Health Care Week in Review | Oz Confirmed as CMS Administrator; CMS finalizes CY 2026 MA/Part D Final Rule

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, Mehmet Oz was confirmed by the Senate as Administrator of CMS and CMS finalized the Contract Year 2026 Medicare Advantage and Medicare Part D rule.

1. Regulations, Notices & Guidance

• On March 31, 2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. SAMHSA released a list of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using oral fluid.
• On April 2, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, National Vaccine Injury Compensation Program List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On April 4, 2025, the Social Security Administration (SSA) released a notice entitled, Notice of Tier Fee Decrease for Our Electronic Consent Based Social Security Number Verification Service. SSA is announcing a decrease in the fees across all tiers for the electronic Consent Based Social Security Number (SSN) Verification (eCBSV) service. In accordance with statutory requirements, a permitted entity (PE) is required to provide payment to reimburse SSA for the development and support of the eCBSV system.
• On April 4, 2025, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, etc.. This final rule revises the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to prescription drug coverage, the Medicare Prescription Payment Plan, dual eligible special needs plans (D-SNPs), Part C and D Star Ratings, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.
• CMS is not finalizing certain provisions from the proposed rule at this time, including, Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies, Procedures and Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence, and Part D Coverage of Anti-Obesity Medications (AOMs) and Application to the Medicaid Program. CMS may address these proposals in future rulemaking, as appropriate.

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

** - New addition

• 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 15-16, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
• April 17, 2025: The National Institutes of Health (NIH) announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• April 21, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• April 21, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• April 22, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is a virtual meeting with some sessions open to the public.
• April 23, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a virtual meeting open to the public.
• April 23, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• April 24, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with one session open to the public.
• April 30, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions 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 5-6, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health. This is a hybrid meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
• May 6, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
• May 8, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting open to the public.
• May 13, 2025: NIH announced a meeting of the National Advisory Council on Drug Abuse. This is a virtual 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.
• May 22, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• May 28, 2025: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• June 3-4, 2025: The Food and Drug Administration (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.
• June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
• June 6, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• ** June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• ** June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions 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 the Advisory Committee on Training in Primary Care Medicine and Dentistry. 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. Reports, Studies, & Analyses

• On April 4, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Most Institutions That Received NIH Funding Did Not Fully Understand When They Must Report Monetary Donations. In the report, OIG found that only 19 percent of institutions correctly identified all scenarios in its survey that described monetary donations they must report to NIH. Furthermore, a quarter of institutions did not correctly identify any of the reporting scenarios in the OIG survey. The report states that three-quarters of institutions reported that a better understanding of NIH’s distinction between monetary donations that must be reported and gifts that do not need to be reported would help them comply with reporting requirements. OIG recommended that NIH clarify with NIH-funded institutions as to when monetary donations need to be reported as other support, to which the NIH concurred.

3. Hearings & Markups

• On April 1, 2025, the House Homeland Security Committee, Cybersecurity and Infrastructure Protection Subcommittee held a hearing entitled, Cybersecurity is Local, Too: Assessing the State and Local Cybersecurity Grant Program. Witnesses included: Mr. Robert Huber, Chief Security Officer, Tenable, Inc.; Mr. Alan Fuller, Chief Information Officer, State of Utah; The Honorable Kevin Kramer, First Vice President, National League of Cities and Councilman, Louisville, KY; and Mr. Mark Raymond, Chief Information Officer, State of Connecticut.
• On April 1, 2025, the House Oversight and Government Reform Committee, Economic Growth, Energy Policy, and Regulatory Affairs Subcommittee held a hearing entitled, America’s AI Moonshot: The Economics of AI, Data Centers, and Power Consumption. Witnesses included: Mr. Neil Chilson, Head of Artificial Intelligence (AI) Policy, Abundance Institute; Mr. Josh Levin, President, Data Center Coalition; Mr. Mark P. Mills, Executive Director, National Center for Energy Analytics; and Mr. Tyson Slocum, Director, Energy Program, Public Citizen.
• On April 1, 2025, the House Veterans Affairs’ Committee held a hearing entitled, Harnessing Biomedical Innovation: Modernizing VA Healthcare for the Future. Witnesses included: Mr. Will Gray, Vice President, Marketing, Commercial Operations, and Government, Boston Scientific; Dr. Jon Bloom, Chief Executive Officer, Podimetrics; Mr. Jeff DiLullo, Executive Vice President and Chief Regional Leader, Philips North America; and Dr. Sai Parthasarathy, Director, Center for Sleep, Circadian and Neuroscience Research, University of Arizona Health Sciences.
• On April 1, 2025, the House Energy and Commerce Committee, Health Subcommittee held a hearing entitled, Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs. Witnesses included: Mr. Kevin Menzel, Member, Board of Directors, Consumer Healthcare Products Association and President, Focus Consumer Healthcare; Mr. Douglas M. Troutman, Interim Co-Chief Executive Officer, American Cleaning Institute; Ms. Kim Wezik, MPH, Director of Advocacy, Melanoma Research Foundation; Mr. Scott Faber, Senior Vice President, Government Affairs, Environmental Working Group; and Mr. Carl D’Ruiz, Senior Science, Advocacy, and Business Development Manager for Beauty and Care, North America, DSM-Firmenich.
• On April 1, 2025, the House Energy and Commerce Committee, Oversight and Investigations Subcommittee held a hearing entitled, Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices. Witnesses included: Dr. Christian Dameff, MD, MS, FACEP, Emergency Physician and Co-Director, Center for Healthcare Cybersecurity, University of California San Diego Health; Mr. Greg Garcia, Executive Director, Healthcare Sector Coordinating Council Cybersecurity Working Group; Mr. Erik Decker, Vice President and Chief Information Security Officer, Intermountain Healthcare; Ms. Michelle Jump, Chief Executive Officer, MedSec; and Dr. Kevin Fu, PhD, Professor, Department of Electrical and Computer Engineering, Khoury College of Computer Sciences, Department of Bioengineering, Kostas Research Institute (KRI) for Homeland Security, Northeastern University.
• On April 2, 2025, the House Education and Workforce Committee, Health, Employment, Labor, and Pensions Subcommittee held a hearing entitled, A Healthy Workforce: Expanding Access and Affordability in Employer-Sponsored Health Care. Witnesses included: Ms. Angela Shields, Chief Executive Officer, Tennessee REALTORS, Nashville, Tennessee, on behalf of the National Association of REALTORS; Ms. Bethany Lilly, Executive Director, Public Policy, The Leukemia & Lymphoma Society, Washington, D.C; and Ms. Marcie Strouse, Senior Policy Analyst, Kaiser Family Foundation.
• On April 3, 2025, the Senate Judiciary Committee held a mark-up session. Bills discussed included:

1. 527, Prescription Pricing for the People Act of 2025;
2. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes;
3. 1041, A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes;
4. 1097, Interagency Patent Coordination and Improvement Act of 2025;
5. 1095, Stop STALLING Act; and
6. 1096, Preserve Access to Affordable Generics and Biosimilars Act.

4. Other Health Policy News

• On April 3, 2025, the Senate voted 53-45 along party lines to confirm Mehmet Oz, MD, as CMS Administrator. Dr. Oz takes lead of CMS following a recent directive from HHS Secretary Robert F. Kennedy, Jr. to reduce the number of full-time employees at CMS by 300, which is about four percent of the total workforce. Dr. Oz will also oversee a Medicaid program that has come under increasing scrutiny for potential budget cuts. During his confirmation hearing, Dr. Oz confirmed that he supported the Medicaid program, but agreed with Republican criticisms that it was rife with waste, fraud, and abuse.
• On April 5, 2025, the Senate is expected to vote on a budget resolution that Republican leadership has negotiated with House Republican leadership and the Trump Administration. This will be the second budget resolution voted upon by the Senate. A preliminary “skinny” budget resolution that addressed only border security, defense, and energy issues was passed by the Senate in February, but this differed significantly from the House-passed budget resolution that also included spending and tax cuts, so a compromise resolution was required. President Trump has been advocating for one “big, beautiful bill” that will include all of his budget priorities, notably the extension of the tax cuts first passed in 2017 as a part of the Tax Cuts and Jobs Act (TCJA) and an increase of the debt ceiling.
• The negotiated budget resolution, which was released on April 3, 2025, aligns more closely with the vision espoused by the Trump Administration and House leadership, and includes up to $1.5 trillion in tax cuts, in addition to an extension of the current TCJA cuts, and a debt ceiling increase of about $5 trillion. The resolution maintained instructions for the House Energy and Commerce Committee to reduce the federal deficit by $880 billion, which is largely expected to include some form of cuts to the Medicaid program. A recent report by the Congressional Budget Office indicates that all non-Medicaid spending under the Energy and Commerce Committee’s jurisdiction makes up only about $581 billion, so the Committee must cut Medicaid spending by at least $299 billion (out of a total $8.2 trillion) in order to reach the $880 billion target.
• The resolution cleared a key procedural hurdle the night of April 3, 2025. If the Senate ultimately passes the budget resolution, the House will then vote on it, likely before April 11, 2025. The margins between House Republicans and Democrats are slim, and there are several budget hawks within the Republican conference who are hesitant to support what they view as a large increase of the debt ceiling without appropriate spending offsets. Currently, House Republicans can afford to lose only three votes.
• If the budget resolution passes both chambers, Congress will begin the process of packaging legislative changes into a single reconciliation bill. It is during this subsequent process when more concrete insight will be available into how state Medicaid programs may be impacted as part of budget reconciliation.
• On March 31, 2025, a federal judge in Texas struck down an FDA rule which sought to classify laboratory-developed tests (LDTs) as medical devices and allow the agency to actively regulate the tests. The judge ruled in favor of the American Clinical Laboratory Association and the Association for Molecular Pathology, citing Loper Bright v. Raimondo, the Supreme Court case that established the duty of the courts to exercise independent judgement when agencies’ regulations are not explicitly authorized by Congress. In overturning the FDA’s May 2024 final rule on LDTs, the court determined that the FDA exceeded its regulatory authority. It remains to be seen whether the FDA will appeal the court’s decision. During a federal court hearing in February 2025, the Trump Administration expressed support for the FDA’s authority to regulate LDTs.
• The final judgment can be found here.
• On Wednesday, April 2, 2025, President Trump announced that he was moving forward with broad 10 percent global tariffs and reciprocal tariffs of 20 percent or more on dozens of counties.  The reciprocal tariffs would not apply to pharmaceuticals, semiconductors, or copper, but no other health supply exemptions were included in the announcement. The broad 10 percent tariffs on all countries would begin on April 5, 2025, and the reciprocal tariffs on selected countries would begin on April 9, 2025.

5. Additional Alston & Bird Publications

• We maintain an online tracker for all executive orders issued by the Trump Administration, which is updated regularly and can be found here.

View our Health Care Legislative & Public Policy team.

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