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LCD Reference Article Response To Comments Article

Response to Comments: Special Histochemical Stains and Immunohistochemical Stains (L36805)

A55404

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Source Article ID
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Article ID
A55404
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Article Title
Response to Comments: Special Histochemical Stains and Immunohistochemical Stains (L36805)
Article Type
Response to Comments
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02/16/2017
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Special Histochemical Stains and Immunohistochemical Stains. Thank you for the comments.

Response To Comments

Number Comment Response
1 Comment states: To minimize the risk of missing an infection, in cases in which no organisms are identified on the H&E stain, I contend that it is appropriate to include a stain for H. pylori as part of a gastric biopsy evaluation. This leads me to my second issue which is regarding the statement “Scientific data demonstrates that the combined number of gastric biopsies requiring special stains or IHC is roughly 20% of biopsies received and examined in pathology practice.” What scientific data? Will I be monitored for the percentage of biopsies that have special stains? How will you take into account differences in patient populations and biopsy rates? Even if I feel that the stain is medically necessary and document this in my reports, will there be consequences if I exceed this number? Will I be investigated? Fined? Subject to other disciplinary action? To me, this carries the implication of rationing of medical services and limits the physician’s role in determining the medical necessity of services. This contractor recognizes that the practice of pathology is both an art and a science, and recognizes there are differing levels of skill among pathologists, and different kinds of pathology practices. Consequently, Medicare contractors are cognizant of these issues and allow clinical leeway for a provider to exercise their best clinical discretion in the selection of special stains and immunohistochemical testing. However, Medicare expects that these decisions are documented in the medical record to support the testing performed. This policy addresses medically necessary testing. Pre-ordering specials stains and/or IHC prior to reviewing the H&E is not reasonable and necessary, excluding the exceptions noted in the policy. If H. pylori is evident on H&E, one has the answer. If H. pylori is not evident, then testing may be indicated. This policy is addressing those practitioners whose claims data shows testing volume and/or frequency that may be outside reasonable medical necessity.
2 Commenter states: I concur that a large panel set of IHC stains should not be performed on every single bone marrow specimen (e.g. 15 IHC stains) on every patient regardless of the diagnosis. However, the DLCD states that: “The use of IHC stains may assist in the interpretation of cases … for the evaluation of cell types that are not detected or significantly underrepresented in FC studies, such as large cell lymphoma, plasma cells and Reed-Sternberg cells.” If the stated situations in the DLCD are meant to be examples of a few of many scenarios, then the paragraph is adequate. Requiring a pathologist to state and/or prove that an H&E stain was reviewed first is a statement on the practice of medicine. Therefore, the DLCD should be revised to drop these sentences in order to make the DLCD compliant with regular expectations by Medicare of a LCD. Review of the H&E is a required pre-requisite prior to ordering special stains and/or IHC, except as noted in the policy. However, there is no requirement of the pathologist to designate H&E review in the pathology report.
3 Commenter states: The dLCD’s purported evidence base lacks credibility. The dLCD encroaches on matters of pathologist medical judgment. As a result of its lack of clarity and reliance on retrospective claims evaluation, neither providers nor patients are able to prospectively determine if a particular service is covered for a particular patient. Most concerning, the dLCD seems to approach the patient’s diagnostic evaluation in an arbitrary fashion, potentially adversely affecting not only the efficiency with which care is delivered, but also diagnosis, clinical decisions, and treatment options. Even more concerning is the adoption of this flawed policy by WPS, whose regional coverage policies affect physicians and patients in 13 states. In addition to its overreaching scope on coverage, the dLCD sets forth similarly broad documentation requirements. The words “usually”, “rarely”, “often”, etc. are used throughout the LCD. Commenter states: After reading DL36805 and the attached letter from the College of American Pathologists, I concur with the CAP’s elegant and thorough analysis of the dLCD and urge you to withdraw it. Commenter states: As expressed in the CAP letter, the evidence on which the dLCD guidelines are based is partial at best, and in certain instances, directly contradicted by the entirety of the medical literature and generally accepted clinical practice. It is the belief of the IAP that the proposed dLCD is too rigid to allow pathologists to be at the forefront of this medical revolution to the benefit of their clinical colleagues and their patients. An order of a stain does not establish medical necessity. Multiple commenters provided generalities as to why they disagree with the policy, but most did not provide us with specific information to support their comments or provided us with observational studies or abstracts. This policy does not allow standing orders to facilitate efficiency or lab workflow. This is not an acceptable approach as it drives overutilization when a service is not medically reasonable and necessary. For example, a lab may choose to perform a mucin stain on every esophageal or duodenal biopsy to increase efficiency and/or workflow. However, a business decision does not constitute medical necessity. Medicare (or any payer) should only be billed for those cases where medical necessity is indicated and documented in the report. Some pathology practices have developed reflex or algorithmic orders that allow additional testing when an initial test is positive. The formulation of evidence-based algorithms prevents the potential for overutilization and allows efficiency between the ordering provider and the pathologist, delivering results and planning treatment in the most efficient manner possible. Algorithms, based on sound medical evidence, can define the parameters for the pathologist to perform SS or IHC.
4 Commenter states: In response to IHC for bone marrow sample: There are situations when IHC is required in addition to flow cytometry or despite flow cytometry results. This contractor agrees that sometimes flow cytometry and IHC may be used in the same case, and that the justification must be stated in the pathology report. However, this contractor regularly reviews documents, particularly from reference labs, where redundant testing (IHC, Flow cytometry, FISH, molecular) is performed without documentation for such testing.
5 Commenter states: Our oncologists specifically request Ki67 quantitative assessments on every breast cancer case and also on metastatic breast carcinoma. The Ki 67 index will help us in determining the molecular subtype of breast cancer especially when have little tissue in the neoadjuvant setting. Poor PR positivity and higher Ki 67 index of more than 14% are used to separate Luminal B tumors from Luminal A tumors in hormone receptor positive tumors. The predictive value of Ki67 IHC for adjuvant treatment of ER-positive and HER2-negative breast cancer has not been investigated in a prospective, randomized study. There is a lack of consensus regarding the use of the Ki67 labeling index, which results in inconsistencies in inter-laboratory methodology. Furthermore, there is no standardized labeling index. The CAP’s biomarker protocol notes that Ki-67 is optional and are not currently recommended for all carcinomas. CAP notes “there is also a paucity of data on the effects of pre-analytic variables (eg, ischemic time, length of fixation, antigen retrieval) on Ki-67 staining. For these reasons, routine testing of breast cancers for Ki-67 expression is not currently recommended by either ASCO or the National Comprehensive Cancer Network (NCCN).
6 Commenter states: As for format, this LCD seems to be more a somewhat rambling narrative of issues that have been identified as potential abuses in the areas of special and immunohistochemical stains. As for the content, the level of granularity of the discussions is beyond the scope of scientifically validated guidelines and move into personal opinions on the appropriate way of working up specific cases. The policy addresses medically inappropriate and un-necessary testing: reflex testing prior to review of H&E stained specimens; use of special stains and/or IHC that the stain is actionable or provides the treating physician with information that changes patient management, and use of stains when the diagnosis is already known based on morphologic evaluation of the primary stain. This policy was never intended to tell pathologists what stain to use to obtain a diagnosis. Rather it is a compilation of examples of inappropriate testing.
7 Commenter states: Most duodenal biopsies submitted by gastroenterologists have normal length duodenal villi. In this situation (most cases) it is imperative to get an accurate CD3 count to diagnose possible celiac disease. In comparison to just doing an H/E stain on the esophageal biopsies most laboratories also perform an Alcian Blue stain to diagnose this premalignant disease. "It is customary for pathologists in small biopsy specimens to do a special stain to check for acid muci in goblet cells." The Alcian Blue stain is less expensive than the CDX2 immunostains and patients need to be made aware of their increased risk so that appropriate surveillance can be done to prevent invasive cancer and death. Mucin staining in the right clinical milieu may be indicated. However, mucin staining on every duodenal biopsy is not reasonable and necessary. Please read: Stoven, SA, et al. Analysis of biopsies from duodenal bulbs of all endoscopy patients increases detection of abnormalities but has a minimal effect on diagnosis of celiac disease. Clinical Gastroenterology and Hepatology 2016;14:1582–8.
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