Priority: Submit response to OMB’s proposed changes to regulations governing federal awards 

The Office of Management and Budget (OMB) issued a proposed rule to revise the Uniform Guidance governing federal grants and financial assistance (91 FR 32198; OMB-2026-0034). The proposal represents a significant framework overhaul to the Uniform Guidance (2 CFR Part 200), which serves as a primary regulatory framework for federal awards distributed to research universities, non-profits, and other recipients. This proposal, which is the largest revision to the Uniform Guidance since its initial release in 2013, represents the effort to codify the Trump Administration’s grantmaking priorities and ongoing activities. 

These changes establish new oversight and accountability standards and also substantially expand agency discretion over award design, selection, and termination. Essentially, these changes weaken longstanding award processes by creating more opportunities for political interference in federal funding decisions. For example, these changes support the termination of grants for discretionary and/or ideological reasons (i.e., aligned with administration priorities, such as prohibiting grants supporting science deemed as “DEI” or those with foreign collaborations) and restrict legal challenges to those decisions. Through these revisions, the administration can exert more political control over funding processes that have traditionally been guided by objective, merit-based evaluation.

The Uniform Guidance touches all corners of the federal government, covering 42 co-issuing agencies across the executive branch. It also affects every county that receives federal funding, whether directly or as a pass-through entity.

Action opportunity: All interested parties are strongly encouraged to submit comments on the docket by the July 13 deadline. Check back here for updates on possible sign-on opportunities from the broader health and science communities. 

Priority: Provide comment to CMS on sweeping new Medicaid community engagement requirements

The Centers for Medicare & Medicaid Services (CMS) has issued an interim final rule (91 FR 33348; CMS-2454-IFC) implementing new statutory requirements for certain adults in Medicaid to meet an 80 hours per month work requirement as a condition of eligibility (referred to as “Medicaid community engagement”).  Among other substantial changes, the rule requires medically-frail individuals not only to confirm that they have a qualifiable condition but, for certain medically-frail individuals, also demonstrate the condition prevents them from working. Individuals living with mild cognitive impairment or in the early stages of Alzheimer’s disease or a related disorder, along with their family care partners, are particularly vulnerable to increased administrative burden created by this new rule, and are at greater risk of coverage disruptions and added stress as they navigate these more complex Medicaid eligibility and reporting requirements. According to initial estimates, these sweeping new requirements are expected to reduce federal Medicaid spending by $326 billion and cost 5.3 million people their Medicaid coverage. 

States must generally implement this requirement no later than January 1, 2027. Individuals who qualify for a medical exemption from work requirements will be allowed to self-attest to their health conditions initially, but are expected to get medical care and documentation verifying their conditions beginning in 2028. 

This rule is being issued as an Interim Final Rule with Comment (IFC) to remain consistent with the legislative directive and implementation timeline established by Public Law 119-21, while allowing CMS to continue to collect and consider public feedback.

Action opportunity: LEAD Coalition members and allies are strongly encouraged to provide comments on the docket by the July 31 deadline.

Provide feedback on FDA’s request for information on drug repurposing 

 The U.S. Food and Drug Administration (FDA) has announced it is soliciting input on drug repurposing efforts to help address unmet medical needs across a range of diseases and conditions (FDA-2026-N-4492). 

Identifying potential new uses—such as a new indication or a new population—for FDA-approved drugs can help accelerate the availability of treatments by using existing knowledge about the drugs. This request for public input is part of a broader FDA initiative to update the labeling of FDA-approved drugs, when supported by sufficient evidence, to ensure that information in the labeling is clinically meaningful for health care providers and patients and scientifically up-to-date.

Drug repurposing plays an important role in Alzheimer’s disease (AD) drug development. Repurposed agents account for 35% of AD drugs in development, and nearly half of Phase 2 drugs (Cummings et al., 2026).

Action opportunity: Interested parties are encouraged to submit comments on the docket by the June 11 deadline.

Nominate experts to participate in National Academies’ workshop on cognitive change 

The National Academies is seeking experts for an upcoming workshop aimed at exploring the science of cognitive change measurement, including approaches for distinguishing normal and pathological trajectories, integrating population-level norms with individual-level information, determining appropriate assessment intervals, and increasing the feasibility of more frequent cognitive measurement. Experts will participate in a planning committee to develop the workshop agenda and objectives, commission a paper on best practices for cognitive assessments, and identify appropriate participants. 

Action opportunity: Interested parties are encouraged to submit nominations by the June 12 deadline. Self-nominations are welcome. Using these nominations, National Academies staff will build a committee of approximately 6 to 8 volunteer experts and collect information for potential speakers, participants, and peer reviewers for any publications resulting from this workshop.

Respond to CMS and ONC proposed rule on prior authorization processes and IT infrastructure

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have released a proposed rule (CMS-0062-P) outlining efforts to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. The rule proposes new requirements for certain entities to make available electronic prior authorization for drugs. Covered entities include Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF-SHOP) Exchanges. To reduce patient and provider burden, the proposed rule aims to extend many existing interoperability requirements for the prior authorization of non-drug items and services. ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications to support a more robust health IT infrastructure.

Action opportunity: Interested parties are encouraged to submit comments on the docket by the June 15 deadline.

Apply for funding from Department of Defense’s CDMRP Alzheimer’s Research Program 

The Department of Defense has released formal announcements for fiscal year (FY) 2026 funding opportunities associated with its Congressionally Directed Medical Research Programs (CDMRP). Among the programs is the Alzheimer’s Disease Research Program (AZRP) which supports innovative, high-impact research with clinical relevance that will address critical needs and improve the quality of life for service members, veterans, their families, and the public who are living with Alzheimer’s disease or a related form of dementia (AD/ADRD). Program announcements include:

• Transforming Care Award: Supports impactful clinical research and trials in dementia care.
  • Funding: Up to $1.9M total costs over 4 years

• Transforming Diagnosis Award: Focuses on solutions to overcome barriers to diagnosis, prognosis, and disease monitoring.
  • Funding: Up to $1.7M total costs over 4 years.

• Transforming Research Award: Drives transformative advancements in reducing risk and preventing AD/ADRD.
  • Funding: Up to $1M total costs over 3 years.

Each program announcement includes a Career Initiation/Transition Partnership Option (CITPO)

• Career Initiation Investigators: Those with 3-7 years of post-degree research experience in their first independent position.
• Career Transition Investigators: Those new to the fields of military health, traumatic brain injury (TBI), or AD/ADRD.

Action opportunity: Interested researchers should submit a pre-application using the electronic biomedical research application portal by the June 22 (5pm ET) deadline.

Apply to ACL’s Health at Home Challenge  

The Administration for Community Living (ACL) has announced the launch of Phase 1 of the Health at Home Challenge. This competition is designed to improve health, independence, and affordability of care for dually eligible Medicare and Medicaid beneficiaries by scaling advanced community care networks, led by community care hubs (CCHs) that integrate health care and community care.

The Health at Home Challenge will recognize and reward partnerships between health plans, health systems, and community-based organizations that support whole-person health for dually eligible and near dually eligible Medicare and Medicaid beneficiaries. Applicants must represent a partnership between an advanced community care network and at least one health care organization. CCHs interested in applying must be connected to an area agency on aging, an aging and disability resource center, a center for independent living, or another aging or disability network organization. 

The competition will run in three phases, each offering up to $2 million in prize funding. Phase 1 will reward innovative strategies to scale comprehensive services to reach more higher-need dually eligible and near dually eligible Medicare and Medicaid beneficiaries through community-clinical partnerships. Phase 2 will focus on implementing the winning strategies selected in Phase 1. Phase 3 will focus on scaling and demonstrating an increase in days at home and reductions in total cost of care among dually (and near) eligible Medicare and Medicaid beneficiaries.

Action opportunity: Interested applicants are encouraged to submit an optional Intent to Apply letter by Friday, May 15, at 5:00 p.m. to healthathome@acl.hhs.gov. Phase 1 submissions are due on Wednesday, June 24, at 5:00 p.m.

Apply to CDC’s FY2026 AD/ADRD funding opportunities 

The Centers for Disease Control and Prevention (CDC) has announced funding opportunities (CDC-RFA-DP-26-0227) to support public health efforts addressing Alzheimer’s disease and related dementias (AD/ADRD) in Fiscal Year (FY) 2026. These opportunities include three components:

1. National Healthy Brain Initiative:
   • Funds at least two (2) organizations to develop and implement public health strategies guided by the HBI Road Map Series. 
   • Funding range: $2,500,000 – $3,000,000 per 12-month budget period.
   • Funded organizations will: 
     • Develop evidence-informed training for health care and public health professionals on ADRD and caregiving.
     • Expand the availability and use of public health surveillance data, including adaptation & revision of the Behavioral Risk Factor Surveillance System (BRFSS) subjective cognitive decline and caregiver optional modules.
     • Facilitate the coordination of recipients and national partners to address AD/ADRD.
2. BOLD Public Health Centers of Excellence:
   • Funds at least two (2) Centers, each specializing in one of three topic-specific areas: dementia risk reduction, early detection and management of dementia, or dementia caregiving. 
   • Funding range: $750,000 – $1,000,000 per 12-month budget period. 
   • Centers will: 
     • Support the needs of the BOLD public health program and other public health agencies. 
     • Identify, disseminate, and promote best practices. 
     • Translate promising research into practical tools and resources.
     • Increase professional education and develop materials to address specific individual needs to improve health outcomes.
3.  AD/ADRD Public Health Adoption Accelerator:
   • Funds up to two (2) organizations to serve as public health strategy adaptation accelerator programs. This means using dissemination and implementation of science to spread and put into practice effective public health strategies, tools, and resources to tackle AD/ADRD. 
   • Funding range: $750,000 – $1,200,000 per 12-month budget period.
   • Organizations will: 
     • Collaborate with CDC and other organizations to create a prioritized list of ADRD approaches & strategies.
     • Use proven strategies to engage partners, health care organizations, and policymakers to enhance uptake and implementation, accelerating the impact of AD/ADRD efforts.
     • Provide technical assistance to Component 1 & 2 recipients.

Action opportunity: Eligible organizations are encouraged to apply on grants.gov by the June 26 deadline. Applicants may apply for multiple components, but must submit a separate application per component. The awards are expected to be made by the end of August, with project start dates of September 30.

Provide input on the FDA Commissioner’s National Priority Voucher pilot program

The U.S. Food and Drug Administration (FDA) is seeking public comment on the Commissioner’s National Priority Voucher (CNPV) pilot program (FDA-2026-N-2366). The CNPV pilot program was established in June 2025 to reduce review times for qualifying new drug applications (NDAs), biologics license applications (BLAs), and manufacturing or efficacy supplements through enhanced regulatory engagement and streamlined review procedures. So far, the agency has awarded vouchers for 18 products and granted four approvals. In addition to accepting written feedback, the agency will host a public hearing on June 12 to seek input about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.

Action opportunity: Interested parties are encouraged to attend the June 12 public hearing and/or submit written comments by the June 27 deadline. Details about meeting registration, including requests for participation, can be found here; written comments can be submitted via the Federal Register.

Respond to FDA’s request for information and comments on PFDD meetings

The U.S. Food and Drug Administration (FDA) has issued a request for information and comments (FDA-2026-N-3947) to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders’ drug development efforts.

In response to requests to better understand the outcomes of PFDD meetings, FDA is seeking to collect information about their impacts outside of specific regulatory decisions. The FDA recognizes that there are many significant outcomes, such as community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas, that can occur in forums to which FDA is not typically a party. Similarly, changes made by medical product developers in response to patient input may not be communicated to FDA outside of a formal regulatory submission.

Action opportunity: All interested parties – including patient organizations, medical product developers, healthcare providers, and academic researchers – are encouraged to submit comments on the docket by the June 30 deadline.

Submit feedback to NIH on return of results to research participants

The Office of Science Policy (OSP) at the National Institutes of Health (NIH) is undertaking a comprehensive policy development process to establish requirements tied to the responsible return of summary-level study results to research participants for all NIH-funded clinical research. Public input is vital to ensuring NIH develops a policy that is flexible, forward-thinking, and serves the best interest of the research participants and the researcher community. NIH is interested in understanding what information should be included in the summary-level results, best practices for participant engagement to ensure that results are returned in meaningful ways, and the timing of sharing summary level results. 

Action opportunity: Interested parties – including study participants, researchers, clinicians, and the broader public— are encouraged to provide feedback to NIH OSP via the available form to help shape the future return of results policy.

Respond to NIH RFI on drug development to prevent or treat specific aging-related conditions

The National Institute on Aging (NIA) has released a request for information (RFI; NOT-AG-26-001) on the development of disease-modifying drugs to prevent or treat specific aging-related conditions. There is evidence that some biologic mechanisms contribute both to physiologic aging changes and to specific aging-related conditions, but few drugs expressly target these mechanisms to modify such conditions.

The RFI seeks input from academic and industry stakeholders who have identified relevant therapeutic targets or are actively developing such drugs. Responses to the RFI will aid NIA in assessing the extent to which potential mechanistic targets for interventions have been identified and validated and will inform planning for possible drug development research initiatives.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to submit comments to NIA_DrugDevelopment@NIH.gov by the July 1 deadline.

Submit comments and register to participate in the NDSS Externally-Led PFDD Meeting

The National Down Syndrome Society (NDSS) is hosting an Externally-Led Patient Focused Drug Development (EL-PFDD) meeting with the U.S. Food and Drug Administration (FDA) on June 2, at 10 a.m. ET, about Down syndrome-associated Alzheimer’s disease (DS-AD). 

The goal of the virtual meeting is to show the FDA and other decision makers how DS-AD impacts the lives of adults with Down syndrome and their families. Topics include the symptoms of DS-AD, individual experiences with available treatments, and hopes for future therapies. The insights shared during the PFDD meeting will help inform future FDA regulatory policies to better reflect the unique challenges that Alzheimer’s disease has on the Down syndrome community.

Action opportunity: All interested parties are encouraged to register for the virtual meeting and submit comments using the online form. Comments will be accepted through July 1; all input will be aggregated and added to the Voice of the Patient Report.

Provide comment on FDA’s proposed rule to remove “gender” terminology in Title 21

The U.S. Food and Drug Administration (FDA) has issued a proposed rule (FDA-2026-N-2886) to modify certain terminology in Title 21 of the Code of Federal Regulations to comply with President Trump’s Executive Order 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” 

The proposed rule, if finalized, would remove the term “gender” wherever it appears and either delete it or replace it with the term “sex”,as applicable, along with other editorial changes.

Though FDA expressed that the policy “does not impact industry practice” and they “do not anticipate any measurable change in industry,” some legal experts see potential for broader damaging impacts on representativeness of clinical trial cohorts, especially individuals from groups that have been underrepresented in research, and therefore risk to the generalizability of research results.

Action opportunity: Interested parties are encouraged to submit comments on the docket by the July 6 deadline.

Apply to ADDF and AFTD joint funding opportunities on FTD research 

The Alzheimer’s Drug Discovery Foundation (ADDF) and the Association for Frontotemporal Degeneration (AFTD) jointly announced two new funding opportunities focused on research for frontotemporal degeneration (FTD).

• The Treat FTD Fund aims to support the development of drugs or devices for FTD disorders while building a better understanding of FTD pathophysiology, biological mechanisms of disease, and analytically and clinically validated biomarkers with a well-defined context-of-use. This request for funding proposals (RFPs) supports novel or repurposed drug candidates or devices in early-stage (phase 0, 1, or 2) clinical trials for FTD disorders. The award will be up to $2,500,000 over one to three years. 
• The Accelerating Drug Discovery for FTD intends to support innovative small molecule and biologic drug development programs for FTD, either in lead optimization or in vivo testing of novel lead compounds, biologics, vaccines, or repurposed drug candidates. Funding is open to academic researchers or biotechnology companies worldwide. The average one-year award is expected to be $300,000, based on stage and scope of research. 

Action opportunity: Researchers and biotech companies worldwide are encouraged to apply to these funding opportunities. For the Treat FTD Fund opportunity, a Letter of Intent (LOI) is due by March 30 and a full proposal is due by June 1. For the Accelerating Drug Discovery of FTD opportunity, the LOI deadline is May 11 and invited full proposals are due by July 20.

Urge Members of Congress to co-sponsor dementia-specific legislation

Alzheimer’s Screening and Prevention (ASAP) Act

Congressmen Vern Buchanan (R-FL) and Paul Tonko (D-NY), and Senators Susan Collins (R-ME) and Catherine Cortez Masto (D-NV), have introduced the Alzheimer’s Screening and Prevention (ASAP) Act (H.R. 6130/S.3267). This bipartisan legislation aims to ensure timely access to innovative screening tests that can detect Alzheimer’s disease and related forms of dementia in their earliest stages.

Under current law, Medicare can cover only preventive services that Congress has specifically authorized or that are recommended by the U.S. Preventive Services Task Force (USPSTF). This process can delay coverage for years after screening tests receive Food and Drug Administration (FDA) approval. The ASAP Act modernizes that process by authorizing the Secretary of Health and Human Services to provide Medicare coverage for FDA-approved or cleared blood-based biomarker tests for the early detection of Alzheimer’s and other dementias. For more information about the ASAP Act, read the Alzheimer’s Impact Movement press release, ASAP Act Fact Sheet, and the joint LEAD Coalition/Alzheimer’s Association/AIM letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act

Senators Shelley Moore Capito (R-WV) and Mark Warner (D-VA) have reintroduced the Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act, bipartisan legislation to encourage early assessment and diagnosis of Alzheimer’s. Companion legislation was also introduced in the U.S. House of Representatives by Representatives Linda T. Sánchez (D-CA), Darren LaHood (R-IL), Doris Matsui (D-CA), and Gus Bilirakis (R-FL). The CHANGE Act (S. 1799 / H.R. 3501) would better utilize the existing Welcome to Medicare initial exam and Medicare annual wellness visits to screen, detect, and diagnose Alzheimer’s and related dementias in their earliest stages. An early documented diagnosis communicated to the patient and caregiver enables timely access to care planning services along with available medical and non-medical treatments, and optimizes peoples’ ability to build a care team, participate in support services, and enroll in clinical trials. For additional information, see the bill text and the and the LEAD Coalition letters to Congress encouraging all Representatives and Senators to become co-sponsors.

Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act

Representatives Troy Balderson (R-OH), Nanette Barragán (D-CA), Darin LaHood (R-IL) and Paul Tonko (D-NY) and Senators Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN), Jerry Moran (R-KS), Cory Booker (D-NJ), Dan Sullivan (R-AK), Andy Kim (D-NJ), James Lankford (R-OK), and Maria Cantwell (D-WA) have reintroduced the bipartisan Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act (H.R. 3747/S.4036). The AADAPT Act would provide grants to providers participating in structured Alzheimer’s and dementia virtual education programs to build on their knowledge of detection, diagnosis, care, and treatment of Alzheimer’s and other forms of dementia. The legislation would address knowledge gaps and workforce capacity issues being faced by primary care providers across the nation, connecting their practices with dementia care experts using free, remote continuing education. These programs have added importance in reaching rural and medically underserved areas where primary care providers are especially strained. Read the full legislative text.

Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act

The Bridging Relief in Delayed Government Enrollment (BRIDGE) for Young Onset Alzheimer’s Disease Act of 2025 (H.R. 6799) would provide more timely coverage of treatment and care for individuals living with young-onset Alzheimer’s by removing the 29-month waiting period for individuals under the age of 65 to qualify for Medicare after obtaining Social Security Disability Insurance. For more information, please see the one-pager.

Global Alzheimer’s Initiative Now (GAIN) Act

Representatives Ami Bera (D-CA), Brian Fitzpatrick (R-PA) and Young Kim (R-CA) have reintroduced the bipartisan Global Alzheimer’s Initiative Now (GAIN) Act (H.R.3674). The GAIN Act would authorize the United States to participate formally in the Davos Alzheimer’s Collaborative (DAC), a global public–private–patient partnership advancing Alzheimer’s and dementia research, diagnosis, treatment, and care. Alzheimer’s and dementia affect nearly 60 million people globally and cost the world economy more than $1.3 trillion annually—an amount that doubles every decade. DAC aims to raise and deploy $700 million over six years and currently supports 19 health systems in 12 countries, including the United States. Read the full legislative text.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of these important pieces of legislation. 

Support the Geriatrics Workforce Improvement Act

U.S. Senators Susan Collins (R-ME) and Tim Kaine (D-VA) have introduced the Geriatrics Workforce Improvement Act (S.2699) to reauthorize funding for the Geriatrics Workforce Enhancement Program (GWEP) and the Geriatrics Academic Career Awards (GACA). Both programs were last authorized in 2020 as part of the CARES Act and are set to expire at the end of September, 2025. The Geriatrics Workforce Improvement Act would reauthorize the GWEP and GACA programs at a combined $48.2 million per year over the next five years.

The GWEP is the only federally funded program that exists to educate and train health professionals in geriatrics. There are currently 42 GWEP recipients. GACA support early-career training of junior faculty to develop emerging leaders in geriatric education and clinical care. There are currently 25 GACA recipients funded under four-year awards through June of 2027.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Geriatrics Workforce Improvement Act.

Support the Older Americans Act (OAA) Reauthorization Act

The Older Americans Act (OAA) Reauthorization Act (S.2120) has been reintroduced in the Senate by Senators Bill Cassidy (R-LA), Bernie Sanders (I-VT), Rick Scott (R-FL), Kirsten Gillibrand (D-NY), Susan Collins (R-ME), Tim Kaine (D-VA), Markwayne Mullin (R-OK), Edward Markey (D-MA), Lisa Murkowski (R-AK), and Ben Ray Luján (D-NM).. The legislation would renew funding and strengthens services for American seniors. Senator Collins is an original cosponsor of the bill, and she was a member of the bipartisan working group that authored this legislation. Since 1965, the OAA has supported and improved the lives of seniors—particularly those who are low-income—through programs that promote nutrition, improve transportation options, support caregivers, offer employment and community service opportunities, and prevent abuse and neglect. This critical law was last reauthorized in 2020.

Specifically, this legislation would reauthorize OAA programs through Fiscal Year 2030 and make improvements to promote innovation and flexibility, strengthen program integrity, and better support family caregivers and direct care workers. The bill also takes steps to better serve Tribal seniors and those with disabilities in their communities. The OAA authorizes an array of services through a network of 56 State Units on Aging and more than 600 Area Agencies on Aging serving older Americans throughout the nation. In the last year alone, OAA programs served more than 12 million caregivers and older adults, including providing more than 2.4 million seniors with at-home or congregate meals.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to urge Members of Congress to co-sponsor and press for swift committee and floor passage of the Older Americans Act (OAA) Reauthorization Act.