Reimbursement for Heart Transplant Surveillance Testing to Remain At Previous Level
Decision is Victory for Transplant Community
BRISBANE, Calif., Nov. 17, 2015 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant recipients, today commended the Centers for Medicare and Medicaid Services (CMS) for revising the 2016 pricing determinations for AlloMap in the final Clinical Laboratory Fee Schedule (CLFS), released by CMS on November 17 2015. Final pricing determinations for the 2016 CLFS include a payment rate for AlloMap of $2,821, which is the same as the existing rate set by a number of Medicare Administrative Contractors (MAC) including Noridian Administrative Services, Cigna Governmental Services, and Palmetto GBA.
The revised pricing determination for AlloMap is a victory for personalized medicine, the transplant community and is a positive example of the CMS public comment process that allowed stakeholder input to inform final decision making. Stakeholders – patients, providers, industry groups, and professional societies – mobilized to support revision of pricing for AlloMap during the open comment period. The CMS Advisory Panel on Clinical Diagnostic Laboratory Tests met on October 19, 2015 and, once again, issued a unanimous 12-0 vote in support of using the gapfill methodology to price AlloMap.
"The reversal is a victory for transplant patients, not only for CareDx. We compliment CMS' consideration of the additional data, and its decision to apply the appropriate methodology to price AlloMap," said Peter Maag, Chief Executive Officer and President of CareDx. "Most importantly, clinicians and their patients will continue to have surveillance options for heart transplant recipients."
Beverly Turner, a heart transplant recipient who has received biopsies as well as AlloMap, was involved in the initial response to CMS and is thrilled about the reversal. "This is a tremendous win for transplant patients. AlloMap is a less invasive, more appealing option that will now remain available for patient care."
Bruce Quinn, Senior Director at FaegreBD, a recognized expert for reimbursement says: "This means that AlloMap remains at its established reimbursement rate of USD $2,821 for 2016 during which the gapfill process will run its course. If PAMA is finalized in early 2016 and the pricing provisions take effect for 2017, AlloMap would most likely be priced at the same rate or, as it stands, with a maximum discount of 10%. Alternatively, it is possible that AlloMap will remain at the current rate beyond January 2017 assuming further delay of the upcoming PAMA regulation and the current MAC reimbursement that we are seeing."
The renewed clarity surrounding reimbursement for AlloMap will enable CareDx to continue its mission to provide this innovative, non-invasive test to heart transplant recipients, developing AlloSure, a pan-organ donor-derived cell-free DNA surveillance solution, and building partnerships with leading institutions and companies in the field of transplantation.
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 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 Statements
This press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding future potential, development, commercial activities and anticipated future financial results. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx's limited operating history and experience with developing new markets; risk relating to new partnerships and commercialization of those relationships; CareDx's dependence on the sales of one test, AlloMap, for substantially all of its current revenue, its dependence on Medicare for a substantial portion of its revenue, its dependence on health insurers and other third-party payers to provide coverage for its current test and future tests, if any, as well as other risks stated in CareDx's filings with the SEC located at www.sec.gov. 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.
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