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.
MALAYSIA – Asian countries, like India, have been struggling to find a middle ground to the effective pricing of drugs and medical devices over the past year and several are looking at health technology assessment (HTA) programs as a solution for this issue in the coming year.
MALAYSIA – Asian countries, like India, have been struggling to find a middle ground to the effective pricing of drugs and medical devices over the past year and several are looking at health technology assessment (HTA) programs as a solution for this issue in the coming year. Boston-headquartered consulting firm Analysis Group Inc. recently looked at how HTA programs in Japan, South Korea and China varied and what could be gleaned from their experiences.
While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip.
