By Amy Goldstein
Washington Post Staff Writer
Wednesday, November 19 1997; Page A01

It was 9 a.m. last Thursday when 73-year-old Anne Coalla was wheeled into an operating room in the Johns Hopkins Outpatient Center, where a surgeon spent two hours removing both her cancer-ridden breasts. By 3:30 p.m., she had checked out of the hospital and was being helped into a taxi.

That evening and the next morning, a Hopkins nurse visited Coalla at a nearby Baltimore hotel to check her bandages and the drain bottles snaking from an incision on each side of her chest. By midday Friday, her son was driving her home.

When Coalla's sister lost a breast to cancer 10 years ago, it required a hospital stay of nearly a week. So when her own surgeon first told Coalla she'd be able to leave within hours, she said, "It floored me. It just seemed unreal."

But now that the surgery is over, she said after arriving home on Maryland's Eastern Shore, "I would recommend it to anybody."

Not all agree.

Whether women should be coaxed -- or ordered -- out of the hospital right after a mastectomy is a question that has gripped the attention of politicians in Washington and across the United States.

This year, legislation to require more insurance coverage for breast cancer surgery has passed in 13 states and been debated in 23 others. Congress is considering two such bills, aimed at preventing outpatient mastectomies for women who don't want them. And in his State of the Union address last winter, President Clinton denounced the idea of same-day mastectomies as "dangerous and demeaning."

For all its political seductiveness, tapping into a disease of acute concern to female voters and public anxiety about the changing way Americans receive their medical care, the debate over breast cancer surgery is curiously devoid of something else: fundamental research to help lawmakers decide whether they are wise to intervene.

How the issue of breast surgery has emerged -- and how much evidence undergirds both sides of the debate -- is instructive because it is part of a new generation of government efforts to protect patients by regulating specific medical and insurance practices.

In addition to hospital stays for breast surgery, Congress and the states also have been considering whether to make it easier for managed care patients to obtain specialized care, sue their health plans, and be sure that their doctors are free to discuss all treatment options, no matter how expensive. The "drive-through mastectomy" bills are direct heirs to the "drive-by delivery" law enacted by Congress last year, which is intended to allow women to stay in the hospital for up to two days after having a baby.

The Government Role

The debate over government's proper role in medical care will gain momentum today, when a presidential advisory commission expects to finish work on a wide-ranging "bill of rights" for American patients.

Proponents of more regulation contend that, in the absence of more fundamental government health reforms, insurance companies have gained the upper hand, leaving patients at the mercy of an industry whose main goal is to make money. Opponents contend that lawmakers do not know enough about medicine to dictate specific practices, and that their meddling will stifle innovation while increasing health costs.

It is in the context of this broad philosophical discussion that the debate over mastectomies is taking place. Many breast cancer survivors and some of their doctors have become aggressive lobbyists urging government to step in, arguing that it is barbaric for women to leave the hospital when they remain physically and emotionally fragile.

But numerous health researchers say there is little solid evidence showing that outpatient mastectomies cause medical harm. And though the issue has been framed as an abuse by insurance companies zealous to cut their costs, the changes stem at least partly from doctors trying to improve patient care.

Despite the political passions it has aroused, it is not even clear how common outpatient breast surgery has become. The most widely cited figures are based on women age 65 and older who have traditional, "fee-for-service" insurance. That study suggests the percentage of patients who leave the hospital the day of their mastectomies has increased but remains relatively low, rising from nearly 2 percent in 1991 to nearly 8 percent in 1995. There are no good national data for younger women or, perhaps more important, for managed care plans, which tend to be the chief targets of the new legislation.

"There is a lot of hysteria about this when it isn't really clear what is going on," said Robert A. Smith, an epidemiologist at the American Cancer Society. "The rush to [legislate] this isn't sensible. Is it well-intentioned? Definitely. Well-founded? It's hard to say."

In some ways, the appeal of the mastectomy issue for lawmakers is understandable. Breast cancer is the most common form of cancer among women, striking one U.S. woman in eight sometime during her life. Yet at the same time, the trend toward outpatient breast surgery is simply part of a broader shift. In the mid-1980s, two-thirds of all surgery patients stayed in the hospital at least overnight. Now less than half do, and many procedures -- repairing hernias and removing gallbladders, for example -- routinely are done on an outpatient basis.

"There is no uproar about that," said Claudia Steiner, a research physician at the Health and Human Services Department's Agency for Health Care Policy and Research. "When there are a whole lot of things going outpatient, why did mastectomy get on the hit parade?"

At the end of her operation, two ropes of plastic tubing were stitched into Coalla's chest wall, and now empty out into a grenade-shaped bottle resting by her side. Twice a day, she will have to clean the tubes, empty the bottles' contents into a measuring cup and carefully record the amount of liquid in a log. That way, Hopkins nurses will be able to tell from a distance whether she is healing properly.

If the tubing clogs, the liquid will seep out and soak the bandage covering her wound. "This isn't an emergency," Mary Strozzo, a nurse practitioner, told Coalla the day before her surgery. "You are going to treat yourself. You are going to strip the tubing and change your bandage. If that doesn't work, you will call me, but I want you to try first."

These are the lessons patients are being taught now as medical science has evolved.

A Decade of Change

Ten years ago, women who had mastectomies stayed in the hospital until their drains could be removed, said Stephen B. Edge, chief of the breast surgery department at Roswell Park Cancer Institute in Buffalo. But as insurance companies began prodding hospitals to spend less money, Edge said, surgeons began sending women home after a few days with their drains in place.

At Hopkins Breast Center, patients were going home sooner in part because improvements in anesthesia had reduced their nausea and vomiting after surgery. But the real change began after the center's director, William Dooley, got a late-night call at home four years ago. On the other end was a woman he'd operated on that morning, who complained that the hospital was too noisy for her to sleep. She wanted to go home.

He told her she could. After that, he asked former patients whether they would have preferred not to stay overnight. To his surprise, two-thirds said they would have liked to leave. "We decided, hey, why are we being prison wardens here?" he said.

Now, Dooley and his co-workers assess each patient ahead of time to determine whether she is generally in good health and whether she has someone to care for her at home. Hopkins determines whether a woman is suitable for outpatient surgery, but in the end, Dooley said, it is the patient who decides.

Of the 600 women who went to Hopkins last year for mastectomies and lumpectomies -- less extreme surgery that saves part of the breast -- 83 percent left the same day. Like Coalla, many spend the night at the Cross Keys Inn -- a hotel 20 minutes away with which Hopkins has arranged to provide breast cancer patients fresh roses, catered meals and visits from a nurse.

"I was a little hesitant about this program, to be frank. But everything is working out," said Coalla, whose medical care is paid for by Medicare and the retirement benefits given to her husband, Skip, 77.

Based on the experience of Hopkins and a few other hospitals that have specialized in outpatient breast cancer surgery, Milliman & Robertson Inc., a consulting and actuarial firm that develops guidelines on medical practice, two years ago revamped its advice. Both lumpectomies and mastectomies can be performed safely on an outpatient basis, according to revised guidelines meant to apply to relatively straightforward cases.

Some health plans rely on those guidelines in deciding what care to pay for, though Milliman & Robertson said it was responding to, not driving, changes in medical practice.

The managed care industry insists that it, too, is not responsible for the shift. Rick Smith, vice president for policy and research for the American Association of Health Plans, checked last year with 25 members covering more than 50 million patients. "We found not a single one required women having mastectomy on an outpatient basis," he said.

But Smith acknowledged that something subtler is going on. While not forbidding hospital stays outright, some plans now agree to pay for them only when doctors can prove they are needed.

Judy Willis believes her health plan was the reason she was sent home 18 hours after having both breasts removed three years ago. Her doctor through Kaiser Permanente, the nation's largest health-maintenance organization, told her she could expect to spend a few days at Fairfax Hospital. She was groggy, nauseous and in pain when a nurse stopped by her bed to say that her doctor already had discharged her.

"Another day in the hospital where I could have gotten my senses back would have made a world of difference," said Willis, now 50, who had to call her sister for help because she is divorced and lives alone.

Fighting to Stay

Willis's experience is the kind that Kristen Zarfos, a general surgeon in Middletown, Conn., feared when she heard in the spring of 1996 that two major health plans in her area were changing their rules. By that August, one of Zarfos's own patients was told by her insurer that it would pay only for an outpatient mastectomy. Zarfos decided to fight back.

It took seven telephone calls, she said, but the insurer, ConnectiCare, relented and paid for the woman to stay overnight. Since then, health plans have tried to deny hospital stays for five more of Zarfos's patients. She said she has never lost a fight.

But she became convinced that the government needed to act. By last spring, she had helped to persuade state lawmakers to adopt legislation prohibiting insurance companies from dictating how long breast cancer patients may stay, making Connecticut one of the 13 states that have passed similar bills this year. Maryland and Virginia have considered such measures but not approved them.

In the meantime, Zarfos also called her congresswoman, Rep. Rosa L. DeLauro, a Democrat sympathetic to women's health issues who had ovarian cancer 11 years ago. By January, DeLauro had introduced a bill in Congress that would guarantee women two days in the hospital after mastectomies and one day after having nearby lymph nodes removed. The bill has attracted 213 co-sponsors and nearly 9,000 people who signed an electronic petition on the Internet.

"We've gotten calls from all over the country. People say, `A friend, myself, my mother, my sister, my aunt, my wife,' " DeLauro said. "It really has hit a nerve."

The momentum was building for a cross-country crusade. Last February, Zarfos bought a plane ticket to Washington so she could sit in the same box in the House gallery as Hillary Rodham Clinton during the State of the Union address. Before inviting Zarfos to stand for applause, the president introduced her as the doctor "whose outrage at this practice spurred a national movement."

The next week, Health and Human Services Secretary Donna E. Shalala told the 350 HMOs that treat patients in Medicare, the government insurance program for the elderly, that they cannot demand that women receive outpatient mastectomies.

Medicare paid for 8,400 mastectomies last year, but the government has no data on whether any of its HMOs were actually denying women the right to stay overnight.

Nor does there exist any broad-based research on whether women are harmed by going home right away. Based on several small studies from hospitals specializing in outpatient mastectomies, it appears they do not cause greater medical complications. Dooley at Hopkins said that, among his own patients, he has found that those who leave the same day develop fewer infections than those who stay in the hospital longer.

But other researchers said it is unclear what the results would be from analyzing the effects on women who were chosen less carefully for outpatient surgery at hospitals that have less expertise at it.

Similarly, there has been little research into the effect on medical costs. One of the few studies comes from Bruce Hillner, a professor of medicine at the Medical College of Virginia in Richmond, who examined the bills of 30 patients at his own hospital in 1994. He found that a typical mastectomy cost about $7,000 and that the cost would have been about 10 percent less if women had gone home the same day.

Such fundamental questions are starting to be researched more rigorously. But the political debate is not waiting for the results. And given the scanty information so far, the intense passions of women and certain doctors are leaving some politicians in a quandary.

"We have this dilemma," Sen. John D. "Jay" Rockefeller IV (D-W.Va.) said at a hearing this month on another mastectomy bill. "Philosophically . . . I don't think it is the best course for medical policy to be determined by men and women who aren't physicians.

"But I don't want my lack of understanding," Rockefeller said, "to cause people to be denied care they need."