Heart Transplant Patients Warn That CMS Decision Could Deprive Them Of Needed Care

Wednesday, October 26, 2016 Organ Donation News
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CMS proposed rate of reimbursement for the AlloMap blood test would jeopardize AlloMap's availability, leaving transplant patients with a more invasive and frightening biopsy as their only alternative and costing taxpayers more money for heart transplant care

BRISBANE, Calif., Oct. 26, 2016 /PRNewswire/ -- Heart transplant patients and doctors today called for the Center for Medicare and Medicaid Services

(CMS) to reverse its recent proposal to drastically reduce reimbursement for the FDA-cleared diagnostic test AlloMap, which is produced by CareDx, which measures gene expression levels to help clinicians determine a heart transplant recipient's risk for organ rejection.

At a national telephonic press conference held this morning, doctors and patients around the country came together to call for the reversal of the CMS proposed reimbursement reduction.

"I rely on AlloMap as a safer, less invasive, and less stressful option to biopsies," said Patrick Sullivan, who received his heart transplant several years ago.  "If CMS doesn't reconsider its proposed pricing, I might never have access to AlloMap again."

Heart transplant cardiologist Dr. Jon Kobashigawa, Chair of Heart Transplantation Medicine at Cedars-Sinai Heart Institute spoke today at a telephonic press conference along with Dr. Jeffrey Teuteberg, Associate Professor of Medicine in the Heart and Vascular Institute, Heart Failure/Transplantation, at the University of Pittsburgh, and Dr. Peter Maag, CEO of CareDx, Inc. (NASDAQ: CDNA), a molecular diagnostics company, that provides the AlloMap blood test.

"AlloMap is a critical alternative to heart biopsies," said Dr. Jon Kobashigawa, Chair of Heart Transplantation Medicine at Cedars-Sinai Heart Institute.  "It does not make any sense to transplant care for CMS to adopt a price that would force it off the market."

"We are working closely with CMS to help CMS understand the consequences of the current price proposal," added Dr. Maag.  "We are hopeful that CMS will come to the right decision."

AlloMap is a unique tool in heart transplant health care and is currently the only test produced and marketed by CareDx. Even at the current reimbursement rate, CareDx has not posted a significant profit since it first offered the test in 2005. The price reduction would result in a price well below the company's cost of performing the test.

Attorney for CareDx, Lanny Davis added, "If this proposed reduction remains unchanged it would threaten the viability of CareDx as a business.  The inevitable result: the only remaining alternative for heart transplant patients would be biopsy -- more invasive, more stressful, and more expensive to Medicare and taxpayers, since it is a procedure performed in a hospital."

CareDx, based in Brisbane, California, developed AlloMap and has been distributing the test since 2005.  AlloMap is currently utilized in 110 of 130 transplant centers in the U.S. and received FDA 510(k) de novo clearance in 2008.  AlloMap's unique surveillance system allows patients to avoid many invasive biopsies. Results are reported to health care providers less than 48 hours after the test is administered, which is a critical time when assessing the risk of organ rejection.  AlloMap is often referenced as one of the first examples of precision or personalized medicine already put into widespread clinical practice.

About CareDxCareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next generation sequencing, to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. For more information, please visit: www.CareDx.com.

Forward Looking StatementsThis press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding the effect of possible CMS decisions on the Company's financial results and commercial operations. Forward looking statements are subject to uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including the Company's ability to enter new businesses or other geographies if it is forced to discontinue AlloMap testing in the United States. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:Eleanor McManusEmcmanus@tridentdmg.com202-460-1451 cell

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/heart-transplant-patients-warn-that-cms-decision-could-deprive-them-of-needed-care-300351671.html

SOURCE CareDx, Inc.

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