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only 35% of adult nicotine pouch users previously smoked, and only 10% of those were able to stop smoking completely
If CMS determines the generic Part D rebatable drug is likely to be in shortage in a second applicable period as described in paragraph (c)(5) of this section, then CMS will reduce the total rebate amount owed by the manufacturer for a generic Part D rebatable drug by 75 percent for a second consecutive applicable period
As proposed in 428.303(c)(4), CMS would grant a reduction in the rebate amount owed if a manufacturer of an eligible drug submits to CMS a request in writing demonstrating that (1) the generic Part D rebatable drug is likely to be in shortage, (2) the manufacturer is taking actions to avoid the potential drug shortage, and (3) the reduction of the rebate amount would reduce the likelihood of the drug appearing on an FDA shortage list
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