This Week (March 3 - 7)

This week, President Trump will give his State of the Union on March 4. The House and Senate will be in session and lawmakers will continue to negotiate a final budget resolution and work toward a new CR for FY 2025 funding. The Senate also will continue consideration of Trump nominees, including key health care leaders.

Senate Health, Education, Labor & Pensions Committee will hold a hearing to Nomination of Jayanta Bhattacharya to serve as Director of the National Institutes of Health

• Date: Wednesday, March 5 at 10am ET
• More information available here.

Senate Health, Education, Labor & Pensions Committee will hold a hearing to consider the Nomination of Martin Makary to serve as Commissioner of Food and Drugs

• Date: Thursday, March 6 at 10am ET
• More information available here.

Last Week (February 24 - 28)

Health Care Highlights

House and Senate pass separate budget resolutions with health implications. On Tuesday (February 25), the House voted 217-215 to pass a fiscal year 2025 budget resolution that requires at least $2 trillion in deficit reduction from committees to offset the $4.5 trillion net deficit increase needed to extend Tax Cuts & Jobs Act (TCJA) provisions expiring at the end of 2025. A minimum of $1.5 trillion in mandatory spending cuts is required from the other committees, including $880 billion from the Energy & Commerce Committee that has jurisdiction over Medicare and Medicaid. The action, which provides instruction for a future reconciliation bill, comes after the Senate last week adopted its two-bill strategy. During the Senate vote-a-rama, Democrats sought to highlight Republican plans to continue tax cuts and cut programs like Medicaid to pay for them. Those amendments were ruled out of order to the budget resolution and votes on the amendments were on motions to waive the Budget Act with respect to specific amendments, with a 60-vote threshold. Health care related amendment votes included:

• A proposal to establish a deficit-neutral reserve fund relating to protecting Medicare and Medicaid, agreed to 51-49 (but deemed insufficient by Democrats to be supported)
• A proposal to prevent tax cuts for the wealthy if a single dollar of Medicaid funding is cut, motion to waive the budget point of order not agreed to 49-51
• A proposal to establish a deficit-neutral reserve fund relating to protecting access to maternal and pediatric health care through Medicaid, not agreed to 49-51
• A proposal to "prevent millions of Americans from being kicked off their health coverage," motion to waive the budget point of order not agreed to 47-53
• A proposal to establish a deficit-neutral reserve fund to extend Affordable Care Act premium tax credits for millions of Americans, not agreed to 48-52

House leaders must now negotiate a compromise budget resolution with the Senate and then turn to crafting the actual reconciliation legislation, which under the House FY2025 budget resolution passed February 25 must include deep mandatory spending cuts. In a CNN interview on Wednesday (February 25), House Speaker Mike Johnson (R-LA) said Republicans would not include per-capita caps on Medicaid in a budget reconciliation bill, but left open the possibility of other proposals that would generate Medicaid savings. "We're not going to cut into those programs that way," Johnson said when asked if he would cap federal funding. "We're talking about finding efficiencies in every program, not cutting benefits for people who rightly deserve them."

Government funding. With the expiration of government funding looming March 14, President Trump posted on social media last night, "We are working very hard with the House and Senate to pass a clean, temporary government funding bill ('CR') to the end of September." Senate Appropriations Committee Ranking Member Patty Murray (D-WA) said Congress will need to pass a short-term CR to avoid a government shutdown without providing a target date, but she previously said a full-year continuing resolution is a nonstarter that could allow the "administration to adjust spending priorities and potentially eliminate longstanding programs." As part of government funding, lawmakers will need to address Medicare telehealth flexibilities, which are set to expire at the end of March, as well as extensions of certain hospital and public health programs and looming Medicaid disproportionate share hospital cuts. The December 2024 CR also failed to address Medicare physician payment cuts and a host of other policies, including pharmacy benefit manager (PBM) reforms, but it's unclear if those items will be considered in the next CR.

Confirmations: This week, senators continued to advance and consider Trump nominees:

• On Thursday (February 27), the Senate Health, Education, Labor & Pensions (HELP) Committee voted 14-9 to advance the nomination of Lori Chavez-DeRemer for Department of Labor Secretary to the full Senate.
• On Wednesday (February 26), the Senate confirmed the nomination of Jamieson Greer to be US Trade Representative 56-43. Four Democrats joined most Republicans in supporting the nomination — Senators John Fetterman (D-PA), John Hickenlooper (D-CO), Gary Peters (D-MI), and Sheldon Whitehouse (D-RI) — while Republican Senator Rand Paul (R-KY) opposed.
• On Tuesday (February 25), the Senate Committee on Commerce, Science, and Transportation held a nomination hearing for Michael Kratsios to serve as the director of the Office of Science and Technology Policy (OSTP) and for Mark Meador to serve as a commissioner for the Federal Trade Commission (FTC).
• On Tuesday (February 25), Senate Homeland Security & Governmental Affairs Committee held a nomination hearing for Dan Bishop to serve as deputy director of the Office of Management and Budget (OMB). Bishop's next confirmation hearing will be March 5 with the Senate Budget Committee.
• A Senate HELP confirmation hearing for Jayanta Bhattacharya to serve as Director of the National Institutes of Health is scheduled for Wednesday (March 5) and a hearing for Marty Markary to serve as FDA administrator is scheduled for next Thursday (March 6).

Administrative Procedure Act. On Friday (February 28), HHS issued a policy statement that rescinds the so-called "Richardson Waiver," effective immediately, that required HHS to use the APA's notice and comment rulemaking procedures for rules and regulations relating to public property, loans, grants, benefits, or contracts. HHS in the statement said "matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts, are exempt from the notice and comment procedures of 5 U.S.C. 553, except as otherwise required by law. Agencies and offices of the Department have discretion to apply notice and comment procedures to these matters but are not required to do so, except as otherwise required by law." The exact scope of the rules that could be impacted by the change is not immediately clear, however underlying statutes do require notice and comment remain for certain Medicare reimbursement rules, such as the Medicare Physician Fee Schedule and Advanced Notice for Medicare Advantage policy.

NIH partially lifts regulatory freeze. On Wednesday (February 26), the National Institutes of Health (NIH) partially lifted a freeze on posting new notices to the Federal Register related to "meetings of scientific review groups/study sections," according to a statement viewed by NPR and other media outlets. The statement said NIH's Center for Scientific Review would submit notices for the next 50 meetings. The move comes after dozens of study section meetings, which evaluate grant applications for medical research, did not occur as planned. NIH in the statement said other types of meetings remain "on hold."

CMS drug price negotiation implementation. On Friday (February 21), CMS announced it will hold Medicare Drug Price Negotiation Program public engagement events. CMS on April 30 will host a town hall meeting for all selected drugs, focused on the clinical considerations related to the selected drugs and from April 16 to 30 CMS will host 15 private patient-focused roundtable events, one for each selected drug. Those private events will be open for registration until March 12 and may include patients, patient advocacy organizations, and caregivers.

ICYMI: Updates on executive actions since February 17

Latest Trump executive actions. In the past two weeks, President Trump signed several executive orders (EO) and other actions with implications for health care:

• Price transparency: On Tuesday (February 25), Trump signed an EO that directs the US Departments of the Treasury, Labor, and HHS to "rapidly implement and enforce" health care price transparency regulations within 90 days. The EO directs agencies to require disclosure of prices of items and services, not estimates; update guidance or proposed regulatory action to ensure pricing information is standardized and comparable across hospitals and plans, including prescription drug prices; and issue guidance or proposed regulatory action to update enforcement policies designed to ensure compliance. Click here for a fact sheet.
• In vitro fertilization (IVF): On February 18, Trump signed an EO that directs the assistant to the president for domestic policy to submit within 90 days a list of policy recommendations to protect in vitro fertilization (IVF) access and reduce the out-of-pocket and health plan costs for the treatment. Click here for a fact sheet.
• COVID-19 vaccines: On February 15, Trump signed an EO that directs the Department of Education to withhold discretionary funds from schools and institutions of higher education that require COVID-19 vaccination. Click here for a fact sheet.
• Independent agencies: On February 18, Trump signed an EO that requires independent agencies, including the Federal Trade Commission, to submit proposed regulations to the Office of Information and Regulatory Affairs before publication in the Federal Register. The EO also directs OMB to establish performance standards and management objectives for independent agencies and to review agency actions for consistency with presidential priorities.
• Deregulation: On February 19, Trump signed an EO that directs the heads of federal agencies to work with DOGE and OMB to review all regulations for consistency with law and the president's priorities. The EO gives agencies 60 days to submit to OMB a list of regulations considered outside the scope of statutory authority. It instructs agencies to deprioritize enforcement of those regulations.
• Federal workforce: On February 19, Trump signed an EO that directs the heads of certain agencies to terminate federal advisory committees, including the HHS Secretary's Advisory Committee on Long COVID, the CMS Health Equity Advisory Committee, and the USAID's Advisory Committee on Voluntary Foreign Aid.

Updates on legal challenges to previous Trump executive actions. This week, dozens of court cases challenging Trump administration actions continue to progress.

• Federal workforce. On Thursday (February 27), a San Francisco-based judge ruled that the Office of Personnel Management (OPM) broke the law when it directed federal agencies to terminate probationary workers. The ruling came in response to a lawsuit filed by several labor unions, including the A.F.L.-C.I.O. and the American Federation of Government Employees. The order only applies to agency employees involved in the lawsuit, which includes the Department of Veterans Affairs but does not include the Department of Health and Human Services, which has initiated layoffs under the OPM guidance. According to media reports, layoffs have impacted about 750 workers at the Centers for Disease Control and Prevention and up to 1,200 workers at the National Institutes of Health. FDA staff have also been impacted, but total numbers remain unclear. The administration has reportedly re-hired some FDA staff in critical jobs. More layoffs within HHS are expected and it's unclear whether the judge's order will impact those decisions. On February 19, all 47 Democratic senators signed a letter asking HHS Secretary Kennedy to provide information on the number of recently fired HHS employees, how the personnel decisions were made and communicated, and how the cuts will impact HHS programs and activities.
• Gender-affirming care. On February 14, a federal judge issued a two-week temporary restraining order that blocks the federal government from withholding funds from health care entities that provide gender-affirming care to patients under 19.

Hearings, Markups, and Other Committee Activity

House Energy and Commerce Committee held a hearing on "An Examination of How Reining in PBMs Will Drive Competition and Lower Costs." On Wednesday (February 26), the Subcommittee held a hearing that focused on the impact PBMs have on pharmacies, drug prices, formulary placement and patient costs. The hearing largely focused on a bipartisan package of PBM reforms, including several that advanced out of the House Energy and Commerce Committee last session, that were included in an initial continuing resolution last December, with members from both parties calling for their passage. Democrats often criticized House Republicans for removing the legislation from the year-end funding agreement and spoke critically of the House-passed budget resolution's potential impact on Medicaid funding.

• More information available here.

Senate Special Committee on Aging hearing on "Combating the Opioid Epidemic." On Wednesday (February 26), the Committee heard from a panel of witnesses representing caregivers, county commissioners, law enforcement, think tanks, and medical professionals. During the hearing, topics discussed included medication-assisted therapy, eliminating the Medicaid inmate exclusion, and law enforcement tactics to combat drug dealers. Democrats during the hearing highlighted ways in which Medicaid cuts would impact access to and coverage of substance use disorder treatment, while Republicans spoke favorable of increasing boarder security.

• More information available here.

House Ways and Means Trade Subcommittee held a hearing on American Trade Enforcement Priorities. On Tuesday (February 25), the Subcommittee held a hearing on American Trade Enforcement Priorities, which included discussion of the de minimis exception, the upcoming review of the USMCA in 2026, inaction on the trade agenda during the last Administration, and, from Democrats, concerns about the consumer costs of tariffs that may be pursued by the current Administration, including the potential to increase drug costs. There was relatively little discussion about the specifics of the tariff announcements by President Trump, and some of the Administration's plans are in flux, waiting on, for example, the conclusion of reviews, investigations and recommendations under the America First Trade Policy memo due April 1.

• More information available here.

House Energy and Commerce Committee held a markup of their authorization and oversight plan. On Tuesday (February 25), the Committee discussed the committee's oversight and authorization plan for the 119th Congress. Each House committee must submit such a plan to the House Administration and Oversight and Government Reform Committees by March 1. The plan states that the Energy & Commerce Committee will conduct oversight of federal agencies' efforts on biological threat preparedness and response, ensure cost transparency in Medicare and Medicaid, examine the cost of chronic diseases, and examine government cybersecurity initiatives.

• More information available here.

House Veterans Affairs Subcommittee on Technology Modernization Oversight held a hearing on "From Reset to Rollout: Can the VA EHRM Program Finally Deliver?" On Monday (February 24), the Subcommittee held a hearing on the VA's electronic health record modernization (EHRM) project during which lawmakers heard testimony from representatives from the VA, the VA Office of Inspector General, and the Government Accountability Office, as well as former CMS administrator Seema Verma who now leads Oracle Health. During the hearing, Ms. Verma fielded questions on Oracle's implementation of the VA's EHRM, which it took over when it acquired Cerner in June 2022.

• More information available here.

House Energy and Commerce Committee Data Privacy Working Group issues RFI. On Friday (February 21), Chairman Brett Guthrie (R-KY) and Rep. John Joyce (R-PA) issued a request for information on artificial intelligence, data security, enforcement, and other topics that will be covered by the Data Privacy Working Group.

• More information available here.

Senate Judiciary Committee votes to advance HALT Fentanyl Act. On Thursday (February 20), the Committee voted 16-6 to advance the HALT Fentanyl Act (S. 331) that would permanently classify fentanyl-related substances as schedule I controlled substances, align penalties for offenses with those for fentanyl analogues, establish a new registration process for certain fentanyl research, and update research registration requirements. The bill, which passed the House earlier this month, now goes to the full Senate.

• More information available here.

Reports, Studies, and Journals

Congressional Budget Office: CBO Explains Common Sources of Uncertainty in Cost Estimates for Legislation. The primer explains how CBO prepares cost estimates for legislation and describes six sources of uncertainty in their estimates, including broad legislative language, insufficient data, behavioral responses, dependence on a future event, and more.

HHS Office of Inspector General: Medicare Part D Spending for 10 Selected Diabetes Drugs Totaled $35.8 Billion in 2023, an Increase of 364 Percent From 2019. The report provides an overview of Medicaid enrollment for children who age-out of the foster care system, finding 112,000 individuals were enrolled in this group in 2023.