Priority: Sign onto the LEAD Coalition letter to CMS on AD/ADRD intensive lifestyle interventions

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 on intensive lifestyle interventions (ILI) to slow progression of AD/ADRD.

The LEAD Coalition sign-on letter outlines evidence and recommendations to assist in the development of a new CMS-supported ILI program to reduce risk of AD/ADRD and protect brain health. The letter also encourages CMS to develop a program that can adapt to the emerging evidence, including what new research may reveal regarding differences across various forms of AD/ADRD and which interventions are most effective for different populations.

Action opportunity: LEAD Coalition member and allied organizations and researchers are encouraged to review and sign onto the letter. To be added as a signatory, please complete one of the Google sign-on forms (form for organizations; form for researchers) by Friday, September 11. For any questions about the letter, or if you cannot access the forms, please reach out to Ian Kremer or Courtney Wallin.

Provide comment on 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).

Apply for DoJ funding for training and services to end abuse in later life

The Department of Justice (DoJ) Office on Violence Against Women has released a notice of funding opportunity for the Training and Services to End Abuse in Later Life Program. This program assists states, Tribal governments and organizations, local governments, and nonprofit entities in supporting a comprehensive approach to address abuse in later life, including domestic/dating violence, sexual assault, stalking, neglect, abandonment, economic abuse, or willful harm committed against victims who are 50 years of age or older. Funds must be used for all the following purposes:

1. Provide training programs to assist law enforcement agencies, prosecutors, agencies of States or units of local government, population specific organizations, victim service providers, victim advocates, or relevant officers in Federal, Tribal, State, territorial, and local courts in recognizing and addressing instances of abuse in later life;
2. Provide or enhance services for victims of abuse in later life;
3. Establish or support multidisciplinary collaborative community responses to victims of abuse in later life; and
4. Conduct cross-training for law enforcement agencies, prosecutors, agencies of States or units of local government, attorneys, health care providers, population specific organizations, faith-based leaders, victim advocates, victim service providers, courts, and first responders to better serve older victims.

In addition, applicants must demonstrate that services will be delivered as part of a multidisciplinary partnership, which must include:

• At least one law enforcement agency;
• At least one prosecutor’s office;
• At least one victim service provider; and
• At least one nonprofit or government agency with demonstrated experience in assisting individuals 50 years of age or over

Action opportunity: Qualified applicants are encouraged to submit grant applications by the September 14 deadline.

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 input to NIH on potential funding approaches to support future clinical trial investigators

The National Institutes of Health (NIH) is soliciting feedback on potential funding models to support the development of future clinical trial investigators (NOT-OD-26-095). NIH is in the process of revising its mentored career development award policies to separate career development support from clinical trial costs, now requiring “K” award recipients who lead clinical trials to secure separate funding for those activities. Accordingly, NIH is considering approaches that would allow recipients of mentored “K” awards to serve as principal investigators of clinical trials and the agency is seeking input on the advantages, challenges, eligibility criteria, and implementation of these potential funding models. 

Action opportunity: Interested parties are encouraged to review proposed funding models and submit comments by the September 30 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).

Provide feedback on proposed changes to NIH peer review outcome reporting

The National Institutes of Health (NIH) is requesting input on proposed changes to how outcomes from NIH peer review are reported (NOT-OD-26-088). Under the proposal, NIH would replace the reporting of final overall impact scores and percentiles with three categories: “most competitive,” “competitive,” and “not discussed.” Applications in these categories would reflect the top 25%, 26-50%, and the bottom 50% (inclusive of “not discussed” applications) of final overall impact scores, respectively. The proposed approach is intended to reduce the emphasis on numerical scores while providing NIH Institutes, Centers, and Offices with greater flexibility to consider peer review outcomes alongside other factors when making funding decisions. Concerningly, by replacing standardized numerical scores with broad categorical labels, peer review outcomes would become much less transparent, reducing predictability for applicants and creating new opportunities for political influence on funding decisions. Diminished transparency makes normal congressional oversight more difficult and less rigorous, and risks weakening the general public’s confidence in the scientific integrity of NIH decision-making. 

Action opportunity: Interested parties are encouraged to provide comments on the proposed peer review reporting changes by the October 13 deadline.

Submit comments to CMS on the RAPID coverage pathway

The Centers for Medicare and Medicaid (CMS) has issued a proposed procedural notice (CMS-3487-NC) outlining the process the agency will use to expedite approval of new devices covered by Medicare. Announced in April, the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway applies to U.S. Food and Drug Administration (FDA) Breakthrough-designated devices that address unmet medical needs for Medicare beneficiaries. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS. The agencies will use existing programs and coverage frameworks to analyze and approve devices that demonstrate positive clinical health outcomes in a timelier and more predictable way during the premarket phase. By aligning CMS and FDA evidence expectations in advance, the RAPID coverage pathway is designed to reduce significantly the review time between FDA market authorization and Medicare national coverage determinations (NCDs). For additional information, see the RAPID pathway infographic, the CMS factsheet and the FDA fact sheet.

Action opportunity: Interested parties are encouraged to provide comments on the docket by the October 13 deadline.

Provide input on FDA’s proposed PDUFA VIII recommendations for FY 2028–2032

The U.S. Food and Drug Administration (FDA) released the proposed PDUFA VIII commitment letter, outlining recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028–2032. PDUFA is a federal program that allows the FDA to collect user fees from pharmaceutical and biotechnology companies in exchange for resources that support the review of human drug applications. The program is periodically reauthorized by Congress and establishes performance goals and commitments intended to make the drug review process more predictable and efficient. This commitment letter represents the FDA’s proposed recommendations for the next five-year iteration of the program and will inform the broader reauthorization process.

The FDA is hosting a hybrid meeting on September 16 to discuss the recommendations with the public and also accepting written comments on the commitment letter.

Action opportunity: Interested parties can register for the hybrid public meeting and request to provide a verbal statement during the public comment session. Requests to provide public comment must be submitted by September 2. Written comments can be submitted on the docket through the October 16 deadline.

Provide feedback to inform FDA’s regulatory approach for generative AI-enabled medical devices

The U.S. Food and Drug Administration (FDA) has issued a discussion paper on how generative AI (GenAI)-enabled medical devices could be regulated and is seeking feedback on relevant topics (FDA-2026-N-7874). The effort, led by the FDA Digital Health Center of Excellence, aims to consider how existing approaches may need to evolve to address the unique capabilities and risks of GenAI-enabled devices while continuing to support innovation and patient safety. The discussion paper offers potential frameworks and raises questions about regulatory considerations specific to GenAI, including risk assessment, premarket evaluation, and postmarket monitoring.

Action opportunity: All interested parties are encouraged to provide comments on the docket by the October 19 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.

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.