Take Action
Submit comments to FDA CDER on innovation in clinical trial design and conduct
Provide input on federal Elder Justice Coordinating Council priorities
The Administration for Community Living (ACL) has published a Request for Information (RFI) regarding priorities for the Elder Justice Coordinating Council (EJCC), which brings together 17 federal departments, agencies, and entities. Specifically, ACL would like seeks inputs regarding:
- how the Council can benefit the larger elder justice community
- the areas of elder justice in which the Council should focus their attention
- the activities, tools, resources, or components that would best help states and communities create and strengthen their systems of services and supports in order to maximize the independence, well-being, and health of people at risk for elder abuse, neglect, and exploitation, their family members, and their support networks.
- how the Council can advance equity
The EJCC was established by the 2010 Elder Justice Act and is a permanent group that meets twice annually. In 2014, the EJCC adopted “Eight Recommendations for Increased Federal Involvement in Addressing Elder Abuse, Neglect, and Exploitation.”
Action opportunity: LEAD Coalition member and allied organizations, advocates, and other interested parties are encouraged to respond to the RFI by emailing ejpubliccomments@acl.hhs.gov (subject line “EJCC Priorities”) by the April 24 deadline.
Submit comments to FDA on draft guidance on collection of race and ethnicity data in clinical trials and clinical studies
Submit comments to FDA on making informed consent easier to understand
The U.S. Food and Drug Administration (FDA) has released a draft guidance, “Key Information and Facilitating Understanding in Informed Consent,” which provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.”This draft guidance provides research sponsors, investigators, and institutional review boards (IRBs) with recommendations on how to implement two proposed requirements in the FDA proposed rule, “Protection of Human Subjects and Institutional Review Boards,” and the corresponding current requirements under the revised Common Rule, including that:
- Informed consent begins with key information about the research presented in a clear and concise manner.
- Informed consent as a whole be presented in a way that facilitates understanding of the reasons why someone might or might not want to participate in the research.
Submit Fiscal Year 2025 testimony to House Appropriations Labor-H Subcommittee
Respond to CMS RFI on Medicare Advantage data
The Centers for Medicare & Medicaid Services (CMS) has announced a request for information (RFI) (Docket Number:CMS-4207-NC) about how to enhance Medicare Advantage (MA) data capabilities and increase public transparency. In particular, CMS requests comments on all aspects of data related to the MA program, including:
- Data-related recommendations related to beneficiary access to care including provider directories and networks.
- Prior authorization and utilization management, including denials of care and beneficiary experience with appeals processes as well as use and reliance on algorithms.
- The cost and utilization of different supplemental benefits.
- All aspects of MA marketing and consumer decision-making.
- Care quality and outcomes, including value-based care arrangements and health equity.
- Healthy competition in the market, including the impact of mergers and acquisitions, high levels of enrollment concentration, and the effects of vertical integration.
- Data topics related to Medicare Advantage prescription drug plans (MAPDs).
- Special populations such as individuals dually eligible for Medicare and Medicaid, individuals with end-stage renal disease (ESRD), and other enrollees with complex conditions.
Respond to Center for Dementia Respite Innovation funding opportunity
Respond to CMS Minority Research Grant Program funding opportunity
Respond to Volunteer Community Care Corps Program funding opportunity
- Telephone Number: 800-369-1836
- Participant Pass Code: 1376555
Submit comments to FDA on revised draft guidance for development of drugs to treat early Alzheimer’s disease
Apply for two ACL Lifespan Respite Care Program funding opportunities
The U.S. Administration for Community Living (ACL) has opened two new funding opportunities to eligible entities under the Lifespan Respite Care Program. Lifespan Respite Care programs are coordinated state systems of accessible, community-based respite care services for family caregivers of children and adults across all age groups, disabilities, and chronic conditions. The goals of the program include improving equitable access to, and quality of, respite care services to all family caregivers, thereby reducing family caregiver burden when supporting individuals across the lifespan. Such programs reduce duplication of effort and assist in the development of respite care infrastructures at the state and local levels. With the release of the 2022 National Strategy to Support Family Caregivers, applicants are encouraged to align their proposals with the strategy and to look for opportunities to re-think or enhance their existing respite systems of care.
Lifespan Respite Care Program: State Program Enhancement Grants (HHS-2024-ACL-AOA-LRLI-0019)
Applicants to this funding opportunity will propose approaches grounded in the principles and actions of the strategy to make advancements in and strengthen their lifespan respite care systems. Grantees will be expected to build on previous efforts to improve equitable access, consistency, quality, and sustainability, and reduce duplication in respite service delivery. Additionally, grantees will be expected to provide respite services, continue building collaborations and partnerships across the state, expand options for volunteers, ensure adequate respite provider training is offered, identify gaps in current services and conduct outreach to reduce those gaps, and continue to (or increase) efforts to target underserved populations across the lifespan.
There will be an informational conference call on Tuesday, April 23, 2024, at 2:00 PM ET.
- Toll-free number: 888-469-1602
- Passcode: 9897610
Lifespan Respite Care Program: Grants to New States and States Re-Establishing Their Core Respite Infrastructures (HHS-2024-ACL-AOA-LRLR-0020)
Applicants to this funding opportunity will propose approaches to, at a minimum, establish or re-establish state and local coordinated lifespan respite care systems to serve family caregivers regardless of the age, disability, or chronic condition of the care recipient. Applicants will also be expected to propose how they will develop or expand new and emergency respite services and provide such services; train and recruit respite workers, including volunteers; and assist caregivers in gaining access to respite care services that meet the needs of both the caregiver and care recipient.
There will be an informational conference call on Wednesday, April 24, 2024, at 2:00 PM ET.
- Toll-free number: 888-469-1602
- Passcode: 9897610
Action opportunity: Eligible organizations are encouraged to submit proposals by the June 11 deadline for each of these two ACL Lifespan Respite Care Program funding opportunities.
Urge Members of Congress to co-sponsor dementia-specific legislation
Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act
Senators Shelley Moore Capito (R-WV) and Debbie Stabenow (D-MI), along with Senators Bob Menendez (D-NJ) and Roger Wicker (R-MS), have reintroduced the Concentrating on High-Value Alzheimer’s Needs to Get to an End (CHANGE) Act (S.2379 / H.R.4752), 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) and Gus Bilirakis (R-FL). The CHANGE Act 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 patients’ ability to build a care team, participate in support services, and enroll in clinical trials. For additional information, see the bill text and a section-by-section summary.
NAPA Reauthorization Act and Alzheimer’s Accountability and Investment Act
Senators Susan Collins (R-ME), Mark Warner (D-VA), Shelly Moore Capito (R-WV), Ed Markey (D-MA), Jerry Moran (R-KS), Bob Menendez (D-NJ), Lisa Murkowski (R-AK) and Debbie Stabenow (D-MI) introduced two critically important pieces of bi-partisan legislation to advance progress against Alzheimer’s disease and related forms of dementia. Representatives Paul Tonko (D-NY), Maxine Waters (D-CA), and Chris Smith (R-NJ) have introduced companion legislation in the House. The NAPA Reauthorization Act (S. 133 / H.R. 619) would reauthorize the National Alzheimer’s Project Act (NAPA) through 2035 and modernize the original 2011 legislation to reflect strides that have been made to understand dementia, such as including a new focus in the National Plan on promoting healthy aging and reducing risk factors. The Alzheimer’s Accountability and Investment Act (S. 134 / H.R. 620) would continue through 2035 a requirement that the Director of the National Institutes of Health submit an annual budget directly to Congress (a Professional Judgement Budget aka Bypass Budget) estimating the funding necessary for NIH to implement fully NAPA’s research goals. Only two other areas of biomedical research – cancer and HIV/AIDs – have been the subject of special budget development aimed at speeding discovery. Click here for additional information and advocacy resources.
BOLD Infrastructure for Alzheimer’s Reauthorization Act
Senators Catherine Cortez Masto (D-NV), Susan Collins (R-ME), Shelley Moore Capito (R-WV), and Tim Kaine (D-VA), along with Representatives Brett Guthrie (R-KY) and Paul Tonko (D-NY), have introduced legislation to reauthorize funding for the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act. The bipartisan BOLD Infrastructure for Alzheimer’s Reauthorization Act (S.3775 / H.R.7218) would renew and strengthen the nation’s public health response to Alzheimer’s for another five years. By providing state, local, and tribal public health officials with funding and resources, Congress would help continue to increase early detection and diagnosis, reduce risk, support the needs of caregivers, and address health disparities—all of which impact those living with the disease, and their millions of unpaid caregivers. For additional information, click here.
Accelerating Access to Dementia & Alzheimer’s Provider Training Act
Representatives Buddy Carter (R-GA), Nanette Barragán (D-CA), Darin LaHood (R-IL) and Paul Tonko (D-NY) have introduced the Accelerating Access to Dementia & Alzheimer’s Provider Training (AADAPT) Act (H.R. 7688). Building upon the existing Project ECHO video-conference-based education program, this legislation aims to empower primary care providers to better diagnose Alzheimer’s disease and other forms of dementia and deliver high-quality, person-centered care in community-based settings by addressing the knowledge gaps and workforce capacity issues primary care providers often face. The Alzheimer’s and Dementia Care ECHO Program connects dementia care experts with primary care providers to address these knowledge gaps using free, remote continuing education. ECHO’s video-conferencing based program reaches rural and medically underserved areas where primary care physicians are especially strained.
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 each of these important pieces of legislation.