Health Care Watch: April 21, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 13 – April 19. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On April 13, Energy & Commerce Committee Chairman Brett Guthrie (R-KY) told reporters that he expects between $500 billion and $600 billion of the Committee’s $880 billion spending-cut target to come from health care programs. The Committee could meet as soon as the week of May 5 to begin marking up its portion of the budget reconciliation package.
On April 14, a group of 12 moderate House Republicans, including Reps. David Valadao (R-CA) and Don Bacon (R-NE), sent a letter to Republican leadership, including House Speaker Mike Johnson (R-LA) and Energy & Commerce Committee Chairman Guthrie, stating that they will not support a final reconciliation bill that includes any reduction in Medicaid coverage for vulnerable populations.
On April 16, Reps. Lloyd Doggett (D-TX) and Greg Murphy (R-NC) sent a letter to Government Accountability Office (GAO) Comptroller Gene Dodaro asking that GAO investigate the growth of Medicare Advantage (MA) insurers. The letter asks that GAO examine if Medicare Advantage Organizations (MAOs) have been avoiding the federal Medical Loss Ratio (MLR) requirement to spend at least 85% of revenue on beneficiaries' health care. Reps. Doggett and Murphy cite concerns that the acquisition of related businesses such as health care providers by MAOs could undermine the effectiveness of MLR requirements.
On April 16, the Ways & Means Committee Chairman Jason Smith (R-MO) and Oversight Subcommittee Chairman David Schweikert (R-AZ) issued a Request for Information (RFI) on activities of tax-exempt Organ Procurement Organizations (OPOs). The request comes as part of the Committee’s examination into whether OPOs are abiding by existing laws and regulations. The Committee is also interested in reports that suggest certain OPOs have billed Medicare for costs that may not be appropriate or allowable under law. The open letter requests information and input regarding OPO operations, their allocation of resources, and the existing rules and regulations governing them. Responses are due by May 16.
On April 17, Ways and Means Committee Chairman Smith, Health Subcommittee Chairman Vern Buchanan (R-FL), and Ways and Means Committee Member Representative Jimmy Panetta (R-CA) sent a letter to Acting Internal Revenue Service (IRS) Commissioner Gary Shapley, Jr., asking that IRS update and expand the list of services and treatments for chronic diseases covered under employer-sponsored high-deductible health plans (HDHP).
The House is in recess until April 28.
Senate
The Senate is in recess until April 28.
REGULATORY UPDATE
On April 11, Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. visited the Food & Drug Administration’s (FDA) headquarters in Silver Spring, MD, where he delivered remarks where he charged employees with the responsibility of responding to and ending the chronic health care crisis.
On April 14, the Department of Commerce announced, via a Notice of Request for Public Comment in the Federal Register, an investigation into the national security impacts of importing drugs and active pharmaceutical ingredients. The investigation – which could lead to “Section 232 tariffs” on the pharmaceutical industry – includes both generic and brand drugs. Comments are due by May 7, 2025.
On April 14, FDA notified Ozempic (semaglutide) users and sellers of the need to check their products’ lot and serial numbers after the agency seized counterfeit versions of the drug. Novo Nordisk notified the agency that several hundred units of counterfeit Ozempic had entered the U.S. drug supply chain.
On April 16, HHS Secretary Kennedy held a press conference to discuss the Centers for Disease Control and Prevention’s (CDC) latest Autism and Developmental Disabilities Monitoring (ADDM) Network survey. According to the report, autism prevalence in the U.S. has increased from 1-in-36 children to 1-in-31. Secretary Kennedy stated that he thinks environmental toxins are a primary cause of autism and highlighted the need to move away from the ideology that autism prevalence increases are due to better diagnoses, directly contradicting CDC’s report which stated that the increase is tied to better screening.
On April 15 and 16, CDC’s outside panel of vaccine experts, the Advisory Committee on Immunization Practices (ACIP), met to consider several vaccines. ACIP expanded its recommendation for respiratory syncytial virus (RSV) vaccination to include adults aged 50-59 at increased risk of severe RSV disease. ACIP also voted to recommend the use of a 5-in-1 meningococcal vaccine for some individuals who would have otherwise received two separate meningococcal vaccines at a provider visit, including healthy individuals aged 16-23 receiving the routine meningococcal vaccine schedule, or individuals 10 or older at increased risk.
On April 17, FDA Commissioner Dr. Martin Makary announced a policy directive that limits individuals employed at companies regulated by FDA, such as pharmaceutical companies, from serving as official members on FDA advisory committees.
WHITE HOUSE
On April 14, President Trump issued a wide-ranging drug pricing Executive Order (EO) entitled Lowering Drug Prices by Once Again Putting America First. The EO includes the following provisions grouped by topic area:
Medicare Drug Price Negotiation: The EO directs the HHS Secretary to seek comment on new negotiation guidance, and to make recommendations on how to stabilize and reduce Part D premiums. The EO also directs the HHS Secretary to work with Congress to eliminate the “pill penalty” by “aligning” the treatment of small molecule drugs with biological products.
New Drug Pricing Model: The EO directs the HHS Secretary to take steps to develop and implement a “rulemaking plan” to test a new payment model to obtain “better value” for high-cost Medicare drugs.
340B: The EO directs the HHS Secretary to conduct a survey to determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments (HOPDs), and to consider adjustments to align Medicare payment with the acquisition cost. The survey may be a precursor to Medicare ASP-based payment cuts to 340B-acquired drugs administered in the HOPD, as attempted under President Trump’s first term. The EO also directs the HHS Secretary to reinstitute a policy from President Trump's first term to make insulin and injectable epinephrine available at or below the 340B discounted price paid by Federal Qualified Health Centers.
Site-Neutrality: The EO directs the HHS Secretary to consider regulations to ensure that Medicare payment is not encouraging a shift in drug administration volume away from physician office settings to HOPDs.
Drug Manufacturer Anti-Competitive Behavior: The EO directs the HHS Secretary to conduct public listening sessions with the Departments of Justice and Commerce, and the Federal Trade Commission and issue a report to reduce anti-competitive behavior from pharmaceutical manufacturers.
PBM Transparency: The EO directs the Secretary of Labor to propose regulations to improve employer health plan fiduciary transparency into the direct and indirect compensation received by PBMs.
Other Provisions: The EO directs the FDA to issue a report providing recommendations to accelerate the approval of generics and biosimilars and improve the process through which drugs can be reclassified as over-the-counter medications. The EO also directs the FDA to “make it easier” for states to pursue drug importation programs. The EO directs the Secretary to provide recommendations on promoting innovation in Medicaid drug payment methodologies.
On April 16, an internal budget document, providing a vision of HHS Secretary Kennedy’s Administration for a Healthy America (AHA), was leaked to the press. The document, from the Office of Management and Budget (OMB), calls for $20 billion in cuts to NIH funding and provides $14 billion of HHS’ $80 billion budget to AHA. Ultimately, the document calls for about $40 billion, or one-third of the HHS discretionary budget, to be cut under the proposal compared with fiscal 2024 levels. The document suggests eliminating programs for rural health care providers, HIV treatment efforts, health care workforce initiatives and childhood lead poisoning and offices such as the Administration for Preparedness and Response. The document also reflects HHS’ intention to move regulation of the 340B program from HRSA to CMS and to seek new authority to regulate all aspects of the 340B program including requiring covered entities to report on the use of 340B savings.
On April 17, President Trump extended, through July 15, the freeze on the hiring of Federal civilian employees within the executive branch, as initially directed in the Presidential Memorandum of January 20.
On April 18, the White House’s COVID-19 website, which previously provided information about the virus and where people could seek free tests, redirected to a page that details the Trump administration’s endorsement of the “lab leak” theory that the pandemic originated in the Chinese laboratory, and blames American health officials including Anthony Fauci for an alleged cover-up.
A list of all administrative and health care-related EOs can be found here. FHP Strategies will update this document, as needed.
HEARINGS
Senate
Appropriations Committee
April 30; 10:30 AM; 106 Dirksen
Biomedical Research: Keeping America’s Edge in Innovation
REPORTS
Congressional Budget Office (CBO)
On April 14, CBO released a report entitled Transparency at CBO: Plans for 2025 and a Review of 2024. CBO states that transparency is a top priority and transparency efforts are intended to promote a thorough understanding of CBO's work, help people gauge how estimates might change if policies or circumstances differed, and enhance the credibility of the agency's analyses and processes. The report states that in 2025, the agency will undertake a variety of activities aimed at fostering transparency, such as: 1) sharing more information to help people understand the federal budget process and CBO's role in it; and 2) explaining the methods it uses for its analyses in several topic areas, including national security, health care, taxation, and economic projections. These efforts build on CBO's activities in 2024, which included testifying before Congressional committees and answering Members' questions, releasing data, evaluating the accuracy of the agency's estimates, comparing current and previous estimates, estimating the effects of policy alternatives, characterizing the uncertainty surrounding estimates, creating data visualizations, and conducting outreach.
Government Accountability Office (GAO)
On April 14, GAO released a report examining Medicare enrollees’ use medications to treat opioid use disorder (OUD). GAO found that opioid overdoses among Medicare beneficiaries increased slightly in 2023 to 53,000. GAO also found that with the buprenorphine waiver repealed, more providers ordered buprenorphine for Medicare enrollees in 2023 than in 2022, however, despite the increase in the number of providers ordering buprenorphine, fewer than one-in-five Medicare enrollees received any medication to treat their OUD. Additionally, GAO found that more than 750,000 Medicare enrollees received opioid overdose-reversal drugs through Part D in 2023, a record high. Virtually all received naloxone, however, with the most dispensed form of naloxone now available over the counter, Medicare enrollees are losing Part D coverage of this form of naloxone, which could lead to higher out-of-pocket costs. GAO stated that its findings show a continued need for CMS to work to ensure access to both medications for OUD and opioid overdose-reversal drugs. OIG encourages CMS to implement recommendations that were previously made related to these topics.