Drugs and Biologicals

Monoclonal Antibodies in Treatment of Alzheimer’s Disease - Medicare Advantage Plan Responsibility

NCD 200.3 was issued by CMS in April,2022 and outlines Medicare coverage policy for monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease.

Medicare beneficiaries enrolled in MA plans are included in this coverage, with specific cost information available through each individual MA plan.

When CMS determines that an NCD meets the criteria for “significant cost,” an MA plan is not required to assume risk for that cost until the contract year for which the MA payments are appropriately adjusted to account for the cost of the NCD. When an NCD does not meet the “significant cost” criteria, the MA plan is required to provide coverage for the NCD and assume the risk for the cost as of the effective date of the NCD.

CMS has determined that the coverage cost under NCD 200.3 does not meet the significant cost threshold described above. Therefore, MA plans are required to assume the costs of anti-amyloid monoclonal antibody treatments for Alzheimer’s Disease as per the coverage criteria described in NCD 200.3. MA plans must include the applicable registry trial number on each claim or encounter for monoclonal antibodies that receive traditional FDA approval.

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Posted 8/9/2024