July 31, 2008 - ASM Sends Comments to CMS on 2008 Clinical Laboratory Fee Schedule

Centers for Medicare & Medicaid Services
Center for Medicare Management
Division of Ambulatory Services
Mailstop: C4-02-14
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 5813), “2008 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 more than 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical microbiology.

Many of ASM’s 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.

Regarding fees for new CPT codes established for 2008:

For codes pertaining to infectious agent testing, 87500 (Infectious agent detection by nucleic acid (DNA or RNA), vancomycin resistance, and 87809 (Infectious agent detection by immunoassay with direct optical observation, Adenovirus), we concur with the crosswalks assigned.

For code 86356 (Mononuclear cell antigen, quantitative (eg, flow cytometry), not otherwise specified, each antigen), we do not concur with the crosswalk assigned.  This code, used to detect specific mononuclear cell markers by flow cytometry, is more similar to the detection of specific cell markers for B cells (86355), NK cells (86357), T cells (86359) and Stem cells (86367). The NLA for each of these codes is $52.70. In contrast, the assigned crosswalk code, 86361 (T cells; total count, absolute CD4 count) with an NLA of $37.41 is not representative of the technical or financial parameters associated with the quantitative detection of a specific cell marker using specific immunochemical reagents and flow cytometry. We would request that reconsideration be given to this crosswalk.

General comments

We continue to have concerns with the inconsistent application of 1833(h)(4)(B)(viii) of the Social Security Act (the Act) which specifies that for tests established on or after January 1, 2001, the NLA is 100% of the median of the local fees. For infectious disease testing, with the exception of code 87338 (Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; Helicobacter pylori, stool), new codes established since 2001 have continued to be priced at 74% of the median of the local fees. For example, new code 87500 (vancomycin resistance) for 2008, and codes 87640 (S. aureus, amplified probe) and 87641 (S. aureus, methicillin resistance, amplified probe) are all priced at the 74% level. We believe a systematic review of currently assigned fees should be undertaken to insure compliance with the above cited provision of the Act.

We also continue to have concerns with the pricing for codes for infectious agent detection by nucleic acid for detection of an RNA target. In general, the amplification methodology used for RNA targets is a reverse transcriptase, real time polymerase chain reaction methodology. These tests therefore require the use of the antecedent reverse transcriptase step prior to performing the nucleic acid amplification procedure on the resulting DNA transcripts. To account for this additional step, the ASM recommendation at the July 2006 Laboratory Public Meeting for New CPT codes was to crosswalk the code for RNA virus enterovirus code 87498 to 87798 (infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism) PLUS 83902 (Molecular diagnostics; reverse transcription).

Our justification for this recommendation is as follows: 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. This approach was described in Program Memorandum AB-97-23 (December, 1997) in which new 1998 codes for detection of infectious agents by nucleic acid amplification were crosswalked to a composite sum of 83890 (Molecular diagnostics; molecular isolation or extraction) + 83892 (Molecular diagnostics; enzymatic digestion) + 83894 (Molecular diagnostics; separation by gel electrophoresis) + 83898 (Molecular diagnostics; amplification of patient nucleic acid) + 83912 (Molecular diagnostics; interpretation and report). These included new codes as follows: 87471 (Bartonella), 87476 (Borrelia), 87481 (Candida), 87486 (Chlamydia pneumoniae), 87491 (Chlamydia trachomatis), 87496 (cytomegalovirus), 87511 (Gardnerella), 87516 (hepatitis B), 87521 (hepatitis C), 87526 (hepatitis G), 87529 (herpes simplex virus), 87532 (herpes virus-6), 87535 (HIV-1), 87538 (HIV-2), 87541 (Legionella pneumophila), 87551 (Mycobacterium species), 87556 (Mycobacterium tuberculosis), 87561 (Mycobacterium avium-intracellulare), 87581 (Mycoplasma pneumoniae), 87591 (Neisseria gonorrhoeae), 87621 (human papillomavirus), 87651 (Streptococcus, group A), and 87798 (Infectious agent, not otherwise specified). In this list of crosswalked infectious agent codes, no distinction was made between those infectious analytes with a DNA target and those with an RNA target, the latter requiring the additional reverse transcriptase step.

It should also be noted that in 2001, the AMA modified the descriptor for 83898, one of the codes in the composite described above. 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” with the descriptor for the latter being “Molecular diagnostics, reverse transcription.” However, this clarification was not considered in re-pricing any infectious analyte RNA target assays. Therefore, for RNA target assays, such as the enterovirus code, it would be appropriate to account for the reverse transcription component of the assay.

Based on this sequence of events in the assignment of fees for infectious agent detection by nucleic acid methods, the ASM would like to propose a reconsideration by CMS to include additional payment for the required RNA transcription step, code 83902, for all amplified assays for detection of infectious agent RNA targets. Codes for infectious agent detection by nucleic acid (DNA or RNA), RNA viruses include:

87498 Enterovirus, amplified probe technique
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

We also continue to have concerns regarding pricing for medically necessary infectious agent quantification codes including the following:

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).
Thank you for the opportunity to provide comments on the 2008 Annual Update for the Clinical Laboratory Fee Schedule. Please contact Suzy Leous, Manager, Public Affairs at 202-942-9262 or sleous@asmusa.org, if you require additional information or reference materials.

Sincerely,

Vickie S. Baselski, PhD, DABMM, FAAM
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board

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