The draft rules for the Stark and Anti-Kickback statutes (AKS) seem to have excluded makers of devices, but Meena Datta of Sidley Austin told BioWorld MedTech that while these agencies have plenty of reasons to rethink that notion, the final rules are unlikely to emerge in 2020 simply because of the complexity of the undertaking. While the final rules may reverse the drafts’ exclusion of makers of devices and diagnostics, device makers were upbeat at the prospect that they could engage in value-based payment arrangements with providers.

The controversy over paclitaxel (PCT)-associated mortality in devices for the peripheral arteries is far from over, but another medical journal article has punched a hole in the credibility of the paclitaxel theory with the conclusion that the evidence is unequivocal and may be unpersuasive to physicians.

In the Dec. 20, 2019, issue of Science, Stefan Kaufmann, who is the founding director of the Max Planck Institute for Infection Biology, and his colleagues report that the immune system could calibrate its response to Pseudomonas aeruginosa by monitoring the bacterial quorum sensing chatter.