CareDx calls for reversal of reimbursement cut to diagnostic test
CareDx said this morning it is calling for a reversal of a decision by the Centers for Medicare & Medicaid Services to 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, according to the company. "This decision is unwise, unfair, and misaligned with President Obama's Precision Medicine Initiative," remarked CEO Peter Maag, who called on CMS to reconsider and reverse its proposed 32% decrease in reimbursement -- from $2,821 to $1,920.93. Maag expressed confidence that CMS will reconsider the decision, saying, "The transplant community of providers, patients, and caregivers will continue to engage with CMS during the reconsideration process." If left unchanged, the new rate would take effect as of January 1, 2017. "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... 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," the company added.