Elizabeth Hardcastle

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.

Feb 14, 2023 | lexology.com | Meenakshi Datta |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear |Elizabeth Hardcastle |Catherine Y. Starks

The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) has issued a Technical Assistance Brief (the Brief) identifying anticipated challenges the Centers for Medicare & Medicaid Services (CMS) will face in implementing the inflation-indexed rebates for Medicare Part B drugs under the Inflation Reduction Act (IRA). The Brief builds on findings from prior evaluations by HHS-OIG of potential Part B drug rebates.