Comparative Effectiveness: Is Obama Really Calling for Rationing?

President wants to link computerized records with standardized care.

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By Bernadine Healy, M.D.

Patients and doctors, get ready for pop-ups, a feature of healthcare reform described by President Obama in his budget. His plan to cut medical costs and standardize quality of care envisions a national computerized medical record system tied to treatment guidelines based on "comparative effectiveness" studies of how well the treatments work. Suppose you're a teen with acne or a woman with heart failure. You're a chronic diabetic or a middle-aged man with erectile dysfunction. As your doctor types your information into his or her government-certified computer, user-friendly pop-ups provide alerts in real time of what is deemed to be the best option for care. This could be a dream if it cuts costs while reducing unnecessary and harmful care—or a nightmare if we fall into a trap of inappropriate rationing.

Getting all Americans into a certified national health computer system in the next five years would start with Medicare and Medicaid patients. Doctors and hospitals would get incentives starting in 2011 for using certified electronic records, followed in 2015 by financial penalties on those who are not with the program. Inevitably, private health insurers would be drawn into the system.

Obama believes that a national record will improve care and decrease medical errors, and he offers a full-throated assurance that patient privacy will be protected. He also promises that by revealing the worthiness of treatment, this electronic record system will prevent unnecessary spending. Health information from patient records of all Americans will become a giant research laboratory. You name it: Prevention strategies, diagnostic approaches, treatments, outcomes, and costs will be analyzed to reach a better understanding of practice patterns and find those that seem to work the best. Resulting insights, integrated with evidence from clinical research, will be distilled into clinical decision-making tools for doctors—such as those user-friendly pop-ups.

But depending on how they are chosen, guidelines can lead to inappropriately rationed care. That same computer system will have the ability to monitor practice. The Centers for Medicare and Medicaid Services already has made some limited efforts to tie pay to how hospitals and doctors perform. For example, CMS will not pay for certain complications related to care that it deems negligent, such as a bedsore or a postoperative wound infection. In the Obama scheme, adherence to designated standards of care, which would be easy to monitor online, is likely to quickly become part of insurance reimbursement. The practice standards would rest on that other pillar of reform, comparative effectiveness.

A little over a year ago, the Congressional Budget Office, under Peter Orszag (now the head of Obama's Office of Management and Budget), issued a paper noting the opportunity for "an expanded federal role" in constraining costs without adverse health consequences by more aggressively investing in comparative-effectiveness research. Orszag frequently points out that new treatments and technologies account for about half of the soaring costs. The CBO report refers to one well-known National Institutes of Health study showing that thiazide diuretics, around for years, are more effective at a few pennies a day than newer, more costly drugs in lowering blood pressure and cardiovascular risk in older patients. Using these oldies but goodies is a money-saving bonanza. No surprise that Orszag is shepherding this program big-time; OMB's just released budget commits over a billion dollars to comparative-effectiveness research.

However, when the new and more expensive treatments turn out to be the better option, their cost, plus doctors' and patients' appetite for them, will still have to be tamed. An obvious approach is tough and open negotiations on price—between the government and drug companies, say—to benefit all. We haven't done that in this country, letting prices float in some cases to unsustainable heights.

Our friends across the pond, where most healthcare is government run, use both approaches, and their cost of care and negotiated prices for expensive drugs are far below ours. The most developed and respected comparative-effectiveness program resides in Great Britain, where the National Institute for Clinical Excellence, or NICE, does the heavy lifting in assessing a therapy's value and setting standards of care. Its pronouncements guide what the country's health system, the National Health Service, offers patients. Treatments that don't justify their high cost are nixed or limited—rationed, by another name. Breast cancer patients were denied Herceptin, for example, until enraged women fought back.

Britain arrives at its judgments by using a standard economic research measure, the quality-adjusted life year, to assess whether a treatment is worthwhile. It takes into account how patients' health status affects their well-being. On the QALY scale, 0 means you're dead, 1 means you're in perfect health, and varying levels of debility fall in between. Imagine two groups of people, one with a QALY of 1 and the other with a score of 0.5. An expensive technology brings a year of life to both groups. But in the second, that technology would be counted as having provided only six months, and thus be twice as expensive. It may be deemed too costly for that patient group.

QALYs are commonly used for research in this country and for reimbursement decisions in several other countries. But they present clear ethical issues; society is making judgments about the worth of a less-than-"perfect" life. The Germans, for example, have categorically rejected QALYs, and many believe fervently that they have no place in healthcare decisions. While Obama's plan doesn't comment specifically on the British model, Tom Daschle, his first choice to lead healthcare reform, is a fan of creating a NICE equivalent. I doubt it would be so welcomed here.

These are issues for doctors and patients to weigh in on. One-size-fits-all care flies in the face of personalized medicine, or tailoring treatment to patients' unique makeup. Standardized care does upgrade the performance of mediocre docs, and there are some out there. But it does not take into account the reality of doctoring in a complex situation riddled with uncertainty, multiple health problems, and many options. The public knows this, and perhaps that's why the outrageous, defiant, fictional Dr. House is so popular. Patients often fool and humble us, by walking when they should be in a wheelchair, being joyous when their quality of life seems grim, and living when the odds tell us they should be gone.