Medicare says it will pay, but patients say 'no thanks'

To test whether federal health spending actually helps patients, Medicare has been requiring more and more of the nation's retirees to participate in clinical trials to measure the effectiveness of a growing range of treatments, before agreeing to pay for them. Now, the outcome of the first and most extensive Medicare trial yet indicates that the public, armed with the data developed, may make surprisingly conservative decisions.

It was a study of a risky but popular operation for patients with advanced emphysema, and after its results were announced in May 2003, Medicare agreed to pay for the procedure.

Some health economists were alarmed. The operation and months of rehabilitation can cost more than $50,000 and, they predicted, tens of thousands of patients could end up having the procedure. It could cost Medicare as much as $15 billion.

What happened instead was a complete surprise. After seeing the clinical trial's results -- no lengthening of life for most patients and a nearly 10 percent mortality risk from the operation itself -- many patients and the doctors who refer them to surgeons seemed to lose their enthusiasm.

From January 2004 through last September, only 458 Medicare patients filed claims for the surgery, at a total cost to the government of less than $10.5 million.

"You could have knocked me over with a feather," said Dr. Scott Ramsey, an internist and health care economist at the University of Washington who had been predicting financial doom.

Many health economists and medical experts praised the study's impact, saying that replacing anecdotal evidence with scientific data saved money and the lives of patients who were unlikely to benefit from the surgery. And they say such scrutiny is necessary as Medicare, a program covering more than 42 million Americans and with expenditures approaching $327 billion a year, tries to come to grips with the spiraling cost of health care.

The main critics seem to be lung surgeons, who say that the study's findings are being interpreted in an overly negative light and that too many seriously ill people stopped seeking treatment.

But Medicare officials say the results have given them the public and political support they need to continue the clinical trial approach with other diseases. Although the agency is forbidden by law to consider cost when deciding whether to pay for treatments, it can consider how well a treatment works.

So Medicare is now enrolling patients in other trials or registries, examining the effectiveness of a wide range of expensive and popular treatments and procedures -- new cancer drugs, defibrillators, PET scans to detect early Alzheimer's disease and. possibly, home oxygen therapy for emphysema. These are often costly treatments -- Medicare paid $1.2 billion for defibrillators in 2002, for example, according to Medtronic, which makes the devices.

No matter what those studies end up showing, the use of clinical trials can make them controversial even at the outset. The very nature of a clinical trial means that only some patients actually receive the new treatment, while others, for comparison's sake, do not. Paying for some patients but not others to receive a new treatment is a stark departure for Medicare.

When Medicare first headed down that path with its lung surgery trial, it got an earful from patients, surgeons and even members of Congress who said it was unethical and just plain wrong to deny some patients a lifesaving operation simply to glean data.

What has most dismayed many lung surgeons, though, is the aftermath of the emphysema study, which Medicare sponsored with the federal National Heart, Lung and Blood Institute.

Medicare officials say that they did not anticipate taking such a bold step as a clinical trial. Instead, their effort began in sort of a stunned panic. In the 1990's, Medicare discovered that surgeons were performing the procedure, called lung volume reduction surgery, on thousands of very sick emphysema patients and that Medicare was paying for it under established cost codes.

The operation involves cutting out sections of diseased lungs to give healthier tissue room to expand.

Reviewing data for 1996, the agency found that it had paid for 3,000 of the operations at 27 medical centers.

The procedure's popularity was growing, as surgeons told of patients who had been tethered to oxygen tanks and so ill that they had to stop and rest every few steps. After the operation, according to the reports, many improved so much that they could walk steadily, even uphill, and breathe on their own.

Patients were posting testimonials on Web sites, hospitals were advertising, and doctors were referring their advanced emphysema patients to surgeons.

Some doctors, like Dr. Joel Cooper, a lung surgeon, published reports of his patients that were so promising that his medical center, Washington University, could hardly keep up with the demand. And Dr. Cooper, now at the University of Pennsylvania, still stands by the operation, saying in a recent interview that lung volume reduction surgery patients "are among the most grateful patients we have."

But back in 1997, noting the surgery's risks and the opinion of some doctors that it did not work at all, Medicare officials proposed a marked change in policy. There would be no more payments except for patients who enrolled in an agency-sponsored clinical trial.

Many surgeons and patients balked. Dr. Cooper refused to participate in the trial, saying he could not in good conscience randomly assign patients to the control group who would receive no treatment. Congress held hearings and listened to complaints that desperately ill patients would suffer. Representative Jim Ramstad, a Minnesota Republican, predicted the study would "negatively affect the lives of thousands of older Americans who suffer from the disease."

Patients and their families, along with reporters, called Medicare, an agency spokesman recalled, asking "Why aren't you paying for this lifesaving miracle?"

In May 2003, four years after the study began, the results based on 1,281 patients were published. For two years, the study followed both patients who had the operation and those who did not to see how they fared. Over all, patients in the study lived no longer, whether or not they had the surgery -- although a certain subset of surgery patients did outlive similarly ill patients who did not have the operation. Others who had the surgery found it easier to walk or breathe. But still another subset receiving the procedure did not get any benefit at all.

Surgeons, focusing on the prolonged life for some patients who had the operation and the improved symptoms for others, were elated. In 2004, Medicare began paying for the operation in all advanced emphysema patients except those whose condition resembled that of patients in the study who received no benefits from the surgery.

•	Medicare says it will pay, but patients say 'no thanks' New York Times, Friday, March 3, 2006 Byline: Gina Kolata

	Story also ran in 2 others:  The Ledger (FL) and Tuscaloosa News (AL)