comparing one treatment approach

Lastly, some stakeholders have expressed concerns that increased use of CER to inform clinical decisions could cause harm by holding innovative therapies to an inappropriate or onerous standard of effectiveness and discouraging their development and diffusion.

With the PPACA’s enactment, many decisions already have been made to minimize risks to innovation from comparative effectiveness research. For example, the law explicitly bars the PCORI from mandating coverage, reimbursement or other policies for any public or private payer.

Patient Protection and Affordable Care Act (Public Law No. 111-148), Section 6301.

Second, the CER program should establish an initial list of priority topics and evaluate the current state of knowledge about each.

First, the national CER program must develop an overall funding strategy.

Deciding which research questions to address first is complex, because the priority topics vary widely in their potential impact on health care costs and outcomes, target population, and the most suitable research methods and their costs. We propose a five-step process.

Third, the CER program, with the help of expert advisory committees and the research community, should choose the research methods that will fill gaps in the evidence for a specific topic.

Defining the desired future state — a desired patient care outcome, reduced harms, or a change in clinical practice — is a key step in defining research objectives and refining the research question, which in turn drive the choice of methods and the projected research costs

Modeling potential population-level effects can help the CER program to decide which research questions to fund. Modelers will need to estimate the likelihood of various study results, implementation strategies, and possible shifts in practice and policy

This conceptualization of policymaking means that the end users of research results must identify their requirements for certainty in decision making and communicate them to the CER program as input into the design of a research portfolio

Fourth, the program should strive for a balanced portfolio of high-impact research topics.

Fifth, the CER program should evaluate progress and report to the public.

So a second requirement for work funded under the stimulus package should be that successful innovations are implemented immediately