“The Medicare trust fund cannot become a blank check for any drug or device manufacturer granted authorization by the FDA,” write authors of a Viewpoint article on unproven therapies. “Medicare’s survival and public health demand that officials distinguish between better and worse therapies when determining reimbursement.”
“Two bills in Congress would make it harder for the Centers for Medicare & Medicaid Services (CMS) to limit coverage of FDA-regulated products under Medicare Part B,” the authors write. “The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (HR 1691) would reinstate a rule finalized in 2021 during the Trump administration mandating 4 years of Medicare coverage of all medical devices designated as ‘breakthrough’ by the FDA.… The Access to Innovative Treatments Act of 2023 (HR 2408), would create a process for second-guessing CMS coverage decisions for new drugs when the conditions for CMS coverage do not mirror FDA’s approved indications.” These bills “are a step in the wrong direction,” the group concludes.