These studies included sample sizes ranging from 430,596 to 160
For example, in the case of Leqembi (lecanemab-irmb), the second drug targeting cerebral amyloid-beta plaques in Alzheimer's disease to receive FDA approval, the first date of sale reported to CMS via the Average Sales Price (ASP) portal was in January 2023, as it was marketed and sold under accelerated approval granted on January 6, 2023
CMS proposes at proposed 427.501(d)(1), to conduct a reconciliation 12 months after issuance of the subsequent Rebate Report specified in 427.501(c) to include any restatements that have occurred in the drug pricing data and claims billing data reported to CMS and used in the rebate calculation specified in subpart D of the part
Overall, these modifications address MDPP supplier and beneficiary needs based upon available monitoring and evaluation data received to date, feedback from Medicare Advantage plans and existing MDPP suppliers, and feedback from beneficiary focus groups