Letters Section Editor: Robert M. Golub, MD, Senior Editor.
In Reply: Dr Groeneveld's comments highlight the difficulty, and importance, of distinguishing the evidentiary thresholds that are linked to the research requirements of Medicare's CED policy. He posits that new technologies covered through CED have a high probability of being beneficial and that unfettered coverage for them is required to ensure access to quality care. If Medicare does its job right, this will not be true.
Coverage with evidence development should only be considered for technologies for which the benefits and risks for many patients are truly uncertain. At the time new technologies come under consideration for coverage, there are often many serious questions about the evidence supporting their use. Little information is usually available on the risks and benefits within particular patient populations. There is rarely good evidence on the comparative effectiveness of new technologies compared with established alternatives. Data on the long-term risks and benefits beyond a year or 2 are routinely absent. As an example of these concerns, the cautionary tale of autologous bone marrow transplant for metastatic breast cancer is a reminder that what appears promising may not ultimately prove beneficial.1
Pearson SD, Miller FG, Emanuel EJ. Medicare Requirement for Research Participation—Reply. JAMA. 2006;296(24):2923-2925. doi:10.1001/jama.296.24.2924-b