03/15/01

The Honorable Jennifer Dunn
U.S. House of Representatives
1501 LHOB
Washington, DC 20515-4708

Dear Representative Dunn:

The American Association for Clinical Chemistry (AACC) supports congressional efforts to reform the Medicare program and, more specifically, to reform how the Health Care Financing Administration (HCFA) makes reimbursement decisions. Our members, as laboratory directors and scientists, are concerned that the closed and arbitrary nature of the current Medicare payment process may stifle the development and introduction of new medical technologies-thereby delaying or denying patients access to devices that could improve the quality of their care. We believe this process can be improved, however, by opening the Medicare payment decision-making process to outside scrutiny and input.

In December 2000, the Institute of Medicine (IOM) released a study, the "Medicare Laboratory Payment Policy: Now and in the Future," which examined how the Medicare program pays for clinical laboratory tests. Among the issues the Institute considered was the impact of recent advances in medical technology on the delivery of patient care and what, if any, barriers exist to the delivery of such care. According to IOM, one of the major problems affecting the introduction of new clinical laboratory technologies is the closed nature of the HCFA payment decision-making process, which can result in inadequate payments for new devices.

To address this problem, IOM recommended that HCFA consult with stakeholders, including laboratorians, pathologists, other physicians and scientific experts, health services policymakers and economists to advise the agency on whether a new test is clinically similar to existing tests. Currently, if the test is similar, HCFA "crosswalks" it to existing tests and pays a comparable fee, but if the tests are not clinically similar, then the agency "gap fills" or creates a new payment level for the test. AACC believes that this process of whether a test is "crosswalked" or "gap filled" should be open to public scrutiny and comment. AACC strongly supports legislative reform in this area. We believe that a rational, open and timely process will reduce the bureaucratic barriers to introducing new technologies and lead to an overall improvement in patient care.By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC's members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.

If you have any questions or we may be of any assistance, please call me at (215) 662-6575 or Vince Stine, Director, Government Affairs, at (202) 835-8721.

Sincerely,

Larry Kricka, D.Phil., F.A.C.B.,
C.Chem., F.R.S.C., F.R.C.Path.
President

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