Final Medicare Decision Provides Maximum Reimbursement to
Hospitals for CardioWest temporary Total Artificial Heart
CMS Reverses 1986 National Non-Coverage Decision for the Artificial Heart
TUCSON, Ariz. (Business Wire EON) May 6, 2008 --
On May 1, 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.
“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, because most
smaller insurers use CMS decisions as their benchmark for coverage,”
said Rodger
Ford, President and CEO of SynCardia
Systems, Inc. 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. These patients are days, if not hours
from death. Their survival is dependent on receiving an immediate
matching donor heart or a CardioWest 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 & 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.
“With this decision, CardioWest certified
centers will be eligible to receive CMS reimbursement as a part of our
FDA Post-Approval Study,” said Cary Marcot,
SynCardia Vice President of Regulatory Affairs and Quality.
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. CardioWest certified hospitals
are eleven additional U.S. hospitals that are in the process of gaining
CardioWest certification so they can be part of this study.
“CMS approval and the IDE clinical study of
our discharge driver will finally allow hospitals to be adequately
reimbursed for the life-saving services they provide,”
said Ford. “When a stable CardioWest patient
is discharged through the IDE study and then returns for a donor heart
transplant, the hospital will be eligible to receive maximum
reimbursement for both the implantation of the artificial heart and for
the heart transplant procedure.”
The CardioWest artificial heart is the first and only FDA, Health
Canada and CE Mark approved temporary Total Artificial Heart in the
world. Originally designed as a permanent replacement heart, it is
currently approved as a bridge to human heart transplant for patients
dying from end stage biventricular failure.
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 artificial heart survived to transplant. This is
the highest bridge-to-transplant rate for any heart device in the world.
There have been more than 715 implants of the CardioWest, accounting for
more than 125 patient years of life on the artificial heart.
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5677173
Post Comment:
Trackback URL: http://eon.businesswire.com/pingpr.php/U3F1YS1DcmFzLVN1bW0tRW1wdC1DcmFzLVplcm8=
Bookmark -
Del.icio.us |
Digg |
Furl It |
Spurl |
RawSugar |
Simpy |
Shadows |
Blink It |
My Web
|
