Notice with Comment - Transitional Coverage for Emerging Technologies (CMS-3421-NC)

CMS issued a proposed procedural notice on June 22nd that describes a new Medicare coverage pathway to achieve more timely and predictable access to new medical technologies for people with Medicare. The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices uses current national coverage determination and coverage with evidence development processes to expedite Medicare coverage of certain Breakthrough Devices. The TCET pathway is intended to balance multiple considerations when making coverage determinations: (1) facilitating early, predictable, and safe beneficiary access to new technologies; (2) reducing manufacturers’ and innovators’ uncertainty about coverage...