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CMS intends to apply this unit exclusion at the month level and would exclude all units of a generic drug that ceases to meet the definition of a Part D rebatable drug beginning with the first day of the first month when a therapeutically equivalent drug approved under a 505(j) ANDA is marketed based on the marketing start date in the NDC Directory or when the reference listed drug, or an authorized generic of the reference listed drug is marketed based on the marketing start date in the NDC Directory

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Key Features: Nicotine Replacement Therapy (NRT): Contains nicotine polacrilex (4mg per piece) to curb cravings and reduce dependency on nicotine over time

The design of the device is also noteworthy

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As a result, RHCs would be able to improve access to care by serving more patients in communities served by RHCs and FQHCs, including rural communities, and not requiring patients to travel longer distances to receive specialty services