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In the proposed rule, we explained that for the first performance year of the current agreement period, we would monitor the ACO's use of prepaid shared savings by comparing the anticipated spending as set forth in the spend plan submitted with an ACO's application against the actual spending as reported by the ACO, including any expenditures not identified in the spend plan

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[29] [30] Vials should not be frozen, and any cloudy or particulate solution should be discarded

However, a question remained - does MMA also promote tumor progression by having suppressive effects on anti-tumor immunity