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Consistent with the policy established in section 50.12 of the revised Medicare Part B Drug Inflation Rebate Guidance, we proposed at 427.402(c)(5) that a manufacturer may receive only one extension of the rebate reduction per Part B rebatable biosimilar biological product per CMS determination of a severe supply chain disruption

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Traditionally, the diagnostic criteria of the American College of Rheumatology (ACR) have been followed (Wolfe et al., 1990, 2011, 2016), and most healthcare professionals treat their patients with numerous drugs focused on symptoms such as pain, depression, and fatigue