Proposal Would Speed Up Approval of 'Breakthrough' Devices to Medicare Patients

According to the Wall Street Journal , Medicare could approve coverage of some "breakthrough" medical devices the same day that FDA green-lights them, under a proposed rule published Sept. 1 in the Federal Register. The Trump administration plan aims to address the nearly year-and-a-half gap between FDA approval and CMS coverage decisions on new medical devices. The president signed an executive order last fall to improve Medicare service, and CMS Administrator Seema Verma said Monday that this proposal "would give seniors immediate access" to novel products targeting life-threatening or irreversibly debilitating diseases or disorders. Coverage approval would coincide with the start date of FDA market authorization and remain in place for 4 years. The rule also probably would expand Medicare reimbursement for breakthrough devices, by changing the criteria that determines whether they are reasonable and necessary to diagnose or treat a medical issue. Public comment on the proposal will be accepted for 60 days.