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CMS continues to be interested in comments on this topic and welcomes additional comments on this approach and alternative approachesspecifically, how CMS should address the situations in which the manufacturer of a Part D rebatable drug does not have an MDRP agreement in effect for any part of the applicable period or when a Part D rebatable drug may be excluded from the definition of a COD and manufacturers may not be required to report pricing and drug product information under section 1927(b)(3) of the Act

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Revising paragraph (a)(8) and paragraph (a)(9) introductory text

This mini review highlights critical priorities for research, including the need for long-term prospective studies, standardized product testing, independent toxicological assessments and surveillance of patterns of use, dual use and youth uptake