Three Perspectives on the Impact of Comparative Effectiveness Research on Decision Making

BaCkgRound: Comparative effectiveness research (CER) is rapidly add- ing to the amount of data available to health care coverage and payment decision makers. Medicare’s decisions have a large effect on coverage and reimbursement policies throughout the health insurance industry and will likely influence the entire u.S. health care system; thus, examining its role in integrating CER into policy is crucial. oBjECtIvES: to describe the potential benefits of CER to support payment and coverage decisions in the Medicare program, limitations on its use, the role of the Centers for Medicare & Medicaid Services (CMS) in improv- ing the infrastructure for CER, and to discuss challenges that must be addressed to integrate CER into CMS’s decision-making process. SuMMaRy: a defining feature of CER is that it provides the type of evidence that will help decision makers, such as patients, clinicians, and payers, make more informed treatment and policy decisions. Because CMS is responsible for more than 47 million elderly and disabled beneficiaries, the way that Medicare uses CER has the potential to have a large impact on public and individual health. Currently many critical payment and coverage decisions within the Medicare program are made on the basis of poor- quality evidence, and CER has the potential to greatly improve the quality of decision making. despite common misconceptions, CMS is not prohibited by law from using CER apart from some reasonable limitations. CMS is, however, required to support the development of the CER infrastructure by making their data more readily available to researchers. While CER has substantial potential to improve the quality of the agency’s policy decisions, challenges remain to integrate CER into Medicare’s processes. these chal- lenges include statutory ambiguities, lack of sufficient staff and internal resources to take advantage of CER, and the lack of an active voice in set- ting priorities for CER and study design. ConCLuSIon: although challenges exist, CER has the potential to greatly enhance CMS’s ability to make decisions regarding coverage and payment that will benefit both the agency and their patient population. J Manag Care Pharm. 2012;18(4-a):S5-S8 Copyright © 2012, academy of Managed Care Pharmacy. all rights reserved. • Without comparative effectiveness research (CER), payers and Centers for Medicare & Medicaid Services (CMS) must make decisions based on the best evidence available, which often lacks headto-head data comparison, uses surrogate endpoints, and excludes the specific elderly or disabled population that Medicare covers. • There is a common misperception that the CMS is not allowed to use CER data when making decisions. What is already known about this subject • Contrary to a common misperception, CMS is allowed to use CER data when making coverage decisions, albeit with some limitations. • CER could be used when creating patient decision aids, establishing value-based insurance design, and in coding (determining whether there is enough of a significant therapeutic distinction for a particular product to assign it a new code). • CMS could use CER data in pricing decisions—specifically in the area of least-costly alternative (or reference pricing). What this article adds • Greater use of Coverage with Evidence Development is a mechanism to stimulate the generation of relevant CER for the Medicare