We've submitted formal comment to HHS on its update to the National Plan to Address Alzheimer's Disease (Docket HHS-ASPE-2026-0298). It's a response we've been building toward for a while — the product of work across our NEWDIGS Consortium, which brings together more than 100 organizations spanning patient advocacy, payers, health systems, biopharma, and diagnostics developers, convened through the Center for Biomedical System Design at Tufts Medical Center.

HHS asked eight questions. We answered five, and we kept our scope deliberately narrow: detection, diagnosis, prevention, and treatment of early Alzheimer's disease — the stages known as mild cognitive impairment and mild dementia due to AD. We didn't weigh in on caregiver support or late-stage care. Other respondents are better positioned to speak to those from direct experience.

For years, the open question in Alzheimer's disease was scientific: would a therapy that could meaningfully delay progression ever exist. Opinions still differ, including within our own membership, on how much benefit today's disease-modifying therapies offer individual patients — but more options, including new anti-amyloid and anti-tau therapies, appear likely to enter the pipeline in the coming years. Alongside that, a different question is opening up: whether the health care system can identify the right patients early enough, and route them to the right care, at the scale this moment requires.

We don't think that's a given, and it isn't specific to Alzheimer's disease. Transformative treatments are typically adopted incrementally, even when they work well: direct-acting antivirals have cured hepatitis C at rates above 95% since 2013, and studies show average medical cost savings of over $65,000 per treated person — yet only about a third of eligible patients have received them. That pattern, our comment argues, is what early Alzheimer's care is on track to repeat absent deliberate intervention.

Our comment argues that the National Plan should treat system readiness as a strategic goal in its own right — not something that follows automatically once the science is settled.

Six domains, one system

We've mapped early AD care readiness across six domains. The point of laying them out this way isn't to rank them — it's that progress in any one, on its own, tends to get absorbed by gaps in the others. A better diagnostic test doesn't help much if primary care has no standard for interpreting it, or no way to get paid for using it.

• Learning. Practicing early AD detection and diagnosis is close to a new area of medicine. The evidence base for what works needs to be built and shared faster than it currently is.
• Standards. Clinicians need authoritative, harmonized guidance on interpreting blood biomarker tests and cognitive assessments — without it, better tools don't translate into better decisions.
• Payment. Coverage for early AD services needs to be clear, adequate, and predictable. Right now, the people who bear the cost of detection aren't always the ones positioned to capture the benefit.
• Health care delivery. Care models need to be built to work inside primary care, since that's where the vast majority of patients will actually be seen.
• Workforce. The specialist shortage is real, but the deeper issue is task allocation — which parts of detection and diagnosis can safely move to trained primary care teams, and what backup they need to do it well.
• Access. Some barriers are specific to early AD; others — geography, insurance status, language — are barriers to care generally that fall hardest on populations already underserved.

An offer, not just a comment

Beyond our answers to HHS's questions, we made a specific offer: NEWDIGS exists to provide neutral, pre-competitive ground where organizations that don't ordinarily sit at the same table — competitors among them — can work from shared evidence instead of past each other. We've run that kind of convening for seventeen years, across cell and gene therapy financing, adaptive licensing, and now early Alzheimer's disease. We made that capability available to HHS with no funding request attached.

That's also, in miniature, what we think the next decade of the National Plan needs to get right: no single organization closes this gap alone.

Read our full comment to HHS

Whatever your stake in this — as a clinician, a health system, a caregiver, a company building the next generation of diagnostics or therapeutics — we'd welcome you reading it, and telling us where you agree or where you'd push back.