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the proposal to use a calculation methodology to account for the impact of improper payments in recalculating expenditures and payment amounts for certain Shared Savings Program financial calculations, upon reopening an ACO's payment determination and issuing a revised initial determination pursuant to 425.315(a) as described in section III.G.7.c of this proposed rule

A subsequent analysis by the FDA also warned there were "significant analytical issues" with the study that made it difficult to compare the levels of harmful and potentially harmful compounds from heated tobacco to those from cigarettes