Manufacturers of innovative medical devices are on pins and needles right now. That is because the Centers for Medicare and Medicaid Services (CMS) delayed implementation of a final rule that was supposed to take effect on March 15, 2021 that would have ensured at least four years of Medicare coverage for new medical products cleared by the Food and Drug Administration (FDA) as breakthrough devices under Section 510(k). Unlike many Trump administration regulations, the breakthrough device coverage rule may still come to fruition. But CMS is currently studying the rule and will not make a final decision sooner than May 15. Here is a look at the rule and its prospects of actually taking effect. The Final Rule Medicare covers only medical services and products that are “reasonable and necessary.” The Social Security Act (Section 1862((a)(1)(A), to be precise) gives the Department of Health and Human Services (HHS) Secretary authority to determine whether a particular service or product meets the standard. However, HHS has never established a formal regulation to define “reasonable and necessary.” The rule, which was finalized on Jan. 12, creates such a definition, one that would enable breakthrough devices to qualify as reasonable and necessary. Specifically, the […]