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However, because of the small size of the demonstration and uncertainty associated with the projected Medicare utilization and costs, the policy we finalized for the demonstration initial period of performance in the FY 2022 IPPS/LTCH PPS final rule provides a contingency plan to ensure that the budget neutrality requirement in section 123 of Public Law 110-275 is met

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While GHK-Cu has a strong safety record and compelling mechanistic data, most of the clinical evidence remains in the early-to-moderate phase