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Consistent with the policies established in section 40.5.3 of the revised Medicare Part D Drug Inflation Rebate Guidance, a manufacturer may receive only one extension of the rebate reduction per generic Part D rebatable drug per CMS determination of likelihood of shortage, as proposed in 428.303(c)(5)

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In some ways, this could be true since dipping tobacco doesnt release tobacco smoke, which is the key source of extra chemicals that can damage ones body

CMS proposes that for a recalculation due to agency error, the error must be identified within 3 years of the date of receipt of the reconciled rebate amount for the applicable calendar quarter (see proposed 427.501(d)(2)(i))

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With the unregulated sale and use of these products, rural consumers in LMICs are the ones who are affected the most, the report said