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Papers and Issue Briefs

CMTP leaders, staff, and advisors regularly publish papers in national medical and health policy-related journals.  These papers cover a range of topics, from comparative effectiveness methodologies to how clinical results may be used for evidence-based decision making.  Below are a selection of recent papers and older papers that frame major CER-related issues.  In addition, CMTP releases issue briefs to provide an overview of timely CER-related topics and issues.

Recently Published Papers

  
Penny E. Mohr and Sean R. Tunis.  Pharmacoeconomics 2010;28(2): 153-162
 

The concept of access with evidence development (AED), also known as ‘coverage with evidence development’ in the Medicare programme, has long been discussed as a policy option for ensuring more appropriate use of new technologies in the US. This article provides a comprehensive overview of more than 10 years of US experience with AED, both in the public and private healthcare sectors. Beginning with a discussion of the successes of private plans’ conditional coverage for high-density chemotherapy for autologous bone marrow transplants for metastatic breast cancer and Medicare’s conditional coverage of lung-volume-reduction surgery in the 1990s, the article moves on to describe how Medicare worked to codify AED as one of its coverage policy options in the early part of this decade. More recent private and public sector initiatives are also discussed, including an overview of barriers to implementing AED. 

 
Uncertainty in Assessing Value of Oncology Treatments PDF Icon
C. Daniel Mullins, Russ Montgomery, and Sean Tunis.  The Oncologist 2010;15(suppl 1):58–64
 

This paper investigates the convergence of incentives and circumstances that lead to widespread uncertainty in oncology and proposes new paradigms for clinical research, including pragmatic clinical trials, methodological guidance, and coverage with evidence development. Each of these initiatives would support the design of clinical research that is more informative for postregulatory decision makers, and would therefore reduce uncertainty and provide greater confidence.

 
 
Peter J. Neumann and Sean R. Tunis.  New England Journal of Medicine 2010; Jan. 20 (online)
 
In deciding whether to pay for new medical technologies, the Centers for Medicare and Medicaid Services (CMS) is becoming more specific about its requirements for evidence of improved health outcomes in the Medicare population. In our view, this is a positive and overdue step, but one whose rationale and likely consequences must be better understood by the medical community, policymakers, and the public.Expansions of access to health insurance under the health care reform legislation pending in Congress — and resulting financial pressures — would almost certainly intensify the emphasis on more relevant and robust evidence.
 
 
 
Justine Seidenfeld and Wade M. Aubry.  Imaging in Medicine 2010;2(3)
 

Medical imaging research questions comprise 11 of the 100 topics highlighted by the Institute of Medicine's report on priorities in comparative effectiveness research (CER).  The current report was solicited by Congress in the 2009 American Recovery and Reinvestment Act to provide guidance for the distribution of US $1.1 billion in new funding for CER studies.  Besides suggesting cautious use of imaging technologies that lack sufficient evidence of effectiveness, the report will impact future research by supporting the use of comparative study designs, more appropriate outcomes and a great emphasis on subpopulation analysis.  Results from CER on medical imaging technologies has significant potential to help end users of evidence, such as patients, providers and payers, make more informed clinical and policy decisions.

 

Additional Publications of Interest


Coverage Options for Promising Technologies: Medicare's 'Coverage with Evidence Development'PDF Icon

Sean Tunis and Steven Pearson.  Health Affairs 2006;25: 1218-1230

A Clinical Research Strategy To Support Shared Decision Making PDF Icon

Sean Tunis.  Health Affairs 2005;24: 180-184

Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy PDF Icon

Sean Tunis, Daniel Stryer, and Carolyn Clancy JAMA 2003;290: 1624-1632

 

Issue Briefs

 
      • The Patient Protection and Affordable Care Act, the health reform bill recently signed into law by President Obama, establishes a private, non-profit entity called the Patient-Centered Outcomes Research Institute, which will spearhead efforts to prioritize and fund comparative effectiveness research (CER).  This issue brief discusses the duties, authority, and funding of the Institute
  • Pragmatic Clinical Trials
      • This brief describes the defining characteristics of a pragmatic clinical trial.
  • Coverage with Evidence Development:  A Conceptual Framework PDF Icon
      • What is CED and why would a health plan or government payer consider utilizing it?  This issue brief lays out the rationale for using CED to generate evidence on medical technologies while providing coverage for beneficiaries.
 
 
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