Billy Wynne

Draft Guidance Issued on Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products The Food and Drug Administration (FDA) issued draft guidance on recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of Human Immunodeficiency Virus (HIV)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

Commissioners Approve Recommendations to Allow States to Restrict Drug Coverage Based on Medicare Coverage with Evidence Development Decisions The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session to review its draft chapter on Medicaid coverage based on Medicare National Coverage Determinations (NCDs) and draft recommendations. Principal Policy Analyst Chris Park presented revised…

Commission Begins Work Examining the Role of External Quality Reviews for Managed Care The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session on the role of external quality review (EQR) in managed care oversight and accountability. This builds on the Commission’s work on managed care oversight, including rate setting, risk mitigation, and…

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…

Commissioners Continue to Debate Potential Part B Drug Spending Recommendations The Medicare Payment Advisory Commission (MedPAC) convened a session to discuss ways to lower Medicare spending on Part B drugs. Staff presented three sets of policy options to Commissioners that addressed spending incentives, including: (1) first-in-class drugs and ways to cap payment rates for high-cost…

Commission Responds to Senate RFI on Dual Eligibles The Medicaid and CHIP Payment and Access Commission (MACPAC) released its response to a Senate request for information (RFI) on recommendations to improve care for individuals who are dually eligible for Medicare and Medicaid. Highlights from the response are included below: Requiring State Strategies to Integrate Care…