August 1, 2007 - ASM Sends Comments to CMS on 2007 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 5362), “2007 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 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.

The Society has specific comments on fees established in the 2007 Clinical Laboratory Fee Schedule as follows:

1. Code 87305: Infectious agent detection by an enzyme immunoassay (EIA) technique, qualitative or semiquantitative, multiple step; Aspergillus

Concerns have been raised by ASM members regarding the fee established for code 87305 by simple crosswalking to 87327, an EIA for another unrelated fungal antigen, Cryptococcus neoformans. The Aspergillus test detects galactomannan residues of the outer cell wall of most clinically significant Aspergillus species in serum specimens using a microtitration plate based double antibody sandwich technique. However, specimen processing is complex and involves both immune complex dissociation and centrifugation to remove interfering substances. The assay is considered important in immunocompromised patients, particularly those undergoing hematopoietic stem cell transplantation or with hematologic malignancies, as an aid in the diagnosis of invasive aspergillosis. Testing may be performed on samples collected serially, generally twice per week, during the infective episode in at-risk patients to insure accurate diagnosis of an evolving infection.

At the July 2006 Laboratory Public Meeting, the ASM recommended a crosswalk of 87305 to 87338 (Infectious agent antigen detection by enzyme immunoassay (EIA) technique, qualitative or semiquantitative, multiple step method; Helicobacter pylori, stool). ASM’s justification was that code 87338 described a similar EIA which detects a specific agent antigen in a specimen which also requires complex processing steps. In addition, 87338 was appropriately priced at 100% of the midpoint in compliance with provisions of BIPA 2000 for emerging technology. However, pricing for 87338 did not take into consideration the complex specimen processing required. Therefore, the ASM currently recommends that new code 87305 be priced at a composite of fees for 87338 and 87015 (concentration, any type, for infectious agents). The reimbursement for the specimen processing code 87015 approximates the costs of specimen processing for the procedure code 87305.

2. Code 87498: Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe technique.

In general, the amplification methodology used for RNA targets is a reverse transcriptase, real time polymerase chain reaction methodology which targets, in this case, pan-enteroviral RNA sequences in a variety of clinical samples. This test therefore 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 and other serious infections, 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 recommendation at the July 2006 Laboratory Public Meeting for new CPT codes was to crosswalk this new code 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).

ASM’s 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 infectious analytes with a DNA target and infectious analytes 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 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 agents detection by nucleic acid methods, the ASM would like to propose a reconsideration of the CMS determination to crosswalk 87498 to code 87496 alone (Infectious agent detection by nucleic acid; cytomegalovirus) because 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. ASM’s original recommendation stated during the 2006 Laboratory Public Meeting stands to crosswalk the 87498 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.

For several codes established prior to 2007, the ASM continues to have concerns previously expressed regarding pricing as follows:

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

The 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, the ASM recommends a revision to include pricing by crosswalking to both code 86361 (T cells, absolute CD4 count) and code 86359 (T cells, total count) to set payment for code 86587 in order to account for more than a single flow cytometric 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 cleared or approved by the Food and Drug Administration (FDA) 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, the 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, the 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 protocols compliant with the Clinical Laboratory Improvement Amendments (CLIA) 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, the 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

The ASM recommends that each code for the detection or quantification of an RNA virus be adjusted to include additional payment for the required RNA transcription step, code 83902.

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.

8.) The ASM is concerned with the inconsistent application of the following instruction from Change Request 5362: “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 that only 3 clinical laboratory codes are priced at 100% of the midpoint, including:

86294 and 86294-QW Immunoassay for tumor antigen, qualitative or quantitative
(new 2001)
86336 Inhibin A (new 2002)
87338 Infectious agent antigen by enzyme nimmunoassay, 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 should qualify for payment at the 100% of midpoint level. These include the following:

2007 codes
:
87305 Infectious agent antigen detection by enzyme immunoassay, qualitative or semiquantitative, multistep; Aspergillus (Note our previous more extensive comments on the fee set for this new 2007 code)
87498 Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe technique (Note our previous more extensive comments on the fee set for this new 2007 code)
87640 Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, amplified probe technique
87641 Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, methicillin resistant,
amplified code technique
87653 Infectious agent detection by nucleic acid (DNA or RNA); Streptococcus, Group B, amplified probe technique
87808 Infectious agent antigen detection by immunoassay with direct optical observation; Streptococcus Group B

2006 codes:
87900, Infectious agent drug susceptibility phenotype prediction

2002 codes:
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


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

Again, thank you the opportunity to provide comments on the 2007 Annual Update for the Clinical Laboratory Fee Schedule. Please contact Suzy Leous, Manager, ASM Office of 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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