The Renal Pathology Society (RPS) held a Board of Directors meeting on Sunday February 12, 2006 during the annual USCAP meeting at the Hyatt Regency Hotel in Atlanta, Georgia.
In attendance were Drs Racusen, Liapis, Cook, Fogo, Haas, Bonsib, Alpers, Meleg-Smith, Seshan, Picken, Truong, Roberts and Nickeleit.
Medicare and Medicaid Services Proposed Edits Affecting Pathology
Letter by Steve Bonsib on behalf of RPS
Mr. John Scott
College of American Pathologists
1350 I Street NW
Suite 590
Washington, DC 20005
Re: Centers for Medicare and Medicaid Services Proposed Edits Affecting Pathology
Dear Mr. Scott,
The Renal Pathology Society views with concern the proposed reimbursement limitation to four immunohistochemical tests per specimen. To satisfy current ‘Standard of Care’ practice for renal biopsy evaluation, an immunofluorescnece (IF) protocol testing for more than four antigens is required. A minimum of nine antigens are necessary and more antigen testing may be required depending upon the clinical context. The defense for a more extended staining protocol is that for each antigen tested, there are multiple renal diseases that could not be correctly diagnosed if testing did not include that antigen. Although this letter cannot explain all diagnostic nuances of immunohistochemical testing in renal pathology, a listing of specific antigens that must be tested for are displayed below. A brief statement is included of some of the diagnoses compromised should testing for that antigen not be performed.
The usual immunofluorescnece panel includes a minimum of 9 antigens. Integration of the complex data generated, including antigen composition, location, and pattern of staining, determine the final diagnosis.
IgG stain: A number of IgG immune complexes diseases are recognized by staining for this antigen. Anti-glomerular basement disease, a medical emergency, can only be rapidly diagnosed by testing for this antigen.
IgA stain: IgA nephropathy is the most common glomerular disease in the world and accounts for at least 15% of glomerular diseases in the United States. It can only be diagnosed by staining for this antigen.
IgM stain: This antigen is required to diagnose Waldenstrom’s macroglobulinemia and mixed cryoglobulinemic glomerulonephritis.
C3 stain: Several glomerular diseases stain only for C3; for instance dense deposit disease, C3 mesangial glomerulonephritis, and resolving post infectious glomerulonephritis.
C1q stain: C1q nephropathy can only be identified with this stain. This stain also is helpful in distinguishing lupus glomerulonephritis from similar lesions that occur in patients without lupus.
Fibrin stain: This stain is used to identify necrotizing lesions in vasculitis and other glomerular diseases, and to diagnose a family of thrombotic diseases.
Kappa and lambda stains: These stains are required to diagnose a family of monoclonal protein diseases that are often the initial manifestation of malignant disease.
Albumin stain: This control stain is used to distinguish specific from non specific staining.
In addition to the above standard panel of stains, antigen testing could include viral identification, C4d staining for humoral rejection, collagen stain for hereditary nephritis, amyloid AA protein, and lymphoid markers for post transplant lymphoproliferative disorders. Most of these diseases can be identified only by this form of testing. Furthermore, some patients will have more than one disease identified based upon testing for multiple antigens, and there are a group of diseases that are diagnosed only when all antigens tested are negative. In the final analysis, in order to create a 4 antigen protocol permitting accurate renal biopsy diagnosis, the diagnosis must be known in advance of the biopsy.
The Renal Pathology Society believes that limitations on testing reimbursement would force pathologists to choose between three untenable options. One choice would be to maintain medical quality by adherence to published ‘Standard of Care’ practice guidelines. This means that hospitals and pathology laboratories would incur significant uncompensated expenses. The problem of uncompensated expenses is magnified because ‘Standard of Care’ for renal biopsies also mandates performance of multiple H&E stained levels and duplicates of several special stains, for which compensation is already not provided.
The second choice would be to create a staining protocol commensurate with reimbursement levels. This would have a substantial deleterious impact upon the quality of medical care. As documented above, regardless of the antigens selected in a restricted protocol, a substantial number of renal diseases will not be diagnosable. Who will decide which renal diseases merit testing in a restricted staining protocol, and which renal diseases we can ignore? Who will assume responsibility for the litigation that results from misdiagnosis and improper treatment?
The final choice for pathology laboratories would be to discontinue offering renal biopsy evaluation because there is a limit to the amount of uncompensated work that a laboratory can absorb. This would reduce the availability of a clinically important diagnostic service.
The Renal Pathology Society recognizes the need for controlling medical costs. In response to that concern, the routine panel of immunohistochemical stains discussed above, and electron microscopy, are no longer routinely performed on renal transplant biopsies. However, restricting antigen testing reimbursement without regard for clinical necessity risks inadequate biopsy evaluation. This could ultimately contribute to increased medicals because cost effective medical care is dependant upon rendering a correct diagnosis to optimize therapy. Therefore, before restricting antigen testing reimbursement to an arbitrary number, please consider the minor savings for an improperly evaluated renal biopsy compared to the substantial medical costs that would result from misdiagnosis.
Sincerely yours,
Stephen M. Bonsib, MD
Vice President, Renal Pathology Society
Director, Surgical Pathology
Indiana University School of Medicine
317-274-7005 phone
317-274-5346 fax
sbonsib@iupui.edu