By Lisa Seachrist

Washington Editor

WASHINGTON - Sen. Orrin Hatch (R-Utah) introduced legislation Thursday to ensure new medical technologies are made quickly available to Medicare beneficiaries and that those therapies are adequately reimbursed by the Health Care Financing Administration (HCFA).

The bill, titled "The Medicare Patient Access to Technology Act of 1999," or S.1626, seeks to cut some of the red tape currently involved with Medicare coverage of new medical devices, drugs and biologics as well as reform the agency's proposed Ambulatory Patient Classification (APC) system, a prospective payment system for outpatient services.

"Currently, Medicare beneficiaries have to wait months, many times years, for the most innovative treatments to be approved by Medicare," Hatch said. "And that just isn't fair to older Americans. So my bill changes this by requiring HCFA to speed up the way it approves new medical technologies for all Medicare patents."

Once a drug, biologic or medical device has cleared FDA, it faces a new hurdle - being covered by Medicare. That process requires HCFA to determine whether or not to cover the technology, develop a six-month market experience with the product, assign a procedure code to the product, and determine an appropriate payment level.

Hatch's bill, a companion to a House bill introduced in June by Rep. Jim Ramstad (R-Minn.), shortens the time to Medicare coverage by instituting an advisory committee that would recommend the coverage, coding and payment for a new product. It also calls for more frequent updates of the coding system and the use of external data in making these decisions.

For the APC system, which was legislated by the passage of the Balanced Budget Act in 1997, one of the biggest criticisms is the reliance on old and inaccurate data for determining reimbursement levels for drugs and biologics. The bill also seeks to reform this system to ensure proper coding and reimbursement for these products in the outpatient setting. (See BioWorld Today, Sept. 16, 1999, p. 1.)

"While FDA reforms have made the approval process more efficient and transparent, Congress now needs to make the same sun shine on HCFA," Ramstad said.

The reforms included in the two proposals are by no means comprehensive. Nevertheless, Hatch sees the bill as a reasonable first step to large-scale Medicare reform.

"The real question is whether there will be a Medicare package this year," Hatch said. "As for these measures, I don't think even the people at HCFA oppose them."

Hatch has the support of five other senators including Senate Assistant Majority Leader Don Nickles (R-Okla.) and Sen. John Breaux (D-La.), who co-chaired the ill-fated Bipartisan Commission on Medicare Reform. Both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) support the bill.

"This is a bill that is very aptly named - it does exactly what it says it does," said Carl Feldbaum, president of BIO. "It's not a comprehensive reform of HCFA, but it does no harm at all. Even in this highly partisan environment, this bill has a chance."

Hatch vowed even if Congress failed to enact comprehensive Medicare reform this year, it would take up the measure and complete the job next year. However, with a presidential election coming up next year, Medicare reform may have to wait for the 107th Congress.