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Assessing Medicare's Coverage With Evidence Development Program
Maryam Mooghali1, Osman Moneer2, Guneet Janda3
1Maryam Mooghali (maryam.mooghali@yale.edu), Yale University, New Haven, Connecticut.
Health Affairs (Project Hope)
|January 6, 2025
Summary
The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program could be strengthened. CMS often relies on lower-quality studies for coverage reconsiderations, missing opportunities to use robust CED-approved evidence.
Area of Science:
- Health policy
- Medical economics
- Clinical evidence evaluation
Background:
- The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program allows Medicare coverage for items/services lacking "reasonable and necessary" status, contingent on clinical study participation.
- CMS periodically reevaluates CED decisions based on emerging evidence.
Purpose of the Study:
- To analyze the characteristics of studies cited by CMS in CED reconsiderations.
- To assess the quality and representativeness of CED-approved versus non-CED-approved studies used in coverage decisions.
Main Methods:
- Review of 235 publications cited by CMS for reconsideration of 10 out of 26 CED-approved items/services since 2005.
- Comparison of study design robustness, sample size, and patient demographics between CED-approved and non-CED-approved studies.
Main Results:
- CMS reconsidered 38% of CED items/services, citing 235 publications.
- CED-approved studies (24% of cited evidence) featured more robust designs (67% RCTs vs. 13%), larger enrollment (median 1,000 vs. 125), and greater US patient inclusion (93% vs. 44%) compared to non-CED-approved studies (49% of cited evidence).
Conclusions:
- CMS's reliance on non-CED-approved studies for reconsiderations, despite their lower quality and representativeness, indicates potential areas for CED program enhancement.
- Prioritizing higher-quality, CED-approved evidence could improve the rigor and relevance of Medicare coverage decisions.
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