August 2, 2001 - Clinical Laboratory Fee Schedule and Laboratory Costs

The American Society for Microbiology (ASM) appreciates the opportunity to comment on Transmittal AB-00-109, "Clinical Laboratory Fee Schedule and Laboratory Costs Subject to Reasonable Charge Payment Methodology." 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 42,000 microbiologists, including scientists and science administrators in academic, industry and government institutions working in a variety of areas, including biomedical, environmental, and clinical microbiology.

Many of our members have primary involvement in the clinical laboratory environment including individuals directing clinical microbiology or immunology laboratories, individuals licensed to perform such testing, industry representatives marketing new products for diagnosis, and researchers involved in evaluating the performance of new technologies. Thus, our organization has a significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory tests to ensure quality patient care for Medicare beneficiaries.

The ASM's Public and Scientific Affairs Board's Committee on Professional Affairs reviewed Transmittal AB-00-109 and has the following comments and concerns regarding the proposal.

The 2001 Clinical Laboratory Fee Schedule included National Limitation Amounts (NLA) for a significant number of microbiology and immunology CPT-4 codes which were added or revised in the 2001 CPT Manual. In general, the code changes have greatly improved the accountability and reasonable reimbursement for clinical microbiology laboratory tests. In addition, we believe many of the reimbursement decisions made by the Centers for Medicare and Medicaid Services (CMS) based on the payment methodology of "cross walking" and "gap filling" detailed in Transmittal AB-00-109, appear to be reasonable within the context of the existing NLA structure. However, we have identified several issues of concern to clinical microbiologists. These concerns are summarized as follows:

  • Some of the reimbursement decisions made for new culture based codes and for some immunoassays are illogical based on current "cross walking" payment methodology. Equivalence should be carefully considered in the cross walking methodology when assessing the comparability of tests, since this significantly impacts the total costs of performing these procedures. Examples of illogical cross walks include:
  1. 87071 Quantitative aerobic culture...any source except urine blood or stool, is cross walked to 87045 Culture, bacterial…stool.
  2. 87073 Quantitative anaerobic culture…any source except urine, blood, or stool, is cross walked to 87045 Culture, bacterial…stool.
  3. 87254 Virus isolation…shell vial, is cross walked to 87250 Virus isolation; inoculation of embryonated eggs or small animals.
  4. 87300 infectious agent detection by immunofluorescent technique, is cross walked to 87301 infectious agent detection by enzyme immunoassay.
  5. 86683, antibody for detection of hemoglobin (fecal), is cross walked to 82270 blood, occult, by peroxidase.

The codes listed in 1-4 (87071, 87073, 87254, 87300) describe common microbiology procedures performed on clinical specimens that do not demonstrate substantial equivalence to the primary codes to which they were crosswalked. The 5th example (86683) is an immunoassay which was cross walked to a biochemical assay. Codes 87071 and 87073 should have been gap filled since they are not equivalent to any existing primary culture codes. Code 87254 which uses shell vial isolation, is more comparable to code 87110 (Culture, Chlamydia) which also uses a shell vial technique.However, 87254 is worded to be inclusive of an immunofluorescence stain for detection of a specific virus, whereas 87140 (culture typing, immunofluorescent method) is used in addition to 87110 to describe the entire Chlamydia isolation composite process. Code 87300 should be cross walked to a similar immunofluorescent assay, and code 86683 should be cross walked to similar immunoassay method.

  • The application of reasonable charge methodology is not based on procedural considerations. In addition to the illogical cross walks, in several cases, reimbursements have been reduced by an arbitrary amount that do not consider the direct costs of performing the work. Cross walks should accurately reflect testing processes, and reasonable charge methodology reduction should represent a real reduction in activity costs proportionate to the rate adjustment. In the absence of a mechanism to identify components of a process, it is difficult to "subtract" payment representative of an appropriate cost reduction. Examples of arbitrary and procedurally unjustified reductions include:
    1. 87046 Culture, bacterial, stool, each additional pathogen, is reduced to 25% of 87045 Culture, bacterial, stool, for Salmonella and Shigella. A culture for the most common additional pathogen, Campylobacter, is actually more costly than the primary culture costs.
    2. 87071 and 87073, quantitative bacterial cultures, is reduced to 50% of 87045 Culture, bacterial, stool. Not only is this illogical cross walking, but quantitative cultures require significantly more effort than the selective, qualitative approach to stools or the semi-quantitative approach used for other primary culture sources.

  • Some of the reimbursement decisions made using "cross walking" methodology did not consider current laboratory practice.

Examples include:

    1. 87077 aerobic isolate, additional methods, is cross walked to deleted code 87072 (culture or direct bacterial identification, each organism, by commercial kit). This does not acknowledge the previous coding convention in which add-on code +87163 (additional identification methods, which was also deleted in this Transmittal), was recommended for use in coding for specific isolate identification in several American Medical Association (AMA) guidance documents. This code implies a more extensive battery of testing than provided by a single "kit" product. Logically, the same reasoning would hold for reimbursement for the revised definition for 87076, anaerobic isolate, additional methods excluding GLC, which is separately codeable.
    2. 86611 Infectious agent antibody, Bartonella, and 86666 Infectious agent antibody, Ehrlichia, are cross walked to 86602 Infectious agent antibody, actinomyces. This represents the lowest fee posted for antibody assays for infectious agents other than the generally higher volume and lower cost HIV/HTLV test assays. Absent data to support the selection of the lowest possible fee, we recommend that the cross walk be made to a code for an infectious agent antibody representing the median amount.
  • Some cross walks are invalidated by inadequate code specificity. Immunology codes are cross walked based on analyte without consideration to specific method. This is a shortcoming based on the current CPT-4 coding system for antibody assays which fails to consider both specific analyte and methodology. This is in distinct contrast to the situation in microbiology for antigen detection where codes have been established for specific analyte in each of several methodology categories (i.e., immunofluorescent technique, enzyme immunoassay, optical immunoassay). Examples of code specificity problems for antibody tests include:

    1. 86696 antibody to HSV-2, is cross walked to 86689 HIV antibody confirmation (western blot).
    2. 86757 antibody to Rickettsia, is cross walked to 86689 HIV antibody confirmation (western blot).

    While immunoblot methods exist for these analytes, the HIV confirmation NLA is higher than for other antibody immunoassays using alternative methods like enzyme immunoassay. Thus, HSV-2 would have been more equivalent to HSV-1 (86695), and Rickettsia cross walked to another specific infectious agent antibody code, but with the same concern expressed for Ehrlichia and Bartonella antibody codes.

  • Gap fill justification for Helicobacter pylori antigen testing in stool is unclear. There is a new code for H. pylori antigen testing by enzyme immunoassay. The generic code 87339 is appropriately cross walked to 87449 for antigen detection by immunoassay. However, 87338 which is used for H. pylori testing specifically on stool samples using an identical descriptor methodology, has been specified for gap fill. This negates the approach for all other antigen tests which defines reimbursement by analyte and methodology rather than by specific application.

  • The trend toward payment of significantly reduced amounts for multianalyte testing is of particular concern. This trend has been identified through several 2001 reimbursement decisions as follows:

    1. 87300 Infectious agent antigen detection by immunofluorescent technique, polyvalent for multiple organisms, is cross walked to 87301, a single analyte test using a non-comparable enzyme immunoassay method at a 50% payment rate.
    2. 87400 Influenza virus A or B detection by enzyme immunoassay, is cross walked to 87301, a single analyte test at a 50% rate, thus creating a "2 for 1" payment situation.
    3. 87451 Infectious agent detection by enzyme immunoassay, multiple step method, polyvalent for multiple organisms, is cross walked to 87450, a single analyte code using a non-comparable "single step" method.
    4. 87800 Infectious agent detection by nucleic acid, multiple organisms, direct probe technique, is cross walked to 87797, a single analyte generic code for the same method.
    5. 87801 Infectious agent detection by nucleic acid, multiple organisms, amplified probe technique, is cross walked to 87798, a single analyte generic code for the same method.
    6. 87046 Culture, bacterial, stool, additional pathogens, is cross walked to 87045 Culture, bacterial, stool (primary code) at 25% of the primary rate.
    7. Simultaneous use of 3 codes for a multianalyte direct probe product for 3 specific etiologic agents (Candida, Trichomonas, Gardnerella) is directed to be billed as a single test (87797 Infectious agent detection by nucleic acid, direct probe, each organism), thereby creating a "3 for 1" situation.

This trend toward reduced reimbursement for multianalyte testing using several different test formats demonstrated in the 2001 Clinical Laboratory Fee Schedule, is incompatible with the laboratory costs associated with doing these tests in many situations. Unlike the situation in performing chemical analyses, performing tests employing immunoassays or molecular probes requires the addition of a complex antibody or probe reagent, which renders costs more additive than simply incremental. This coding scenario is, in fact, more similar to test formats using antibody reagents in which the code descriptor specifies "each antiserum."

Thus, the issues are twofold:

    1. The intended use of the "multianalyte codes" (87300, 87451, 87800, 87801) is unclear. Following the philosophy that use of multiple specific codes requires that there be a final specific qualitative result for each analyte, few products would require use of the multianalyte codes. Those that do are necessarily followed by confirmatory steps that necessitate mandatory "reflex" coding. It is of note that the precedent has been set for the coding of confirmation tests for a number of infectious agent antibody assays including HIV/HTLV, Hepatitis C, and the new code for Hepatitis B surface antigen neutralization, 87341.
    2. Setting the same reimbursement amount for multiple analytes as for single analytes does not acknowledge the frequently additive costs of doing such testing using cultures, immunoassays, or hybridization methods. While one may realize some labor and reagent pricing efficiencies from use of multianalyte products, the costs are higher than for single analyte testing.

We recommend that until these issues can be resolved, that CMS consider issuing a guidance document for coding those products that are potentially considered to be "multianalyte" as was done for the aforementioned triple analyte test, but with consideration given to the increased costs of performing multianalyte testing.

Again, ASM appreciates the opportunity to offer comments on Transmittal AB-00-109. We commend CMS for moving toward a more open process, as mandated by the Benefits Improvement and Protection Act (BIPA) and based on the Institute of Medicine's (IOM) report, Medicare Laboratory Payment Policy, which recommends public consultation on reimbursement decisions. We are confident that such an open process will allow the successful coordination of science, business, and program integrity interests to ensure quality laboratory medicine for Medicare beneficiaries. ASM stands ready to work with you on this process.