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.
Week in Review Highlight of the Week:
This week, the Senate confirmed Robert F. Kennedy, Jr. to be the next HHS Secretary and Congress began the budget reconciliation process by marking-up budget resolutions in both chambers.
I. Regulations, Notices & Guidance
Note: For many Executive Office of the President (EOP) actions, the stated day reflects when the action was submitted to the Federal Register, not when it was first released by the White House.
- On February 10, 2025, the Department of Health and Human Services (HHS) released a notice entitled, Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Delay of Effective Date. HHS is delaying the implementation of this final rule until April 14, 2025, to comply with a regulatory freeze issued by the Trump Administration. The final rule adopted updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of HIPAA, which constitute modifications to the adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. It also adopted a modification to the standard for the Medicaid pharmacy subrogation transaction.
- On February 11, 2025, the Social Security Administration (SSA) released a notice entitled, Agency Information Collection Activities: Proposed Request. SSA is soliciting comments on the accuracy of the agency’s burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Comments and recommendations on the information collection(s) to the Office of Management and Budget (OMB) Desk Officer and SSA Reports Clearance Officer can be mailed, emailed, or faxed at the addresses or fax numbers listed here.
- On February 11, 2025, the EOP released an executive order (EO) entitled, President’s “Department of Government Efficiency” Workforce Optimization Initiative. This EO details the implementation of the President's “Department of Government Efficiency” (DOGE) Workforce Optimization Initiative. It mandates a hiring ratio of one new employee for every four that depart, and establishes DOGE Teams within agencies to modernize technology and optimize productivity. Additionally, it includes a Software Modernization Initiative to enhance government-wide information technology systems.
- On February 13, 2025, the EOP released an EO entitled, Establishing the President’s Make America Healthy Again Commission. This EO details the establishment of the President’s “Make America Healthy Again” Commission, which aims to address the root causes of America’s health issues, with a focus on childhood chronic diseases. Chaired by the HHS Secretary, the Commission will investigate health issues, produce an assessment of America’s health within 100 days, and develop a strategy to address the underlying causes within 180 days.
- On February 14, 2025, HHS and the Drug Enforcement Administration (DEA) released a notice entitled, Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients; Delay of Effective Date. The notice states that a final rule granting flexibility regarding the prescribing of buprenorphine via telemedicine, originally slated to go into effect on February 18, 2025, has been delayed until March 21, 2025, due to a blanket regulatory freeze issued by the Trump Administration on all Biden Administration rules not finalized or implemented. Under the final rule, practitioners registered by DEA are authorized to prescribe Schedule III-V controlled substances approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. The effective date of a Department of Veterans’ Affairs (VA) telemedicine final rule has also been delayed to March 21, 2025.
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings have been cancelled or postponed. We are continuing to monitor.
February 25, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
February 25, 2025: FDA announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.
February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
March 5, 2025: VA announced a meeting of the Rehabilitation Research and Development Service (RR&D) Scientific Merit Review Board. This is a virtual meeting, partially open to the public.
March 5, 2025: VA announced a meeting of the National Research Advisory Council (NRAC). This is a virtual meeting open to the public.
March 5-6, 2025: The Health Resources & Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
March 27-28, 2025: 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 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 the National Advisory Council on Nurse Education and Practice (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 (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 the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
II. Hearings & Markups
- On February 11, 2025, the House Committee on Ways and Means held a hearing entitled, Modernizing American Health Care: Creating Healthy Options and Better Incentives. Witnesses included: Brooks Tingle, CEO, John Hancock Financial; Dr. Jay Carlson, OB/GYN and Clinical Chair, Mercy Clinical Research; Marcie Strouse, Small Business Owner and Partner, Capitol Benefits; and Leslie Dach, Founder and Chairman, Protect Our Care.
- On February 12, 2025, the Senate Committee on the Budget held a hearing entitled, Markup of Fiscal Year 2025 Budget Resolution - Day 1. The committee considered the Concurrent Resolution on the Budget for Fiscal Year 2025 (S.Con.Res. 5). The resolution was successfully voted out of committee by a margin of 11-10.
- On February 12, 2025, the House Committee on Oversight and Government Reform held a hearing entitled, The War on Waste: Stamping Out the Scourge of Improper Payments and Fraud. Witnesses included: Dawn Royal, Director, United Council on Welfare Fraud; Haywood Talcove, Chief Executive Officer, LexisNexis Risk Solution.; Stewart Whitson, Senior Director of Federal Affairs, Foundation for Government Accountability; and Dylan Hedtler-Gaudette, Director of Government Affairs, Project on Government Oversight (POGO).
- On February 12, 2025, the House Committee on Veterans’ Affairs, Subcommittee on Health, held a hearing entitled, Roles and Responsibilities: Evaluating VA Community Care. Witnesses included: Dr. Steven Braverman, Chief Operating Officer, Veterans Health Administration, U.S. Department of Veterans Affairs; Dr. Sachin Yende, Chief Medical Officer for Integrated Veteran Care, Veterans Health Administration, U.S. Department of Veterans Affairs; Sharon Silas, Director, Health Care Team, Government Accountability Office; and Dr. Julie Kroviak, Principal Deputy Assistant Inspector General, Office of Healthcare Inspections, Office of the Inspector General, U.S. Department of Veterans Affairs.
- On February 12, 2025, the Senate Special Committee on Aging held a hearing entitled, Optimizing Longevity: From Research to Action. Witnesses included: Dan Buettner, Founder, Blue Zones; Dr. Rhonda Patrick, Founder, FoundMyFitness; Dr. Eric Verdin, President and CEO, Buck Institute for Research on Aging; and Dr. Sarah C. Nosal, President-Elect, American Academy of Family Physicians.
- On February 13, 2025, the House Committee on the Budget held a markup entitled, Markup of The Concurrent Resolution on the Budget for Fiscal Year 2025. The committee considered the Concurrent Resolution on the Budget for Fiscal Year 2025 (H.Con.Res. 10). The resolution was successfully voted out of committee by a margin of 21-16.
III. Other Health Policy News
On February 13, 2025, the Senate voted to confirm Robert F. Kennedy, Jr. as HHS Secretary, by a vote of 52-48. Senator Mitch McConnell (R-KY) was the lone Republican to vote against Mr. Kennedy’s confirmation, in addition to every Democratic Senator. Mr. Kennedy’s confirmation followed a pair of contested hearings before the Senate Committee on Finance and the Senate Committee on Health, Education, Labor, and Pensions (HELP), featuring sharp criticism from Democratic members for his previous stances on vaccines and lack of experience in federal health care policy. Several Republican members also expressed concern, most notably Senator Bill Cassidy (R-LA), a physician and Chairman of the Senate HELP Committee, Senator Susan Collins (R-ME), and Senator Lisa Murkowski (R-AK); however, all three ultimately voted to confirm Mr. Kennedy.
This week, both the House of Representatives and the Senate began the process of budget reconciliation, the process by which large changes to spending and tax policy can be implemented under an expedited timeline. This first step consists of the Budget Committee in each chamber holding a mark-up on their respective Budget Resolution, which is used to set topline spending levels for each congressional committee. Each committee will then submit a package of legislation within their jurisdiction that adjusts federal spending and revenues to meet the Budget Resolution’s targets.
Notably, the Senate Budget Committee, chaired by Senator Lindsey Graham (R-SC), and House Budget Committee, chaired by Representative Jodey Arrington (R-TX-19) have released significantly different resolutions. The Senate’s resolution focuses primarily on border security, defense, and energy spending, and accounts for about $300 billion in spending increases. The House’s resolution includes $1.5 trillion in spending cuts, $4.5 trillion in tax cuts, and a $4 trillion debt limit extension. This is reflective of the opposing viewpoints the House and Senate Republicans have had on how to approach reconciliation, with the Senate Republicans favoring two bills while House Republicans favor just one. A second Senate resolution featuring larger tax and spending cuts is expected at a later date.
The House resolution also includes instructions for the House Committee on Energy and Commerce to propose legislation under its jurisdiction that would reduce federal spending by $880 billion over the next ten years. This is widely expected to come in the form of cuts to Medicaid spending, but Energy and Commerce Chairman Brett Guthrie (R-KY) has yet to announce how and to what degree those cuts will take shape.
On February 10, 2025, a federal judge in a Massachusetts district court issued a temporary, nationwide halt to the Trump Administration’s efforts to cap facility and administration (F&A) costs at 15 percent of a NIH grant’s value in response to a suit brought by the Association of American Medical Colleges (AAMC). The halt was issued in order to maintain the status quo until a hearing on the case could be held on February 21, 2025. F&A costs are costs that a research institute incurs from conducting research that cannot be directly attributable to specific research projects, such as facility maintenance and information technology costs. Institutions are reimbursed for these costs in addition to any research grants’ award value and are calculated as a percentage of that value. While the average F&A percentage is about 28 percent, some institutions have negotiated percentages exceeding 50 percent, which the institutions argue are due to extenuating factors such as higher real estate prices and wage laws. Many argue that a 15 percent cap would ultimately limit the amount of funding available for ongoing medical research. The Administration’s proposal has been criticized by Democrats and some Republicans, such as Senator Susan Collins (R-ME), as endangering medical research.
On February 13, 2025, following the confirmation of Robert F. Kennedy, Jr. to be HHS Secretary, the White House issued an executive order titled “Establishing the President’s Make America Healthy Again Commission.” The goal of the commission is to address health trends in the U.S. regarding chronic diseases and mental health with an initial focus on children. The order cites statistics on the high prevalence of chronic diseases and mental illnesses among Americans, and significant health challenges faced by children, including rising rates of autism and obesity. The commission will be chaired by the HHS Secretary and include at least thirteen other members, including the Surgeon General, the CDC Director, the NIH Director, and the FDA Commissioner. After 180 days, the commission is to present a comprehensive strategy for addressing chronic disease in American children. The full executive order can be viewed here.
On February 11, 2025, the District Court for the District of Columbia awarded a temporary restraining order and ordered the Trump Administration, specifically HHS, CDC, and FDA, to restore a selection of public health webpages that the Administration removed because they “promote[d] or inculcate[d] gender ideology” by the end of the day. This action came in response to a lawsuit filed by the organization, Doctors for America, which sought to reinstate the webpages following their removal. The court found that the group was likely to ultimately prevail in demonstrating that the removal of the webpages violated federal law. The court also stated in the decision that it was in the public’s interest to ensure that the webpages were available during the ongoing litigation to ensure that patient care is not disrupted.
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