CareDx in California is pushing the Centers for Medicare and Medicaid Services to keep the current reimbursement price for its heart transplant blood test AlloMap, or the company may have to close, according to CEO Peter Maag.
Reimbursement for AlloMap had been set at $2,821, but on September 25 when it released its draft Clinical Laboratory Fee Schedule for 2016, CMS proposed a reimbursement of $644.21, a reduction of over 70 percent, Maag said. CMS proposed similar changes in reimbursement for a number of established molecular diagnostic tests, according to Maag.
Though with the "the best intentions" CMS erred in its method to determine price based on erroneous comparisons, Maag said.
An estimated 40 percent of heart transplant patients are covered by Medicare, he said.
The blood test determines whether a recipient is rejecting the new organ.
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.
"Without this test we will be compelled to rely on the heart biopsy," Kobashigawa said. "This proposal leads to taxpayers paying more money for heart transplant care, while leaving patients with a more invasive and stressful biopsy procedure as their only alternative."
The AlloMap test is currently used by 110 of 130 transplant centers in the United States, according to CareDx.
The new clinical laboratory fee goes into effect Jan. 1, 2016. CMS is taking open comment until November 24, prior to issuing final guidance.
"We're led to believe CMS is open-minded," said CareDx attorney Lanny Davis. "In the next 30 days we're optimistic they will hear us, they will invite us to provide additional information."