Staff Contact: Daniel Landon or Andrew Wheeler
The Centers for Medicare & Medicaid Services proposes to reverse a regulatory change designed to provide expedited Medicare payment for “breakthrough” medical devices offering potential lifesaving effects. The original Trump administration regulatory change was finalized Jan. 14, 2021, but its effective date subsequently was delayed until Dec. 15. CMS decided that the original proposal “may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment for the Medicare patients that have the particular disease or condition that the device is intended to treat or diagnose.” MHA published an issue brief on the proposed repeal.