CareDx (CDNA) Calls on CMS to Reverse Reduced AlloMap Reimbursement

October 3, 2016 8:16 AM EDT

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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."

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