Key TakeawaysThe proposed RAPID pathway would create a new voluntary CMS/FDA process for certain innovative medical devices, with the stated goals of expediting Medicare coverage, improving efficiency and supporting patient access. On Aug. 7, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) published a proposed procedural notice for certain innovative medical devices governing a new, voluntary CMS/FDA dual pathway titled the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway that is designed to expedite Medicare coverage, promote efficiencies and foster patient access to innovative medical devices. The new RAPID coverage pathway is another reminder of the increasing importance of integrating reimbursement, FDA, intellectual property and compliance strategies from the earliest possible stages of product development. For those interested in submitting written comments, comments will be due 60 days after publication in the Federal Register. The proposed notice can be found here.