not maintained or updated to reflect current clinical guidelines, which are not reflective of a clinician's scope of practice
Hergens M-P, Lambe M, Pershagen G, Terent A, Ye W
* * * * * (b) * * * (1) Except as provided in paragraphs (b)(2) and (3) of this section, a person who has received an overpayment must report and return the overpayment by the later of either of the following: * * * * * (2) The deadline for returning overpayments will be suspended (or will continue to be suspended following the completion of a timely, good faith investigation in accordance with paragraph (b)(3) of this section) when any of the following occurs: * * * * * (3)(i) The deadline for reporting and returning overpayments will be suspended when both of the following occurs: (A) A person has identified an overpayment but has not yet completed a good-faith investigation to determine the existence of related overpayments that may arise from the same or similar cause or reason as the initially identified overpayment
21 , S38S45 (2019)
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
