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28-10-2016Academy Laureates
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Antibacterial Development Conference

The American Society for Microbiology (ASM) welcomes the opportunity to make comments regarding the proposed version 8.3 National Correct Coding Initiative (NCCI) edits for CPT-4 codes 87800 (infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique) and 87801 (infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe(s) technique).ASM is 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 in academic, industry and government institutions working in a variety of areas, including biomedical, environmental, and clinical microbiology.Many ASM members are directly involved in diagnostic clinical laboratory testing particularly in the areas of testing for infectious and immunologic diseases.

The continuing emergence of infectious diseases including those caused by antibiotic resistant organisms, food and waterborne agents, blood-borne agents, sexually transmitted disease agents, agents affecting the immunocompromised population, and agents of bioterrorism render the results generated by ASM members critical to health care in our nation.Similarly, the diagnosis of chronic diseases with an immunologic basis or using immunologic methods has assumed increasing importance.These diseases are often disproportionately represented in patients enrolled in federally funded health care programs, thus the development of rational, logical pre-payment edits is of significant concern to our members.It has also been in the area of diagnosis of these same conditions that emerging molecular technologies have had the greatest financial and utilization impact.Thus, appropriate reimbursement for the CPT-4 codes in these proposed edits is critical to diagnostic advancements in this area.ASM provides the following comments regarding the NCCI version 8.3 edits scheduled for implementation on October 1, 2002:

  1. The Centers for Medicare and Medicaid Services (CMS) or the American Medical Association (AMA) must clarify the intent of CPT codes 87800 and 87801 prior to the issuance of any NCCI edits.These codes, which appeared in the 2001 edition of the CPT-4 coding manual, are believed to be intended for use with multiplex testing formats.However, such tests may be formatted in one of two ways.In one case, the assay generates final results for each analyte tested.In the second case, an initial nonspecific result must necessarily be followed up with specific analyte testing to determine the source of the positive signal.However, there are still multiple specific results generated.Neither CMS nor AMA have defined the cases in which the "multiple organism" codes are deemed appropriate. ASM recommends that any test format capable of generating more than one specific analyte result be coded for each analyte in accordance with CPT-4 coding guidelines.
  1. The costs of performing multiplex tests are additive rather than incremental; however, there is a definite trend toward "two-or-more for one" reimbursement for these tests.This trend was initiated in 1998 when specific CPT-4 codes were developed for single device immunoassay testing for Giardia and Cryptosporidium.Reimbursement for these combination codes was the same as for a single analyte, despite the fact that each individual analyte required the addition of one or more specific monoclonal antibody reagents. This trend has continued, including in 2001 when the molecular multiple organism codes were established with the same reimbursement as a single analyte.This situation was particularly highlighted by Program Memorandum AB-00-109 which specified that one particular product using 3 distinct probe reagents to detect 3 distinct agents of vaginal infection could only be billed as a single test.While multiple organism format tests may generate some cost savings in preanalytical and occasionally analytical testing processes, the costs related to the development of and the addition of specific reagents, monoclonal antibody or molecular probe or primer reagents, results in significantly increased reagent costs for the laboratory that generally offsets any potential labor savings.While it may be appropriate to initiate a reimbursement system whereby payment for analytes beyond the initial assay are reimbursed at a prorated amount, it is not logical or rational to expect multiple molecular results for the price of a single analyte assay.
  1. The proposed edits eliminate one avenue of legitimate reimbursement for additional testing needed to confirm an initial nonspecific test result.In either test scenario described, the final test results delineate the presence or absence of each analyte tested for, and it is most logical and rational to reimburse for each analyte tested.The proposed edits serve only to confound the situation regarding payment for these individual results.However, if the multiple organism codes are defined to be used when nonspecific results are obtained, then it is critical to perform a specific analyte confirmation.ASM recommends that confirmatory testing be reimbursed assuming all other compliance conditions are met, as in the case with Hepatitis b surface antigen testing (CPT-4 87340) and the confirmatory neutralization test (CPT-4 87341).
  1. The trend toward payment for single analyte testing when in fact multiple analyte testing with expensive reagents has occurred may serve to stifle the development of more labor efficient test processes.For molecular tests, reagent costs generally represent the major cost component.Multiple organism testing serves primarily to conserve labor costs.At a time when the clinical laboratory scientist labor force is in documented critical short supply, any reimbursement policy or edit which inhibits utilization of more labor effective test formats will only serve to worsen the workforce situation.Moreover, the current reimbursement approach and the proposed NCCI edits will serve to drive utilization towards single analyte testing which may be the only avenue available to recover the costs of testing.To ensure continued development of more cost and labor effective tests, more appropriate, non-punitive reimbursement codes would be desirable.For example:

(1)Codes for direct probe or amplification for single organisms

(2)Codes for direct probe and amplification for multiple organisms coded for on an "each" basis and reimbursed for each analyte

(3)Codes for direct probe and amplification used for confirmatory testing after an initial test with a nonspecific result or one requiring confirmation.It should be noted that a new Centers for Disease Control and Prevention (CDC) guideline may be released that specifies the need for a confirmation of a nucleic acid test (NAT) for a sexually transmitted disease agent in a low prevalence population using an alternative NAT test.

In summary, molecular testing, particularly using labor efficient multiple organism ("multiplex") formats, is clearly a major emerging trend in rapid and effective diagnosis of emerging infectious diseases.We respectfully request that CMS and it's contracted entities carefully consider the impact of these proposed edits in particular, and the more general trends of inadequate reimbursement for such testing, on the future of laboratory medicine in our country.

We appreciate the opportunity to comment and would be pleased to respond to any questions or requests for additional information.We would also welcome an opportunity to discuss this specific issue and several other related NCCI issues with you in person.