Humana Special Stains - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territor ies Special Stains Page: 2 of 6 Internet- Only Manuals (IOMs) 100-02 Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services §80.6.5 - Surgical/Cytopathology Exception Medicare Manual Medicare National Correct Coding Initiative (NCCI) Policy Manual Medicare NCCI Policy Manual LCD LCA LCD LCA LCD LCA LCD LCA LCD LCA Lab: Special Histochemical Stains and Immunohistochemical Stains L36805 A57733 J5 – J8 Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE, IN, MI Special Histochemical Stains and Immunohistochemical Stains L35986 A59292 J15 - CGS Administrators, LLC (Part A/B MAC) KY, OH Lab: Special Histochemical Stains and Immunohistochemical Stains L36351 A57611 Lab: Special Histochemical Stains and Immunohistochemical Stains L36353 A57614 Lab: Special Histochemical Stains and Immunohistochemical Stains L35922 A56838 JE - Noridian Healthcare Solutions, LLC CA, HI, NV, American Samoa, Guam, Northern Mariana Islands JF - Noridian Healthcare Solutions, LLC AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY JJ – JM Palmetto GBA (Part A/B MAC) AL, GA, TN NC, SC, VA, WV Special Stains Page: 3 of 6 Description Routine hematoxylin and eosin (H&E) staining is the cornerstone of tissue-based microscopic diagnosis. Thin sections of tissue are stained with H&E to visualize the tissue morphology. Hematoxylin dye stains the cell nuclei blue and the eosin dye stains other structures pink/red. Special stains are called “special” because they are dyes used to stain particular tissues, structures, or pathogens such as bacteria that may not be visible by routine H&E staining. Special stains can identify whether a substance is present or absent, where the substance is located in the tissue specimen, and frequently, how many or how much of a substance is present. There are special stains to identify bacteria, yeast, and fungi; for connective tissue, muscle, collagen, lipid, and fibrin; for nuclei acids; and multi-purpose stains to identify basement membranes, mucins, and various other cellular constituents. Two major categories for special stains are recognized: One is specifically for microorganisms; the second is for all other purposes (not microorganisms) and specifically excludes detection of enzyme constituents. Immunohistochemistry (IHC) is a powerful tool for identifying substances and cells in tissue sections using the specificity of antigen-antibody reactions, where the antibody is linked to a colored indicator (stain) that can be seen with a microscope. More than 400 distinct antibody targets are currently available with varying sensitivity and specificity for a given target. Morphometric analysis is a laboratory test is performed to analyze the morphometric characteristics of tumor cells using immunohistochemistry (IHC). Morphometric analysis may include a study of the size, shape, and features of the cell and nucleus, a determination of the nucleus/cytoplasm ratio, and specific DNA/RNA markers. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the following CMS sources for guidance regarding special stains: • Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services, Section 80.6.5 - Surgical/Cytopathology Exception • Medicare NCCI Policy Manual In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following: Special stains will be considered medically reasonable and necessary when ALL the following requirements are met: • These services are medically necessary so that a complete and accurate diagnosis can be reported to the treating physician/practitioner; AND Special Stains Page: 4 of 6 • The results of the tests are communicated to and are used by the treating physician/practitioner in the treatment of the beneficiary; AND • The pathologist documents in his/her report why additional testing was done. The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage The following special stains will not be considered medically reasonable and necessary: • Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist; OR • Use of special stains and/or IHC stains without clinical evidence that the stain is actionable or provides the treating physician with information that changes patient management; OR • Use of added stains when the diagnosis is already known based on morphologic evaluation of the primary stain H&E staining provides excellent detail required for tissue-based diagnosis and is NOT a separate service, as pathology services include routine H&E staining. “Acid hematoxylin” is not a special stain given that all hematoxylin stains are acidic and that this stain has never been recognized by the Biological Stain Commission. It is not reasonable and necessary to claim this stain as a special stain. H&E staining is included as part of pathology services.