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Polycythaemia vera: Caution is advised in patients with this condition, as vitamin B12 supplementation may affect blood cell production

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Comment: In response to our concerns that all components or parts of the aprevo Cervical ACDF System may not be integral parts of the service furnished because it is unclear how and when these components or parts are used and whether they can be substituted with other products, the applicant commented that the aprevo insertion instrument, integrated fixation screws, and the CAM components are all part of the 510(k) cleared aprevo Cervical ACDF System's kit, are integral to the implant and arthrodesis services furnished, and are not supplies that are incident to the procedure

Packaging costs into a single aggregate payment for a service, encounter, or episode of care is a fundamental principle that distinguishes a prospective payment system from a fee schedule