America's Health Insurance Plans
Expansion of the evidence base through rigorous research on the safety, effectiveness and value of new technologies, biologics and pharmacological products is critical to ensuring that patients receive the most effective and appropriate treatments. CMS’ CED policy was created to provide access to promising but unproven therapies within a framework designed to collect evidence and inform future coverage policy. In order to maximize the effectiveness of CED, we recommend three modifications.
First, there should be additional clarity provided regarding the evidentiary threshold needed to invoke CED. Without a clear and transparent evidentiary standard by which items and services will be judged eligible for CED, there is a risk that new technologies with only very preliminary evidence of effectiveness may be considered for coverage under CED’s Coverage with Study Participation (CSP) track. The establishment of clear and rigorous criteria for when CED should be used will result in research with more useful, definitive results.
Second, we recommend that CED rely on qualified clinical trials, as defined in CMS’ Clinical Trial Policy, when it determines that an item or service be covered as long as it is provided within a research setting where additional data can be collected in the context of clinical care. Qualified clinical trials have the scientific rigor and control that better enable them to generate the evidence necessary to make definitive judgments as to whether an item or service meets the evidentiary standards for reasonable and necessary. These trials should be focused on addressing safety and efficacy so that usable information is collected and applied to the coverage determination process.
Third, we recommend that CMS provide a clearer pathway for the reassessment of coverage decisions upon completion of CED. Timeframes, procedures and evidentiary thresholds should be specified so that the process for evaluating and incorporating the data collected into coverage determinations is clear and transparent. Resulting coverage decisions should be disseminated along with information on the evidence that led to the decision and the accompanying rationale.