High Noon In Arizona

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published April 2000

EDITOR'S PAGE

For small children and other over-impressionable souls, the gift shop in the Pointe Hilton Resort at Squaw Peak, near Phoenix, is a fearsome place. Wolves and coyotes glower from every corner. Scorpions and tarantulas infest the shelves, where rattlesnakes coil and rear to strike. As pretty as their backdrops, Gila monsters and coral snakes lurk atop Navajo blankets. Of course, the wolves are printed on scarves and sweatshirts, the spiders encased in resin, the desert snakes stuffed or plaster-cast. Instead of howling and hissing and rattling, there is only polite conversation and the frequent chuck-chuck of the cash register.

The Pointe Hilton was the site of this year's annual meeting of the Health Industry Manufacturers Association (HIMA)—a gathering pervaded by a similar spirit of sublimated menace. Plausible threats to the industry are becoming harder to identify, since, by most accounts, device manufacturers are doing rather well, thank you. Breakthrough technologies abound, from genetic therapies to tissue engineering to minimally invasive procedures. Demographic prospects have never been better, as vast ranks of baby boomers conveniently "transition," as one speaker put it, into "candidates for chronic disease." E-commerce and Internet distribution promise to improve efficiencies and spur business—or not, but at least will keep everyone interested. And with FDA reengineering and FDAMA implementation proceeding appropriately—under the equitable leadership of Commissioner Jane Henney and CDRH director David Feigal—the bête noire of Rockville has for the moment been largely defanged and declawed.

The loss of the monolith of obstructionism that was the old FDA has put the industry into a situation similar to that which Mike McCurry sees in the country as a whole. President Clinton's former press secretary, addressing the meeting on its final day, claimed to detect in America a certain "aimlessness" since the end of the Cold War and fall of the arch-rival "'evil empire.'" Trying to avoid such drift, the device industry has lately refocused its energy on reimbursement, nominating HCFA for the role of villain.

For example, the first installment of the HIMA-commissioned Lewin Report, Outlook for Medical Technology Innovation, cites "unpredictable and inconsistent payment requirements," maintaining that manufacturers "find that the complexity of the coverage, coding, and reimbursement process creates a significant challenge that can delay patient access to new technologies." Device makers, the report states, "uniformly expressed great frustration with the lack of clarity, consistency, and timeliness of the process as well as the criteria used to make decisions."

And yet, the black hat doesn't appear to quite fit today's HCFA, either. In fact, few in the crowd seemed to express much frustration at all with the frank and open presentation of HCFA administrator Nancy-Ann DeParle, who spoke via a live video hookup. Acknowledging that coverage processes in the recent past "at best weren't working well and at worst were moribund," DeParle described how HCFA is attempting to clarify coverage criteria, announced that industry could henceforth track national coverage decisions in real time on the Internet, and committed the agency to publish quarterly updates on new technologies. DeParle repeatedly exhorted attendees to communicate their concerns directly to her or other HCFA officials; she also appealed for support for increased HCFA resources, pointing out that the agency employs 40 full-time reviewers—compared with 4000 at FDA.

Though work clearly remains to be done, the manufacturers were notably positive and energized, as was HIMA, whose president, Pamela Bailey, revealed several new initiatives (to be reviewed in upcoming issues of MD&DI). At least for this springtime in the desert, you could gift wrap trouble and take it home.

Jon Katz
[email protected]

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