Happy Monday! Nimitz Health is back this week with Washington open for business and a packed health policy agenda returning to center stage. With agencies back at work and Congress racing the calendar, debates over coverage, costs, and innovation are quickly moving to the forefront. Here is what we are tracking.

In this week’s Nimitz Health:

• Federal News: The fate of enhanced ACA subsidies; shifting leadership and strategy at key health agencies

• State News: Marketplaces and regulators navigate open enrollment

• Industry News: New drug breakthroughs; changing expectations on pricing and access

WHO’S HAVING EVENTS THIS WEEK?

Wednesday, November 19th

• Senate HELP: “Examining the Future of the U.S. Organ Procurement and Transplantation Network” at 10am. Watch here.

• *Senate Finance: “The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans” at 10am. Watch here.

• *House Ways & Means: “Modernizing Care Coordination to Prevent and Treat Chronic Disease” at 2pm. Watch here.

• *Senate Aging: “Made in America: Restoring Trust in Our Medicines” at 3:45pm. Watch here.

*Will be covered by Nimitz Health. Please email [email protected] if you would like a readout of any other hearings.

NEWS DRIVING THE WEEK

Federal News

With the shutdown over, attention has shifted to the fate of the enhanced Affordable Care Act premium tax credits, which are still set to expire at the end of 2025. The funding deal brought health agencies back to full operations but only promised a Senate vote in December and left the House uncommitted, so families shopping during open enrollment are planning ahead with a possible 2026 premium spike in mind.

Many possible solutions are floating around. Senate Democrats are pushing for a clean extension, while Senator Bill Cassidy and other Republicans want a shorter renewal that adds an income cap, anti fraud rules, and more visible aid to patients instead of insurers, aligning with Trump’s calls to send more help directly to consumers. Senator Jeanne Shaheen and allies warn that bolting major structural changes onto an extension risks missing the deadline and triggering sharp premium hikes. On the House side, Republicans are holding internal health care sessions around a broader conservative package, while some Democrats explore procedural options to force a longer extension, but there is no clear bipartisan landing zone yet. Read more here.

Inside the agencies, FDA Commissioner Marty Makary has elevated longtime oncology chief Richard Pazdur to lead the drug center, a move widely seen as an effort to steady leadership after recent departures and legal disputes that unsettled staff and sponsors. The agency is also advancing a plausible mechanism pathway for highly individualized therapies, which could speed access for patients with rare conditions while raising new questions about evidence standards and pricing.

At NIH, the decision to place a scientist on leave after she helped organize the Bethesda Declaration that criticized leadership has intensified concerns about morale and scientific independence inside the federal research workforce.

State News

State-based marketplaces are running open enrollment under a cloud of federal uncertainty. Many regulators asked insurers to file dual rate scenarios, one that assumes the enhanced ACA credits continue and another that assumes they end, which allows some flexibility but risks confusing consumers who see very different price paths depending on what Congress does. Read more here.

Exchange leaders say they can quickly update premiums and notices if Congress simply extends the current structure. They warn that more complicated changes, such as new income caps or different subsidy formulas, would be harder to implement mid season and could lead some households to delay sign up or step down to leaner coverage. States are ramping up outreach that stresses current financial help while urging federal policymakers to provide clear direction before year end.

Industry News

Health plans are leaning hard on Congress to extend the enhanced credits, warning that a sharp premium jump in 2026 would hollow out risk pools and destabilize markets, even as conservatives escalate attacks on large insurers and promote more visible, patient facing support through tax favored accounts. Drug makers have taken a more cooperative posture, cutting deals on pricing and trade that have helped ease tariff threats and win friendlier rhetoric from the White House.

In life sciences, the promotion of Richard Pazdur is seen as a bid to restore predictability in FDA drug reviews at a time when companies are betting heavily on bespoke gene and cell therapies that could use the new pathway. Novo Nordisk’s new chief executive is defending a disciplined approach to obesity, signaling that the company will focus on scaling its existing GLP-1 portfolio rather than paying any price for acquisitions, while rivals race to bring competitors to market.

Global product developments are also in focus. A new malaria regimen from Novartis has shown strong results against drug resistant strains and is moving toward regulatory submissions, with a promised non profit pricing model in low income regions and likely implications for travel medicine and defense buyers.

FOR FUN

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