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, House Energy and Commerce Committee Republicans unveiled a package of 14 bills to strengthen government efforts to prevent and detect health care fraud, and the Center for Medicare & Medicaid Services (CMS) finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) mandatory model, which is intended to reduce spending on certain drugs covered under Medicare Part B.
Regulations, Notices & Guidance
- On September 28, 2026, the Centers for Medicare & Medicaid Services (CMS) released a correction to a final rule entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards; Correction. This document corrects technical and typographical errors in the final rule that appeared in the Federal Register on August 4, 2026, entitled Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards. This correction became effective on October 1, 2026.
- On September 28, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Statement of Organization, Functions, and Delegations of Authority. This notice revises and restates the Statement of Organization, Functions, and Delegations of Authority for the HHS Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.
- On September 28, 2026, the Health Resources and Services Administration (HRSA) released a notice of supplemental funding entitled, AIM Incarcerated Women Resource Kit. In FY 2026, a Congressional Report accompanying the Consolidated Appropriations Act of 2026 included additional funding for the Innovation on Maternal Health program specifically to “support the development and implementation of a resource kit for providers, as well as correctional custody and healthcare staff, who care for pregnant, birthing and postpartum women who are incarcerated.” HRSA is awarding supplemental funding in the amount of $750,000 to JSI Research & Training Institute Inc., the current Alliance for Innovation on Maternal Health (AIM) Technical Assistance Center Program award recipient, to develop the Care for Incarcerated Pregnant and Postpartum Women Resource Kit.
- On September 28, 2026, HRSA released a final notice entitled, Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response to Honor Our Living Donors Act. On July 1, 2026, HRSA published a notice of proposed eligibility guideline modifications in the Federal Register entitled, Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response To Honor Our Living Donors Act. Through this notice, HRSA requested comments on proposed modifications to the Living Organ Donation Reimbursement Program (LODRP) eligibility guidelines in response to the Honor Our Living Donors (HOLD) Act. The HOLD Act, enacted in February 2026, prohibits consideration of an organ recipient's household income in determining a living organ donor's eligibility for reimbursement. This notice responds to the comments received and finalizes the Program Eligibility Guidelines.
- On September 29, 2026, CMS released a correction to a final rule entitled, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction. This document corrects technical errors in the final rule that appeared in the Federal Register on August 3, 2026, entitled, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements. This correction became effective on October 1, 2026.
- On September 29, 2026, HRSA released a notice of supplemental funding entitled, Autism Longitudinal Data Project and Linking the Boston Birth Cohort and Pregnancy to Early Life Longitudinal Data System and Community-Level Health Databases: A Longitudinal Cohort of Mother-Child Dyads. HRSA is administering this grant using funding made available by the HHS Assistant Secretary for Planning and Evaluation (ASPE) from the Patient Centered Outcomes Research Trust Fund (PCORTF) to Johns Hopkins University, a current HRSA awardee for the Autism Longitudinal Data Project. This is the final year for this award, following supplemental funding previously awarded in FY 2024 and FY 2025 to initiate the data linkage and user testing process.
- On September 29, 2026, HRSA released a notice entitled, Recharter for the Council on Graduate Medical Education. In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the Council on Graduate Medical Education (COGME) has been rechartered. The effective date of the charter renewal is September 30, 2026.
- On September 29, 2026, HRSA released a notice of supplemental award entitled, Maternal Health Research Collaborative for Minority-Serving Institutions Coordinating. HRSA is announcing a supplemental award to Morgan State University, a current HRSA awardee for the Maternal Health Research Collaborative for Minority Serving Institutions (MH-RC-MSI) Coordinating Center (CC). HRSA administers this grant using funding made available by HHS ASPE PCORTF.
- On September 30, 2026, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Antimicrobial Drugs Advisory Committee. The FDA Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the October 7, 2028, expiration date.
- On September 30, 2026, FDA released a notice entitled, Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee. The FDA Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2028, expiration date.
- On September 30, 2026, CMS released a correction to a final rule entitled, Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System– Rate Update; Correction. This document corrects technical errors in the final rule that appeared in the Federal Register on July 31, 2026, entitled Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System–Rate Update. This correction became effective on October 1, 2026.
- On September 30, 2026, CMS released a correction to a final rule entitled, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program; Correction. This document corrects technical errors in the final action that appeared in the Federal Register on August 3, 2026, entitled Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program. This correction became effective on October 1, 2026.
- On September 30, 2026, FDA released a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2026.
- On September 30, 2026, FDA released a notice entitled, Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees. FDA is requesting nominations for qualified individuals to serve as voting members of FDA's standing public advisory committees and panels. This notice covers scientific, technical, professional, and other voting-member positions in which appointees serve as individuals rather than as designated representatives. FDA will consider nominations for current and future vacancies as they arise. FDA encourages nominations of all appropriately qualified candidates whose expertise and perspectives would contribute to the work and balanced composition of its advisory committees. FDA will accept nominations on a continuing basis.
- On October 1, 2026, CMS released a final rule entitled, Global Benchmark for Efficient Drug Pricing (GLOBE) Model. CMS is implementing the GLOBE model, a new mandatory Medicare payment model under section 1115A of the Social Security Act. The GLOBE Model will test whether a payment model that uses an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Medicare Part B drugs and biological products reduces costs for Medicare fee-for-service (FFS) beneficiaries and the Medicare program while preserving quality of care. These regulations are effective on November 30, 2026.
- On October 2, 2026, CMS released a correction to a payment advisory entitled, Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians – Request for Current Billing Information for Qualifying APM Participants; Correction. This document corrects a technical error in the final action that appeared in the Federal Register on August 13, 2026, entitled Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians — Request for Current Billing Information for Qualifying APM Participants. This correcting document is applicable August 13, 2026.
- On October 2, 2026, the Administration for Children and Families (ACF) released a notice of proposed rulemaking entitled, Reforming Federal Reporting and Assessments in Child Welfare. ACF is proposing to enact regulations that implement title IV-B of the Social Security Act because they refer to dates that have passed, have been superseded by subsequent amendments, duplicate or restate requirements already in other federal law, or impose administrative and reporting requirements on agencies that do not meaningfully support federal program oversight and administration of title IV-B programs. Four of these regulatory requirements are redesignated to the regulations addressing titles IV-E and IV-B plan requirements. ACF is also proposing to remove the regulation that articulates the principles of child and family services reviews because it provides unenforceable recommendations and to remove redundant cross-references.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- October 8, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
- October 8, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
- October 9, 2026: The National Institutes of Health (NIH) announced a meeting of the National Center for Advancing Translational Sciences (NCATS). 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.
- **October 19, 2026: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
- **October 19-20, 2026: NIH announced two Tribal Consultations and one Tribal listening session at the National Congress of American Indians (NCAI) Annual Convention. This is a hybrid meeting open to the public.
- October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
- October 20, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public.
- October 22, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- October 26, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act. This is a hybrid meeting open to the public.
- October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
- October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
- October 28, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting open to the public.
- October 29, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute on Aging. This is a virtual meeting with some sessions open to the public.
- October 30, 2026: FDA announced a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. This is a hybrid meeting open to the public.
- November 2-3, 2026: CMS announced the second biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026. This is a hybrid meeting open to the public.
- November 4, 2026: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). This is a virtual meeting with some sessions open to the public.
- November 5, 2026: ONC announced a meeting of HITAC. This is a virtual meeting open to the public.
- November 18, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting open to the public.
- November 19, 2026: FDA announced a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. This is a hybrid meeting open to the public.
- November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, NIDDK. This is a virtual meeting with some sessions open to the public.
- December 1, 2026: NIH announced a meeting of the NCI. This is an in-person meeting with some sessions open to the public.
- December 3, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board (SDRAB). This is a virtual meeting 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 the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
- December 9-10, 2026: CMS announced a town hall meeting to discuss FY 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). This is a virtual meeting open to the public.
- January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a virtual meeting open to the public.
Hearings & Markups
- On September 29, 2026, the Senate Judiciary Committee held a hearing entitled, Oversight of the United States Patent and Trademark Office. Witnesses included: The Honorable John A. Squires, Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office.
- On September 30, 2026, the Senate Health, Education, Labor, & Pensions (HELP) Committee held an executive session to consider the following nominations:
- Dr. Nicole Saphier to be Surgeon General and Medical Director in the Regular Corps of the U.S. Public Health Service;
- Mr. Timothy Westlake to be Assistant Secretary for Mental Health and Substance Use, HHS;
- Ms. Mary Lazare to be Assistant Secretary for Aging, HHS;
- Ms. Loren E. Sweatt to be a Member of the National Mediation Board; and
- Mr. Douglas Ralph to be a Member of the National Mediation Board.
Reports, Studies & Analyses
Many Independent Organ Procurement Organizations Did Not Meet Medicare Requirements for Reporting Kidney Transportation Costs and Some Did Not Transport Organs in Accordance With Medicare Requirements
On September 28, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Many Independent Organ Procurement Organizations Did Not Meet Medicare Requirements for Reporting Kidney Transportation Costs and Some Did Not Transport Organs in Accordance With Medicare Requirements. OIG conducted this report to assess whether independent Organ Procurement Organizations (OPOs) (1) reported kidney transportation costs that met Medicare requirements and (2) transported organs in accordance with Medicare requirements. Out of 43 independent OPOs selected for analysis, OIG found that 21 OPOs reported kidney transportation costs totaling $188,147, that did not meet Medicare requirements due to improperly allocated or inadequately supported costs. Additionally, OIG stated that 26 OPOs reported additional kidney transportation costs totaling $240,178, that did not meet Medicare requirements and 4 OPOs did not meet Medicare requirements for organ preparation and transport. Following this analysis, OIG made recommendations to CMS that it instructs the Medicare Administrative Contractor (MAC) to (1) recover $428,325 in unallowable organ transportation costs by adjusting the applicable OPOs’ cost reports and (2) provide additional education to the independent OPOs. CMS concurred with both recommendations.
Tracking Implementation of the 2025 Reconciliation Law: Medicaid Work Requirements
On September 29, 2026, Kaiser Family Foundation (KFF) released an analysis entitled, Tracking Implementation of the 2025 Reconciliation Law: Medicaid Work Requirements. The One Big Beautiful Bill (OBBB) / Working Families Tax Cut (WFTC) Act requires 44 states and the District of Columbia to condition Medicaid eligibility for adults in the Affordable Care Act (ACA) Medicaid expansion group and certain enrollees in Section 1115 waiver programs on meeting work requirements beginning January 1, 2027. KFF published this analysis to serve as a resource to understand Medicaid work requirements and state options, gauge readiness, and track state-level implementation of the requirements. This resource will be updated to include guidance from CMS, information on state policy decisions as they are made, and new data when available.
Other Health Policy News
CMS Projects Stable Medicare Advantage and Part D Coverage for 2027
On September 28, 2026, CMS announced Medicare Advantage (MA) and Medicare Part D prescription drug coverage are expected to remain broadly stable in 2027, with continued plan availability and relatively modest premium changes for most beneficiaries. In the press release, CMS noted that the weighted average MA premium is projected to decline from $14.37 to $12.00 per month and supplemental benefit offerings, including hearing, dental, and vision benefits, are expected to remain stable. Additionally, average stand-alone Part D premiums are expected to increase by less than $1 per month to reach $36 monthly.
Based on plan projections, enrollment in MA is estimated to be 34 million in 2027, representing approximately 47.4% of all people enrolled in Medicare. Access to MA plans will remain broad, as more than 99% of Medicare beneficiaries are expected to have access to at least one MA plan, and 97% will be able to choose from 10 or more plans during the 2027 open enrollment period. CMS noted that approximately eight in 10 MA beneficiaries will be able to remain in their current plan with the same or a lower premium in 2027.
The CMS press release may be found here and the state-by-state fact sheet may be found here.
House Republicans Introduce Medicaid Fraud and Program Integrity Package
On September 29, 2026, Republican members of the House Energy and Commerce (E&C) Committee introduced a package of 14 bills aimed at strengthening federal and state efforts to prevent, detect, and recover improper Medicaid payments and other forms of health care fraud. The legislation reflects continued congressional interest in program integrity initiatives and increased oversight of federal health care spending.
The package would expand federal-state data sharing, strengthen audits and reporting requirements, and increase oversight of high-risk providers and Medicaid spending. Additional provisions would encourage states to pursue fraud investigations by allowing them to retain a portion of recovered funds, enhance whistleblower protections, and require new auditing and compliance measures to reduce improper payments and strengthen Medicaid program integrity.
While the bills are unlikely to advance before the end of the current Congress given the limited legislative calendar remaining after the November elections, the package provides insight into House Republicans’ health policy priorities and ongoing focus on fraud prevention, program integrity, and federal oversight of Medicaid spending. The proposals may also serve as a foundation for future legislative efforts should Republicans seek to advance broader health care fraud and abuse reforms in the next Congress.
A press release and full list of the 14 bills introduced may be found here.
CMS Finalizes GLOBE Model for Medicare Part B Drug Payments
On September 30, 2026, CMS finalized the implementation of the GLOBE Model, a new mandatory payment model designed to reduce spending on certain drugs covered under Medicare Part B. The model will test an alternative approach to calculating inflation rebates for selected physician-administered drugs and biologics by incorporating drug pricing information from a set of economically comparable countries. Under the model, CMS will compare U.S. drug prices against international benchmarks and use that information to calculate rebate amounts for certain separately payable Medicare Part B drugs. CMS stated that the model is intended to reduce drug spending for both Medicare and beneficiaries while maintaining access to care and preserving incentives for medical innovation.
CMS finalized several changes from the proposed model. The agency excluded biosimilars and their reference products once biosimilar competition enters the U.S. market, as well as orphan-only drugs, plasma-derived products, and certain cell and gene therapies. The GLOBE Model will run for five years, beginning January 1, 2027, and apply to beneficiaries in randomly selected geographic areas representing approximately 25 percent of Medicare beneficiaries enrolled in Original Medicare as their primary coverage. Beneficiaries in selected areas could begin seeing changes in out-of-pocket costs as early as April 2027. CMS will continue manufacturer rebate invoicing and reconciliation activities through March 2034.
A CMS press release on the GLOBE Model may be found here. The final rule on the GLOBE Model as published in the Federal Register may be found here.
Senate HELP Committee Advances Three HHS Nominees
On September 30, 2026, the Senate HELP Committee voted to advance three nominees for senior positions at HHS, clearing the way for consideration by the full Senate. The committee approved the nominations of Dr. Nicole Saphier to serve as Surgeon General and Medical Director in the Regular Corps of the U.S. Public Health Service, Dr. Timothy Westlake to serve as Assistant Secretary for Mental Health and Substance Use, and Ms. Mary Lazare to serve as Assistant Secretary for Aging. The nominations were advanced en bloc by a party-line vote of 12-11. If confirmed by the Senate, the nominees would assume key leadership roles overseeing public health, behavioral health, and aging-related programs and policies across HHS.
A press release from the Senate HELP committee is available here.
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