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CMS is considering requiring covered entities to submit the following data elements from Part D claims for covered Part D drugs that are purchased under the 340B Program and dispensed to Medicare Part D beneficiaries: (1) Date of Service (that is, the date the prescription was filled by the pharmacy)

In proposed 427.503(a), similar to the Suggestion of Error process proposed for the Preliminary Rebate Report in proposed 427.501(a), within 10 calendar days after date of receipt of the information about the preliminary reconciliation of the rebate amount, CMS proposes that a manufacturer may suggest to CMS that the manufacturer believes the preliminary reconciled rebate amount contains a mathematical error

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This exclusion will apply to applicable calendar quarters even after the year in which the EUA Declaration ends, as long as after the EUA Declaration is terminated, these products have an FDA-approved application or license

The marketing of smokeless tobacco products has also significantly increased