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Clinical trials are composed of carefully selected patients who meet stringent inclusion and exclusion criteria that are specific to the indication and medication being evaluated, such that they are the best candidates to test a new therapy

22 Similarly, the large phase 3 EVOKE and EVOKE+ trials of oral semaglutide in early Alzheimers disease failed to slow cognitive decline on the primary endpoint, despite positive effects on certain disease-related biomarkers

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However, as we stated in the proposed rule, we have come to understand that if hospitals use substantially different lookback periods, particularly across multiple years, it could distort the allowed amounts, for example, because of pricing changes over time such as inflation, efficiencies, or the introduction of new products or services