DecisionHealth, DecisionHealth - 2021 Issue 1 (January)
Rule speeds approvals for ‘breakthrough’ devices, other commercially covered services
A new final rule will allow items and services to gain approval for Medicare reimbursement more quickly than in the past, particularly medical devices that clear a specific FDA hurdle. But the devil is in the details, and the rule’s finer points will be ironed out in sub-regulatory guidance.
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