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Biotech / Medical : IFLO is Breaking Out -- Ignore unavailable to you. Want to Upgrade?

To: arnold silver who wrote (1014)	9/6/2000 12:17:57 AM
From: Toni Wheeler	Read Replies (1) \| Respond to of 1018

Borrowed from Yahoo! IFLO thread... "In (early) August, IFLO received HCFA reimbursement approval for On-Q and PainBuster. This was a major step and the following editorial provides some insight into the process and its relevance." A BOSTON GLOBE EDITORIAL: The monitoring of medical devices <<<Imagine you are the inventor of an ingenious new device for detecting a disease and the Food and Drug Administration (FDA) 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 (HCFA), 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 HCFA 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… 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 HCFA 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 HCFA 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 HCFA 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.>>> "This story ran on page A18 of the Boston Globe on 9/4/2000." © Copyright 2000 Globe Newspaper Company