Keckley: Knowing What Works Is Critical

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The Arguments

• Daschle: Comprehensive Health Care Reform Is Long Overdue in U.S.
• Delgado: Health Care System Must Reflect the Values Of American Society
• Miller: U.S. Needs a Holistic, Cradle-to-Grave System of National Health Care
• Simmons and Neas: National Plan Must Be Product of Capitol Hill Bipartisanship
• Sullivan: Shortfall of Professionals Must Be Solved
• Tanner: Reform Must Empower the Consumers
• Gephardt and Thompson: Steep Costs Damage Families, Businesses

What We Know

• Bigby: Massachusetts’ Rate of Uninsured Has Fallen Since Reform Passed
• Marchildon: O Canada — Exploding the Myths About Its Health Care System

Stakeholders Weigh In

• Brown: Cost Denies Many the Care They Require
• Grover: U.S. Teaching Hospitals Need Federal Support
• Kennedy: Retailers Are Already Shaping the Landscape

Ensuring Success

• Gingrich and Frogue: Congress Must Eliminate Fraud
• Saputo and Belitsos: D.C. Needs to Catch Up to Public
• Waters: Telemedicine Boosts Access to Needed Care

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The annual U.S. investment in health care is more than 16 percent of its gross domestic product and is projected to increase at 6.2 percent annually through 2018. Although the current annual health care investment is $2.3 trillion, studies have shown that less than 1 percent of that total is used for assessing the comparative effectiveness of available treatments.

Simply stated, clinical decisions about health care interventions, for individuals or populations, are not always informed by adequate evidence of the clinical effectiveness of those interventions. And credible analytics from Rand and others indicate a significant gap exists between evidence and practice.

There are many reasons for the widening gap — lack of accurate or complete information from patients, pressure from patients to get “the latest and greatest” based on what they just read, or lack of helpful information technologies that prompt medical professionals to be more accurate in diagnosing problems and recommending treatments. The biggest reason is simply lack of availability of evidence in the teachable moments when clinical decisions are made by medical professionals and consumers.

Health care is complex. Matching patient data (signs and symptoms, risk factors, co-morbidities and genetics) requires substantial investments to amass data adequate to evaluate even the most prevalent medical problems. Building a national program to monitor the efficacy and effectiveness of existing and new diagnostic tests, surgical procedures and medications is a major undertaking. The payoff — reduced inappropriate variation, better care and improved efficiency in the delivery of care — may not be realized for many years.

The allocation of $36 billion in the stimulus package to promote adoption of electronic health records by physicians and hospitals is an important step toward narrowing the gap. It’s a start. A second major element is a process whereby approaches to care are systematically evaluated so the most appropriate diagnosis and treatment options are made readily available to medical professionals and patients at the point of care — that’s the essence of the current health reform discussion about “comparative effectiveness” — how it should be done in the pluralistic and complicated environment of the U.S. health system.

At least 16 of the world’s 30 developed health systems have a comparative effectiveness program to guide clinical decisions. Ours is the exception. But those systems are primarily government run and operated. They are not as complex and fragmented as ours.

Patients in these systems are accustomed to the way their health care is provided — typically a general practitioner serves as a gatekeeper to specialty services and hospitals. Funding is through taxes and in some cases employer contributions, and often 10 percent to 20 percent of the populace pursues private insurance to augment or replace the government’s coverage.

In most developed systems, data about patient care is captured, de-identified and analyzed by agencies to assess correlations between diagnostics and therapeutics and to advise their government about what works best. In 16 developed systems of the world, an entity is in place to evaluate new approaches to care, compare them to other options and direct doctors and hospitals to practice per their recommendations.

The current health reform discussion includes prominent attention to comparative effectiveness as a means of reducing costs associated with inappropriate variation. But its implementation will not be easy. Differences between four prominent health systems’ approaches to their comparative effectiveness programs illustrate the challenges:

Scope of Authority. The comparative effectiveness programs in the United Kingdom (National Institute for Health and Clinical Excellence, or NICE) and Australia (Pharmacy Benefits Advisory Committee and Medical Services Advisory Committee) have statutory authority to approve coverage requirements for their nationalized health systems; the comparative effectiveness programs in Germany (Institute for Quality and Efficiency in Health Care) and Canada (Canadian Agency for Drugs and Technology in Health) are advisory only.

Scope of Review Process. Some systems of comparative effectiveness focus on comparisons between surgical options, diagnostic tests and medications; others like the United Kingdom’s NICE focus almost exclusively on comparisons of medications.

Availability of Data. Information about patient care in the United States is all over the place. Long-term relationships between physicians and patients is not the norm, and most information about patients is in paper records. Health plans capture data from claims filings, but much of the information about patient signs and symptoms is incomplete, lacking clinical data only accessible in the medical record. As clinical researchers have learned, knowing what works in the controlled setting of a clinical trial study is relatively straightforward — that’s efficacy research. But clinical effectiveness research requires data about actual use of the intervention in “the real world.” That’s effectiveness research. Studies showed Vioxx to be efficacious, but it faced notable legal issues about its effectiveness. Both are important.