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We are proposing a new 425.672 to describe adjustments CMS could make to Shared Savings Program calculations to mitigate the impact of SAHS billing activity for CY 2024 or subsequent calendar years

Cigarettes contain over 7,000 chemicals, many of which are toxic and at least 69 are known to cause cancer, including polycyclic aromatic hydrocarbons, volatile aldehydes and tobacco specific nitrosamines (15, 16)

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For example, a multiple source drug approved under an NDA may become a single source drug if all other therapeutically equivalent drugs are no longer marketed and the now-single source NDA is later shifted into a separately payable code