Provide input on a proposed framework for NIH’s next five-year strategic plan

The National Institutes of Health (NIH) is inviting input on a proposed framework for its next five-year strategic plan, which will cover fiscal years (FY) 2027 through 2031 (NOT-OD-26-047). The NIH-Wide Strategic Plan communicates how NIH will advance its mission to support research in pursuit of fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. 

The Framework for the NIH-Wide Strategic Plan for FY27-FY31 articulates NIH’s priorities in three key areas: 

• Priority 1: Research Areas
  • Goal 1: Advance Foundational Knowledge of Human Health and Disease
  • Goal 2: Prevent Disease and Promote Health Across the Lifespan
  • Goal 3: Advance and Optimize Interventions, Treatments, and Cures
• Priority 2: Research Capacity
  • Goal 1: Develop and Sustain an Interdisciplinary Research Workforce
  • Goal 2: Build, Improve, and Sustain Research Resources and Infrastructure
• Priority 3: Research Operations
  • Goal 1: Enhance Scientific Stewardship and Decision-Making
  • Goal 2: Foster Transparency and Accountability to Improve Public Trust in Science

Action Opportunity: Interested parties throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, are encouraged to submit electronic responses using this form by the May 26 deadline. Individuals are also welcome to share ideas with LEAD Coalition staff (email Courtney Wallin, cwallin@leadcoalition.org) to inform the development of the LEAD Coalition’s response to the RFI. Though the Coalition’s submission will not be a sign-on opportunity, the draft response will be circulated by May 11, from which others are encouraged to “borrow liberally” for their own submissions.

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. Feedback is also being sought via a webinar on April 27; individuals can register to attend the webinar here.

Provide feedback on new ICD code for Alzheimer’s biomarkers

On March 17 and 18, the International Classification of Diseases (ICD) Coordination and Maintenance Committee, overseen by the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics (NCHS), reviewed proposals for new diagnosis codes and revisions. One new code under consideration for implementation on October 1, 2027 – “Biomarkers for Alzheimer’s Disease” – is of great relevance to the LEAD Coalition community. Implementation of the proposed code is expected to allow clinicians to accurately reflect the rationale for continuing clinical evaluations and work-ups on patients who are not experiencing cognitive symptoms, avoid misuse of diagnosis codes for symptomatic Alzheimer’s disease, identify potential participants in future clinical trials for asymptomatic patients with abnormal biomarkers, and track evolving care management. The final agenda and meeting materials for all proposed and revised codes discussed during the March meeting are posted on the CDC website.

Action Opportunity: Interested parties may provide public comments on proposed new diagnosis codes, addenda, and revisions being considered for October 1, 2027 implementation. Comments should be directed to the NCHS at nchsicd10cm@cdc.gov and must be received by the May 15 deadline.

Nominate candidates to serve on the U.S. Preventive Services Task Force

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF; 91 FR 21821). The USPSTF, a body of experts in prevention and evidence-based medicine first established in 1984 under the auspices of the U.S. Public Health Service, works to improve the health of people nationwide by making evidence-based recommendations about the effectiveness of clinical preventive services and health promotion. USPSTF recommendations address clinical preventive services for adults and children, and include screening tests, counseling services, and preventive medications.

To qualify for the USPSTF and support its mission, an applicant or nominee should possess expertise in: 

• Reviewing scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and 
• Updating previous clinical preventive recommendations for individuals and organizations delivering clinical services, including primary care professionals, health care systems, professional societies, employers, community organizations, non-profit organizations, Congress and other policy-makers, governmental public health agencies, health care quality organizations, and organizations developing national health objectives.

Nominated individuals will be selected for the USPSTF on the basis of how well they meet the required qualifications and the current expertise needs of the USPSTF. It is anticipated that new members will be invited to serve on the USPSTF beginning in July 2026 and serve for a four-year term. 

Action Opportunity: LEAD Coalition member and allied organizations and researchers are encouraged to nominate qualified individuals electronically via https://uspstfnominations.ahrq.gov/​register by the May 23 deadline.

Respond to RFI regarding the CMS FY 2027 proposed rule on hospice payment policies and quality reporting

On April 2, the Centers for Medicare & Medicaid Services (CMS) issued the Fiscal Year (FY) 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements Proposed Rule (CMS-1851-P). In this rule, CMS proposes to:

• Increase hospice payments by 2.4 percent
• Update the hospice wage index to adjust rates based on local labor costs
• Mandate the provision of the hospice election statement addendum to ensure transparency of items, services, and drugs not covered by Medicare
• Implement a Service and Spending Variation Index (SSVI), to identify potential utilization, quality of care, or compliance concerns
• Conform regulation text changes to allow physician designees to discharge patients,
• Maintain the Hospice Outcomes & Patient Evaluation (HOPE) instrument quality measure set
• Identify hospices that have not submitted required quality data with an icon on the Compare Tool on Medicare.gov.

For more information on these proposed elements, please see the CMS fact sheet. The proposed rule also includes three Requests for Information (RFIs): 

1. Comments on ways to enhance the provision of palliative care outside of hospice care
2. Input on the potential construction of a hospice-specific wage index
3. Feedback on issues that may occur when a Medicare hospice patient requests Medical Aid in Dying (MAID), as well as potential federal oversight mechanisms.

Action Opportunity: Interested LEAD Coalition member and allied organizations and researchers are encouraged to provide feedback to CMS on the requested RFI topics. Feedback must be submitted on the docket by the June 1 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.

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 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.

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.

Support the Lifespan Respite Care Reauthorization Act

Senators Susan Collins (R-ME) and Tammy Baldwin (D-WI) have introduced the Lifespan Respite Care Reauthorization Act of 2025, bipartisan legislation to support the health and wellbeing of family caregivers. The legislation would reauthorize, at $50 million over five years, the Administration on Community Living (ACL) Lifespan Respite Care Program, which provides critical short-term relief to unpaid caregivers. Companion legislation was introduced by Representatives Nick Langworthy (R-NY) and Jill Tokuda (D-HI), which would reauthorize the program through fiscal year 2029. Both versions of the bill (S.830 / H.R. 2560) broaden the definition of a family caregiver, replacing “unpaid adult” with “unpaid individual.” As an essential component of home- and community-based long-term services, these respite services contribute to healthier families and the health and well-being of caregivers and care recipients. For additional information, see the Senate bill text and this letter of support.

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 Lifespan Respite Care Reauthorization Act of 2025.