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Exclusive Update on Medicare Coverage Determination for Special Stains and IHC Stains by Palmetto and WPS Effective July 14, 2024, two Medicare Administrative Contractors (MACs), Palmetto and WPS, have finalized their Local Coverage Determinations (LCDs) concerning medical necessity guidelines for special stains and immunohistochemical (IHC) stains. These determinations, LCD L36805 (WPS) and LCD L35922 (Palmetto), provide clear and stringent criteria under which Medicare will cover these stains. Key Points of the LCDs: *Conditions for Coverage: 1.Medical Necessity: The special stains and IHC stains must be medically necessary to ensure a complete and accurate diagnosis is reported to the treating physician. 2.Communication and Utilization: The results of the stains must be communicated to and used by the treating physician in the patient's treatment plan. 3.Documentation: The pathologist must document in the pathology report the rationale for performing the additional stains. *Prohibitions and Requirements: -A statement in the pathology report that merely says "IHC confirms the diagnosis" will not be considered sufficient for coverage. -The necessity of the stains must be justified with specific documentation within the surgical pathology report, detailing why the stains were performed and the results obtained. *Specifics of the LCD L36805 (WPS): -This policy emphasizes that reflex templates or pre-orders for special stains and IHC stains before reviewing the routine hematoxylin and eosin (H&E) stain by the pathologist are not considered reasonable and necessary. -Only the pathologist may determine the need for special stains after reviewing the routine H&E stain. -Exceptions include recognized standards of care in certain biopsies and the suspicion of infectious diseases. *Specifics of the LCD L35922 (Palmetto): -Like WPS, Palmetto’s policy requires detailed documentation of the medical necessity for special stains or IHC studies and their results in the pathology report. -The policy delineates scenarios where over-utilization or incorrect billing of these stains may occur, such as the use of pre-orders for special stains without prior review of the H&E stain. Implications for Pathologists and Healthcare Providers These determinations highlight the critical role of pathologists in ensuring that the use of special stains and IHC stains is both necessary and properly documented. Healthcare providers must ensure compliance with these guidelines to secure Medicare coverage for these diagnostic tests. Proper documentation and communication with treating physicians are paramount to adhere to these new standards. For further details, you can review the complete LCDs on the CMS website using the following LCD IDs: L36805 and L35922. #Medicare #Healthcare #Pathology #MedicalNecessity #IHCStains #SpecialStains #Palmetto #WPS

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