August 1, 2006 - ASM Comments on 2006 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 provide comments on Publication 100-04 (Change Request 4144), “2006 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment.” 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 approximately 42,000 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, immunology, or molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use in these laboratories, and researchers involved in developing and evaluating the performance of new technologies. Thus, the ASM has 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 on the 2006 clinical laboratory fee schedule are as follows:

1.) Code 86367 (Stem cells (i.e., CD34), total count:

ASM continues to recommend a revision to the 2005 and 2006 crosswalks for Stem cell analysis that acknowledges the increased complexity of the flow cytometry method for stem cell analysis as compared to those for other lymphocyte types (i.e. 86355, B cells, total count; 86357, NK cells, total count, 86359, T cells, total count). The International Society of Hematotherapy and Graft Engineering (ISHAGE) has established a specific protocol for stem cell determinations which requires at least two monoclonal antibodies (CD34 and CD45), a viability determination, and an accurate cell count (J Hematotherapy, 1996, June; 5(3):213-226). This protocol requires a complex instrument gating scheme to ensure correct identification and enumeration of viable cells. The results are given as total CD4+ stem cells per unit volume, which requires yet another sophisticated gating strategy using carefully measured fluorescent beads. A simple crosswalk to 86359 (T cells, total count) does not account for this increased complexity. Therefore, ASM recommends a revision to include pricing by crosswalking to both code 86361 (T cells, absolute CD4 count; $37.41) and code 86359 (T cells, total count; $52.70) to set payment for code 86587 (recommended fee, $90.11) in order to account for more than a single flow procedure in the analysis.

2.) Code 87556 (Infectious agent by nucleic acid; Mycobacterium tuberculosis, amplified probe technique):

The direct specimen amplified molecular tests for Mycobacterium tuberculosis are FDA-cleared or approved tests kits for use particularly with smear-positive samples for rapid confirmation of patients as tuberculosis cases. Rapid identification allows for timely institution of management protocols including contact tracing and prophylaxis of additional cases, both critical to the future control of tuberculosis in the United States. To be clinically effective, these tests must be run in a timely fashion, generally in very small batches, including single sample testing in many situations. However, the current reimbursement does not take into consideration the actual clinical utility of the test and the higher costs associated with small batch or single sample testing. Therefore, ASM recommends a revision to the fee schedule, adjusting payment for 87556 (amplified M. tuberculosis testing) to a level 2X the current fee (2 x $49.04 = $98.08).

3.) Code 87541 (Infectious agent by nucleic acid; Legionella pneumophila, amplified probe technique)

A direct specimen amplified probe technique for the detection of Legionella pneumophila has been recently cleared by the FDA. Similar to the situation for M. tuberculosis, the test is used to make a rapid determination of the etiology of a lower respiratory tract infection so that appropriate antimicrobial therapy may be instituted. In addition, there is significant epidemiologic significance to the finding of a positive result that may be used in the timely institution of measures to prevent additional cases. Also similar to the M. tuberculosis amplified probe test, in order to be maximally clinically effective, tests are generally run in very small batches including single patient testing in many cases. Again, the current reimbursement does not take into consideration the actual clinical utility of the test and the higher costs associated with small batch or single sample testing. Therefore, ASM recommends a revision to the fee schedule, adjusting payment for 87541 (amplified L. pneumophila testing) to a level 2X the current fee (2 x $49.04 = $98.08).

4.) Nucleic acid quantification codes:

Code 87497 (Infectious agent by nucleic acid; cytomegalovirus quantification)
Code 87517 (Infectious agent by nucleic acid; hepatitis B virus quantification)
Code 87522 (Infectious agent by nucleic acid; hepatitis C virus quantification)
Code 87527 (Infectious agent by nucleic acid; hepatitis G virus quantification)
Code 87533 (Infectious agent by nucleic acid, Herpesvirus-6 quantification)
Code 87539 (Infectious agent by nucleic acid; HIV-2 quantification)
Code 87799 (Infectious agent detection by nucleic acid, not otherwise specified, quantification, each organism):

When used for quantification of other clinically relevant latent viral agents which may reactivate including Epstein-Barr Virus, Parvo-B19 virus, Polyomaviruses JC/BK, and Varicella-zoster virus. Viral load determinations are a critical component of management of many viral infections which may remain latent for many years, but may reactivate to cause clinically significant disease, particularly under conditions of immunosuppression, most notably post-transplantation. Similar to HIV-1 quantification (code 87536), these procedures for Hepatitis B and C are available in FDA-cleared or approved formats and costs of testing are comparable to those for HIV-1. For the other agents listed, Analyte Specific Reagents are used in CLIA-compliant protocols and also have costs comparable to those for HIV-1. The discrepancy between payment for HIV-1 viral load, code 87536 ($118.89) and payment for other medically necessary viral load procedures as listed does not reflect the economic reality of testing. Given the large number of Medicare beneficiaries afflicted by these serious chronic diseases, and the potential for decreased access to laboratory testing due to inadequate reimbursement, ASM recommends that a revision to payments for quantification of CMV (87497), HBV (87517), HCV (87522), HGV (87527), HHV-6 (87533), HIV-2 (87539), and the “NOS” code 87799 be made, matching payment for HIV-1, quantification (87536).

5.) Codes for infectious agent detection by nucleic acid (DNA or RNA), RNA viruses:

87521 hepatitis C, amplified probe technique
87522 hepatitis C, quantification
87526 hepatitis G, amplified probe technique
87527 hepatitis G, quantification
87535 HIV-1, amplified probe technique
87536 HIV-1, quantification
87538 HIV-2, amplified probe technique
87539 HIV-1, quantification

ASM recommends that each code for detection or quantification of an RNA virus be adjusted to include additional payment for the required RNA transcription step, code 83902 (NLA + $19.83).

It should be noted that the original infectious agent molecular diagnostic codes for amplified probe techniques were priced by crosswalking to a composite of molecular diagnostic codes which did not include the reverse transcription code for RNA targets. As described in Program memorandum AB-97-23, amplified codes were crosswalked to 83890 (isolation or extraction) + 83892 (enzymatic digestion) +83894 (separation by gel electrophoresis) +83898 (amplification of patient nucleic acid, each sequence) +83912 (interpretation and report). Nucleic acid quantification codes were to be gap-filled, with a recommendation for subsequent crosswalking of all other quantification codes to code 87536 (HIV-1) which was to be based on the previous HCPCS code for HIV-1, G0100. However, in the 1999 fee schedule, the quantification codes were inconsistently priced at fees ranging from $48.31 - $59.20 except for 87536, which was again subject to gap-fill. Finally, in the 2000 fee schedule, 87536 (HIV-1 quantification) was priced at a rate approximately twice that for other quantification codes ($111.07).

Subsequently, in 2001, the AMA modified the descriptor for 83898. In AMA CPT Changes 2001: An Insider’s View it was clarified that for 83898 (amplification of patient nucleic acid, single primer pair, each primer pair), the reverse transcription step was not included and that “it would be appropriate to report 83898 in addition to 83902.” However, this clarification was not considered in re-pricing any infectious analyte RNA target assays either for amplified probe technique or for amplified probes with quantification. Therefore, for RNA target assays, it is appropriate to account for the reverse transcription component of the assay by adding the fee for 83902 to the existing payments, also taking into consideration the previous recommendation that all amplified probe tests with quantification be brought to a uniform payment amount.

6.) Codes for infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified:

87798 amplified probe technique, each organism
87799 quantification, each organism

For situations where a “not otherwise specified” RNA target analyte is either detected (87798) or quantified (87799) using amplification with antecedent reverse transcription, it is appropriate to add the code for reverse transcription (83902). At present, these codes do not differentiate DNA from RNA targets, therefore there should be an adjustment to the National Correct Coding Initiative edits which will allow use of codes 87798 and 87799 with 83902.

7.) ASM has a concern with the inconsistent application of the following instruction from CR 4144: “For tests for which NLAs are first established on or after January 1, 2001, the NLA is 100% of the midpoint in accordance with §1833(h)(4)(viii) of “The Act”: A review of new codes established on or after 2001 reveals only 3 clinical laboratory codes that are priced at 100% of the midpoint. These include:

86294 and 86294-QW Immunoassay for tumor antigen, qualitative or quantitative (new 2001)
86336 Inhibin A (new 2002)
87338 Infectious agent antigen by enzymenimmunoassay, qualitative or semiquantitative, multistep, Helicobacter pylori, stool
new 2001)

In fact, there are a number of other new technology codes pertaining to microbiology or immunology established on or after 2001 that we believe should qualify for payment at the 100% of midpoint level. These include the following codes. From 2006:

87900, Infectious agent drug susceptibility phenotype prediction

From 2002:
86141, High sensitivity CRP
87802 Antigen detection by optical immunoassay, Group B Streptococcus
87803 Antigen detection by optical immunoassay, Clostridium difficile toxin A
87804 Antigen detection by optical immunoassay, Influenza
87902 HCV genotyping

From 2001:
87901 HIV-1 genotyping
87903 HIV-1 phenotyping, first 10 drugs
87904 HIV-1 phenotyping, each additional drug

Thank you for the opportunity to provide comments on the 2006 Annual Update for the Clinical Laboratory Fee Schedule.

Please contact Suzy Leous, Manager, Public Affairs, ASM at 202-942-9262 or sleous@asmusa.org, if you require additional information or reference materials.

Sincerely,

Vickie S. Baselski, Ph.D.,
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board

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