When a new drug or technology enters the market following FDA approval, Medicare may approve or deny coverage on a claim-by-claim basis and beneficiaries may face coverage restrictions until a national or local coverage determination is made. National coverage determinations and local coverage determinations are key decisions on whether a particular medical service, procedure, or…
A chart review, also referred to as a chart abstraction or medical record review, is a specific method of RWD collection commonly used to gain insights in healthcare research. Chart reviews involve systematically reviewing the medical records, or charts, of a patient population to gather information on a specific clinical issue, treatment, or outcome. Chart…
Critical to ensuring market access success for your product or technology, global value dossiers and AMCP dossiers are utilized to communicate product value with an eye to the unique access and reimbursement influencers within the market. Your product’s GVD or AMCP dossier should be started early in development and updated frequently with new clinical evidence…
A Delphi panel is a group of experts who provide opinions on a particular topic through a series of surveys administered in rounds. The expert group is a Delphi panel, while the methodology used to survey these experts is the Delphi method. The Delphi method utilizes a specific set of scientific methodologies to achieve expert…