The Centers for Medicare and Medicaid Services and FDA announced a new coverage pathway—called the Regulatory Alignment for Predictable and Immediate Device, or RAPID pathway—designed to expedite access to certain FDA-designated Class II and Class III Breakthrough devices for people with Medicare.
Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.
