In this edition of AcademyHealth’s Situation Report, we spotlight an opportunity to share how recent federal statistical data cuts are affecting research and policy, alongside growing payer participation in CMMI’s ACCESS model for chronic care despite raising concerns about viability and questions about how payment design can shape the adoption of digital health tools. We also examine proposals to modernize the FDA, shifting vaccine review pathways, and the expanding use of AI in insurance decision-making. Read on for key developments and opportunities to engage.
The Situation Report is now on Substack! We’ll be transitioning over to Substack fully starting in March. Subscribe here:
In today’s issue:
Action Opportunity: Share How Changes to Federal Statistical Data Has Impacted Your Work
Payers Align with CMMI’s ACCESS Model as Questions Emerge About Viability
GOP Senator Unveils Proposal for FDA Overhaul
FDA Reverses Course, Will Review Moderna Vaccines
Insurers Utilize AI for Fraud Detection Raising Concerns about Excess Claim Denials
Action Opportunity: Share How Changes to Federal Statistical Data Has Impacted Your Work
The integrity and accessibility of robust, unbiased federal statistical data are foundational to informed governmental and private sector decision making. Recent actions, including the firing of employees at federal statistical agencies and budget cuts to statistical programs, have created gaps in our national data infrastructure, impacting our collective ability to understand pressing societal and economic challenges.
The Emergency Mobilization for Essential Research and Government-Data Equivalents (EMERGE) Initiative aims to explore the feasibility of establishing an independent, non-governmental platform to catalogue, collect, analyze, and disseminate vital household-level statistical information in areas critically impacted by these actions. The EMERGE initiative is asking people to take a survey to capture how these changes have impacted a wide range of users of public data.
The results will be anonymous and you can take the survey here.
Payers Align with CMMI’s ACCESS Model as Questions Emerge About Viability
Major commercial payers, including Blue Cross affiliates, Centene, Cigna, CVS Health, Humana, Guidewell, Devoted Health, Horizon, and UnitedHealthcare, have signed a pledge to join the Center for Medicare & Medicaid Innovation’s (CMMI) ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) model, signaling broad interest in scaling tech-enabled chronic care beyond Medicare. If implemented as planned, the model could reach up to 165 million commercially and publicly insured people by 2028, extending outcome‑aligned payments for tools like telehealth software, wearables, and behavioral health apps across Medicare Advantage, Medicaid, and commercial markets.
As CMS prepares reference materials and standardized billing codes to support multi-payer participation, early reaction from industry analysts raises concerns about whether the program’s payment rates are sufficient to sustain clinical involvement. Since ACCESS prohibits participating providers from billing Medicare fee-for-service for enrolled patients, traditional clinical practices may find the model financially impractical, while tech-heavy or AI-enabled vendors could be better positioned for participation. Several experts noted that the ACCESS payment amounts fall far below current reimbursement for remote monitoring and chronic care management, shifting the incentive structure toward lower-cost, highly automated solutions.
ACCESS introduces important questions about how payment design shapes the adoption of digital health tools, whether outcome-aligned payments improve chronic disease management across diverse populations, and how AI-driven efficiencies may influence care quality and provider roles. As implementation details evolve and payers commit to participation across markets, evaluation will be critical to understanding whether ACCESS advances high-quality chronic care or primarily incentivizes low-cost digital interventions.
GOP Senator Unveils Proposal for FDA Overhaul
This week, chair of the Senate Committee on Health, Education, Labor, and Pensions Bill Cassidy (R-La.) unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on the agency to reform some of its practices and embrace innovations to get more products approved for patients. Senator Cassidy’s report calls for “novel clinical trial approaches” and the incorporation of artificial intelligence in the pharmaceutical review process to speed up the approval of new drugs.
Senator Cassidy’s report cites the “reviewer lottery” system as a bottleneck for pharmaceutical companies trying to get their products approved by the FDA, and how this can impact drug treatment of rare diseases by adding additional time and obstacles to approval. He also scrutinizes the FDA’s apparent lack of oversight when it comes to reviewing the safety of food ingredients, noting that food manufacturers do not need FDA review of food ingredients if they are Generally Recognized as Safe (GRAS).
Senator Cassidy, a physician, has recently been at odds with Health Secretary Kennedy, particularly regarding Kennedy’s claim that ties Tylenol usage to autism, and the disbanding of the Advisory Committee on Immunization Practices (ACIP) last year. This could prevent buy-in from HHS, despite Kennedy’s strong criticism of the current GRAS review system. Health services researchers should assess how the usage of AI and other modern technologies affects biomedical innovation, and ultimately the access and efficacy of drugs for patients.
FDA Reverses Course, Will Review Moderna Vaccine
The U.S. Food and Drug Administration agreed to review Moderna’s application for a new mRNA influenza vaccine for adults aged 50 and older after initially declining to do so because of concerns about the clinical trial design. In its earlier refuse to file letter, the agency questioned whether the study met standards for an adequate and well controlled trial, particularly regarding the comparator vaccine used. The decision sparked industry backlash and raised concerns about regulatory consistency. Following discussions between FDA officials and Moderna, the agency will now proceed with review using the regular approval pathway for adults aged 50 to 64 and accelerated approval for adults 65 and older, with a required post marketing study and a target action date of August 5.
For health services researchers, this development is less about a single vaccine and more about how regulatory decisions shape the broader evidence and policy environment. When standards for trial design or acceptable comparators shift, it affects how evidence is generated, interpreted, and translated into practice. Approval pathways that rely on post marketing studies increase the importance of real-world evidence, implementation research, and ongoing evaluation of safety, effectiveness, uptake, and equity in diverse populations.
It also signals that regulatory predictability cannot be taken for granted. Uncertainty at the federal oversight level can influence research investment, partnership decisions, and the pace of innovation entering the delivery system. For the field, this moment reinforces the need to study how regulatory governance affects access, trust in public institutions, health system performance, and disparities. Health services researchers are uniquely positioned to assess not just whether a product is approved, but how it is implemented, who benefits, and whether it ultimately improves population health.
Insurers Utilize AI for Fraud Detection Raising Concerns about Excess Claim Denials
The nation’s largest health insurance providers are turning to AI to cut expenses amid increasing medical costs. The rapid uptake of this technology aims to speed up decision-making and cut through bureaucracy but its utilization in pivotal medical decisions, especially claim denials, raises concerns about how to monitor and oversee AI models whose conclusions will impact the health, care delivery, and financial well-being of patients. Insurance companies also don’t have to be transparent about their use of AI and the Trump administration has largely been against regulating AI while integrating the technology into federal agencies and Medicare. Providers have also been rolling out AI for clinical documentation and billing so it’s important for insurers and providers operate in tandem with each other to avoid delays and denials in care especially if the AI makes errors when denying claims and prior authorizations. This also decreases distrust among providers, insurers, and patients. Given the role of health services research in improving health and health care as well as care delivery, it’s important that this isn’t viewed as an administrative change but a change that will influence coverage and care decisions that may disproportionately impact marginalized populations.
These denials of care will have real impact on patients and increase the burden on providers to appeal these claims. As AI is being deployed to detect fraud, there is concern that consumers will be harm because it will over-deny legitimate care delivery and make it harder for providers to serve patients.
Health services researchers should educate policymakers on the importance of regulating AI use within health care to ensure adequate human oversight of the technology especially as they have financial, health, and other consequences for patients. As AI becomes embedded in payment and coverage decisions, health services researchers are uniquely positioned to ensure that innovation advances value and efficiency without undermining patient access, provider sustainability, or public trust.
Previous Editions
This is the latest in a series of Situation Report updates from AcademyHealth. You can find prior issues here.
We’re pleased to offer this work as a free resource, and if you’d like to support our efforts to keep it going, we’d truly appreciate your donation. You can contribute here. Thank you for your support!