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.
Highlight of the Week
This week, the Senate HELP Committee Majority unveiled a discussion draft to reform the 340B Drug Pricing Program, and the House Energy and Commerce Health Subcommittee advanced 15 bipartisan health care bills during a committee markup.
Regulations, Notices & Guidance
- On June 22, 2026, the Food and Drug Administration (FDA) released draft guidance entitled, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA is announcing the availability of this revised draft guidance for industry in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner. Advances in FDA’s understanding of biological processes and the increasing availability of high-quality data have transformed the evidentiary landscape for drug development. Given these advances, the draft guidance discusses the many factors that can impact the strength of evidence of effectiveness for a drug and would clarify how sponsors can rely on one adequate and well-controlled clinical investigation with confirmatory evidence to satisfy the substantial evidence of effectiveness standard. When final, this guidance will replace the 1998 guidance titled Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
- On June 22, 2026, FDA released draft guidance entitled, Master Protocols for Drug and Biological Product Development. FDA is announcing the availability of this draft guidance for industry that revises and replaces the previous draft guidance for industry issued on December 22, 2023, entitled, Master Protocols for Drug and Biological Product Development. The draft guidance would provide recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory review. The primary focus is on randomized trials utilizing a master protocol that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the FDA’s thinking on the use of master protocols in drug and biological product development.
- On June 22, 2026, FDA released draft guidance entitled, Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials. FDA is announcing the availability of this draft guidance for industry that is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in-human (FIH), phase 1 trials for drugs and biological products is recommended. This draft guidance focuses on drugs and biological products for which the MABEL approach can be used to guide starting doses for FIH trials. This includes, but is not limited to, drugs and biological products that may cause cytokine release, T-cell activation, or other potent pharmacological reactions.
- On June 22, 2026, FDA released a request for information (RFI) entitled, Expedited Investigational New Drug Pilot Program. FDA is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. The pilot program would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or “QRIs”), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. Information provided through this public docket will help FDA refine its approach and consider other opportunities to accelerate time to FIH clinical trials.
- On June 22, 2026, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an RFI entitled, Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP. This RFI seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the “Beneficiary Inducements CMP”) for remuneration provided to individuals in connection with their participation in clinical trials.
- On June 22, 2026, the Administration for Children and Families (ACF) released a notice entitled, Privacy Act of 1974; System of Records. In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is making updates to an existing system of records maintained by the Office of Family Assistance (OFA) within HHS ACF’s System No. 09-80-0375, Temporary Assistance for Needy Families (TANF) Data. The system of records contains data about TANF clients received from TANF grantee agencies in the states, territories, and tribal organizations, as well as verification information obtained from those agencies, other HHS records, or other government agencies or entities engaged to assist ACF with program integrity reviews or projects.
- On June 23, 2026, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2026 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting an administrative supplement in scope of the parent award for one eligible grant recipient funded in FY 2024 under the Prevention Technology Transfer Centers Cooperative Agreements, Notice of Funding Opportunity (NOFO) SP-24-002. The recipient may receive up to $1,198,000 for a project end date of September 29, 2029. The supplemental funding supports the implementation of a substance use prevention fellowship program to be developed in collaboration with national-level state and community organizations. The program would aim to develop and sustain a highly trained and knowledgeable workforce of prevention professionals drawn from communities that have faced challenges in maintaining sufficient prevention staffing to meet the full scope of community needs. This program will support a state level fellowship program and a community level program. This program will also prepare fellows to achieve certification from the International Certification and Reciprocity Consortium (IC&RC). The supplemental funding will support fellows in the following areas: hands-on experience working in state agencies and community organizations while supported by agency mentors; virtual and in-person training in professional development and prevention; acquiring proficiency in appropriate core competencies in preparation for the Certified Prevention Specialist exam; developing management and leadership skills; and preparing for potential employment opportunities within the prevention field.
- On June 23, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right to Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists. CDC is announcing that it is issuing an Order under Section 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This notice was issued on June 21, 2026, and shall remain in effect through 4:59 p.m. Eastern Daylight Time (EDT) on Tuesday, July 21, 2026. This notice may be amended or rescinded prior to that time at the discretion of the CDC Director.
- On June 23, 2026, 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 Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the U.S. Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
- On June 23, 2026, the National Institutes of Health (NIH) released a notice entitled, Government Owned Inventions Available for License: Compositions and Methods for Producing Dendritic Cell-based Vaccines with Enhanced Efficacy. NIH is announcing that the National Cancer Institute (NCI) is seeking research co-development partners and/or licensees for NCI’s compositions and methods to enhance the efficacy of dendritic cell-based cancer vaccines.
- On June 23, 2026, NIH released a notice entitled, Government Owned Inventions Available for License: C8166-45 Cell Line. NIH is announcing that NCI seeks licensees for a human T-cell line, C8166-45, transformed by HTLV-1. C8166-45, also known as C63/CRII-2, contains three transcriptionally active proviruses useful for testing biological activities involved in T-cell immortalization and growth.
- On June 24, 2026, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled, Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program. This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This proposed rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this proposed rule would update the requirements for the ESRD Quality Incentive Program.
- On June 25, 2026, SAMHSA released an RFI entitled, Solicitation for Public Comments on the Development of an Independent Accreditation System for Certified Community Behavioral Health Clinic Expansion (CCBHC-E) Grant Recipients. SAMHSA is seeking public comment to inform the development, implementation, and oversight of an independent accreditation system for Certified Community Behavioral Health Clinic Expansion (CCBHC-E) grant recipients. SAMHSA intends to establish a process for evaluating and approving accrediting bodies, transitioning certain CCBHC-E grant recipients to independent accreditation, developing a federal oversight framework, and providing technical assistance to states, providers, and accrediting organizations. Input received through RFI will help SAMHSA design an accreditation system that promotes quality, reduces administrative burden, and supports consistent national standards.
- On June 26, 2026, CMS released a correction to an interim final rule entitled, Medicaid Program; Community Engagement Requirement for Certain Individuals; Correction. CMS is correcting provisions in the interim final rule entitled, Medicaid Program; Community Engagement Requirement for Certain Individuals (91 Fed. Reg. 33348 (June 3, 2026)). Beginning on page 33476, § 435.557 and §435.558 should read as noted in the correction.
- On June 26, 2026, CDC released a notice entitled, Advisory Committee on Breast Cancer in Young Women; Notice of Charter Renewal. CDC is providing notice under 5 U.S.C. Sections 1001-1014 of the renewal of the charter of the Advisory Committee on Breast Cancer in Young Women, Centers for Disease Control and Prevention, Department of Health and Human Services. This charter has been renewed for a two-year period through June 17, 2028.
- On June 26, 2026, FDA released a proposed rule entitled, Establishment Registration and Product Listing for Tobacco Products. FDA is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate establishment registration and product listing information is important to accomplish statutory, regulatory, and public health objectives. Currently, only domestic owners and operators are required to register their establishments and list their tobacco products with FDA while foreign owners and operators are not subject to these requirements, creating significant gaps in FDA information. This proposed rule, if finalized, would extend registration and listing requirements to include owners and operators of foreign establishments.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- June 29, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
- June 29, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
- June 29, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a virtual meeting open to the public.
- June 30, 2026: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting with some sessions open to the public.
- July 1, 2026: 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.
- July 6-7, 2026: NIH announced a meeting of NCI. This is a virtual meeting with some sessions open to the public.
- July 7, 2026: FDA announced an educational conference entitled, Third Annual Animal Drug User Fee Educational Conference. This is a hybrid event open to the public.
- July 8, 2026: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
- July 14-15, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
- July 15, 2026: NIH announced a meeting of the NCI Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
- July 16, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- July 23-24, 2026: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open to the public.
- **July 29, 2026: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This is a virtual meeting open to the public.
- **August 2-4, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences. This is a virtual meeting with some sessions open to the public.
- August 6, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is a hybrid meeting open to the public.
- August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
- September 2, 2026: NIH announced a meeting of NCI. This is a virtual 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 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
- September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
- September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a virtual meeting 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.
- September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
- October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
- November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions open to the public.
- December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
- December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
- January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
Reports, Studies & Analyses
- On June 23, 2026, OIG released a report entitled, Medicare Could Have Saved $255.1 Million Related to Hospice Services for Certain New Hospice Enrollees. In this audit, OIG assessed whether CMS made Medicare payments for hospice services provided in FY 2021 in accordance with Medicare requirements for certain new hospice enrollees. In the report, OIG stated that, of the 100 initial certification periods that OIG reviewed, the documentation for 45 were found to not meet Medicare hospice requirements. OIG reported that for 21 periods, the clinical information in the enrollee’s medical records did not support that the enrollee had a terminal illness, resulting in $251,067 in unallowable payments, and for 24 periods, the medical records did not meet hospice eligibility documentation requirements, resulting in $294,432 in unallowable payments. OIG estimated that Medicare could have saved $255.1 million in hospice claim payments associated with the new hospice enrollees in OIG’s sampling frame if the hospice Medicare Administrative Contractors (MACs) had eligibility review procedures for enrollees who did not have inpatient or emergency room claims 18 months prior to starting hospice care.
Hearings & Markups
- On June 23, 2026, the House Committee on Oversight and Government Reform and the Senate Permanent Subcommittee on Investigations held a bicameral public forum entitled, Abandoning Americans to Disease: The Trump Admin’s Reckless Crusade is Harming America’s Health. Witnesses present included: Daniel Jernigan, MD, MPH, Former Director, CDC National Center for Emerging and Zoonotic Infectious Diseases; Ms. Anita Patel, MD, Pediatric Critical Care Physician; Mr. Jonathan E. Agin, JD, Co-Founder and Executive Director, PREP4Gold Childhood Cancer Organization; and Mr. Scott Faber, JD, Senior Vice President, the Environmental Working Group.
- On June 24, 2026, the House Science, Space, and Technology Investigations and Oversight Subcommittee held a hearing entitled, Safeguarding Federal Research Funds: The False Claims Act's Role in Combating Grant Fraud. Witnesses present included: Mr. Robert Steinau, Senior Official Performing the Duties of Inspector General, National Aeronautics and Space Administration Office of the Inspector General; Ms. Jennifer Springmann, Special Agent in Charge, National Science Foundation Office of the Inspector General; and Ms. Brenna Jenny, Deputy Assistant Attorney General for Commercial Litigation Branch, Department of Justice.
- On June 24, 2026, the Joint Economic Committee held a hearing entitled, Protecting Patients and Taxpayers: Combating Healthcare Fraud and Leakage to Strengthen Program Integrity. Witnesses present included: Dr. Brian Blase, Founder and President, Paragon Health Institute; Dr. David Meyers, Associate Professor of Health Services, Policy and Practice, Associate Director of the Center for Advancing Health Policy through Research, Vice Department Chair, Brown University; Dr. Chris Pope, Senior Fellow, Manhattan Institute; and Ms. Jessica Tillipman, J.D., Associate Dean for Government Procurement Law Studies, Government Contracts Advisory Council Distinguished Professorial Lecturer in Law, George Washington University Law School.
- On June 25, 2026, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, State Medicaid Program Integrity: Examining Fraud Risks and Oversight Deficiencies. Witnesses present included: Mr. John Connolly, Temporary Commissioner and State Medicaid Director, Minnesota Department of Human Services; Mr. Tyler Sadwith, State Medicaid Director, California Department of Health Care Services; Mr. Amir Bassiri, State Medicaid Director, New York State Department of Health; and Mr. Scott Partika, Director, Ohio Department of Medicaid.
- On June 25, 2026, the House Committee on Energy and Commerce Health Subcommittee held a markup for the following legislation: H.R. 1266, Combatting Illicit Xylazine Act; H.R. 2004, Tyler’s Law; H.R. 7970, STOP Nitazenes Act; H.R. 1561, ALERT Communities Act; H.R. 7994, HERO Act; H.R. 9389, Nutrition Education and Chronic Disease Prevention in Community Health Centers Act of 2026; H.R. 8201, Expanding Community Access to Health Services Act; H.R. 9393, Lower Costs, More Transparency Act of 2026; H.R. 9397, Premium Transparency Act; H.R. 9396, Prior Authorization Accountability Act; H.R. 9390, Prices on the Wall Act of 2026; H.R. 3514, Improving Seniors’ Timely Access to Care Act of 2025; H.R. 9392, Medicare Advantage Cost Transparency Act; H.R. 5243, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage; H.R. 9395, Transparency in Medicare Advantage Steering Act. All 15 bills were agreed to via voice vote and reported favorably to the full committee.
Other Health Policy News
Health Care Fraud Oversight & Student Loan Borrowing Limits Update
On June 24, 2026, the U.S. Congress Joint Economic Committee held a hearing entitled, Protecting Patients and Taxpayers: Combating Healthcare Fraud and Leakage to Strengthen Program Integrity. The hearing examined systemic drivers of fraud, waste, and “leakage” across federal health programs, with witnesses emphasizing that many issues stem not only from criminal activity but from structural incentives embedded in program design. Testimony highlighted vulnerabilities across the Affordable Care Act (ACA) marketplaces, Medicaid, and Medicare, including improper enrollment, weak eligibility verification, and payment systems that incentivize overutilization or aggressive coding. Witnesses cited examples such as phantom ACA enrollments, Medicaid’s open-ended federal matching structure, and substantial overpayments in Medicare Advantage (MA) driven by coding practices, duplicative payments, and bonus structures. While members broadly agreed that fraud is a significant problem that harms taxpayers and undermines program integrity, they disagreed over the scale of the issue and the role of policy design versus enforcement.
On June 24, 2026, the U.S. District Court for the District of Columbia ruled to stay implementation of the portion of the Department of Education’s final rule defining “professional student” for the purpose of determining federal student loan amounts under new statutory borrowing limits. The Trump Administration planned to implement a regulation on July 1, 2026, which would have capped student borrowing at $50,000 annually, or $200,000 total, for professional degrees in 11 fields and limited graduate degrees to $20,500 a year, or $100,000 total. Advanced nursing and other health-related degrees were not included in the definition of a professional student.
The court’s decision may be found here.
340B Drug Pricing Reform & Reporting Requirements Proposal
On June 25, 2026, Senator Bill Cassidy (R-LA) released a discussion draft entitled, the 340B Drug Pricing Integrity and Affordability for Patients Act (340B for Patients Act). This bill would require standardized, regular reporting from participating nonprofits on their 340B revenues, costs, and eligibility. Providers would be able to request adjudication on any disputed information and audits, to be conducted at either the government or a drug manufacturer’s expense. The bill would also provide allowances for drug manufacturers to offer upfront discounts or rebates following the submission of claims data to reduce diversion or duplication of discounts. Further, the bill would create a sliding fee scale for low-income patients being served by hospital covered entities and reform the 340B Prime Vendor Program to offer choice to covered entities in how they access 340B drugs.
The discussion draft may be found here, a section-by-section summary may be found here, and a one-pager may be found here.
Medicare Cost-Sharing Cap and Expanded Eligibility Proposal
On June 25, 2026, U.S. Senator Lisa Blunt Rochester (D-DE), Senate Finance Committee Ranking Member Ron Wyden (D-OR), and Senate Democratic Leader Chuck Schumer (D-NY) introduced the Medicare Cost Cap Act, which would create a $5,000 financial liability cap for hospital and provider benefits (Medicare Parts A and B). Direct out-of-pocket cost sharing and payments made by wraparound health coverage or Medigap plans on behalf of the beneficiary to cover cost sharing would count toward the cap. Further, the bill would eliminate asset limits for Medicare Savings Programs (MSPs) asset tests, align eligibility criteria across Medicare cost-sharing programs, and increase the income threshold to 200 percent of the Federal Poverty Line (FPL).
The text of the bill is available here and a fact sheet for the bill is available here.
Health Care Price Transparency & Prior Authorization Reform Bills Advance
On June 25, 2026, the House Energy and Commerce Health Subcommittee advanced 15 bipartisan health care bills, with the package focusing primarily on health care price transparency, MA oversight, community health centers, and efforts to address illicit drugs. Among the most significant measures was H.R. 9393, the Lower Cost, More Transparency Act of 2026, which is a revised version of a similar bill passed by the House, but not the Senate, in 2023. This bill would codify and strengthen existing hospital and insurer price transparency regulations by authorizing the Secretary of HHS to standardize public reporting of prices, enhancing enforcement authority, increasing penalties for noncompliance, and expanding transparency requirements to clinical laboratories, ambulatory surgical centers, and imaging centers. The markup also included H.R. 9390, the Prices on the Wall Act of 2026. This bill would require hospitals to physically post cash prices for certain shoppable services and procedures in public spaces within the hospital for patients to see. Finally, the markup included two bills related to prior authorization, H.R. 3514, the Improving Seniors’ Timely Access to Care Act of 2025, and H.R. 9396, the Prior Authorization Accountability Act. H.R. 3514 would codify agency authority to require MA plans to enable electronic prior authorization and respond to prior authorization requests within a set timeline. It would also require MA plan sponsors to publicly report metrics on how frequently prior authorization requests are approved or denied for certain services.
The subcommittee also advanced several bipartisan public health and substance use disorder bills. These included H.R. 1266, the Combating Illicit Xylazine Act, which would classify xylazine as a Schedule III controlled substance while preserving its legitimate veterinary uses; H.R. 2004, Tyler’s Law, directing HHS to study the use of routine fentanyl testing in hospital emergency departments and issue related guidance; H.R. 7970, the STOP Nitazenes Act, permanently scheduling nitazene substances under the Controlled Substances Act; H.R. 1561, the ALERT Communities Act, legislation expanding access to fentanyl and xylazine test strips and opioid overdose reversal medications; and other legislation that is intended to strengthen community health centers by supporting nutrition education, chronic disease prevention, behavioral health, and substance use disorder services.
More information on this markup can be found here.
State Medicaid Program Integrity & Fraud Oversight Hearing
On June 25, 2026, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, State Medicaid Program Integrity: Examining Fraud Risks and Oversight Deficiencies. The Subcommittee examined fraud risks and oversight deficiencies in state Medicaid programs, with testimony from Medicaid directors in Minnesota, California, New York, and Ohio. Members from both parties acknowledged that fraud exists across states and can harm vulnerable populations and taxpayers, but differed sharply on the scope of the problem and the appropriate federal response. Republican members emphasized significant documented fraud cases and argued that stronger oversight, enforcement, and state accountability are necessary to prevent misuse of funds and ensure care is delivered as intended. While Democratic members recognized the need to address fraud, they argued that recent actions by CMS—including funding deferrals and heightened scrutiny of certain states—have been overly broad and insufficiently justified, and risk disrupting care delivery, particularly in states with large Medicaid populations.
Throughout the hearing, witnesses and members emphasized that effective solutions require both improved oversight and structural reforms. Proposed strategies included strengthening pre-payment verification and data sharing, modernizing technology systems, addressing misaligned financial incentives, and implementing targeted policy changes such as risk adjustment reforms and standardized broker compensation. Several witnesses stressed that existing tools—such as Government Accountability Office (GAO) and HHS Office of Inspector General (OIG) recommendations—are underutilized due to an “implementation deficit,” rather than a lack of ideas. Others highlighted the importance of foundational oversight work, including audits, staffing, and whistleblower protections, warning against overreliance on high-profile enforcement actions alone. Overall, the discussion underscored the tension between pursuing aggressive fraud prevention, maintaining access to care, and redesigning federal health programs to better align incentives and reduce opportunities for waste and abuse.
More information on this hearing is available here.
State Medicaid Program Integrity Enforcement & Federal–State Tensions
State witnesses described extensive efforts to strengthen program integrity, including provider screening, data analytics, audits, payment suspensions, and coordination with law enforcement. States reported billions of dollars in recoveries and large numbers of investigations and enforcement actions, while stressing the importance of balancing fraud prevention with maintaining access to care. Several witnesses raised concerns about federal actions they characterized as unclear, abrupt, or inconsistent, particularly regarding payment deferrals and corrective action requirements, and emphasized the need for a collaborative federal–state partnership. Throughout the hearing, members debated whether current federal policies reflect necessary accountability measures or politically motivated actions that increase administrative burdens and threaten coverage, highlighting ongoing tension between efforts to combat fraud and the goal of preserving Medicaid services for beneficiaries.
More information on this hearing is available here.
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