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Thus, we are proposing to codify in regulations at 414.904(e)(6) that, for radiopharmaceuticals furnished in a setting other than the hospital outpatient department, MACs shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003

Under the first alternative, we would include the ASP data and billing units sold of the reference biological for a given quarter along with those of the other biosimilars in the volume-weighted average calculation

Amin MB, Greene FL, Edge SB, et al

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Schedule 2 covers broader categories such as fruit flavours, sweeteners, spices, and menthol