Medicare Stops Pay for Popular Lung Surgeries

Controversial lung surgeries that draw hundreds of desperate emphysema sufferers each year to Orange County specialists no longer will be covered by Medicare, until the federal government is satisfied the procedures are safe and effective.

The announcement has forced at least two hospitals in the county with growing surgical programs for emphysema patients to notify scores of seriously ill people across the country that their scheduled operations must be put off indefinitely. Almost all of the patients who undergo the procedures are Medicare recipients.

“This has created a tremendous uproar among patients,” said Dr. Robert McKenna Jr., a surgeon at Chapman Medical Center, where as many as 50 operations had to be canceled.

The federal government has targeted all forms of so-called lung reduction surgery. Essentially, the operations involve either shrinking or removing portions of diseased lung tissue, enabling some patients to breathe more freely and, in some cases, discard wheelchairs and oxygen tanks.

Many patients who have undergone the procedures say they were miraculous.

“I was confined to a wheelchair,” said Bob Miller of Mission Viejo, who underwent two lung reduction surgeries by Dr. Akio Wakabayashi at Irvine Medical Center. “I couldn’t do anything. I couldn’t go anyplace, with oxygen stuck in my nose all day and all night long. I was ready to commit suicide. I couldn’t even walk up the stairs to church any more.

“But I walked out of that hospital.”

So taken was Miller with the procedure that he volunteered to work in the program, helping other patients.

“All of a sudden, now, after 1,500-plus surgeries, Dr. Wakabayashi has done, it’s experimental? That doesn’t seem right . . . It’s very disturbing.”

In a statement in December’s Medicare coverage manual, federal officials cite a “lack of scientific evidence . . . concerning the safety and effectiveness of lung volume reduction.”

In the past, Medicare funded the procedures when its contractors deemed them necessary.

“The statutory requirement is that procedures not be experimental. They have to be proven,” said Tom Ault, director of Medicare’s Bureau of Policy. “It’s a rapidly changing field . . . There’s great controversy about which procedures are the best for patients.

Some hospitals and doctors, he acknowledged, “undoubtedly are on the cutting edge and are getting very good results. What we need to do is get the information.”

Ault said the agency has asked for data from a variety of sources for consideration by its advisory panel at its February meeting.

In the meantime, most patients will have to wait.

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Irvine Medical Center announced Friday that it will go forward with seven operations on patients who already had made the trip to Orange County. If Medicare won’t cover the surgeries, hospital spokeswoman Anne Warde said, the hospital will absorb the cost.

“After that, we’re not going to be able to continue,” Warde said, forcing postponement of at least 38 surgeries.

Chapman will operate on the approximately 10% of patients who have private insurance coverage, McKenna said. If Medicare patients want to go forward, they must agree to cover the bill, usually $40,000 to $45,000, if Medicare denies the claim.

A variety of factors led to the federal decision, doctors say. Perhaps most significant is the controversy among the specialists themselves about which lung reduction procedure works best.

Wakabayashi, who has done far more of the procedures than anyone else in the country, uses a combination of a laser technique he pioneered and a surgical stapler. He claims more than 70% of his patients improved with this method.

But Wakabayashi has been criticized by others in the field for doing a high volume of surgeries without subjecting his results to rigorous scientific review.

He points to a 1995 study in the Annals of Thoracic Surgery, in which he contends follow-up evaluation of 229 of his patients showed “highly significant improvement.”

McKenna says he has done some studies of his own and the results show the stapling technique is far more effective than the laser method in improving patients’ lives. In a study of 72 patients, 87% of the staple patients no longer needed their oxygen afterward, compared to 52% of laser patients.

McKenna, whose team has done more than 300 lung reductions, was so swayed by his own findings that he stopped doing the laser procedure. In addition, he is convinced that operating on both lobes of the lung at once works best, whereas Wakabayashi tends to do one at a time.

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Another pioneering surgeon, Dr. Joel Cooper of Washington University in St. Louis, reports good results using a technique similar to McKenna’s. Yet he performs open-chest surgery while McKenna uses a keyhole procedure, operating through two small incisions on each side of the chest.

The competing claims of success have led some scientists to question the wisdom of forging ahead with any of the techniques.

“It’s an area of great uncertainty right now,” Ault said, explaining why his agency wants to consider the evidence more closely.

Another problem, specialists say, is that inexperienced physicians in hospitals scattered around the country, encouraged by success stories, have harmed patients during lung reduction operations.

“I’ve heard of a number of places where they were done with disastrous results,” McKenna said.

McKenna stressed that only about one in four emphysema patients is a candidate for the surgery. And the patients must be carefully screened and prepared.

In that sense, McKenna understands the federal government’s position.

“We’re still writing the cookbook . . . and it’s better [for most doctors] to hold off until the cookbook is written,” he said.

But the Medicare policy also leaves researchers in a bind. On one hand, they are being encouraged to provide large amounts of information about patient outcomes. On the other, Medicare has shut off the funding that allows most patients to have the surgery.

“It might be better if they continued to fund [the procedures] at selected centers, like for lung transplantation,” said Dr. Paul Selecky, chairman of the clinical practice assembly for the California Thoracic Society.

Selecky said the technique used by Cooper shows early promise over the laser procedure, which he called “more experimental.” But until the data are more firm, he said, his society will take the same wait-and-see stance as the American Lung Assn.

Both Selecky and McKenna are hopeful the Medicare impasse can be resolved soon.

Patients, not surprisingly, are impatient. Though emphysema is a slow-moving disease that worsens over years, it eventually creates chronic misery.

“It’s a degenerative disease-- there’s no real hope for it” besides the surgery, said Aloysius McFarland, 66, of Victorville, who gratefully accepted Irvine Medical Center’s offer Friday to perform the surgery as planned.

“It’s bad. It’s like breathing every day with a bag over your head.”