Government shutdown reaches one month. While the House remained in recess this week, the Senate was in session, although no tangible progress was made to end the government shutdown, which is in its 31st day at the time of this writing. Conversations this week largely focused on targeted relief for the impacts of the shutdown, including piecemeal legislative efforts to prevent a lapse in Supplemental Nutrition Assistance Program (SNAP) funding and to pay federal employees. Senate Majority Leader Thune (R-SD) showed uncharacteristic anger on the Senate floor when Senate Democrats tried to pursue a vote to ensure SNAP funding continues beyond November 1, 2025.
Twenty-five attorneys general, all from Democratic states, filed suit this week against the US Department of Agriculture, asserting that the decision to suspend SNAP benefits is not legal and that the department is required to make payments to those who meet the program requirements. A ruling in this case is expected shortly.
As the shutdown drags on and federal workers continue to go without pay, the American Federation of Government Employees (a union representing more than 800,000 government workers that is typically aligned with Democrats) called for the shutdown to end, urging senators to pass the “clean” continuing resolution (CR) that the House approved in September. At the time of this writing, congressional Democrats remain committed to the position they’ve held since the beginning of the shutdown: that congressional Republicans must work with them to address rising healthcare costs before they’ll vote to reopen the government. This position has largely centered around the December 31, 2025, expiration of the enhanced advanced premium tax credits (APTCs) for ACA Marketplace plans. The Marketplace open enrollment period begins this weekend, which means that customers will be able to see their actual premium increases for 2026 if Congress fails to act to extend the enhanced APTCs. President Trump also returned to the White House after a long Asia trip. He immediately called for the Senate to “go nuclear,” which means to change the Senate rules so that appropriations bills can pass with a simple majority vote. That would enable Republicans to pass their clean CR without any Democratic votes. However, it would also be a significant change to Senate rules that most Republican Senators have opposed because it would be turned back on them when Democrats are again in the majority. How this new push plays with efforts to bring an end to the shutdown will be closely watched in the coming days.
Senate Finance Committee holds hearing on HHS inspector general nominee. This week, the Senate Finance Committee considered several presidential nominations, including Thomas Bell as inspector general of HHS. During the hearing, committee Republicans expressed support for Bell’s qualifications and emphasized the importance of oversight in areas such as Medicare Advantage, Medicaid fraud, nursing home paperwork reduction, assisted suicide funding, and abortion clinic investigations. Committee Democrats focused their questions on the potential politicization of the role, asking Bell whether he would uphold the law and maintain independence in his oversight responsibilities.
The Senate Health, Education, Labor, and Pensions (HELP) Committee was scheduled to hear from US surgeon general nominee Casey Means this week, but the hearing was postponed because she went into labor. Means’ brother, Calley Means, who had been serving as a special government employee and health adviser to HHS Secretary Kennedy, saw his term expire earlier this month and is no longer a government employee.
Senate HELP Committee examines biotechnology. During the hearing, members from both parties expressed concerns about the United States losing its global leadership in biotechnology. Republican members stated that US Food and Drug Administration (FDA) review processes should be improved to ensure a faster pathway for innovative treatments to reach the market. While Democratic members acknowledged the importance of biotechnology advancements, they focused their statements on healthcare affordability, raising concerns regarding the high rates of uninsured Americans and the impact on access to innovative treatments.
HHS leadership unveils biosimilar development reform plans to lower drug pricing. In a press conference, FDA Commissioner Makary, joined by HHS Secretary Kennedy and CMS Administrator Oz, announced new draft guidance that proposes to reduce the amount of clinical testing necessary for biosimilars to be eligible for market entry as a more affordable option for patients. The draft guidance would eliminate the requirement for comparative studies associated with biosimilar market approval, known as interchangeability studies, cutting the five-to-eight-year timeframe in half and helping to accelerate competition to lower drug prices. This move follows bipartisan legislation, S.1954/H.R.5526, which would make permanent the same policies that FDA is proposing in their draft guidance. In addition to making it easier for biosimilars to gain FDA authorization, eliminating the interchangeability studies requirement would make it easier for pharmacists to substitute biosimilars for their biologic reference products, as they can for generic drugs.
The Trump administration likely will soon announce the negotiated prices for the next round of Medicare drug price negotiation. There are 15 selected drugs, including popular GLP-1 drugs such as Ozempic, and the negotiated prices will be effective January 1, 2027.
CMS employees return. Last week, CMS announced that it would use funding from user fees charged to academic researchers to bring back all staff, specifically to address increased needs during the Medicare and Marketplace open enrollment periods, along with the final calendar year payment rules that are pending. CMS announced that the funding would last for up to eight weeks, if necessary. This week, CMS indicated that staff would also review and process applications for the Rural Health Transformation (RHT) Program, which are due November 5, 2025. The RHT Program is a five-year, $50 billion program authorized by the One Big Beautiful Bill Act (OBBBA) that will award funds to states to invest in rural health. It does not appear that CMS is returning to normal operations, however, as most external meetings are still being declined.
CMS releases information on 2026 Marketplace plans and prices. A CMS fact sheet outlines the following information for enrollees in the federal Marketplace ahead of the open enrollment period, which begins on November 1, 2025:
Earlier this week, Senate Democrats sent a letter to CMS expressing concern that the window-shopping feature, which traditionally has gone live by the last week in October, had not yet been launched. The next day, that feature was enabled on Healthcare.gov. Consumers can visit the website today, in advance of the official start of open enrollment, to see the premium prices and plan options that will be available if enhanced APTCs are not extended.
In contrast to the statistics released by the Trump administration, Democrats in Congress are noting that many people who purchase their coverage through the ACA Marketplace and depend on the enhanced APTCs will see significant price increases. The governor of New Jersey highlighted this week that consumers who purchase coverage through New Jersey’s ACA Marketplace are expected to pay nearly 175% more in their premiums.
Education Department releases final PSLF rule on employer eligibility. The US Department of Education released a final rule addressing employer eligibility for the PSLF program by excluding employers that engage in a “substantial illegal purpose.” The PSLF program provides loan forgiveness to student borrowers who work for qualifying government and nonprofit organization employers, helping to attract workers (including healthcare workers) to qualifying employers. After a borrower makes 120 monthly payments, the remaining balance of their eligible federal student loans is forgiven, tax-free.
The final rule amends the definition of a PSLF “qualifying employer” to exclude organizations that “engage in activities such that they have a substantial illegal purpose.” These activities are defined largely on administration priorities, as outlined previously in executive orders:
The regulations become effective July 1, 2026. The Department of Education also released a fact sheet and press release on the final rule.
HRSA announces approvals of 340B rebate pilot programs. On October 30, HRSA announced it approved eight drug manufacturer plans to participate in 340B Rebate Model Pilot Program, which will begin January 1, 2026. This program will test a rebate model (rather than the direct discount which is how the program has always operated) on a select group of drugs. Consistent with the August Federal Register Notice announcing the 340B Rebate Model Pilot Program, the approved rebate models will apply to nine of the 10 drugs selected for the Inflation Reduction Act negotiated drug prices for Medicare Part D, effective January 1, 2026.
Under a rebate model, a covered entity would pay for the drug at a higher price upfront and then later receive a post-purchase rebate that reflects the difference between the higher initial price and the 340B price. A summary of the individual manufacturer plans will be published on HRSA’s website prior to implementation. Additionally, manufacturers are required to communicate details of their plans directly to covered entities no later than 60 days prior to implementation of their respective plans.
The Senate will be in session next week, while the House is currently scheduled to continue its recess, subject to a 48-hour callback from Speaker Johnson (R-LA). With the SNAP deadline and the start date of the Marketplace open enrollment period falling this weekend, we will be watching for any movement toward ending the government shutdown, which will surpass the longest shutdown on record (35 days in 2018 – 2019) if it goes beyond November 4, 2025. The Senate Aging Committee is scheduled to hold a hearing on the Older Americans Act, and CMS likely will be working to release several final payment rules, including those for physicians, hospitals, and dialysis facilities.
