CMS Agrees to Cover ‘Breakthrough’ Medical Devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for four years.

The MCIT pathway would be voluntary, and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.“This coverage pathway delivers on the Administration’s commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits.