May 25, 2009

Medical Device Innovation Raises Questions Of Costs

The last of the nation's first stair-climbing wheelchair was quietly sold this spring, with its high-price tag having resulted in disappointing sales. 

The poor sales of Johnson & Johnson's iBOT, which failed to sell more than a few hundred units, raises the question of how much society is willing to pay for such high-tech assistance for the disabled. 

A veteran who lost both legs in Iraq received the last known available iBOT last month, which was donated after its original owner had died.

Current iBOT users who now fear their chairs would wear out are joining high-profile Segway-inventor Dean Kamen in lobbying Congress for changes in Medicare reimbursements. Medicare currently reimburses just $6,000 for the iBOTs, despite their price tag of $22,000.
"If I ever had to get out of this chair, I really don't know if I'd want to live anymore, to be honest with you," said Alan T. Brown, who is mostly paralyzed from the chest down and on his second iBOT, during an interview with the Associated Press.

"Guys in these chairs ... we might be disabled now, but then we'd really become disabled," said Brown, 42, of Hollywood, Florida.

However, price wasn't the iBOT's only downfall.  Because the high-tech chair requires use of at least one arm and some upper-body control, only a fraction of the paralyzed were candidates to use the chair.

Nevertheless, disability specialists say what has happened with the iBOT carries implications beyond the chair itself, and raises the question of how the country will handle such specialized medical equipment.

Dr. Michael Boninger, director of the University of Pittsburgh Medical Center's rehabilitation institute, gave an example.  Medicare, he said, routinely pays tens of thousands of dollars for hip replacements to keep patients walking pain-free.  However, a 70-year-old who can't undergo that procedure must become too impaired to easily care for at home before Medicare will approve even just a basic electric wheelchair.

Medicare says that's how Congress established its rules.

"The wheelchair is maybe the most enabling technology in medicine, period," Boninger told the AP.

"What it is, is discriminatory policy."

The iBOT saga also sounds a cautionary signal about expensive innovation. Henry Claypool, the new director of the federal Office on Disability, says new technology must come with scientific evidence that it changes users' lives in ways current alternatives cannot.

"Innovative technology should be treated as something we need to embrace when we really find it has a chance to advance a group's function and integration into the community," Claypool, himself a wheelchair user, told the Associated Press.

Opinions differ on whether or not the iBOT accomplished that task.

The iBOT's wheels rotate up and over one another to move up and down stairs.  The device uses gyroscopes that sense and adjust to a user's center of gravity.

The Department of Veterans Affairs had purchased the iBOTs for a limited number of disabled soldiers.

However, by the end of 2006, Medicare concluded that the iBOT's stair-climbing function and some other features, such as lifting users to standing height and moving over uneven terrain, were not medically necessary for at-home care.  As a result, they decided to pay only the basic electric wheelchair price.

When doctors deem them required, Medicare does provide far more expensive wheelchairs equipped for some pressure-easing motions or to handle breathing equipment.

Johnson & Johnson said reimbursement was partly to blame for lack of a "sustainable market," but also committed to provide iBOT users repair service through 2013.

"Giving people independence and access and freedom and technology ought to be something we do," said Kamen, adding that an iBOT might also save money on home modifications.

However, today's priority is to expand health care access rather than provide pricier enhancements, warns University of Michigan business professor Erik Gordon, who tracks Johnson & Johnson.

Gordon said that venture capitalists that fund device research have warned the industry that new designs must demonstrate a better value than existing alternatives.

"To a certain extent, there are breakthroughs we just can't afford," he told the AP.

Army pilot Gary Linfoot of Clarksville, TN, demonstrates the pros and cons of such advancements.  He was paralyzed last year in a helicopter crash in Iraq, and received an iBOT through the nonprofit Huey 091 Foundation.  However, he alternates between it and his VA-provided manual wheelchair, which lets him drive a car, not a van, to Fort Campbell, where he now runs an aquatic training facility. 

He had an elevator installed in his home, but uses the iBOT to reach high shelves or to work under the hood of his car. 

He also uses his iBOT when visiting friends whose houses have a step or two that "may as well be Mount Everest."

"You don't understand all the accessibility issues until you find yourself in one and you're trying to navigate the world yourself," he told the AP.


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