Health Care Week in Review | Senate Finance Committee Holds Hearing on the Rising Cost of Health Care; CMS Released Additional Payment Rules

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 November 17, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, CY 2026 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2026 under Medicare's Hospital Insurance Program (Medicare Part A). For CY 2026, the inpatient hospital deductible will be $1,736. The daily coinsurance amounts for CY 2026 will be as follows: $434 for the 61st through 90th day of hospitalization in a benefit period; $868 for lifetime reserve days; and $217 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
• On November 17, 2025, CMS released a notice entitled, Medicare Program: CY 2026 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This notice announces the CY 2026 Medicare Part A premium for uninsured enrollees. This premium is paid by enrollees aged 65 and over who are not otherwise eligible for benefits under Medicare Part A and by certain individuals with disabilities who have exhausted other entitlements. The monthly Medicare Part A premium for the 12 months beginning January 1, 2026, for these individuals will be $565. The premium for certain other individuals as described in this notice will be $311.
• On November 17, 2025, CMS released a notice entitled, Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2026. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2026. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2026, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2026 are $405.40 for aged enrollees and $548.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2026 is $202.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus the $0.20 repayment amount required under current law. The Part B deductible for 2026 is $283.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment amount, that individual will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $0.30, $0.40, $0.50, $0.60, or $0.70, respectively. Beginning in 2026, certain Medicare enrollees who are 36 months post kidney transplant, and therefore no longer eligible for full Medicare coverage, can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2026, the immunosuppressive drug premium is $121.60.
• On November 17, 2025, the Food and Drug Administration (FDA) released guidance entitled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. This guidance is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can submit patient experience and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on June 30, 2022.
• On November 19, 2025, FDA released a notice entitled, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).
• On November 20, 2025, CMS released a rule entitled, Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. This final rule updates and revises the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year (CY) 2026. This rule also includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, the rule updates the requirements for the ESRD Quality Incentive Program and terminates and modifies requirements for the ESRD Treatment Choices Model.
• On November 20, 2025, CMS released a rule entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots. This final rule revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for CY 2026. In the rule, CMS  describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, the final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information.
• On November 20, 2025, CMS released a notice entitled, Notice of Medicaid Information Sharing Between the Centers for Medicare & Medicaid Services and the Department of Homeland Security. This notice announces that CMS will begin sharing Medicaid data it receives from states with Immigration and Customs Enforcement (ICE) for immigration enforcement. This information will be provided upon request from ICE, consistent with federal laws, to advance the Administration’s immigration policies.

Event Notices

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

• December 1, 2025: The National Institutes of Health (NIH) announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1, 2025: 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.
• **December 2, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• December 3, 2025: FDA announced a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• **December 3, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. This is a hybrid meeting open to the public.
• December 4, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a hybrid meeting with some sessions open to the public.
• **December 4, 2025: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
• December 4-5, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: 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.
• **December 5, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices. This is a hybrid meeting open to the public.
• **December 9, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• December 10, 2025: CMS announced a town hall meeting on fiscal year (FY) 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• **December 10, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• **December 10, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a virtual meeting open to the public.
• **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.
• **January 22, 2025: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid 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 26-27, 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 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.
• 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.
• 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.
• **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. 

Reports, Studies & Analyses

• On November 19, 2025, the HHS Office of Inspector General (OIG) released a report entitled, CMS Put $11.2 Billion at Risk of Fraud, Waste, and Abuse by Not Properly Closing Contracts. OIG conducted an audit to examine whether CMS closed contracts in accordance with administrative closeout requirements. The closeout process is generally the last opportunity to detect and recover improper payments. Previous OIG reviews have identified issues in HHS contract closeout procedures, which are required once a contracting officer receives evidence that a contract has been completed. In this latest audit, OIG found that CMS failed to close selected contracts in compliance with federal requirements. OIG found that CMS did not meet one or more administrative closeout requirements for the 50 contracts selected for review. 12 contracts worth $2.1 billion remained overdue for close-out. OIG recommended that CMS complete the administrative closeout requirements for these overdue contracts and develop policies and procedures that clearly define documentation standards, roles and responsibilities, and alternative processes to ensure timely contract closure. CMS concurred with OIG’s recommendations.
• On November 20, 2025, the Government Accountability Office (GAO) released a report entitled, Health Savings Accounts: Information on Features and Use, and Characteristics of Account Holders. The report examined how health savings accounts (HSAs) are marketed, how account holders use them, and the characteristics of individuals who utilize tax-advantaged savings accounts. Eight of nine providers interviewed primarily focused their marketing efforts on employers, and all but one required account holders to pay at least one fee. Among individuals with high-deductible health plans, HSAs and similar medical expense accounts were more common among those with higher incomes, Asian or White individuals, those in excellent or very good health, and those with employer-sponsored coverage. According to Internal Revenue Service (IRS) data for 2022, approximately 16.5 million tax returns reported HSA activity, with contributions totaling an estimated $43.6 billion and an estimated $25.4 billion in withdrawals. About 84 percent of contributions were made through payroll deductions by employers or employees, while individuals contributed the remaining 16 percent directly. Of the reported withdrawals, more than 97 percent were used for qualified medical expenses.
• On November 20, 2025, KFF released a report entitled, Chart Reviews Increase Payments to Medicare Advantage Insurers for 1 in 6 Enrollees. The report analyzed Medicare Advantage (MA) encounter data from 2022 to examine how chart reviews increase payments to MA insurers. KFF found that 17 percent of MA enrollees had a diagnosis added during a chart review that resulted in increased federal payments to their MA plan, while less than one percent had a diagnosis removed. Among 29 million MA enrollees, 62 percent had at least one chart review record in 2022. Of note, the proportion of enrollees with chart review records varied substantially across insurers.

Hearings & Markups

• On November 18, 2025, the House Committee on Energy & Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Innovation with Integrity: Examining the Risks and Benefits of AI Chatbots. Witnesses included: Dr. Marlynn Wei, M.D., J.D., Psychiatrist, Psychotherapist, and Author; Dr. John Torous, M.D., M.B.I., Director of Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center and Associate Professor of Psychiatry, Harvard Medical School; Dr. Jennifer King, Ph.D., Privacy and Data Policy Fellow, Stanford Institute for Human-Centered Artificial Intelligence.
• On November 19, 2025, the Senate Committee on Finance held a hearing entitled, The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans. Witnesses included: Dr. Douglas Holtz-Eakin, Ph.D., President, American Action Forum; Mr. Jason Levitis, Senior Fellow, Health Policy Division, Urban Institute; Dr. Brian Blase, Ph.D., President, Paragon Health Institute; and Mr. Bartley Armitage, Affordable Care Act (ACA) Marketplace Plan Enrollee.
• On November 19, 2025, the House Committee on Ways & Means Subcommittee on Health held a hearing entitled, Modernizing Care Coordination to Prevent and Treat Chronic Disease. Witnesses included: Dr. Michael Hoben, M.D., Chief Medical Officer of Population Health Services, Novant Health; Mrs. Allison Reichert, PharmD, Pharmacist, Bode Drug; Dr. Ashish Parikh, M.D., Chief Population Health Officer, Summit Health; and Mr. Brian Connell, Vice President of Federal Affairs, Blood Cancer United.
• On November 19, 2025, the Senate Special Committee on Aging held a hearing entitled, Made in America: Restoring Trust in Our Medicines. Witnesses included: Mr. Tom Neely, Chairman of the Board, Oxford Pharmaceuticals; Mr. Allan Coukell, Chief Government Affairs & Public Policy Officer, CivicaRx; Mr. Patrick Cashman, President, USAntibiotics, LLC; and Dr. Eric Edwards, M.D., Ph.D., CEO, Phlow Corp.

Other Health Policy News

• On November 17, 2025, DHS issued a notice of proposed rulemaking entitled, Public Charge Ground of Inadmissibility. The new approach would replace the definition of “public charge” under the 2022 Final Rule entitled, Public Charge Ground of Inadmissibility, with a broader, discretionary standard for federal officers to reject applications for green cards or work visas. Instead of solely evaluating an individual’s likelihood of primary dependence on government support for income maintenance or long-term institutionalization at the government’s expense, officers would instead evaluate multiple factors based on “a totality of the alien’s circumstances” to determine whether an individual is likely to become a public charge at any time “using their good judgement and discretion.” These factors include age; health; family status; assets, resources, and financial status; and education and skills. The proposed rule would allow officers to consider an immigrant’s participation in public assistance programs, such as Medicaid and the Supplemental Nutrition Assistance Program (SNAP), when determining whether they are found to be a public charge, potentially discouraging use of government health and nutrition services.
  
  DHS is accepting comments on the proposed rule until January 20, 2026.
  
  The full proposal can be found here.
• On November 19, 2025, HHS released a peer-reviewed report entitled, Treatment for Pediatric Gender Dysphoria: Review of Evidence and Best Practices. The report found that the negative impacts of “sex-rejecting procedures,” including puberty blockers, cross-sex hormones, and surgical operations, are substantial yet insufficiently tracked. Identified risks associated with pediatric medical transition include infertility/sterility, sexual dysfunction, impaired bone density accrual, adverse cognitive impacts, cardiovascular disease and metabolic disorders, psychiatric disorders, surgical complications, and regret.
  
  In a press release, HHS Secretary Robert F. Kennedy, Jr., stated that “so-called ‘gender-affirming care’ has inflicted lasting physical and psychological damage on vulnerable young people,” characterizing these procedures as “malpractice.” The report further noted that U.S. medical associations have contributed to the perception of professional consensus supporting pediatric medical transition, noting that there is evidence that some organizations have suppressed dissent and stifled debate about this issue among their members.
  
  Of note, CMS proposed rules entitled, Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth, and Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children, are currently under review by the Office of Management and Budget (OMB).
• On November 19, 2025, the Senate Committee on Finance held a hearing entitled, The Rising Cost of Health Care: Considering Meaningful Solutions for all Americans. This hearing highlighted issues around the affordability of health care and the upcoming expiration of enhanced premium tax credits (EPTCs) for ACA Marketplace plans on December 31, 2025.
  
  Some Members criticized the ACA as flawed and inflationary, advocating for long-term structural reforms, patient-centered solutions like HSAs, and increased market competition, while also raising concerns about fraud within the current subsidy structure. Other Members emphasized the urgent need for an extension of these credits to prevent millions of Americans from drastic premium increases, highlighting the impracticality of implementing complex new systems before the end of the year. While some witnesses emphasized the necessity of immediate action to maintain coverage for individuals on ACA Marketplace plans, others proposed alternatives to address systemic issues.
  
  More information on this hearing can be found here.
• On November 19, 2025, the House Committee on Ways and Means Subcommittee on Health held a hearing entitled, Modernizing Care Coordination to Prevent and Treat Chronic Disease. The hearing focused on strategies to improve chronic disease management but was marked by significant debate over the future of ACA EPTCs.
  
  Witnesses proposed several strategies to improve chronic disease management and reduce costs. Dr. Michael Hoben, Chief Medical Officer at Novant Health, and Dr. Ashish Parikh, Chief Population Health Officer at Summit Health, emphasized the role of accountable care organizations (ACOs) and alternative payment models. According to Dr. Hoben, Novant Health’s ACOs saved Medicare more than $90 million since 2017 while maintaining high quality standards. Dr. Parikh added that these models encourage prevention and better outcomes, noting that their patients experienced 38 percent fewer emergency room visits, and 30 percent fewer hospital visits compared to the overall Medicare population.
  
  Ms. Allison Reichert, a pharmacist from Bode Drug, emphasized the importance of pharmacists’ roles in care delivery, especially in rural areas. She described pharmacists as the most accessible healthcare professionals and voiced support for Rep. Adrian Smith’s (R-NE) legislation, the Ensuring Community Access to Pharmacist Services Act (ECAPS), which would allow, in part, Medicare reimbursement for testing and treating of common infectious diseases. Rep. Smith emphasized that ECAPS is particularly important to provide patients with more options. He emphasized that while Medicaid and commercial payors reimburse for these services, Medicare does not, thus leaving an access gap for seniors.
  
  Telehealth and remote monitoring also received broad bipartisan support. Dr. Hoben reported that Novant Health conducted 373,000 telehealth encounters in 2024, which reduced specialty care wait times and improved stroke diagnoses. Several lawmakers, including Rep. Brian Fitzpatrick (R-PA) and Rep. Greg Steube (R-FL), emphasized the importance of telehealth for managing chronic disease and expanding access to care. While there was broad agreement over telehealth and pharmacists’ scope of practice, members remain polarized over the extension of EPTCs.
  
  More information on this hearing can be found here.
• On November 21, 2025, CMS released the CY 2026 Hospital OPPS and ASC Payment System final rule (CMS-1834-FC), which introduces updates to outpatient payment policy, quality reporting programs, and limited modifications to existing hospital price transparency enforcement. While the rule includes some technical adjustments to transparency requirements, including a revised enforcement timeline and updated civil monetary penalty procedures, the bulk of the policy changes focus on modernizing outpatient care delivery, strengthening quality oversight, and addressing long-term Medicare program sustainability.
  
  In the rule, CMS finalized an update to the OPPS payment rates for hospitals that meet applicable quality reporting requirements by 2.6 percent. Additionally, CMS finalized policies to address unnecessary increases in the volume of covered outpatient department services, by applying the Medicare Physician Fee Schedule (PFS) equivalent payment rate for drug administration ambulatory payment classifications (APCs) when provided at an off-campus provider-based department (PBD) excepted from section 603 of the Bipartisan Budget Act of 2015. The rule also finalizes policies that will phase-out the inpatient-only list beginning with the removal of 285 mostly musculoskeletal procedures for CY 2026, while also expanding the ASC covered procedures list.
  
  Further, the agency did not finalize its proposed accelerated clawback of funds related to the 340B Final Remedy rule and will maintain a 0.5 percent reduction in the OPPS conversion factor applicable to non-drug items and services, excluding hospitals that enrolled in Medicare after January 1, 2018, for CY 2026. However, CMS explained that it anticipates finalizing a larger payment reduction beginning in CY 2027. Additionally, CMS finalized its proposal to significantly modify how skin substitutes are paid under the OPPS.
  
  The final rule includes several updates to Medicare quality programs. CMS will remove selected health equity and COVID-19 vaccine reporting requirements, adopt a new measure evaluating emergency department wait times, and modify the Overall Hospital Star Rating methodology. Under the finalized changes, hospitals ranked in the lowest quartile of the Safety of Care measure group cannot receive a five-star rating, and beginning in future years, these hospitals will be subject to an automatic one-star downgrade.
  
  The full rule can be found here. A fact sheet on the rule can be found here. A fact sheet on the hospital price transparency policy changes in the final rule can be found here.  A press release can be found here.

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