With spinal fusions, a debate over necessity

Peter Whoriskey and Dan Keating / The Washington Post /

By some measures, Federico Vinas was a star surgeon. He performed three or four surgeries on a typical weekday at the Daytona Beach, Fla., hospital that employed him, and a review showed him to be nearly five times as busy as other neurosurgeons. The hospital paid him hundreds of thousands in incentive pay.

Yet given his productivity, some hospital auditors wondered: Was all of the surgery really necessary?

To answer that question, the hospital in early 2010 paid for an independent review of cases where Vinas and two other neurosurgeons had performed a common procedure known as a spinal fusion. The review was conducted by board-certified neurosurgeons working for AllMed, a company accredited to audit health-care businesses.

Of 10 spinal fusions by Vinas that were selected, nine were deemed not medically necessary.

Vinas is still working at Halifax Health, and a hospital spokesman said that, after the AllMed report, the hospital conducted an internal review that validated his surgeries. Another review conducted earlier this year in response to litigation also validated them, the spokesman said.

Vinas “has never and will never perform an unnecessary surgical procedure on any patient,” said his attorney, Robert Pritchard.

More than 465,000 spinal fusions were performed in the United States in 2011, according to government data, and some experts think that a portion of them — perhaps as many as half — were performed without good reason.

The rate of spinal fusion surgery has risen sixfold in the U.S. over the past 20 years, according to federal figures. And the expensive procedure, which involves the joining of two or more vertebrae, has become even more common than hip replacement.

It can be difficult, in individual cases, to get doctors to agree about when the procedure is warranted.

But at a broader level, the rapid rise of spinal fusions in the U.S., especially for diagnoses that generally don’t require the procedure, has raised questions from experts about whether, amid medical uncertainty, the financial rewards are spurring the boom.

Advancements in diagnostic and surgical technology may explain some of the increase in surgery. And patients may have become more demanding.

But a Washington Post analysis of 125,000 patient records also shows that roughly half the tremendous rise in spinal fusions in Florida has been on patients with diagnoses that experts and professional societies said should not routinely be treated with spinal fusion.

Normally, information that might shed light on the ways that economics shape medical decisions by doctors and hospitals doesn’t become public. But a wide-ranging lawsuit at Halifax Health offers an unusual glimpse into these issues.

Whistleblower lawsuit

In 2009, a former compliance official at the hospital filed a whistleblower lawsuit alleging illegal financial incentives for doctors. The court filings make available an array of documents — emails, testimony, audits. These and other sources allow a fuller depiction of the financial rewards and relationships that depended on treatment decisions. They also show how hospital administrators responded when suspicions arose that a doctor, who was generating millions in profits, might have been performing unnecessary surgery.

The compliance official, Elin Baklid-Kunz, couldn’t determine by herself whether any of the surgeries Vinas had performed were unnecessary — she is not a doctor.

But just as the numbers of spinal fusions in the U.S. have raised questions about the procedure’s necessity, audits she and an outside firm had conducted showed unusual productivity in parts of the hospital. Those numbers, she says, demanded further review.

Moreover, the compensation agreements the hospital had with Vinas and other doctors essentially offered large incentives for more treatment, she has alleged. The U.S. Department of Justice has joined her lawsuit regarding illegal compensation.

As at many hospitals, the financial benefits of operating at Halifax Health extended to at least three groups.

• Vinas and his colleagues in neurosurgery earned as much as thousands of dollars extra — above their base salaries — for each procedure after a certain threshold.

• According to government estimates, each neurosurgeon at Halifax Health was generating more than $2 million a year in hospital profits. The hospital charged fusion patients an average of about $80,000, according to Florida records on Halifax Health analyzed by The Washington Post, ranking the procedure as one of the more expensive.

• The companies that sell the hardware — screws and braces — already a multibillion-dollar business in theU.S., also benefited. Those companies often have a representative positioned in the operating room, where the equipment for one fusion can typically amount to a $7,000 sale, according to the Millennium Research Group.

Baklid-Kunz detected Vinas’ rapid pace of work in an audit and asked for further review of his surgeries, documents show.

But she was discouraged from investigating, she says.

“Hospital administrators didn’t want to touch Dr. Vinas,” she said in an interview.

Instead, they referred to Vinas and the hospital’s two other neurosurgeons as “our high rollers,” she said, and told her that rather than cracking down on their billing that “we need to make them happy.”

More than two years would pass before the hospital pursued the further review Baklid-Kunz had recommended — the AllMed report — and it was during the wait that she decided to file the lawsuit. Even after the AllMed report, she said, the hospital did little to curb his practices.

“The hospital was caught in the act and did nothing,” said Marlan Wilbanks, Baklid-Kunz’s attorney. “They didn’t send anyone to extra training. They didn’t take any extra steps at all. They were making a lot of money.”

Satisfied patients

Hospital spokesman John Guthrie said the AllMed report was “bogus” because it was based on cases that Baklid-Kunz had selected.

“The AllMed report was based on incomplete medical records that were cherry-picked,” the hospital said in a statement. “For the Post to accept this unsupported report as fact is irresponsible and creates a grossly misleading perception.”

Pritchard, Vinas’ attorney, said his client is a well-respected surgeon, with almost 100 publications and book chapters to his credit, who takes steps to make sure that surgery is done only as a last resort.

Vinas has never had a malpractice action filed against him and, even though he has seen 15,000 patients in his career, only “a very small handful” expressed dissatisfaction with his care, Pritchard said.

Some of Vinas’s patients are pleased with his work.

Steven Huntt, 62, a heavy-equipment mechanic, said Vinas operated on him four or five times.

“I’d have one and then another,” he said. “I can’t explain it, but I had to have them. Dr. Vinas said if I didn’t have it, I’d have been paralyzed. Some people said to let it go, but being a mechanic, I like to fix what’s broken.

“He’s a gentle, kind man,” Huntt said. “I don’t think he ever did a surgery that was unnecessary.”

What is necessary?

As U.S. medical costs have risen, questions about unnecessary treatment have become frequent. By some estimates, Americans are spending billions every year in unnecessary surgery and other medical care.

Medicare, the nation’s health-care system for people older than 65, is at the center of the debate.

As the nation’s largest insurer, it is critical to determining what kinds of surgeries in the U.S. are covered — and therefore, performed. Many private insurers look to Medicare when making their own decisions.

Today, by its own admission, Medicare may be spending billions annually on unnecessary medical treatment.

The Medicare agency every year audits a sample of the claims it has paid and determines how many of those have “medical necessity” errors. The agency estimated the amount of money spent improperly on spinal fusions was more than $200 million in 2011, for example, and most of that was because the treatment was deemed unnecessary, often because a more conservative course hadn’t been tried, officials said.

How could this happen?

The answer, in part, is that the Medicare system is not designed to discourage doctors from performing surgery, according to past and present Medicare officials.

At a very practical level, the bureaucracy offers little incentive to weed out unnecessary treatment: Medicare hires contractors to issue payments to doctors, and those contractors are paid based not on how many claims they reject but on how many they approve.

“The contractors are incentivized to efficiently process claims and not to accurately evaluate clinical effectiveness” of treatment, according to a paper by three former senior officials at the Medicare agency and one current one.

Moreover, when bureaucrats try to restrict what surgeries Medicare will pay for, they sometimes face punishing political backlash.

In 1978, Congress created the National Center for Health Care Technology, which among other things recommended to Medicare what procedures it should cover.

It ran on a $4 million budget, and within just a few years of its inception, it was estimated that its advice had saved the government between $100 million and $200 million a year.

But two influential groups opposed the agency’s mission: the American Medical Association and the Health Industry Manufacturers Association.

Medical judgements are “better made — and are being responsibly made — within the medical profession,” an AMA spokesman told Congress at the time. “The advantage the individual physician has over any national center or advisory council is that he or she is dealing with individuals in need of medical care, not hypothetical cases.”

In 1981, Congress zeroed out the agency’s budget. Again in 1989, Congress decided that there should be a government effort to review the effectiveness of medical treatments.

It was called the Agency for Health Care Policy and Research, and in its first years, it issued guidelines on how to treat hysterectomies, strokes and ulcers.

Then, in 1994, the agency published a set of guidelines on back pain, discouraging spinal fusion for some cases.

“For several low back disorders, no advantage has been demonstrated for fusion over surgery without fusion, and complications of fusions are common,” its researchers concluded.

The reaction from some surgeons was furious. The North American Spine Society suggested that the effort was a waste of taxpayer money. A letter-writing campaign was launched. A Virginia spine surgeon founded a group called the Center for Patient Advocacy, which sought to kill the agency.

Some physicians rallied to its defense. But when the dust settled in Congress, the agency’s budget was cut by 21 percent, and the agency curtailed its efforts at developing guidelines.

Patient requests

Moreover, Americans may be demanding more mobility as they age, surgeons say.

“Patients want to be able to play tennis and golf and go surfing at much higher ages than they did in the past,” said Gunnar Andersson, chairman emeritus of the department of orthopedic surgery at Rush University Medical Center in Chicago and president-elect of the International Society for the Advancement of Spine Surgery, a professional group. “They are more likely to seek out treatment and more likely to accept surgery as an option.”

He added that some of the critics of the procedure, who believe spinal fusions are being performed too frequently, are “not wrong.”

“The problem is we don’t know what the rate of spinal fusions ought to be,” he said.

The growth in spinal fusion in the U.S. has been much faster than other surgeries of wear and tear, such as knee and hip replacements. And Americans are far more likely to undergo the procedure than people from other countries.

The rate of spinal fusions in the country is about 150 per 100,000 people, according to federal data. In Australia, it is about one-third of that; in Sweden, it is about 40 per 100,000; and in Britain it is lower still.

To get a better understanding of the reasons for the boom, the Post reviewed 125,000 records of patients who underwent spinal fusions in Florida. The data included primary and secondary diagnoses.

The analysis shows that the procedure has been used more and more to treat ailments of the lower back that experts say are generally better addressed with safer and less-costly treatments.

Professional societies and other experts rule out or discourage the routine use of spinal fusion for several common problems of the lower back — stenosis, herniated discs and disc degeneration — when there are no accompanying problems of spinal instability or deformity.

Yet about half of the rise in lumbar spinal fusions has come from its use for just such ailments.

Between 2000 and 2012, the number of lumbar spinal fusions for those ailments in the state rose fivefold, from 2,014 to 9,887, according to the analysis of Florida records.

Lumbar spinal fusions to treat stenosis, an ailment caused by a narrowing of the spinal canal, rose the fastest, from 292 in 2000 to 2,565 in 2012.

Medicare and insurance companies could stop paying for such procedures, of course. When they object, however, their motivations are often viewed as profit-driven as much as scientific.

Unhappy patients

Ever since the news of Baklid-Kunz’s lawsuit against the hospital, some of Vinas’s patients, especially those who say the surgery did nothing — or worse, harmed them — have begun to wonder whether their surgery was necessary after all.

Eunice Murphy was a retiree playing tennis four times a week before the surgery; she says she has had trouble walking since then.

“I wasn’t his patient; I was his victim,” Murphy said.

William Scott, 62, a pipe fitter, had been having back pain for years. He was diagnosed with lumbar stenosis and degenerative problems. He was tired of taking medication for the problem and decided to see if the surgery would help him.

“Vinas told me I’d be back on my motorcycle in time for Bike Week” in a few months, he said.

But instead of curing him, the surgery has all but crippled him, he says. He can’t stand for long; can’t take walks because he is prone to falling. He had to sell his motorcycle.

“He took my life away,” Scott said, his voice rising. “He took being a man and a husband away from me. And for what?”

Pritchard, Vinas’s attorney, said his client was barred by law from commenting on individual patients.