Washington Waving the flag of accessibility-not to buildings but to new technologies-the Health Care Financing Administration and a bipartisan group on Capitol Hill has unveiled plans to change the Medicare process by which new products and services are covered.

HCFA issued in mid-May a Federal Register notice proposing standards to guide new coverage decisions. "The process we are launching today will help establish the most open, timely and dependable system possible for making national Medicare coverage decisions," said Nancy-Ann Min DeParle, HCFA administrator. The notice of intent of rule making is what HCFA calls the first step in creating national criteria for what is "reasonable and necessary."

"Manufacturers have been pushing for this for a long time, and it will have an effect on products across the health care spectrum," said Asela Cuervo, vice president of government relations for the Alexandria, Va.-based American Association for Homecare. "We still need to look at the specifics of the standards and get feedback from our manufacturer members, but we will make their views known."

The proposal would require that an item or service be "shown to have medical benefit" and that it "must demonstrate added value to people in Medicare." According to HCFA, cost would not be considered in making a coverage decision if a new item or service "would be medically beneficial and there is no Medicare-covered alternative available" or if it "would be medically beneficial and is a different clinical type than a Medicare-covered one." However, HCFA says cost limits could come into play with more expensive items or services that do not offer "significant added medical benefit."

HCFA officials say the new standards would create an "understandable and predictable" process for making "more consistent and timely decisions." A national definition of coverage criteria, they noted, also would allow HCFA to expand patient access to new technologies.

Meanwhile, Reps. Jim Ramstad, R-Minn., and Karen Thurman, D-Fla., have introduced H.R. 2030, the Medicare Patient Access to Technology Act. The bill would reduce delays in covering, coding and paying for new devices and diagnostic tests.

According to the Health Industry Manufacturers Association, the current process can delay patient access to new technologies for years. This new Medicare reform bill, HIMA officials added, builds on several related provisions in the 1999 Balanced Budget Refinement Act.

For more information on the bill, go to www.thomas.loc.gov. For more information on HCFA's proposed rules, go to www.hcfa.gov/pubaffr.htm.