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Response: While we understand the commenters' concerns, section 1833(t)(3)(F)(i) of the Act requires that after determining the OPD fee schedule increase factor under subparagraph (C)(iv), the Secretary shall reduce such increase factor by the productivity adjustment described in section 1886(b)(3)(B)(xi) of the Act

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There is a large potential for variation in results according to the assay used, and support for the authenticity of a given assay is best generated by showing a correlation with an in vivo outcome

10.1073/pnas.2014879117 [DOI] [PMC free article] [PubMed] [Google Scholar] Kawasaki, Y

At 6 months, there was no significant change in median body weight between groups (L:2.6 kg, P:2.9 kg, p = 0.92, Table 2)

Chainani-Wu N