May 16, 2006
CENTERS FOR MEDICARE & MEDICAID SERVICES REVERSES PROPOSED
NON-COVERAGE DETERMINATION FOR CHARITÉ™ ARTIFICIAL DISC
(RAYNHAM, Mass., May 16, 2006) -- The Centers for Medicare & Medicaid
Services (CMS) has announced that they will reverse its proposed non-coverage
determination for the CHARITÉ Artificial Disc and now allow for coverage
at the discretion of the local Medicare medical directors for patients aged 60
and under. This decision means that these Medicare patients will continue to have
access to the CHARITÉ Artificial Disc for single-level degenerative disc
disease from L4 to S1.
“This reversal signals recognition that the CHARITÉ Artificial Disc
has an important role in treating the right patients,” said Gary Fischetti,
President, DePuy Spine, Inc. “As we have consistently indicated, this technology
is most appropriate for younger patients and this decision allows access to the
disabled population who qualify for Medicare – and may benefit from this
technology.”
In the U.S. IDE clinical trial comparing artificial disc replacement to spinal
fusion surgery, CHARITÉ Artificial Disc patients maintained flexibility,
experienced improvements in pain and function, left the hospital sooner and were
more satisfied with the procedure. Complication rates for both groups of patients
were similar. More than 5,000 patients have received the disc in the U.S. since
its U.S. Food and Drug Administration (FDA) approval in 2004.
The CHARITÉ Artificial Disc is made of two metallic endplates and a movable
high-density plastic center that, once implanted, is designed to help align the
spine and preserve its ability to move. Spinal discs maintain the position of
the spine and allow for the flexibility to bend and twist.
Lumbar spinal fusion surgery, a common surgical treatment for low back pain or
degenerative disc disease, is often effective in reducing pain, but limits range
of motion and may transfer extra stress to discs above and below the fusion site.
More than 200,000 of these procedures are performed each year in the U.S.
“We hope this decision will provide further support to other insurers of
the importance of the CHARITÉ Artificial Disc as a treatment option for
patients with degenerative disc disease,” said Richard Toselli, MD, DePuy
Spine, Vice President, R&D.
The CHARITÉ Artificial Disc offers clinical advantages when implanted by
highly trained surgeons in carefully selected patients. DePuy Spine reports that
additional data and analysis on outcomes will become available later this year.
While patients have to meet selection criteria to be eligible for the procedure,
patients experiencing severe back pain should ask their doctors to see if artificial
disc replacement is appropriate for them.
As with any surgery, there are some possible complications that can occur with
disc replacement surgery with the CHARITÉ™ Artificial Disc. Complications
can occur singly or in combination and may include: allergic reaction to the implant
materials; bladder problems, bleeding, which may require a blood transfusion,
infection and continued pain. Visit www.charitedisc.com for more information.