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Regarding the comment suggesting that the change be effective for cost reporting periods ending after December 31, 2024, we agree

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We proposed to amend 414.904(i) to include the above proposal regarding how CMS would calculate the payment limit in circumstances in which only negative or zero manufacturer's ASP data is reported for a multiple source drug

Molar values assume approximate molecular weights of 1,419 Da for BPC-157 and 889 Da for the TB-500 fragment per Velora product-page specifications

*In-competition refers to the period commencing at 11:59 pm on the day before a competition in which the athlete is scheduled to compete through the end of such competition and the sample collection process related to such competition