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what I can do is situate that experience within the published mechanistic literature and ask what it implies for trial design and patient characterization

Specifically, as adopted, the agency intends to incorporate recommendations to utilize the supplemental NPI approach using data sources such as the CMS Integrated Data Repository to map 340B OPAIS database provided organizational NPIs to corresponding individual NPIs and MPNs, as well as the approach raised by certain commenters, as discussed earlier in this section, identifying additional pharmacies registered as Shipping Addresses of covered entities within the OPAIS data as part of the Prescriber-Pharmacy Methodology to determine the total number of units of a Part D rebatable drug for which a discount was provided under the 340B Program for the last three calendar quarter of the applicable period that begins on October 1, 2025 that is, January 1, 2026 through September 30, 2026, in order to implement section 1860D-14B(b)(1)(B) of the Act

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