Copyright 2000 Globe Newspaper Company
The Boston
Globe
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September 4, 2000, Monday ,THIRD EDITION
SECTION: EDITORIAL; Pg. A18
LENGTH: 499 words
HEADLINE:
THE MONITORING OF MEDICAL DEVICES
BODY:
Imagine you are the inventor of an ingenious
new device for detecting a disease and the Food and Drug Administration has just
decided that your scanner is safe and effective. You might think you're home
free, but you're not. The agency that runs Medicare has to give
its review, and that process can make the FDA's like a day at the beach.
The agency, the Health Care Financing Administration, wants to make sure
your new device is "reasonable and necessary" before it will authorize any
payment for it, and then it has to decide what the reimbursement rate should be.
Companies can wait five years or more for the agency's approval.
Recent changes at the FDA have gotten its average
approval time for new medical devices down to about nine
months, from 16. But because many private insurers follow
Medicare's lead, new products that haven't been approved by the
Health Care Financing Administration can sit on the shelf. Device manufacturers
have the option of seeking local approvals on a state-by-state basis, and most
choose this route. The national review ends up serving like an appeals court,
addressing the most difficult coverage decisions, and inevitably it works more
slowly.
In Massachusetts, the issue affects not just the health care of
citizens but some of their paychecks as well. There are 250 medical
device companies in the state employing 23,000 workers. Only California
has a bigger industry.
To streamline Medicare's
approval of new devices, industry representatives are asking Congress to include
a set of revisions in pending legislation designed to correct an array of
Medicare reimbursement problems created by the Balanced Budget
Act of 1996.
For its part, the Health Care Financing Administration
acknowledged shortcomings in its approval process 18 months ago when it began
making internal changes, not least by creating a new medical advisory board,
imposing timelines on itself, and making the approval gauntlet more transparent.
In May it proposed new criteria for approvals, but the industry fears that a
proposal for large-scale, longer-term trials could complicate bringing new
technology to Medicare patients.
The review of devices
for acceptance by Medicare is a useful one. There is no reason
for the government to pay substantially higher reimbursements for new gadgetry
that does not greatly improve upon existing equipment. The Health Care Financing
Administration believes it is not Medicare's responsibility to
help industry cover excessive start-up costs for products that offer just
incremental advances. Still, agency officials are open to further improvements
and are willing to look at the proposals in the legislation that the industry is
backing.
In that spirit, industry and the Health Care Financing
Administration should be able - through regulatory or statutory changes - to
arrive at a process that serves both patients and taxpayers well and ensures
device makers that their products get a timely and open review.
LOAD-DATE: September 6, 2000 
