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Draft Guidance Issued on Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products The Food and Drug Administration (FDA) issued draft guidance on recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of Human Immunodeficiency Virus (HIV)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

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…

Draft Guidance Issued on Optimizing Dosages for Oncologic Disease Treatments; Comments Due March 19 The Food and Drug Administration (FDA) issued draft guidance on optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases. The guidance is intended to assist sponsors in identifying the optimal dosage during clinical development…

Actions Aimed at Inappropriate Antipsychotic Use and Increased Transparency in Nursing Homes Announced The Centers for Medicare and Medicaid Services (CMS) announced new actions to reduce the inappropriate use of antipsychotic medications and to increase transparency about nursing home citations. Additional details on each action follows: Reinforcement of Safeguards Against Unnecessary Medications and Treatments –…

Agency Announces $73.4 Million for Substance Use Disorder Grants The Substance Abuse and Mental Health Services Administration (SAMHSA) announced funding opportunities for five grants related to substance misuse and treating substance use disorder(SUD). SAMHSA highlights that 46.3 million people aged twelve or older had a SUD in 2021. Additionally, 94 percent of people aged twelve…

13.2 Million Medicare Beneficiaries will Participate in Accountable Care Arrangements in 2023 The Centers for Medicare & Medicaid Services (CMS) announced today an increase in providers and beneficiaries participating in three leading accountable care programs for 2023. Overall, CMS reported that 700,000 health care providers and organizations will participate in at least one of the…