FOR IMMEDIATE RELEASE December 9, 1999

CONTACT: Linda Ruckel (202) 434-7243 Bahar Morid (202) 434-7273

HIMA UNVEILS MEDICARE COVERAGE PRINCIPLES
AT ADVISORY COMMITTEE MEETING

WASHINGTON, D.C. - The Health Industry Manufacturers Association (HIMA) unveiled December 8, its core principles of national Medicare coverage criteria at a meeting of the Executive Committee of HCFA's Medicare Coverage Advisory Committee (MCAC). At the same time, the association urged both HCFA and the Executive Committee to implement coverage criteria through the formal rulemaking process, not the MCAC.

The presentation followed approval of the principles the day before by the HIMA Board of Directors' Payment Committee during the board's meeting in Washington, D.C.

"These principles represent a patient-centered, common sense approach to Medicare coverage criteria, one that will make sure innovative technologies are provided to beneficiaries in a timely manner," HIMA President Pam Bailey said. The principles were presented to the MCAC Executive Committee by Greg Raab, HIMA's Senior Health Affairs Advisor.

"Medical technology has advanced by quantum leaps since Medicare was enacted in 1965," Bailey said. "In that time, HCFA has provided no formal standards for Medicare coverage of these technologies. We applaud the agency for undertaking rulemaking to set these standards, and hope that it considers HIMA's recommendations in doing so. In order for Medicare beneficiaries to enjoy tomorrow's life-saving and life-enhancing technologies, HCFA today must create a system that is in step with the rapid yet incremental nature of device innovation."

The Medicare coverage principles released by HIMA state that coverage decisions fundamentally relate to patient care and should not involve economic factors. Economic factors are properly considered in the context of payment policy, HIMA says. "This is a very important policy issue for patients and manufacturers, and at the same time is very challenging for HCFA to implement properly," Bailey said. "HIMA continues to develop recommendations to ensure that if and when HCFA employs economic factors, it does so in a way that will not deny patients' access to beneficial technologies."

"HCFA deserves praise for undertaking the effort to develop coverage criteria and also for establishing a public advisory committee and moving toward a more open coverage process," Bailey said. "HIMA looks forward to working closely with HCFA as it crafts a coverage criteria policy that recognizes the important benefits of medical technology and the unique nature of innovation in this field."

HIMA's recommendations call for Medicare coverage criteria that:

• Are based on clinical effectiveness, not economic factors
• Rely on clinical data that are reasonable, clinically relevant and collaboratively developed
• Ensure reimbursement for all investigational devices that represent incremental advances covered by Investigational Device Exemptions (So-called "Category B" products).
• Guard against premature national non-coverage decisions
• Ensure that coverage restrictions are set only when warranted by existing data and are frequently updated to reflect current medical technology and physician practices.

While taking the opportunity to present its core coverage criteria principles in the public forum afforded by the Executive Committee meeting, HIMA cautioned against use of the meeting by HCFA to skirt formal rulemaking. "The proper forum for developing these coverage criteria for the Medicare program is the federal rulemaking process, not the deliberations of this advisory committee," Raab told the group.

HIMA said that MCAC's charter does not authorize it to provide input on a policy issue such as coverage criteria and that by discussing it the Executive Committee ran the risk of supplanting public input provided through formal rulemaking. The association also cautioned HCFA against delivering coverage criteria in presentations to the panel instead of through the rulemaking process.

Raab also praised HCFA for "fostering an open coverage review process by providing ample time at panel meetings for beneficiaries and outside experts to speak." Noting that this gave MCAC panel members valuable information from the "front lines" of medical care, Raab urged the committee to continue this pattern of openness.

Click here to read HIMA's presentation.

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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 $62 billion of health care technology products purchased annually in the United States, and more than 50 percent of the $147 billion purchased annually around the world.