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We proposed to amend 428.402(c)(1)(ii) and (c)(2)(ii) to add the word within prior to the specified number of months (for example, 21 months for the applicable period beginning October 1, 2022, and 9 and 33 months for the applicable period beginning October 1, 2023) to be consistent with the regulatory text and cadence for regular reconciliation cycles, as well as to provide operational flexibility on the timing of the release of the report with the reconciled rebate amount

11 in London documented a case of a 24-year-old woman with pernicious anemia who primarily presented with neurological symptoms

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