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A commenter requested that CMS rerun the cost modeling for the APCs excluding low volume or anomalous facility reports and consider volatility guards, public analysis regarding observed changes, and maintain payment levels that preserve beneficiary access until stable cost data can be established

This standardization process removes the effects of differences in area wage levels from the determination of a national unadjusted OPPS payment rate and copayment amount

[3] The speed of response depends on multiple factors including the severity and duration of deficiency, the presence of neurological complications, and individual metabolic differences

Food and Drug Administration (FDA), or any other regulatory authority for human or animal use