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When the status of a Part B rebatable drug changes from currently in shortage to resolved during a calendar quarter and then changes to currently in shortage during one or more of the subsequent three calendar quarters, CMS would apply the shortage reduction as if there was a continuous shortage beginning with the quarter in which the drug has re-entered a shortage and move to the percent reduction applicable for the second four consecutive quarters

Validation steps are taken to ensure the accuracy and reliability of the findings, minimizing biases and errors

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(ii) [Reserved] * * * * * (g) Performance threshold methodology

Established companies have strong brand recognition, access to distributors, and economies of scale that make it difficult for new players to enter the market

If the ACO does not earn sufficient shared savings to offset the advanced payment of shared savings during the applicable performance year, CMS may withhold or terminate the ACO's prepaid shared savings under proposed 425.640(h)(1)(iii)