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Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
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 exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
