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Limitations of CD38 inhibitors An off-target effect occurs when CD38 inhibitors interact with other biomolecules that are not their intended targets, resulting in undesirable side effects

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of this final rule, we have revised 428.202(d) to add a paragraph (3), which provides that to the extent that a new NDC-9 of a Part D rebatable drug is reported under section 1927 of the Act and AMP has not been reported for such NDC-9 under section 1927(b)(3)(A)(i)(I) or (ii) of the Act during the period described at 428.202(c)(1) or (2), as applicable, CMS will identify the payment amount benchmark period and calculate the benchmark period manufacturer price for such NDC-9 using other information reported by a manufacturer under section 1927(b)(3) of the Act for the Part D rebatable drug, as available, such as the base date AMP if such base date AMP is reported for a calendar quarter that overlaps with the period described at 428.202(c)(1) or (2), as applicable