Health Care Week in Review | CMS Releases Proposed Rule to Implement Sections of the Consolidated Appropriations Act, 2026 Reforming MA and Part D Policies; Bipartisan House Bill Introduced to Delay 340B Rebate 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 October 12, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Announcing Solicitation of Written Comments to inform the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance. HHS is announcing the solicitation of public comments to inform the development of the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance. Written comments will be accepted through 11:59 p.m. E.T. on November 12, 2026.
• On October 12, 2026, the Food and Drug Administration (FDA) released a notice entitled, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry that provides answers to commonly asked questions from applicants and other interested parties regarding post-approval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. This guidance finalizes the draft guidance entitled, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability, issued on July 23, 2024. Comments will be accepted at any time.
• On October 12, 2026, FDA released a final rule entitled, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods. FDA is issuing a final rule to amend the standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. FDA believes reducing sodium may help reduce the risk of hypertension, a major risk factor for heart disease and stroke and will help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods. The final rule is effective December 14, 2026.
• On October 12, 2026, the National Institutes of Health (NIH) released a notice entitled, 2025-2026 IACC Summary of Advances. The Interagency Autism Coordinating Committee (IACC) is preparing its Summary of Advances, a statutorily mandated report that highlights the most consequential autism research of the past year. IACC is seeking suggested research articles to highlight for this report. On behalf of the IACC, the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is collecting research article suggestions from members of the public. Electronic comments will be accepted from October 9, 2026, through October 23, 2026.
• On October 13, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Delegation of Authority. This notice announces that HHS Secretary Robert F. Kennedy Jr. has delegated to CMS Administrator Mehmet Oz, M.D., the authorities previously allocated to the HHS Secretary under Section 1128(b) of the Social Security Act. This formalizes CMS as having exclusive authority to investigate, identify, and develop the evidentiary basis underpinning provider exclusion determinations from Medicare and Medicaid. This delegation will be exercised in accordance with applicable policies, procedures, guidelines, and regulations under HHS. These authorities may be redelegated. Excluded from this delegation is the authority to conduct hearings and to issue regulations.
• On October 13, 2026, the Administration for Children and Families (ACF) released a notice of proposed rulemaking entitled, Further Reducing Bureaucracy and Burden from the Administration for Native Americans. ACF is proposing to further amend the Native American Programs Act to remove duplicative language and streamline the remaining text to ease readability and understanding.
• On October 13, 2026, FDA released a notice entitled, Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal. FDA has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until October 28, 2028.
• On October 13, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Health Center Program Performance Period Extensions; Correction. HRSA is correcting a document published in the Federal Register on September 24, 2026, entitled, Health Center Program Performance Period Extensions. This document outlined performance period extensions for health centers scheduled to compete for a January, February, or March fiscal year (FY) 2027 Service Area Competition. The document did not include one service area that was not eligible for a performance period extension at the time of publication but has since become eligible. This notice corrects that exclusion
• On October 13, 2026, NIH released a notice entitled, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director Notice of Proposed Reorganization. NIH is seeking public comment regarding its proposal to establish the Office of the NIH Chief Artificial Intelligence Officer (OCAIO) within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) and move the Office of Dietary Supplements (ODS) under the Office of Nutrition Research (ONR) within DPCPSI in the Office of the Director (OD), NIH.
• On October 14, 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 the issuance of an Order under Sections 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 order became effective on October 11 at 5:00 p.m. Eastern Daylight Time (EDT) and shall remain in effect through 4:59 p.m. EDT on Tuesday, November 10, 2026. This order may be amended or rescinded prior to that time at the discretion of the CDC Director.
• On October 14, 2026, FDA released a notice entitled, Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC). FDA is requesting nominations for members to serve on the TPSAC. Specifically, TPSAC is seeking to fill two voting member vacancies with physicians, dentists, scientists, or health care professionals practicing in the areas of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty. Nominations received on or before December 13, 2026, will be given first consideration for membership on TPSAC. Nominations received after December 13, 2026, will be considered as later vacancies arise.
• On October 14, 2026, the Internal Revenue Service (IRS) released a notice of proposed rulemaking and notice of public hearing entitled, Premium Tax Credit. IRS is announcing proposed regulations that would amend regulations regarding an individual taxpayer’s eligibility for a premium tax credit (PTC), the computation of a PTC, and an individual’s tax liability due to excess advance payments of the PTC. The proposed regulations would affect taxpayers who enroll themselves or a family member in individual health insurance coverage through a Health Insurance Exchange and may be allowed a PTC for this coverage. Comments must be received by November 30, 2026, to be considered. Additionally, a telephonic public hearing on this proposed regulation has been scheduled for December 8, 2026, at 10 a.m. EDT. Requests to speak and outlines of topics to be discussed at the public hearing must be received by November 30, 2026. Requests to attend the public hearing must be received by 5 p.m. EDT on December 4, 2026.
• On October 16, 2026, CMS released a proposed rule entitled, Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026. CMS is proposing to implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager Accountability) of the Consolidated Appropriations Act, 2026. Comments must be received no later than 5 p.m. EDT on December 15, 2026.

Event Notices

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

• 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: FDA announced a public meeting entitled, Fit-for-Purpose Rare Disease Framework Initiative. 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: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (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 1-3, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences (ESBSC). This is a hybrid meeting with some sessions 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: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health IT Advisory Committee (HITAC). This is a virtual meeting open to the public.
• November 9, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a hybrid meeting open to the public.
• November 16, 2026: NIH announced a meeting of the Sickle Cell Disease Advisory Committee. 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 2, 2026: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.
• **December 2, 2026: NIH announced a meeting of the NCI. This is a virtual 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 the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD). This is a hybrid meeting open to the public.
• **December 8, 2026: IRS announced a hearing on the proposed regulations amending an individual taxpayer’s eligibility for a PTC. This is a telephonic 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.

Reports, Studies & Analyses

Medicare Advantage Enrollees Face Medigap Coverage Barriers

On October 13, 2026, the Kaiser Family Foundation (KFF) released a report entitled, Nearly Three-Quarters of Medicare Advantage Enrollees Could be Denied a Medigap Policy Due to a Pre-Existing Condition. In the report, KFF examined the share of Medicare Advantage (MA) enrollees who have a pre-existing condition that could result in a Medigap denial if they were to switch to Medicare fee-for-service (FFS) outside their one-time 12-month trial period. KFF identified that in 2023, 74 percent of MA enrollees, or 20.9 million individuals, had a pre-existing medical condition that could result in a denial for a Medigap policy. Further, the authors noted that the share of MA enrollees who have a deniable pre-existing condition increased with age among people 65 and older, with close to nine in 10 enrollees 85 and older (88 percent) having a medical condition that could trigger a Medigap denial. However, KFF found that the share of MA enrollees with a deniable pre-existing condition varied by state, with 82 percent of MA enrollees in Florida being at-risk of denial, while 59 percent of MA enrollees in Alaska being at-risk of denial.

Individual Market Enrollment Continues to Decline

On October 14, 2026, KFF released a report entitled, Individual Market Enrollment Continues to Fall Through Mid-2026. KFF found that enrollment in the individual health insurance market, composed primarily of individuals with Affordable Care Act (ACA) Marketplace coverage and those who have purchased similar coverage off-exchange, fell 18 percent between June 2025 and June 2026. This represents a greater decline in coverage than the previously reported 12 percent decrease in effectuated enrollment from February 2025 to February 2026. In total, KFF researchers estimate that individual market enrollment has fallen by over 4.6 million people, from 25.2 million in June 2025 to 20.5 million in June 2026.

Other Health Policy News

House Bill Seeks Delay of 340B Rebate Model Implementation

On October 9, 2026, U.S. Representatives Rob Bresnahan, Jr. (R-PA-8), Debbie Dingell (D-MI-6), Tracey Mann (R-KS-1), and Lois Frankel (D-FL-22) introduced H.R. 10770, the 340B Rebate Model Delay Act. This legislation would delay the implementation of the 340B Rebate Model Pilot Program until 2029. Under the Rebate Model, participating providers would pay the full price of certain prescription drugs upfront and receive the 340B discount later through rebates. The bill sponsors note that the 340B Rebate Model threatens to place significant financial and administrative pressures on hospitals and community health centers, particularly safety-net providers.

The text of the bill can be found here. The affiliated press release from the office of Representative Bresnahan may be found here.

CMS Granted New Authority to Exclude Medicare and Medicaid Providers

On October 13, 2026, HHS Secretary Robert F. Kennedy formally delegated to CMS the immediate authority to exclude providers from Medicare and Medicaid, according to a notice posted in the Federal Register. This replicates the authority previously held solely by the HHS Office of the Inspector General (OIG) to exclude providers following an investigation. Secretary Kennedy has noted that the new authority will not impact the previous delegation of these authorities to OIG. Further, CMS will not be permitted to conduct hearings and to issue regulations related to this authority.

This notice follows a press conference hosted by HHS on July 21, 2026, during which Secretary Kennedy announced his intent to grant CMS this authority.

The notice may be found here. The press release from the July 21, 2026, HHS press conference may be found here.

HHS Presses Medical Organizations on Gender-Affirming Care Policies for Minors

On October 14, 2026, HHS sent letters to medical organizations requesting that they identify whether they will “continue to support sex-rejecting procedures for minors” in their guidance and position statements. Specifically, HHS is requesting a clear statement of the current position of these organizations, identification of any planned revisions to their respective guidance, and a timeline for any changes. HHS has requested a written response from notified organizations within 10 business days. According to the HHS press release, these letters were sent to organizations including the World Professional Association for Transgender Health (WPATH), the American Medical Association, American Psychiatric Association, American Psychological Association, and the Endocrine Society. These letters follow a December 30, 2025, HHS request for a “substantive response” from the listed organizations regarding their positions on gender-affirming care for minors and any planned updates to their position statements.

The HHS press release may be found here.

HHS Launches Healthy Lifestyle Initiative for Community Health Centers

On October 14, 2026, HHS announced the launch of the HHS Health Center Healthy Lifestyle Commitment, a voluntary initiative that encourages HRSA-supported health centers to recenter evidence-based best practices that support nutrition, prevention, and “healthy living” while providing patient care. Health centers that sign on to this initiative will be encouraged to prioritize chronic-disease prevention and educate patients about behavior change; promote healthy eating through the Dietary Guidelines for Americans; connect patients to community health activities, including community gardens, fresh produce programs, nutrition education, and physical activity education; strengthen the prevention workforce through training and resources to integrate prevention into everyday patient care; and build a culture of encouraging healthy choices and empowering patients to take an active role in improving their health.

The HHS press release may be found here.

FDA Unveils Rare Disease Drug Development Framework Initiative

On October 14, 2026, FDA released a white paper announcing the Rare Disease Framework Initiative (hereinafter “Initiative”) to restructure the development of drugs and biologics for rare diseases. The Initiative is intended to develop an optimized, fit-for-purpose framework that encourages consideration of the nuances of rare diseases, patient needs, product type, and evidence that can be realistically generated in small patient populations. The Initiative is led by FDA’s Rare Disease Innovation Hub in partnership with the Office of the Commissioner, the Center for Biologics Evaluation and Research, and the Center for Drug Evaluation and Research.

In developing the framework, FDA aims to increase the speed of rare disease drug development and is committed to the following principles: providing greater clarity, consistency, and predictability in regulatory decision-making; concentrating on patient needs at clearly defined milestones; leveraging external expertise to support customization of regulatory review; building shared resources, robust training, and institutional knowledge on rare disease drug development and review; applying risk-based approaches to review and pre-approval inspections; and championing the use of novel methods in development.

FDA will host a meeting on October 28, 2026, from 1:00 p.m. EDT to 5:00 p.m. EDT at FDA’s White Oak Campus to solicit feedback on the Initiative. FDA is planning additional opportunities for stakeholder input following the public meeting, including sector-specific roundtables, requests for information (RFIs), and internal feedback sessions, which will help inform the development of a new framework.

The HHS press release may be found here and the meeting home page may be found here. The FDA white paper may be found here.

Senate Democrats Seek Feedback on Long-Term Care Reform Proposals

On October 16, 2026, Senate Finance Committee Democrats, led by Ranking Member Ron Wyden (D-OR), released an RFI seeking input on policy proposals designed to provide affordable and accessible long-term care options. The RFI invites comment on three policy goals: (1) ensuring accessible and affordable home care; (2) improving the quality of care in nursing homes; and (3) strengthening the long-term care workforce. In addressing long-term care policy, the RFI notes that the following core principles will be utilized for long-term care reform: universality of the system; affordability and simplicity; flexibility of care setting; investment in the long-term care workforce and informal caregivers; and safeguards from corporate corruption.

This RFI follows a Dear Colleague letter released by Senate Finance Committee Democrats on May 20, 2026, outlining their vision for comprehensive long-term care reform, and more than 95 listening sessions conducted by Finance Committee Democratic staff representing 180 organizations to solicit further policy feedback.

Comments must be received by December 18, 2026, to be considered.

The Senate Finance Committee RFI may be found here. The May 2026 Dear Colleague letter may be found here.

CMS Proposes Medicare Advantage and Part D Transparency Reforms

On October 16, 2026, CMS released a proposed rule to amend the regulations for the MA (Part C) program and the Medicare Prescription Drug Benefit (Part D) program to implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions For Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager Accountability) of the Consolidated Appropriations Act, 2026.

In this proposed rule, CMS proposes to reduce the generic drug copayment from $1 to $0 for full-benefit dual eligible individuals at or below 100 percent of the Federal Poverty Level (FPL), effective for plan years starting January 1, 2028. Additionally, CMS proposes to implement the REAL Health Providers Act by strengthening MA provider-directory verification and maintenance standards, including mandating an update every 90 days; public reporting of accuracy scores; and beneficiary cost-sharing protections when directories are inaccurate. CMS also proposes to codify the statutory requirements for contract year 2029, including that CMS must publicly display provider directory accuracy scores in a machine-readable format and MA organizations must prominently display those scores in their provider directories.

Lastly, CMS proposes to establish enhanced requirements for pharmacy benefit manager (PBM) compensation related to Part D drugs, including a requirement that PBM payments reflect fair market standards, rather than drug costs; expanded reporting to Part D plan sponsors and CMS; greater transparency into price guarantee agreements; and disclosure of certain agreements between PBMs and pharmaceutical manufacturers.

The proposed rule may be found here. The CMS fact sheet may be found here and the CMS press release may be found here.

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