Gene Expression Profiling for Noncancer Indications - Medicare Advantage
HUMANA-GENE-EXPRESSION-PROFILING-FOR-NONCANCER-INDICATIONS-MA
Covers gene expression profiling (GEP) and related molecular diagnostic tests (MDTs)/LDTs for noncancer indications — notably the Envisia (Veracyte) classifier to assist diagnosis of idiopathic pulmonary fibrosis (IPF)/identify a usual interstitial pneumonia (UIP) pattern, with other specified noncancer applications such as certain epigenetic/imprinting and developmental‑delay screening. Coverage is restricted to Medicare‑allowed, “reasonable and necessary” uses per applicable NCDs/LCDs/LCAs and MAC jurisdictions, requires demonstration of analytical/clinical validity and clinical utility (MolDX/DEX review where CMS guidance is lacking), and is not a substitute for germline testing or for use when UIP/IPF is already definitively established or would not change management.
"Humana and subsidiaries apply a Medicare Administrative Contractor's (MAC's) LCD to all requests (both Part A and Part B services) within the MAC's applicable geographic jurisdiction."