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We are making a change that was omitted from the CY 2026 PFS proposed rule to ensure consistency with existing regulation text in 425.512(b)(4)(iv)(A)( 1 )(ii) and (b)(4)(iv)(A)( 2 )(i) by finalizing the addition of clarifying text at 425.512(b)(4)(iv)(A)( 2 )( ii ) to align language within these paragraphs, namely to consolidate the terms LIS and Medicare Part D LIS, which are synonyms in this context

In establishing these limits, we cited concerns regarding these patients' potential acuity and complexity

For storage after reconstitution, keep at 2-8 degrees C and use within 28 days