Health Care Week in Review | Congress Passes Government Funding Package; HHS Nominee Confirmation Process Heats Up

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.

Week in Review Highlight of the Week:

This week, Congress passed a continuing resolution to fund the government through September 30, 2025 and nominees to head the FDA, NIH, and CMS all took steps in their confirmation process while the White House withdrew its nomination for CDC Director.

1. Regulations, Notices & Guidance

• On March 11, 2025, the Executive Office of the President (EOP) released a memorandum entitled, Ensuring the Enforcement of Federal Rule of Civil Procedure 65(c). This executive order mandates that federal agencies enforce Federal Rule of Civil Procedure 65(c), which requires parties seeking preliminary injunctions or temporary restraining orders against the federal government to provide security to cover potential costs and damages if the injunction is wrongly issued. This aims to deter frivolous lawsuits and ensure that taxpayers do not bear the financial burden of such legal actions. The order directs agency heads, in consultation with the Attorney General, to request that federal courts require plaintiffs to post security equal to the government's potential costs and damages. This policy comes in the context of a series of injunctions issued against the Trump Administration’s actions by federal courts.
• On March 12, 2025, the Food and Drug Administration (FDA) released a notice entitled, E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period. FDA is reopening the comment period for the draft guidance announced in the Federal Register of December 30, 2024 to allow interested persons additional time to submit comments. Electronic or written comments on the draft guidance must be submitted by March 31, 2025.
• On March 12, 2025, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib).  FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GOMEKLI (mirdametinib), approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher.
• On March 13, 2025, the Department of Health and Human Services (HHS) released a proposed rule entitled, Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability. This proposed rule would revise standards relating to past-due premium payments; exclude Deferred Action for Childhood Arrivals recipients from the definition of “lawfully present”; the evidentiary standard HHS uses to assess an agent’s, broker’s, or web-broker’s potential noncompliance; failure to file and reconcile; income eligibility verifications for premium tax credits and cost-sharing reductions; annual eligibility redetermination; the automatic reenrollment hierarchy; the annual open enrollment period; special enrollment periods; de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and the premium adjustment percentage methodology; and prohibit issuers of coverage subject to EHB requirements from providing coverage for sex-trait modification as an EHB.
• On March 13, 2025, HHS’ Office of the Secretary released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. This notice revises and restates the Statement of Organization, Functions, and Delegations of Authority for HHS’ Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.

Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings may be cancelled or postponed. We are continuing to monitor.

• March 27-28, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
• March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.
• April 2, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a hearing to reconsider its decision to disapprove Idaho’s Medicaid State Plan Amendment, numbered 24-0015. This is a hybrid hearing open to the public.
• April 3, 2025: The National Institutes of Health (NIH) announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
• April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
• April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• May 14, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
• June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
• August 6-7, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of ACTPCMD. This is a hybrid meeting open to the public.
• September 11-12, 2025: HRSA announced a meeting of the COGME. This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.

2. Hearings & Markups

• On March 11, 2025, the Senate Armed Services Committee held a hearing entitled, Stabilizing the Military Health System to Prepare for Large-Scale Combat Operations. Witnesses included: Dr. Douglas Robb, retired Air Force Lieutenant General, former Director of the Defense Health Agency; Dr. Paul Friedrichs, retired Air Force Major General, former Joint Staff Surgeon; and Dr. Jeremy Cannon, retired Air Force Colonel, trauma surgeon, and faculty member at the University of Pennsylvania School of Medicine.
• On March 11, 2025, the House Oversight and Government Reform Committee, Government Operations Subcommittee held a hearing entitled, Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud. Witnesses included: Ms. Kristen Kociolek, Managing Director, Financial Management Assurance, U.S. Government Accountability Office; Mr. Ken Dieffenbach, Executive Director, Pandemic Response Accountability Committee; Ms. Jennifer Wagner, Director of Medicaid Eligibility & Enrollment, Center on Budget and Policy Priorities.
• On March 11, 2025, the House Ways and Means Committee, Health Subcommittee held a hearing entitled, After the Hospital: Ensuring Access to Quality Post-Acute Care. Witnesses included: Dr. Dana Madison, Compassion Home Health Care; Dr. Paul Dongilli, CEO, Madonna Rehabilitation Hospitals; Mr. Jonathan Fleece, President and CEO, Empath Health; Ms. Lisa Grabert, Visiting Research Professor, Marquette University; Mr. Eric Carlson, Director of Long-Term Services and Supports Advocacy, Justice in Aging.
• On March 12, 2025, the Senate Aging Committee held a hearing entitled, Breaking the Cycle of Senior Loneliness: Strengthening Family and Community Support. Witnesses included: Mr. Andrew MacPherson, Founder and Executive Chair, Foundation for Social Connection – Action Network; Mr. James Balda, President and CEO, Argentum; Ms. Suzanne McCormick, President and CEO, YMCA of the USA; and Ms. Tori Strawter-Tanks, Director, Clayton County Senior Services Department.
• On March 14, 2025, the Senate Finance Committee held a hearing entitled, To examine the nomination of Mehmet Oz, of Pennsylvania, to be Administrator of the Centers for Medicare and Medicaid Services. Dr. Mehmet Oz was the only witness.

3. Reports, Studies, & Analyses

• On March 11, 2025, the Government Accountability Office (GAO) released a report entitled, Program Integrity: Agencies and Congress Can Take Actions to Better Manage Improper Payments and Fraud Risks. The report states that since fiscal year 2003, improper payments by federal agencies have totaled approximately $2.8 trillion. In fiscal year 2024, the estimated improper payments were about $162 billion, a decrease from the previous year which the report states is due to the conclusion of several COVID-19 relief programs. The report identifies five program areas where 75% of these improper payments were concentrated, including Medicaid, which the report states accounted for $31.1 billion of the improper payments. It also outlines steps for federal agencies and Congress to improve management practices, including better planning, data sharing, and accountability measures.

4. Other Health Policy News

• Congressional leaders have sought to find common ground this past week on a fiscal year 2025 funding package that needed to be passed by midnight on Friday, March 14 in order to prevent a government shutdown. House Speaker Mike Johnson (R-LA-4) unveiled a narrowly focused continuing resolution (CR) on Saturday, which would largely extend current funding for most programs through September 30 – the end of the fiscal year.
• The package would extend through September 30 the expiring health extenders which include the Medicare telehealth flexibilities and payments for Medicare Dependent Hospitals and Low-Volume Hospitals. Notably, the CR does not contain a provision addressing the 2.83 percent cut to the Medicare Physician Fee Schedule (PFS) that went into effect in January. However, Representative Greg Murphy (R-NC-3), the lead sponsor of a bill to increase PFS payment rates, announced on the website “X” that he received a guarantee from Speaker Johnson that PFS relief would be included in the House’s budget reconciliation bill.
• On March 11, 2025, the House ultimately passed the CR by a vote of 217-213, with only one Democrat voting in favor and one Republican voting against. The Senate voted on the package on Friday. Senate rules require a 60-vote cloture process before a final vote on the CR, and it was unclear whether enough Democratic Senators would lend their support for cloture to avoid a government shutdown. Senate Minority Leader Chuck Schumer (D-NY) had announced that he would vote for the CR, and urged his colleagues to do the same. In the end, ten Democratic Senators joined fifty-two Republican Senators to end debate on the CR, which is expected to pass on the final vote, preventing a government shutdown.
• The CR can be accessed here.
• On March 13, 2025, the Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report the nominations of Dr. Martin Makary to be Commissioner of the FDA and Dr. Jay Bhattacharya to be Director of the NIH, by votes of 14-9 and 12-11, respectively. That day, the HELP Committee was also scheduled to hold a hearing on the nomination of Dr. Dave Weldon to be Director of the Centers for Disease Control and Prevention (CDC). However, hours before the hearing it was announced that the White House was withdrawing Dr. Weldon’s nomination. This decision comes during a significant spike in measles cases in the country, which has accounted for at least two deaths. Dr. Weldon has been criticized for prior statements suggesting that vaccines were unsafe and may cause autism, and it has been reported that these statements and the current measles situation may have caused a loss of support for his nomination among some Republican Senators.
• Meanwhile, Dr. Mehmet Oz, the nominee for Administrator of CMS, appeared at a hearing before the Senate Finance Committee on March 14, 2025. Dr. Oz has previously announced support for the Medicare Advantage program as well as greater implementation of emerging health care technologies, including telehealth services and artificial intelligence.
• On March 11, 2025, the House Ways and Means Committee’s Subcommittee on Health held a hearing entitled “After the Hospital: Ensuring Access to Quality Post-Acute Care.” The hearing covered a range of topics impacting the post-acute care industry, including reimbursement rates, workforce issues, quality reporting regulations, prior authorizations in the Medicare Advantage (MA) program, and proposed reductions to Medicaid spending.
• While both Republicans and Democrats on the subcommittee agreed that post-acute care was critical to the health of older Americans, the two parties largely differed on their approach: Republicans focused on ways to reduce regulatory burden and ensure appropriate reimbursement for post-acute care facilities and agencies while Democrats primarily focused on how reductions in Medicaid spending would affect these organizations. There was bipartisan agreement, however, among some members on addressing prior authorization policies in MA due to concerns with delays and denials of care. In addition, one witness representing post-acute care hospitals, including long-term acute care hospitals and inpatient rehabilitation facilities, advocated for the ability to have patients be directly admitted to these facilities from critical access hospitals, as well as to lower the recently raised high-cost outlier fixed-loss amount threshold.
• More information on the hearing, including witness statements and a recording, can be found here.
• On March 12, 2025, CMS announced that it would be ending several CMS Innovation Center (CMMI) models before their planned end dates, including the “Maryland Total Cost of Care Model,” the “Primary Care First” model, the “ESRD Treatment Choices (ETC) Model,” and the “Making Care Primary” model.
• The Maryland Total Cost of Care model was originally scheduled to run through the end of 2026 and established a per capita limit on the Medicare total cost of care in the state of Maryland. CMS noted that this model will instead be transitioned to the AHEAD model beginning in January 2026.
• The Primary Care First model, which began in 2021 and was scheduled to run through the end of 2026, aimed to provide flexibility to primary care providers to provide care designed for their unique patient population. This model provided value-based payments based on quality measures selected as clinically meaningful, including patient experience of care, controlled high blood pressure, A1c management, colorectal cancer screening, and advance care planning.
• The ETC model was originally scheduled to run through the end of 2027 that intended to encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD, while reducing Medicare expenditures and preserving or enhancing the quality of care furnished to beneficiaries with ESRD. It was a mandatory model for thirty percent of ESRD facilities and Managing Clinicians in the United States.
• The Making Care Primary model, which began in 2024 and was scheduled to run through the end of 2034, sought to improve health outcomes through increasing care management and integration between primary care providers and specialists and providing prospective, risk-adjusted enhanced services payments.
• In its press release, CMS stated that these models were cancelled to save taxpayers $750 million and instead invest in models designed to make Americans healthier by preventing disease and driving choice and competition.
• The press release can be viewed here and a fact sheet from CMS can be viewed here.

5. Additional Alston & Bird Publications

• We have released an advisory on the potential ramifications of HHS rescinding the Richardson Waiver, which can be found here.
• We have also released an advisory on how the Trump Administration’s indirect cost guidance could impact NIH and other grant recipients, which can be found here.
• Finally, we maintain an online tracker for all executive orders issued by the Trump Administration, which is updated daily and can be found here.

View our Health Care Legislative & Public Policy team.

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