CMS Proposal Threatens Availability Of Standard Of Care Blood Test To Heart Transplant Patients

Monday, October 3, 2016 Organ Donation News
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WASHINGTON, Oct. 3, 2016 /PRNewswire/ -- CareDx, Inc. (NASDAQ: CDNA), a molecular diagnostics company, today called for

a reversal of a decision by the Centers for Medicare & Medicaid Services (CMS) to drastically reduce reimbursement for its diagnostic test AlloMap – the only FDA-cleared blood test to monitor heart transplant patients for rejection, and the only alternative to more costly and invasive biopsies. 

"This decision is unwise, unfair, and misaligned with President Obama's Precision Medicine Initiative," stated Peter Maag, President and CEO of CareDx.  "If CMS won't ensure that medical innovators are compensated for their investments, there won't be medical innovators. If this reduction remains unchanged, it will send a very clear signal to other companies hoping to improve the level of care and improve long term outcomes and block discoveries supported by NIH from being translated into the practice of medicine."

Maag called on CMS to reconsider and reverse its proposed 32% decrease in reimbursement -- from $2,821 to $1,920.93.  If left unchanged, this new rate would take effect as of January 1, 2017 and jeopardize Medicare patients' access to AlloMap's less expensive, less invasive, and less stressful surveillance solution.  This process is only being used due to the delay in implementation of PAMA, where this type of reduction in reimbursement would not be permitted.

Last year CMS reversed a prior proposal to dramatically reduce price of test and maintained AlloMap at historical price of $2821. This continued assault on patient care undermines patient, physician and private sector confidence in our government's commitment to the health.

CareDx, based in Brisbane, California, developed AlloMap, invested in the generation of high quality clinical evidence, and has been offering the assay since 2005 with FDA IVD 510K clearance in 2008.  The AlloMap testing service was incorporated into the International Society of Heart and Lung Transplantation guidelines in 2010. AlloMap is used in the vast majority of heart transplant centers nationwide, with more than 75,000 commercial tests performed to date. During this time CareDx has never increased the price of AlloMap.  CareDx has continued to further invest in improvements of the technology and new transplant services despite not having made a profit on AlloMap. Ironically, the cost of a biopsy, usually 2 to 3 times higher than the current rate for AlloMap, is significantly higher to both the patient and overall healthcare system. AlloMap is often referenced as one of the first examples of precision or personalized medicine.

Maag expressed confidence that CMS will reconsider this flawed decision. "The transplant community of providers, patients, and caregivers will continue to engage with CMS during the reconsideration process to reinstate the appropriate reimbursement for this vital test." 

About CareDx

CareDx, 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 AlloMapŪ, 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:

CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.

For more information, please visit:  

Forward Looking Statements

This 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 McManus, 202-460-1451

To view the original version on PR Newswire, visit:

SOURCE CareDx, Inc.


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