October 30, 2018
On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) announced an Advance Notice of Proposed Rulemaking with Comment (ANPRM) proposing to implement an international pricing index (IPI) model for Medicare Part B drugs and biologicals (IPI Model). Part B drugs and biologicals include many drugs and biologicals administered by physicians in physician offices and hospital outpatient departments. If implemented, the proposed model would make sweeping changes to the drug and biological supply chain for participants, and would pose a variety of expected and unknown implications for drug and biological manufacturers, distributors, group purchasing organizations (GPOs), hospitals and physician clinics, among other industry stakeholders.
CMS is accepting public comments on the ANPRM until December 31, 2018, and is considering issuing a proposed rule in spring 2019. The model would be implemented in spring 2020 and operate for five years. This On the Subject provides a comprehensive list of CMS’s requests for comment at Appendix A.