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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

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Individuals suffering from conditions like irritable bowel syndrome (IBS), Crohn's disease, ulcers, and leaky gut syndrome may benefit from its reported ability to repair the digestive tract lining

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