Health Care Watch: February 3, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 26 – February 1. 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 January 25, Speaker Mike Johnson (R-LA) said that President Trump has been invited to address a Joint Session of Congress on March 4.
On January 31, Rep. Greg Murphy (R-NC) introduced bipartisan legislation that would increase pay to doctors and effectively eliminate the Medicare payment cut by 6.62% for the rest of the year. The legislation would also provide extra payment to address inflation and offset the deficit from the cut in the first part of the year.
On February 3, the House will consider H.R. 27, the Halt All Lethal Trafficking of Fentanyl Act.
Senate
On January 27, Homeland Security and Governmental Affairs Committee Chairman Rand Paul (R-KY) announced that the Committee subpoenaed 14 agencies from the outgoing Biden-Administration regarding the origins of COVID-19 and taxpayer-funded gain-of-function research. Agencies that received the orders include the National Institutes of Health (NIH), Department of Health and Human Services (HHS) and the U.S. Agency for International Development (USAID).
On January 28, Sen. Gary Peters (D-MI) announced that he will not seek reelection in 2026.
On January 29, Appropriations Committee Chair Susan Collins (R-ME) and Ranking Member Patty Murray (D-WA) announced the subcommittee chairs, ranking members, and subcommittee rosters for the 119th Congress. Sen. Shelley Moore Capito (R-WV) will Chair the Labor, Health and Human Services (HHS), and Education, and Related Agencies Subcommittee and Sen. Tammy Baldwin (D-WI) will serve as Ranking Member.
On January 29, the Finance Committee held a hearing to consider the nomination of Robert F. Kennedy, Jr. (RFK Jr.), to serve as HHS Secretary. Members discussed topics including vaccine safety, pharmacy benefit manager (PBM) reform, the Inflation Reduction Act (IRA) Medicare drug price negotiation program, and abortion. The Finance Committee will vote on RFK Jr.’s nomination in the coming days.
On January 30, the Health, Education, Labor & Pensions (HELP) Committee held a hearing to consider the nomination of RFK Jr. to serve as HHS Secretary. Committee members spent most of the time discussing RFK Jr.’s views on vaccines including past statements made by the nominee claiming that vaccines cause autism and questioning the effectiveness of the polio and measles vaccines. Members also discussed the IRA’s Medicare drug pricing provisions, coverage of abortion medications, hiring at agencies within HHS, and RFK Jr.’s ethics filings.
On January 30, the Budget Committee voted to advance Russ Vought’s nomination to serve as Director of the White House Office of Management and Budget (OMB). The Committee voted 11-0 without any Democratic members present.
On January 30, Finance Committee Ranking Member Ron Wyden (D-OR) led all 12 Democratic members of the committee in sending a letter to RFK Jr. asking him to answer a dozen questions regarding his views on Medicare drug price negotiation and confirm that he will not pause negotiations. Specifically, the letter asks whether RFK Jr., if confirmed, will follow IRA’s statutory requirements related to Medicare drug price negotiation and whether the Trump administration will continue to defend the law in the court.
On January 30, Judiciary Committee Chairman Chuck Grassley (R-IA), HELP Committee Chairman Bill Cassidy (R-LA) and Sen. Martin Heinrich (D-NM) introduced the Halt Lethal Trafficking (HALT) Fentanyl Act. The bipartisan legislation would permanently classify fentanyl-related substances as Schedule I under the Controlled Substances Act.
On January 31, the Finance Committee released RFK Jr.’s answers to committee members questions submitted for the record.
REGULATORY UPDATE
On January 26, the Food & Drug Administration (FDA) approved Biogen and Eisai’s application for monthly intravenous maintenance dosing for the Alzheimer’s drug Leqembi. Leqembi is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment or the mild dementia stage of disease.
On January 26, Centers for Disease Control & Prevention (CDC) Official John Nkengasong sent a letter to senior CDC leadership stating that all staff who work with the World Health Organization (WHO) must immediately stop their collaborations and await further guidance. The letter comes after President Trump signed an Executive Order (EO) withdrawing the United States from the WHO.
On January 27, HHS Acting Secretary Dorothy Fink released a statement announcing that the Office for Civil Rights (OCR) will reevaluate its regulations and guidance pertaining to Federal laws on conscience and religious exercise. She stated that pursuant to the President Trump’s EO, Enforcing the Hyde Amendment, HHS will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion.
On January 29, CMS released a statement maintaining that lowering the cost of prescription drugs for Americans is a “top priority” of President Trump and his Administration. The statement also confirmed that CMS – “in accordance with statutory requirements of the Inflation Reduction Act” – already released the list of 15 Part D drugs selected for Medicare negotiation for initial price applicability year (IPAY) 2027. CMS also noted that they Agency is committed to incorporating lessons learned to date and to considering opportunities to bring greater transparency in the negotiation program.
On January 30, CMS issued a Health Plan Management System (HPMS) memorandum notifying manufacturers and other stakeholders that the Negotiation Data Elements and Drug Price Negotiation Process information collection request (ICR) form for IPAY 2027 is now open for submissions from manufacturers and the public. The memo notes that manufacturers of drugs selected for negotiation must submit the requisite information by March 1, 2025. Additionally, other stakeholders may submit evidence about the selected drug and alternative treatments by March 1, 2025.
On January 30, FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Journavx is the first drug to be approved in this new class of pain management medicines.
WHITE HOUSE
On January 24, President Trump fired 18 inspectors general across federal agencies, including the former HHS Inspector General Christi Grimm. As a result, Senate Judiciary Chairman Charles Grassley (R-IA) and Ranking Member Richard Durbin (D-IL) sent a letter to President Trump requesting him to “provide the lawfully-required substantive rationale behind his recent decision to dismiss Inspectors General (IGs) from 18 offices.” The letter also asks President Trump to name who will serve in an acting IG capacity and urges the President to quickly nominate qualified and nonpartisan individuals to permanently fill the current IG vacancies.
On January 27, OMB released a memorandum directing a regulatory freeze of agency grant, loan, and other financial assistance programs. The freeze requires Federal agencies to identify and review all Federal financial assistance programs and supporting activities consistent with the President’s policies and requirements and respond to a variety of questions by February 7, 2025. The memo explicitly excluded Medicare and Social Security but caused confusion as to other programs that could be impacted, including Medicaid. As a result of the confusion, a lawsuit was filed and a federal judge granted an administrative stay that temporarily paused the order until February 3. On January 29, the Trump Administration rescinded the original OMB memo; however, stated that the rescission only applies to the memo, and that the Administration will proceed with freezing federal funds implicated by President Trump’s EOs. In response, another federal judge indicated that they may intervene with a broader action to prohibit the freeze in payments.
REPORTS
Government Accountability Office (GAO)
On January 29, GAO released a report examining public health workforce challenges and gaps. GAO found gaps between the existing public health workforce and the workforce needed. GAO stated that the gaps have existed across multiple occupations and jurisdictions and were exacerbated during public health emergencies and limit the ability of jurisdictions to conduct key public health functions, such as disease investigation and control, identification of hazards, and readiness to respond to emergencies. GAO stated that HHS and selected jurisdictions have taken some steps to mitigate challenges and gaps including: 1) HHS responding to funding challenges by offering jurisdictions greater flexibility in using certain grant funds for workforce hiring and support; and 2) selected jurisdictions addressing the challenges of market competition, cumbersome hiring processes, and stressful workplace environments by offering financial incentives and improving hiring processes.
HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
February 6; 10:00 AM; 2123 Rayburn
Hearing on Illicit Drug Threats
Senate
Judiciary Committee
February 4; 10:30 AM; 226 Dirksen
The Poisoning of America: Fentanyl, its Analogues, and the Need for Permanent Class Scheduling
ADDITIONAL POLICY NEWS
On January 24, the European Commission announced that it signed a contract with Moderna to procure up to 146 million doses of the company's mRNA COVID-19 vaccine over the next four years.
On January 27, the Medicare Payment Advisory Commission (MedPAC) released its comment letter on the Centers for Medicare & Medicaid Services (CMS) 2026 Policy and Technical Changes proposed rule. MedPAC’s comments focus on: 1) network transparency for pharmacies; 2) Medicare Advantage (MA) supplemental benefits; 3) analysis of utilization management policies and procedures; 4) MA network adequacy plan benefit package–level reviews; 5) format MA organizations’ provider directories for Medicare Plan Finder; and 6) formulary inclusion and placement of generics and biosimilars.
On January 27, Novo Nordisk filed a motion with the U.S. Court of Appeals for the Third Circuit urging the court to accelerate its ongoing legal complaint against IRA’s Medicare drug price negotiation program.
On January 28, KFF released a report examining MA insurers’ prior authorization determinations. KFF found that MA plans made nearly 50 million prior authorization determinations in 2023, reflecting steady year-over-year increases since 2021 (37 million) and 2022 (42 million). Additionally, KFF found that in 2023, there were nearly 2 prior authorization determinations, on average, per MA enrollee. KFF also found that a small share of denied prior authorization requests were appealed in MA (11.7% in 2023), however, most appeals (81.7%) were partially or fully overturned in 2023.
On January 31, Genentech sued HHS in the U.S. District Court for the District of Columbia for wrongfully certifying “supposed STD clinics” to receive discounts through the 340B program despite being ineligible.