Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3432-NOI
P.O. Box 8016
Baltimore, Maryland 21244-8016

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the May 16, 2000 notice of intent, which outlines the Health Care Financing Administration's (HCFA's) criteria for making Medicare coverage decisions. In general, we support the agency's efforts to create a more uniform coverage process, in lieu of the carrier-by-carrier practice currently in place. Further, we support your efforts to make the coverage process more open, responsive and understandable to the public. Our comments are described below.

Evidence-Based Process
AACC agrees that coverage decisions should be based on objective clinical scientific evidence that provides statistical proof of clinical benefit. Specifically, we suggest that HCFA:

  • Incorporate specific reference to "peer reviewed published studies" (when available) that document benefit and/or value;
  • Adopt a definition of "clinical benefit" that includes, when applied to diagnostic tests, sensitivity, specificity, and diagnostic accuracy; and
  • Develop a flexible evidence gathering and review process.

While we believe that reproducible, controlled, blinded, randomized clinical trials are the gold standard of peer reviewed published studies, we recognize that holding all studies to this standard would unfairly prevent some diagnostic procedures from achieving covered status. Some clinical trials, however, by the nature of their therapy or procedure, cannot be done with ideal attributes and should be allowed to compensate by a larger population, a higher degree of statistical certainty, or a greater clinical benefit. Similarly, a completely new technology may require more evidence than a substitute technology and an orphan test is likely to require different evidence than that required for a test with a wider population base.

AACC also recommends that HCFA commit itself to working with product manufacturers, early in the product development process, so that health care innovators can develop an appropriate research design for gathering the necessary data to gain Medicare coverage.

Medicare Coverage and Payment Decisions
In general, AACC believes that coverage and payment decisions should be made separately. We are concerned that including cost as a criterion for coverage may:

  • Limit physicians' options in choosing the most appropriate test(s) for their patients;
  • Hinder the development of new technologies (manufacturers may not pursue incremental improvements if their test may not be covered); and
  • Place an undue burden on HCFA for determining the cost of a test, and identifying and quantifying how the increased values should be compensated (e.g., faster turn-around time, slightly more accurate, etc.).

We recognize that HCFA has a responsibility for maintaining the fiscal integrity of the Medicare program. This is not an easy task. However, we do not believe that using cost to deny or remove coverage is the answer. This could place HCFA in the difficult position of having to continually make subjective decisions regarding the added values of new tests (or items or services), creating new problems for the agency.

For these reasons, AACC suggests that HCFA continue to make coverage and payment decisions separately. If a new test is developed and brought to market, which is equally as good as similar tests, and less expensive--then it would be appropriate for the agency to considering lower payment rates for such tests. Under such a scenario, HCFA would lower the rates for the alternative tests, not remove coverage. The intent of this NOI should be to expand patient and physician choices and encourage the development of new technologies, not hinder it.

Also, AACC suggests that language be included to clarify how coverage requests involving existing procedures will be handled. For example, we anticipate that most petitions involving laboratory diagnostic procedures will request broader coverage of diagnoses or groups of diagnoses rather than for a new and different technology. Since these tests are already covered (and paid for) under Medicare, the type information needed for making such a determination is likely to be much different than if it was a new, breakthrough technology. Thus, we request that the agency spell out what data would need to be submitted in any future rulemaking.

We also recommend that HCFA publish in the Federal Register, with the opportunity for comment, any proposed payment reductions for tests (or other items or services) in a similar clinical modality. This will ensure that all parties have an opportunity to express their opinion on the matter, as well as reduce the likelihood that HCFA has unintentionally misclassified a test.

Finally, AACC suggests that HCFA develop draft definitions of "equivalent health outcomes," "clinical modality," and "substantially more beneficial" and other terms and place them on the agency website for review and comment (similar to FDA draft guidance documents). As previously stated, when these terms are applied to diagnostic laboratory procedures, they should be defined in terms of improved analytical sensitivity and specificity, clinical sensitivity and specificity, and clinical accuracy, when appropriate.

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 (919) 684-8724 or Vince Stine, Director, Government Affairs, at (202) 835-8721.



Frank A. Sedor, PhD

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