Billy Wynne

CMS MA and Part D CY 2024 Advance Notice Estimates 1.03 Increase in Revenue; Implements IRA Part D Benefit Provisions and Proposes Revised Risk Adjustment The Centers for Medicare and Medicaid Services (CMS) announced the Contract Year (CY) 2024 Advance Notice for Medicare Advantage (MA) an Part D (fact sheet). What it is. The Advance…

Agency Releases Reports on COVID-19 Vaccination Programs The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released two reports on COVID-19 vaccination program efforts. The first report highlights early challenges and areas for improvement within programs, and the second report discusses challenges with federal vaccination data for state and local…

MEDCAC Will Meet to Refine CED Criteria February 13-14, Materials Available Now On February 13th and 14th, 2023 the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) will meet to examine the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED). The meeting was originally scheduled to take place in…

Senators Reintroduce Legislation Aimed at PBM Transparency Sens. Chuck Grassley (R-IA) and Maria Cantwell (D-WA) reintroduced legislation aimed at increased transparency of pharmacy benefit managers (PBMs). Additional details on each bill follows: The Pharmacy Benefit Manager Transparency Act (summary) – The bill features the following provisions: Pricing Practices: Prohibits PBMs from engaging in spread pricing,…

Draft Guidance Issued on Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products The Food and Drug Administration (FDA) issued draft guidance on recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of Human Immunodeficiency Virus (HIV) transmission by…

New Requirements for Unwinding from COVID-19 PHE for State Medicaid and CHIP Programs The Centers for Medicare and Medicaid Services (CMS) issued guidance outlining new requirements for state Medicaid and CHIP programs in Consolidated Appropriations Act of 2023 (CAA, P.L. 117-328)  regarding the unwinding of continuous coverage requirements and conditions for receipt of the temporary…

Temporary Final Guidance Issued to Allow for the Compounding of Ibuprofen Oral Suspension Products to Address Shortages The Food and Drug Administration (FDA) issued immediately in effect final guidance on compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems. The agency details that the FDA has received reports…

Guidance Issued on How IRA Inflation Rebates and Maximum Fair Price Impact Medicaid AMP and Best Price The Center for Medicaid and CHIP Services (CMCS) issued manufacturer guidance that addresses the impact of certain changes on pricing metrics for drug manufacturer covered outpatient drugs (CODs) required to be reported under the Medicaid Drug Rebate Program…

FNS Announces $25 Million for Electronic Healthy Incentives in SNAP The Department of Agriculture (USDA) Food and Nutrition Service (FNS) announced $25 million in funding for Supplemental Nutrition Assistance Program (SNAP) healthy incentive initiatives. FNS will select up to three states to receive funding and support to run an Electronic Healthy Incentives Pilot (eHIP) for…

Report Finds HHS Oversight Shortcomings with Research Involving Potential Pandemic Pathogens The Government Accountability Office (GAO) released a report on public health preparedness finding that the Department of Health and Human Services (HHS) needs to improve oversight of research involving potential pandemic pathogens to ensure the safety of conducting such research. HHS oversees high-risk research…