In a Decision Memorandum, issued July 9, 2007, CMS issued “clarifications” to its 2000 National Coverage Determination related to its Clinical Trial Policy (“CTP”). The clarifications included two additions to the CTP. First, CMS has decided to modify the language in the 2000 CTP that could be interpreted to restrict payment for an investigational item and service itself. More specifically, CMS clarified that routine costs of a clinical trial include the costs of an investigational item or service itself, if otherwise covered outside of the clinical trial. In addition, CMS adopted the proposed addition of the Coverage with Evidence Development (“CED”) regarding items and services for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a “reasonable and necessary” determination. Such items and services may be approved through the NCD process. Apart from these two revisions, CMS opted to preserve the status quo of the CTP for now due to perceived confusion on the 2000 CTP and its scope. However, CMS stated that it is reopening the reconsideration of the clinical trial policy NCD and will shortly issue proposed changes to regulations. Baker Hostetler has been involved in commenting on behalf of its clients to the proposed decision memorandum and, specifically, regarding a seminal issue relating to investigator-initiated trials and coverage of items or services related to the provision of care in such trials. This new CMS clarification leaves the industry without a clear answer to the questions posed relating to investigator-initiated trials.