CardioWest™ Artificial Heart Approved For
Highest Reimbursement in CMS History
Plus Up To $53,000 New Technology Add-on Payments
TUCSON, Ariz. (Business Wire EON/PRWEB ) August 7, 2008 --
On July 31, the 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 FY 2009, which
starts Oct. 1, 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.
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5750701
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