Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010….
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with guidance given prior to the start of Phase 3 testing. The post Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance appeared…
This data note analyzes the extent to which hospital spending has contributed to the growth in national health expenditures in recent years and over the long term using data from the Centers for Medicare & Medicaid Services (CMS) National Health Expenditures Accounts (NHEA).
The Medicare drug price negotiation program could improve coverage of drugs selected for negotiation for Medicare beneficiaries because the law requires all Medicare Part D plans to cover each of the selected drugs, including all dosages and forms, when negotiated prices take effect. This analysis examines 2026 Medicare Part D formulary coverage of drugs selected…
AI can help health plans reduce friction, speed revenue-cycle throughput, and improve member experience, but only when it is deployed with strong data discipline, modern integration patterns, and a governance model that treats AI as “augmented intelligence,” meaning powerful, assistive, and accountable. The post From Claims Payer to Care Partner: What AI Really Changes in…
[Sponsored] Patient care improves when people get accurate test results from an excellent diagnostic company. The post This Diagnostic Company Is Rapidly Expanding in Emerging Markets: What to Know appeared first on MedCity News.
Healthcare cannot achieve its goals for quality, equity, and value without breaking down the persistent barriers that keep critical information siloed across sectors. The post The Next Frontier of Interoperability: Additional Clinical Data Sources – Dentistry, Devices, Social Care, and More appeared first on MedCity News.
The challenge for policymakers is balance: encouraging rigor without unintentionally weakening a program that now serves the majority of Medicare beneficiaries. Thoughtful rate calibration can determine whether this transition strengthens the program or strains it unnecessarily. The post Medicare Advantage’s Discipline Era — and Why the Final Rate Notice Matters More Than It Appears appeared…
Leonard Bighorn said his mother tried for two years to get help for severe stomach pain through the limited health services available near her home on the Fort Peck Reservation in northeastern Montana. After his mom finally saw a specialist in Glasgow, about an hour away, she was diagnosed with stage 4 colon cancer, Bighorn…
Lori Kelley’s deteriorating vision has made it hard for her to find steady work. The 59-year-old, who lives in Harrisburg, North Carolina, closed her nonprofit circus arts school last year because she could no longer see well enough to complete paperwork. She then worked making dough at a pizza shop for a bit. Currently, she…
By JEFF BRANDES To say healthcare’s safety net experienced tectonic shifts in 2025 would be an understatement. The rapid introduction of multiple and massive policy shifts left many healthcare leaders reeling with more questions than answers. As the industry turns the corner into 2026 and the dust begins to settle, it’s time for stakeholders to…