Steven D. Pearson

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an inde...

Outside of their uses in drug development and clinical research trials, the current clinical value of performing any type of formal biomarker testing for the diagnosis or exclusion of Alzheimer's disease (AD) is controversial, and most biomarker tests for AD are not covered by public or private insurers. This situation raises the issue of how insurers determine whether there is “adequate” evidence to justify a positive coverage determination in this area. This article, a focused condensation of a larger white paper, is the product of an initiative led by the Institute for Clinical and Economic Review to convene a multiple‐stakeholder AD Diagnostics Policy Development Group composed of patient advocates, clinicians, clinical researchers, manufacturers, and insurers. The larger white paper was the basis for the evidence review presented to the Medicare Evidence Development and Coverage Advisory Committee meeting on January 30, 2013, as part of its deliberations on positron emission tomography–amyloid imaging. Herein we focus on the description of the core elements of what insurers will be looking for in evidence on all potential diagnostic tests for AD. Corresponding research recommendations are also included, framed to serve as a guide for future AD diagnostics research.

Opinion from JAMA Internal Medicine — Placebo-Controlled Trials, Ethics, and the Goals of Comparative Effectiveness Research — Comment on “Lack of Head-to-Head Trials and Fair Control Arms”

Background: An important challenge facing the research community is how to make comparative effectiveness reviews “fit for purpose”—how to translate the results into a format that can provide actionable guidance for all stakeholders trying to improve the quality and value of health care. Methods: To communicate transparently the overall judgments on the findings from a comparative effectiveness review, the Institute for Clinical and Economic Review (ICER) uses an integrated evidence rating that combines separate ratings of comparative clinical effectiveness and comparative value. These integrated ratings look somewhat like bond ratings, and are suited to foster more direct consideration by all decision makers for potential application to patient information, clinical guidelines, and value-based coverage and payment policies. Results: ICER Integrated Evidence Ratings have supported coverage decision-making processes in a limited number of public and private payers, and demonstration efforts are underway to link reviews to patient information and revised payment policies. Several important challenges to rating have been encountered and addressed. Early feedback has suggested that the rating format helps decision makers understand the key issues underlying judgments about the comparative effectiveness of alternative interventions. Conclusion: Decision makers need comparative effectiveness reviews to be objective and rigorous; they also need key judgments regarding the evidence to be translated so all stakeholders can understand and consider them fully. A rating format that captures key judgments about comparative clinical effectiveness and comparative value could prove an effective method for helping ensure that comparative effectiveness reviews are understandable and useful to all stakeholders.

As health care costs continue to rise, an increasing number of self-insured employers are using financial rewards or penalties to promote healthy behavior and control costs. These incentive programs have triggered a backlash from those concerned that holding employees responsible for their health, particularly through the use of penalties, violates individual liberties and discriminates against the unhealthy. This paper offers an ethical analysis of employee health incentive programs and presents an argument for a set of conditions under which penalties can be used in an ethical and responsible way to contain health care costs and encourage healthy behavior among employees.

Medical imaging is a prime example of an innovation that has brought important advances to medical care while triggering concerns about potential overuse and excessive costs. Many hopes are riding on comparative effectiveness research to help guide better decision making to improve quality and value. But the dynamic nature of medical imaging poses challenges for the traditional paradigms of evidentiary review and analysis at the heart of comparative effectiveness. This paper discusses these challenges and presents policy lessons for manufacturers, evidence reviewers, and decisionmakers, illustrated by an assessment of a prominent emerging imaging technique: computed tomography (CT) colonography.

Pay-for-performance (P4P) has become one of the dominant approaches to improving quality of care, yet few studies have evaluated its effectiveness. We evaluated the impact on quality of all P4P programs introduced into physician group contracts during 2001-2003 by the five major commercial health plans operating in Massachusetts. Overall, P4P contracts were not associated with greater improvement in quality compared to a rising secular trend. Future research is required to determine whether changes to the magnitude, structure, or alignment of P4P incentives can lead to improved quality.