The Advocate
July 2025: Volume 5, Issue 7
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In This Issue:
Final F&A Reimbursement Model Restructures Research Funding
President Trump Signs Reconciliation Package into Law
In Brief: Policy Updates
Around the Field
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ASGCT Advocacy
Final F&A Reimbursement Model Restructures Research Funding
In response to the proposed caps on indirect cost rate reimbursements through NIH, the Joint Associations Group (JAG) on Indirect Costs has released two draft “Fiscal Accountability in Research” (FAIR) models as potential successors to the current F&A system. Stakeholders were invited to test the models and submit feedback.
The final model was presented at a town hall on July 15. The hybrid model restructures research funding by creating three distinct cost categories: Research Performance Costs (formerly direct costs), Essential Research Performance Support (project-linkable costs previously buried in indirect expenses), and General Research Operations (institution-wide infrastructure that can't be allocated to specific projects). This approach aims to eliminate the current negotiation system between institutions and the federal government while ensuring that overhead rates would vary based on the actual type of research being conducted at each institution, using established tools like recharge centers and space surveys to map specific research requirements to facilities and services.
President Trump Signs Reconciliation Package into Law
President Trump signed an FY25 reconciliation package into law on July 4, which included significant changes to US health policy. The legislation, which narrowly passed the Senate and House in recent weeks, cuts more than $1 trillion from federal health programs over the next decade while extending 2017 tax cuts.
The bill implements a number of changes to Medicaid:
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Work Requirements: Adults under 65 (including parents of children older than 14) must work, volunteer, or attend school at least 80 hours per month to maintain coverage, beginning December 2026.
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Eligibility Verification: States must check enrollees' eligibility every six months instead of annually starting in 2027.
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Cost-Sharing: Beneficiaries with incomes above the poverty line must pay co-pays up to 5% of their annual income.
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Provider Tax Limits: Freezes provider taxes in non-expansion states and gradually reduces allowed rates in states that expanded Medicaid through the Affordable Care Act. This represents a shift in how states can draw down federal Medicaid dollars without increasing state spending.
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Federal Medical Assistance Percentage Changes: Modifies federal Medicaid matching rates and restricts state-directed payments. In particular, it limits the ability of states to use supplemental payments (like directed payments to hospitals and managed care plans) as a mechanism to draw down enhanced federal funds. ASGCT has previously advocated for increased FMAP rates to help state budgets accommodate CGTs with high upfront costs.
According to the Congressional Budget Office, nearly 12 million Americans will lose insurance by 2034. A $50 billion rural healthcare relief fund was included to offset the law’s impact on rural hospitals. ASGCT advocates for robust Medicaid funding to ensure that patients eligible for CGTs maintain access to these innovative treatments.
In Brief: Policy Updates
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FDA Industry Listening Tour: FDA launched a national listening tour to engage directly with pharmaceutical and biotech industry leaders. Four meetings have been held to date; FDA Commissioner Makary and CBER Director Prasad discussed takeaways from the first roundtable on their FDA Direct podcast.
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FDA Leadership Vision: Commissioner Makary and CBER Director Prasad outlined their priorities for a “new FDA,” calling for faster drug approvals and greater use of AI and big data in regulatory science. They emphasized that they envision shifting FDA to be more proactive, transparent, and health-focused.
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New Pathways at FDA: FDA Commissioner Makary announced the agency is exploring new pathways and pilot programs to accelerate drug development, with plans to release details in the near future. He advocated for the use of real-world data and synthetic controls beyond traditional randomized controlled trials.
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FDA Post-marketing Data: FDA released its FY23 annual report on the performance of drug and biologics firms in meeting post-marketing requirements and commitments. The report details the status of required and agreed-upon post-approval studies, including compliance with reporting timelines and fulfillment of study obligations.
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CMMI Strategic Plan: The Centers for Medicare & Medicaid Services (CMS) Innovation Center (CMMI) has released a new 2025 strategic plan. CMMI oversees health care pilots including the CGT Access Model.