Pending CMS Reimbursement Cuts Devastates CareDx

CMS has been proposing changes in reimbursement for a number of established molecular diagnostic tests provided by CareDx. According to its CEO Peter Maag, the company is urging the CMS to keep the current reimbursement price for AlloMap, a heart transplant blood test, that is currently used by 110 of 130 transplant centers in the United States. Without current reimbursement prices, the company may have to close its door soon. On September 25, CMS released a draft of its Clinical Laboratory Fee Schedule for 2016 and proposed that reimbursement for AlloMap drop from $2,821 to $644.21. 

AlloMap determines whether a recipient is rejecting a new heart. The only alternative is an invasive biopsy that takes out snippets of a patient's heart, said Cedars-Sinai Heart Institute surgeon Dr. Jon Kobashigawa. The CMS proposal to cut reimbursements for the blood test would lead taxpayers to pay more money for heart transplant care, while leaving patients with a more invasive and stressful biopsy procedure as their only alternative.

CMS may have good intentions, but reducing reimbursements by 70% for such a useful test seems nothing short of foolish since an estimated 40% of heart transplant patients are covered by Medicare. CMS is taking open comment prior to issuing final guidance on reimbursement changes that would officially go into effect Jan. 1, 2016. CareDx is hopeful that CMS will rethink its evaluation and realize the importance of AlloMap for so many heart transplant patients. 

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