TUCSON, Ariz. (PRWEB) August 7, 2008
On May 1, 2008, 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 31 decision, CMS agreed that, "the TAH-t fulfills a role that no other mechanical circulatory support device can for patients in irreversible biventricular failure."
The thresholds for new technology add-on payments for MS-DRGs 001 and 002 are $345,031 and $178,142 respectively and are retroactive to May 1, 2008. CMS also finalized a new technology add-on payment for the CardioWest artificial heart of up to $53,000, starting Oct. 1, 2008.
"We continue to believe that the TAH-t meets the newness criterion despite having received FDA approval more than three years ago because it was not covered by Medicare until May 1, 2008," the CMS decision stated.
"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, Inc., 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 centers 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.
The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. There have been more than 740 implants of the CardioWest, accounting for more than 135 patient years of life on the artificial heart.
In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the CardioWest survived to transplant. This is the highest bridge-to-transplant rate for any heart device in the world.
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