Proposed LCD - Special Histochemical Stains and Immunohistochemical Stains (DL35986)

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 Code of Federal Regulations (CFR) 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.6.5 Surgical/Cytopathology ExceptionCoverage Indications, Limitations, and/or Medical NecessityThis policy does not designate specific special histochemical stains (aka special stains) and/or immunohistochemical (IHC) stains that should be used in the differential diagnosis of tissues or neoplasms because this information is readily available in textbooks and various scientific publications. This policy identifies the medically necessary criteria for the use of special stains and/or IHC stains and addresses, based on claims review, the scenarios that may be driving medically unnecessary over-utilization or incorrect billing of these services including: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, orUse 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, orUse of added stains when the diagnosis is already known based on morphologic evaluation of the primary stain.The surgical pathology report is expected to designate the specific block(s) upon which IHC testing is performed, the reason and results for IHC testing, the specific markers, and whether single antibody(ies) or a cocktail of antibodies is utilized. 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