FOR IMMEDIATE RELEASE May 17, 2000

CONTACT: Mary Plock 202-434-7240

HIMA STATEMENT ON HCFA’S MEDICARE COVERAGE CRITERIA NOTICE

The Health Care Financing Administration took an important step towards creation of Medicare coverage standards by publishing in the May 16 Federal Register a notice announcing its intent to promulgate a coverage criteria regulation.

HIMA supports HCFA’s stated goal in the notice of facilitating “timely and expanded access for Medicare beneficiaries to appropriate new technologies.”

HIMA is in the process of reviewing the notice and is doing so with an eye towards assuring that Medicare coverage criteria rules do in fact achieve the agency’s goal of timely and expanded beneficiary access. HIMA will continue to work with HCFA in the coming months to ensure the agency creates coverage criteria that support timely beneficiary access to the innovative medical technologies that save and improve lives and help reduce health care costs.

HIMA has identified several sections of the notice of intent that we believe will conflict with the agency’s overall goal of improved patient access:

• Cost as a Medicare coverage factor: In its notice of intent, HCFA raises the possibility of denying Medicare coverage of certain technologies on the basis of their cost. HIMA believes that economic factors such as cost properly are considered in the context of payment, not coverage, decisions. In a recent nationwide survey by polling firm Penn, Schoen & Berland, 67% of Americans said they would oppose limiting availability of new technologies on the basis of cost.
• Recognizing the full spectrum of data: As HCFA further defines levels of evidence required for drug and device coverage decisions, it must recognize important differences between the two types of products. New devices emanate from a dynamic, incremental innovation process and have very short life cycles. As a result, many different types of evidence must be used to guide clinical use of new technologies. Medicare’s coverage criteria should recognize this range of evidence types.
• Preserving the role of patients and physicians in making treatment decisions: HIMA is concerned that as defined in the notice of intent HCFA’s upcoming coverage criteria reg could be overly prescriptive and curtail physicians’ and patients’ ability to decide which treatment option is best. Society has entered an era in which patients are playing an increasingly important role in making decisions about their health care. Patients and physicians have a unique role to play in deciding whether, for example, the improved quality of life offered by a new technology outweighs potential risks. Medicare should craft coverage criteria that empower patients and physicians rather than unnecessarily restricting their ability to decide among different treatment options.

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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 $68 billion of health care technology products purchased annually in the United States, and more than 50 percent of the $159 billion purchased annually around the world.