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The commenter recommended that CMS consider a volume threshold of 500 single major claims (or the existing greater or equal to 99 claims that constitute greater than or equal to the 2 percent criterion) as the standard for designating an item or service significant for purposes of the 2 times rule

However, there are no clinical studies examining this combination

Regular monitoring by healthcare professionals may ensure safety and effectiveness throughout the treatment period

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Their interaction further enhances metabolic function