Top News
Republicans Caution Democrats as Funding Talks Deadlock and Shutdown Looms
Lawmakers remain divided on a path forward for government funding negotiations, with just five days remaining before the current continuing resolution (CR) expires. Congressional Democrats and health care advocates are intensifying pressure on Republicans to extend the enhanced Affordable Care Act premium tax credits (APTCs), warning that failure to act would trigger double-digit premium hikes, widespread coverage losses, and significant financial strain on hospitals and providers nationwide. On Sept. 19, House Republicans passed a clean, seven-week stopgap funding package that notably omitted the ACA premium tax credits — the main concession Democrats are seeking as the subsidies are set to expire at the end of this year. The likelihood of a compromise ahead of Sept. 30 further diminished when President Trump canceled a planned meeting with House Minority Leader Hakeem Jeffries (D-NY) and Senate Minority Leader Chuck Schumer (D-NY).
Congress remains in recess until next week, when Senate Majority Leader Thune (R-SD) is expected to begin holding votes on the House funding package. As of now, the only Democrat publicly committed to supporting the CR is Senator Fetterman (D-PA), while the rest of Senate Democrats remain united in pushing for the APTC extension. Advocates warn that insurers are already proposing steep 2026 premium increases, and failure to extend the subsidies could leave millions of Americans uninsured, threaten hospital revenue, and increase uncompensated care nationwide. Despite the mounting urgency, GOP lawmakers and conservative groups continue to resist renewing the credits, setting the stage for a high-stakes standoff over both government funding and health care coverage.
Administrative Action
Trump Administration Targets Drug Prices with Tariffs and Global Benchmark Pilot
The Trump administration is stepping up efforts to reshape U.S. drug pricing with a dual approach of tariffs and a new pricing pilot. President Trump has threatened to impose a 100% tariff on branded or patented drugs unless companies build manufacturing plants in the United States, a move the pharmaceutical industry criticized as unnecessary given that most prescriptions sold domestically are already produced in the country. The tariff threat comes as the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid services (CMS) have submitted details of the long-awaited Global Benchmark for Efficient Drug Pricing (GLOBE) Model to the White House for review, with the president expected to announce the initiative in the coming weeks. The GLOBE Model, tied to Trump’s “most favored nation” (MFN) executive order, would require drugmakers to align U.S. prices with those in other developed countries, with companies facing a Sept. 29 deadline to comply after missing an earlier 30-day voluntary window.
The administration has emphasized enforcement of the MFN policy, directing U.S. trade officials to pressure foreign governments to raise drug prices in an effort to end global “freeloading.” Officials are also considering a digital platform, tentatively called “TrumpRx,” to let patients search for medicines and connect directly with pharmaceutical company portals offering discounted prices, aiming to reduce middleman costs and expand access to lower-cost treatments. Drugmakers have responded by ramping up domestic production and exploring direct-to-patient sales models, though tighter rules on direct-to-consumer advertising have limited some efforts. Companies including Eli Lilly, Pfizer, Merck, AstraZeneca, and GlaxoSmithKline have pledged tens of billions in new U.S. facilities and R&D investments, while some have also raised list prices abroad to comply with the administration’s pricing strategy.
Experts caution that tariffs could raise U.S. drug costs, potentially undercutting the MFN goal, and that legal challenges could arise under recent Supreme Court rulings. Much of the U.S. pharmaceutical supply chain still passes through India and Europe, meaning tariffs could inadvertently reinforce reliance on foreign ingredients rather than reduce it. Despite these complexities, the Trump administration is signaling a renewed push to reshape drug pricing policy, enforce lower prices for Americans, and boost domestic manufacturing, navigating a challenging mix of international trade, legal hurdles, and market dynamics.
AstraZeneca Launches Direct-to-Patient Platform Amid Trump Pressure to Slash Drug Prices
AstraZeneca will launch a new direct-to-patient platform on Oct. 1 offering steep discounts on its asthma and diabetes drugs Airsupra and Farxiga, a move widely seen as a response to escalating pressure from the Trump administration. The launch comes just days before the Sept. 29 deadline for drugmakers to cut prices to “most favored nation” (MFN) levels matching those in other wealthy countries.
Facing threats of 100% tariffs on brand-name products made outside the United States, AstraZeneca has also pledged a $50 billion investment to expand domestic manufacturing. Its new “AstraZeneca Direct” platform will sell select medicines at discounts of up to 70% and offer home delivery, positioning the company to show compliance with administration demands without formally committing to MFN pricing.
The company’s pivot reflects mounting federal and state pressure on drugmakers to lower costs, from Medicare price negotiations and looming tariffs to state affordability boards. AstraZeneca joins a growing list of pharmaceutical companies embracing direct-to-patient sales, as U.S. officials consider launching a national “TrumpRx” portal to connect patients with discounted medicines.
ARPA-H Launches THRIVE Program to Advance Affordable Precision Genetic Medicines
The Advanced Research Projects Agency for Health (ARPA-H) on Sept. 25 announced a new initiative, known as the Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program, to accelerate the development of affordable, one-time precision genetic treatments for both rare and common diseases. THRIVE aims to create integrated platform technologies that deliver single-intervention therapies capable of slowing, reversing, or preventing diseases at the genetic level. The treatments would be provided through existing regional treatment centers and virtual clinics to improve accessibility and reduce costs.
The program will solicit proposals focused on rapid, low-cost development of precision genetic medicines, real-world viability and scaling pilots, and investigational therapies, while excluding gene supplementation and ex vivo approaches. ARPA-H is encouraging public-private partnerships to support the effort, and funding levels will depend on the quality of proposals submitted. Proposal summaries are due Oct. 31, with full proposals due Dec. 19.
Acting ARPA-H Director Jason Roos said the initiative represents a shift toward universal, widely available cures, positioning the United States as a leader in advanced genetic medicine. The launch comes as HHS explores strategies to improve the affordability and accessibility of personalized treatments, including CMS’ cell and gene therapy access model and FDA’s advanced manufacturing technology program, both aimed at scaling production and payment models for next-generation therapies.
US Hikes H-1B Visa Fees And Moves to Weighted Selection
On Friday September 19th, President Trump issued a proclamation requiring all new H-1B visas that are furnished from September 21st, 2025 through September 21st, 2026 to be accompanied or supplemented by a payment of $100,000. H-1B visas are a type of temporary visa that allows employers to petition for “highly educated” foreign professionals to legally work in “specialty occupations” in the United States for 3-6 years, including medical residents and physicians referred to as international medical graduates. In 2023, 8,200 H-1B visas were approved to international medical graduates working in general medicine and surgical hospitals.
In the proclamation, President Trump claims the program has been abused to artificially suppress wages, prevent American college graduates from finding employment, and fire American employees. He stated that H-1B visas ultimately undermine the nation’s economic and national security, especially at information technology (IT) firms. The increased application costs are intended to disincentivize abusive practices and encourage domestic companies to hire American workers. However, experts warn that domestic shortages in medical practitioners are likely to be exacerbated by the policy. International medical graduates comprise over 30% of residents, filling 10,000 residency slots across the country including at rural locations facing a shortage of clinicians. Additionally, impacts on graduate-level medical programs may significantly hinder the industry’s ability to train enough practitioners to overcome health care professional shortages. While the administration has signaled they may permit exemptions for specific professions to promote national security, it is unclear if health care practitioners will be included in the exemptions.
In accordance with the proclamation, the Department of Homeland Security (DHS) issued a notice of proposed rulemaking to increase the application fees. DHS also proposed to switch the H-1B visa selection process away from the current, randomized lottery. The proposed weighted selection process would create four categories of jobs based on wage, favoring the highest skilled workers for H-1B visas. If health care professionals are not exempted from the policy, it is unclear how professionals at different stages of their career will be categorized.
Judicial Action
Texas Judge Vacated RADV Rule
A federal judge has vacated a Biden-era CMS rule. In 2023, CMS finalized a new methodology for determining payment recoveries from MA audits. The rule, related to the Risk Adjustment Data Validation (RADV) audit process, would have enabled regulators to find unsupported diagnoses in a sample of MA enrollees that suggest a payer is inflating risk scores in order to receive higher government reimbursement. Regulators then planned to utilize those results across an entire contract and receive repayments based on that estimate. Humana challenged the rule, arguing that CMS improperly removed a “fee-for-service adjuster”, which could unfairly penalize MA plans.
On Thursday, federal judge Reed O’Conner agreed with Humana’s argument. O’Connor stated that harm to insurers was exacerbated due to the lack of notice that actuarial equivalence does not apply to RADV audits. O’Connor vacated the RADV rule, determining that CMS violated the Administrative Procedure Act by not properly notifying stakeholders and by applying the rule retroactively back to 2018. This decision complicates CMS’s efforts to decrease overpayments, estimated at $4.7 billion over ten years, and may lead to a revised rule or appeal. The ruling temporarily reduces regulatory pressure on MA plans.
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21st Annual Conference
Wednesday, November 5 – Friday, November 7, 2025
The Mayflower Hotel, Washington, D.C.
Visit: Healthcare Roundtable Events – HealthCare Roundtable
