Hypersensitivity to Generic Drugs with Soybean Oil

The authors reply: The analysis of CT colonography that Cash cites used a model that was validated in younger adult populations, 1 and the CMS's final decision memo noted that this model had been neither well tested nor previously used. 2 Furthermore, the memo acknowledged that this analysis combined outcomes from screening for colorectal cancer and abdominal aortic aneurysm.The Preventive Services Task Force recommends performing such screening only once in men who are 65 to 75 years of age and who have a history of smoking; the task force does not recommend such screening in women.3 Thus, less than one sixth of Medicare beneficiaries would be expected to have any benefit.Although the CMS reviewed other data showing that CT colonography is costeffective only at reimbursement levels that are much lower than current rates, 4 its decision was based primarily on the inadequacy of the evidence of benefit for this test and not its cost-effectiveness. 2 The CMS covers what is "reasonable and necessary."5 It would be irresponsible to cover services for which there are no clinical data show-ing benefits among its beneficiaries, since such services may be associated with harm -from additional unnecessary testing and procedures, anxiety about "incidentalomas," and additional diagnoses of uncertain clinical implications.It is essential that the CMS make decisions on the basis of high-quality clinical trials that reflect the effects on its elderly population.