Health Care Matters | September 12
MAHA Strategy Report Advances Drug Repurposing Initiative
The Trump administration released its Make America Healthy Again (MAHA) strategy report this week, detailing proposed changes to address chronic disease in children. Among the initiatives, the report calls for NIH and FDA to jointly investigate opportunities to accelerate approvals for repurposed older drugs in treating chronic diseases through harmonized regulatory pathways and collaborative clinical trial designs. The strategy also proposes a Real World Data Platform linking multiple datasets (claims, EHRs, wearables) for chronic disease research, while targeting childhood medication patterns, particularly ADHD prescriptions, and establishing new vaccine safety frameworks.
The report avoids the more aggressive regulatory changes some industry groups feared, steering clear of pesticide restrictions while focusing on research and process modifications. Despite criticism from some MAHA allies that it's too industry-friendly, the document outlines the administration's health reform priorities, including a new Administration for Healthy America within HHS and increased AI integration in healthcare delivery. Read more here, here, and here.
Why It Matters
While the strategy remains a policy framework without dedicated funding or immediate regulatory mandates, it sets direction for Agency action.
The drug repurposing language signals that this administration has specific interest in generic drug repurposing as a priority within the MAHA initiative which is a positive development for potential future momentum. This aligns with growing recognition that repurposing older drugs could address chronic diseases without the massive costs and lengthy timelines of new drug development. While this work could potentially align with existing policy proposals from institutions like the Duke-Margolis Institute for Health Policy and the University of Chicago, that connection isn't clear from this source.
The report’s proposal to create an integrated Real World Data Platform that would link claims, electronic health records, and wearable device data represents an ambitious effort to modernize chronic disease research and policy evaluation. Targeting childhood medication patterns, particularly ADHD prescriptions, and establishing updated vaccine safety frameworks highlight areas of key interest for the administration.
Spring 2025 Unified Agenda Prioritizes No Surprises Act Updates
The Trump administration released its Spring 2025 Unified Agenda last week, outlining the regulatory roadmap for the coming year. Notable among the planned regulations are critical updates to No Surprises Act (NSA) implementation. Enacted in December 2020 as part of the Consolidated Appropriations Act of 2021, the NSA established new patient protections against surprise medical billing for those with private insurance, taking effect in early 2022. The Unified Agenda highlights two pivotal NSA regulations:
Independent Dispute Resolution (IDR) Operations Final Rule (November 2025): This final rule will streamline the IDR process, revise fee structures, and establish new requirements for dispute batching procedures.
Requirements Related to Advanced Explanation of Benefits and Other Provisions Proposed Rule (April 2026): This proposed rule will advance patient cost transparency by requiring insurers to provide beneficiaries with estimated costs for scheduled services prior to treatment.
Read here.
Why It Matters
The health care industry has been waiting nearly two years for the IDR Operations Final Rule since CMS released the proposed version in late 2023. The agency's IDR framework has faced significant legal turbulence, with medical associations successfully challenging core provisions including qualified payment amount calculation methods, administrative fee increases, and dispute batching protocols. Federal courts have repeatedly found these regulations violated the Administrative Procedure Act, forcing CMS to suspend IDR decisions and creating substantial backlogs in an already strained system.
With mounting pressure from Congress and healthcare stakeholders demanding effective implementation, CMS faces a critical moment to deliver a legally sound and operationally viable final rule. The stakes are high and successful implementation will determine whether the NSA achieves its promise of protecting patients from surprise billing while maintaining a functional dispute resolution mechanism for providers and insurers.
Ongoing Scrutiny of the WISeR Model
The Trump administration's Wasteful and Inappropriate Service Reduction (WISeR) model has faced intense criticism following a prominent New York Times article that highlighted concerns about bringing private insurer tactics to traditional Medicare. The program, which will use AI algorithms to determine prior authorization for certain procedures in six states starting January 2026, has drawn sharp opposition from House Democrats who worry that AI-driven decisions could result in denials of life-saving care. Critics worry about the financial incentives built into the model, where private companies receive a share of savings from claim denials, creating what opponents call a "bounty hunter" system. However, defenders including the influential right-leaning Paragon Health Institute argue the program targets documented abuse in specific services like skin substitutes, where spending grew 4,000 percent to $10 billion in 2024, and includes safeguards such as payment reductions for companies with excessive appeals. Read more here, here, and here.
Why It Matters
This pilot represents a fundamental shift that could establish precedent for expanding AI-driven prior authorization throughout Medicare's 65 million beneficiaries. If successful at saving money, the program may expand beyond current targeted procedures to more essential services, potentially transforming the entire Medicare system. Despite strong opposition from MedPAC commissioners and Democratic lawmakers, the Trump administration appears committed to implementation, backed by conservative policy groups and some physician organizations. The program's success or failure over its six-year timeline will likely determine whether AI-driven authorization becomes standard across Medicare, fundamentally altering how the federal insurance program operates.
What We Are Reading
Regulatory Outlook for MA
This Regs & Eggs blog post analyzes the pending second CMS final rule for Medicare Advantage that's expected to address remaining provisions from a 2024 proposed rule, including controversial utilization management reforms, supplemental benefits restrictions, and medical loss ratio changes that could significantly impact MA plans starting in 2026. Read here.
Patient Experience Dossiers: Connecting Decision Makers With Patient-Centered Evidence
This Health Affairs Forefront article proposes "Patient Experience Dossiers" as a standardized template to help patient organizations consolidate and communicate patient-centered evidence more effectively to decision-makers across government agencies, payers, and manufacturers who increasingly rely on patient experience data for therapy development, approval, and coverage decisions. Read here.
A Rare Opportunity for Rural Health Transformation
Hopscotch Primary Care published a blog post describing the Rural Health Transformation Program's $50 billion in federal funding over five years as a "generational opportunity" for states to move beyond traditional patch-up approaches and invest in technology-enabled care expansion, workforce development, and sustainable care models to address rural America's healthcare crisis. Read here.
HCCI Research on Site Neutral Services
The Health Care Cost Institute published a report analyzing 57 site-neutral services and found that hospital outpatient departments consistently charge 1.27 to 13.5 times more than physician offices for identical services among employer-sponsored insurance patients from 2018-2022, with the price differentials affecting patient out-of-pocket costs and overall healthcare spending. Read here.
Pop Health Podcast
Navigating Drug Pricing, Policy, and Access
In this episode, Coral’s Founder Meg Koepke talks with Alison Falb about her journey from CMS to FDA to Coral. We explore current policy trends and challenges in Life Sciences – what they mean for organizations navigating drug pricing reforms, coverage, and access challenges.