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Instead, we agree that manufacturer payments for preparatory procedures—such as cell collection and local processing—may meet the four-part regulatory criteria for BFSFs under § 414.802 when they are itemized, represent FMV, are performed on behalf of the manufacturer, and are not passed through to a purchaser

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Results: 35 patients were included, 31 with ReA and 4 with post-infectious arthritis, 68.6% male, median age: 38 years (IQR 29-49) and median disease duration: 18 months (IQR 2-45)