Stephanie P. Hales

Jul 17, 2023 | lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +1 more

In the past two weeks, the Centers for Medicare & Medicaid Services (CMS) unveiled important details regarding implementation of the Medicare Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act (IRA).

Jul 11, 2023 | lexology.com | Stephanie P. Hales |Meenakshi Datta |William A. Sarraille |Trevor L. Wear |Taylor Andelman

On June 22, 2023, the Centers for Medicare and Medicaid Services (CMS) released a Notice With Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be available for certain devices that the Food and Drug Administration (FDA) has designated as Breakthrough Devices. Comments are due by August 28, 2023.