September 26, 2006 - ASM Submits Comments on CMS Proposed Payment Determinations for New Tests for 2007 Medicare Clinical Laboratory Fee Schedule

Anita Greenberg
Centers for Medicare and Medicaid Services
Mail Stop C4-08-06
7500 Security Blvd.
Baltimore, Maryland 21244-1850

Dear Ms. Greenberg:

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding proposed payment amounts set for new codes which will be included in the 2007 Medicare Clinical Laboratory Fee Schedule, effective January 1, 2007. These fee amounts were determined following the July 17, 2006 Public Meeting on Payment Methodology in which ASM was a participant. 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, professionally employed as scientists and science administrators working in a variety of areas, including biomedical, environmental, and molecular fields as well as in clinical microbiology, clinical immunology, and molecular diagnostics.

Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology, and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies. Therefore, 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.

The ASM is concerned about CMS’s proposed fee for 8749X, Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe technique. In general, the amplification methodology used is a reverse transcriptase, real time polymerase chain reaction methodology which targets pan-enteroviral RNA sequences in a variety of clinical samples. This test requires the use of the antecedent reverse transcriptase step prior to performing the nucleic acid amplification procedure on the resulting DNA transcripts. The detection of enteroviral RNA in an invasive sample (e.g. CSF, serum, pleural fluid) is considered diagnostic for invasive disease, and has been shown to be cost-effective in managing enteroviral meningitis, particularly through avoidance of unnecessary antibiotic therapy. In addition, detection of enteroviral RNA in mucous membrane samples may provide supportive evidence in clinically compatible cases. The ASM recommends a crosswalk 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, which was previously submitted during the July 17th CMS Public Meeting on Payment Methodology, 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 an antecedent reverse transcriptase step.

Subsequently, 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 new 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, ASM requests that CMS reconsider its proposed crosswalk to code 87496 alone (Infectious agent detection by nucleic acid; cytomegalovirus) as this code is for an agent that is a DNA virus not requiring reverse transcription prior to nucleic acid amplification by the polymerase chain reaction. Our recommendation stands to crosswalk the new code for enterovirus detection 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). While code 87798 describes the detection of the enteroviral target DNA transcript, code 83902 accounts for the antecedent reverse transcription step required to convert the enteroviral RNA sequence to a suitable DNA target.

Thank you for the opportunity to provide comments.

Sincerely,

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

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