August 14, 2026
The Honorable Robert F. Kennedy, Jr.
Secretary, Department of Health and Human Services
c/o Maria-Theresa Okafor, Ph.D., MCG
Office of the Assistant Secretary for Planning and Evaluation
Submitted electronically via regulations.gov
Re: Comments in Response to “Request for Comment on the Update to the National Plan to Address Alzheimer's Disease”; Docket No. HHS-ASPE-2026-0298-0001
On behalf of National Taxpayers Union (NTU), the nation’s oldest taxpayer advocacy organization, we write with brief comments on your request pertaining to policies that could strengthen the National Plan to Address Alzheimer’s Disease. While the Plan is fundamentally focused on the well-being of patients, providers, and caregivers who are coping with the disease, Alzheimer’s also has profound, massive economic and fiscal impacts that deserve some exploration. It is from this perspective that NTU’s comments originate.
Introduction
NTU is the nation’s oldest taxpayer advocacy organization, founded in 1969. For nearly as long, our experts and advocates have engaged policymakers on important questions surrounding the fiscal effects of federal legislation and regulations on the health care space. We have noted with great concern the decades-long cost spiral in federal health care programs, which has seemed to defy attempts at reducing or at least controlling the burden on taxpayers. According to the Congressional Budget Office (CBO), between 2026 and 2056, the share of federal noninterest outlays consumed by major health care programs is projected to rise from 30% to 38%.1
To NTU, it is abundantly clear that innovative approaches to reducing health care costs must be explored and implemented, to begin shifting this unsustainable trajectory toward a more realistic and affordable direction. We believe that thoughtful deployment of prescription drugs (both branded and generic/biosimilar) and diagnostic tools in more settings, as alternatives to costlier treatments, can be a vital part of this necessary exercise.
Alzheimer’s and Taxpayers
NTU is all too familiar with the fiscal impact of Alzheimer’s on taxpayer-funded health care programs. As our extensive 2023 paper, “How Much is Medicine Worth to the American Taxpayer?” explains, the quest for Alzheimer’s treatments has been marked by sporadic approvals of new drugs, reversals in government reimbursement for coverage, and controversies over patient affordability.2 A thorough review of the costs Alzheimer’s disease imposes on the American public, and federal regulatory decision-making regarding the approval for and coverage of new treatments indicates that, while most of the media focuses on pricing, the question of offsetting financial benefits is often ignored.
The Alzheimer’s Association, a group for Alzheimer’s patients and caregivers, wrote that, in 2022, “the total national cost of caring for people living with Alzheimer’s and other dementias is projected to reach $321 billion,” or $41,757 per person living with Alzheimer’s or other dementias. That does not account for an additional $35,330 per person, or $271.6 billion, in the Association’s estimate for unpaid caregiving costs—$77,087 in total direct and indirect costs per patient.3 A USC-Schaeffer analysis, utilizing a different methodology, put the 2026 total cost for Alzheimer’s and dementia at $818 billion.4
The Alzheimer’s Association estimates that care costs for people with Alzheimer’s will more than triple to nearly $1 trillion by 2050. Conversely, a treatment that delays the onset of Alzheimer’s by five years, if introduced in 2025, could “reduce total health and long-term care spending for people with Alzheimer’s” by a third.
An earlier study from the Alzheimer’s Association found that a treatment delaying the onset of the disease by five years would save Medicare and Medicaid alone $47 billion in 2030, $105 billion in 2035, $152 billion in 2040, $189 billion in 2045, and $218 billion in 2050—before accounting for treatment costs. Savings in the first ten years (2026–35) would total $345 billion to Medicare and $189 billion to Medicaid ($534 billion total)—again before accounting for treatment costs.5
Thus, the consequences of Alzheimer’s costs for taxpayers are rivaled only by cardiovascular and other obesity-related conditions. One form of treatment for obesity, GLP-1s, has been a source of contention over their upfront costs to coverage under government health care programs. Yet, early evidence is showing the potential that these medications may have to bend the cost curve over the intermediate term, not just the long run. One ongoing study by Aon, involving 192,000 workers who utilized GLP-1s, found significant slowdowns in medical treatment costs and claims on employer-provided health insurance, as well as reduced hospitalizations for major adverse cardiovascular events over both 18- and 30-month periods.6
The upshot here for the National Plan to Address Alzheimer’s Disease is that persistent research and development, brought expeditiously to markets with strong oversight, well-designed financial safeguards, and thoughtful cost-benefit analysis, could very well provide a promising path forward for taxpayers, not just patients.
Comments
With the foregoing analysis in mind, NTU will focus on two of the eight questions presented in HHS-ASPE-2026-0298-0001. The responses also happen to relate directly to another question.
“3. What barriers or challenges affect early detection and timely diagnosis of AD/ADRD [Alzheimer's Disease/Alzheimer’s Disease and Related Dementias]?”
The key to successful treatment for many diseases is early detection, but this is particularly true for AD/ADRD. As the Alzheimer’s Association notes:
Today, blood tests are already improving the design of clinical trials, and they are being used in some specialty care centers. In the future, they are very likely to revolutionize the diagnostic process for Alzheimer’s and all other dementia.7
As explained earlier, taxpayers could likewise benefit from early diagnoses that can initiate treatments to slow the progression of AD/ADRD and keep patients out of expensive memory and nursing care for longer periods of time.
An opportunity exists for HHS to liaise with Congress over policy options to ensure that Medicare (and other health programs) have the appropriate tools to phase in coverage of tests that show solid evidence of early detection. NTU does not urge a headlong rush into approval for any and all tests to be funded by taxpayers. Rather, we suggest that government entities be prepared for “the moment” when such tests demonstrate measurable, meaningful predictability. Preparation does not equate to immediate deployment of coverage, but it does mean building the regulatory infrastructure in advance so that it can be used to facilitate quick onboarding of the right diagnostic vehicles once their roadworthiness is established.
One legislative approach to this issue exists in the Alzheimer’s Screening and Prevention [ASAP] Act of 2025. This bill, H.R. 6130, would “provide for Medicare coverage” of certain “blood-based dementia screening tests.”8 To be clear, NTU believes that comprehensive congressional hearings over H.R. 6130 are necessary to thoroughly explore the medical economics and fiscal impacts of the types of tests this legislation would permit. After such hearings, improvements to the legislative language of the bill will likely be needed to ensure that proper fiscal safeguards are put into place. Nonetheless, H.R. 6130 presents an opportunity for HHS and Congress to dialogue over the matter of AD/ADRD testing in Medicare.
“7. What barriers exist to accessing timely, high-quality, person-centered care across different community settings and stages of disease progression?”
To answer this question, NTU wishes to highlight one emblematic program about which we have previously commented to the Centers for Medicare and Medicaid Services (CMS) in 2025—Coverage with Evidence Development (CED).9 Much of the following has been drawn from those 2025 comments. Originally conceived more than 20 years ago to encourage innovative treatments and their swift uptake under National Coverage Determinations (NCDs), the CED process provided Medicare coverage for breakthroughs only if eligible patients submitted to clinical studies or other trials.
In theory, CED could help to expedite the introduction of lifesaving diagnostics and treatments, but, in practice, it has sometimes functioned in a contrary manner by effectively stranding therapies in a regulatory limbo. On the diagnostic side, for example, PET scans for early signs of Alzheimer’s and dementia underwent CED for ten years before those restrictions as well as the NCD were lifted in 2023. This occurred despite the promulgation of an “Expedited Process to Remove National Coverage Determinations” in 2013 that was finalized in 2015. In fact, most CEDs persist for an average of more than a decade.
History might be repeating itself with CMS’s decision to enforce CED as part of a 2022 NCD for Alzheimer’s therapies known as anti-amyloid drugs. NTU would urge HHS to consider the impact of CED not only on AD/ADRD treatment progress. Just last month, NTU comments on Trans Aortic Valve Replacement observed that some of the same CED shortfalls could impede cost-saving breakthroughs in this realm as well.10
Even though a CED may be important in providing needed data prior to full non-clinical coverage for anti-amyloid drugs, it could at the same time be delaying wider introduction into the Medicare population that could begin chipping away at the daunting programmatic expenses for less-effective Alzheimer’s responses. Establishing that balance to which NTU has alluded in these comments—managing short-term costs to “buy time” for longer-term benefits—is vital.11
How should CED be reformed going forward? We offer the following ideas.
- Re-orient CED toward the compact, expedited process it was intended to be. As Drs. Emily P. Zeitler and Lauren G. Gilstrap wrote in the August 2022 edition of the American Journal of Managed Care:
Making the program more transparent and predictable may improve stakeholder engagement in a process that could ultimately bring promising therapies and services to Medicare beneficiaries in a timely way while offering a mechanism to restrict access to those therapies that are not beneficial. Changes to the CED program to improve transparency and predictability can be applied to future and existing CED NCDs.12
- Achieving the transparency and predictability Zeitler and Gilstrap recommend could be facilitated through a “regulatory sandbox.” NTUF has proposed this framework to the Internal Revenue Service for developing tax regulations governing cryptocurrency.13 CMS could adapt this proposal, as well as actual sandbox procedures already in place, by calling upon experts from the industry to design the least burdensome methods of coverage determinations and other approvals.
- Evaluate how NCD both comports and conflicts with the goals of the Accelerated Approval Process more recently developed under the auspices of FDA. While created under different circumstances to address distinct parts of the medical development ecosystem, there is potential for holistic thought about these programs that could lead to useful consolidation or streamlining.
- Incorporate useful cross-pollination with other CMS and FDA programs in need of regulatory reform, including the Center for Medicare and Medicaid Innovation (CMMI) and generic/biosimilar approvals. NTU has published extensive analyses of how CMMI demonstrations are falling far short of their promise to deliver taxpayer savings.14 Equally comprehensive reviews of FDA’s often flawed interpretation of the Biologics Price Competition and Innovation Act of 2009 have shown how even streamlined licensure can encounter obstacles.
- Finally, U.S. policy could benefit from more reciprocal paths to coverage and treatment approvals. As far back as 2019, NTU endorsed legislation from Senator Ted Cruz (R-TX) called the RESULT Act, which would have created an “expedited, reciprocal approval process for drugs, biologics, or medical devices that have been authorized to be lawfully marketed in a limited set of other countries.”15 Some of the concepts in this bill could be implemented on a limited basis through executive branch activity.
NTU’s responses to both the questions above in turn provide guidance on the very first question HHS poses in HHS-ASPE-2026-0298-0001: “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?” Reforms to expedite early detection and treatment, while maintaining a clearheaded appreciation for fiscal discipline, are vital.
Conclusion
The author wishes to make a personal observation that could be minimally relevant to HHS-ASPE-2026-0298-0001. It is quite true that many of the current drug therapies for AD/ADRD are expensive, well into the tens of thousands per patient per year.16 Medicare must take caution in designing coverage that exercises some control over short-term costs to taxpayers. Yet, according to this author’s rough calculations, the cost of keeping his parent in a comprehensive memory care facility is between 2-1/2 and 5 times higher per year than the drug treatments.
Numerous caveats apply, among them the fact that a base level of care for my parent would be necessary due to other physical ailments, and that Medicare’s (and taxpayers’) exposure to memory care costs is limited. Nonetheless, the calculus reinforces some of the research cited above that suggests early detection and early treatment can forestall bigger patient, caregiver, and taxpayer expenses in the final stages of life. The challenge is ensuring that the accelerated introduction of new diagnostics and therapies into government health programs carefully account for near-term costs to taxpayers. Those costs can be managed while long-term fiscal benefits gradually materialize, but it will take thoughtful executive and legislative branch policies such as those NTU outlined above.
Thank you for your consideration of these comments, and should you have any questions on this or any other fiscal or regulatory matter before HHS, we are at your service.
Sincerely and respectfully,
Pete Sepp, President
National Taxpayers Union
1 See the CBO Outlook at: The Long-Term Budget Outlook Data: 2026 to 2056 | Congressional Budget Office.
2 See the paper at: How Much is Medicine Worth to the American Taxpayer? A Cost-Benefit Analysis - Publications - National Taxpayers Union.
3 See the analysis at: Alzheimer's Facts and Figures Report | Alzheimer's Association.
4 See the study at Dementia Will Cost the U.S. $818 Billion in 2026, USC-Led Study Finds - June 24, 2026 - USC Schaeffer.
5 See the analysis at: The discovery of Alzheimer's disease treatment by 2025 will save the U.S. $220 billion within first five years.
6 See the study at: Workforce-Focused Analysis on GLP-1s: Phase Two Findings.
7 See: Earlier Diagnosis | Alzheimer's Association.
8 See the bill text at: Text - H.R.6130 - 119th Congress (2025-2026): ASAP Act | Congress.gov | Library of Congress.
9 See the comments at: Taxpayers Benefit From Regulatory Reform at Centers for Medicare and Medicaid Services - Publications - National Taxpayers Union.
10 See the comments at: Expanding Access to Cardiac Procedure Could Control Medicare Costs, Benefit Taxpayers - Publications - National Taxpayers Union.
11 NTU has made many recommendations in federal and state settings for policy responses in regard to maintaining this balance, including lifetime per-person coverage of reimbursements, pilot programs limited to the most at-risk patients, and counseling requirements for patients to encourage adherence. See, for example, https://www.ntu.org/publications/detail/ntu-comments-on-medicare-and-medicaid-coverage-of-anti-obesity-medications; and https://www.ntu.org/publications/detail/anti-obesity-medications-can-boost-patient-health-and-lower-expenditures.
12 See https://pubmed.ncbi.nlm.nih.gov/35981123/.
13 For further details, see: https://www.ntu.org/foundation/detail/ntufs-comments-on-irs-cryptocurrency-regulations.
14 See the papers at https://www.ntu.org/foundation/detail/resetting-the-scoreboard and https://www.ntu.org/publications/detail/center-for-medicare-and-medicaid-innovation-12-years-into-the-game-taxpayers-still-dont-know-the-score.
15 See NTU Thanks Senator Cruz for Introducing the RESULT Act - Publications - National Taxpayers Union.
16 Randomly selected search results; see How Expensive Is Alzheimer’s Medications.