NEWS - Experts call for more data on spinal fusions

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ScientificAmerican.com

SCIENCE NEWS

November 30, 2006

Experts call for more data on spinal fusions

By Heavey

BALTIMORE (Reuters) - Spinal disc fusion surgery to treat low-back

pain is not very likely to be better than other, more conservative options

such as physical therapy over the long term, most members of a panel of U.S.

medical experts told Medicare officials on Thursday.

The outside experts were more divided over whether data from various

clinical trials conducted on mostly younger patients without complicating

factors could apply to elderly and disabled patients in the Medicare

insurance program.

Medicare called for the advisory panel to discuss fusion to treat low

back pain in patients with degenerative discs that usually stem from aging.

The procedure binds discs together with bone grafts, screws, plates or other

hardware.

The Centers for Medicare & Medicaid Services said it is not formally

seeking to alter its current policy of covering the surgery, but some

analysts and doctors have voiced concern that officials may use the panel

recommendations to reverse course.

Such a turnaround would affect a number of companies that make related

products, including Medtronic Inc, Stryker Corp and & 's

DePuy unit, as well as some hospitals and surgeons. Many private insurance

companies also base their own coverage on Medicare policy.

At the meeting, most panelists said overall fusion was reasonably

likely to be beneficial in the short term but less likely in the long term,

based on available data.

Results from several major studies are less likely to be useful in

determining possible risks for Medicare patients, they also said. The panel

was more mixed over whether the findings could help gauge pain relief for

those patients.

The panelists told Medicare officials that current studies are flawed

and more solid trials are needed.

" I don't think there's enough information, " to compare the various

data, panelist Dr. Ondra, a surgeon at Northwestern University, said.

" What we're really looking for is how do we design a study to answer these

questions. "

Six groups representing surgeons told panelists that while more

evidence is needed, data now show fusion helps some patients regain basic

functions like walking. Most of the doctors who spoke said they received

some funding from devicemakers.

Another expert, University of Washington surgeon Dr. Sohail Mirza,

told the panel the number of fusion procedures for degenerative discs is

growing, especially among the elderly.

In 1992, Medicare paid $75 million to cover fusion compared to $482

million in 2003, he added.

Devicemakers are developing more artificial spinal discs as an

alternative that aim to relieve pain while allowing the spine to move.

" Artificial disc replacement may get around some of the problems with

fusion...but that, I think, remains to be shown, " Mirza said.

Medicare earlier this year agreed to pay for & 's

Charite disc for those younger than 60 but questioned its benefits as well

as those of fusion. This week, the agency said it would reconsider its

spinal disc coverage.

That could pave the way for older Medicare patients to receive

Synthes's ProDisc, which won U.S. approval in August. Medtronic and Stryker

are also developing their own discs, which have not yet been approved.

Steve Phurrough, director of coverage for the Centers for Medicare &

Medicaid Services, said the agency was unlikely to curb coverage. " I think

we would have a difficult time saying we would not pay for fusion except in

trials. That would be a challenge, " he said.

Medicare is expected to post the final panel votes on its Web site by

Monday.

http://www.sciam.com/article.cfm?chanID=sa003 & articleID=A6E94D012DF993C363FB358B\

F365EE05

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org