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Removal day is not an inspection day

First, it extended the statutory phase-in of payment reductions resulting from private payor rate implementation by an additional year, that is, through CY 2024 instead of CY 2023

[ii] Carl, Gerald P

We are proposing to codify that for single source drugs that are not biosimilars with all negative or zero manufacturer's ASP data for a given quarter, the payment limit would ( be, until at least one NDC for the drug has positive manufacturer's ASP data for a quarter, the lesser of 106 percent of the volume-weighted average of the most recent available positive manufacturer's ASP data for at least one NDC from a previous quarter and 106 percent of the WAC, and we would use 106 percent of the lowest WAC per billing unit if there is more than one WAC per billing unit available

The manufacturer-reported AMP units represent the total units of a drug sold by the manufacturer each month to retail community pharmacy and wholesaler purchasers as described under section 1927(k)(1)(A) of the Act