FOR IMMEDIATE RELEASE December 21, 1999

CONTACT: Linda Ruckel (202) 434-7243 Randy Burkholder (202) 434-7269

MEDICARE COVERAGE COMMITTEE CUTTING OFF PUBLIC INPUT

MCAC Committee's closed-door policy-making sessions challenged as illegal by HIMA

Washington, DC - The Health Industry Manufacturers Association (HIMA) delivered a letter to HCFA yesterday challenging the agency's moves to involve the Medicare Coverage Advisory Committee (MCAC) in development of coverage standards and hold private MCAC meetings. These actions violate federal law and undermine HCFA's formal rulemaking process, HIMA says.

"The Medicare coverage criteria under development at HCFA will have a profound impact on patient access to innovative technology for many years to come," HIMA President Pam Bailey said. "Beneficiaries will have access to cutting-edge technologies only if coverage criteria are in step with the innovation process. Patients, providers and other stakeholders must be given a voice to ensure that this happens."

"Involving the MCAC in development of coverage criteria and holding private MCAC subcommittee meetings would shut off public input on this critical issue. After making great strides over the past year towards an open, public Medicare coverage process, it is troubling that HCFA now would be moving to hold closed-door meetings and circumvent formal rulemaking."

In a December 20 letter to HCFA, HIMA says that private MCAC subcommittee meetings would directly violate the laws and regulations that guide the conduct of federal advisory committees. In addition, involving the advisory committee in development of coverage criteria would undermine the formal rulemaking process that HCFA has been pursuing separately.

HCFA chartered the MCAC one year ago to replace the Technology Advisory Committee after the General Accounting Office found that the TAC violated federal law by meeting in private to make Medicare coverage recommendations. At a December 8 meeting, the MCAC "Executive Committee" recommended creation of a private subcommittee to conduct further work on coverage issues. At the meeting, HIMA challenged the Executive Committee's discussion of coverage criteria on the grounds that it went beyond the scope of the MCAC charter and undermined HCFA's formal rulemaking process.

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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.