Intersect Healthcare submitted comments on April 16, 2021 regarding the proposed rule entitled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’’’ (CMS-3372-IFC). If the MCIT Program is implemented and changes to the definition of reasonable and necessary are codified, then commercial insurers gain unfettered authority to decide whether they should make payment for treatment and it staggers the treating physician’s ability to provide optimal care to patients.
Intersect Healthcare urges CMS to clarify the modified and codified “reasonable and necessary” definition and consider how the MCIT Program will affect hospitals. The letter also notes that Interest Healthcare does not support effecting a modified and codified definition of “reasonable and necessary” as well as the FDA’s Breakthrough Program through the MCIT unless the agency considers clinical evidence supported by the practice of medicine.
