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Historically, the first line of the impact table, which estimates the change in payments to all facilities, has always included cancer and children's hospitals, which are held harmless to their pre-Balanced Budget Act (BBA) amount

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In the European Union, the Food Safety Authority (EFSA) relies on the Qualified Presumption of Safety (QPS) approach for microorganisms in foods and has issued strict guidance on health claims, which, in practice, has made approval of probiotic health claims very difficult