Trump Order Would Delay Medicare Drug Price Negotiations for Pill-Based Drugs
President Trump’s April 22 executive order targets the Inflation Reduction Act’s drug pricing rules, proposing a change that would delay Medicare price negotiations for small-molecule drugs. Currently eligible for negotiation nine years after approval, these drugs, typically oral pills, would instead receive a 13-year window, matching the timeline for biologics like vaccines.
Pharmaceutical companies argue this “pill penalty” discourages investment in cheaper, more convenient treatments. Analysts say the change could significantly raise Medicare spending and premiums. KFF estimates that over $60 billion in drug costs from treatments like Eliquis, Jardiance, and Ozempic could be exempt from negotiation if the timeline is extended.
The order also includes provisions on drug importation from Canada and broader regulatory reforms at the FDA, signaling more changes ahead for the pharmaceutical sector.
Key Takeaways: If enacted, the change could raise hospital drug costs and increase pressure on pharmacy budgets. Health systems should evaluate their exposure to high-cost medications, reassess formularies, and track policy developments to anticipate future reimbursement shifts.
Senate Report Urges Transparency Reforms for 340B Drug Discount Program
A new Senate report led by Sen. Bill Cassidy, M.D., R-La., calls for legislative reforms to the 340B Drug Pricing Program, citing a lack of transparency and oversight that may be undermining its original goal of aiding low-income patients.
Launched after a months-long investigation into eight major 340B participants—including hospitals, federally qualified health centers, pharmacies, and drugmakers—the report highlights hundreds of millions of dollars in 340B savings not directly passed to patients. Instead, health systems reported using the funds for operating expenses, capital improvements, and community programs. The report also flagged rising contract pharmacy fees and growing concerns from drugmakers about program integrity.
Cassidy’s team recommended new legislation requiring detailed annual reporting on 340B revenues and usage, tighter definitions for eligible patients, and reforms targeting third-party fees. Hospital and pharmacy groups pushed back, arguing that the report overlooks how 340B savings support broader access to care for underserved populations.
Key Takeaways: If enacted, the proposed changes could significantly increase reporting requirements and financial scrutiny for 340B participants, particularly nonprofit hospitals and contract pharmacies. Health systems should proactively evaluate how they track and document the use of 340B savings in case future compliance audits intensify. With Congress signaling bipartisan interest in 340B reform, health providers should prepare for the possibility of new transparency mandates and greater pressure to show direct patient benefit.
Trump Administration Reverses Mass Termination of International Student Records
The Trump administration is restoring the legal status of thousands of international students whose records were abruptly terminated in recent weeks, a Justice Department attorney said at a federal hearing Friday. The announcement marks a major reversal following widespread outcry over the targeting of students, many of whom were believed to have been flagged for political activism or minor criminal offenses.
Speaking in the Northern District of California, DOJ attorney Elizabeth D. Kurlan said Immigration and Customs Enforcement (ICE) will reactivate terminated SEVIS records while the agency crafts a new policy outlining when student status can be revoked. Going forward, ICE will no longer terminate records solely based on National Crime Information Center findings, which fueled many of the recent terminations. Still, the administration asserted that ICE retains authority to terminate records for violations of immigration law or unlawful activity.
The reversal follows mounting legal pressure, including a federal court decision ordering the reinstatement of an Ohio State University student’s visa. U.S. District Court Judge Tanya Chutkan ruled that the termination of the student’s SEVIS record over an expunged misdemeanor was likely unlawful, calling the government’s actions “arbitrary and capricious.” As part of broader litigation, the administration confirmed that it would reactivate student records nationwide until a new policy framework is finalized. However, immigration experts caution that reinstatement may not fully shield affected students from future risks, as visa revocations and termination notations may still appear on records.
Key Takeaways: Academic medical centers should closely monitor ongoing policy developments, particularly for international students engaged in research, clinical rotations, and academic programs that depend on valid SEVIS records and uninterrupted visa status. While record reinstatements reduce the immediate risk of disruption to education and training, outstanding visa revocations and the lingering presence of termination notations could complicate future visa renewals, residency placements, and employment-based immigration filings. Centers should proactively identify affected students and scholars, engage legal counsel to evaluate immigration risk exposure, and prepare institutional protocols to support continued participation in academic and clinical programs.
RFK Jr. Autism Initiative Sparks Concerns Over Privacy and Scientific Credibility
The NIH is launching a national health data initiative under Health Secretary Robert F. Kennedy Jr. to uncover potential environmental causes of autism. The project aims to compile private health records from pharmacies, insurers, hospitals, and even wearable devices into a centralized research platform. Kennedy has described autism as a preventable disease and pledged to find its root cause within a year, though experts caution the science does not support such claims.
Privacy advocates and scientists have raised alarm over the plan’s scope and messaging. Critics warn that the data collection lacks clear oversight and could violate long-standing norms around health privacy and consent. Disability advocates say the rhetoric surrounding the initiative is stigmatizing and fails to reflect the complex genetic and developmental nature of autism.
Key Takeaways: Health systems may soon face new federal requests for private health data, raising compliance and reputational risks. Organizations should review their data-sharing policies, evaluate participation in federal research initiatives, and prepare to communicate clearly with patients about data use, especially as public trust in health institutions is increasingly at stake.
Supreme Court Poised to Uphold ACA’s Preventive Care Coverage Mandate
The U.S. Supreme Court appears likely to preserve a key provision of the Affordable Care Act that mandates no-cost coverage for preventive services such as HIV prevention, cancer screenings, and heart disease medication. During oral arguments, conservative justices Brett Kavanaugh and Amy Coney Barrett joined the court’s liberal wing in questioning the claim that the volunteer panel recommending coverage must be Senate-confirmed.
The plaintiffs argued that the Preventive Services Task Force wields too much power without Senate approval, but most justices were skeptical. A decision is expected by June. If the mandate is overturned, coverage for millions of Americans could be at risk.
Key Takeaways: Health systems should prepare for continued coverage of preventive services but monitor the ruling closely. A shift in mandate authority could disrupt benefit design and create confusion around cost-sharing for core preventive services. Leaders may want to assess reliance on USPSTF recommendations and coordinate with payers and legal teams on potential plan updates.
Vaccine Experts Launch New Initiative Amid Concerns Over RFK Jr.’s Vaccine Stance
In response to fears that federal vaccine policy could be undermined under HHS Secretary Robert F. Kennedy Jr., leading public health figures have launched the Vaccine Integrity Project. Spearheaded by the University of Minnesota’s Center for Infectious Disease Research and Policy, the initiative aims to protect science-based vaccine guidance and could result in the creation of an independent body to evaluate vaccine data if official sources are compromised.
Led by former FDA Commissioner Margaret Hamburg and former Institute of Medicine President Harvey Fineberg, the project will explore options such as issuing clinical guidelines and flagging gaps in vaccine research. Critics say Kennedy’s rhetoric and policy moves, including suggesting changes to the CDC’s childhood vaccination schedule, could erode public trust and limit access to vaccines through insurance and federal programs.
Key Takeaways: Health systems should prepare for increased confusion around vaccine schedules and reimbursement policies. As federal guidance grows more uncertain, providers may need to rely on external clinical recommendations and reinforce patient education to maintain immunization rates and public trust in vaccines.
On the Horizon
Medicaid Cuts Loom as GOP Reconciliation Bill Takes Shape – On April 11, the House passed the fiscal year 2025 Concurrent Budget Resolution, clearing the way for a reconciliation bill aligned with President Trump’s domestic agenda. The resolution directs the House Energy and Commerce Committee to identify $880 billion in savings from health programs over the next decade, with Medicaid expected to face significant cuts.
While the details remain in development, proposals could include limits on federal funding, work requirements, and stricter eligibility rules. Congress is now in recess until April 28 and will soon reconvene. Health systems should prepare for policy shifts that could affect funding, coverage, and care delivery.
