Abelson, Reed. "Heart Procedure Is Off the Charts in an Ohio City," New York Times, 18

 

Abelson, Reed. "Heart Procedure Is Off the Charts in an Ohio City," New York Times, 18
August 2006, pp. 1, C4.

ELYRIA, Ohio — People with blocked coronary arteries can typically choose among drugs,
bypass surgery and vessel-clearing procedures like angioplasty.

But in this small, aging industrial city in northeast Ohio, doctors are much more likely than those
anywhere else in the country to steer patients toward angioplasty — a treatment that typically
involves threading balloon catheters through arteries and sometimes placing drug-coated stents to
unblock them.

No one has accused the doctors involved of any wrongdoing. But the statistics are so far off the
charts — Medicare patients in Elyria receive angioplasties at a rate nearly four times the national
average — that Medicare and at least one commercial insurer are starting to ask questions. And
the hospital where most of the procedures take place says it plans to conduct an independent
review.

As it turns out, nearly all the procedures at the Elyria hospital are performed by a group of
cardiologists who dominate coronary care in this city and have an unabashed enthusiasm for
angioplasties, the highly profitable procedure in which they specialize.

Whether the preference for angioplasty is good for the patients of Elyria is open to medical
debate. The cardiology group's leader says the high rate of angioplasties is simply a function of
his doctors' detecting disease more often in their patients than physicians elsewhere might spot,
and being quicker to intervene.

"We do manage very aggressively the patients we care for," said Dr. John W. Schaeffer, the
founder and president of the group, the North Ohio Heart Center, which employs 31
cardiologists.

But some outside experts say they are concerned that Elyria is an example, albeit an extreme one,
of how medical decisions in this country can be influenced by financial incentives and
professional training more than by solid evidence of what works best for a particular patient.

"People are rewarded for erring on the side of an aggressive, highly expensive intervention," said
Dr. Elliott S. Fisher, a researcher at Dartmouth Medical School, which analyzed Medicare data
and found Elyria to be an outlier.

Medicare pays Elyria's community hospital, EMH Regional Medical Center, about $11,000 for
an angioplasty involving use of a drug-coated stent.

The cardiologist might be paid an additional $800 for the work. That is well above the fees for
seeing patients in the office. And with the North Ohio doctors performing thousands of
angioplasties a year — about 3,400 in 2004, for example — the dollars can quickly add up.

Some medical experts say Elyria's high rate of angioplasties — three times the rate of Cleveland,
just 30 miles away — raises the question of whether some patients may be getting procedures
they do not need or whether some could have been treated just as effectively and at lower cost
and less risk through heart drugs that may cost only several hundred dollars a year. Or whether,
in some cases, patients might be even better off with bypass surgery — even though a bypass is a
riskier, more invasive and more expensive procedure. At EMH Regional, Medicare pays the
hospital about $25,000 for a bypass operation, and as much as $2,200 to the surgeon.

The Elyria cardiologists do not perform bypasses. Because they are not surgeons, the North Ohio
cardiologists must refer a patient to another doctor if they conclude that bypass surgery is that
patient's best option. The bypasses are performed at the Elyria hospital by surgeons from the
Cleveland Clinic who have operating privileges there.

But even in cases of extensive disease where other doctors might typically recommend bypass
surgery, the Elyria doctors say they frequently favor the use of stents.

For patients with less serious disease, the doctors say they do prescribe drug-only treatment.

But generally, Dr. Schaeffer argues, the group's aggressive use of angioplasty provides the best
results for its patients. "We have excellent outcomes," he said.

No Definitive Studies

When it comes to treating blocked arteries, there are no definitive studies showing which
approach most benefits patients in the long term. And some local insurers agree that the Elyria
hospital provides high-quality care.

But there is little doubt that hundreds of Elyria patients each year are getting angioplasties that
they would not be getting if they lived elsewhere in Ohio — or in any other part of the country
for that matter — at a cost of millions of dollars a year to Medicare, the federal insurance
program for the elderly. Elsewhere in the state, some of the sickest of these patients might have
received bypass surgery, while many others might have simply been treated with drugs. Or, for
those whose conditions were not diagnosed or were not deemed serious enough, there might have
been no treatment at all. .

Experts know that changing the financial incentives can change the way medicine is practiced.

For example, Kaiser Permanente, the big health system that employs its own doctors, says its
patients in Ohio, including some in Elyria, are slightly less likely than the national average to
undergo the type of cardiac procedures the North Ohio Heart Center doctors perform so
prolifically.

Kaiser's cardiologists, who work on salary instead of being paid by the procedure, typically treat
patients in that region at the Cleveland Clinic, where they have hospital privileges. And they
follow established protocols about when a patient should undergo an angioplasty, when drugs
might suffice and when bypass surgery might be the best resort.

"It's not just individual doctors making up their minds," explained Dr. Ronald L. Copeland, the
executive medical director for Kaiser's medical group in Ohio. With no financial reason to
perform expensive procedures, the Kaiser doctors frequently choose to manage the patients' heart
disease with drugs only. "Our doctors have no disincentive to do that," Dr. Copeland said.

EMH Regional, the small, nonprofit Elyria hospital where North Ohio doctors perform most of
their angioplasties, says it is aware that the volume of procedures is higher than it is elsewhere.

"We believe we're doing a good job," said Dr. Donald Sheldon, the hospital's vice president for
medical affairs. But he conceded that the high rates raise questions. He said the hospital had
decided to ask a professional society of heart specialists to review the cardiac program and "give
us an honest and objective outside look."

Medicare officials, after being asked about the Elyria data by a reporter, said they intended to
take a closer look. And at least one commercial insurer that covers patients in Elyria, Anthem
Blue Cross and Blue Shield, said it had discussed with the hospital whether all the procedures
were appropriate.

Among Dartmouth's findings is that for the years 2001 through 2003, the approximately 3,000
angioplasty procedures performed on Medicare patients in Elyria were nearly triple the number
that might have been expected if the same people had lived elsewhere in Ohio. Elyria's statistics
have stood out at least since 1998, according to the Dartmouth researchers. By 2003, the most
recent year for which information is available, Elyria had 42 procedures per 1,000 Medicare
patients, compared with an average of 13.5 throughout Ohio and 11.3 in the rest of the nation,
according to Dartmouth's analysis.

A Lucrative Area of Medicine

Experts say that cardiac care is one of the most lucrative areas of medicine. EMH Regional says
it generates nearly half its profit from cardiac services.

Government officials had recently discussed significantly lowering Medicare payments for heart
care. But they ended up proposing only modest changes, allowing cardiac care to remain an
important source of hospital income. EMH Regional says it does not expect the new Medicare
rates to have a significant impact on its revenue.

In Elyria and its environs, where Dr. Schaeffer says there are perhaps only two cardiologists not
affiliated with his practice, patients appear highly likely to get their cardiac advice from the
North Ohio group. In some cases, they may even be referred to the North Ohio cardiologists by
doctors from the separate primary care practice that the group also operates.

For many cardiologists, the natural tendency when they see a patient with heart disease is to
perform a procedure to try to clear arterial blockages. And patients, cardiologists say, tend to rely
on their doctors' judgment.

"It's sort of like, you go to a barber and ask if you need a haircut," said Dr. David D. Waters,
chief of cardiology at San Francisco General Hospital, who is currently studying the effectiveness
of different kinds of treatment for heart disease. "He's likely to say you do."

But the Dartmouth data also shows that the Elyria doctors have a higher than average tendency to
perform diagnostic coronary angiographies on patients — the primary test that is used to detect
blockages in the first place.

"People are just geared to be looking at things, and they find them," said Dr. John E. Wennberg,
who pioneered the Dartmouth data analysis.

Aggressive Treatment

Dr. Schaeffer says the North Ohio doctors follow medical guidelines in determining treatments.
And he argues adamantly that patients with coronary artery disease are best served when doctors
intervene quickly. "With absolutely no exception," he said, "patients given aggressive treatment
will come out with a better outcome."

Among the insurers that say the doctors and hospital deliver good care is UnitedHealth, one of
the state's largest insurers, which has designated the Elyria hospital as one of its centers of
excellence for heart care.

Richard Waldron, the director of hospital contracting for another insurer, Medical Mutual of
Ohio, says that EMH scores well on traditional quality measures like the number of patients
readmitted, complications and mortality. "They are a very high-quality provider," he said.

Although Medical Mutual says it is aware of Elyria's unusually high rates of angioplasties, Mr.
Waldron said the insurer tended to leave clinical decisions to the doctors and patients involved.

Elyria's reputation in heart care has also become a matter of community pride. Harvey Gittler, a
columnist for the local newspaper, The Chronicle-Telegram, wrote glowingly last year of the
doctors and hospital, saying there was no reason to travel to the Cleveland Clinic, which has a
world-renowned heart center.

Mr. Gittler, who is 83 and insured through Medicare and his former employer, received a stent
and a pacemaker last summer after being taken to EMH by ambulance, suffering from pneumonia
and an irregular heart beat.

"The care in that hospital is excellent," he said in an interview, adding that the doctors at North
Ohio Heart Center "have this thing down to such a science."

But outside experts say such a locally dominant cardiology group could make it hard for patients
to be aware of other treatment options. They also say there is no clear medical reason for so many
patients in Elyria to be so much more likely than heart patients elsewhere to require angioplasty.

The high rates do not have "a good explanation," said Dr. Eric J. Topol, a nationally known
cardiologist at Case Western Reserve University in Cleveland. He said Elyria did not appear to
have significant differences in risk factors and demographics from Cleveland and the rest of Ohio
that would explain the sharply higher rates.

One clear reason for the high number of angioplasties in Elyria, though, is the way the doctors
tend to perform the procedures. In many other parts of the country, doctors who perform
angioplasties try to unblock all of the blood vessels during a single session. Or they may elect not
to put a stent in another vessel that might require an additional session because there is only a
minor blockage.

But in Elyria, patients are more likely to undergo two or more procedures, sometimes requiring
separate hospital stays and additional bills. As many as 31 percent of patients there who receive
treatment undergo additional procedures, according to Dr. Scott Sheldon, a North Ohio Heart
Center cardiologists, who is not related to the hospital's Dr. Sheldon. That would be three times
the national average.

"There's a safety issue," Dr. Sheldon said. North Ohio doctors, he said, do not want to endanger
patients by operating on too many vessels during a single procedure. Among other concerns, he
said, it could mean subjecting them to too much of the contrast agent that enables doctors to see
the arteries.

Using separate procedures, a practice known as staging, "is a reasonable option for patients," said
Dr. Howard C. Herrmann, the director of interventional cardiology at the Hospital of the
University of Pennsylvania. But Dr. Herrmann emphasized that in all of these decisions, much is
left to the cardiologist's own judgment.

"The cardiologists are the gatekeepers about who gets stents or surgeries," he said.

Even the North Ohio doctors, who say they believe their patients do well, concede that there is no
conclusive long-term evidence about what actually works best. They say they, too, want to know
what the long-term outcomes are going to be.

Patterns of Activity

No one has accused the North Ohio doctors of inappropriate conduct. But there have been cases
in which unusual patterns of medical activity that also showed up in the Dartmouth data have
prompted federal law enforcement investigators to look into whether unnecessary procedures
have been performed.

In one well-known instance, doctors at a community hospital in Redding, Calif., owned by Tenet
Healthcare were accused of defrauding Medicare by performing unnecessary heart operations on
hundreds of healthy patients. Without admitting wrongdoing, Tenet settled the accusations with
the federal government in 2003 for $54 million.

Earlier this year, a doctor in Lafayette, La., Dr. Mehmood M. Patel, was indicted on federal
charges that he committed Medicare fraud by performing unnecessary heart procedures.
Residents of Lafayette had more than twice the national rate of angioplasties in 2003, the second
highest in the country behind Elyria, according to the Dartmouth researchers.

A lawyer for the physician, J. Michael Small, said Dr. Patel had pleaded not guilty to all of the
government's counts. "He intends to vigorously contest the allegations," Mr. Small said. The
Doctor's Decision

Experts say it can be difficult to detect cases in which doctors cross a medical line and are clearly
performing unnecessary treatments.

"A lot of decisions are discretionary," said Dr. Harlan M. Krumholz, a cardiologist and professor
at Yale.

"It's about where the thermostat is set," he said, arguing that doctors in a particular geographic
area tend to be unaware if the way they are treating their patients is markedly different from the
practices of their peers in other areas.

Traditional measures of medical quality are not set up to detect whether patients are being treated
too much, he said, unlike the kinds of safeguards that prompt credit card companies to call their
customers to discuss unusual spending activity. "Right now there are no ‘smart' systems in
place," Dr. Krumholz said.

In the absence of any real monitoring or oversight, doctors in most places, including Elyria, have
few incentives not to favor the treatments that provide them the most reimbursement. Dr. Waters,
the San Francisco cardiologist, said that the way physicians are typically paid — more money for
more procedures — results in too many decisions to give a patient a stent.

"You can't be paying people large sums of money to do things without checks and balances," he
said.