United States: CMS Final Decision On Reconsideration Of The Clinical Trials NCD: Maintains Status Quo.

On July 10, 2007, the Centers for Medicare and Medicaid (CMS) posted its much awaited final decision regarding its reconsideration of the Clinical Trials NCD (National Coverage Determination). The draft guidance, issued in April 2007, was a mixed bag—clarifying certain aspects of the NCD to provide greater coverage, but also raising new concerns and uncertainties. Providers and patients turned their attention to July to learn whether CMS would issue a final decision that incorporated comments received.

After two rounds of public comments, however, CMS determined that the public has not yet had an adequate opportunity to comment on the changes CMS was proposing. In reaching this conclusion CMS recognized that other Medicare policy statements appear to be inconsistent with the NCD, rendering current policy confusing and potentially ambiguous. CMS also recognized that some of its contractors may have paid for services furnished in clinical trials that did not satisfy the requirements of the original NCD adding to the confusion. Accordingly, CMS has opted to maintain the status quo, making only two discrete revisions to the original NCD at this time, and to immediately reopen its reconsideration of the NCD.

For now, effective July 9, 2007, the original NCD remains unchanged except that: (1) if the investigational item itself would be covered outside of the trial it is still covered within the trial and (2) that within the Coverage with Evidence Development process CMS may approve coverage under a clinical trial of particular research proposals 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 determinations will be issued as independent NCDs.

Beyond these changes, there is some good news and some bad news. The good news is that there will be no immediate disruption of Medicare beneficiary access to new drugs since the investigational new drug application (IND)-exempt route to clinical trial qualification, which would have been eliminated under the draft NCD released in April, remains in effect. The bad news is that, for now, the clarifications and policy improvements reflected in the draft NCD have not been adopted. For example, the troublesome provision of the original NCD excluding from otherwise covered routine costs those items and services that are "customarily provided by the research sponsors free of charge for any enrollee in the trial" remains in effect. CMS had proposed to limit this exclusion to items and services that the sponsor provided for Medicare subjects. Accordingly, providers and sponsors will have to continue to analyze clinical trial arrangements as they had under the original NCD with the changes noted.

Regarding the further reconsideration, CMS announced that it "expect[s] shortly to propose changes to the regulations that pertain to clinical trials and Medicare payment and to implement changes to claims processing instructions." This will afford all interested parties an opportunity to participate in notice and comment rulemaking on this important area of Medicare coverage policy. While this final decision does not provide the needed clarification regarding the original NCD, CMS should be commended for taking a thoughtful and inclusive approach to policymaking in this area, affecting Medicare beneficiaries access to cutting edge care, and the ability of research sponsors and providers to pursue sound science to improve the efficiency and effectiveness of medicine and health care.

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