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The commenters supported the proposal to reserve payment methodology under section 1847A of the Act for products that have undergone the rigorous FDA Biologics License Application (BLA) process under section 351 and agreed that non-BLA products do not meet the statutory definition of biologicals contemplated for payment under section 1847A of the Act, making the “incident-to supply” classification a rational approach

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If you’re feeling well and your provider confirms there are no underlying health concerns, high B12 levels from supplementation are usually harmless

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