Medicare Part D Rebate Rule Delayed Until 2023 As PBMs Notch Legal Win
HHS initially postponed only those provisions of the final regulation that were scheduled to go into effect 29 January, but Biden Administration now faces April deadline from court to determine how to proceed with the rest of the rule.
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Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
Assurances from HHS Secretary Azar that rule will not significantly raise premiums and federal spending amount to a request to ‘just trust me.’
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.