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//Debating Costs of Price Considerations in Health Care// (Washn)

By Ricardo Alonso-Zaldivar(c) 2008, Los Angeles Times

WASHINGTON -- Medical researchers and politicians are tiptoeing into an area of health care that makes some Americans uncomfortable, even angry, and it has nothing to do with such hot-button issues as cloning and stem-cell research. This time, the idea is to press doctors and patients to use particular drugs and treatments in order to save money.

On the surface, it seems simple enough: Billions of dollars could be saved if everyone adopted the regimens that research showed were best and most cost-effective -- which, experts say, happens far less often than most patients think.

The problem is that any move to push doctors and patients to make a particular choice collides with the American belief that medical decisions are nobody's business but the patient's and the doctor's. Least of all, the government's.

Also, because the research is based on statistical analyses and there are trade-offs in almost all medical choices, there's sometimes room to disagree about what constitutes the "best practice."

Yet scientists, medical-policy specialists and leading politicians are starting to embrace the idea of using cost-effectiveness research to drive individual medical decisions. They call it "comparative effectiveness" research, sidestepping a direct reference to costs.

Democratic presidential candidate Barack Obama of Illinois is calling for substantial investment in the idea. And Republican candidate John McCain is interested.

In Congress, Democratic Sens. Max Baucus of Montana and Kent Conrad of North Dakota are expected to introduce legislation soon that would create a government institute to conduct such research. Baucus chairs the Finance Committee, which oversees Medicare and Medicaid, and Conrad is budget chairman.

Americans are expected to spend $2.4 trillion on health care in 2008. Within a decade, the figure is expected to surpass $4 trillion a year and account for 20 percent of the Gross Domestic Product, the most commonly used measure of total U.S. economic output.

"Learning how to spend smarter is one of the three or four critical things that needs to happen in our health-care system," says Gail Wilensky, a leading Republican health policy expert and former Medicare administrator. "Not only is it something the Democrats have been interested in, but a number of Republicans think this is the kind of information that is consistent with market strategies that help doctors and patients make better decisions."

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Obama includes the concept in his plan to control costs and make insurance more affordable. McCain's health-care adviser says a greater role for cost/benefit studies is "imperative."

The candidates insist that their sole purpose would be to generate information that can help doctors and patients make better decisions, not to steer insurance coverage. But experts say that's exactly where the process leads: First, researchers would identify "best practices," then pressure would rise for Medicare and private insurers to begin penalizing those who rejected the guidance.

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Initially, the research probably would focus on new treatments that have not been widely adopted. But common treatments that are debated within the medical community -- such as surgery versus physical therapy for bad backs -- also could get scrutiny.

In the future, some experts say, approved medical tests and treatments could be treated the same way prescriptions drugs are now: Patients would pay little or nothing for generic drugs or "high value" procedures and higher co-payments for treatments judged to be of "low value."

Medicare does not explicitly take costs into account. It bases coverage decisions on whether a new treatment is "reasonable and necessary." Supporters of adding cost considerations to the equation -- using "comparative effectiveness" research -- say the goal is to develop a knowledge base that government programs and private insurers can rely on to guide decisions.

"People have pointed out that a lot of the care in our system is inefficient, wasteful or inappropriate -- maybe 20 percent or 30 percent. The problem is, it doesn't come tagged," said Sean Tunis, Medicare's former chief physician. "So any efforts to restrain spending on unnecessary care are going to involve difficult decisions depriving people of things they need or think they might need. We haven't been very honest about it, and we haven't figured out a good way to do it."

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Prostate cancer, which occurs in older men, illustrates both the potential savings and the potential controversy of the "best value" approach.

If the cancer is discovered before it has spread, doctors and patients have several options. They can choose so-called "watchful waiting" to see how the normally slow-growing tumor progresses. Chemotherapy is another possibility. But radiation is increasingly the option of choice because of the relatively lower level of side effects.

Three-dimensional CT-scan images are used to aid in focusing X-rays on the tumor while sparing surrounding tissue.

Over roughly the past five years, intensity-modulated radiation therapy, commonly called IMRT, has become practically standard in this country. But a panel of scientists, including Tunis, recently conducted a study comparing IMRT to an early radiation regimen called 3-D CRT.

The study was sponsored by the Institute for Clinical and Economic Review, which is affiliated with Harvard Medical School. Director Steven Pearson is a former primary care doctor who as a practitioner had found himself wanting data to help assess the relative benefits, risks and costs of treatments for his patients.

The panel analyzed medical studies on the two treatments. The conclusion: Both were about equally effective at zapping tumors and preventing the cancer from returning.

But IMRT -- the newer treatment -- costs about four times as much as the older approach: $42,450 compared with $10,900.

A opportunity to save health-care dollars? Yes, the panel concluded: Using the far more expensive regimen was a "low value" choice.

But some critics say long-term effectiveness is not the only consideration. Treating prostate cancer with radiation can damage healthy tissue near the tumor. That sometimes inflames the digestive tract and can cause pain and diarrhea. The side effects usually clear up in weeks or months, but they are distressing while they last.

The research showed that these complications occurred much less often when the IMRT procedure was used, because it can target the tumor more precisely. About 1-in-7 patients develop the complications with the older treatment, compared with fewer than 1 in 20 with IMRT.

Researchers were not indifferent to the greater possibility of complications, but they calculated that given the relative infrequency of the problem regardless of treatment method, IMRT would cost $300,000 to prevent one case of bowel inflammation. Faced with the need to rein in medical costs, the researchers concluded that 3D-CRT was a better choice.

"As consumers of health care, we have to be more clear about what we want," Pearson said. "We want to be clear that we are willing to pay for significant innovations, but we are not willing to pay any price for something that is just as good as what we are doing or a just a teeny bit better."

What makes such an approach controversial is that in particular cases, individual patients and their doctors might not see it that way.

Dr. Andre A. Konski, a radiation oncologist who participated in the prostate cancer evaluation, said he has treated patients with both kinds of technology, and he concluded that IMRT is superior.

"I have seen patients have less side effects, and you are able to go to higher doses," said Konski, who is affiliated with the Fox Chase Cancer Center in Philadelphia. He thinks higher doses could bring higher survival rates, although the study found no significant difference.

Despite his dissent on the prostate cancer study, Konski said he believed that before new technology was adopted, the U.S. health-care system needed a way to determine whether it was worth the cost.

"The one thing that is the big hurdle is finding the money to do those studies," Konski said. "There has to be money from the government."

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Republican health-care expert Wilensky has proposed the creation of a federal agency with a budget of as much as $5 billion a year to fund effectiveness research.

Viewed in the context of the $2 trillion Americans spend on health care, Wilensky said it would be a prudent investment.