January 2008
The Cost of Overregulation

HMT From the Editor

By Michael McBride

Can America have its cake and eat it too? The Health Insurance Portability and Accountability Act (HIPAA)—good legislation originally intended to enable patients to retain their healthcare when changing jobs—has grown into something of a nuisance for researchers who now spend more time placating government bureaucracy than they do completing research studies. According to a recent national survey of more than 1,500 epidemiologists, which was commissioned by the Institute of Medicine (IOM) and published in The Journal of the American Medical Association (JAMA), three quarters of the respondents believe that HIPAA has not "enhanced participants' confidentiality and privacy," but instead, has "had a substantial, negative influence on the conduct of human-subjects health research, often adding uncertainty, cost and delay."

On the same day that JAMA published the survey, it also published a related editorial co-authored by Norman Fost, M.D., of the University of Wisconsin School of Medicine and Public Health, and Robert J. Levine, M.D., Yale University School of Medicine, in which Fost wrote, "There are increasing concerns that the system is overregulated, with more time and expense devoted to activities of marginal utility in protecting human research participants." And, in an Associated Press article, Fost also states that patients are "worse off" because they may not be reading the longer consent forms that HIPAA requires in order to participate in the research studies.

HIPAA is important legislation, however, it would appear that there are downsides to bureaucratic overregulation. Go figure. One can imagine Fost's words being used to describe the bureaucratic behemoth that would be national healthcare, where clinicians would spend more time completing governmental oversight reports than attending patients. If one piece of legislation can have such an impact on only one aspect of healthcare, what will it be like when all of healthcare is similarly regulated? Will Americans be better or worse off? In spite of hard evidence to the latter, the contentious debate over nationalizing healthcare continues.

Nevertheless, change is inevitable. The Boomer tsunami is coming to shore, millions of Americans remain un- or underinsured, and costs skyrocket while quality plummets in some areas. The dam will soon burst, but it doesn't have to be a disaster. By acknowledging that there are multiple, critical emergencies in healthcare, we can seek as a nation a multi-faceted solution, rather than a one-size-fits-all.

For example, a limited single-payer national health plan covering all Americans at the most basic level funded by existing tax dollars (not new taxes), blended with tax incentives that makes higher quality private health coverage available to those who can afford it, and who need it, coupled with government grants to help care providers purchase EMR, CPOE, ePrescribing and decision support technologies. This multi-faceted approach would go a long way toward resolving much that needs fixing in healthcare today. And, it can be accomplished without radically changing our healthcare system. But it would require leaders in both parties to work together. Not an easy task during a presidential election.

Until government bureaucracy gets out of its own way, we will never see a multi-faceted solution because there is too much power to be gained by controlling the outcome of the healthcare debate in America.

Copyright 2008
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