This week (October 5-9)

The House and Senate are scheduled to be in recess this week and are not scheduled to return until after the midterm elections. This Week in Health Policy will not publish while Congress is in recess.

Last week (September 28-October 2)

Congressional Highlights

Congress adjourns until after midterms. On September 30, the Senate adjourned ahead of a lame-duck session expected to begin on November 9. The House began its recess on September 16. Both chambers adjourned without taking further action on several outstanding health policy issues, including FY 27 appropriations, which are now expected to remain unresolved until Congress returns after the November 3 midterm elections.

Administrative Highlights

CMS finalizes mandatory Medicare Part B drug payment model. On Wednesday (September 30), CMS finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a mandatory payment model that will incorporate international pricing benchmarks into the Medicare Part B Drug Inflation Rebate calculation, requiring impacted drug manufacturers to pay revised rebates when prices for certain physician-administered drugs exceed the lowest prices charged for the same drugs in a market basket of non-U.S. OECD countries. CMS estimates the model will save Medicare $440 million over seven years, down from the $11.9 billion projected in the proposed rule. The final rule includes key changes that CMS said account for the lower anticipated savings, including additional drug and manufacturer exclusions. Notably, CMS said it will waive mandatory participation for manufacturers participating in the GENEROUS Model and expects only four manufacturers to remain subject to the GLOBE Model. The model begins on January 1, 2027, with a five-year performance period running from April 1, 2027 through March 31, 2032; rebate reconciliation activities will continue through March 31, 2034. Click here for WCEY's full alert on the model.

HRSA publishes drug manufacturers' 340B rebate plans. On Thursday (October 1), Health Resources and Services Administration (HRSA) published approved 340B Rebate Model implementation plans from 10 drug manufacturers. Each manufacturer is expected to begin the rebate model on January 1, 2027.

White House launches Amreica.gov federal service portal. On Tuesday (September 29), President Trump issued an executive order directing agencies to begin integrating covered public-facing federal services through America.gov, a single digital entry point for government information and services. According to a White House fact sheet, users are expected to be able to complete certain transactions, including Medicare enrollment, later this year.

HHS launches SURPASS initiative to accelerate clinical trials. On Wednesday (September 30), HHS, through the Advanced Research Projects Agency for Health (ARPA-H), announced the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program and related efforts to modernize clinical development. HHS said the initiative will focus on phaseless trials, real-time data analysis and automation, with the goal of reducing clinical development timelines and costs.

HHS launches school fitness innovation challenge. On Thursday (October 1), HHS announced a $10 million Presidential Fitness School Innovation Challenge. HHS said the initiative will support school-based approaches to physical fitness.

Hearings, Markups, and Other Committee Activity

Senate HELP Committee advances health nominees. On Wednesday (September 30), the Senate Health, Education, Labor and Pensions (HELP) Committee voted 12-11 to advance three nominees to the full Senate: Nicole Saphier to serve as Surgeon General ; Timothy Westlake to serve as Assistant Secretary for Mental Health and Substance Use at HHS; and Mary Lazare to serve as Assistant Secretary for Aging at HHS. The Committee also voted 12-11 to advance the nominations of Loren Sweatt and Douglas Ralph to the National Mediation Board.