FOR IMMEDIATE RELEASE May 10, 2000

CONTACT: Mary Plock 202-434-7240 Kristen Lerch-Kosin 202-434-7273

BILL AIMS TO GIVE AMERICA’S SENIORS ACCESS TO ADVANCED MEDICAL TREATMENTS MEDICARE PATIENT ACCESS TO TECHNOLOGY ACT SEEKS ELIMINATION OF BARRIERS TO LIFESAVING TREATMENT

WASHINGTON, D.C. – The Health Industry Manufacturers Association lauded the introduction of The Medicare Patient Access to Technology Act as an important step forward in making the latest medical technology advances available to America’s seniors. The bipartisan legislation, introduced today by Reps. Jim Ramstad (R-MN) and Karen Thurman (D-FL), addresses significant problems in Medicare that can deny beneficiaries access to the innovative technologies that can improve their lives and help reduce health care costs.

“The problems in Medicare are real, and they hurt real people,” Ramstad said in announcing introduction of the legislation. “Without this bill, Medicare will continue to fall short of making the latest technologies and procedures available to beneficiaries in a timely manner.”

“We all want our parents and grandparents to receive quality health care, and when a patient is denied access to a new test or medical device – already approved by the Food & Drug Administration following its rigorous and lengthy review – because the Medicare reimbursement rate is too low or non-existent, they’re being denied the best care available,” Thurman said.

“Medical technology saves and improves lives,” said Pamela G. Bailey, president of the Health Industry Manufacturers Association. “Reforms are needed to ensure that advanced technologies like cochlear implants, ventricular assist devices, positron emission tomography scans and diagnostic tests are getting to the Medicare patients who need them.”

“Representatives Ramstad and Thurman have taken the lead in responding to these problems by introducing a bill to eliminate the delays and barriers to access that have arisen in the way Medicare decides to cover, code and pay for new devices and diagnostics,” Bailey noted. Currently, Medicare’s hurdles in coverage, coding and payment decisions result in delays – of four-and-a-half years or more – to make a new technology fully available to beneficiaries. The Medicare Patient Access to Technology Act takes simple, common sense steps to eliminate these delays and remove barriers to access. Provisions of the bill would require the Health Care Financing Administration to:

• Update annually several payment programs;
• Issue temporary procedure codes for new technologies at the time of FDA review;
• Update codes every quarter instead of annually;
• Make better use of external data to improve the timeliness and appropriateness of reimbursement decisions;
• Prepare an annual report on the timeliness of its coverage, coding and payment decisions;
• Create open, timely procedures and sound methods for making coding and payment decisions for new diagnostic tests.

The Medicare Patient Access to Technology Act of 2000 builds upon the enactment of several provisions in the bill introduced last year by Rep. Ramstad. The provisions, enacted as part of the Balanced Budget Refinement Act, fundamentally reformed Medicare services furnished in the outpatient setting and preserved patient access to technology in that environment. The bill introduced today targets similar reforms for hospital inpatient and other settings such as ambulatory surgical centers.

One of the most significant additions to the current bill is the new section devoted to clinical laboratory tests and other fee-schedule items. "We stand on the cusp of an explosion in new technology in diagnostic testing,” said Bailey. “Genetic testing, cancer screenings, and cardiac marker tests that can tell almost instantly whether or not a patient is actually having a heart attack, have tremendous potential to save lives and reduce costs. Yet, these tests often meet an uphill battle to obtain Medicare coverage and adequate reimbursement.”

Illustrating this point, Bailey cited a breakthrough diagnostic test. Medicare assigned an improper procedure code to a bladder cancer test when used in the physician’s office or at home, where 90% of testing is performed. Medicare’s reimbursement for use of the test is about 70% less than its payment for use in other settings. With Medicare under-payment so severe the company can no longer afford to actively market the test to physicians, diffusion of the product for use in physicians’ offices or at home is limited.

The bill would rectify the problems associated with new technologies by requiring the Secretary to develop a new methodology for paying for them. It also calls for developing procedures that are more open, transparent, and affords interaction between the innovator and the regulator.

“America’s seniors need the help that this bill provides to gain access to the advanced treatments that can save and improve their lives and help reduce costs, " said Bailey.

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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.