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The FDAs ability to interpret FAERS reports is limited by a lack of information and confounding factors, such as concomitant medications

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We note that, for purposes of identifying significant procedure codes for examination under the 2 times rule, we consider procedure codes that have more than 1,000 single major claims or procedure codes that both have more than 99 single major claims and contribute at least 2 percent of the single major claims used to establish the APC cost to be significant (75 FR 71832)

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