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While CMS considered a longer period until a revision is completed, such as the 36-month period provided by the Medicaid Drug Rebate Program (MDRP) for AMP restatements in 447.510(d)(3), CMS believes that a 12-month reconciliation period is appropriate for the Part B rebate program because of requirements to submit timely and accurate ASP data (specified in 414.806(b)), and it provides sufficient time to capture the majority of updates to the data specified in proposed 427.301 while closing out (except for the proposed circumstances in proposed 427.501(d)(2) regarding CMS' identification of mathematical errors or manufacturer misreporting) the calculation of the rebate amount for a Part B rebatable drug for an applicable calendar quarter within a reasonable time period after the Rebate Report is issued

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A four-year internet survey of marijuana-using adults found that: People increasingly felt that exposure to cannabis smoke was safer than tobacco smoke

We also provide proposed additional burden discussions that we are not able to quantify