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National Coverage Determination: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (NCD 200.3)
Centers for Medicare & Medicaid Services, 2022-04-07
Topic: Amyloid, tau and blood-test diagnosis
CMS's national policy covers FDA-approved anti-amyloid monoclonal antibodies (such as lecanemab and donanemab) for Medicare patients with a documented diagnosis of mild cognitive impairment or mild Alzheimer's dementia and confirmed amyloid pathology, under a framework called 'Coverage with Evidence Development.' Coverage requires the prescribing clinician and site to participate in a qualifying registry that collects outcomes and safety data; use outside an FDA-approved trial, a CMS-approved registry, or an NIH-supported study is not covered nationally.
Key findings
- NCD effective April 7, 2022; requires clinical diagnosis of MCI or mild AD dementia with confirmed amyloid pathology
- Coverage contingent on participation in a CMS-approved registry (Coverage with Evidence Development)
- Applies to all FDA-approved amyloid-directed monoclonal antibodies meeting the criteria, including lecanemab and donanemab
Why it matters
CMS covers FDA-approved anti-amyloid monoclonal antibodies for Medicare patients with mild cognitive impairment or mild Alzheimer's dementia and confirmed amyloid pathology, but only under Coverage with Evidence Development requiring participation in a qualifying registry. Use outside an FDA-approved trial, a CMS-approved registry, or an NIH-supported study is not covered nationally.
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Study details
- Study designcoverage determination
Limitations
This is a coverage policy document, not primary research; coverage is contingent on registry enrollment (Coverage with Evidence Development).
How this study scored 10/100
Regulatory decision — not a study. It scored 10 on the same rubric, which is below the 16 cap we apply to non-peer-reviewed sources. Scored zero for study design, sample size, effect reported, studied in people, randomised / blinded and indexed in PubMed because the record does not state it. We have no data on strength of evidence, times cited, citations per year, impact for its field and year, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 6 of the 61 points we could judge it on, which is 10 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (Centers for Medicare & Medicaid Services) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| Study design | 0 / 12 | Design recorded as “coverage determination”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | — / 5 | No evidence rating recorded — left out of this score |
| Peer-review validation | 1 / 10 | Regulatory decision — not a study. Named source is a regulator (FDA / EMA / CMS / SEC). |
| How recent | 3 / 5 | 2022 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 0 / 2 | No PubMed ID and no DOI — scores zero (not stated in the record — scored 0) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 6 / 61 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 6 of the 61 points we could judge it on is 10 out of 100. |
| Total | 10 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. This record has no authors, DOI, so the citation leaves them out. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
National Coverage Determination: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (NCD 200.3). (2022). Centers for Medicare & Medicaid Services.
Vancouver
National Coverage Determination: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (NCD 200.3). Centers for Medicare & Medicaid Services. 2022.
BibTeX
@article{study2022-ff44148a,
title = {{National Coverage Determination: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (NCD 200.3)}},
journal = {Centers for Medicare \& Medicaid Services},
year = {2022}
}