KidneyIntelX and KidneyIntelX.dkd Testing

Jurisdiction: J6 MAC Part B. States: Illinois, Minnesota, Wisconsin. Type: Active LCD

Indications of Coverage Once in a lifetime KidneylntelX or KidneyIntelX.dkd test is considered reasonable and necessary when all the following criteria are met: The results are used to facilitate therapeutic prognostic decision-making in the medical management of a selected patient population, and The results are used to assess the risk of progressive decline in kidney function in patients over the age of 21 years of age with: Type 2 diabetes (T2D) and existing early-stage chronic kidney disease (CKD) (stages 1-3b), and The test is ordered by the treating physician or qualified non-physician practitioner, and The test is performed in a CLIA certified laboratory qualified to perform high complexity testing, and The specific reason for the test must be documented by the treating practitioner in the medical documentation and demonstrate that the test is medically reasonable and necessary. Note: Kidney function decline is defined as: a decline in eGFR slope of ≥: 5 ml/min/l.73m 2 /year; or a sustained decrease in eGFR ≥40% confirmed at least 3 months apart; or kidney failure, defined by sustained eGFR Limitations of Coverage KidneylntelX or KidneyIntelX.dkd test is not medically reasonable and necessary for: Patients with eGFR Patients with eGFR ≥60 ml/min/l.73m 2 without albuminuria Patients with ESRD or on renal recovery treatments Patients who are pregnant Patients who are currently hospitalized Patients taking Etanercept KidneylntelX or KidneyIntelX.dkd is not covered as a screening or standalone diagnostic.