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Firsthand smoke is linked causally to 25 health problems, including, but not limited to, cancer of the bladder, cervix, lung, oral cavity, pancreas, stomach and kidney

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(i) To receive consideration for a rebate reduction extension, a manufacturer must submit a request with updated or new information and supporting documentation on why the Part B rebatable biosimilar biological product continues to be affected by the severe supply chain disruption during the fifth through eighth applicable calendar quarters