FOR IMMEDIATE RELEASE APRIL 7, 1999

CONTACT: Karen Alcorn (202) 434-7240 Linda Ruckel (202) 434-7243

MEDICAL DEVICE INDUSTRY RELEASES
LEGISLATIVE PROPOSALS TO EXPEDITE INNOVATIVE
PRODUCTS INTO THE MEDICARE SYSTEM

WASHINGTON, DC--Citing several problems plaguing the Medicare system that deny Medicare patients timely access to needed treatments and threaten medical innovation, the Health Industry Manufacturers Association (HIMA) today released its legislative proposals to improve Medicare's ability to keep its payment systems current with advances in medical technology. The proposals address the technical methods and systems Medicare uses to adopt and pay for new products. "Though these problems might appear arcane and technical, they get to the heart of what beneficiaries expect Medicare to be, a program that offers appropriate access and the highest quality of care," said Ted Mannen, HIMA's executive vice president for health care systems. "Our proposals are designed to alleviate delays in the introduction of, and use of, new treatments and expedite medical innovation."

HIMA's legislative proposals cover three key areas: integrating medical technology into Medicare's various payment systems; improving Medicare Part B purchasing authorities such as inherent reasonableness and competitive bidding; and clarifying the intent of Medicare's fraud and abuse "exclusion" law.

"Though the nature of these problems is as diverse as the mechanisms themselves, they share a common theme," explained Mannen. "Medicare's methods for deciding the appropriate payment categories are cumbersome and lag dangerously behind the rapid pace of medical innovation and advances in medical practice."

Clarifying the odyssey by which medical devices must go through before reaching the market, Steve Ubl, HIMA's vice president for government and public affairs explained, "After medical technologies are cleared by the Food and Drug Administration, they must pass several critical hurdles in the Medicare program before they are integrated into the portfolio of services that Medicare makes available to its beneficiaries." Medical technologies must be covered, have an identifying procedure code, and be reimbursed through one of Medicare's payment systems. "If a problem arises at any of these levels, the technology will, in many cases, not become available to Medicare patients."

Some of the proposals put forth by HIMA to address these problems include:

• Adjusting Medicare payment levels and categories at least annually to reflect changes in medical practice and technology.
• Using valid external sources of information to update payment categories if Medicare's data are limited or not yet available.
• Updating HCFA's procedure codes to ensure availability of the most recent advances in medical technology.
• Clarifying HCFA's inherent reasonableness authority and process to ensure fairness, due process, and continued availability of appropriate products and services for patients.
• Clarifying Medicare's "exclusion" law to make clear that it applies solely to direct providers, and in no way applies to indirect providers.
• Delaying the expansion of competitive bidding until a broad impartial analysis of the competitive bidding projects is completed by the Institute of Medicine.

HIMA believes that the legislative proposals put forth today will help shorten the length of time it currently takes to get products properly integrated into the myriad of Medicare payment systems. "These proposals to reform the current problems in the Medicare system will allow Medicare beneficiaries access to the very innovations that are helping other patients live a longer, more productive life," concluded Mannen.

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To view legislative proposals, click on the appropriate title.

• Integrating Medical Technology into Medicare
  
• Medicare Part B Reform Summary
  
• Providing Access to Therapies for Medicare Patients in Skilled Nursing Facilities
  
• Clarifying the Intent of Medicare's "Exclusion" Law

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 $58 billion of health care technology products purchased annually in the United States, and more than 50 percent of the $137 billion purchased annually around the world.