Preliminary Decision by Centers for Medicare & Medicaid Services
Favors Reimbursement for CardioWest Artificial Heart
TUCSON, Ariz. (Business Wire EON/PRWEB ) February 4, 2008 --
On February 1, the Centers
for Medicare & Medicaid Services (CMS) announced that after
completing a review of its 1986 national non-coverage policy for
artificial hearts, its preliminary decision is to provide reimbursement
for patients who receive the CardioWest™
temporary Total Artificial Heart (TAH-t) as part of FDA studies that
meet CMS specifications. Following a public comment period, CMS will
post its final decision on May 1, 2008.
“Our proposal relaxes a long-standing
non-coverage policy, gives access to our beneficiaries and promotes
evidence development through FDA approved studies of this advanced
technology,” said CMS Acting Administrator
Kerry Weems. “This device may be able to
help patients that otherwise have no treatment options available to them.”
“This decision is a historic step toward
making the artificial heart available to most Americans,”
explained Rodger
Ford, president and CEO of SynCardia
Systems, Inc., manufacturer of the CardioWest artificial heart. “Many
smaller insurers use CMS reimbursement decisions as their benchmark for
coverage.”
The CardioWest artificial heart is currently covered by about half of
insurers, including Aetna and BlueCross BlueShield. With final CMS
approval, most insurers are likely to cover the CardioWest artificial
heart.
On Aug. 1, 2007, CMS posted
a notice to its web site announcing the review of this non-coverage
policy, after SynCardia submitted a formal request for coverage of the
CardioWest artificial heart when used in accordance with its
FDA-approved labeling as a bridge to human heart transplant.
The CardioWest artificial heart received FDA approval on Oct. 15, 2004.
It is the world’s only FDA, CE and Health
Canada approved temporary total artificial heart. It has been implanted
in more than 700 patients, accounting for more than 120 patient years of
life on the device.
See 28-year-old Vanessa Cirillo work out and box without a human heart.
Originally designed as a permanent replacement heart, the CardioWest
artificial heart is currently approved as a bridge to transplant for
patients dying from end stage biventricular failure. These patients are
often days, if not hours from death. Their survival depends on receiving
a matching donor heart, or a CardioWest artificial heart as a bridge to
transplant.
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 TAH-t 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=5601056
See the original story at: http://eon.businesswire.com/releases/cardiowest/heart/prweb675003.htm
Post Comment:
Trackback URL: http://www.prweb.com/pingpr.php/SG9yci1Ib3JyLVN1bW0tU3F1YS1aZXRhLVplcm8=
Bookmark -
Del.icio.us |
Furl It |
Technorati |
Ask |
MyWeb |
Propeller |
Live Bookmarks |
Newsvine |
TailRank |
Reddit |
Slashdot |
Digg |
Stumbleupon |
Google Bookmarks |
Sphere |
Blink It |
Spurl
|
