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Specifically, per § 428.402(c), CMS will issue a Preliminary Rebate Report for each applicable period followed by issuance of the Rebate Report for each applicable period no later than December 31, 2025

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(A gray market of non-reputable pharmacies may dispense KPV for use with “for research purposes” labeling, but these are often nonaccredited and unregulated sources.) What the science says: What we currently know about KPV comes almost entirely from lab and animal studies