CardioWest artificial heart approved for reimbursement in the US

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At the end of July, the US Centers for Medicare and Medicaid Services (CMS) issued its final decision to reimburse the CardioWest temporary Total Artificial Heart (TAH-t) through the highest paying Diagnostic Related Group codes, MS-DRG 001 and 002. In addition, CMS also approved the CardioWest artificial heart for new technology add-on payments for the financial year 2009 (which started on 1st October 2008).

In May, CMS reversed its 1986 non-coverage policy for artificial hearts and approved Medicare reimbursement for the CardioWest artificial heart when implanted as part of an FDA study that meets CMS specifications. For more than two decades prior to this decision, Medicare denied reimbursement for the CardioWest artificial heart. In the July decision, CMS agreed that “the TAH-t fulfills a role that no other mechanical circulatory support device can for patients in irreversible biventricular failure.”

“This decision helps ensure that our hospitals receive adequate reimbursement for the life-saving artificial heart technology they provide,” said Rodger Ford, CEO and president of SynCardia Systems, manufacturer of the CardioWest artificial heart. “In the past, hospitals and their patients have experienced great success with our device, but hospitals risked taking substantial economic losses in order to bridge these patients to transplant. Now, our certified centres can afford to save thousands of end stage heart failure patients.”

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival is dependent upon receiving a matching donor heart, or a CardioWest artificial heart as a bridge-to-transplant.

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