Health Care Week in Review | Lawmakers Introduce Bipartisan Cancer Screening Bill; President Trump Establishes New NIH Women’s Health Division and Task Force

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 20, 2026, the Food and Drug Administration (FDA) released final guidance entitled, New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information about the NDI. This final guidance focuses on frequently asked questions about the new dietary ingredient notification (NDIN) submissions. This final guidance is intended to help provide recommendations to manufacturers and distributors of NDIs and dietary supplements containing an NDI regarding the identity and safety information that should be included in an NDIN.
• On October 21, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Civil Monetary Penalty Inflation Adjustment. HHS is notifying the public that there will be no civil monetary penalty (CMP) inflation adjustment for 2026 in accordance with the April 17, 2026, guidance from the Office of Management and Budget (OMB). HHS will continue to use the 2025 CMP levels because there will be no cost-of-living adjustment for 2026.
• On October 21, 2026, FDA released final guidance entitled, Regulatory Considerations for Prescription Drug Use-Related Software. This final guidance describes FDA’s application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead center. This final guidance finalizes the draft guidance of the same title issued on September 19, 2023.
• On October 23, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Patient Protection and Affordable Care Act, Exchange Pre-Eligibility Verification. This proposed rule would implement new requirements specified under the Working Families Tax Cut (WFTC) legislation related to Exchange eligibility and verification. This proposed rule contains related updates to provisions affecting inconsistency periods, inconsistency verification procedures, annual eligibility redeterminations and eligibility redeterminations during the plan year, as well as expanding enrollment methods during the verification process and establishing new coverage effective dates.

Event Notices

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

• 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 26, 2026: The National Institutes of Health (NIH) announced a meeting of the President’s Cancer Panel. This is a virtual 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 5, 2026: NIH announced a meeting of the President’s Cancer Panel. 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: NIH announced a meeting of the National Cancer Advisory Board. 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: The Internal Revenue Service (IRS) announced a hearing on the proposed regulations amending an individual taxpayer’s eligibility for a Premium Tax Credit (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.
• **January 20, 2027: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• **January 25-26, 2027: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• **February 8-9, 2027: NIH announced a meeting of the Fogarty International Center advisory Board. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

CRS Examines Medicare Part D Premium Stabilization Demonstration

On October 22, 2026, the Congressional Research Service (CRS) released a report entitled, Medicare Part D Premium Stabilization Demonstration. The report examines the Medicare Part D Premium Stabilization Demonstration, which CMS launched in 2024 in response to concerns about rising stand-alone prescription drug plan (PDP) premiums following implementation of the Inflation Reduction Act (IRA) Part D benefit redesign. The voluntary demonstration provided additional federal subsidies and, initially, modified risk protections to limit premium increases, reducing average PDP premiums by an estimated $26 in 2025 and $13 in 2026 compared with the IRA’s existing six percent premium-growth cap alone. CMS estimated the demonstration would cost $6.2 billion in 2025 and $3.6 billion in 2026, but announced in July 2026 that it would end the program after the 2026 plan year because its analysis indicated the additional subsidies were no longer needed to stabilize the PDP market. The report also discusses questions surrounding CMS’s legal authority to establish the demonstration and outlines options for Congress, including allowing the program to end, restricting CMS’s demonstration authority, or extending the program through legislation such as the Affordable Premiums for Seniors Act of 2026. CRS recommends that CMS establish model contract terms and standardized performance metrics for Medicaid eligibility and enrollment vendors, require greater public disclosure of vendor contracts and performance data, mandate independent audits, and promote outcome-based contracting and open-source or state-owned system architectures.

Other Health Policy News

Lawmakers Introduce Bill to Standardize Cancer Screening Recommendations in Health IT

On October 19, 2026, Representatives Ashley Hinson (R-IA) and Hillary Scholten (D-MI) introduced the Standardizing Cancer Recommendations for Earlier Evaluation and Navigation of Screenings (SCREENS) Act (H.R. 10850), which would require the National Coordinator for Health Information Technology (IT) to establish a national, computable framework for cancer screening recommendations within one year of enactment. Developed in consultation with federal health agencies and oncology stakeholders, the framework would translate recommendations from the U.S. Preventive Services Task Force (USPSTF) and National Cancer Institute into publicly available, machine-readable screening logic that can be incorporated into interoperable health IT.

The bill would also direct HHS to issue guidance within two years encouraging Medicaid managed care organizations (MCOs), Medicare Advantage (MA) plans, and qualified health plans (QHPs) offered through ACA exchanges to integrate technology using the framework. Within five years, certified health IT would be required to include functionality allowing providers to determine whether patients have completed recommended cancer screenings. The legislation would also authorize the Patient-Centered Outcomes Research Institute to support research, pilots, and implementation efforts involving interoperable technologies and clinical decision-support tools designed to improve the use of evidence-based cancer screening recommendations.

A press release is available here. The full bill text is available here.

Trump Establishes NIH Women’s Health Division and White House Task Force

On October 19, 2026, President Donald Trump signed an executive order (EO) entitled, Advancing Women’s Health to Improve Outcomes in All Phases of Life to establish a new Women’s Health Division within NIH. The EO directs NIH to establish the new division within 90 days in conjunction with the NIH Office of Research on Women’s Health to coordinate research into conditions that uniquely or disproportionately affect women, including cardiovascular disease, cancer, autoimmune disorders, infertility, maternal health, menopause, and Alzheimer’s disease. The division is directed to increase inclusion of women and girls in clinical trials, reinforce NIH requirements to account for sex as a biological variable, and translate scientific discoveries into clinical practice.

The EO additionally establishes the White House Women’s Health Task Force (hereinafter “Task Force”), led by HHS Secretary Robert F. Kennedy Jr. and White House Chief of Staff Susie Wiles, to coordinate a comprehensive federal approach to women’s health across all stages of life. The Task Force will focus on addressing evolving health needs from infancy and adolescence through pregnancy, midlife, menopause, and aging, while advancing policy and regulatory reforms to support timely, stage-specific prevention, diagnosis, treatment, and care.

The EO is available here. The White House press release is available here and the HHS press release is available here.

HHS Launches National Kidney Care Plan

On October 20, 2026, HHS launched the National Kidney Care Plan, a department-wide strategy focused on addressing root causes and implementing better treatment at every stage of kidney disease. Building off the Executive Order on Advancing American Kidney Health released on July 10, 2019, during the first Trump Administration, the plan is composed of a three-part approach.

First, HHS aims to prevent kidney disease and its progression through a review of screenings for at-risk populations and model designs that prioritize prevention; expedited FDA approvals and creation of research pathways to accelerate new diagnostics and therapies, including precision treatment; and Medicare payment models that reward providers for maintaining patient health.

The second part of the agenda is oriented towards boosting competition and patient choice in the dialysis market by easing barriers to market entry and reducing artificially high prices. HHS is considering policies to streamline the Medicare conditions for coverage for end-stage renal disease (ESRD), improve support of home-based care, and adapt policies that may impede adoption of new dialysis technologies.

The third agenda item aims to reform the transplant system through competitive, multi-vendor contracting for the Organ Procurement & Transplantation Network (OPTN) and make improvements to the transplant IT system. HHS intends to strengthen accountability by ensuring that Organ Procurement Organizations (OPOs) adhere to their obligations as non-profits and supporting certification of new OPOs to further enable competition. The plan also seeks to expand living-donor kidney transplantation, supported by a public awareness initiative designed to encourage living donation.

The Kidney Care National Plan is available here. The HHS press release is available here and the HHS fact sheet is available here.

CMS Targets Medicaid Program Integrity in New York and California

On October 21, 2026, CMS announced new Medicaid program integrity actions targeting social adult day care and personal care services in New York and California, part of a broader administration effort to shift from a “pay and chase” model toward preventing potentially improper payments before they are made. CMS Administrator Dr. Mehmet Oz said the agency stopped approximately $42 billion in Medicare payments and $4 billion in Medicaid payments over the past year through proactive oversight. In New York, CMS sent monitoring letters to nearly 100 social adult day care providers identified as billing outliers, issued 10 notices of intent to exclude providers from federal health programs, and sent the state a compliance warning over its oversight of managed long-term care plans. CMS also announced a federal audit of New York’s Medicaid personal care spending.

The agency is separately scrutinizing California’s personal care program, deferring another $1.2 billion in federal Medicaid funding while it reviews claims that officials said included services billed for deceased beneficiaries, by terminated providers, and while beneficiaries were hospitalized. Across both states, CMS officials emphasized the responsibility of states, managed care plans, and other entities overseeing Medicaid benefits to identify questionable billing and strengthen program integrity controls. Officials said more than half of New York’s managed long-term care plans reported no fraud referrals last year, an outcome the agency questioned given its findings, signaling heightened federal scrutiny of how Medicaid MCOs monitor providers and detect and report potential fraud.

The full press conference is available here.

HHS Updates National Plan to Address Alzheimer’s Disease and Related Dementias

On October 22, 2026, HHS released the 2026 update to the National Plan to Address Alzheimer’s Disease and Related Dementias, outlining a revised federal strategy focused on dementia risk reduction, research and innovation, care delivery, and support for individuals living with dementia and their families. The updated plan replaces six previous goals with four priorities: (1) promoting dementia risk reduction across the lifespan; (2) accelerating research, diagnostics, prevention, and treatment development; (3) advancing high-value dementia care; and (4) strengthening evidence-based services and caregiver supports. HHS also announced several initiatives tied to the plan, including a new FDA Alzheimer’s Prevention Accelerator and up to $48.8 million in new Advanced Research Projects Agency for Health (ARPA-H) investments focused on earlier detection and intervention, bringing ARPA-H’s related Alzheimer’s investments to as much as $155.3 million. Other planned activities include expanding dementia training and screening in health centers, strengthening resources for caregivers and older adults experiencing cognitive decline, studying diagnostic delays and the economic burden of dementia, and testing lifestyle intervention for Medicare beneficiaries with mild cognitive impairment. HHS said it will track progress on the four goals over the coming year and report on the plan’s impact in its 2027 update.

Details on the National Plan and participating agencies’ initiatives are available here.

CMS Proposes New ACA Exchange Pre-Eligibility Verification Requirements

On October 23, 2026, CMS released a proposed rule entitled, Patient Protection and Affordable Care Act, Exchange Pre-Eligibility Verification. This proposed rule would implement new Affordable Care Act (ACA) Exchange eligibility-verification requirements under the WFTC legislation, including requirements that take effect beginning with plan year 2028. The proposed rule would generally prohibit Exchanges from providing advance premium tax credits (APTCs) and cost-sharing reductions (CSRs) while certain data-matching issues—such as those involving income, family size, citizenship or immigration status, residency, or other health coverage—remain unresolved. However, consumers could enroll in Exchange coverage without financial assistance during this period while verifications are pending. The proposed rule would also require enrollees to provide or confirm key eligibility information annually to continue receiving financial assistance. It would further establish a pre-open-enrollment verification period beginning August 1, 2027, and revise policies governing eligibility redeterminations, coverage effective dates, and special enrollment periods.

A press release is available here. A fact sheet is available here.

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