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Characterization of studies considered and required under Medicare's coverage with evidence development program
Maryam Mooghali1,2, Osman Moneer3, Guneet Janda4
1Department of Internal Medicine, Yale New Haven Hospital, New Haven, CT, USA.
Clinical Trials (London, England)
|February 8, 2025
Summary
Medicare’s Coverage with Evidence Development program generates higher-quality clinical studies. These studies, compared to initial National Coverage Determination studies, feature more randomization, larger patient populations, and a focus on clinical outcomes.
Area of Science:
- Health Services Research
- Clinical Trial Design
- Health Policy Analysis
Background:
- The Centers for Medicare and Medicaid Services established Coverage with Evidence Development (CED) in 2005 to assess items and services with limited evidence.
- CED mandates participation in approved clinical studies to determine if services meet
Purpose of the Study:
- To compare the quality of evidence from CED-approved studies with studies used for initial National Coverage Determinations (NCDs).
Main Methods:
- Identified CED-covered items/services and their associated studies.
- Searched PubMed and Google Scholar for primary endpoint results of CED-approved studies.
- Reviewed NCD decision memos to identify original research studies used for initial coverage decisions.
- Characterized and compared CED-approved studies and NCD studies.
Main Results:
- CED has supported 26 items/services with 196 NCD studies and 116 CED-approved studies (2005-2023).
- CED-approved clinical trials were more likely to be randomized (93.2% vs. 52.5%), focus on clinical outcomes (87.9% vs. 65.8%), and enroll Medicare beneficiaries (25.9% vs. 3.1%) than NCD studies.
- CED-approved studies had larger patient populations (median 302 vs. 100).
- Half of CED-approved studies had not yet publicly reported primary endpoint results.
Conclusions:
- The CED program successfully promotes the generation of more robust clinical studies compared to those informing initial coverage decisions.
- While CED enhances study design, opportunities remain to improve the dissemination of study results.
- Further strengthening study design and timely result reporting under CED is recommended.
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