One proposed change in the requirement for automatic coverage consideration to the IDE process is to mandate the design of an acceptable superiority endpoint. This is unachievable for spine surgery trials, the letter argues, because they cannot be studied against a placebo. Most spinal clinical studies are looking to indentify less invasive surgical treatments or use the current standard in IDE studies as the control group.
If CMS does not remove the requirement for a superiority endpoint, then ISASS requests a dual process be developed to accommodate spine.
CMS is also proposing to centralize the Medicare clinical study review through requiring all institutional review board approval letters before being considered for coverage. ISASS maintains that this is not feasible because multiple sites require multiple IRBs. Completion of all IRB approvals would slow down patient recruitment, enrollment and treatment.
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