decisionhealth Newsletters, Part B News - 2025 Issue 2 (February)
Proposed guidance document: Study protocols that use real-world data
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Article Overview
This article reviews a CMS proposed guidance document focused on study protocols that use real-world data in the context of national coverage determinations and coverage with evidence development. It is relevant to manufacturers, study sponsors, and others involved in developing evidence plans, and it summarizes the purpose of the guidance and the role of the standardized HARPER+ template.
Why This Topic Matters
The guidance shapes how study sponsors structure protocols when real-world data are used to support CMS coverage decisions. It matters to organizations preparing evidence-development submissions because it clarifies the type of framework CMS expects and the documentation structure it wants sponsors to use.
What You Will Learn
- What the CMS proposed guidance document addresses
- How real-world data fits into coverage with evidence development
- Why CMS introduced a standardized study protocol template
- What the HARPER+ template is intended to support
Who Should Read This
- Manufacturers
- Study sponsors
- Health policy professionals
- Reimbursement and coverage teams
- Medical coding and compliance professionals
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