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To identify the payment amount benchmark period for the purpose of calculating the benchmark period manufacturer price for a subsequently approved drug, CMS would look to the first calendar year beginning after the drug's first marketed date and if no AMP was reported to the MDRP for such NDC-9 for that 4-quarter period, CMS would then identify the payment amount benchmark period as the first calendar year in which such drug has at least 1 quarter of AMP reported

*PMI reported global shipment volumes and in-market sales estimates of nicotine pouch units, from January 2025 to December 2025

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