CMS has made two significant changes to the Clinical Trial Policy (CTP) National Coverage Determination (NCD), which addresses Medicare coverage when beneficiaries participate in clinical research trials. CMS' final decision memorandum, issued on July 9, 2007, in response to public comments regarding its April 10, 2007, proposed decision, preserves the status quo with the exception of these two changes.
First, CMS is modifying language in the CTP that could be read to restrict payment for the item or service under investigation to the extent that the item or service would be covered outside of the clinical research trial. The final decision clarifies that these items or services would be covered if they would be covered outside of the clinical research trial.
Second, CMS is adopting the proposed addition of Coverage with Evidence Development (CED) to the CTP. CED is for items and services in clinical research trials for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a “reasonable and necessary” determination. Coverage under CED is for items and services that would not be covered otherwise. By adding CED to the CTP, items and services furnished to Medicare beneficiaries under CED will be deemed reasonable and necessary.
CMS Acting Administrator Leslie Norwalk said, “This decision will expand access for Medicare beneficiaries to participate in clinical trials that seek to establish better evidence for the management of care and treatment of Medicare beneficiaries.”
In addition to the final decision on the current reconsideration of the CTP, CMS plans to reopen the CTP NCD and post a new proposed decision memorandum for a 30-day public comment period. The proposed decision memorandum will build upon the extensive public comments already received.
CMS Press Release, July 10, 2007; Decision Memo for Clinical Trial Policy, CAG-00071R, July 9, 2007.
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