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(iii) If a generic Part D rebatable drug or biosimilar that is currently in shortage experiences a severe supply chain disruption, CMS will reduce the rebate amount as described in paragraph (b)(1) of this section, and will not grant a reduction under 428.301 during that applicable period

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In 2012, the 100 th International Agency for Research on Cancer monograph outlined the association between smokeless tobacco products, including but not limited to chewing tobacco, and oral cancer, determining smokeless tobacco to be a carcinogen 10,11