This week (September 21-25)

The House is in recess this week, while the Senate is scheduled to be in session, with a HELP Committee hearing for President Trump's FDA nominee.

Senate HELP Committee will hold a hearing on the "Nomination of Heidi Overton to be Commissioner of Food and Drugs":

• Date: Thursday, September 24 at 10:30am ET
• More information available here.

Last week (September 14-18)

Congressional Highlights

House adjourns until after midterms. On Wednesday (September 16), the House began a recess expected to last until a lame-duck session is scheduled to begin on November 9. Before adjourning, the House passed a number of bills under suspension, including a bill that would require states to consider adopting federal rate standards for data centers and other large-scale industrial power users. The House adjourned one day earlier than planned, while the Senate is currently expected to remain in session through September. Numerous outstanding policy issues will remain unresolved until after the November 3 midterm elections when Congress returns for the lame-duck session.

Administrative Highlights

CMS announces MFN actions. On Friday (September 18), CMS announced that 40 states and Puerto Rico have already signed agreements to participate in the GENEROUS Model, under which participating manufacturers will provide covered outpatient drugs to Medicaid programs at Most Favored Nations prices. CMS said the remaining states have until September 30, to sign agreements, and that all 50 states, DC and Puerto Rico have applied.

HHS establishes PPE forecast. On Friday (September 18), HHS's Office of the Assistant Secretary for Financial Resources (ASFR) announced a new policy establishing the HHS Personal Protective Equipment (PPE) Forecast. HHS said the forecast will provide American PPE manufacturers with greater visibility into anticipated federal demand to enable better-informed decisions around hiring, production, capital investment, and manufacturing capacity. HHS said the effort aims to bolster US PPE supply chains.

ARPA-H launches autism precision-care program. On Thursday (September 17), ARPA-H launched the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program. The research effort is intended to combine biological, clinical, behavioral and real-world data with computational tools to support earlier and more accurate autism diagnosis, identify factors shaping individual trajectories and develop more tailored approaches to care.

HHS appoints eight members to the U.S. Preventive Services Task Force. On Thursday (September 17), HHS announced eight new members of the U.S. Preventive Services Task Force, including a new chair. The appointees join eight current members. Task Force recommendations inform federal requirements for coverage of preventive services without cost sharing.

HHS seeks input on electromagnetic fields and wireless radiation. On Thursday (September 17), HHS issued a request for information seeking evidence on potential health effects of electromagnetic fields, radiofrequency radiation and wireless radiation exposure. HHS said the inquiry will examine the state of the science, compare domestic and international standards and regulatory approaches, identify research gaps and inform evidence-based recommendations.

FDA launches expedited IND pilot. On Tuesday (September 15), FDA announced the final design of its Expedited Investigational New Drug (IND) Pilot. The pilot will test a model in which drug sponsors work with qualified research institutions to support more efficient preparation of first-in-human IND applications, including rolling submission and review of discipline-specific components during the pre-IND phase. FDA will accept applications through October 30 and expects to select 8 to 10 sponsor-institution pairs.

ICYMI: Health Care Highlights from Recess

CMS targets suspected medical equipment fraud. On Tuesday (September 8), CMS said it identified and barred 11 durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) companies associated with more than $3.4 billion in suspected fraudulent billing in 2025 and 2026 from receiving future Medicare Advantage and Part D payments. CMS said the suppliers were added to its Preclusion List after findings that included billing for deceased beneficiaries and for equipment beneficiaries did not request or receive.

HHS awards nearly $25 million to small rural hospitals. On Thursday (September 10), the Health Resources and Services Administration (HRSA) announced nearly $25 million in Rural Hospital Provider Assistance Program awards to 132 hospitals across 13 states. HHS said the funding is intended to help eligible small rural hospitals maintain their workforce, sustain essential services and reduce the risk of avoidable closures.

HHS awards $383.4 million for behavioral health and crisis response. On Tuesday (September 8), the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $383.4 million in grants for behavioral health treatment, prevention and crisis response. Of the total, $252 million will support the 988 Suicide & Crisis Lifeline, suicide prevention and mobile crisis services, including $205.8 million for state and territory capacity-building agreements.

HHS announces FDA leadership selections. On Tuesday (September 8), HHS announced four senior FDA leadership selections: Jared Seehafer as the agency's first Deputy Commissioner for Technology and Artificial Intelligence; Michael Davis as Director of the Center for Drug Evaluation and Research; Karim Mikhail as Director of the Center for Biologics Evaluation and Research; and Bret Koplow as Director of the Center for Tobacco Products.

Hearings, Markups, and Other Committee Activity

House Ways and Means Committee Markup. On Wednesday (September 16), the Committee approved three health care bills, advancing them to the full House:

• the Alzheimer's Screening and Prevention (ASAP) Act (H.R. 6130) was approved 40-0.
• the Medically Tailored Home-Delivered Meals Program Pilot Act (H.R. 5439) was approved 39-0.
• the Apples-to-Apples Comparison Act (H.R. 4093), to require Health and Human Services to publish information on expenditures under the Medicare program, was approved 25-15.

Senate Health, Education, Labor and Pensions Committee held a hearing to consider several health care nominees. On Wednesday (September 16), the Committee heard testimony from Chris Klomp, President Trump's nominee to be Deputy Secretary of Health and Human Services, Nicole Saphier, President Trump's nominee to be the U.S. Surgeon General, and Timothy Westlake, President Trump's nominee to be Assistant Secretary for Mental Health and Substance Use. During the hearing, the nominees fielded a range of questions related to scientific integrity, public health policy, mental health services, and HHS management. Republican members focused their questions on the nominees' plans to address chronic disease, mental health and substance use disorders, regulatory efficiency, restoring public trust in public health institutions, and more. Democratic members spoke of the need to defend scientific independence and asked the nominees questions related to vaccine policy, HHS staffing and funding cuts, Medicaid and ACA coverage impacts, and concerns about political interference in public health decision-making.

The Senate Finance Committee held a hearing to consider two health care nominees. On Tuesday (September 15), the Committee heard testimony from Chris Klomp, President Trump's nominee to be Deputy Secretary of Health and Human Services, and Ge Bai, Trump's nominee to be Assistant Secretary for Planning and Evaluation (ASPE) at HHS. During the hearing, Mr. Klomp and Dr. Bai fielded questions from Democrats on their willingness to uphold the law. Mr. Klomp also faced several questions related to his position on vaccines, and mifepristone. During the hearing, Mr. Klomp spoke of his intent to coordinate across HHS departments and break down silos, while Dr. Bai spoke of the importance and value of data in finding ways to lower health care costs.

House Energy and Commerce Health Subcommittee held a hearing on "Examining Legislative Proposals to Reform Medicare Provider Payment and Bolster Health Care Cybersecurity." On Tuesday (September 15), the Subcommittee held a hearing to discuss more than a dozen bills that aim to modernize Medicare physician payment, expand access to care, strengthen rural health services, and improve cybersecurity resilience. During the hearing, members heard from a panel of witnesses representing cybersecurity, pharmacists, dermatologists, and physicians. The dominant topic of the hearing was the long-term sustainability of physician practices under the Medicare Physician Fee Schedule, with members largely voicing support for the bipartisan Patients First Act (H.R. 9693) and related proposals. Members also discussed legislation to address cybersecurity threats to hospitals, rural maternal health shortages, pharmacist-provided care, Alzheimer's screening, kidney care, epilepsy research, and access to specialty services.

House Oversight and Government Reform Health Care and Financial Services Subcommittee held a hearing on "Unequal Treatment: Addressing the Drivers of Unaffordability for Oral Chemotherapy." On Tuesday (September 15), the Subcommittee held a hearing on oral chemotherapy costs. During the hearing, members heard from a panel of witnesses representing oncologists and patients. During the hearing, members and witnesses raised concern about the growing disparity between advances in cancer treatment and insurance benefit design. Members from both parties expressed concern about affordability and access, with some members also discussing the role of pharmacy benefit managers (PBMs), insurers, prescription drug pricing, and broader health care coverage issues.