Copyright 2000 Boston Herald Inc.
The Boston Herald
December 25, 2000 Monday ALL EDITIONS
SECTION: FINANCE; Pg. 028
LENGTH: 821 words
HEADLINE:
Doctors prescribe faster medical device approval
BYLINE: By JENNIFER HELDT POWELL
BODY:
Nearly every month for the last eight years,
Dr. Alexander Norbash has performed a procedure that helps keep his patients
from having a stroke.
Not one of the procedures, which cost $ 8,000 to $
10,000, has been paid for.
Medicare has refused
coverage and therefore private insurers have as well.
Norbash, an
interventional neurologist at Brigham and Women's Hospital, works with patients
who have hardening in their neck arteries. Surgery is usually performed to
remove the blockage, but for some patients the surgery isn't appropriate. The
blockage is too high for surgery or there is scarring from previous procedures,
for instance.
Instead, Norbash inserts a stent - a small wire tunnel
that opens in the artery to keep the blood flowing.
Medicare refuses to pay for the technology because it
considers the surgery to be the preferred alternative, even though it's not
always the best option for everyone, Norbash said.
The stent procedure
is caught in a complex, convoluted reimbursement system that forces hospital
administrators and doctors to choose between giving out services for free or
denying seniors access to the latest and best technologies. Sometimes the
seniors lose out.
Those pushing for reform won a major victory last week
when President Clinton signed into law a plan that makes it easier for
Medicare to pay for some new technologies and requires more
reporting of how long it takes to get new technologies approved.
It's
long overdue, say those in the industry.
"The system for making coverage
and payment decisions for medical technologies hasn't changed since
Medicare was established 35 years ago," said Thomas J. Sommer,
executive director of the Massachusetts Medical Device Industry
Council.
But those who have been working on the bill caution that real
reform depends on how the bill is implemented, a process that will take months.
Medicare officials defend the system, saying it
prevents abuse and fraud and helps protect Medicare members
from unnecessary procedures.
But industry leaders say the procedures
unnecessarily delay access to new products. Getting Medicare to
approve products typically takes five to 10 years, according to industry
studies.
It's a multi-step process that involves first getting a code,
which can take 18 months, and then getting a reimbursement level.
"These
delays can mean that a product can wait up to five years before it's on the
market and reimbursable in this country," Sommer said. "That denies the
Medicare population new and innovative ways to health care
delivery."
If Medicare refuses to cover a product,
private insurers are less likely to pay for it.
In some cases,
procedures already covered by Medicare are improved with new
technology, but Medicare doesn't increase the reimbursement
rate even though the procedure has become more expensive.
This is the
case with implantable defibrillators used to regulate heart rhythyms. Newer ones
can affect both chambers rather than just one. They work better, they make
patients feel better, but they cost $ 4,000 to $ 6,000 more than the old ones.
"Therapies are not being withheld based on the cost, but what is
happening is that institutions are facing increasingly intense financial
pressure because of the fact that that they have to absorb the costs of these
devices without an increase in reimbursement," said Dr. Jeremy Ruskin, director
of the Cardiac Arrhythmia Service at Massachusetts General Hospital.
The
new law allows Medicare to give an extra payment to hospitals
that use the new technology. One concern the industry has is how
Medicare officials will decide when to send the extra money.
As industry leaders watch over the implementation of the law, they will
be pushing for other changes as well, such as getting codes issued more often
and improving the appeals process for products that are denied coverage or
reimbursed at a rate a company deems to be too low.
Officials at Thermo
Cardiosystems hope to see the changes come before they are ready to launch a
product that may offer hope to patients who don't qualify for heart transplants.
The Woburn company's ventricular assist device is now used as a
temporary procedure before a transplant, but it is being tested on patients who
won't be getting a transplant.
"Our greatest concern is that the
reimbursement problems explode if that trial is successful," said Edward Berger,
Thermo Cardiosystem's senior consultant for reimbursement strategy.
Currently, hospitals that use the technology get reimbursed, but at
rates much lower than their costs. Hospitals lose $ 30,000 to $ 50,000,
according to the company's estimates. They are generally willing to lose the
money because the procedure is done so rarely. But, if it is approved for use in
more patients, they may not be as willing.
Photo Caption: LATEST
TECHNOLOGY: A stent, above, is inserted into a blocked neck artery to keep blood
flowing.
LOAD-DATE: December 25, 2000
