July 28, 2003 - Payment Determinations for Calendar Year 2004 for New Clinical Laboratory Tests

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2004 Medicare Clinical Laboratory Fee Schedule, as announced in the June 27, 2003 Federal Register [CMS-1190-NC].  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 microbiology.

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 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.


Attached to this statement is a summary table outlining the ASM’s recommendations with respect to payment determinations for select new Current Procedural Terminology (CPT) codes to be included in the 2004 Medicare Laboratory Fee Schedule.  Recommendations are based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs, which reviewed the “2004 New Laboratory Tests” document on the CMS web site and provided comment.  For each code, the following information is provided, as outlined in the June 27 Federal Register presentation guidance: 
 

  • New code and descriptor
  • Test purpose and method
  • Costs
  • Charges
  • ASM recommendation on payment methodology

Proposed code 8726x, infectious agent antigen detection by immunofluorescent technique; giardia

Test Purpose and Method:

The purpose of this procedure is the highly sensitive and specific detection of Giardia species in stool samples of patients with clinically compatible signs and symptoms (e.g. nausea, anorexia, malaise, fever, and chills, some or all being associated with explosive, watery, foul-smelling, intermittent diarrhea with malabsorption, flatulence, and bloating). The procedure is a supplement to rather than a substitute for a routine microscopic “ova and parasite” exam, since the latter provides information regarding a wider variety of intestinal parasites which may produce clinically similar symptoms.  However, it should be noted that in select patient populations without significant risk for pathogens other than those endemic in the United States (primarily Giardia and Cryptosporidium in pediatric populations), reflex protocols in which antigen specific tests for both of these protozoans are performed initially, with “ova and parasite” follow-up only on negative samples, have proven to be cost effective and clinically appropriate.  The method described by this code involves the reaction of anti-Giardia antibodies labeled with fluorescent compounds directly with patients stool samples fixed to slides, followed by fluorescent microscopy, to detect specific binding of the tagged antibodies to Giardia organism forms present.

Costs:

The
costs of this procedure are comparable to those of other single analyte immunofluorescent direct antigen detection procedures in the code series 87260 – 87299.  These procedures have common general material and reagent costs (e.g. collection and transport devices, slides, fixative, wash fluids, and mounting fluid) and common equipment maintenance and utilization costs (particularly fluorescent microscopy).  However, the most significant cost item in any direct immunofluorescent test is the specific, generally monoclonal antibody or antibody pool used for detection of the infectious agent analyte in the CPT-4 descriptor.  The labor component for all analytes is roughly comparable due to similarities in the actual testing processes.  It should also be noted that these products are purchased in complete kit form for either Giardia or Cryptosporidium alone, or in a dual analyte form, and costs are generally determined on a “per reportable” basis.

Charges:

The
charges for codes in this series are generally based on the total costs for both common and specific reagents as well as the labor costs.  For fee schedules other than Medicare, it is typical for charges to be set for each specific analyte due to cost differences.  However, the current Medicare NLA establishes the same payment for each specific analyte with this common descriptor.

ASM Recommendation on payment methodology:

The
recommendation of ASM is to crosswalk proposed code 8726x to the first analyte specific code in the “antigen detection by immunofluorescent technique”series, 87260 “infectious agent antigen detection by immunofluorescent technique, adenovirus.”  This recommendation is made rather than a recommendation to crosswalk to code 87272 for “cryptosporidium/giardia” dual analytes.  It should be noted that there appears to be a concomitant descriptor change for this code for 2004 to reflect only the single analyte “cryptosporidium.”  In accordance with established AMA CPT coding guidance, and with actual laboratory practice including billing compliance, ASM believes analyte specific coding and reimbursement for both Giardia and Cryptosporidium is an appropriate approach.

Proposed code 8732x, infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; giardia

Test Purpose and Method:

The
purpose of this procedure is the highly sensitive and specific detection of Giardia species in stool samples of patients with clinically compatible signs and symptoms (e.g. nausea, anorexia, malaise, fever, and chills, some or all being associated with explosive, watery, foul-smelling, intermittent diarrhea with malabsorption, flatulence, and bloating). The procedure is a supplement to rather than a substitute for a routine microscopic “ova and parasite” exam, since the latter provides information regarding a wider variety of intestinal parasites which may produce clinically similar symptoms.  However, it should be noted that in select patient populations without significant risk for pathogens other than those endemic in the United States (primarily Giardia and Cryptosporidium in pediatric populations), reflex protocols in which antigen specific tests for both of these protozoans are performed initially, with “ova and parasite” follow-up only on negative samples, have proven to be cost effective and clinically appropriate.  The method described by this code involves the reaction of anti-Giardia antibodies (generally specific monoclonals or monoclonal pools) with antigens extracted from patient stool samples, with the subsequent detection of specific antigen antibody complexes by another step involving an enzyme linked reagent which can be detected by reaction with an appropriate reactant.

Costs:

The
costs of this procedure are comparable to those of other single analyte enzyme immunoassay direct antigen detection procedure in the code series 87301 – 87449.  While these procedures have common general processes, the products used to perform this test are purchased in complete kit form for either Giardia or Cryptosporidium alone, or in a dual analyte form, and costs are generally determined as a “per reportable” based on costs of reagents and labor.  Both reagent costs and labor costs may vary significantly based on the exact commercial method used.  However, as for the immunofluorescent technique, the most significant cost item is the specific, generally monoclonal antibody or antibody pool used for detection of the infectious agent.

Charges:

The
charges for codes in this series are generally based on the total costs for each reportable in a kit based on costs of specific reagents as well as on the labor costs.  For fee schedules other then Medicare, it is typical for charges to be set for each specific analyte due to cost differences.  However, the current Medicare NLA establishes the same payment for each specific analyte with this common descriptor.

ASM Recommendation on payment methodology:

The
recommendation of ASM is to crosswalk proposed code 8732x to the first analyte specific code in the “antigen detection by enzyme immunoassay technique…” series, 87301 “infectious agent antigen detection by enzyme immunoassay technique…, adenovirus enteric types 40/41.”  This recommendation is made rather than a recommendation to crosswalk to code 87328 for “cryptosporidium/giardia” dual analytes.  It should be noted that there appears to be a concomitant descriptor change for this code for 2004 to reflect only the single analyte “cryptosporidium.”  In accordance with established AMA CPT coding guidance, and with actual laboratory practice including billing compliance, ASM believes analyte specific coding and reimbursement for both Giardia and Cryptosporidium is an appropriate approach.

Proposed code 8766x, infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, direct probe technique

Test Purpose and Method:

The
purpose of this procedure is the sensitive and specific detection of the protozoan flagellate Trichomonas vaginalis in patients with signs and symptoms of vaginitis or vaginosis (excessive vaginal discharge with accompanying pruritis, burning, and other manifestations of vaginal discomfort).  Because it may be difficult for patients to distinguish vaginal from urethral origin of discomfort, and because signs and symptoms may overlap significantly with other urogenital disease states, it is generally necessary to perform testing for Trichomonas simultaneously with tests for other agents.  Such tests may include, but are not limited to those for vaginal Candida infection, those for bacterial vaginosis or for relevant markers (Gardnerella species), tests for urinary tract infection, and tests for cervical and urethral sexually transmitted bacterial agents (e.g. Neisseria gonorrhoeae and Chlamydia trachomatis).  It may on occasion also be appropriate to perform testing on samples from males or infants at risk for acquisition from an infected female. 

The
method described by this code involves the extraction of nucleic acids from clinical samples (generally vaginal secretions), followed by a hybridization process using a specific labeled nucleic acid probe reagent which will uniquely hybridize to Trichomonas nucleic acids from the sample, and finally a detection step which will identify the presence of the Trichomonas-specific nucleic acid hybrids which have formed by binding of the labeled probe.  Detection may use a number of approaches.  For example, the currently available Becton Dickinson Affirm product uses an enzymatic, colorimetric detection process.  The test may be performed as a follow-up to a negative “wet mount” performed in a PPM (Provider Performed Microscopy) or moderate complexity CLIA licensed laboratory setting, or it may be performed as a primary test alternative to detect Trichomonas due to its high sensitivity and specificity as well as its non-reliance on acquisition of a fresh sample with viable trichomonads present.  The other primary test method employed is specific culture for Trichomonas (recommended CPT code, 87081).

Costs:

The
costs for this procedure are comparable to the costs for other codes in the “infectious agent detection by nucleic acid (DNA or RNA); (specific agent), direct probe technique” in CPT-4 series 87470 – 87797.  While these procedures have common general processes, the products used to perform this testing are generally purchased in complete kit form with the most costly component being the nucleic acid probe that infers analyte specificity.  At this point in time, a single product designed for convenient and cost effective testing for the three most common agents of bacterial vaginitis/vaginosis is available, and costs are generally determined on a “per reportable” basis from total costs of reagents and labor.  Due to formatting, the costs for a single or triple analyte test are identical; however, in accordance with compliance guidance, requests for all three analytes must be medically necessary prior to reporting.  The request for this new code suggests that this or a similar product will be available in a single analyte format in the future.  This is essential due to the 2001 payment determination (PM AB-00-109) “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 and should not be billed individually.”  As the major cost component of any molecular assay is the “probe” or other detection component, this new code will allow for more reasonable cost accounting for laboratories performing the assay.  However, it eliminates any minor labor savings by the laboratories performing comprehensive testing in appropriate circumstances.

Charges:

The
charges for codes in the “direct probe” molecular microbiology series are generally based on the total costs for each reportable in a kit based on costs of specific reagents as well as on the labor costs.  For fee schedules other than Medicare, it is typical for charges to be set for each specific analyte due to cost differences.  However, the current Medicare NLA establishes the same payment for each specific analyte with this common descriptor.

ASM Recommendation on payment methodology:

The
recommendation of ASM is to crosswalk proposed code 8766x to the first comparable analyte specific direct probe technique code in the molecular series, 87470 “infectious agent detection by nucleic acid (DNA or RNA); Bartonella henselae and B. quintana, direct probe technique.”  In accordance with established AMA CPT coding guidance, and with actual laboratory practice including billing compliance, ASM believes analyte specific coding and reimbursement for Trichomonas is appropriate.  However, CMS may encounter some significant confusion regarding correct coding and reimbursement by physicians and laboratories when individual tests that are medically necessary for the etiologic diagnosis of patients with signs and symptoms of vaginitis and vaginosis, including testing for Trichomonas, are performed using the product described in PM AB-00-109, which instructs coding for a single analyte regardless of the number of medically necessary tests performed. 

ASM appreciates the opportunity to participate in CMS’s public meeting to determine payment for new laboratory tests.  It is our belief that the open process established by CMS will ensure that quality laboratory medicine for Medicare beneficiaries will result.  ASM stands ready to work with you throughout this process and recommends Diagnostic Medical Parasitology (L.S. Garcia, 2002, ASM Press, Washington, DC), for additional technical and scientific information on the diagnosis of infection by any of the agents specified in these proposed codes.  We would be pleased to answer any questions that you may have.  Thank you.

TPL_asm2013_SEARCH