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After consideration of public comments, we are finalizing the proposed ASM redistribution percentage at 85 percent as proposed at 512.750(c)(1)(iii)

[1] Because the ingredients are compounded rather than supplied as an FDA-approved fixed-dose product

It contains water for injection with benzyl alcohol as a preservative, producing a clear, colorless solution suitable for controlled laboratory handling and storage at room temperature

They also requested whether CMS would adjust the denominator for a group's data completeness calculation in its MVP or APP if ASM participation supersedes all other reporting obligations

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