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January 13, 2021
On Wednesday, the Centers for Medicare and Medicaid Services (CMS) posted the final rule and amendments to the Code of Federal Regulations regarding the new Medicare Coverage of Innovative Technology (MCIT) pathway. The final rule becomes effective March 15 and establishes an optional pathway that medical device manufacturers and medical facilities can use to seek payment coverage of new and cutting-edge devices more quickly than the current processes allow.
Under the current division of responsibilities, the Food and Drug Administration (FDA) reviews new medical devices for efficacy and safety for use by all patients. These determinations include any restrictions on use, both for safety purposes and intended use. However, a determination from the FDA that a product is safe and effective to use for a person who qualifies for Medicare coverage does not mean that the device automatically is approved for Medicare coverage and payment. Devices ha