Billy Wynne

FNS Releases Proposed Rule to Align School Meal Nutrition Standards With Dietary Guidelines; Announces $100 Million Investment In Healthy Meals The US Department of Agriculture (USDA) Food and Nutrition Service (FNS) released a proposed rule to update school meal standards to align with the Dietary Guidelines for Americans, 2020-2025 (rule; press release). The rule will…

Early Results of the Research to Accelerate Cures and Equity for Children (RACE) Act Show Increased Research But Unclear Impact The Government Accountability Office (GAO) released a report on the early results of the Research to Accelerate Cures and Equity for Children (RACE) Act. The RACE Act was included in the Food and Drug Administration…

Agency Finds That MA Plans Generally Offer Supplemental Benefits But CMS Has Limited Data on Utilization The Government Accountability Office (GAO) released a report on supplemental benefits offered by Medicare Advantage (MA) plans. About 49 percent of Medicare enrollees are enrolled in private MA plans which have the flexibility to offer additional or supplemental benefits…

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…