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Finally, while we have no obligation to categorize products based on the FDA's current regulatory framework, in this case, we have determined that the FDA regulatory categories provide an appropriate level of distinction for a heterogeneous category of products that exhibit clinical and resource variability for purposes of setting payment rates

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The SGLT inhibitors empagliflozin and dapagliflozin are approved to treat chronic kidney disease and heart failure, regardless of diabetes status

Introducing a scale of disease severity such as the New York Heart Association (NYHA) classification for heart failure and degree of albuminuria in CKD may have further strengthened our propensity matching

Hospitalization and surgical intervention: A number of plaintiffs allege repeated hospitalizations and surgical procedures directly tied to their GI complications