cover AlloMap. The CMS memo acknowledges that since 2013 there have been multiple studies that have demonstrated the clinical utility of AlloMap, and concludes that continuing the current AlloMap reimbursement process by MACs is clinically appropriate and in the best interests of beneficiaries.   

“AlloMap has stood the test the time and is now cemented as the standard of care, being part of ISHLT guidelines since 2010. We continue to generate new insights with AlloMap with a strong growing evidence base, and it is positive to see CMS evaluate this evidence and continue to support use of AlloMap,” said Jeffrey Teuteberg, MD, Stanford.

“CareDx is appreciative of the thorough evidence reviews performed by CMS, which reaffirm the clinical utility of AlloMap, and supports the CMS proposal to continue the current reimbursement process through MACs. Our dedication to patients continues to provide relevant testing services that are well supported by clinical data,” said Reg Seeto, President and Chief Business Officer, CareDx.

About CareDx
CareDx, Inc., headquartered in South San Francisco, 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. For more information, please visit: www.CareDx.com.

CONTACTS:

CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Greg Chodaczek
347-620-7010
investor@caredx.com 

FAQ

What is AlloMap's reimbursement status as of October 2020?

The CMS has recommended continued coverage of AlloMap through local MACs.

How widely is AlloMap used in the U.S. transplant centers?

AlloMap is adopted by over 90% of transplant centers across the U.S.

Since when has AlloMap been part of the ISHLT guidelines?

AlloMap has been included in ISHLT guidelines since 2010.