Medicare Coverage Policy Change Opens Up Commercial Market Pathway – If Biden Likes It
Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.
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Proposed rule would also clarify standard for determining whether coverage of a drug, device, or biologic is ‘reasonable and necessary.’
Agency decides against requiring coverage with evidence development for off-label uses.