March 5, 2007
Kimberly L. Brandt
Director, Program Integrity Group
Centers for Medicare and Medicaid Services
7500 Security Blvd., C3-02-17
Baltimore, MD 21244-1850
Dear Ms. Brandt:
The College of American Pathologists and the undersigned applaud the agency for their efforts to reduce fraud and abuse in the Medicare program. We recognize that Medically Unlikely Edits (MUEs) are intended to lower Medicare’s paid claims rate through identification of billing and typographical errors. We do, however, have concerns about the process under which these MUEs are being developed. The MUE process has morphed from the issue of unbelievability to unlikelihood and now most recently we have heard that certain of the edits will be based on medical necessity as well. We are very concerned that the level of expertise of the NCCI/MUE contractor and CMS physicians, who are not full time practitioners representing the spectrum of potentially implicated specialties, is inadequate to properly set MUE levels based in whole or in part on clinical judgment.
The College of American Pathologists (CAP) and the undersigned societies request that the Centers for Medicare and Medicaid Services (CMS) establish an Advisory Committee for the development of Medically Unlikely Edits (MUEs) for pathology and laboratory services. During our meeting with you last May, you proposed the establishment of such a working group of stakeholders to include CMS’ NCCI/MUE contractor and medical staff, together with representatives of the pathology and laboratory community, to provide guidance on this complex problem. Since the criterion of medical necessity has now entered the mix, we believe such a group should be bolstered by representation from clinical specialty societies potentially implicated, including gastroenterology, urology, and dermatology. An Advisory Committee so constituted will lend transparency and assurance that edits will be based on appropriate evidence, to achieve CMS’ objectives without impeding good medical practice. The remainder of this letter describes in greater detail our reasons to believe that an Advisory Committee is necessary at this time.
Movement Toward Non-Anatomic MUEs
While the last two releases of MUE proposals have largely focused on anatomic edits, we understand that the National Correct Coding Initiative/ Medically Unlikely Edit (NCCI/MUE) contractor is proceeding with the development of additional edits some intended to capture “typographical errors” on a statistical basis, while others are based on his clinical judgment regarding medical necessity.
We believe that the first approach is appropriate only after an open and transparent discussion about the rationale, criteria and specific methodology that will be used to establish such edits on a statistical basis. CMS’s own website states “throughout this effort CMS will work with the provider community to discuss the statistical basis for establishing MUEs.”1 The second approach, which requires assessment of medical necessity, demands the establishment of a process to utilize the knowledge of appropriate practitioners of the involved specialties.
The need for broader input into the MUE process is further evidenced by recent actions of the current contractor. At the recent CPT Editorial panel meeting, Dr. Niles Rosen approached representatives from various medical societies requesting claims data on frequencies for surgical pathology CPT codes within the next 30 days. While the intended application of the data was not clear, some societies viewed this as a formal request to which they must respond.
A number of concerns arise from these requests. First, it appears that they are being made informally, neither as an official agency action nor through an established process. There is no uniformity to the sources of data or analyses used by the societies, and potential contributors do not know the implications of either submitting or failing to submit data. We believe the Advisory Committee structure provides an ideal forum to build a consensus on the appropriate methodology.
Second, reliance on ad-hoc data to determine MUEs is inappropriate. This data is unlikely to be statistically reliable across regions or subspecialties. The NCCI/MUE contractor stated in a recent letter to the American Society of Cytopathology that he relied on information from “a national healthcare organization” to determine MUEs for cytopathology codes. He does not state the sample size or statistical reliability of this data, but that the data was derived from an organization “whose members generate a very large number of clinical specimens for screening and diagnostic cervical/vaginal cytopathology.” Such reliance on ad-hoc data, unaccompanied by any statement of statistical representation of Medicare claims, should not be acceptable to CMS and is not acceptable to the provider community. We believe that reliable data to determine MUEs must come from CMS itself, which has datasets that represent 100% of billed services provided to Medicare beneficiaries. The CMS data provides a more robust, relevant, timely and statistically reliable data set than ad-hoc data from any other source.
The NCCI/MUE contractor has stated that he does not have access to this data and that is why he is seeking ad-hoc data from various sources. The data that is available to the public and thus the NCCI/MUE contractor is the 5% sample of Medicare data. This data generally has an 18–month lag, and the sample size is insufficient to assess exactly those upper bounds of utilization that the MUEs are intended to address. We believe that an Advisory Committee would provide an ideal forum to discuss with CMS the data analysis that is appropriate to this assessment and can be derived from their most current 100% claims file. In fact, this proposal is consistent with CMS statements in public forums that they would provide access to Medicare data to evaluate appropriate levels for MUEs.2
Inconsistencies in Communications on MUEs
Over the past year, there has been conflicting information regarding MUEs. For example, CMS officials have made contradictory statements on both the use of modifiers and the intent to communicate the MUEs. On the one hand, in an e-mail message from John Stewart of your office, it was stated that CMS had not decided whether to actually publish the final MUEs because the concern with “making the edits public is that unscrupulous providers may always bill at the MUE allowed level.”3 On the other hand, the NCCI/MUE contractor has clearly stated in recent responses to MUEs that if necessary a modifier –59 can be used to report additional specimens. These two statements are incompatible—how will a physician know to use a modifier to override the MUE if he does not know what the MUE limit is/will be for a particular code? There are additional concerns with the use of modifiers that need to be discussed. Most notable is the fact that most private payers do not recognize modifiers, but have, and will continue to adopt the NCCI and MUE edits as released. These inconsistencies illustrate the importance of establishing an Advisory Committee to improve communications with the stakeholders. By establishing an Advisory Committee, CMS will establish a process to receive comments, deliberate alternatives, and distribute authoritative communications to the provider community.
Complexity of Clinical Rationale and Evidence
Another important reason to form an Advisory Committee is the sheer complexity of these edits with respect to their clinical rationale. Through an Advisory Committee, CMS and its contractor can obtain technical expertise that can be tested and confirmed in an open and transparent manner for consensus building on MUEs. This issue of complexity is also evident with respect to NCCI edits, which are developed and implemented by the same contractor. The College’s approach to addressing these proposed NCCI edits is to confer with experts in the various subspecialties. These proposals are then brought for detailed consideration and revision to the full committee of 16 pathologists, each of whom is in active practice, and who represent overall of the full range of practice types across all regions of the United States.
It does not appear that development of MUEs is being approached in a manner to utilize a broad knowledge base. The latest round of NCCI edits suggest that the process used to formulate edits may not include even casual familiarity with current standards of patient management found in textbook/literature recommendations, much less appropriate application of new technologies by practicing experts. This has been most evident in the area of molecular pathology, where the rationale for the edits suggests an incomplete understanding of the usual scope and optimal use of molecular pathology applications across laboratory disciplines in current patient management. Despite detailed clinical rationales provided by some of the most respected molecular pathologists in the country, the NCCI/MUE contractor’s responses to comments by the College and other societies on molecular pathology have disregarded the corresponding recommendations, casting substantive doubt as to the basis of the edits, and whether there is any evidence to support them.
There are many other instances where clinical commentary on NCCI edits has been ignored. We look forward to the opportunity to share these with you. The point we would like to make here is that the practice of pathology is complex and spans many subspecialties that each has its own knowledge base. The creation of an Advisory Committee that includes expertise from pathology and appropriate clinical specialties, as well as CMS staff and the NCCI/MUE Contractor, would enable CMS to develop edits (whether NCCI or MUE) that accurately reflect the current practice of laboratory medicine throughout the United States. An Advisory Committee would also provide an appropriate venue for recourse to address concerns about lack of clinical evidence. If an edit is based on a misunderstanding of current practice, it is imperative that there be a transparent opportunity for its resolution prior to implementation of the edit to avoid imposing a time and cost burden on the provider community in correcting the oversight.
CAP wishes to make every effort to cooperate and work together with CMS and its contractor in enhancing the agency’s ability to accurately assess the validity of the existing and proposed NCCI and MUE edits in the difficult and important areas of pathology and laboratory services. Given the range of issues discussed in this letter, we strongly urge you to move forward with the creation of an Advisory Committee that includes members of the pathology and clinical communities, CMS medical staff and officials, and the NCCI/MUE contractor, to ensure that CMS receives the best broad-based advice prior to further development and implementation of these edits.
Please contact Janemarie Mulvey at (202) 354-7110 with questions and/or comments regarding this request.
The College of American Pathologists
American Pathology Foundation
American Society for Clinical Pathology
American Society of Cytopathology
Association for Molecular Pathology
Association of Directors of Anatomic and Surgical Pathology
Association of Pathology Chairs
National Association of Medical Examiners
U.S. and Canadian Academy of Pathology
Leslie Norwalk, CMS, Acting Administrator
Niles Rosen, MD, Correct Coding Solutions, LLC
Valeria Allen, CMS, Program Integrity
Lisa Zone, CMS, Program Integrity
Thomas M. Sodeman, MD, President, College of American Pathologists
George F. Kwass, MD, Chair, CAP Economic Affairs Committee
W. Stephen Black-Schaffer, MD, Chair CAP Regulatory Affairs Workgroup
Karl Proppe, MD, President, American Pathology Foundation
John S.J. Brooks, MD, President, American Society for Clinical Pathology
Mary Sidawy, MD, President, American Society of Cytopathology
Andrea Ferreira-Gonzalez, PhD, President, Association for Molecular Pathology
Christopher Otis, MD, President, Association of Directors of Anatomic and Surgical Pathology
James M. Crawford, MD, PhD, President, Association of Pathology Chairs
Joseph A. Prahlow, MD, President, National Association of Medical Examiners
Henry D. Appelman, MD, President, US and Canadian Academy of Pathology
- CMS Division of Medical Review and Education PDF
- Lisa Zone, Update on MUES before the Practicing Physicians Advisory Committee 8/28/06
- Email correspondence from John Stewart (CMS/OFM) to Dennis Padget on Monday January 8, 2007.