Medicare CED Could Enhance Efficiency Of FDA Post-Approval Studies – CMS Draft Guidance
Medicare’s coverage with evidence development policy could help enhance the efficiency of research conducted under FDA post-approval requirements, CMS says in a draft guidance on CED released Nov. 29.
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CMS’ guidance on its “coverage with evidence development” policy for Medicare Part B does not elaborate on the scope of its application to off label drug use, only stating the agency could apply CED to drugs that have received FDA approval for at least one indication.
Former CMS coverage chief Louis Jacques told House lawmakers that the agency’s authority to implement coverage-with-evidence-development policies are fragmented, hindering application of the program.
Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.