Niles R. Rosen, M.D.
Medical Director
National Correct Coding Initiative
Correct Coding Solutions, LLC
P.O. Box 907
Carmel, IN 46082-0907

Dear Dr. Rosen:

The American Society for Microbiology (ASM) appreciates the opportunity to review and comment on the proposed National Correct Coding Initiative entitled Medically Unbelievable Edits. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences, and their application to the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators who work in a variety of areas including biomedical, environmental, and clinical microbiology.

Almost one quarter of our members are directly involved with clinical laboratory medicine, including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives developing and/or marketing products for use, institutional infection control personnel who are dependent upon the results of the clinical microbiology laboratory, and researchers involved in developing and 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 appropriate care for Medicare beneficiaries.

The MUE file provided was reviewed by both the Professional Affairs Committee and the Laboratory Practices Committee of ASM’s Public and Scientific Affairs Board, as well as by a MUE Working Group composed of interested board-certified clinical microbiologists and immunologists. The ASM appreciates the need to perform systematic post-claim reviews to identify aberrant utilization patterns including obviously erroneous over utilization or utilization that is incompatible with CPT code descriptors, CPT coding instructions, or medical standards of care. We support any reasonable program to promote correct coding and appropriate utilization. However, we have significant concerns with the current proposal regarding the application of these the proposed edits to microbiology, immunology and molecular diagnostics:

  1. Many reviewers are concerned that the terminology, “medically unbelievable edits” is misleading, and recommend that these edits be designated using terminology which more accurately reflects their basis, e.g. “daily use edits.” 
  2. By its very nature, requirements for infectious disease laboratory testing are unpredictable as applied to specific patients who present with a myriad of signs and symptoms, associated with a broad spectrum of infectious diseases. Both the scope and the frequency of testing differ as a function of the presentation of a given patient. We are concerned that the proposal does not adequately address the severity of illness of a given patient, the diagnostic clarity of the patient’s presentation, and/or the presence of co-morbidity, any of which would impact the utilization of microbiologic tests. While it might be appropriate to divert selected claims for additional review by using modifiers, edits, or other means of expanded documentation, the process, which is likely to be frequently required, should not be burdensome for the physician ordering the test, the laboratory performing the testing, or the organization responsible for reimbursement reviews. The current MUE proposal, given its unrealistic nature, will be burdensome and potentially prevent patient access to critical testing. 
  3. Given the unpredictability of utilization in diverse patient populations, if CMS proceeds with application of MUE’s (frequency limits) to laboratory services, then the ASM recommends that such limits be established with the intent of identifying egregious, likely erroneous over utilization, possibly resulting from “typographical errors” rather than being set at a lower limit that would obstruct either the obtaining of clinically appropriate and medically necessary laboratory testing, or timely payment for such services rendered. Edits based on “anatomic” incongruities are unlikely to have relevance for microbiology, immunology, or molecular diagnostics code utilization. 
  4. Microbiology data required to diagnose and monitor infectious diseases are generated by a series of complex, progressive procedures which result in the billing of a composite of CPT codes on any given date of service. As a consequence, it is unreasonable to set arbitrary and restrictive limits on many codes that are appropriately used multiple times in the course of evaluating a given patient (e.g. code 87070 is used for any specimen source for a bacterial culture that is not blood, urine, or stool; and multiple isolates from multiple unique body sources may require definitive identification [87077], culture typing [87140-87158], and antimicrobial susceptibility studies [87181-87197]).
  5. Many immunology codes do not have an adequate level of specificity to accurately describe both an analyte and method specific procedural service. As a result, it is often appropriate to use a specific code multiple times for multiple analytes (e.g. infectious agent antibody codes often do not specify immunoglobulin class, but both total antibody, or IgG and/or IgM and IgA testing may be required.) Additionally, many other codes are method-based, but may be used for multiple related analytes (e.g. antibody to multiple serovars of a given infectious agent). Finally, for some method-based codes, multiple uses can be justified by the need to test unique specimens, e.g. serum, CSF, and/or urine. 
  6. Non-infectious disease molecular diagnostic CPT procedure code descriptors have been established to allow for testing for multiple analytes, either by traditional methods or by multiplex technologies. Therefore sample preparation and interpretation codes, may be appropriately used multiple times on a single date of service, and multiple primer pairs may be used in an analysis. In fact, it is our understanding that the codes in series 83890-83912 are intended for detection of up to 10 unique sequences. Beyond 10, it may be more appropriate to use the array codes, 88384-88386. However, in both cases, the numbers of unique sequences tested for are unpredictable and based on individual patient situations. 
  7. For infectious disease diagnostics, 87470-87799, any edits developed should consider that multiple unique clinically relevant sequences may be detected for a given pathogen, and that one or more unique body sources may be analyzed using a single primer pair. 
  8. Many CPT code descriptors exist which include the term “each” generally referring to specific analytes which are tested for using a common method. It is clear that these codes are designed to be used multiple times and therefore a limit of “1” applied for reimbursement purposes is clearly incompatible with the descriptor. 
  9. CPT code descriptors for “unlisted procedures” or for “analytes not otherwise specified” cannot rationally be assigned a frequency unit. For these codes, it is also recommended that an upper limit be established designed to identify egregious utilization. 
  10. Given the complexity and unpredictability of the procedures appropriately used to diagnose and monitor patients with infectious or immunologic diseases, and therefore the inability to rationally and reasonably establish daily frequency limits for many microbiology, immunology, and molecular diagnostic codes, it is strongly recommended that a modifier be established that can signal that a unique circumstance exists that justifies utilization over the established limit. In addition, clear guidance on additional documentation that should be provided to support the claim, should be provided.

We believe that these general concerns identify some serious flaws in the application of the initially proposed MUE (frequency) edits that could potentially restrict access to essential laboratory services, and in so doing, compromise patient care. The ASM strongly supports CMS efforts to improve laboratory ordering practices, and to identify egregious over utilization of laboratory services. We also understand the difficulty in achieving that goal without impinging upon medically necessary testing. We have considered how to help clarify appropriate utilization in our disciplines that might help detect egregious events, without losing the flexibility required for our complex task of diagnosing the cause of infection in diverse patient populations.

However, appreciating the need to identify such egregious instances, we have reviewed the MUE file provided, and have in good faith attempted to suggest possible “MUE” limits for those procedure codes applicable to our disciplines, or in consideration of a general principle. Our recommendations are based on an upper rather than a lower limit for potential utilization, and general commentary has been made to support our recommendations. Given the short timeframe, a comprehensive list of references to support our recommendations is not at this time provided, but ASM will endeavor to do so upon request. It is also our understanding that there will be an additional opportunity to review the proposed edits prior to implementation; therefore, these recommendations should not be construed as our final statement on the matter. The recommendations are provided in the attached spreadsheet.

The ASM sincerely appreciates the opportunity to review the proposed MUE edits and make recommendations for changes prior to their implementation. We support the goals of CMS and its contractors in the provision of medically necessary and clinically appropriate laboratory testing to Medicare Part B beneficiaries through the process of correct coding and judicious utilization. However we are dedicated to ensuring that claims review programs not be established which could inappropriately restrict the ability of ordering providers to obtain medically necessary diagnostic information, the ability of beneficiaries to receive the benefit of such services, or the ability of the laboratory to receive reimbursement for such services. We are certainly willing to provide any additional information that may assist you, and, if helpful, meet with representatives of CMS or CCS, Inc. to further clarify our concerns and recommendations.

Sincerely,

Vickie S. Baselski, Ph.D., Chair, Committee on Professional Affairs
Joseph M. Campos, Ph.D., Chair, Committee on Laboratory Practices

CC:
Kimberly L. Brandt, Director, Program Integrity Group, CMS
Marsha Mason-Wonsley, CPT Coding Specialist, CMS
Linda S. Dietz, RHIA, Coding Specialist, NCCI, CCS

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