This month’s post comes to us from past president of ACC’s Virginia Chapter, John Brush, Jr., M.D., F.A.C.C. In addition to serving three years as Chapter president, Dr. Brush practices at Cardiology Consultants, Ltd., in Norfolk, Va., and is an Assistant Professor of Clinical Internal Medicine at Eastern Virginia Medical School. He also has been a leader in quality improvement, assisting ACC efforts with “Door-to-Balloon: An Alliance for Quality” and the IC³ Program, and as a member of ACC’s Clinical Quality Committee.

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In the current health care reform debate, there has been considerable discussion about comparative effectiveness. This method of evaluation could provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction. Critics are concerned, however, that comparative effectiveness could be used to deny coverage, squelch innovation and ration care. Because of these concerns, some stakeholders forcefully argue that comparative effectiveness evaluations should be totally devoid of cost considerations.

But how can you compare competing treatments and ignore costs? To use heart failure as an example, could you really compare the relative effectiveness of ACE inhibitors and left ventricular assist devices and ignore the wide difference in costs between the two treatments? And isn’t the public’s desire to gain “more bang for the buck” what’s driving health care reform in the first place?

The Case for Cost Effectiveness
Cost effectiveness research is difficult and has recognized limitations. Yet no method of research is perfect or definitive. Although cost effectiveness research has some limitations, we should not reject the useful information that it provides for comparative effectiveness analysis.

There is a compelling need to contain costs in order to extend health care coverage universally in America.  Comparative effectiveness research will give policy makers important information that will help set priorities for spending.  As with clinical practice guidelines, comparative effectiveness analysis should inform, but not dictate clinical decisions.  Personalized decision-making for individual patients should always trump broad policy recommendations.

Comparative + Cost Effectiveness
Comparative effectiveness research and analysis will require a disciplined approach.  Comparative effectiveness research should be a transparent scientific process, absolutely free of economic influence.  Advisory boards that oversee this research and analyze the results should be shielded from undue political influence.  For years, NIH has distributed billions of dollars in funding, using established methods that are generally respected as fair and non-biased.  Similar independence and discipline can be established for overseeing comparative effectiveness research and analysis. 

Comparative effectiveness research using cost considerations should be a two-stage process.  The first stage should pertain to relative clinical effectiveness and the second stage should deal with costs.  For competing treatments with similar clinical effectiveness, no further cost effectiveness research is needed because direct cost comparisons would be simple.  But in comparisons where one treatment is more effective, careful analysis of costs will be necessary to estimate the monetary value of the increased effectiveness.

Constructing a Firewall against Undue Influence
To maintain the integrity of this process, and to shield the process from political and financial influence, a firewall should be constructed between comparative effectiveness evaluation and insurance coverage decisions.  The funding level for coverage is a political or a business issue, not a scientific issue.  The funding level for Medicare is up to Congress, and, ultimately, to taxpayers.  The funding level for private health plans is up to the purchasers and benefit design managers.

Comparative effectiveness analysis can be separated from coverage decisions by borrowing the method used in the process of grant funding:  

• When judging grants, the judges evaluate the grants based on the scientific merit of the grant, without consideration of whether the grant will actually receive funding.
• Grants are graded on a relative scale.
• Top grants that fall within the funding range receive a grant.

Is that rationing?  Perhaps so, but this explicit method of determining coverage seems more rational than the current method for rationing where we deny care to nearly 50 million Americans because they lack employer-based insurance or don’t meet the criteria for Medicare or Medicaid.

The device and pharmaceutical industry is predictably worried about comparative effectiveness.  Undoubtedly, comparative effectiveness would provide pressure on pricing, which is generally lacking when providers and patients pass on costs to third party payers. Transparent comparative effectiveness would give consumers of health care an opportunity to shop for greater value, which will help contain overall costs. 

We Can’t Have it All
This is the unfortunate truth: the growth in health care spending is unsustainable and is making health care unaffordable for average Americans.  In health care, we can have nearly anything we want – we just can’t have everything we want.  Because of escalating costs and limited funding, we need mechanisms to differentiate medical treatments with high value and those with little incremental value.  Without a method to objectively analyze the relative value of treatments, the costs of medical care will continue to rise to unaffordable levels.

-- John E. Brush, Jr., M.D., F.A.C.C.

* Dr. Brush’s post is part of a monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

*** Image from morgueFile (jdurham). ***

 
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