September 11, 2025
Congress
Appropriations
Congress continues to advance FY2026 appropriations bills as we creep closer to the October 1 deadline when the new fiscal year starts. The White House has proposed a Continuing Resolution (CR) funding plan through January 31, however, top congressional appropriators would like the stopgap measure to expire in November or December.
This week, the House advanced the final two spending bills for the Labor, Health and Human Services, Education, and Related Agencies (L-HHS) bill and the Commerce, Justice, Science, and Related Agencies bill. The House will also consider a motion to work on three spending bills with the Senate Military Construction-VA, Agriculture-FDA, and Legislative Branch.
Health
For FY2026, both the House and Senate rejected the Trump Administration’s requested $29.3 billion cut (40%) to NIH. The House L-HHS Appropriations bill calls for a 6% cut to the Department of Health and Human Services (HHS).
The House L-HHS bill provides:
- $108 billion for HHS ($7 billion cut)
- $47.8 billion for the National Institutes of Health (NIH)
- $100 million for President Trump’s Make America Healthy Again (MAHA) initiative
- $945 million for the Advanced Research Projects Agency for Health (ARPA-H)
- $7.452 billion for CDC (19% cut with the elimination of funding for several programs at the CDC’s Center for Global Health including Global HIV/AIDS, Global Tuberculosis, and some global vaccination activities)
- $0 for the Agency for Healthcare Research and Quality (AHRQ)
- $1.1 billion for BARDA
- $0 for the Agency for Healthcare Research and Quality (AHRQ)
- $100 million for Office of Research on Women’s Health (ORWH) ($23.5 million increase)
The Senate L-HHS Appropriations bill provides:
- $116.6 billion for HHS ($446 million increase)
- $48.7 billion for the NIH ($400 million increase)
- $0 for MAHA
- $1.5 billion for ARPA-H (level funding)
- $9.15 billion for CDC ($5 million cut)
- $345.3 million for the AHRQ
- $1.015 billion for BARDA (level funding)
- $130 million for ORWH ($30 million increase)
The House bill also proposes stripping funding entirely from the Title X grant program, which subsidizes family planning and preventive health services across hundreds of clinics nationwide, which is not zeroed out in the Senate. The Senate level funds Title X with $286.5 million, which would be the 12th consecutive year of stagnant funding, which is 10% less than FY10.
Another key sticking point is the Affordable Care Act (ACA) provisions that expire on September 30. Senate Minority Leader Chuck Schumer (D-NY) is threatening to block passage of any stopgap funding measure that does not include extensions of subsides for ACA health insurance plans. For example, one subsidy caps premiums at a maximum of 8.5% of a household's income and another removed the cap on income eligibility for subsidies, allowing people earning over 400% of the federal poverty level to receive assistance. The expiration of these temporary enhancements included in the 2021 COVID legislation and 2022 climate bill could lead to significantly higher monthly premiums (estimated to rise by 18%) and a potential rise in the uninsured rate for millions of people.
This issue is a priority for a handful of Republicans as well. Reps. Jen Kiggans (R-VA) and Tom Suozzi (D-NY) introduced legislation last week to extend the ACA’s Enhanced Premium Tax credit. Along with Kiggans, other Republican co-sponsors include Reps. Brian Fitzpatrick (R-PA), Rob Bresnahan (R-PA), Young Kim (R-CA), David Valadao (R-CA), Jeff Hurd (R-CO), Carlos Gimenez (R-CO), Tom Kean (R-NJ), Juan Ciscomani (R-AZ) and Mike Lawler (R-NY). While unlikely to pass on its own, it may get included in the CR and year-end omnibus.
Overall, the differences between the House and Senate bills will make negotiations challenging for not just this bill, but the CR that must be enacted to continue funding agencies and programs past September 30.
Defense
Both the House and Senate continue to make headway on the National Defense Authorization Act (NDAA), which sets Defense Department priorities for the year and is considered a must-pass bill. Congress has passed the NDAA every year since 1961 and hopes to pass it again before the end of the calendar year.
This week, the House considered nearly 300 amendments to their version of the NDAA before passing the $893 billion bill. Some of the amendments address cultural issues and making bipartisan support challenging. The Senate began considering its $926 billion version last week, and the chamber will continue to move through more than 700 amendments – ranging from counter drone technologies to domestic biosecurity.
Business
Small Business Innovation Research Program (SBIR)
The House Small Business Committee advanced a one-year extension of SBIR and STTR programs on September 9 ahead of the program’s authorization expiring on September 30. According to the markup memo, this bill “allows Congress to continue working towards a long-term reauthorization that would strengthen both programs for small businesses across the country. Without a one-year extension, small businesses risk losing access to the funding they rely on to innovate and bring new technologies to the market.”
This is considered a big victory for what many feared would be a reauthorization bill that made the current foreign disclosure law that is blocking NIH grant recipients with the appropriate payline from receiving funding even stricter and alter criteria to ensure recipients in the middle of the country with historically lower award rates obtain more funding. On the other hand, efforts to increase the percentage of agency budgets dedicated to SBIR/STTR grants, to direct more funding toward women’s health innovation that currently receives just 2% of VC funding, or to carve out awards for businesses that are majority-owned by a single venture capital operating company, hedge fund or private equity firm are all stalled until 2026.
Agencies
Health and Human Services (HHS)
HHS Secretary Robert F. Kennedy Jr. testified before the Senate Finance Committee on September 4 to discuss President Trump’s healthcare agenda, amid significant turnover of leadership at the CDC, alarms over how vaccine recommendations were made and the makeup of the Advisory Committee on Immunization Practices (ACIP), the sudden firing of CDC Director Dr. Susan Monarez, and the recent op-ed signed by nine former CDC Directors stating Secretary Kennedy is endangering the health of Americans.
Secretary Kennedy defended his decision to fire CDC Director Monarez after just under a month on the job, despite expressing support for her earlier. As expected, several Democratic Senators on the Committee sharply criticized Secretary Kennedy for actions on vaccinations and called on him to resign. Of note, Republican Senators Bill Cassidy, MD (R-LA), John Barrasso, MD (R-WY) and Thom Tillis (R-NC) expressed concerns over limiting the public's access to vaccines and the abrupt dismissal of all members of the ACIP. Tillis said he would follow up with the Secretary with questions on interference eroding HHS scientists’ ability to do their jobs and the lack of detail on reductions in force at the department.
These exchanges represent the most significant dissonance between Congressional Republicans and the Administration since President Trump took office in January. Even more is expected when Director Monarez testifies before the Senate HELP Committee to share her perspective on her dismissal. She may also comment on the plans she had laid out in an internally circulated memo at HHS, to re-organize CDC that has been noted to be largely in alignment with Secretary Kennedy’s stated priorities.
Make America Healthy Again (MAHA)
On Tuesday, the MAHA Commission released its second major report, which is focused on ending childhood chronic disease. The proposals are divided into four pillars: advancing research, realigning incentives, fostering private sector collaboration and increasing public awareness. Many recommendations in the 19-page report will require coordination by different agencies to be put in practice. Substantial reform of food and agriculture systems do not appear to be included in the document.
Centers for Medicare and Medicaid Services (CMS)
CMS issued its proposed Physician Fee Schedule (PFS) rule for 2026 last month. A summary of provisions can be found here. Public comments for this proposed rule are due on September 12.
Health Resources and Services Administration (HRSA)
A pilot program announced in July to change the structure of the 340B rebate for certain drugs subject to CMS price negotiation will meet its first milestone soon. Under the pilot, 340B providers would pay market prices for relevant medicines upfront, and receive a rebate from manufacturers at a later date instead of the current scheme where the provider pays the discounted price upfront. Eligible manufacturers are required to submit implementation plans to HRSA by next Monday September 15.
FDA
FDA is welcoming comments until September 24 on the risks and benefits related to menopause hormone therapy as a follow-up to the July 17 meeting on this topic. The public comment portal is here. Additionally, earlier this summer, the agency announced the ‘Pre-check’ Program which is focused on strengthening the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating construction of domestic manufacturing sites. An associated public meeting will be held on September 30th and the relevant public comment portal can be accessed here.