May 9, 2008 – The Centers for Medicare and Medicaid Services (CMS) issued its final National Coverage Decision (NCD) to reimburse the CardioWest temporary Total Artificial Heart (TAH-t) as part of FDA studies that meet CMS specifications, marking a reversal of a 1986 National Non-Coverage Decision for the artificial heart.
“Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology,” said CMS Acting Administrator Kerry Weems. “Our decision also encourages the completion of FDA post-approval studies.”
“This final decision makes the CardioWest artificial heart available to nearly all insured Americans. Prior to this decision, approximately half of all insurers covered the CardioWest, including Aetna, Cigna and BlueCross BlueShield.
Effective May 1, 2008, Medicare patients who are dying from end stage biventricular failure are eligible to receive the artificial heart as a bridge to human heart transplant. Their survival is dependent on receiving an immediate matching donor heart or an artificial heart as a bridge-to-transplant.
In a CMS document published April 14, 2008, CMS proposed reimbursement through the highest paying Diagnostic Related Group (ms-DRG 1 and 2) codes for the artificial heart. In addition, centers implanting the CardioWest artificial heart may qualify for new technology add-on allowance payments. These proposals will become final following a 60-day public comment period on August 1.
Later this year, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the new Companion Drive System, which is designed for use both in the hospital and for discharge. Joining the 11 current U.S. The CMS approval and the IDE clinical study of our discharge driver will allow hospitals to be reimbursed for the devices.
For more information: www.syncardia.com