ARTICLE SUMMARY:
CMS gave itself another seven months to mull over the Medicare Coverage of Innovative Technology program. And it is signaling that substantive changes, particularly regarding evidence development, are in the offing when, or if, MCIT ultimately comes into force. Congress could also play a role.
CMS has sent the Medicare Coverage of Innovative Technology program back to the drawing board and it could come out looking a lot more like already existing Medicare programs than industry has envisioned.
The Trump HHS fast-tracked finalization of the MCIT rule in its closing days, but the Biden administration has slammed the brakes and signaled plans to rework the program. Last week, as predicted by Market Pathways, the agency delayed MCIT implementation until December 15, following a prior three-month postponement, saying it needs more time to address concerns about how the program would operate. The switch in approach illustrates what is likely to be a key distinction between the Trump-era HHS/CMS leadership, which stepped up the emphasis the department put on speeding access to next-generation technologies, and the Biden team, which may favor more careful evidence development as a check on patient safety and system costs.