FOR IMMEDIATE RELEASE February 09, 2000

CONTACT: Linda Ruckel 202-434-7243 Mary Plock 202-434-7240

HIMA RESPONDS TO PRESIDENT'S FY 2001 BUDGET

WASHINGTON, D.C. – The Health Industry Manufacturers Association (HIMA) today endorsed the Administration’s proposed increase in FDA appropriations in the Administration’s fiscal year 2001 budget request. The association called on the agency to apply any additional funds appropriated for its device and biologics centers to continue the progress in speeding up premarket review of these products. Last year, HIMA strongly supported a $7 million increase in FDA’s device premarket review activities.

HIMA also praised the Administration’s goal of improving premarket application review times for breakthrough medical technologies. In its fiscal year 2001 budget proposal, the Administration set the goal of taking a “first action” on 90 percent of PMAs within 180 days. FDA’s device center has made substantial improvements and appears to be on track towards this goal.

“FDA has made significant strides in bringing review times down over the past several years, and this progress should continue,” HIMA President Pamela G. Bailey said. “This is important because patient access to medical technology depends on timely FDA premarket reviews. The combination of additional appropriated funds for premarket reviews and full implementation of the FDA Modernization Act will go a long way towards achieving the Administration’s stated goal of preparing FDA for a new age of rapid medical technology innovation.”

While HIMA supports the effort to prepare FDA for the coming revolution in medical technology, it urges the Administration to make a similar effort in the Medicare program. “Any improvements in FDA review times will be undermined by delays in Medicare coverage and payment,” Bailey said.

“The Health Care Financing Administration (HCFA) has made some important improvements by publishing a formal Medicare technology review process and chartering the Medicare Coverage Advisory Committee and this momentum for change should continue,” Bailey said.

In its efforts to help strengthen Medicare, HIMA has identified three important ways that Medicare can be improved to speed up access to innovative technologies:

• Establishment of objective, common-sense coverage standards that are sensitive to the rapid, incremental nature of technology innovation;
• Creation of open, timely and market-based coding and payment procedures;
• Restructuring Medicare so that it is based on patient choice among a wide range of competing health plans.

“HIMA looks forward to working with the Administration, FDA, HCFA and Congress in the coming year to improve patient access to needed technologies,” said Bailey. “We also will work to advance the debate over broad Medicare reform. By taking these steps, we can help prepare both FDA and the Medicare program for the new age of rapid medical technology innovation.”

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The Health Industry Manufacturers Association (HIMA) is a Washington, D.C.-based trade association and the largest medical technology association in the world. HIMA represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems. HIMA's members manufacture nearly 90 percent of the billion of health care technology products purchased annually in the United States, and more than 50 percent of the billion purchased annually around the world.