OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

By Carol Poindexter (US) and Savannah Wiseman (US) on February 5, 2019 Posted in Regulatory

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Centers for Medicare & Medicaid Services finalizes policies and updates to Medicare Advantage and Part D programs for 2019

By Jeff Wurzburg (US) on April 10, 2018 Posted in Regulatory

On April 2, 2018, CMS released the 2019 Rate Announcement and Final Call Letter (Call Letter) and published an expansive final rule containing updates to policies for Medicare Advantage (MA) and the Medicare Part D Prescription Drug Program (Part D). A Health Law Pulse summary of the proposed Annual Notice and Draft Call Letter may … Continue reading

Centers for Medicare & Medicaid Services proposes policies and updates to Medicare Advantage and Part D programs for 2019

By Jeff Wurzburg (US) on February 6, 2018 Posted in Regulatory

On February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the Medicare Advantage and Part D programs through the Advance Notice and Draft Call Letter (Advance Notice) for calendar year 2019. As required by section 1853(b) of the Social Security Act, CMS publishes annually the Advance Notice at least 60 … Continue reading