THIS WEEK’S DOSE
- Government shutdown ends. President Trump signed the bill to reopen the government and reinstate expired health extenders on November 12, 2025.
- FDA adjusts hormone replacement therapy warning labels. The US Food and Drug Administration (FDA) will remove certain black box warnings from certain hormone replacement therapy treatments.
CONGRESS
Government shutdown ends. The record-setting 43-day shutdown ended when eight Senate Democrats – Sens. Cortez Masto (D-NV), Durbin (D-IL), Fetterman (D-PA), Hassan (D-NH), Kaine (D-VA), King (I-ME), Rosen (D-NV), and Shaheen (D-NH) – agreed to vote with Republicans, providing the 60 votes necessary to pass the bill on November 10, 2025. The bill then moved to the House, where six Democrats crossed party lines to support the continuing resolution (CR), which passed the House the evening of November 12, 2025, by a vote of 222 – 209. President Trump signed the bill into law the same evening, reopening the government.
The bill’s Congressional Budget Office (CBO) score can be found here. Key elements of the agreement include:
- Enactment of three full-year appropriations bills for fiscal year (FY) 2026 – Military Construction and Veterans Affairs; Agriculture, Rural Development, and FDA; and Legislative Branch. The Agriculture bill fully funds the Supplemental Nutrition Assistance Program (SNAP) through the remainder of FY 2026, which means that the threat of another lapse in food assistance will not be on the table at the end of January 2026, when the new CR expires.
- Funding for a new stopgap CR through January 30, 2026. Congress will continue working to enact additional appropriations bills before that deadline. One of the outstanding appropriations bills is the Labor, Health and Human Services (HHS), Education, and Related Agencies bill. Senate appropriators are aiming to have another “minibus” (a grouping of several appropriations bills) ready for consideration by the full Senate as soon as next week, and are forecasting that the Labor-HHS bill will be part of that package.
- A health extenders package that retroactively restores policies that expired once the government shut down on October 1, 2025. These programs include Medicare telehealth flexibilities, funding for community health centers, prevention of Medicare disproportionate share hospital cuts, the Medicare-dependent hospital program, and the low-volume hospital payment adjustment. They are restored in a retroactive manner from October 1, 2025, through January 30, 2026.
- A provision addressing Medicare statutory Pay-As-You-Go Act of 2010 requirements. By wiping the slate clean in this package, Congress prevented the $491 billion in Medicare cuts that CBO forecast following passage of the One Big Beautiful Bill Act.
- Provision of back pay for furloughed federal employees and reversal of the reductions in force the administration implemented during the shutdown.
Missing from the package are provisions to address the Affordable Care Act’s enhanced advanced premium tax credits (APTCs), which will expire on December 31, 2025, without congressional action. Republicans’ refusal to include an extension of these enhanced tax credits was the key reason Democrats opposed the earlier CR when the government shut down on October 1, 2025. Democrats in Congress and the party base have expressed significant anger that a small group of Senate Democrats crossed party lines to support the CR and reopen the government without the APTC provision included.
As part of the agreement, Senate Majority Leader John Thune (R-SD) committed to a Senate vote in December on an APTC extension bill of Democrats’ choosing. Negotiations are ongoing to see if enough Republicans will agree on a compromise package that could get 60 votes in the Senate. Speaker Johnson (R-LA) has not committed to any action in the House at this time.
ADMINISTRATION
FDA adjusts hormone replacement therapy warning labels. At an HHS event on women’s health, the FDA announced that drug manufacturers will remove certain black box warnings on certain hormone replacement therapy treatments prescribed to address 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 Makary also wrote a JAMA Viewpoint article about the updated labeling, noting that underlying adverse event information will continue to appear in the package insert.
QUICK HITS
- DEA appears poised to extend telemedicine prescribing flexibilities. The Office of Management and Budget received a US Drug Enforcement Administration (DEA) final rule that may provide another temporary extension of telemedicine flexibilities for prescription of controlled medications. If the administration does not act, these flexibilities will expire on December 31, 2025.
- ACIP schedules December meeting. The Advisory Committee on Immunization Practices (ACIP) agenda includes discussions and possibly votes on vaccine safety, the childhood and adolescent immunization schedule, and hepatitis B vaccines.
- FDA introduces new approval pathway. In a New England Journal of Medicine article, FDA Commissioner Makary introduced the “plausible mechanism pathway,” which is designed to streamline approval for manufacturers of highly individualized therapies, such as gene-editing, for diseases with well-understood biologic causes.
- CMS holds Connectathon. The Centers for Medicare & Medicaid Services (CMS) invited signers of the Health Tech Ecosystem interoperability pledge to attend a closed all-day event in Washington, DC, for networking and discussions about advancing the ecosystem.
- HHS officials attend MAHA Summit. The private event had many high-level attendees, including HHS Secretary Kennedy, CMS Administrator Oz, National Institutes of Health Director Bhattacharya, FDA Commissioner Makary, and Vice President Vance, whose remarks were televised.
NEXT WEEK’S DIAGNOSIS
Both chambers of Congress will be in session next week for the first time since the beginning of the shutdown, and hearings will be in full swing:
- The Senate Finance Committee will hold a hearing on the rising cost of healthcare.
- The House Ways and Means Subcommittee on Health will hold a hearing on chronic disease prevention and treatment.
- The Senate Health, Education, Labor, and Pensions Committee will hold a hearing on the Organ Procurement and Transplantation Network.
- The Senate Aging Committee will hold a hearing on domestic production of medicines.
- The Senate Homeland Security and Governmental Affairs Committee will hold a hearing on the nomination of Thomas Bell to be HHS inspector general, and the Senate Finance Committee will hold a vote on his nomination.
- CBO Director Swagel will testify at an oversight hearing of the House Budget Committee.
- The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing on artificial intelligence chatbots.
The Senate may also take up its next appropriations package, potentially including the Labor-HHS bill. We also await the publication of outstanding calendar year 2026 Medicare payment rules.
