Services’ (CMS’s) opportunities for influencing change through regulatory and payment processes but also notes that its leadership in implementing policies that assist in developing evidence might encourage similar efforts throughout the healthcare system. A very powerful approach taken by CMS in this respect is Coverage with Evidence Development (CED), in which reimbursement is conditional on the creation or submission of additional data. Phurrough describes recent revisions of CED that define two CED components: Coverage with Appropriateness Determination and Coverage with Study Participation, as well as the range of gaps in the evidence base that such policies may help to fill.

Wayne A. Rosenkrans and colleagues discuss the importance of providing incentives for appropriate evidence creation and appropriate use of evidence. Establishing standards of evidence and processes for reimbursement decisions would help manufacturers design better studies and work to provide the evidence needed. In addition, flexibility to account for individual variation needs to be built into the system. Evidence generated must be put to good use through thoughtful structuring of guidelines, decision support, and outreach to providers and patients. New models for product development such as evidence-based drug development will accelerate the creation of a learning healthcare system by making clear breaks with outdated approaches. For example, embedding the creation of effectiveness data into the process of drug development or developing a continuous process of evidence creation in partnership with the regulators and payers might provide sufficient financial incentives to drive change.

Margaret E. O’Kane discusses the important role that standards organizations have played in improving the quality of health care by measuring performance and identifies the significant barriers to extending this across the healthcare system: the absence of evidence from basic science, to complex comorbidities, subpopulations, and comparative effectiveness; the lack of usable guidelines; difficulty in obtaining data; and lack of accountability throughout the system. All are significant impediments to improving quality and efficiency of care. O’Kane calls for payment reform, regulatory reform, and liability reform as the key instruments to confront these challenges. System-wide change requires new ways of thinking about gathering, managing, and deploying knowledge and an evolution in our approaches.


Alan Rosenberg, M.D.

WellPoint Inc.

Private insurers have many opportunities to structure the incentives for change both in evidence development and in evidence-based application.

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