This Week (December 22-26)

Congress is in recess until January 2026. The Senate returns January 5, 2026, and the House returns January 6, 2026. This Week in Health Policy will not publish during the recess.

Last Week (December 15-19)

Congressional Highlights

Congress adjourns without addressing expiring ACA credits. The House and Senate have adjourned for the remainder of 2025 without action on the enhanced Affordable Care Act (ACA) premium tax credits that expire on December 31, 2025, though a group of moderate House Republicans continue pushing to engage in negotiations on a deal.

On Wednesday (December 17), the House voted 216-211 to pass a Republican health care package, the Lower Health Care Premiums for All Americans Act (H.R. 6703 ). The bill would allow employers to offer workers tax-advantaged funds to pay for individual health insurance through custom health option and individual care expense (CHOICE) arrangements; fund cost-sharing reduction payments; enable small employers to form association health plans to offer coverage; and increase transparency for pharmacy benefit managers. The bill is unlikely to gain the 60 votes needed to pass the Senate as it does not address the expiring ACA tax credits.

Also this week, four Republicans — Reps. Brian Fitzpatrick (R-PA), Mike Lawler (R-NY), Ryan Mackenzie (R-PA) and Rob Bresnahan (R-PA) — broke with GOP leadership and signed on to a discharge petition by Democratic leader Hakeem Jeffries (D-NY) to force a vote on extending the enhanced ACA credits, which is expected to be held in January. The development was seen as fraying relations between GOP House leadership and a group of moderate Republicans members who have been calling for action on the ACA credits issue.

President Trump signs NDAA; BIOSECURE becomes law. On Thursday (December 18), President Trump signed into law the FY 2026 National Defense Authorization Act (S. 1071 ). The bill primarily authorizes appropriations and sets policies for the Department of Defense (DOD). It also includes several health-related policies, including the BIOSECURE Act, expiring and new health care programs for DOD employees and their dependents and other updates related to biotech, TRICARE benefits, and AI and more.

Senate confirms HHS inspector general. On Thursday (December 18), the Senate voted 53 — 43, along party lines, to confirm Thomas Bell as the next Department of Health and Human Services (HHS) inspector general en bloc with other nominees.

House passes bills restricting gender-affirming care for minors. On Thursday (December 18), the House passed the Do No Harm in Medicaid Act (H.R. 498 ), which would prohibit Medicaid from paying for gender-affirming care for minors, and the Protect Children's Innocence Act, which would criminalize providing gender-affirming care to minors

Wyden calls on EHR companies to protect patient data. On Tuesday (December 16), Sen. Ron Wyden (D-OR) sent a letter to 10 electronic health record (EHR) companies urging them to adopt stronger privacy and data security measures to protect sensitive patient information.

Administrative Highlights

CMS proposes the GLOBE model: On Friday (December 19), CMS issued a rule proposing the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a mandatory seven-year model that would run from October 1, 2026-September 30, 2033. Under the GLOBE model, CMS would test whether modifying the Part B inflation rebate amount using international drug pricing information would reduce Part B expenditures. The benchmark would be based on either manufacturer-reported international pricing information or available information to CMS for countries with a real gross domestic product per capita that is at least 60% of the United States' and with a minimum real economy size of $400 billion. CMS will accept comment on the proposed model until February 23, 2026.

CMS proposes the GUARD Model. On Friday (December 19), CMS issued a rule proposing the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model, a mandatory seven-year model that would run from January 1, 2027, through December 31, 2033. Under the GUARD model, CMS would test whether modifying the Part D inflation rebate amount using international drug pricing information would reduce Part D expenditures. Similar to the GLOBE model, CMS said it will test two different benchmark methodologies: either manufacturer-reported international pricing information or available information to CMS for countries that meet certain GDP per capital and real economy size thresholds. CMS will accept comment on the proposed model until February 23, 2026.

Trump Administration publishes Transparency in Coverage proposed rule. On Friday (December 19), the Departments of Treasury, Labor, and Health and Human Services (the Departments) issued a proposed rule to strengthen price transparency requirements for group health plans and insurers under the Transparency in Coverage Rule. Key changes aim to simplify and reduce the size of files. The rule also proposes ways to improve accessibility for pricing information across web, paper, and phone, along with expanded consumer cost-estimator tools. Notably, the rule does not contain technical guidance for the prescription drug file which the Departments intend to address separately. The deadline to submit comments is February 26, 2026.

ASTP/ONC issues RFI on AI. On Friday (December 19), The HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) published a request for information that seeks comment on ways HHS regulations impact AI adoption and potential use cases for clinical care. The RFI also includes questions on reimbursement and ways HHS may invest in research and development to integrate AI in care delivery. The RFI has a 60-day comment period.

CMMI unveils new payment model. On Thursday (December 18), the CMS Innovation Center unveiled a new ACO model, the Long-term Enhanced ACO Design (LEAD) Model, that aims to build on the ACO REACH model and increase provider participation. LEAD is a 10-year model set to launch in January 1, 2027, after the ACO REACH model concludes. The CMS Innovation Center will issue a Request for Applications in March 2026.

CMS proposes rules to restrict federal funds for providers performing gender-affirming care. On Thursday (December 18), CMS proposed two rules that would block providers providing "sex-rejecting procedures" to minors from receiving federal funds. The first proposed rule would revise the Hospital Condition of Participation for Medicare and Medicaid to prohibit Medicare and Medicaid-participating hospitals from performing "sex-rejecting procedures (SRPs)" on a minor. The second proposed rule would prohibit Medicaid and Children's Health Insurance Program funds from being spent on "sex-rejecting procedures" for a minor.

CDC adopts updated hepatitis B vaccine schedule. On Tuesday (December 16), the CDC approved a recommendation from the Advisory Committee on Immunization Practices (ACIP) to remove the blanket recommendation for hepatitis B vaccination at birth. Instead, CDC will now recommend the vaccine for newborns whose mothers test positive for hepatitis B or whose status is unknown and that those with known negative tests consult with their physicians.

FDA updates guidance for medical device reviews. On Monday (December 15), the FDA updated its guidance for medical device application reviews to remove a requirement that sponsors submit identifiable, patient-level data. The decision will allow sponsors to submit real-world evidence (RWE) derived from real-world data sources that have been de-identified for certain medical device applications. FDA in the guidance said it is considering similar updates to its guidance for drugs and biologics.

FDA proactively grants CNPRV. On Monday (December 15), FDA awarded a national priority voucher (CNPRV) to Johnson & Johnson's Teclisamab in combination with Daratumumab after the company published Phase 3 clinical trial data showing "significant improvements over the standard of care."

CMS publishes 2025 Measures Under Consideration List. On Monday (December 15), CMS published 24 quality and efficiency measures under consideration for adoption or modification in Medicare programs. CMS is accepting public comments on the list until January 6.

Executive Highlights

President Trump unveils MFN agreements with nine drugmakers. On Friday (December 19), President Donald Trump and the CEOs of nine drug manufacturers announced agreements under President Trump's Most Favored Nation's (MFN) executive order. During the announcement, President Trump was joined by HHS Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz, Commerce Secretary Howard Lutnick and the CEOs of Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Gilead, GSK, Merck, Novartis, and Sanofi. For more details see the attached WCEY Alert: Trump Admin Actions on Drug Prices The President also announced he would seek price concessions from health insurers next, stating he would host a meeting with insurers in the near future.

President Trump signs EO on medical marijuana research. On Thursday (December 18), President Trump signed an Executive Order (EO) that directs the attorney general to reschedule marijuana as a Schedule III controlled substance. The EO also states that the administration will work with Congress to update the definition of hemp-derived cannabinoid (CBD) products to increase access to CBD products. Click here for the fact sheet.

President Trump designates fentanyl as weapon of mass destruction. On Monday (December 15), President Trump signed an EO that directs the attorney general to pursue criminal charges and enhanced sentences related to fentanyl trafficking. The EO also directs the U.S. Departments of State and Treasury to pursue actions against financial institutions "involved in or supporting the manufacture, distribution, and sale of illicit fentanyl and its core precursor chemicals." Click here for the fact sheet.

Hearings, Markups, and Other Committee Activity

House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on "Examining Biosecurity at the Intersection of AI and Biology." On Wednesday (December 17), the Subcommittee held a hearing during which members discussed the benefits to patient care and risks to national security related to AI's use in biotechnology. During the hearing, Republicans spoke favorably of President Trump's AI policies, while raising concerns about adversarial countries gaining access to bioweapons. Democrats on the committee spoke critically of HHS Secretary Robert F. Kennedy Jr.'s impact on biosecurity, with ranking member Frank Pallone (D-NJ) calling a motion to subpoena the Secretary for him to testify on this issue. The motion failed along party lines.

• More information available here.

House Veterans' Affairs Subcommittee on Technology Modernization Oversight Hearing held a hearing on "Ready, Set, Go-Live: Assessing VA's EHR Modernization Deployment Readiness." On Monday (December 15), the Subcommittee held a hearing during which members heard testimony from government officials and contractors regarding the implementation of the VA's EHR modernization effort. Members from both parties expressed concern about past delays and expressed concern that the VA may not be ready to launch in 117 days when the new system is scheduled to launch in certain states.

• More information available here.

Joint Economic Committee held a hearing on "Stop Paying More for Less: Realigning Healthcare Incentives to Improve Outcomes and Reduce Costs." On Wednesday (December 17), the Committee held a hearing to discuss ways to improve health care outcomes while lowering costs. During the hearing, Republicans discussed ways to reduce insurance fraud and increase access to innovative technologies, while Democrats focused on the need to extend the enhanced ACA tax credits. Members from both parties voiced support for ways to use preventive measures to reduce health care costs.

• More information available here.

Reports, Studies, and Journals

• HHS Office of Inspector General: Trends in Dual-Eligible Enrollees' Access to Drugs Under Part D, 2011 — 2025. The report outlines trends related to dual-eligible individuals' access to prescription drugs under Part D, showing Part D plan formularies covered 98% of commonly used drugs.
• Congressional Budget Office: Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process. The CBO score projects the bill would reduce the deficit by $35.6 billion over the 2026 — 2035 period, decrease the number of people with health insurance by an average of 100,000 over the 2027 — 2035 period, and lower gross benchmark premiums by 11 percent, on average, through 2035.