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Although commenters appreciated CMS' perspective, as set forth in the proposed rule, that noncompliance with this new requirement would not implicate the FCA, commenters expressed concern that there is no evidence that the Department of Justice, regulators, or judges would agree

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This can lead to a shorter duration of B12 in the body, increasing the need for supplementation or injections to maintain adequate levels

This can be due to weakening of the stomach lining, or to medications that reduce stomach acid