THE MCMANUS GROUP

Access to and reimbursement of medical devices, specifically diagnostics, in the Medicare program. Issues related to Medicare reimbursement for clinical laboratory services under the Clinical Laboratory Fee Schedule (CLFS), specifically reforms to address payment cuts resulting from the Protecting Access to Medicare Act (PAMA) of 2014. Issues related to Medicare coverage and reimbursement for FDA-designated breakthrough medical devices, focusing on establishing a transitional coverage period, including H.R. 5343/S. 1717- Ensuring Patient Access to Critical Breakthrough Products Act of 2025.