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Global surveillance of oral tobacco products: Total nicotine, unionised nicotine and tobacco-specific N-nitrosamines

S2CID 29133230

As discussed above, we believe it is appropriate to propose different policies for determining payment limits for single and multiple source drugs when negative or zero manufacturer's ASP data is reported because of statutory differences in the payment limit calculations

CMS does not intend to conduct separate outlier analysis of PDE for the purposes of the Medicare Part D Drug Inflation Rebate Program, but CMS did consider several adjustments to reduce the effect of outliers not resolved through the Part D payment reconciliation process, including removal of PDE records that were identified by CMS as having potential outlier quantity dispensed fields but were neither corrected nor verified by Part D plan sponsors, removal of the quantity dispensed field for certain records at or above a certain statistically derived threshold, and imputing quantity dispensed values for such records