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Lastly, we are proposing to codify two scenarios when the manufacturer reports negative or zero manufacturer's ASP for all NDCs for a biosimilar for a given quarter: When positive manufacturer's ASP data is available for another biosimilar(s) with the same reference product for the given quarter, we are proposing to set the payment limit equal to the sum of the volume-weighted average of the positive manufacturer's ASP data from all other biosimilars with the same reference product plus 6 percent (or 8 percent for a qualifying biosimilar biological) of the amount determined under section 1847A(b)(4) of the Act for the reference biological product for the given quarter

Benchmark period Consumer Price Index for All Urban Consumers (CPI-U) means the CPI-U identified in 427.302(e)

Tenderness, burning, sores that will not heal, pain, numbness, developments of lumps, leathery and wrinkled patches inside the mouth, or color changes to soft oral tissues are signs that you may have oral cancer

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