Take Action
Apply to serve on PCORI advisory panels
The Patient-Centered Outcomes Research Institute (PCORI) is seeking healthcare professionals, patients with lived experience, and individuals from all backgrounds, disciplines, and experiences to apply for an open seat on one of the following PCORI Advisory Panels: Clinical Effectiveness and Decision Science (CEDS), Healthcare Delivery and Disparities Research (HDDR),Patient Engagement, Clinical Trials, or Rare Disease. These panels help guide PCORI’s research funding priorities and play an integral role in advancing its mission to help people make informed healthcare decisions. To learn more and get answers to some frequently asked questions, watch the replay of the Advisory Panel Town Hall. For details about panel member requirements and expectations, nomination procedures, and other information, click here.
Action opportunity: Interested individuals and organizations are encouraged to submit nominations by the March 29 deadline.
Submit comments to CMS on proposed rule on health care provider and supplier Accrediting Organizations
The Centers for Medicare & Medicaid Services (CMS) has released a proposed rule, “Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest” (CMS 3367-P). AOs survey over 9,000 health care providers and suppliers participating in the Medicare/Medicaid program to ensure they meet CMS compliance standards. When AOs request and receive CMS approval to determine compliance on behalf of CMS for facilities they accredit, they take on a public trust responsibility to hold those providers and suppliers accountable. This proposed rule seeks to bolster AO performance and oversight to ensure providers meet health and safety standards, so patients receive high-quality, safe care from health care facilities. Changes in this Notice of Proposed Rulemaking (NPRM) include addressing conflicts of interest with health care facilities accredited by the AO, holding AOs accountable to the same standards as state Survey Agencies (SAs) that also conduct surveys on behalf of CMS, and improving consistency and standardization in surveys nationwide. The NPRM more closely aligns AO survey activity requirements and staff training with those of SAs. The NPRM also requires AOs with poor performance to submit a publicly reported correction plan to CMS. The NPRM aligns with the CMS national quality strategy to shape a resilient, high-quality health care system. For additional information, read the full CMS statement.
Action opportunity: LEAD Coalition member and allied organizations, advocates, and other interested parties are encouraged to submit public comments by the April 15 deadline.
Respond to the Senate Special Committee on Aging RFI on hoarding disorder among older adults
The Senate Special Committee on Aging has released a request for information (RFI) regarding the impact of hoarding disorder (HD) on older adults. HD is a chronic and progressive condition that leads people to accumulate more objects than their homes can accommodate. Prevalence of hoarding appears to be significantly greater for older adults (roughly 6.2%) compared to younger adults (roughly 2%). The Committee is charged with studying “any and all matters pertaining to problems and opportunities of older people,” including problems related to health, housing, care, and assistance. HD, and its potential impact on communities and older adults in the coming decades, intersects with all of those issues. Accordingly, the Committee has requested information addressing the following questions:
- How has hoarding disorder impacted your community, particularly older adults and people with disabilities?
- How has hoarding disorder impacted your organization, particularly in its ability to carry out its mission?
- How has your organization responded to hoarding disorder, including through establishing any new or unique initiatives? What, if any, challenges has your organization faced while implementing that response?
- How can the federal government help your organization assist older adults and others with hoarding disorder?
Action opportunity: LEAD Coalition member and allied organizations, advocates, and other interested parties are encouraged to e-mail written responses by the April 15 deadline. For questions about the RFI, contact Doug Hartman on the Committee staff.
Submit comments to FDA CDER on innovation in clinical trial design and conduct
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.
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.
Submit comments to FDA on revised draft guidance for development of drugs to treat early Alzheimer’s disease
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 text). 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.