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To the Editor: In their Commentary, Dr Pearson and colleagues¹ discuss the ethics of the relatively new policy by the Centers for Medicare & Medicaid Services (CMS) for coverage with evidence development (CED). This has been required for expanded coverage of such technologies as implantable cardioverter-defibrillators² and carotid stent systems.³ I am concerned about the authors' assertion that differential access to CED technologies by various segments of the Medicare population is "a regrettable practical reality but does not constitute an injustice."

If CED technologies were truly experimental—analogous to a drug undergoing a phase 3 clinical trial—there would be no particular injustice. However, many CED technologies have already demonstrated benefits in large randomized controlled trials (RCTs).^4-5 There may be lingering unanswered questions about the generalizability of trial results among elderly persons or whether "real world" effectiveness will mirror experimental efficacy, yet it is likely that CED technologies that have been proven . . . [Full Text of this Article]

Peter W. Groeneveld, MD, MS
peter.groeneveld@va.gov
Center for Health Equity Research and Promotion
Philadelphia Veterans Administration Medical Center
Philadelphia, Pa

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