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Copyright 1999 The Chronicle Publishing Co.  
The San Francisco Chronicle

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JUNE 11, 1999, FRIDAY, FINAL EDITION

SECTION: BUSINESS; Pg. B1

LENGTH: 900 words

HEADLINE: Healing That Hurts;

New medical devices are saving lives but killing health care finances

BYLINE: Tom Abate, Chronicle Staff Writer

BODY:
New medical devices may be revolutionizing the field of medicine and saving lives, but government officials and insurance executives are increasingly fearful that a steady stream of costly, new medical gadgets could break the health care bank.

Those concerns took center stage at a conference yesterday in San Jose attended by some 400 executives representing all branches of the medical devices industry.

Medical devices encompass a wide variety of hardware used in the treatment of disease, from a simple blood pressure cuff to the most sophisticated system for open heart surgery.

U.S. sales of such devices totaled $17 billion in 1998, according to analyst David Lothson with PaineWebber in New York. More than 300 medical device firms are based in the Bay Area, said J. Casey McGlynn, a partner with the Wilson Sonsini Goodrich & Rosati law firm, which organized the event.

Although the conference treated other topics -- like the difficulty of raising money, given Wall Street's Internet mania -- several speakers addressed the question of whether and how government agencies and HMOs might get a handle on the cost-effectiveness of new medical technologies.

"The good old days in medical devices, where the doctor wanted it so the insurers paid for it, that's over," said Susan Bartlett Foote, a former medical devices lobbyist in Washington, D.C. "The current environment in Washington is, You cost too much, we have to do something about it.' "

To illustrate her point, Foote displayed a chart showing per-capita health care spending in the United States during the past four decades. In 1960, $141 was spent per person. In 1996, the latest year for which she had government data, it was $3,781.

Although no one would argue that new medical devices solely are responsible for that steep rise, a recent report issued by the Public Policy Institute -- a San Francisco nonprofit think tank -- singled out new medical gadgets as one of the drivers of health care inflation.

"There is a strong consensus that technology diffusion -- the development of new technologies and their introduction into medical practice -- is one of the most important factors driving health care costs," noted authors Laurence Baker and Joanne Spetz.

Baker, a health research professor at Stanford University, and Spetz, a Public Policy Institute economist, went on to suggest that "policymakers need to consider limiting tech availability in order to restrain health care cost growth."

To screen new technologies, Spetz and Baker say lawmakers could revive a program they tried and abandoned in the 1980s that requires health care providers to get a "certificate of need" proving that their community needs a new MRI scanner or open heart surgery center.

Although such proposals remain only conjectural, a top federal health care policy official at yesterday's conference said his department is considering whether and how cost-effectiveness testing should factor into deciding whether Medicare should pay for new medical technology.

"We want to get more for our money or the same for less," said Jeffrey Kang, a director of clinical quality with the Health Care Financing Administration.

The agency helps govern the Medicare program, which pays a huge portion of the nation's medical bills. Kang said lawmakers have focused on ways to bring the growth in Medicare spending, which had been running 10 to 12 percent a year, down to more like 2 or 3 percent.

At present, the federal government doesn't have an explicit cost-effectiveness program, but Kang told the group that he thinks it should be developed.

The prospect of taking products through new cost-effectiveness tests, on top of current safety tests by the Food and Drug Administration, only complicates the job of industry executives. They're already struggling in a tight market to raise the $20 million it can take to bring a new device from concept to market.

"There has never been a more difficult time for medical-device financing," said Richard Ferrari, chief executive of CardioThoracic Systems in Cupertino.

His company, which already has a technology on the market, illustrates how the industry keeps inventing new miracles. Ferrari sells a system that allows surgeons to perform open heart surgery while the patient's heart is beating.

Up until now, patients who went in for a bypass operation would be given a drug to slow and eventually stop their heart from beating. At the same time, they would be hooked up to machine that would fill their lungs with air and pump blood through their arteries.

Rebounding from that heart-stopping experience is the most painful part of the patient's recovery. Ferrari's system essentially is a vice that hold's the patient's beating heart absolutely still while the surgeon performs the bypass.

Ferrari said his system costs less than current open heart techniques and allows the patients to recover more quickly because they never had to have their heart stopped and restarted.

But his system is a refinement on a current technique, so it's easier to make direct comparisons. But how would a company prove the cost-effectiveness of an entirely novel device that wasn't comparable to anything in the market. Who would make the judgment? Those were the sorts of questions being asked, but not necessarily answered, at yesterday's conference.





GRAPHIC: PHOTO, U.S. sales of medical devices totaled $17 billion in 1998, according to an industry analyst. / Associated Press 1998

LOAD-DATE: June 11, 1999




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