October 28, 1997 - CLIA Fee Increase

Federal Register Notice:  CLIA Program; Fee Schedule Revision

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

ASM Comments on HSQ-219-GNC: A General Notice with comment period. Department of Health and Human Services, Centers for Disease Control and Prevention, Health Care Financing Administration, CLIA Program; Fee Schedule Revision.

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the August 29, 1997 Federal Register Notice announcing a revision to the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) certification fees. The ASM is an educational and scientific society dedicated to the promotion of the microbiological sciences and their applications for the common good. The Society represents 43,000 microbiologists who work in clinical, public health, industrial and research laboratories. Many of our members apply the CLIA regulations in their laboratories on a daily basis and will be directly impacted by these fee increases.

This notice, if implemented as currently proposed, 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 rise significantly and for those laboratories with volume of over 1,000,000 tests fees would be increasing over 1300 percent, with mid-size laboratories fees more than tripling. Fee increases of this magnitude will place an unfair burden on clinical laboratories who are already facing diminishing reimbursement and an array of changes in the delivery of laboratory services in this country. ASM is concerned about the size and equity of this fee increase and its impact on the laboratory community.

ASM recognizes that the Health Care Financing Administration (HCFA) has not raised CLIA fees since the program's inception in 1992 and that current law requires the CLIA program to be self financing. However, we believe the size of the fee increase for some laboratories is unrealistic and unjustifiable. For many moderate to large size hospitals and independent laboratories, this unbudgeted assessment represents anywhere from a 340 to 1300 percent increase in their certification fees. At a minimum, ASM recommends HCFA consider phasing in these fee increases over at least two billing cycles, if not more. Laboratories budget at least 18 months to two years in advance and require more time to plan and pay for these type of increases.

According to the proposed regulation, these fee increases will not translate into any increased level of regulatory oversight. In fact, many ASM members work in laboratories which are accredited by organizations such as the Joint Commission on the Accreditation of Health Care Organizations and the College of American Pathologists and are charged considerable fees from these entities to be accredited. This fee increase is being applied to all laboratories regardless of accrediting status. However, the fee increase appears to bear more heavily on the non-HCFA accredited laboratories. These laboratories appear to be partially subsidizing some of the program costs of HCFA accredited laboratories. ASM recommends that HCFA more equitably distribute the costs of the CLIA program or that the program costs be reduced.

The ASM appreciates the efforts that HCFA and the Centers for Disease Control and Prevention (CDC) have made in recent years in streamlining the CLIA program and controlling costs. However, the ASM recommends that additional savings be identified before laboratories are required to pay higher certification fees. The ASM recommends that HCFA consider the following suggestions for reducing the costs of administering CLIA:

Eliminate the annual review of proficiency testing (PT) providers. HCFA should require PT providers to periodically update HCFA on program changes. HCFA should only perform a full-scale review on new applications.

Promote the Alternative Quality Assessment Survey (AQAS) more widely. HCFA proposed this self-assessment survey in 1995 and 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 program costs by reducing the number of CLIA inspectors and administrative costs. Additional efforts should be undertaken to achieve cost savings through the AQAS program.

Increase coordination between CDC and HCFA to ensure CLIA staff are not duplicative and are functioning in a collaborative manner. In addition, it is critical that the results of any CDC studies measuring the effectiveness of the CLIA regulations be incorporated into the program, in particular, if changes can achieve program savings.

In conclusion, the ASM would like to strongly emphasize its continued support for the ongoing implementation of the CLIA program. The CLIA program works to ensure the quality and accuracy of patient testing, regardless of where that testing occurs. However, we encourage HCFA to consider these and other recommendations for reducing program costs prior to moving forward with this fee increase.