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The relatively small number of microorganisms in the respiratory tract, compared to other body niches, requires highly sensitive methods for detecting and characterizing microbial species

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This approach would help ensure that CMS shares in any savings generated by ACOs participating in a potential revised ENHANCED track while also not increasing downside risk for ACOs that may be liable for shared losses

(2) Clarification for Identifying Single-Dose Containers In the CY 2023 PFS final rule (87 FR 69719), we finalized that the definition of refundable drug would apply to drugs paid under Medicare Part B (that is, under any payment methodology) that are described in FDA-approved labeling as being supplied in a single-dose container or single-use package