Health Care Financing Administration
Department of Health and Human Services
Attention: HSQ-219-GNC
P.O. Box 26676
Baltimore, Maryland 21207

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the August 29, 1997 notice announcing a revision to the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) certification fees. This notice, if implemented, would significantly increase the biennial certification fees for clinical laboratories. Currently, laboratories are assessed $100, $350 or $600 every two years based on their test volume. Starting January 1, 1998, however, these payments would range from $150 to nearly $8,000. AACC is concerned about the size and inequity of this fee increase on the laboratory community.

AACC recognizes that the CLIA program is self-funding and, therefore, the Health Care Financing Administration (HCFA) must periodically adjust the CLIA fees to keep pace with rising program costs. However, we believe the size of the fee increase, for some laboratories, is excessive. For many moderate to large size hospitals and independent laboratories, this higher assessment represents up to a 1300 percent increase in their certificate fees—far higher than the rate of inflation, which has remained less than five percent annually over the past few years. Yet, neither the public nor these laboratories receive any additional value or improvement in quality of service for the higher fee.

We appreciate the strides that HCFA and the Centers for Disease Control and Prevention (CDC) have made in recent years in streamlining program costs. However, we think that additional savings should be identified and realized before laboratories are required to pay higher fees—either for certification or surveys. AACC believes that the program costs should be more equitably distributed among all participating laboratories or reduced. For example, a modest increase in the fees assessed to low-volume facilities—beyond the increase listed in the August 29th notice—could alleviate some of the financial burden being placed on hospitals and independent clinical laboratories. In addition, we recommend that HCFA consider the following suggestions for reducing the costs of administering CLIA:

re-evaluate the duties of HCFA and CDC personnel working on CLIA. The two agencies need to determine whether the functions and duties of each CLIA staffer are still vital to the CLIA program. In addition, the agencies need to ascertain what percentage of staff time is spent on CLIA and ensure that only that time is charged to the program.

eliminate the annual review of proficiency testing (PT) providers. HCFA should require PT providers to periodically update their program and perform full-scale reviews only on new applicants.

review vendor contracts. HCFA should review and evaluate whether vendor contracts for certificate issuance, the collection of fees and other CLIA-related services remain cost-effective.

more widely promote and utilize the Alternative Quality Assessment Survey (AQAS). When HCFA proposed this self-assessment survey in 1995, it predicted that 20 percent of all CLIA laboratories would qualify for this program. It is our understanding that fewer than five percent of CLIA laboratories are currently participating in this program. By expanding AQAS, HCFA should be able to cut overall program costs by reducing the number of CLIA inspectors.

We strongly encourage HCFA to consider these and any other recommendations for reducing program costs prior to moving forward with this fee increase. Further, we suggest that any fee increase be spread out over the next two inspection cycles to give laboratories more time to absorb the user fee increase.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. Clinical chemists develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations. The AACC represents clinical chemists working in hospitals, independent laboratories and industries nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, or if you have any questions about our comments, please call me at (717) 531-8316 or Vince Stine, Manager, Government Affairs at (202) 835-8721.




Laurence M. Demers, PhD, DABCC

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