ARTICLE SUMMARY:
HHS’ latest regulatory agenda points to the prospect of 2020 progress on Anti-Kickback Statute safe harbors, Medicare medtech reforms, and a new FDA proposal on the controversial issue of redefining “intended use,” but bandwidth of agencies to roll out new regulations will need to be balanced against the continuing pandemic response.
Rolling out and updating COVID-19 policies have been dominating the attention of FDA, CMS, and other HHS agencies. But there are some signs—now about six months into the federally declared pandemic emergency—that regulators are finding some more time to make progress on non-pandemic policies. For instance, FDA’s device center issued four guidance documents in a period of three days in mid-July on three specific non-COVID device types and on future plans for device electronic submissions.
Two weeks prior to that, federal agencies including HHS issued the Spring 2020 Unified Agenda. The official (biannual) inventory of every federal department’s regulatory workload came a little more than a month later than it usually does due to COVID-19. But now that it’s out, the agenda offers the best look into what other important, but non-pandemic-emergency policies might get a public airing soon.
