On June 25, Senate HELP Committee Chair Bill Cassidy (R‑LA) released a legislative discussion draft of the 340B Drug Pricing Integrity and Affordability for Patients Act, alongside a section‑by‑section summary and one‑pager outlining proposed reforms to the 340B Drug Pricing Program. The draft seeks to address concerns regarding program transparency, oversight, and whether and how 340B savings are reaching low‑income and uninsured patients, following several years of HELP Committee investigation and oversight activity. The proposal includes a broad set of policy changes aimed at preventing waste, fraud, and abuse; increasing accountability and reporting on use of 340B savings; clarifying program requirements; and establishing patient protections, including requirements to better ensure affordability for vulnerable populations.  

 The proposal includes provisions which: 

• Allow manufacturers to elect to offer 340B discounts through “upfront discounts, discounts after submissions of standardized claims data to a claims repository operated by the Secretary of Health and Human Services (HHS), or retroactive rebates within 10 days of submission of standardized claims data.” However, the proposal would also allow a covered entity to choose how to receive discounts or rebates; 
• Increase oversight of 340B subgrantees, including “their public nonprofit status, certification that revenues from the 340B Program are consistent with the grant’s scope, and verification that the covered entity’s patient population is primarily low income or uninsured;”  
• Define a “patient” for the purposes of claiming revenue from the patient’s 340B prescription to those that the covered entity has provided care to in the last two years, maintained a relationship with, and written the prescription for;  
• Restrict the use of “child sites,” or off-campus outpatient facilities, such that child sites must be outpatient facilities that provide services other than solely drug dispensing and require the child site to be located in a “personal health services” shortage area; and  
• Require certain hospital covered entities to “establish a sliding fee scale to limit the maximum out-of-pocket obligations for low-income and uninsured patients.” 

The discussion draft signals continued congressional interest in restructuring the 340B program to emphasize patient benefit and improve program integrity, with potential implications for covered entities, manufacturers, and contract pharmacy arrangements. However, Chair Cassidy does not indicate that the draft is the product of broader collaboration with other members. 

 Chair Cassidy is accepting stakeholder feedback via email ([email protected]) through August 28. 

On June 25, President Trump announced the nomination of HHS Chief Counselor Chris Klomp to serve as Deputy Secretary of HHS. President Trump made the announcement on Truth Social, noting that the decision was made jointly with HHS Secretary Kennedy and CMS Administrator Oz. Mr. Klomp, a health tech entrepreneur and former CEO of Collective Medical, has served as HHS Chief Counselor since February 2026, overseeing departmental operations and personnel decisions, including leadership appointments at the CDC and FDA, as well as leading Medicare policy work. He holds the positions of Director of the Center for Medicare and Deputy Administrator at CMS. In the post announcing his nomination, President Trump specifically notes the work done by Mr. Klomp to negotiate voluntary most-favored-nation drug pricing agreements with 17 pharmaceutical companies. The nomination is subject to Senate confirmation, and the Senate Finance Committee is expected to hold a hearing and vote on Mr. Klomp’s nomination prior to consideration by the full Senate.

On June 24, the CDC posted a revised charter for the Advisory Committee on Immunization Practices (ACIP) that broadens the committee’s scope, alters its membership criteria, and reduces its operational resources. In May, HHS noticed an updated charter that was subsequently withdrawn due to administrative errors. ACIP is a CDC advisory body comprised of up to 19 voting members appointed by the HHS Secretary that makes recommendations on vaccine use and for the Vaccines for Children (VFC) program under the Social Security Act. Its recommendations have health insurance coverage implications as well. 

 The new charter expands the description of duties of the committee to include consideration of “non-vaccine interventions for disease prevention,” identification of areas for additional data and evaluation to inform future recommendations, as well as gaps or uncertainties in vaccine safety information, and provision of recommendations on “special populations.” It also specifically references consideration of international vaccine schedules for comparative or contextual purposes when in carrying out its review. The charter also shifts administrative support for ACIP from CDC’s National Center for Immunization and Respiratory Diseases to the CDC Office of the Chief of Staff. 

 With respect to membership, the prior charter required members to be knowledgeable in immunization and public health with expertise in vaccine use and clinical experience. The revised charter states only that members represent a “balanced range of scientific, clinical, and public health expertise relevant to the Committee’s mission.” The prior charter’s recordkeeping provision, which made records available to the public and subject to the Freedom of Information Act (FOIA), has also been removed. 

 The publication of the charter follows a March 2026 preliminary court ruling that found HHS Secretary Robert F. Kennedy, Jr.’s June 2025 restructuring of ACIP’s membership to be likely unlawful. Critics have characterized the revised charter as an effort to align the committee’s formal qualification criteria with the Administration’s existing appointees. 

On June 23, the Federal Acquisition Regulatory (FAR) Council proposed a series of amendments to the Federal Acquisition Regulation (FAR) to streamline federal contracting procedures and reduce administrative processes. The White House announced the proposal’s publication on June 25. The FAR Council consists of members from the Office of Budget Management (OMB), the Department of Defense, NASA, the Office of Federal Procurement Policy (OFPP), and General Services Administration (GSA). These amendments are the first of three expected FAR reform proposals, representing the first significant changes to FAR in the past 40 years. The proposal was first prompted by the White House in an April 15, 2025, Executive Order (EO) titled, “Restoring Common Sense to Federal Procurement,” which calls for revision to FAR to simplify and expedite federal contracting processes.  

The proposal includes amendments to 20 sections of the existing FAR and spans more than 1,000 pages. The primary goals of the amendments are to streamline FAR and regulatory review systems by coordinating regulation across government agencies and reducing paperwork requirements for acquisitions. Overall, the proposal aims to shift FAR policy focus to a principles-based framework, as opposed to the existing procedures-based regulatory requirements. The proposed rules significantly reduce the number of regulations involved in government procurement decisions, allowing contractors more discretion in FAR interpretation and relying more heavily on contractor judgment. The proposed amendments have a broad scope of impact and will address all forms of government contracts involved in national defense, which includes “any activity related to programs for military or atomic energy production or construction,” or “stockpiling.” The comment period for the proposed rule closes July 23.