On November 12, the Centers for Medicare and Medicaid Services (CMS) rescinded the MCIT final rule citing concerns that the patient protections may not have been sufficient. This decision comes despite support from HFSA and other stakeholders for a pathway that would grant patients more immediate CMS coverage for critical FDA-approved breakthrough devices. CMS plans to explore alternative coverage pathways and plans to hold public meetings to gather additional input. Meanwhile, federal legislation has been proposed to address reimbursement for breakthrough devices. The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 4043) would expedite the Medicare coverage determination process by providing temporary coverage for FDA-approved breakthrough products for four years during which CMS would make a permanent coverage determination. This stand-alone legislation was included in a larger legislative package introduced this week, the Cures 2.0 Act (sec. 404, H.R. 6000). HFSA will continue to be engaged on this issue.