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(3) CMS Decision To Approve or Deny an Expansion Exception Request Proposed 411.363(i)(2) identifies factors that CMS would always consider when deciding whether to approve or deny an expansion exception request

Preclinical studies have demonstrated that 5-Amino-1MQ effectively reprograms metabolism in key energy-regulating tissues: it counteracts obesity and associated fat accumulation, reduces pathological liver fat, and enhances the regenerative potential of aged skeletal muscle 1-3

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Based on this mechanism, HDAC5 downregulation protects renal function by inhibiting neutrophil accumulation, decreasing the expression of AKI markers kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL), and downregulating pro-caspase 1, active caspase 1, and IL-1 expression to mitigate tubular cell damage (Sharma et al., 2022)