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In the FY 2021 IPPS/LTCH PPS final rule, to more precisely describe the various types of FDA approvals, clearances and classifications that we consider under our new technology add-on payment policy, we finalized a technical clarification to the regulation to indicate that new technologies must receive FDA marketing authorization (such as pre-market approval (PMA)

Mechanism-focused studies may include receptor-pathway assays, biomarker panels, gene-expression analysis, protein-expression studies, cell-viability controls, migration assays, metabolic marker analysis, or stability testing

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Some doctors arent participating providers with Medicare, but they also havent opted out of Medicare altogether