July 30, 2004 – ASM Comments on 2004 Clinical Laboratory Fee Schedule

Centers for Medicare & Medicaid Services
Center for Medicare Management
Division of Ambulatory Services
Mailstop: C4-07-07
7500 Security Boulevard
Baltimore, Maryland 21244-1850

To Whom It May Concern:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on Publication 100-20 (Change Request 2959), “2004 Annual [Changes] for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Methodology.” 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.

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.

Our specific comments are as follows:

1. Revisions to 2001 microbiology mappings from 2002-2004:

With the 2004 revisions of the mappings for 87046, 87071, 87073, 87254, and 87300, the Centers for Medicare and Medicaid Services (CMS) has completed the necessary corrections for many illogical crosswalks made for new microbiology codes in calendar year 2001. These crosswalks were originally made prior to the initiation of annual CMS-sponsored public meetings to discuss laboratory payment methodology. ASM commends CMS for continually revising the mappings for these problematic codes to render fair and reasonable reimbursement for these services. The summary below shows the progression of the fee schedule adjustments for these codes.

 Code  Description  2001 Mapping to: %  01  02  03  04
 87046 Additional stool isolates 87045 Stool, Salmonella, Shigella  25% 3.26   3.26  3.30  13.18 
 87071 Quantitative aerobic  87045 Stool: Salmonella, Shigella   50%   6.52  6.52  6.59  13.18
 87073 Quantitative anaerobic 87045 Stool: Salmonella, Shigella   50%  6.52  6.52  6.59  13,18
 Code  Description  2001 Mapping to:  %  01  02  03  04
 87254 Virus, shell vial, FA 87250 Virus isolation; eggs animals  50%  6.76  6.76  6.83  27.32
 87300 DFA, polyvalent 87301 EIA, multistep, adenovirus  50%  7.92  8.29  8.38  16.76
 87400 EIA, influenza A or B 87301 EIA, multistep, adenovirus  50%  7.92  16.58  16.76  16.76
 87800 Direct probe multiple 87797 Direct probe, single  100%  27.71  27.71  56.03  56.03
 87801 Amplified probe multiple 87798 Amplified probe single  100%  48.50  48.50  98.07  98.07

2. Trichomonas vaginalis direct probe code and clarification of multianalyte testing for agents of bacterial vaginosis/vaginitis: 

ASM concurs with the crosswalk for the new code for Infectious agent detection by nucleic acid; Trichomonas vaginalis, direct probe technique” to 87470, the first code in this methodologic series (87470-87797). While procedures in this series have common testing processes and costs, the products used to perform this specific test are generally purchased in complete kit form with the most costly component being the nucleic acid probe reagents that confer analyte specificity.

At this point in time, a single commercial product (Affirm, Becton Dickinson) is available which is designed for simultaneous specific testing for the three most common agents associated with bacterial vaginitis/vaginosis (Candida species, Gardnerella vaginalis, Trichmonas vaginalis). Laboratory costs are generally determined on a “per reportable” basis from total costs of reagents and labor. However, due to commercial product design, the costs for a single or triple analyte test are identical. Never-the-less, to perform testing to meet the Office of Inspector General’s (OIG) compliance guidance for clinical laboratories, specific requests for testing for each of the three analytes must be explicit and medically necessary prior to billing. As all three analytes are now defined by individual and specific CPT-4 codes, it is likely that this or a similar product will be available in a single analyte format in the future.

Given this situation, CMS may encounter some significant confusion regarding correct coding and reimbursement by physicians and laboratories when individual tests for these three analytes are explicitly ordered and medically necessary for the etiologic diagnosis of patients with signs and symptoms of vaginitis and vaginosis. This confusion emanates from an instruction included in the 2001 fee schedule (PM AB-00-109) which states that “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, Infectious agent detection by nucleic acid, (analyte) not otherwise specified; direct probe technique and should not be billed individually.” While costs for multiple analyte testing are typically incremental rather than additive, the major cost component of such assays remains the specific probe components. If all three assays are medically necessary, ASM believes it is reasonable to code and bill for each analyte, and, CPT-4 coding convention dictates that code selection should be made according to analyte and method specificity. To alleviate any confusion however, ASM recommends that CMS consider the issuance of an updated guidance statement for this assay which takes into consideration (1) the availability of analyte specific codes for each of the three agents tested for, and (2) the medical necessity of performing testing for each analyte ordered in the setting of vaginitis/vaginosis.

The issue raised is part of a larger one, regarding the definition of “multianalyte testing” in infectious disease diagnostics, as well as the guidance for appropriate use of analyte specific codes versus “multiple organism” (i.e. multiplex) codes for non-culture dependent infectious agent assays. The mapping revisions discussed in #1 have adjusted fees such that dual analyte assays are reimbursed equally by either approach. However, the vaginitis/vaginosis issue involves three potential analytes, and future generations of multiplex assays may in fact, detect large numbers of analytes in a single assay. Clarification of the vaginitis/vaginosis direct probe coding and reimbursement issue in a manner that acknowledges the actual number of analytes tested for may well set a precedent for future multiplex assays. ASM acknowledges that costs and charges for the initial analyte may be higher than costs and charges for each additional analyte due to inclusion of preanalytical costs in the costs analysis for the initial analyte. Therefore, additional analytes may reasonably be reimbursed at a lower percentage reflecting the lower costs. However, ASM also continues to strongly support specific infectious agent analyte coding to enhance the ability to monitor test utilization in specific clinical settings as a component of program integrity.

3. Reimbursement for waived CLO tests as 87077-QW:

The current listing of tests granted waived status under CLIA (www.cms.hhs.gov/clia/waivetbl.pdf) indicates that the Campylobacter Like Organism (CLO) test for Helicobacter pylori produced urease enzyme in gastric biopsy tissue, should be billed as 87077QW. Code 87077 has the descriptor “Culture, bacterial; aerobic isolate, additional methods required for definitive identification, each isolate.” Questions have arisen from ASM members regarding the appropriateness of this code for the CLO procedure. Code 87077 is used for the definitive biochemical identification of aerobic isolates, defined in the Microbiology Section preamble as requiring panels with more than 3 unique biochemical reactions. Definitive biochemical identification is of a significantly higher complexity and cost than the CLO test which measures a single biochemical reaction. While no specific CPT code exists for the “CLO” urease test, code 87081 “Culture, presumptive, pathogenic organisms, screening only” is a more appropriate descriptor for this procedure. While code 87077 has an NLA $11.29, 87081 is set at $9.26. ASM requests that CMS review the most appropriate code and reimbursement for this assay and issue a specific guidance statement.

Again, thank you for the opportunity to provide comments on the 2004 Clinical Laboratory Fee Schedule. Should you desire further input on these or any other microbiology or immunology coding issues, please contact Suzy Leous, Manager, Public Affairs, ASM at 202-942-9262 or sleous@asmusa.org.

Sincerely,

Alice S. Weissfeld, Ph.D., Chair, Committee on Professional Affairs
Public and Scientific Affairs Board

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