An Operation to Ease Back Pain Bolsters the Bottom Line, Too

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December 31, 2003An Operation to Ease Back Pain Bolsters the Bottom Line, TooBy

REED ABELSON and MELODY PETERSEN

 

A complex operation called spinal fusion has emerged as the treatment of choice

for many kinds of unrelenting back pain. A quarter million of the procedures, in

which metal rods are screwed into the spine to stabilize it, were performed this

year in the United States, three times as many as a decade ago.

 

But a number of researchers say there is little scientific evidence to show that

for most patients, spinal fusion works any better than a simpler operation, the

laminectomy. And laminectomies get patients out of the hospital and back to

their daily routine much faster. Some people, experts add, would be better off

with no surgery at all. Even doctors who favor fusions say that more research is

needed on their benefits.

 

In the absence of better data, critics in the field point to a different reason

for the fusion operation's fast rise: money.

 

Medicare can pay a surgeon as much as four times more for a spinal fusion, some

doctors say, as for a laminectomy, an operation in which some bone is removed

from the spine to relieve pressure on the spinal cord and nerves. Hospitals also

collect two to four times as much, a gulf that has grown steadily as fusion

operations have grown more complex. Medicare spent an estimated $750 million

last year on spinal fusions, said Sam Mendenhall, the editor and publisher of

Orthopedic Network News, a newsletter.

 

So like hysterectomies or certain forms of prostate surgery, some doctors say,

back surgery is an example of how money can influence decisions about which

treatments to use — especially when there is limited evidence about which

treatments work best. Indeed, as the nation's biggest health plan, Medicare

plays a huge role in shaping American health care, from the kinds of hospitals

that get built to the amount of chemotherapy drugs that cancer doctors

prescribe.

 

" The reality of it is, we all cave in to market and economic forces, " said Dr.

Edward C. Benzel, a spine surgeon who is chairman of the Cleveland Clinic Spine

Institute. Though doctors, as a rule, should favor the least complicated

treatment — with surgery being the last resort — Dr. Benzel estimated that fewer

than half of the spinal fusions done today were probably appropriate. He

described the current system of paying doctors as " totally perverted. "

 

Doctors and hospitals are not the only players with a financial stake in fusion

operations. Critics blame the companies that make the hardware for promoting

more complex fusions without evidence that they are significantly more

effective. Some sort of hardware is used in almost 90 percent of lower-back

fusions, Mr. Mendenhall said, compared with fewer than half in 1996. Between

Medicare and private insurers, the national bill for the hardware alone has

soared to $2.5 billion a year, he said.

 

" A lot of technological innovation serves shareholders more than patients, " he

said.

 

The hardware makers acknowledge giving surgeons millions of dollars in

consulting fees, royalty payments and research grants, but say the money

promotes technical and medical advances that improve back care.

 

" We can't innovate to help patients without these physician relationships, " said

Bob Hanvik, a spokesman for Medtronic, the Minneapolis company that is the

biggest maker of spinal hardware. " Most physicians don't want to give away their

time. "

 

Some former Medtronic employees, however, have accused the company of paying

surgeons kickbacks. A lawsuit brought by Scott A. Wiese, a former sales

representative, accused Medtronic of trying to persuade surgeons to use its

products with offers of first-class plane tickets to Hawaii and nights at the

finest hotels. Some of those lucrative consulting contracts, the suit claimed,

involved little or no work.

 

Medtronic said it did nothing wrong, and it denied the accusations in the

lawsuit, which was filed in 2001 and settled in 2002. But the company disclosed

earlier this year that the federal government was investigating charges that it

paid illegal kickbacks to surgeons. Federal officials declined to comment on the

investigation, and Medtronic said it would vigorously defend itself.

 

Still, between the allure of money and the quest for breakthroughs in treatment,

some prominent spinal surgeons say that back care has gone astray.

 

" I see too many patients who are recommended a fusion that absolutely do not

need it, " said Dr. Zoher Ghogawala, a Yale University clinical assistant

professor of neurosurgery who is conducting a study comparing spinal fusion with

laminectomy. Health experts note that if Medicare is overpaying doctors for back

operations, other kinds of care are shortchanged, because the program is

budgeted a fixed amount each year for doctor's fees.

 

Fees vary widely around the country, but several surgeons said that Medicare

reimbursed doctors roughly $4,000 for a spinal fusion, versus $1,000 for a

laminectomy. Mr. Mendenhall said that hospitals typically collected $16,000 for

a fusion — and $10,000 more for an increasingly common " 360 degree " operation in

which hardware is attached to both the front and back of the spine — versus

$7,000 for a laminectomy.

 

" The money is driving a lot of this, " Mr. Mendenhall said. The cost to patients

will differ based on their insurance coverage, and patients with traditional

Medicare coverage will have to shoulder some of the higher surgeon fees. But

some patients may push for what they believe is the most-advanced treatment.

 

Many spine surgeons defend fusion operations, saying that some patients clearly

benefit from them, even if some of the procedures are not warranted.

 

" There is some indication that if you do it right, it can benefit people, " said

Dr. Eric J. Woodard, a spine surgeon at Brigham & Women's Hospital in Boston,

who noted that a well-designed Swedish study recently showed positive results

for some patients. More research needs to be done, he added, to identify the

category of patients who have the best odds of being helped. In the meantime,

Dr. Woodard said, many doctors are being more selective about who gets a fusion

operation.

 

In part, the rise of spinal fusions represents the natural process of medicine.

Surgeons perform operations, and when — as in the case of back pain — the

outcomes are mixed, surgeons strive to improve their techniques.

 

The Medicare payment system, in turn, rewards complexity, because it lets

doctors bill for the individual procedures they perform within a single

operation. It also tries to encourage the development of new medical

technologies. And the makers of medical devices like fusion hardware exert

themselves with frequent success in persuading Medicare to pay for their new

products.

 

Earlier this year, for example, Medtronic persuaded the government to cover a

new kind of bone graft material, called Infuse, for use in spinal fusions.

Surgeons describe the new material as having the potential to represent a real

advance. Still, Medtronic scored a significant coup, experts said, in Medicare's

decision to make an additional payment, as much as $4,450, to hospitals to help

cover the cost of Infuse, on top of the flat fee paid for the operation.

 

" The power of the device industry is growing tremendously, " including its

ability to influence Medicare officials, said Susan Bartlett Foote, a professor

of health policy at the University of Minnesota.

 

Medicare officials are unaware of any problems concerning reimbursements for

spinal fusions, an agency spokeswoman said. Industry executives said that

Medicare patients deserved quick access to breakthrough treatments that might

improve the quality of their lives.

 

Because of the scant data on the benefits of back operations, patients with

similar complaints receive widely differing treatments for their pain, according

to a 1999 study by researchers at the Center for the Evaluative Clinical

Sciences at Dartmouth College. The National Institutes of Health is doing a

large study to determine which patients will benefit from various treatments.

 

" There is a real paucity of convincing science about spinal fusion in

particular, " said Dr. Richard A. Deyo, a professor of medicine and of health

sciences at the University of Washington. He was involved in the attempt by the

federal government in the mid-1990's to issue guidelines for back surgery.

 

The guidelines, which recommended a conservative approach and discouraged

surgery, were roundly attacked by spine surgeons. Indeed, the surgeons nearly

succeeded in persuading Congress to eliminate financing for the federal Agency

for Health Care Policy and Research, which developed the guidelines. Sofamor

Danek, the Medtronic unit that makes fusion hardware and was then an independent

company, unsuccessfully sued to prevent the agency from making its

recommendations public.

 

Some surgeons are disturbed by the level of influence that industry has on their

profession, particularly in research. " This is a topic which orthopedic

surgeons, neurosurgeons and the societies associated with both their groups are

definitely concerned about, " said Dr. Brett A. Taylor, an orthopedic surgeon at

Washington University in St. Louis.

 

The absence of solid research means that patients sometimes have little to go on

in deciding whether to have surgery.

 

Three years ago, Dr. Sam Ho, the chief medical officer of PacifiCare, a

California insurer, suddenly developed severe back pain, the result of an

extruded disc. His neurosurgeon, he said, insisted that he needed a laminectomy,

but the surgeon could not offer any studies indicating that the operation would

help. Nor, Dr. Ho said, could the surgeon tell him how many operations he had

performed or how his own patients had fared.

 

Dr. Ho said he refused the surgery and made a complete recovery within two

months.

 

Spinal fusion has a history of controversy. Device makers were the subject of

numerous lawsuits in the early 1990's charging that they were paying surgeons

illegal kickbacks to use their screws. Most suits were unsuccessful, often

because courts were not convinced that the screws had caused injury or pain.

 

But similar accusations have surfaced in recent years. In his lawsuit, filed in

a state court in Los Angeles, Mr. Wiese, the former Medtronic sales

representative, said that he was told by his bosses to do " whatever it takes " to

sell fusion hardware. Two doctors demanded consulting contracts in return for

using Medtronic's products, the suit contended, but the contracts were a " sham, "

because little work was done for the pay. The suit was settled for undisclosed

terms, and Mr. Wiese's lawyer declined to comment on the matter.

 

In interviews, two other former Medtronic employees said that the company

engaged in similar practices as recently as last year. They said that

Medtronic's sales representatives routinely offered enticements to surgeons to

use the company's hardware, including lavish trips and visits to a strip club

near the Memphis headquarters of the Sofamor Danek division. The former

employees said they had spent as much as $1,000 a night per doctor for a night

on the town.

 

" It's a business deal, " said one of the employees, who declined to be named

because he still works in the medical device industry. " It takes money to make

money. "

 

A document provided by one of the former employees listed about 80 surgeons who

have consulting agreements with Medtronic that pay as much as $400,000 a year.

 

Mr. Hanvik, the Medtronic spokesman, said that the company had policies in place

to prevent its sales agents from providing improper inducements to surgeons. The

company works closely with some surgeons, he said, and pays them fairly for

their time creating new devices and improving the design of existing products.

The annual amounts on the list are the maximum each doctor can receive. " They

only get paid for the work they do, " he said.

 

Trying to rise above the flood of money, researchers like Dr. Ghogawala at Yale

say they are now conducting studies free of industry support in search of basic

answers about the efficacy of back operations. Having raised private money to

finance his pilot study comparing fusions and laminectomies, Dr. Ghogawala plans

to apply for government financing for a larger, five-year study.

 

" I think we are identifying who needs it and who does not, " he said. " It's

critical to know if it's a lot of unnecessary surgery for a lot of people. "

 

Copyright 2003 The New York Times Compa

 

 

 

 

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