Health Care Week in Review | Senate Votes Against Extension of ACA Premium Tax Credits; CMS Announces MAHA ELEVATE Model

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. 

Regulations, Notices & Guidance

• On December 8, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a notice entitled, Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts. In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (SSA), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.
• On December 8, 2025, the Centers for Medicare & Medicaid Services (CMS) released guidance entitled, Section 71119 of the “Working Families Tax Cut” Legislation, Public Law 119- 21: Requirements for States to Establish Medicaid Community Engagement Requirements for Certain Individuals. This guidance provides an overview of the Medicaid-related “community engagement” requirement mandated by H.R. 1, the or One, Big, Beautiful Bill Act (OBBBA) or the Working Families Tax Cut Act. Implementation of community engagement requirements will necessitate system, policy, and operational changes to state programs in the coming years. CMS states it is committed to supporting states in this effort and anticipates that ongoing partnership and engagement with states and other stakeholders will inform areas of need for additional guidance, including rulemaking by June 2026. Planning must begin immediately as states enter budget and legislative sessions and start procuring new systems and services to implement Medicaid provisions under the WFTC legislation. Community engagement is not new to Medicaid; several states had already submitted Section 1115 demonstration requests prior to the law’s passage to establish community engagement programs.
• On December 9, 2025, the Food and Drug Administration (FDA) released guidance entitled, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers. The guidance addresses questions that manufacturers, packers, distributors, and their representatives may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHSA). This guidance finalizes the revised draft guidance of the same title issued on April 25, 2024.
• On December 9, 2025, CMS released guidance entitled, 2026 SSI, Spousal Impoverishment, and Medicare Savings Program Resource Standards. This guidance provides an update on the 2026 Supplemental Security Income (SSI) and Spousal Impoverishment Standards as well as the 2026 resource standards for the Medicare Savings Program (MSP) groups.
• On December 10, 2025, FDA released a notice entitled, Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information. FDA is announcing a request for information from interested parties and the public to share their perspectives with FDA on testosterone replacement therapy for men. FDA intends to use the information submitted to help inform considerations related to testosterone therapy for men.
• On December 10, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Conjunctivitis Section. CDC announces the opening of a docket to obtain comment on the draft guideline entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Conjunctivitis Section. The draft guideline includes updates to the 1998 guideline for infection control in health care personnel, Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and its corresponding recommendations in Part II of the 1998 guideline on conjunctivitis. The updated recommendations in the draft guideline are intended for use by the leaders and staff of Occupational Health Services (OHS) and aim to facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
• On December 10, 2025, CMS released a proposed rule entitled, Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model. This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2. The IOTA Model is a six-year mandatory alternative payment model tested by the Center for Medicare & Medicaid Innovation (CMMI) that began on July 1, 2025, and will end on June 30, 2031. This proposed rule would update IOTA Model provisions in response to improvement opportunities that arose during its original implementation and to better align the model with new Administration priorities. The IOTA Model is aimed at kidney transplant hospitals with the goal of increasing the number of kidney transplants, improving quality, and improving patient experience during the transplant process.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• December 16, 2025: FDA announced a public workshop entitled, Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine. This is a virtual workshop open to the public.
• December 17-18, 2025: CMS announced the second biannual virtual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2025. This is a virtual meeting open to the public.
• December 18, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
• January 12-14, 2026: National Institutes of Health (NIH) announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.
• January 22, 2026: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• **January 22, 2026: NIH announced a meeting of the National Institute on Deafness and Other Communication Disorders. This is a virtual meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• **January 27, 2026: NIH announced a meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This is a virtual meeting with some sessions open to the public.
• January 28-29, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• **January 28, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• **January 29, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a virtual meeting with some session open to the public.
• February 8-10, 2026: NIH announced a meeting of the National Institute of Environmental Sciences. This is a hybrid meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• **May 13, 2025: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
• May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On December 10, 2025, HHS OIG released a report entitled, The National Institutes of Health Generally Implemented the Safe Workplace Federal Reporting Requirement, but Opportunities Exist To Improve the Reporting and Monitoring Processes. OIG conducted an audit to assess whether NIH implemented a reporting requirement mandated by the Consolidated Appropriations Act of 2022 (CAA, 2022). Under this requirement, NIH-funded recipient institutions must notify NIH when principal investigators (PIs) or key personnel named in an NIH Notice of Award are removed or disciplined due to harassment, bullying, retaliation, or hostile work conditions. The audit also examined how NIH used reported information to address workplace environments. OIG found that NIH generally implemented the CAA, 2022 reporting requirement but did not take action in cases where institutions delayed reporting. NIH lacked policies and procedures to address such delays. Additionally, while NIH used reported information to respond to harassment and misconduct cases—taking actions related to PIs, grant awards, and recipient institutions—it did not have formal policies to ensure consistent, timely, and appropriate responses. OIG recommended that NIH: (1) educate recipient institutions on the importance of compliance with the reporting requirement; (2) develop policies and procedures to monitor compliance; and (3) establish policies to guide NIH’s actions in response to reported cases. NIH concurred with these recommendations and outlined plans to implement them.
• On December 11, 2025, the Congressional Research Service (CRS) released a report entitled, Work Requirements: Comparison of Medicaid and Supplemental Nutrition Assistance Program (SNAP) After P.L. 119-21. Enacted July 4, 2025, OBBBA introduced new work-related requirements for Medicaid and the Supplemental Nutrition Assistance Program (SNAP). Section 71119 of OBBBA establishes a community engagement requirement for certain Medicaid enrollees, while Section 10102 expands SNAP’s work rules for Able-Bodied Adults Without Dependents (ABAWDs). CBO projects these provisions will reduce federal outlays by $325.6 billion for Medicaid and $69 billion for SNAP over fiscal year (FY) 2025–FY2034. Both policies target similar populations—nondisabled adults ages 18–64 without dependents and parents with children aged 14 or older—and generally require 80 hours per month of work or related activities. Key differences include Medicaid’s seasonal earnings provision, its exemption for individuals already subject to SNAP work rules, and later effective dates (Medicaid by December 31, 2026; SNAP July 4, 2025). While some individuals will be affected by both programs, eligibility differences mean overlap is limited (about 6.2 million in 2025). The report notes that implementation will depend on federal and state guidance.

Hearings & Markups

• On December 9, 2025, the Senate Judiciary Committee held a hearing entitled, Protecting Our Children Online Against the Evolving Offender. Witnesses included: Ms. Tamia Woods, Co-Founder, Do It For James Foundation; Ms. Jessica Lieber Smolar, Esq, Former Assistant United States Attorney, Western District of Pennsylvania; Ms. Lauren Coffren, Executive Director, Exploited Children Division, National Center for Missing & Exploited Children.
• On December 9, 2025, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing entitled, Building Pathways: Advancing Workforce Development in the 21st Century. Witnesses included: Dr. Chris Cox, Deputy Chancellor for Instruction, Research, and Development, Alabama Community College System; Ms. Chelle Travis, Executive Director, SkillsUSA; Mr. Joel Stadtlander, Director of Human Resources, ArcelorMittal Calvert; and Mr. Luke Rhine, Vice President, Rodel Foundation.
• On December 10, 2025, the House Oversight Committee Subcommittees on Health Care and Financial Services and Economic Growth, Energy Policy, and Regulatory Affairs held a hearing entitled, Lowering the Cost of Healthcare: Technology’s Role in Driving Affordability. Witnesses included: Mr. Brian Whorley, Chief Executive Officer, Paytient Technologies, Inc.; Dr. Darius Lakdawalla, Quintiles Chair in Pharmaceutical Development and Regulatory Innovation and Chief Scientific Officer, Schaeffer Center for Health Policy and Economics; Dr. Ziad Obermeyer, Blue Cross of California Distinguished Associate Professor, Health Policy and Management, University of California-Berkeley; Mr. Chris Jacobs, Founder, Juniper Research Group; and Ms. Sophia Tripoli, Senior Director of Health Policy, Families USA.
• On December 10, 2025, the House Judiciary Committee held a hearing entitled, Fighting Obamacare Subsidy Fraud: Is the Administrative Procedure Act Working as Intended? Witnesses included: Mr. Seto Bagdoyan, Director of Audit Services, Forensic Audits & Investigative Service, US Government Accountability Office (GAO); Dr. Ge Bai, Professor of Accounting, Johns Hopkins Carey Business School; Dr. Brian Blase, President, Paragon Health Institute; and Mr. Zack Cooper, Associate Professor of Public Health and Economics, Yale University.
• On December 10, 2025, the House Homeland Security and Governmental Affairs Committee Permanent Subcommittee on Investigations held a hearing entitled, Defining Our Healthcare Problem, and Principles We Should Follow to Solve it. Witnesses included: Mr. Christopher Briggs, Victim of Obamacare; Mr. Nick Stehle, Victim of Obamacare; Mr. Joel White, President, Council for Affordable Health Coverage; and Mr. Tarren Bragdon, President and Chief Executive Officer, Foundation for Government Accountability.
• On December 10, 2025, the House Veterans’ Affairs Committee Subcommittee on Health Oversight held a hearing entitled, Putting Families First: Strengthening CHAMPVA for Survivors and Dependents. Witnesses included: Mr. Dan Jacobs, Small Business Owner and Affordable Care Act (ACA) Marketplace Enrollee; and Mr. Aaron Lehman, Farmer and ACA Marketplace Enrollee.
• On December 10, 2025, the Senate Aging Committee held a hearing entitled, Aging with Purpose: The Positive Impact of Seniors in Today’s Economy. Witnesses included: Mr. Jon Taffer, Chairman & CEO, Taffer Dynamics, Executive Producer & Host, Paramount Network’s “Bar Rescue”; Dr. Paul Broadie II, President, Santa Fe College; Ms. Rachel Greszler, Senior Research Fellow, Workforce and Public Finance, The Heritage Foundation; and Ms. Christine Osasu, Director, Senior Community Service Employment Program, Legacy Link.
• On December 11, 2025, the Senate HELP Committee held a hearing entitled, Examining the Future of the U.S. Organ Procurement and Transplantation Network. Witnesses included: Dr. John C. Magee, M.D., President, Organ Procurement and Transplantation Network, Board of Directors; Dr. Seth J. Karp, M.D., System Surgeon-in-Chief, Vanderbilt University Medical Center; and Mr. Anthony Wright, Executive Director, Families USA.

Other Health Policy News

• On December 8, 2025, CMS issued new guidance entitled, Section 71119 of the “Working Families Tax Cut” Legislation, Public Law 119- 21: Requirements for States to Establish Medicaid Community Engagement Requirements for Certain Individuals, on how states should implement new work requirements for Medicaid enrollees established by OBBBA. The work requirements are scheduled to go into effect for all states on January 1, 2027, except for states that opt-in to early enforcement.

  The guidance outlines the seven possible methods for individuals to meet the work requirements, which include working or performing community service for at least 80 hours a month, enrolling in an educational program, or earning more than $580/month while still meeting other eligibility requirements. Individuals will need to verify they meet these requirements every six months to renew their enrollment.

  In addition, the guidance outlines individuals who are exempted from the work requirement, including parental guardians and family caregivers of a dependent child 13 years or younger or of a disabled individual, disabled veterans, those who are medically frail or disabled, pregnant women, and inmates. There are also short-term hardship exemptions for individuals facing natural disasters or extended hospital care.

  The full guidance can be found here. A press release from CMS on the guidance can be found here.

• On December 11, 2025, the Senate voted 51-48 against advancing a bill that would provide a clean three-year extension of the expiring ACA EPTCs. The bill, a Democratic proposal to address the expiration of EPTCs, was widely expected to fail since it required the support of at least 13 Republican Senators to overcome the 60-vote threshold required to proceed. Only four Republican Senators voted in favor of the bill.

  The same day, the Senate also rejected a Republican counterproposal by a vote of 51-48. This measure, the Health Care Freedom for Patients Act, was led by Senators Bill Cassidy (R-LA) and Mike Crapo (R-ID), the Chairs of the Senate Committees on Health, Education, Labor, and Pensions (HELP) and Finance, respectively. The Republican proposal does not include an extension of EPTCs. Rather, it would provide up to $1,500 over the next two years through health savings accounts (HSA) for certain individuals enrolled in select ACA Marketplace plans, while also funding cost-sharing reduction (CSR) payments.

  The Senate may depart for the holiday break next week without further action on the expiring tax credits despite ongoing proposals by various Senators to offer a compromise on a short-term extension.

  Meanwhile, House Republican leadership is considering a health care package with alternative proposals to extending EPTCs. House Speaker Mike Johnson (R-LA) has proposed a health care affordability framework, which includes pharmacy benefit manager (PBM) reform and policies to strengthen HSAs and CSRs, improve health care price transparency, implement site neutral payments, and repeal limits on physician-owned hospitals. However, no legislative text associated with this framework has been released. Speaker Johnson has indicated that the House will likely hold a vote on a Republican health care package next week, which may be unveiled this as early as this week.

  In the meantime, Rep. Brian Fitzpatrick (R-PA) filed a discharge petition to force a floor vote on a bill that would extend EPTCs through 2027. The bipartisan legislation also includes provisions to expand access to HSAs, simplify premium payments, prohibit PBM spread pricing, require full rebate pass-through, and modernize eligibility standards. The discharge petition would need to receive 218 signatures to trigger a floor vote next month. Separately, another discharge petition, led by Rep. Jen Kiggans (R-VA) and Josh Gottheimer (D-NJ), would bring a floor vote on a one-year extension of EPTCs.

  The Fitzpatrick discharge petition can be found here. The Kiggans discharge petition can be found here.

• On December 11, 2025, CMS announced the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE) Model. This voluntary model will provide approximately $100 million in funding through three-year cooperative agreements for up to 30 proposals that promote health and prevention for beneficiaries in traditional Medicare.
  
  Under this model, CMS will evaluate cost and quality outcomes of whole-person functional and lifestyle medicine approaches, including psychological, nutritional, and physical interventions, to address core lifestyle choices and behaviors associated with chronic disease prevention. CMS will test evidence-based functional or lifestyle medicine interventions currently not covered by Medicare through cooperative agreements with participating organizations. Participants must demonstrate experience integrating these approaches into conventional medical care with documented improvements in health.
  
  Eligible applicants include private medical practices; health systems and accountable care organizations (ACOs); academic organizations; functional, lifestyle, preventive and integrative medicine centers; Federally Qualified Health Centers; Rural Health Clinics; community-based organizations; state or local governments; Indian Health Service, Tribal Services, and Urban Indian Programs; and senior living communities.
  
  Cooperative agreements will be awarded in two rounds for two separate cohorts beginning in 2026 and 2027. CMS will release the MAHA ELEVATE Model Notice of Funding Opportunity (NOFO) for the first cohort in early 2026. The model will begin on September 1, 2026.
  
  Additional information can be found here.

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