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Factors used in the application cycle for ACOs applying to enter a new agreement period beginning 2 years after the SAHS billing activity occurred, and the change request cycle for ACOs continuing their participation in the program, including data used to determine an ACO's eligibility for Advance Investment Payments under 425.630(b) or for the CMS Innovation Center's new ACO Primary Care Flex Model (ACO PC Flex Model) based on ACO revenue status (high revenue or low revenue), and to determine repayment mechanism amounts for ACOs entering, or continuing in, two-sided models (refer to 425.204(f))

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And, clearly, there are shortcomings to the current drug-approval process