Public Comments

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August 7, 2026
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Re: Agency Information Collection Activities: Proposed Collection; Comment Request — Medicare
Coverage of Items and Services for Coverage with Evidence Development (CMS-10697; Docket No.
CMS-2026-2179)
To Whom It May Concern:
The Partnership to Fight Chronic Disease (PFCD) submits this comment in response to CMS's
proposed reinstatement of its information collection for Coverage with Evidence Development (CED).
We write to urge CMS to use this opportunity to critically examine the real-world burden imposed by
its CED requirements, particularly as they apply to CED coverage limitations on FDA-approved antiamyloid monoclonal antibody therapies (ATTs) for early-stage Alzheimer's disease. Multiple clinical
trials address the questions CMS raised with respect to ATTs. We urge you to reconsider the CED and
facilitate broader Medicare coverage for these therapies.
CED Registry Requirements Create Significant Access Barriers for People Living with Alzheimer’s
CMS's CED framework conditions Medicare coverage of ATTs on patient enrollment in a qualifying
clinical registry or trial. In practice, these requirements impose onerous administrative complexity on
physicians, infusion centers, and patients alike and limit the providers available to treat the growing
population living with Alzheimer’s disease in America.
A survey of infusion centers found considerable confusion and logistical challenges with CED
compliance: scheduling difficulties, high out-of-pocket costs, and unclear guidance that complicates
patient management and resource allocation.1 For a single patient to access treatment, providers
must verify eligibility, coordinate across billing, infusion, imaging, and registry systems, conduct
multiple specialist visits, and submit patient data to a registry every six months — a cumbersome
process that is particularly challenging for small and rural practices to implement.2 Adding CED
registry requirements means less time providers have available to see patients. That burden
exacerbates existing dementia provider shortages that delay patient access to care.

1
Medicare’s Patient Registry is Slowing Alzheimer’s Treatment Access. Real Clear Health. November 22, 2024.
https://www.realclearhealth.com/articles/2024/11/22/medicares_patient_registry_is_slowing_alzheimers_treatment_access_1074126.html
2
The Partnership to Fight Chronic Disease. A Cumbersome Path to Treatment: Is This the New Norm? https://9b387f1b-9183-4728-bc19e2eef317a0ca.filesusr.com/ugd/666885_f09f541f01a24cb6ab10a2ba5b315881.pdf

These are not hypothetical burdens. The administrative weight of CED registry compliance has
created a structural access barrier that falls hardest on underserved communities. Registries are
concentrated in large urban centers, leaving rural patients — who already face disproportionate
Alzheimer's burdens — with fewer qualifying sites and greater logistical obstacles to care. Every day
of delay carries irreversible consequences: an estimated 2,000 people a day with Alzheimer's disease
progress from the mild stage to moderate disease and beyond the range of FDA-approved, diseasemodifying therapies.3
The Evidence Is In: CED Questions Answered
Soon, PFCD will publish a white paper making the affirmative case for reconsideration of the NCD for
amyloid-targeting therapies. We invite CMS to consider that analysis as a resource in its ongoing
work.
The scientific record has materially advanced since CMS issued its 2022 CED determination. In the
four years since, the FDA has approved two new ATTs. Nearly a dozen peer-reviewed clinical trial
studies involving more than 5,300 participants across three continents have documented the safety
and efficacy of these therapies. These trials include a range of community clinical practice settings
and extend across multiple years documenting long-term benefits and a manageable risk profile.
Clinical experts in Alzheimer’s and dementia treatment have published Appropriate Use
Recommendations for each medication to aid physicians within community practice settings. The
collective body of evidence directly and sufficiently answers the three questions that CMS identified
as prerequisites for lifting the CED requirement.
The Paperwork Reduction Act asks agencies to consider the necessity and utility of information
collections. PFCD respectfully submits that the CED information collection for ATTs no longer serves a
necessary evidentiary function. Continuing to require registry participation imposes an unjustified
burden on providers and patients while unduly limiting access to life-changing treatment for a fatal,
progressive disease.
CMS should reconsider and remove the CED requirement for all ATTs for early-stage Alzheimer's
disease and provide Medicare beneficiaries with coverage to label for disease-modifying therapies.
Respectfully submitted,
Candace DeMatteis, JD MPH
Vice President, Policy
Partnership to Fight Chronic Disease
www.fightchronicdisease.org

3
Milliman. Alzheimer’s Disease Severity Progression: Prevalent Population Estimates Over Time. June 2023.
https://edge.sitecorecloud.io/millimaninc5660-milliman6442-prod27d5-0001/media/Milliman/PDFs/2023-Articles/6-5-23_AD-SeverityProgression-Population-Estimates.pdf?la=en&hash=D0C2DC7D20AFE3C8E5DA8678FE0B1A07