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Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
The rules say that effective April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) covers Food 
and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of 
AD when furnished in accordance with Section B under coverage with evidence development (CED) for 
patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, 
both with confirmed presence of amyloid beta pathology consistent with AD. 
1) Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based 
upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as 
reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an 
investigational new drug (IND) application. 
2) Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based 
upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS-approved 
prospective comparative studies. Study data for CMS-approved prospective comparative studies may be 
collected in a registry. 
3) For CMS-approved studies, the protocol, including the analysis plan, must include: 
a. A study population whose diversity of patients are representative of the national population with MCI 
due to AD or mild AD dementia. 
b. A neurocognitive evaluation and a description of the instruments used to assess cognition and function 
for the clinical diagnosis of MCI due to AD or mild AD dementia for study enrollment and outcomes 
assessment. 
c. A description of: 
i. The multidisciplinary dementia team and optimal medical management. 
ii. Study sites with clinical expertise and infrastructure to provide treatments consistent with the 
safety monitoring outlined in the FDA-approved label. 4) CMS-approved studies of a monoclonal antibody directed against amyloid (antiamyloid mAb) approved by 
the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit 
must address all of the questions below: 
a. Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and 
function) for patients in broad community practice? 
b. Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, 
depend on characteristics of patients, treating clinicians, and settings? 
c. How do the benefits and harms change over time? 
5) CMS-approved studies must adhere to the following standards of scientific integrity that have been 
identified by the Agency for Healthcare Research and Quality (AHRQ): 
a. The principal purpose of the study is to test whether the item or service meaningfully improves health 
outcomes of affected beneficiaries who are represented by the enrolled subjects. 
b. The rationale for the study is well supported by available scientific and medical evidence. 
c. The study results are not anticipated to unjustifiably duplicate existing knowledge. 
d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is 
sufficient to answer the research question(s) being asked in the National Coverage Determination (NCD). 
e. The study is sponsored by an organization or individual capable of completing it successfully. 
f. The research study is in compliance with all applicable Federal regulations concerning the protection of 
human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by 
the FDA, it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of 
human subjects in studies conducted under CED, the study must provide and obtain meaningful informed 
consent from patients regarding the risks associated with the study items and/or services, and the use and 
eventual disposition of the collected data. 
g. All aspects of the study are conducted according to appropriate standards of scientific integrity. 
h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare 
requirements. 
i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such 
studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 
21 CFR 312.81(a) and the patient has no other viable treatment options. 
j. The clinical research studies and registries are registered on the ClinicalTrials.gov website by the principal 
sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the 
AHRQ Registry of Patient Registries (RoPR). 
k. The research study protocol specifies the method and timing of public release of all prespecified outcomes to 
be measured including release of outcomes if outcomes are negative or study is terminated early. The results 
must be made public within 12 months of the studys primary completion date, which is the date the final 
subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The 
results must include number started/completed, summary results for primary and secondary outcome measures, 
statistical analyses, and adverse events. Final results must be reported in a publicly accessible manner; either in 
a peer-reviewed scientific journal (in print or online), in an on-line publicly accessible registry dedicated to the 
dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in 
abbreviated format (e.g., for studies with negative or incomplete results). 
l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under 
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and 
exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said 
populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the 
recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are 
necessary. m. The study protocol explicitly discusses how the results are or are not expected to be generalizable to 
affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations 
eligible for Medicare due to age, disability or Medicaid eligibility. 
 
You can find this rule in the Centers for Medicare & Medicaid Services (CMS) Internet-Only Manual, 
Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Section 200.3. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.