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.

Mar 20, 2023 | lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |Catherine Y. Starks |Trevor L. Wear | +2 more

On March 15, the Centers for Medicare and Medicaid Services (CMS) made a series of important announcements regarding implementation of the Inflation Reduction Act (IRA). Most crucially, CMS issued new initial guidance on implementation of the Medicare Drug Price Negotiation Program (Medicare Drug Price Program), with public comments due April 14, 2023. Notably, CMS did not issue the initial guidance through notice and comment rulemaking.

Feb 23, 2023 | lexology.com | Elizabeth Hardcastle |Meenakshi Datta |Stephanie P. Hales |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +2 more

On February 14, the U.S. Department of Health and Human Services (HHS)  that the HHS Secretary had selected three new payment and service delivery models for testing by the Center for Medicare & Medicaid Innovation (CMS Innovation Center). HHS has directed the CMS Innovation Center to test whether these new models result in lower prescription drug costs, promote accessibility to therapies, and/or improve quality of care.