08 September 2025 This Week in Health Policy for September 8 The House and Senate will be in session this week as federal appropriators continue work on the 12 annual appropriations bills and leadership continues discussions around ways to address the September 30 government funding deadline. Senate Homeland Security & Governmental Affairs Permanent Subcommittee on Investigations will hold a hearing on "How the Corruption of Science Has Impacted Public Perception and Policies Regarding Vaccines."
House Committee on Oversight and Government Reform Subcommittees on Healthcare and Financial Services will hold a hearing on "Better Meals, Fewer Pills: Making Our Children Healthy Again."
Congress returns to a packed agenda. Congress returned from its August recess and faces a September 30 deadline to address FY 2026 federal funding. Congress has made little progress on advancing the 12 annual appropriations bills and the House and Senate remain divided on funding levels for key health care agencies. For example, the House Labor-Health and Human Services (HHS) bill would provide $108 billion for HHS in FY 2026, while the Senate bill would provide $117 billion. Both bills exceed President Trump's budget request of $94 billion. This increases the likelihood Congress will seek to pass a short-term continuing resolution (CR) that would likely maintain current funding levels until a new deal is reached. However, passage of a CR is not yet guaranteed; unlike reconciliation, Republicans will need Democratic support to pass a CR and some Republicans remain opposed to CRs. If an agreement is not reached before September 30, the federal government would shutdown. House Speaker Mike Johnson (R-LA) on Tuesday told reporters, "The ball will be in [Democrats'] corner" when asked about a federal shutdown. Lawmakers also are discussing how to address a list of health care extenders set to expire at the end of the fiscal year on September 30, including Community Health Center funding, the National Health Services Corps, Medicare telehealth flexibilities, several hospital programs including funding for Medicare Dependent Hospitals, and more. In addition, lawmakers must decide whether to allow the Affordable Care Act's enhanced Advanced Premium Tax Credits (APTC) to expire at the end of the year. This is a traditionally Democratic issue but there is some pressure to extend the credits from vulnerable Republicans, which could be a major issue in the midterm elections. If addressed, Republican leaders say they are likely to want some changes to curb the APTC's cost and impose income limits. For example, Senate HELP Committee Chair Bill Cassidy (R-LA) signaled an interest in ACA subsidy reform and examining policies to address the practice of "silver loading." Other ACA policies that could be explored this year include codifying the ACA Marketplace Integrity Rule and funding cost-sharing reduction payments. Lawmakers reintroduce Biosecure in the House and Senate. On August 28, Rep. John Moolenaar (R-MI) introduced an updated version of the Biosecure Act in the 119th Congress as an amendment to the House's National Defense Authorization Act (NDAA), which is expected to pass by December. A similar version in the Senate also has been reintroduced as a bipartisan amendment to the Senate's NDAA by Sen. Bill Hagerty (R-TN). The latest House and Senate versions make key changes intended to address lawmaker concerns that blocked the bill's passage in the last Congress. For example, the latest House and Senate versions remove the names of specific entities and instead rely on the U.S. Department of Defense's annual 1260H List to designate who qualifies as a "biotechnology company of concern." The bills also update grandfathering provisions, the definition of a biotechnology equipment or service, and add an exception for medical products or services procured in direct response to a public health emergency, among other things. The House and Senate committees are scheduled to continue work on their versions of the NDAA in early September. CMS expands ACA exchange hardship exemptions. On Thursday (September 4), CMS issued guidance to expand the hardship exemption that allows consumers who are newly ineligible for advanced premium tax credits (APTCs) or cost sharing reductions to purchase catastrophic health plans in the ACA exchanges. The plan would expand the hardship exemption to those who are over 250% of the federal poverty level and are ineligible for cost sharing reductions. CMS said beginning November 1, individuals who apply for coverage financial assistance through HealthCare.gov will be automatically evaluated for the new hardship exemption. HHS increases information blocking enforcement. On Wednesday (September 3), HHS announced plans to increase enforcement against health care entities that restrict patients' engagement in their care by blocking the access, exchange, and use of electronic health information. As part of the announcement, HHS said patients and innovators who have experienced information blocking should report it through ASTP/ONC's new Report Information Blocking Portal. The announcement comes after the Administration in late July secured voluntary commitments by 60 major health care and tech companies to advance interoperability. CDC director Susan Monarez fired. On Wednesday (August 27), the White House fired CDC Director Susan Monarez and named Jim O'Neill, deputy secretary at HHS, as acting director. In a Wall Street Journal op-ed published September 4, Monarez wrote that in a meeting in which she was pressure to "resign or face termination," she was told to told "to preapprove the recommendations of a vaccine advisory panel newly filled with people who have publicly expressed antivaccine rhetoric." During a Senate Finance Committee hearing on Thursday, HHS Secretary Kennedy denied those allegations, saying instead, "I told her that she had to resign because I asked her, 'Are you a trustworthy person?' And she said, 'No.'" FDA unveils rare disease evidence principles. On Wednesday (September 3), the FDA announced the Rare Disease Evidence Principles (RDEP), which will allow drug manufacturers of rare disease products to receive approval based on one well-controlled study and certain confirmatory evidence, such as evidence from relevant non-clinical models and clinical pharmacodynamic data. The new process aims to accelerate and simplify the review of treatments for rare diseases impacting small patient populations and driven by a known genetic defect. CMS updates AHEAD model. On Tuesday (September 2), the CMS Innovation Center announced updates to the Achieving Healthcare Efficiency through Accountable Design (AHEAD) Model. The Innovation Center said it will extend the model through December 31, 2035, add a geographic attribution of beneficiaries not attributed to other CMS accountable care organization programs, as well as new flexibilities. White House publishes Spring 2025 Unified Agenda. The Office of Management and Budget has published the Spring 2025 unified agenda outlining federal regulatory and deregulatory actions for the remainder of the year, including those for HHS and the Department of Labor. The agenda includes annual rulemaking, as well as one-off rules, including those related to new or updated CMS Innovation Center models, Transparency in Coverage, and more. FTC resumes PBM antitrust case. On August 27, the Federal Trade Commission announced it will proceed with its antitrust complaint against CVS Caremark, Cigna's Express Scripts, and UnitedHealth's Optum Rx, scheduling an evidentiary hearing for April 8, 2026. The hearing focuses on allegations that the PBMs engaged in anticompetitive rebate practices to inflate the cost of insulin products. CMS launches Rural Health Transformation Fund portal. CMS has launched a new website for the Rural Health Transformation (RHT) Program, authorized under the One Big Beautiful Bill (OBBB) law. The site outlines CMS's strategy and highlights the permitted uses of funds, such as chronic disease prevention and management, provider payments, technology-enabled care solutions, rural workforce recruitment, and cybersecurity improvements. Application instructions will be released in a Notice of Funding Opportunity (NOFO) on grants.gov in mid-September, with submissions closing in early November, and awards announced by December 31, 2025. Appeals court strikes down IEEPA tariffs. A federal appeals court has ruled that the across-the-board tariffs, North American tariffs, and certain tariffs on China exceeded the President's authority under the International Emergency Economic Powers Act (IEEPA) and were illegal. The U.S. Court of Appeals for the Federal Circuit is allowing the tariffs to remain in place until October 14 to give the Administration time for an expedited appeal to the Supreme Court. The Administration on September 3 appealed the case to the Supreme Court, requesting the court hear oral arguments in early November and expedite its ruling. Any ruling in the case will not impact the ongoing Section 232 investigation for pharmaceuticals as the appeals court ruling and a future Supreme Court ruling would only impact the President's authority under IEEPA. Accordingly, any sectoral tariffs implemented under Section 232, which could be announced at any time now, would not be impacted by these legal proceedings. Federal judge partially blocks ACA rule. On August 22, a federal judge in Maryland granted a nationwide stay of certain provisions in the Marketplace Integrity and Affordability final rule, saying HHS violated the Administrative Procedure Act. FDA revokes emergency use authorizations for COVID-19 vaccines. On August 28, the FDA revokes emergency use authorizations that allowed individuals who are below age 65 and not high risk to access the vaccines at local pharmacies. The policy change means those individuals will require a prescription for the vaccines. HHS Secretary Robert F. Kennedy announced the change in a post on the social media platform X. In response to this as well as changes to ACIP's vaccine recommendations, several blue states are considering advancing their own vaccine recommendations and issuing emergency actions to ensure access, while Florida surgeon general announced a shift away from all vaccine requirements. Cabinet meeting focuses on MFN and tariffs. At a cabinet meeting held at the White house on August 26, President Trump spoke about the price disparity for branded pharmaceuticals between U.S. and other countries, including Europe and Canada. The President called for an "equalization" of pricing to make producing pharmaceuticals in the US more competitive. HHS Secretary Kennedy added that the U.S. is "deep" into negotiations with 14 drug manufacturers to carry out the President's "Most Favored Nation's" policy in a bid to lower drug prices. Commerce Secretary Howard Lutnick added that the Section 232 investigation will support Secretary Kennedy in executing his plan to address high US drug costs. Trump signs EO on API stockpiling. On August 13, President Trump signed an Executive Order directing to the Assistant Secretary for Preparedness and Response (ASPR) to develop a plan to stockpile the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) with active pharmaceutical ingredients (APIs) of critical drugs. Specifically, the EO: Directs ASPR to identify 26 drugs critical to the health and security interests of the US and a list of available funds to support the API stockpiling effort within 30 days and to update its 2022 list of 86 essential medicines and develop a plan to domestically source, store, and maintain a 6-month supply of APIs for those products within 90 days. FDA unveils PreCheck program. On August 7, the FDA announced a new FDA PreCheck program, a new two-phase approach designed to increase communication and information sharing during the facility readiness phase and streamline the application process. FDA said the new program aims to bolster the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States. HHS ends mRNA development contracts. On August 5, HHS announced it will wind down all of its 22 mRNA vaccine development projects under Biomedical Advanced Research and Development Authority (BARDA) and will not invest in any new mRNA projects. HHS Secretary Robert F. Kennedy said, "the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We're shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate." HHS finalizes HTI-4. On August 4, HHS published the HTI-4 final rule (Health Data, Technology, and Interoperability), which includes prescription drug reforms that will allow prescribers using certified health IT tools to compare prescription drug prices in real time and identify lower-cost options based on the patient's coverage. The rule takes effect October 1, 2025, with the new "real-time prescription benefit" certification criterion taking effect January 1, 2028. CMS shares Part D bids. On July 28, CMS announced its Part D bid information for contract year 2025, in which the agency said it would phase out the Part D Premium Stabilization Program, which launched last year to address spikes in premiums for standalone Part D plans as a result of the Inflation Reduction Act's redesign of the Part D benefit, which capped out-of-pocket spending at $2,000. For 2026, CMS said it would reduce the uniform base beneficiary premium reduction from $15 to $10, increasing the cap on total Part D premium hikes to $50, and eliminating the narrowed risk corridor thresholds. Senate Finance Committee held a hearing on The President's 2026 Health Care Agenda. On Thursday (September 4), the Committee held a hearing during which they heard testimony from HHS Secretary Robert F. Kennedy Jr. During the hearing, Secretary Kennedy fielded critical questions from both sides of the aisle on his vaccine policies and the recent firing of CDC director Susan Monarez, though several Democrats engaged in more contentious exchanges with several calling for the Secretary's resignation. Following the hearing, a group of 12 Democrats, led by Ranking Member Ron Wyden (D-OR) issued a statement calling for Secretary Kennedy's resignation. Other topics of discussion included pharmacy benefit manager (PBM) reform, One Big Beautiful Bill Act's (OBBA) impact on providers, drug prices, the Affordable Care Act's enhanced subsidies, and more. Members have until Thursday, September 11 at 5pm ET to submit questions for the record.
Senate Finance Committee held an executive session to consider nominations to USTR and HHS. On Thursday (September 4), the Committee advanced the nominations Gustav Chiarello to be Assistant Secretary for Financial Resources at HHS and Michael Stuart to be General Counsel at HHS, each by a vote of 14-13. The Committee also voted 15-12 to advance the nomination of Bryan Switzer to be Deputy United States Trade Representative (USTR).
House Energy & Commerce Health Subcommittee held a hearing on "Examining Opportunities to Advance American Health Care through the Use of Artificial Intelligence Technologies." On Wednesday (September 3), the Subcommittee held a hearing during which lawmakers heard testimony from experts representing health technology companies, payers, AI companies, academics, and psychology. During the hearing, lawmakers and witnesses discussed several topics including ways in which AI can support drug discovery and development and support patient care, while prioritizing patient safety. Lawmakers during the hearing also raised concern with CMS's AI prior authorization model WiSER — which introduces prior authorization for select services in traditional Medicare, with members from both political parties warning incentives could encourage claim denials and calling for an independent review before expansion.
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