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3 Cigarette smoking is responsible for more than 480,000 deaths per year in the United States, including more than 41,000 deaths resulting from secondhand smoke exposure

They can include cancer, respiratory infections, and heart disease

Proposed 427.600 establishes a civil money penalty process in accordance with section 1847A(i)(7) of the Act to address when a manufacturer of a Part B rebatable drug fails to pay the rebate amount in full by the payment deadline for such drug for such applicable calendar quarter

This rulemaking also proposes to codify policies previously established in guidance for the Medicare Prescription Drug Inflation Rebate Program at new parts 427 and 428, including clarifications to certain existing policies, consistent with sections 1847A(i) and 1860D-14B of the Act