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. To learn more about the recent changes associated with PL 119-21 and how advocates can respond effectively, review the new Shifting Ground report from the LEAD Coalition and UsAgainstAlzheimer’s. 

Apply for trio of ACL funding opportunities 

The U.S. Administration for Community Living (ACL) has opened three new funding opportunities relevant to the Alzheimer’s disease and related disorders (AD/ADRD) community.

Advancing State Implementation of the National Strategy to Support Family Caregivers 

ACL has released a notice of funding opportunity (NOFO) to support state implementation of the principles, recommendations, and actions as stated in the National Strategy to Support Family Caregivers (HHS-2026-ACL-AOA-CGNS-0032). Grantees will be expected to address at least three of the Strategy’s goals to more effectively recognize, assist, support, and engage family caregivers. In addition, awardees are required to collaborate with their state’s developmental disabilities agency, as well as at one additional state agency over the course of the project. Eligible applicants include state units on aging.

Alzheimer’s Disease Programs Initiative – Dementia Capable States and Communities

ACL has released a NOFO to strengthen the ability of states and communities to serve people living with Alzheimer’s disease and related dementias and their caregivers in their homes and communities (HHS-2026-ACL-AOA-ADPI-0002). The two options for applicants include expanding access to dementia-capable home and community-based services in states (Option A) and communities (Option B). The dementia-capable systems resulting from program activities under either option are expected to provide quality, person-centered services and supports that help individuals living with dementia and their caregiver remain independent and safe in their communities. Eligible applicants include state/tribal/county/city/township governments, non-profits, Native American tribal organizations, and public/private/state institutions of higher education.

Lifespan Respite Care Program: State Grants

ACL has released a NOFO to enhance state systems and capacities to deliver respite care and related services to family caregivers of children and adults across all age groups, disabilities, and chronic conditions (HHS-2026-ACL-AOA-LRLI-0053). There are two applications options contained in this NOFO. Option A is for states that have never had a Lifespan Respite Care grant or for states seeking to restart or rebuild core respite infrastructure and statewide program activities. Option B is for states that have previously received Lifespan Respite Care funding and are seeking to expand, enhance, and sustain existing respite program activities. Programs should identify and address gaps in respite availability, improve access for unserved and underserved populations, reduce duplication across systems, and ensure services remain responsive to the individualized needs of family caregivers across the lifespan. Eligible applicants include state units on aging or state agencies that administer Medicaid programs.

Action opportunity: Eligible organizations are encouraged to submit proposals by the July 22 deadline for each of these ACL funding opportunities.

Respond to FDA’s call for input on new Expedited IND pilot program to accelerate time from drug identification to first-in-human studies 

The U.S. Food and Drug Administration (FDA) is soliciting input on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program (91 FR 37996; FDA-2026-N-4699), to shorten the time it takes from drug identification to first-in-human studies. while protecting clinical trial participants. FDA is requesting information on the potential pilot program, which would establish a network of qualified research institutions that would partner with sponsors to develop and review protocols for first-in-human clinical trials intended for an IND submission to FDA. Information provided through this public docket will help the FDA refine the approach and consider other opportunities to accelerate time to first-in-human clinical trials.

Action opportunity: Interested parties may submit comments on the docket by the July 22 deadline.

Submit comments to FDA’s call for input on safer starting doses for first-in-human clinical trials 

The U.S. Food and Drug Administration (FDA) is soliciting input on new draft guidance intended to help sponsors determine safer starting doses for first-in-human clinical trials of certain drugs and biologics (91 FR 38004; FDA-2026-D-6539). Historically, first-in-human starting doses have been based largely on animal toxicology studies, which may not adequately estimate human risk. Through this guidance, FDA is signaling stronger support for model-informed drug development, specifically the use of Quantitative Systems Pharmacology (QSP), to establish starting doses in first-in-human trials. The guidance is particularly relevant for advanced biologics and immune-modulating therapies where safety concerns can arise at very low doses.

Action opportunity: Interested parties may submit comments on the docket by the July 24 deadline.

Nominate a researcher to receive grant support through the FNIH Music as Medicine Neuroscience Research Initiative 

The Foundation for the National Institutes of Health (FNIH), in partnership with the Renée Fleming Foundation, Mickey Hart of the Grateful Dead, and Jim Weiss of Real Chemistry, launched the Music as Medicine Neuroscience Research Initiative to provide grant support to outstanding scientists who are examining the connections between neuroscience and music.  

Grants will fund research into music-based therapies with potential to advance the health and well-being of people living with conditions such as Alzheimer’s, Parkinson’s, stroke, and depression. Areas of interest include:

• Basic and translational research aimed at uncovering neural, biological, and behavioral mechanisms through which music engagement and music-based interventions influence human health and well-being.
• Innovative clinical research that seeks to develop, test, optimize, or personalize music-based interventions to improve health, cognitive function, mental health, and quality of life across the lifespan.
• Translational and implementation research designed to accelerate the integration, scalability, and accessibility of evidence-based music interventions within healthcare and community settings, with the potential to improve patient outcomes and models of care.

Awards will be presented to three individual recipients or individual teams for $100,000 for one year, with the potential for an additional year of support. Eligible individuals are independent investigators holding a faculty or research scientist appointment at a U.S.-based academic, medical, or research institution.

Action opportunity: Interested parties are encouraged to submit nominations by the July 31 deadline. Eligible researchers may self-nominate.

Provide comment on NIH’s proposal to limit the number of simultaneous grants per PI 

The National Institutes of Health (NIH) has released a request for information (RFI; NOT-OD-26-086) on a proposal to limit the number of simultaneous NIH Research Project Grants (RPGs) that any individual investigator can hold as a principal investigator (PI) or multi-PI. NIH argues that concentrating large numbers of grants among a relatively small group of investigators may reduce overall scientific productivity and innovation. The agency also states that a cap could broaden the distribution of funding across institutions and geographic regions, support more investigators, strengthen the biomedical workforce, and improve project oversight and mentoring. Note: This aim appears in conflict with current efforts to expand multi-year funding practices, in which NIH commits research dollars up front for entire project periods, limiting near-term flexibility and drastically reducing the ability to redistribute funds more broadly across investigators and institutions.

The RFI asks stakeholders to weigh in on potential caps of two, three, or four simultaneous RPGs. NIH estimates that a cap of four grants could free approximately $1.28 billion for roughly 1,900 additional awards, while a cap of two grants could free about $3.53 billion for more than 5,200 additional awards. Under the primary implementation approach, investigators above the cap would gradually reduce their grant portfolios through renewals, grant relinquishments, or PI transfers before receiving new awards. NIH is also considering an alternative, more rapid implementation approach that would require institutions to bring investigators into compliance within one year.

NIH has requested feedback specifically on the advantages/disadvantages of the proposed policy, the optimal cap level, proposed implementation strategies, and any unintended consequences or policy loopholes.

Action opportunity: LEAD Coalition member organizations and allies are encouraged to submit comments via the NIH form by the August 3 deadline.

Respond to NIH’s RFI on measuring and rewarding scientific impact 

The National Institutes of Health (NIH) is seeking input on how scientific impact should be measured and rewarded. Through its Request for Information (RFI; NOT-OD-26-087), NIH elevates the new agency-wide Replication and Reproducibility Initiative and – in alignment with this initiative – requests input on specific metrics to measure and incentivize collaborative, rigorous, and impactful research.

This RFI notes that biomedical research traditionally has rewarded productivity, often measured in publication and citation counts. NIH aims to shift toward a new framework that places greater emphasis on reproducibility, data and software sharing, mentorship, collaboration, translation of discoveries into practice, foundational scientific exploration, and public impact. Based on input, NIH aims to develop and adopt new metrics that are expected to influence grant review, promotion and tenure processes, and scientific careers more broadly.

By redefining research success, this effort has the power to reshape how and what research questions are pursued, and ultimately what types of research are conducted. Researchers, trainees, institutions, professional societies, and other research stakeholders should consider both the potential benefits and unintended consequences of these changes, including new biases that could emerge, in responses to the RFI.

Action opportunity: All interested parties are encouraged to respond to the RFI via the online submission form by the August 19 deadline.

Apply to serve as the next Director of NIA’s Division of Neuroscience  

The National Institute on Aging (NIA), part of the National Institutes of Health (NIH) and the lead institute for Alzheimer’s disease research, is seeking exceptional candidates for the position of Director, Division of Neuroscience (DN). The Division of Neuroscience (DN) has a budget of approximately $2.4 billion and is supported by 70 full-time equivalent (FTE) employees. 

The DN Director is responsible for planning, directing, and evaluating extramural research and training across the five DN branches – i.e., Neurobiology of Aging and Neurodegeneration, Behavioral and Systems Neuroscience, Clinical Interventions and Diagnostics, Population Studies and Genetics, and Translational Research. The DN Director is also responsible for collaborating with other NIA Divisions, NIH Institutes, Centers, and Offices, and other Federal agencies in the coordination and support of relevant scientific activities. This includes working with components of the NIH and NIA Offices of the Director in developing material for distribution to Congress, scientists, and the public. In addition, the Director maintains liaisons with private and public organizations and professional societies representing researchers and clinicians in research on brain aging. The Director also serves as a spokesperson to public audiences about the activities of NIA, the current state of the science, and research investments and projects.

Applicants must possess an M.D., Ph.D., and/or equivalent degree in biomedical sciences, with broad senior-level experience in neuroscience and aging.  This role has been vacant since September 2024; Jennie Larkin, Ph.D., DN Deputy Director, currently serves in the position in an acting capacity. 

Action opportunity: Qualified candidates are encouraged to apply to this position before the August 21 deadline by submitting a CV with bibliography, three (3) letters of reference, and a statement addressing the qualifications and interest in the position to NIADNDirector@nih.gov. LEAD Coalition members and allies are encouraged to share the position announcement with qualified potential candidates. 

Respond to NINDS RFI to inform the National Plan to End Parkinson’s Disease

The National Institute of Neurological Disorders and Stroke (NINDS) is requesting public input (NOT-NS-26-039) to inform the development of the National Plan to End Parkinson’s Disease required by P.L.118-66. The scope of the RFI includes Parkinson’s disease and related neurodegenerative parkinsonisms, including multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, Parkinson’s disease dementia, Lewy body dementia and dementia with Lewy bodies. NINDS will share responses with the newly-established Advisory Council on Parkinson’s Research, Care, and Services (ACPRCS) to assist in identifying priority actions and developing recommendations for the National Plan to End Parkinson’s. 

Via this RFI, NINDS seeks input on 1) research and 2) care and services relevant to the Parkinson’s disease and related neurodegenerative parkinsonisms community.

• For research, input is requested on: the highest priority areas to understand underlying factors contributing to these diseases; ways to accelerate effective treatments; research on environmental triggers; ways to improve early diagnosis; disparities and interventions for communities disproportionately affected; and barriers to research participation. 
• For care and services, input is requested on: the biggest challenges for people currently living with these diseases; gaps in clinical care and services; current standards of clinical care or services; impacts on physical, mental, social, and financial health; disparities and interventions for communities disproportionately affected; ways to improve care and service delivery; and barriers to receiving care and services. 

The RFI is intended for planning purposes only and does not represent a funding opportunity.

Action opportunity: Interested parties – including individuals living with Parkinson’s disease and related disorders, care partners, researchers, clinicians, advocacy groups, healthcare providers, and other stakeholders – are encouraged to respond to the RFI. Responses to this RFI must be submitted via this form or submitted via email to nationalPDplan@nih.gov (with “RFI” in the subject line) by the August 22 deadline.

Provide feedback on FDA’s revised draft guidance on substantial evidence of effectiveness for drugs and biologics 

The U.S. Food and Drug Administration (FDA) published revised guidance on the demonstration of substantial evidence of effectiveness for drugs and biologics (91 FR 37994; FDA-2019-D-4964). The updated guidance, revised based on public comment and advances in drug development, indicates that two positive Phase 2 trials are not a rigid requirement. Instead, the guidance signals that one, strong pivotal trial — coupled with other confirmatory evidence— may be sufficient to satisfy the evidence of effectiveness standard. 

For sponsors, this revision offers greater flexibility to leverage a broader range of evidence to support approval, which may be  advantageous for certain disease types with small patient populations, e.g., rare diseases, genetically-defined conditions. When final, this guidance will replace the 1998 guidance titled “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.

Action opportunity: Interested parties may submit comments on the docket by the September 22 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.

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.