New England Journal of Medicine · 2021 · 24 citations · 1 references
Public AffairsHealth LawHealth PolicyHealth InsuranceHealthcare PolicyMedicare PolicyCoverage Decision-makingDevice RegulationMedical Device EvaluationMedical Device ReimbursementMedicare AdvantageMedicare Benefit DesignClinical Evidence ReviewDevice Reimbursement PolicyMedical Device InnovationMedicare Coverage DeterminationsMedicare Coverage Rules
CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.
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Vinay K. Rathi, Harlan M. Krumholz, Frederick A. Masoudi et al. · JAMA · 2015 · 109 citations