Priority: Provide comment to HHS on comprehensive update to the National Plan to Address Alzheimer’s Disease

The U.S. Department of Health and Human Services (HHS) is seeking public input on the development of a comprehensive update to the National Plan to Address Alzheimer’s Disease (HHS-ASPE-2026-0298). The National Plan is a broad and ambitious framework to accelerate scientific progress and improve support for individuals living with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) and their families. HHS invites public comment on approaches to advancing AD/ADRD research and development of new interventions to prevent and treat dementia, risk reduction strategies, early detection and diagnostic tools, and/or enhanced care, services, and supports for people living with dementia and their families, caregivers, and care partners. HHS also seeks input on gaps, emerging priorities, and opportunities to strengthen coordination across federal, state, Tribal, local, private sector, faith, and community partners. The HHS Request for Information (RFI) seeks responses specifically on these questions:

1. What opportunities or challenges exist in advancing research and development of interventions to prevent or treat AD/ADRD, including translating scientific progress into effective and scalable treatments and care?

2. What opportunities or challenges exist in improving risk reduction and promoting brain health across the lifespan?

3. What barriers or challenges affect early detection and timely diagnosis of AD/ADRD?

4. What are the most significant gaps in dementia care, services, and supports for people living with AD/ADRD and their families, caregivers and care partners, including caregiver well-being?

5. What models, programs, or practices are currently working well in supporting people living with AD/ADRD and their families, caregivers, and care partners, and what factors contribute to their success (e.g., effectiveness, scalability, or applicability across settings)?

6. What health outcomes and care goals are most meaningful to people living with AD/ADRD and their families, caregivers, and care partners, and how should these be measured and incorporated into care over time?

7. What barriers exist to accessing timely, high-quality, person-centered care across different community settings and stages of disease progression?

8. What workforce or infrastructure challenges most affect:

a. AD/ADRD research and intervention development

b. risk reduction activities

c. public health AD/ADRD initiatives

d. delivery of healthcare and long-term care

e. support for families, caregivers, and care partners?

Action opportunity: LEAD Coalition members, allies, and other interested parties are strongly encouraged to submit comments on the docket by the August 15 deadline.

Priority: Provide input on the LEAD Coalition’s response to the 2027 Medicare Physician Fee Schedule proposed rule

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule on policy changes for Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B issues, effective on or after January 1, 2027 (CMS-1848-P). The proposed rule contains several provisions applicable to the Alzheimer’s disease and related disorders (AD/ADRD) community, including a request for information (RFI) on intensive lifestyle interventions to slow progression of Alzheimer’s disease and related disorders (AD/ADRD). 

LEAD Coalition staff plan to submit comments on the PFS via a sign-on letter and welcome input from the broader Coalition on specific provisions to highlight and/or responses to the specific questions outlined in the RFI. 

Action opportunity: LEAD Coalition members and allies are encouraged to send input on the RFI or other PFS provisions to cwallin@leadcoalition.org for consideration to be included in the LEAD Coalition draft response by Friday, August 14. In late August, Coalition staff will circulate a sign-on letter to the community. The comments will be submitted via regulations.gov on or before the September 14 deadline. 

Priority: Sign onto the LEAD Coalition/Alzheimer’s Association/AIM updated letter urging Congress Members to pass the Alzheimer’s Screening and Prevention (ASAP) Act

The LEAD Coalition, in collaboration with the Alzheimer’s Association and Alzheimer’s Impact Movement (AIM), has prepared an updated sign-on letter urging Congress Members to co-sponsor the Alzheimer’s Screening and Prevention Act (H.R. 6130/S.3267). This letter is an updated version of the letter sent to Congress in March. This version includes minor edits to provide more recent details such as the 2026 Facts & Figures data and the number of congressional co-sponsors on the legislation. Importantly, there have been no changes to the legislation. 

This bipartisan, bicameral legislation, introduced by Congressmen Vern Buchanan (R-FL) and Paul Tonko (D-NY), and Senators Susan Collins (R-ME) and Catherine Cortez Masto (D-NV), 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 and the ASAP Act Fact Sheet.

Action opportunity: LEAD Coalition member and allied organizations and researchers are encouraged to review the updated ASAP Act support letter. To be added as a new signatory, complete one of the sign-on forms (form for organizations; form for researchers) by Friday, August 21. Previous signatories who wish to remain on the updated letter do not need to take any action. For any questions about the updated letter, or if previous letter signatories would like to opt-out of this version, please email Ian Kremer.

Submit comments on the Medicare Drug Price Negotiation Program Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule (CMS-4215-P) that would codify policies established in guidance documents for the Medicare Drug Price Negotiation Program with the initial price applicability year of 2029 and beyond (“Negotiation Program”). Sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117-169) establish the Negotiation Program to negotiate maximum fair prices (MFPs) for certain high-expenditure, single-source drugs and biological products. For the initial price-applicability years 2026 through 2028 of the Negotiation Program, the law directed CMS to implement the Program through instructions and other guidance.

With this program instruction authority expiring, CMS now is proposing to codify the Negotiation Program for 2029 and beyond. Additionally, CMS is proposing new policies to continue implementing statutory provisions under the Negotiation Program, as well as revisions or clarifications to certain previously established policies to incorporate lessons learned. For the initial price applicability year 2029, CMS will select up to 20 drugs covered under Part D and/or payable under Part B. In addition to the drugs selected for negotiation, CMS also can select drugs for renegotiation if selected drugs with an agreed-upon maximum fair price meet certain eligibility and selection criteria. For additional details, see the CMS fact sheet.

Action opportunity: LEAD Coalition members and allies are encouraged to provide comments on the docket by the August 17 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 comment on recent CMS proposed rules to update payment policies and rates 

The Centers for Medicare and Medicaid (CMS) recently issued three proposed rules to update payment policies and rates across physician services, home health agencies, outpatient hospitals, and ambulatory surgical centers for calendar year (CY) 2027. Rules include: 

• Medicare Physician Fee Schedule (PFS) (CMS-1848-P; fact sheet)

• • • For CY 2027, CMS proposes reducing the physician conversion factor to $33.17 for qualifying Alternative Payment Model (APM) participants (-1.19%) and $32.84 for non-qualifying APM participants (-1.68%). The proposed rule would revise payment policies for remote monitoring, transition clinicians from Merit-based Incentive Payment System (MIPS) reporting to specialty-focused MIPS Value Pathways (MVPs), extend Medicare telehealth flexibilities through December 31, 2027, establish 2027 therapy thresholds, and add payment policies for Health and Well-Being Coaching services. CMS is also seeking comments on (1) the “Welcome to Medicare” preventive visit and the Medicare Annual Wellness Visit (2) the influence of the CPT coding system and the American Medical Association (AMA) process on physician payment policy, and (3) the valuation and conditions of payment of Health and Well-Being Coaching services.

• Medicare Home Health Prospective Payment System (PPS) Proposed Rule (CMS-1844-P; fact sheet)

• • • IN CY 2027, CMS proposes increasing home health payment rates by 2.4%, or $420 million, compared to CY 2026. CMS also proposes changes to the Home Health Quality Reporting Program, Durable Medical Equipment Benefit definition for infusion pumps and associated drugs, and the DME Prosthetics, Orthotics, and Supplies Competitive Bidding Program, among other changes. Additionally, CMS proposes provider enrollment provisions aimed at curbing fraud, waste, and abuse. The provisions would affect any providers and suppliers participating in the Medicare program. The agency is seeking comments on how to best promote access to community-based palliative care services through existing Medicare benefits, including the Medicare home health benefit.

• Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1850-P; fact sheet)

• • CMS proposes increasing the OPPS and ASC payment rates by 2.4% each. Additionally, CMS proposes expanding the ASC covered procedures list, modifying 340B-acquired drugs payments to reflect the average sales price (ASP) minus 33.4%, with some hospital type exemptions, and updating the outpatient and ASC quality reporting program. The agency is seeking comments on ways to improve the comparability and standardization of available hospital price transparency data.

These proposed rules – separately and collectively – have the potential to influence access to outpatient, home-based, and virtual care for individuals living with Alzheimer’s disease and related disorders as well as their care partners. 

Action opportunity: Interested parties are encouraged to provide comments on these proposed rules via regulations.gov by the respective deadlines (August 31 for PPS & OPPS/ASC; September 14 for PFS).

Provide feedback to NIH on new programs for the NIH Common Fund

The National Institutes of Health (NIH) is soliciting feedback on new programs for the NIH Common Fund (NOT-RM-26-004). The NIH Common Fund supports bold scientific programs intended to catalyze discovery across all biomedical and behavioral research. These programs bring together investigators and multiple NIH Institutes, Centers, and Offices to collaborate on innovative research. Common Fund programs are expected to address high-priority challenges for the NIH as a whole and yield broad impact on the scientific community. NIH currently seeks ideas for biomedical and behavioral research challenges and opportunities that may be of interest to the Common Fund. 

Action opportunity: Interested parties are encouraged to provide comments via the electronic submission form by the September 19 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.

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 October 2 deadline (originally July 6).

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.

Encourage support for AD/ADRD-relevant legislation

There are several pieces of legislation relevant to the Alzheimer’s disease and Alzheimer’s disease-related disorders (AD/ADRD) community. The bills being tracked by the LEAD Coalition are listed on our Our Activities page and real-time action updates are available via the legislative tracking spreadsheet. We especially want to call attention to the ASAP Act (H.R.6130/ S.3267) and CHANGE Act (H.R.3501 / S.1799), for which the Coalition has submitted letters of support (ASAP; CHANGE).

Action opportunity:  We encourage all LEAD Coalition members and allies to track and support these pieces of legislation. If relevant legislation is missing from our list, we encourage individuals to share bills with the LEAD Coalition’s Federal Policy Director, Courtney Wallin (cwallin@leadcoalition.org), for review and consideration.