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The assays performed were the Ames Salmonella reverse mutation assay, Neutral Red Uptake (NRU) Cytotoxicity assay, and the micronucleus (MN) assay using the Health Canada Official Method T-501, T-502, and T-503 (Canada, 2004a, b, c), respectively by Labstat International Inc

As proposed in 427.402(b)(4)(ii), if CMS grants a severe supply chain disruption rebate reduction request for a Part B rebatable biosimilar biological product, and the product appears as currently in shortage during one of the same four calendar quarter(s) as for which the severe supply chain disruption reduction was granted, CMS would apply the 75 percent reduction to the four calendar quarters for which the severe supply disruption request was granted and would not grant any additional reduction for the shortage status during those quarters

As set forth under 414.1380(c)(2)(i)(C), submission of any data for the Promoting Interoperability performance category overrides reweighting, including reweighting due an approved significant hardship exception and automatic reweighting for clinicians that are Ambulatory Surgical Center (ASC)-based, hospital-based, non-patient facing, and small practices

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