Papers and Issue Briefs

• Coverage with Evidence Development (CED) in the Private Sector: Lessons in Design and Implementation
• This issue brief was developed as part of CMTP's efforts to highlight lessons learned in private-sector CED design, including areas like priority-setting and topic selection, stakeholder engagement in research design, and other operational/implementation challenges. 
• What is CER and What Does it Mean for Patients, Physicians, and Payors?
• This paper, presented at CMTP's first Policy Leadership Briefing on Comparative Effectiveness Research in July 2010, provides background on CER and the role of the of the new Patient Centered Outcomes Research (PCOR) Institute.  The underlying premise of CER as defined in the health reform law is that such evidence is too often lacking. CER attempts to rectify that by conducting studies that differ in critical ways from many traditional clinical studies. What those differences are, how they will be carried out, and the role of the new PCOR Institute in defining and implementing these approaches will be addressed by some of the nation’s leading authorities and decision makers in CER.
• Overview of the Patient-Centered Outcomes Research Institute

• 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
• Definitions of Comparative Effectiveness Research
• Pragmatic Clinical Trials
• This brief describes the defining characteristics of a pragmatic clinical trial.
• Coverage with Evidence Development:  A Conceptual Framework 
• 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.

Access with Evidence Development:  The US Experience 

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.