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PERSPECTIVEThe Emerging Context For Advances In Comparative Effectiveness Assessment
The call for an entity for independent assessment and guidance on alternative medical interventions is timely. The emergence of four developments underscores the importance and sets the stage for progress: an improving evidence base; growing recognition of the importance of variation in the effectiveness of treatments across patients; recent emphasis on transparency; and growing adoption of pay-for-performance initiatives. To advance progress on these issues, the Institute of Medicine (IOM) has convened a Roundtable on Evidence-based Medicine. The roundtable is exploring ways to improve the development of evidence, the thoroughness with which it is applied, and the mechanisms for increasing national capacity for the work.
FORMER FEDERAL HEALTH CARE financing chief Gail Wilensky has presented a compelling case for developing a National Center for Comparative Effectiveness Information in the United States.1 Her analysis points out that spending for health care in this country is already about 50 percent more per capita than any other country in the world, without a concomitant advantage in health outcomes. Wilensky calls for the creation of a quasi-governmental, multi-billion-dollar entity to provide independent assessment and guidance on alternative medical interventions to improve decision making by providers, patients, and payers. The simultaneous emergence of four developments on the health care scene both underscores the importance and sets the stage for progress.
First are developments in information technology (IT), which offer the prospect of fundamental change in how evidence is developed and applied. Meanwhile, various specialty groups seek to develop patient registries that will provide information on the experience in managing certain conditions, the Centers for Medicare and Medicaid Services (CMS) is developing evidence under coverage protocols and the Part D drug benefit data, the Agency for Healthcare Research and Quality (AHRQ) is implementing the comparative effectiveness provisions of Section 1013 of the Medicare law, and the Food and Drug Administration (FDA) is exploring how it might restructure its premarket tests of safety and efficacy. An especially important aspect of developing the evidence base relates to aggregating data across payers. Such aggregation provides a comprehensive view of a provider’s experience and permits comparison of his or her practice patterns with the preferred treatments. Aggregation will also provide the opportunity for observational analysis of the use and perhaps effectiveness of various medications, devices, and procedures. Clearly, progress in development of an electronic health record can improve the content and usefulness of such aggregated databases. Numerous state-specific data aggregation efforts are under way. In addition, two national projects, Care Focused Purchasing (CFP) and the Ambulatory Care Quality Alliance (AQA), are illustrative of the prospects. CFP is a group of more than fifty employers who are partnering with seven major health plans to create a data warehouse—a repository of information with which providers’ performance can be measured—with claims data on more than eighteen million health plan members, and CFP employer claims data on more than two million self-insured lives.2 The output of this effort will be reports on providers’ performance that will be delivered to the CFP partner carriers in early 2007. The AQA is a broad-based national coalition of more than 125 organizations representing physicians, consumers, employers, government, health plans, and accrediting and quality organizations that seeks to improve health care quality by a common approach to measuring, reporting, and improving physician performance.3 Six pilot sites are testing approaches to aggregating and reporting data on physician performance, and others are expected to be added before long.
Second is the growing recognition of the importance of certain patient characteristics (such as sex, age, and race/ethnicity) as modulators of the comparative effectiveness of treatments. Comparative effectiveness evaluation should take these characteristics into account. A case in point is the CMS’s recent decision to limit coverage options for vertebral replacement to those few beneficiaries under age sixty, based on how evidence of effectiveness varies by age. Insights on other such variations, driven by biological predispositions, will greatly increase with the push to refine genetic understanding.
Third is the recent emphasis on transparency. Critics have long complained about the lack of transparency in the U.S. health care system, reflecting the fact that patients rarely have access to information regarding either the quality or the cost of the services they receive. Availability of and use by consumers of information on both the comparative effectiveness of diagnostic or therapeutic approaches as well as their cost should foster prudent purchasing decisions. For several years, newspapers have published the outcomes for procedures such as cardiac surgery at local hospitals, and health plan ratings by state or national organizations are commonplace. To date, the impact of public release of quality information on consumers’ decision making seems to be modest. More recently, efforts have begun to make information available with respect to cost as well as quality. This effort has been fostered by the growth of so-called consumer-driven health products in which high deductibles or other forms of cost sharing provide the consumer with greater financial responsibility.4 The first health plan to make specific cost information available for specific services was Aetna, which did so in 2005 in Cincinnati and has since expanded its cost transparency effort and added quality data for several other large cities. WellPoint recently announced an initiative with General Motors in Ohio to make available to customers the total estimated costs associated with an episode of care, which would include office visits, prescriptions, lab tests, and hospitalization.5 President George W. Bush and secretary of health and human services (HHS) Michael Leavitt gave the focus on transparency a major boost when the president signed an August 2006 Executive Order directing federal agencies that administer or sponsor health insurance to increase transparency in pricing and quality.6 Because this order relates to about one-quarter of insured Americans, it will have path-breaking impact.
Fourth is the widespread interest and growing adoption of pay-for-performance (P4P) initiatives. The CMS has made P4P a major priority, with at least twelve states participating in a wide range of initiatives under Medicaid, and more than 100 projects are currently under way at health plans around the country. These initiatives depend on the development of standards that must increasingly include comparative effectiveness information. Aggregation of large data sets and the presence of a market for comparative effectiveness findings in the form of P4P programs are meaningless without the ability to do the necessary analyses and provide guidance for practice. The nation’s capacity to provide such guidance is woefully underfunded and fragmented. Wilensky notes that AHRQ, the lead agency for this work, has long met resistance to comparative effectiveness research; that it is only since the passage of the Medicare Prescription Drug, Improvement, and Modernization Act in 2003 that the federal government has been specifically directed to assess such issues; and that only $15 million has been appropriated for comparative effectiveness assessment in each of the past two years. In addition, we need a neutral, trusted central entity of the highest capacity to identify the interventions to be assessed, set priorities, determine the most appropriate analyses, commission additional studies as necessary, validate results, and issue findings and recommendations. And we need the political will to make sure we get what we pay for in health care. For instance, the CMS is still prohibited from making coverage decisions based on the relative effectiveness of drugs or devices.
To advance progress on these issues, the IOM has convened a Roundtable on Evidence-based Medicine, with which we are associated. Participants in the roundtable represent leadership from the central stakeholder sectors—patients and consumers, providers, insurers, manufacturers, researchers, and government agencies. In recognition of the fact that with issues of this complexity and size, there is a need for a neutral venue for discussion and collaborative action, sponsors include government, manufacturers, insurers, and private foundations. The United States has shown that it can develop the most sophisticated medical care in the world—care that can tackle the most complicated issues. But the true measure of its value will lie in our ability to ensure that it is delivered effectively and efficiently to all who need it.
John Rowe (jwr2108{at}columbia.edu) recently retired from Aetna, where he had been chief executive officer and chairman since September 2000; he is now with the Department of Health Policy and Management, Mailman School of Public Health, Columbia University. Denis Cortese is chief executive officer of the Mayo Clinic and chair of the Institute of Medicine (IOM) Roundtable on Evidence-based Medicine. Michael McGinnis, a former senior executive in philanthropy and at the federal level in four administrations, is now senior scholar at the IOM. The opinions expressed here are those of the authors and do not necessarily reflect the views of the Institute of Medicine of the National Academies.
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