The agency said codifying the definition will “bring clarity and consistency to the existing coverage determination processes” for the services and items under Medicare Parts A and B.
The updated definition says that services and items will generally have to be safe and effective, appropriate for Medicare members and not experimental. CMS said that if an item or service has inadequate evidence regarding its appropriateness for national or local coverage determinations, it will look to commercial insurer policies to see how coverage should be handled.
The final rule, which takes effect March 15, also established a new, accelerated Medicare coverage process for innovative products that the FDA calls “breakthrough.”
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