Related:

27 October 2013, WP: A Florida case study in surgical necessity

---

http://www.washingtonpost.com/business/economy/spinal-fusions-serve-as-case-study-for-debate-over-when-certain-surgeries-are-necessary/2013/10/27/5f015efa-25ff-11e3-b3e9-d97fb087acd6_story.html

Spinal fusions serve as case study for debate over when certain surgeries are necessary

By Peter Whoriskey and Dan Keating

October 27, 2013

By some measures, Federico C. 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. In all, he earned as much as $1.9 million a year.

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 in which 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, according to a summary of the report.

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 this year in response to litigation also validated them, the spokesman said. The hospital would not answer further questions or release details of those reviews.

Vinas "has never and will never perform an unnecessary surgical procedure on any patient," his attorney, Robert H. Pritchard, said in a statement.

More than 465,000 spinal fusions were performed in the United States in 2011, according to government data, and some experts say 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 United States 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 United States, 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 say should not routinely be treated with spinal fusion.

Questions are raised

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.

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 -- e-mails, 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, may have been performing unnecessary surgery.

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

But just as the numbers of spinal fusions in the United States 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 Justice Department 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. The vast majority of Vinas's earnings came from such incentive pay, according to legal filings.

* 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 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 the United States, 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. Vinas was friendly enough with his parts salesman -- who, among other things, measured the length of the necessary screws -- that he traveled in Thailand with him, according to a deposition.

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

But she was discouraged from investigating further, she said.

"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 Vinas's 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."

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's 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 said they 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 on 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 United States 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 it, 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, for example, 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.

"The larger damage was the message sent by Congress: 'If you get too close to actually changing how clinical or reimbursement decisions are made, Congress is going to slap you down,' " said Sean Tunis, formerly chief medical officer at the Medicare agency. "I think everyone took a lesson from that."

A rise in spinal fusions

Even by American health-care standards, the rise of spinal fusions has been remarkable. According to federal figures, the number of spinal fusions in the United States rose from 56,000 in 1994 to 465,000 in 2011.

Advancements in technology -- more refined imaging, new spinal devices to hold vertebrae in place -- probably account for some of the rise.

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 United States has been much faster than other surgeries to address 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 United States 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.

Or just consider the sales of spinal fusion equipment. Sales of such equipment in the United States amount to $5.1 billion a year, nearly twice what the total sales are in the rest of the world, according to Millennium Research Group.

"My hunch is that as many as half of the spine fusions in the U.S. are unnecessary," said Richard Deyo, a researcher at Oregon Health and Science University and a longtime critic of the procedure.

The International Society for the Advancement of Spine Surgery has sounded a note of caution in its policy statement on lumbar fusion, too.

"Increasing success and optimism may be leading some surgeons to overuse procedures beyond what the current state of medical evidence really supports," it says. The varying rates of spine surgery suggest "a lack of collective adherence to the current state of medical evidence."

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.

But decisions about surgery also have financial ramifications for doctors, as Eugene Carragee, a surgeon and professor at Stanford University, has noted.

He said that a simpler procedure known as a decompression often offers patients, without complications, as much benefit as a fusion and poses fewer risks. But the decompression might yield a surgeon roughly $1,000, while a complex fusion would garner as much as $6,000.

While insurers see a "conspiracy of escalation," Carragee said, "surgeons are saying, 'You can't tell me what the appropriate thing is to do.' "

Medicare weighs in

In 2006, Medicare decided to take a closer look at spinal fusion surgery.

At the time, the number of spinal fusions had been soaring upward, rising by nearly five times over the previous decade.

An increasing number of the spinal fusions were being done to treat something called degenerative disc disease, an affliction that results in pain from a disc that has disintegrated after normal wear and tear.

Medicare officials decided to convene a panel to examine the use of lumbar spinal fusion in patients with degenerative disc disease.

The evidence that a spinal fusion was the best means of treating it was sparse.

The researchers that Medicare commissioned to summarize the evidence found only four randomized clinical trials of spinal fusion for degenerative disc disease. Three trials found no clear benefit of spinal fusion over other therapy.

The fourth found just the opposite -- that there was a benefit. It was alone in another regard as well. While the others had been funded by governments or nonprofit groups, the positive study was funded by two companies that make spinal surgery equipment -- Acromed and Ossano Scandinavia.

The authors of the evidence review, led by Duke University physician and researcher Douglas C. McCrory, reported that there was no conclusive evidence that spinal fusion offers "short-term or long-term benefits compared with non-surgical treatment."

The report was then presented to a Medicare advisory committee of nine voting doctors. Three of them had worked for or owned stock in makers of spinal equipment.

Their votes were cast on a scale of one to five: A one reflected that fusion was "not likely" to benefit patients with lumbar degenerative disc disease, three was "reasonably likely" and five "very likely."

The long-term benefit of spinal fusion was judged a 1.5 -- that is, the panel had voted that it was less than "reasonably likely" that spinal fusion provides a benefit.

Yet Medicare never changed its policy: It still pays for spinal fusions for degenerative disc disease.

A Medicare spokeswoman, Kathryn Ceja, offered this statement: "By law, Medicare must cover items and services that are reasonable and necessary. Within those rules, doctors and their patients are free to make medical treatment decisions that are best for the patient."

After the 2006 advisory meeting, the number of spinal fusions continued its rapid upward trend.

An analysis of health records published last year in the journal Spine showed that the number of spinal fusions for degenerative disc disease in the lumbar spine had more than tripled between 1998 and 2008, becoming the most common primary diagnosis for spinal fusions.

Like Medicare, insurers have proved tentative about restricting payment. Some insurers have put modest limits on lumbar fusion procedures, but the idea of an insurance company putting itself between a patient and a doctor's recommendation often spurs unwelcome publicity.

In late 2009, for example, Blue Cross Blue Shield of North Carolina decided to curb its use based on research and the guidelines of professional societies.

In the first year, the number of lumbar spinal fusions at the insurer dropped 32 percent.

But the insurer was also confronted with unflattering portrayals in the newspaper and on television.

A local TV station ran an investigative story about the insurer denying coverage.

"Guys, a major insurance company here in North Carolina is one of the first to deny a back surgery that some doctors love but some insurers don't," an investigative reporter on Raleigh's ABC affiliate announced one night. "Why? At least one doctor and two patients we talked with say it's all about profit margin."

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.

Among the patients who have come to doubt the surgery they had is a dentist who says he had to sell his practice because after the surgery he could no longer stand for long periods; another is a pipe fitter who can no longer work and became unsteady on his feet; another is a retired aerospace engineer who developed cognitive problems after the surgery.

Three patients said Vinas urged them to get the surgery, too. He warned them that they were going to be "crippled" or "in a wheelchair" if they didn't, they say.

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," Murphy said. "I was his victim."

Vinas fused her spine after she complained of numbness in her thumb and forefinger. Vinas's medical report says she had "intractable neck pain," too. Murphy insists the problem was only in her hand. Three months later, she got a second fusion from Vinas for back pain and leg trouble, according to his report.

The hand trouble was unaffected by the fusion surgery, she says. This year, she went to another doctor for what she says is the same hand trouble. He traced it in part to carpal tunnel syndrome, an ailment of the wrist, according to that doctor's report.

She bought an $18 brace for her forearm at the drugstore, and the numbness receded, she says.

More than a year after the second fusion surgery from Vinas, she got an appointment just to confront him, she said. She is not suing him for malpractice -- the two-year window for filing such a suit has elapsed.

"I said, 'This is the cruelest thing one person could do to another. Why did you ruin the rest of my life?' "

William Scott, 62, the 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 and can no longer work. 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.

But he noted that despite a surgeon's best efforts, "a small percentage may not recover as well as hoped and may be dissatisfied. That in no way means the surgery was unnecessary or should not have been performed."

Any suggestion that a fusion was performed on a patient with only carpal tunnel syndrome is "patently absurd," he said.

Other opinions

Another employee at Halifax Health who came to question Vinas's practice was a fellow neurosurgeon.

William Kuhn said he would no longer assist in surgeries with Vinas, at least in part because he questioned the type of surgery being done, though he said he did not reach any conclusion, according to his deposition.

"On a couple of cases I've walked into the room to assist, and looking at the films alone and hearing a brief description of the patient's symptoms . . . based only on that information, I had felt somewhat uncomfortable regarding the procedure that was being performed," Kuhn said in a deposition.

In 2007, auditors ran the numbers on Vinas -- and he was exceptionally busy.

A physician's work is measured in terms of RVUs, or relative value units. Each procedure is assigned a certain number of them. By that measure, Vinas was nearly five times as busy as the average U.S. neurosurgeon, working at a rate of more than 25,000 RVUs per year, while the national average for a neurosurgeon was 5,600, according to the audit by an outside company.

The proportion of fusion procedures in his practice was about three times the national average for neurosurgery practices, the numbers showed. He told hospital officials that he was tailoring his practice to patients who required a fusion, but he declined to comment for this story.

After the big numbers in the 2007 audit, the hospital's compliance department proposed a clinical review to determine whether Vinas's surgeries were medically necessary, according to a memo at the time written by Baklid-Kunz.

In early 2010, after more than two years, the hospital hired AllMed and its independent board-certified neurosurgeons to conduct the review.

With guidance from AllMed, Baklid-Kunz, as a hospital compliance official, picked 10 of Vinas's cases between October 2008 and December 2009, as well as the five for Kuhn and five for a third neurosurgeon.

AllMed used several board-certified neurosurgeons to perform the reviews. The reviewers had the complete inpatient records and, except for "a few" cases, imaging done before the surgeries, according to a summary Baklid-Kunz prepared at the time.

Kuhn would fare only marginally better than Vinas when his cases were reviewed by AllMed. Their report found that in three of five cases reviewed the surgeries were not medically necessary. He did not return phone calls seeking comment, and his secretary directed calls to the hospital spokesman.

As for Vinas, the report found that nine of Vinas's 10 fusions were not medically necessary, according to a summary. It called into question Vinas's technique in three cases.

When presented with the results, Vinas was "pretty upset," he said in a deposition, and he prepared a written response. As part of a review, he sat with the hospital's chief medical officer, Don Stoner, who is a cardiovascular specialist, not a neurosurgeon. The hospital declined to offer any more information about this review.

"There were not any specific concerns about my practice. And we discussed that there was room to improve my documentation, that not all was perfectly complete," Vinas said in a deposition. "In some cases you have two physicians providing different opinions, and there is more than one way to treat a patient."

About three years later, the hospital decided to take another look at the AllMed report.

By then, the hospital had come under a new level of scrutiny when in late 2011 the Justice Department joined Baklid-Kunz's suit.

The hospital hired Timothy Schoettle of Kentucky, a neurosurgeon, to review the AllMed cases, hospital spokesman Guthrie said.

Schoettle found that all of those 10 surgeries were medically necessary, Guthrie said.

The hospital declined to make available a copy of Schoettle's report affirming Vinas, however, and Schoettle did not return phone calls to his office. The hospital did not answer questions about how it chose Schoettle to do the review.

"We don't want to start a trial in the newspaper, because that's not fair to a judge and jury," Guthrie said.

Peter Whoriskey is a staff writer for The Washington Post handling investigations of financial and economic topics.