August 1, 2003 - ASM Comments on 2003 Clinical Lab Fee Schedule

Centers for Medicare and Medicaid Services (CMS)
Center for Medicare Management
Division of Ambulatory Services
Mailstop: C4-07-07
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: AB-02-163, 2003 Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Method

The American Society for Microbiology (ASM) appreciates the opportunity to comment to the Centers for Medicare and Medicaid Services (CMS) on Transmittal AB-02-163, 2003 Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Method, issued on November 8, 2002. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 40,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical microbiology.

Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating the performance of new technologies. Thus, our Society has a significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries. The ASM’s Public and Scientific Affairs Board’s Committee on Professional Affairs reviewed Transmittal AB-02-163, and submits the following comments and concerns regarding Current Procedural Terminology (CPT) codes 87800, 87801, and 87255:

Codes 87800 and 87801:
AB-02-163 states that “Based on comments regarding codes 87800 and 87801, the mappings (for these two codes) has been revised. Code 87800 has been mapped to two times code 87797 and code 87801 has been mapped to two times code 87798.” ASM supports this revision to allow increased reimbursement for “multiple organism tests.” However, the utility of codes 87800 (infectious agent detection by nucleic acid, DNA or RNA, multiple organisms; direct probe technique) and 87801 (infectious agent antigen detection by nucleic acid, DNA or RNA, multiple organisms; amplified probe technique) is controversial. The established AMA coding hierarchy would suggest that coding for specific analyte take precedence over coding for a generic method. Thus for “multiplex” molecular tests available to date, correct coding should logically account for each specific analyte rather than using the generic “multiple organism” code. Our members report inconsistency in their approaches to coding for the most common “multiple organism” tests available, those for Neisseria gonorrhoeae and Chlamydia trachomatis. While a majority of laboratories continue to use analyte specific codes 87490 and 87590 (direct probe technique) or 87491 and 87591 (amplified probe technique), some report a decision to use 87800 or 87801 based on the recommendation of their institutional coding and compliance groups. While the revision in mapping announced in this transmittal renders reimbursement for either approach equivalent for these two analytes, the larger issue of reimbursement for multiple analyte molecular test formats with more than two analytes remains. Compounding the confusion is the November 29, 2000 Program Memorandum AB-00-109 which instructs the following when using a direct probe microbial identification test for three organisms (Candida, 87480; Gardnerella, 87510, and Trichomonas, 87797, in 2004 approved as an analyte specific proposed code 8766X):

“When all three organisms are tested using one specimen for the test kit, regardless of the number of medically necessary tests performed, payment should reflect one unit of service using code 87797 and should not be billed individually.”

As the major cost component of any molecular assay is the “probe,” “primer” or other specific nucleic acid detection component, ASM believes that correct coding should specify each individual analyte tested for, and recommends that CMS issue a new instruction that clarifies the issue of correct coding for multiple analyte tests to resolve the apparent discrepancies in the current fee schedule. It would also seem desirable from a utilization review perspective to achieve coding consistency among laboratory providers, particularly for emerging molecular technologies.

Code 87255:
AB-02-163 specifies crosswalk methodology for new code 87255 (Virus isolation; including identification by non-immunologic methods, other than by cytopathic effect, e.g. virus specific enzymatic activity) at the same rate as one-half code 87253 and code 87252. While ASM recommended a gap-fill process for this novel technology which uses concomitant virus isolation and specific identification accomplished by growth in modified cell lines with a specific measurable or observable indicator system built in, we believe the CMS crosswalk decision for 87255 is acceptable. However, we remain concerned that this technology has been given an unreasonable competitive advantage over a clinically equivalent alternative methodology using shell vial culture with specific fluorescent antibody detection of viral growth, due to an inherently unreasonable reimbursement established in 2000 for the code for this technique (87254, virus isolation, centrifuge enhanced (shell vial) technique, includes identification with immunofluorescence stain, each virus). Program Memorandum AB-00-109 issued on November 29, 2000, specified an illogical crosswalk for 87254 to 87250 (virus isolation; inoculation of embryonated eggs, or small animal, includes observation and dissection) at one quarter of the rate. In view of the establishment of the 2003 fee for 87255, ASM believes that the reimbursement for code 87254 should be re-evaluated.

Thank you for the opportunity to comment on Transmittal AB-02-163 regarding reimbursement decisions for new 2003 CPT codes. ASM would be pleased to answer questions and to provide any additional information you may require in consideration of our comments.   We stand ready to work with CMS throughout the entire process of establishing appropriate reimbursement for medically necessary testing for Medicare beneficiaries.