Making Health Benefits Meaningful and Accessible Across a Dispersed Workforce Presented by Imagine360

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Featured Story   Moderna Hits Another Obstacle for mRNA Vaccines No FDA love letter for Moderna Valentine's Day is this weekend, but the FDA is showing no love for Moderna. The FDA refused to review mRNA-1010, Moderna's mRNA vaccine for seasonal influenza, telling the company the submission was not based on an adequate and well-controlled clinical trial. The refuse-to-file letter, signed by Vinayak Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), said the comparator to the investigational vaccine did not reflect the best available standard of care — without specifying what that standard is. The trial Moderna evaluated mRNA-1010 in two Phase 3 studies that enrolled more than 43,000 participants. The trial designs were reviewed and cleared by the FDA. The comparator was GSK's standard-dose flu vaccine, Fluarix. The FDA had also recommended a high-dose comparator vaccine for older adults. One of the Phase 3 studies included a cohort of participants age 65 and older. In this group, mRNA-1010 was compared to Sanofi's Fluzone, a high-dose influenza vaccine. Moderna contends the FDA refusal letter contradicts the agency's prior guidance. Why this matters Vaccine companies have had a tough time with the Trump administration, challenges that are particularly pronounced for developers of mRNA vaccines. The FDA revised its stance on Covid-19 vaccines, recommending them only for older adults and at-risk groups, which effectively shrank the market for Moderna's approved Covid shot. The Department of Health and Human Services also terminated Moderna's federal contract to develop an mRNA vaccinefor avian influenza. This means growth for Moderna must come from other products. The influenza vaccine is a key piece of that strategy. The FDA refusal letter casts doubt on the future of this vaccine as well as a Covid-19/influenza combination shot that Moderna is also developing. Soundbite "CBER does not consider the application to contain a trial 'adequate and well controlled' and the application is therefore, on its face, inadequate for review," Prasad wrote in the letter dated Feb. 3. "This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study. I note that this determination is consistent with FDA's advice given to you prior to your study." —By Frank Vinluan Sponsored   Making Health Benefits Meaningful and Accessible Across a Dispersed Workforce Presented by Imagine360 In this candid conversation, Jamie Benton of Rollins Inc, shares what made the shift possible, how the company navigated risk and why cost savings were only the beginning of their alternative health plan journey.  Read the full interview. Top Stories   Why Mount Sinai Chose Microsoft Over Abridge and Suki Inside the deployment Mount Sinai Health System began rolling out Microsoft's ambient listening technology, called Dragon Copilot, in November. The tool listens to clinician-patient conversations during visits and automatically generates clinical notes, which doctors can quickly review, edit and sign off on in the EHR. The deployment is happening in phases, with roughly 500 doctors using the tool today. Mount Sinai's goal is for 1,500 users to be onboarded by the spring, said Robbie Freeman, the health system's chief digital transformation officer. He noted that other members of the clinical care team, not just doctors, will receive access to the tool as part of the rollout, such as nurse practitioners, physician assistants and pharmacists. Head-to-head battle Before choosing Microsoft, Mount Sinai evaluated the company alongside Abridge and Suki, two other vendors in the crowded ambient scribe space, running short pilots and gathering feedback via qualitative surveys given to the clinicians who tested the tools. "At the time, Suki was in a different place technically, and so we weren't actually able to launch a full-fledged pilot. They've come a long way since, but our timing was such that it didn't align. And Microsoft and Abridge were relatively close," said Lisa Stump, Mount Sinai's chief digital information officer. Mount Sinai then had to make a business decision based on contractual terms and shared partnership goals, and Microsoft ended up edging out Abridge, Stump explained. Epic's announcement could change everything, though Stump noted that Mount Sinai has been "totally transparent" with Microsoft that their partnership may change given Epic's launch of a built-in AI charting tool earlier this month. "We will evaluate the Epic solution. They are our partner in the platform as well. We think the market will continue to evolve, and we'll evaluate those options, but we're incredibly grateful for all of the partnership and the innovation that got the entire market to the place that it is," she declared. — By Katie Adams Medicare Advantage's Discipline Era — and Why the Final Rate Notice Matters More Than It Appears More than technical fine print When the Centers for Medicare & Medicaid Services released its recent Advance Notice suggesting Medicare Advantage revenues may remain largely flat heading into 2027, many outside the industry viewed it as technical fine print. But within the system, it was understood as a turning point. In real terms, flat funding in the current environment is not neutral. It represents a contraction in the resources available to deliver coordinated, high-quality care. As the program becomes the dominant form of Medicare coverage, greater fiscal discipline is inevitable and appropriate. Growth alone can no longer mask inefficiency. Operational rigor must replace momentum. The pace of adjustment matters These changes reshape how members experience care. Access becomes slightly harder. Choices slightly narrower. Friction slightly higher. That is what financial pressure looks like — not sudden cuts, but a steady recalibration that beneficiaries feel long before policymakers do. It emerges gradually through narrower networks, tighter utilization management, and quieter reductions in supplemental benefits such as dental, vision, transportation, and in-home supports. Each step may seem modest in isolation. But together, they reshape access and experience for millions of seniors. Provider relationships will tighten as well. With less financial headroom, routine rate increases become harder to absorb, intensifying negotiations around risk sharing and performance expectations. Some provider groups may narrow participation or exit Medicare Advantage altogether, potentially reducing continuity and choice in certain markets. A balancing act Well-calibrated rates help preserve beneficiary access, maintain provider participation, and sustain investments that prevent hospitalizations, manage chronic disease, and improve outcomes. Under-calibration risks accelerating the quiet erosion of benefits and networks in ways that ultimately undermine the value Medicare Advantage was created to deliver. The challenge for policymakers is balance: encouraging rigor without unintentionally weakening a program that now serves the majority of Medicare beneficiaries. Regardless of the final number, Medicare Advantage has entered its discipline era. Growth will no longer compensate for inefficiency. Leaders will be defined by their ability to deliver better outcomes at sustainable cost. But thoughtful rate calibration can determine whether this transition strengthens the program — or strains it unnecessarily. —By Sachin H. Jain Video   Video: Doomed to deskilled dumb docs? Want to know more about deskilling? Read what a Lancet study found.

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