Medicare CED Could Enhance Efficiency Of FDA Post-Approval Studies – CMS Draft Guidance
Executive Summary
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policy could help enhance the efficiency of research conducted under FDA post-approval requirements, CMS says in a draft guidance on CED released Nov. 29.
You may also be interested in...
Medicare To Use Evidence Development For Off-Label Drug Use? CMS Guidance Unclear
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.
Cohesive Coverage-With-Evidence Authority Needed For Medicare, Lawmakers Told
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.
Medicare CED Could Enable Expanded Use Of Expedited Drug Approvals, Policy Groups Suggest
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.