17 November 2025 This Week in Health Policy for November 17 The House and Senate are both scheduled to be in session this week and there are several health-related committee hearings scheduled. House Ways and Means Health Subcommittee will hold a hearing on "Modernizing Care Coordination to Prevent and Treat Chronic Disease."
House Energy & Commerce Committee will hold an oversight hearing on "The Safety of Artificial Intelligence (AI) Chatbots."
Senate Finance Committee will hold a hearing on "The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans."
Senate Health, Education, Labor and Pensions Committee will hold a hearing on "Examining the Future of the U.S. Organ Procurement and Transplantation Network."
Senate Special Committee on Aging will hold a hearing on "Made in America: Restoring Trust in Our Medicines."
Senate Homeland Security and Governmental Affairs Committee will hold a hearing to consider the nomination of Thomas Bell to be Inspector General, U.S. Department of Health and Human Services.
Senate Finance Committee will hold a hearing to vote on the nomination of Thomas Bell to be Inspector General, U.S. Department of Health and Human Services.
U.S. government shutdown ends. On Wednesday (November 12), the House voted 222-209 to end the 43-day government shutdown, passing a deal (HR 5371) negotiated in the Senate that funds the federal government through January 30. The Senate passed the bill on Monday (November 10) with support from Democratic Sens. Catherine Cortez Masto (NV), Dick Durbin (IL), John Fetterman (PA), Maggie Hassan (NH), Tim Kaine (VA), Jacky Rosen (NV) and Jeanne Shaheen (NH), along with independent Angus King (ME). The deal included provisions to reinstate federal workers who lost their jobs due to reductions in force (RIFs) since the start of the shutdown, three full-year FY 2026 appropriations bills — Military Construction-Veterans Affairs, Agriculture (which includes the FDA), and Legislative Branch — and a commitment from Senate Majority Leader John Thune (R-SD) to bring a bill for a vote later this year to extend the Affordable Care Act's (ACA) enhanced premium tax credits. The deal also retroactively extends and funds various health care waivers and flexibilities until Jan. 30, including the Medicare telehealth flexibilities, the Acute Hospital Care at Home (AHCAH) waiver, funding for community health centers, the National Health Service Corps, the Teaching Health Centers that operate GME programs, low-volume hospital payment adjustments and Medicare-dependent hospital programs, ground ambulance add-on, special diabetes programs, Medicare quality measure selection, the work geographic index floor, temporary inclusion of authorized oral antiviral drugs covered by Part D, and more. The deal also includes Over-the-Counter Monograph Drug User Fee Amendments. Congress now faces a January 30 deadline to pass the remaining nine annual appropriations bills for FY 2026, but members remain divided over topline spending numbers and potential add-ons. House Democrats also are trying to gain support for a discharge petition to force a House vote on extending the enhanced premium tax credits if it passes the Senate. House Speaker Mike Johnson (R-LA) has not committed to bringing a bill to the floor for a vote. In addition, the White House is reportedly considering alternative proposals to the ACA premium tax credits. On Sunday (November 9), President Trump in a Truth Social post floated the idea of a Republican health care plan that would give consumers more control over their health care dollars — a plan that was lauded by Sen. Rick Scott (R-FL) and Senate HELP Committee Chair Bill Cassidy (R-LA). "We want a health care system where we pay the money to the people instead of the insurance companies and I tell you, we're going to be working on that very hard over the next short period of time — where the people get the money," Trump said. House and Senate Armed Services committee leaders also are looking to meet next week to continue work on a final agreement on the National Defense Authorization Act, which they aim to pass by year end. Leaders will need to determine whether they will include the updated Biosecure Act, which was included in the Senate version of the NDAA. FDA unveils new plausible mechanism pathway. On Wednesday (November 12), the FDA unveiled a new "plausible mechanism pathway" that aims to accelerate the approval of highly personalized therapies, such as gene-editing therapies, for ultra-rare diseases. In a New England Journal of Medicine article, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad wrote the pathway will provide "regulatory guidance and encouragement" in cases where randomized trials are not feasible, allowing manufacturers to demonstrate success with "several consecutive patients." The agency will require five key elements for eligibility: identification of a known biologic cause, a product that directly targets it, a well-characterized natural history of the disease, confirmation that the genetic target was successfully modified, and evidence of meaningful clinical improvement. HHS officials attend MAHA Summit. On Wednesday (November 12), several Trump Administration officials, including Vice President JD Vance and HHS Secretary Robert F. Kennedy attended and spoke at a Make America Healthy Again (MAHA Summit). The private event included industry executives, prominent MAHA members, as well as CMS Administrator Mehmet Oz, National Institutes of Health Director Jay Bhattacharya, and FDA Commissioner Marty Makary. FDA taps new head of CDER. On Tuesday (November 11), FDA announced it has appointed Richard Pazdur as the director of the Center for Drug Evaluation and Research (CDER), replacing George Tidmarsh who resigned after accusations that he abused his position. Pazdur is a 26-year veteran of the FDA and currently serves as the director of its Oncology Center of Excellence. FDA updates HRT warning labels. On Monday (November 10), the FDA announced the removal of certain black box warnings on certain hormone replacement therapy (HRT) products prescribed to treat menopause symptoms. Warnings referencing risks of cardiovascular disease, breast cancer, and probable dementia will be removed, while warnings for endometrial cancer for systemic estrogen-alone products will remain. FDA Commissioner Marty Makary also wrote a JAMA Viewpoint article and an op-ed in the Wall Street Journal about the updated labeling. Click here for a fact sheet. White House reviewing DEA rule on telemedicine prescribing. On Monday (November 10), the Office of Management and Budget received a U.S. Drug Enforcement Administration (DEA) final rule that may further extend temporary telemedicine flexibilities for prescription of controlled medications. Currently, the flexibilities are set to expire on December 31, 2025.
Document ID: 2025-2303 | |||
