A group of cardiologists
recently had a proposition for Dr. Andrew Rosenblatt, who runs a busy heart
clinic in
The scanner would give
Dr. Rosenblatt a new way to look inside patients’ arteries, enable his
clinic to market itself as having the latest medical technology and provide
extra revenue.
Although tempted, Dr.
Rosenblatt was reluctant. CT scans, which are typically billed at $500 to
$1,500, have never been proved in large medical studies to be better than older
or cheaper tests. And they expose patients to large doses of radiation,
equivalent to at least several hundred X-rays, creating a small but real cancer risk.
Dr. Rosenblatt worried
that he and other doctors in his clinic would feel pressure to give scans to
people who might not need them in order to pay for the equipment, which uses a
series of X-rays to produce a composite picture of a beating heart.
“If you have
ownership of the machine,” he later recalled, “you’re going
to want to utilize the machine.” He said no to the offer.
And yet, more than 1,000
other cardiologists and hospitals have
installed CT scanners like the one Dr. Rosenblatt turned down. Many are
promoting heart scans to patients with radio, Internet and newspaper ads. Time
magazine and Oprah Winfrey have also extolled
the scans, which were given to more than 150,000 people in this country last
year at a cost exceeding $100 million. Their use is expected to soar through
the next decade. But there is scant evidence that the scans benefit most
patients.
Increasing use of the
scans, formally known as CT angiograms, is part of a much larger trend in
American medicine. A faith in innovation, often driven by financial incentives,
encourages American doctors and hospitals to adopt new technologies even
without proof that they work better than older techniques. Patient advocacy
groups and some doctors are clamoring for such evidence. But the story of the
CT angiogram
is a sobering reminder of the forces that overwhelm such efforts, making it
very difficult to rein in a new technology long enough to determine whether its
benefits are worth its costs.
Some medical experts say
the American devotion to the newest, most expensive technology is an important
reason that the United States spends much more on health care than other
industrialized nations — more than $2.2 trillion in 2007, an estimated
$7,500 a person, about twice the average in other countries — without
providing better care.
No one knows exactly how
much money is spent on unnecessary care. But a Rand Corporation study estimated
that one-third or more of the care that patients in this country receive could
be of little value. If that is so, hundreds of billions of dollars each year
are being wasted on superfluous treatments.
At a time when Americans
are being forced to pay a growing share of their medical bills and when access
to medical care has become a major political issue for states, Congress and the
presidential candidates, health care experts say it will be far harder to hold
down premiums and expand insurance coverage unless money is spent more wisely.
The problem is not that
newer treatments never work. It is that once they become available, they are
often used indiscriminately, in the absence of studies to determine which
patients they will benefit.
Some new treatments, like
the cancer drug Gleevec and implantable heart defibrillators,
undoubtedly save lives, contributing to the
And sometimes, the new
technologies prove harmful. Physicians were stunned, for example, when clinical
trials showed last year that expensive anemia medicines
might actually hasten death in kidney and cancer patients. Such drugs are used
more widely in the
“We have too many
situations where we thought we knew what the answer was and it didn’t
turn out like everyone thought,” said Dr. Mark Hlatky,
a cardiologist and professor of health research and policy at Stanford University.
A Tool
of Dubious Value
The problem of inadequate
study is especially serious for medical devices and imaging equipment like
scanners, which typically are not as strictly regulated as prescription drugs.
Under Food and Drug
Administration regulations, the makers of CT scanners — CT is short
for computed tomography — do not have to conduct studies to prove that
their products benefit patients, as drug makers do. The manufacturers must
certify only that the scanners are safe and provide accurate images.
Once the F.D.A. approves
a test or device, Medicare rarely
demands evidence that it benefits patients before agreeing to pay for it. But
last year, Medicare officials raised questions about the benefits of CT heart
scans and said it would demand more studies before paying for them. But after heavy
lobbying by cardiologists, Medicare backed down. Private insurers, while
initially reluctant to pay for the tests, are also covering them.
Physicians in this
country have a free hand in deciding when to use new technology like CT
angiography. Some are conservative. But others, especially doctors in private
practice who own their scanners, use the tests aggressively.
Douglas Ring, a
63-year-old
The CT heart scan by Dr. Karlsberg found a moderate buildup of plaque in one of Mr.
Ring’s coronary arteries. The doctor increased Mr. Ring’s
cholesterol medicines and encouraged him to diet
and exercise.
Dr. Karlsberg
said he considered the information from Mr. Ring’s CT scan
extremely valuable. “Here’s a case of near-serious coronary disease
that required medical management,” said Dr. Karlsberg,
a partner at the Cardiovascular Medical Group of Southern California, which
conducted about 1,400 CT heart scans last year.
Many other cardiologists,
though, say patients like Mr. Ring do not benefit from CT scans. And by the
time they are 50, most people will have plaque visible
on a CT scan, so the findings of Mr. Ring’s scan were not surprising.
Arteries narrowed by
plaque are not necessarily a threat, said Dr. Eric Topol,
a practicing cardiologist and director of the Scripps Translational Science
Institute in La Jolla, Calif. The danger arises when bits of plaque break and
produce a clot that blocks blood to the heart. But CT angiograms cannot tell
whether a particular blockage is likely to rupture or, except in extreme cases,
is keeping the heart from receiving enough blood.
If doctors do choose to
treat blockages, they can insert stents — small
metal scaffolds that prop open arteries. But while stents have been proved to
reduce chest pain, they have not been shown to prolong patients’ lives or
help them avoid heart attacks. Patients with the most severe blockages can
receive bypass surgery, which when necessary can be a lifesaving procedure.
And so patients who do
not have chest pain, like Mr. Ring, should not receive CT heart scans, said Dr.
Rita Redberg, a cardiologist and researcher at the
University of California, San Francisco, who is a leading critic of the scans.
“No data suggests
that there’s any reason for anyone asymptomatic to have a test,”
she said. “There certainly is this idea that having a test can help you
prevent a heart attack,
and I don’t know where it came from.”
Further, each scan creates
an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1
in 5,000, said Dr. David J. Brenner, director of the Center for Radiological
Research at Columbia University.
Younger patients and women are at higher risk.
Dr. Karlsberg
and other cardiologists who support widespread use of CT heart scans argue that
they can reduce the need for other tests — like conventional angiograms,
which can find plaque but require a catheter to be threaded through the
arteries. Conventional angiograms are more expensive than CT scans and carry
their own risks.
If a CT heart scan finds
plaque that a doctor intends to treat with a stent, a
conventional angiogram will still be necessary to determine where and how to
implant the stent. So a CT scan does not always eliminate the need for a
conventional angiogram.
The most valuable use of
a CT angiogram may be when a patient comes to an emergency room complaining of
chest pains but has few other symptoms of a heart attack. The test can quickly
rule out heart trouble. But such patients represent a minority of those
receiving CT heart scans.
Dr. Karlsberg
also pointed to the case of a seemingly healthy 68-year-old patient whom he
scanned in his office in 2006. To the shock of both doctor and patient, the
scan revealed a 95 percent blockage of the patient’s main coronary
artery. The patient had immediate bypass surgery to relieve the blockage, an
operation that may have saved his life, Dr. Karlsberg
said. The man, who cited privacy concerns in asking that his name not be used,
confirmed the doctor’s account.
Cardiologists who oppose
wide use of the scans agree that they can sometimes find dangerous blockages
that require immediate surgery in asymptomatic patients. But they said such
cases are extremely rare — not common enough to justify using the scans
routinely, given their cost and radiation risks.
For too many people, the
scans are simply inappropriate, said Dr. Howard C. Herrmann, director of
interventional cardiology at the University of Pennsylvania. “I find many patients have CT
angiograms who shouldn’t be getting CT
angiograms.”
As more than 13,000 heart
doctors gathered in Chicago in late March for the annual American College of
Cardiology conference, the biggest and best-located booths belonged to General Electric, Philips Electronics,
Siemens and Toshiba, the leading makers of the machines used for CT angiograms.
Cardiologists hired by
the companies offered short briefings on ways to reduce radiation doses, while
sales representatives in business suits quietly talked up the benefits of the
scans and the clarity of the images. The sales atmosphere was low key, more art
gallery than “Glengarry Glen Ross.”
A hard sell is
unnecessary because the manufacturers are finding a receptive audience. Many
cardiologists have been eager for a new tool that lets them see inside the
heart with unprecedented clarity — while also providing a new source of
revenue.
Use of CT scans
accelerated after 2004, when manufacturers introduced a new generation called
64-slice scanners, which are fast enough to capture images of a beating heart.
The scanners fire X-rays in a series of rotations around the torso, generating
thousands of narrow vertical images. Sophisticated software then combines data
from the X-rays into a single image.
The
Financial Incentives
Already, more than 1,000
hospitals and an estimated 100 private cardiology practices own or lease the $1
million CT scanners, which can be used for the angiograms and for other imaging
procedures. Once they have made that investment, doctors and hospitals have
every incentive to use the machines as often as feasible. To pay off a scanner,
doctors need to conduct about 3,000 tests, industry consultants say.
Fees from imaging have
become a significant part of cardiologists’ income — accounting for
half or more of the $400,000 or so that cardiologists typically make in this
country, said Jean M. Mitchell, an economist at Georgetown University who
studies the way financial incentives influence doctors.
Besides generating
profits themselves, the scans enable cardiologists to find blockages in
patients who have no symptoms of heart problems. Doctors can then place stents
in patients who would not otherwise have received them, generating additional
revenue of $7,500 to $20,000 per patient.
While clinical trials
have not shown that stents benefit patients with no symptoms of heart disease,
they are still routinely inserted in such patients when tests find significant
blockages. Cardiologists joke that the phenomenon is “ocular stenosis” — blockages that can be seen are stented.
“You find a lot of
asymptomatic disease,” said John O. Goodman, a business consultant to
cardiologists. “It will put more patients in the cath
lab” — medical shorthand for a cardiac
catheterization laboratory, where conventional angiograms and stenting procedures take place.
Ms. Mitchell said
cardiologists simply practice medicine the way the health system rewards them
to. Given the opportunity to recommend a test for which they will make money,
the doctors will.
“This is not greed,”
she said. “This is normal economic behavior.”
Doctors who perform a lot
of CT heart scans tend to be evangelists for the technology. Dr. John A.
Osborne, a cardiologist in solo practice in Grapevine,
Supported by a staff of
about 20 people, Dr. Osborne estimates that he does 15 CT angiograms a day.
Arterial plaque is “cancer of the coronaries,” he tells patients.
“Do you have it or not?”
Before their plaque
creates symptoms, Dr. Osborne asserts, patients should be aggressively treated,
urged to diet and exercise and given cholesterol-lowering and other drugs.
Scans
‘Sell Themselves’
Like many cardiologists
who perform CT scans, Dr. Osborne relies on primary-care doctors to send him
candidates. He frequently gives lectures to primary-care doctors on the
technology’s benefits. When doctors see the images, he said, “they become true believers.”
Two years ago, Dr.
Osborne persuaded a family practice doctor, Dr. Michael Dotti,
to have his own CT angiogram at no cost. Dr. Dotti
was amazed at the scan’s ability to spot early signs of disease.
“It’s nice to know I have clear arteries at 51,” he said.
“The scans sort of sell themselves.”
The technology has been
covered in the news media, including a September 2005 Time magazine cover on CT
angiograms, “How New Heart-Scanning Technology Could Save Your
Life.” The following month, Oprah Winfrey devoted a segment of her
television program to women’s heart disease and recommended that her
viewers consider taking the test. Representatives for Time and Ms. Winfrey
declined to comment on their coverage of the technology.
Even cardiologists who
think the CT scans are overused say they may one day prove valuable. If
manufacturers can produce scanners that can determine which plaques are stable
and which are likely to rupture, the machines could revolutionize the treatment
of heart disease. Patients found to be at low risk might be able to avoid
taking medicine entirely, while others would be given intensive treatment.
But for now, doctors
cannot use the images that way. Finding out whether the heart
is actually short of blood and at high risk for an attack requires tests other
than a CT scan — most likely, a nuclear stress
test, which uses radioactive dye to track blood flow through the coronary
arteries.
The CT angiogram is
“a great technology searching for a great application,” said Dr. Charanjit S. Rihal, the director
of the cardiac catheterization laboratory at the Mayo Clinic in
CareCore National, a Bluffton, S.C., company that reviews treatment
and test requests for health insurers, has found that when doctors request a CT
angiogram for a patient, they also frequently ask for a nuclear stress test.
“We’re seeing
layering of tests on top of each other,” said Dr. Russell Amico, a CareCore executive. His
company denies as many as 70 percent of the CT scans requested, a much higher
rate of rejection than for other kinds of tests his company reviews.
Impatient
Patients
Sometimes, it is not the
doctor but the patient who is eager for the scan. On a recent Wednesday morning
on the Upper East Side of Manhattan, Dr. Harvey Hecht at
Mr. Franks has a family
history of cardiac disease, and his father and two uncles died of heart
attacks. But Mr. Franks, director of corporate security for Time Inc., is in
excellent shape. He works out daily and takes two cholesterol-lowering
medicines. The drugs have reduced his LDL, or bad, cholesterol to 60, a
remarkably low level.
Nonetheless, in February,
Mr. Franks took a test called a calcium
score, which measures the amount of calcified plaque in the arteries. The test,
a less extensive form of scanning, revealed a moderate buildup of calcium in
his arteries, a potential sign of heart disease.
So he decided to have a
nuclear stress test. When that test showed no problem, the cardiologist who
conducted it said he did not need more testing.
But Mr. Franks was still
not satisfied. “I’m someone who wants to know,” he said.
After doing research on the
Internet, he found Dr. Hecht, who recommended a CT angiogram. Dr. Hecht
acknowledged that Mr. Franks probably did not have severe heart disease. But he
said the scan would be valuable anyway because it might reassure him. And his
insurance would cover the cost.
In the control room,
Salvatore Fevola, the manager of the CT scanning
equipment at Lenox Hill, instructed Mr. Franks, who was raising his hands over
his head, to hold his breath as the table moved through the machine.
Twelve seconds later, the
test was complete, and the machine’s software began to assemble
information from thousands of images into a single coherent picture of Mr. Franks’s heart.
A few minutes later, Dr.
Hecht studied the results. As he had expected, the angiogram revealed that Mr. Franks’s arteries were healthy. In some places,
plaque had blocked 25 percent of their blood flow, but in general,
cardiologists do not consider blockages clinically relevant until they reduce
blood flow at least 70 percent.
After Mr. Franks finished
dressing, he joined Dr. Hecht, who went over the results, explaining that his
heart appeared healthy and that he would not need a stent. Still, Dr. Hecht
recommended that Mr. Franks have another CT angiogram next year to check that
the plaque was not thickening. Mr. Franks agreed, pronounced himself satisfied
and left.
For Mr. Franks, the test
was quick and painless. But it subjected him to a significant dose of
radiation.
Based on a
reporter’s notes about the duration of the scan and the power output
reported by the scanner, Dr. Brenner of the Center for Radiological Research
estimated that Mr. Franks had received 21 millisieverts
of radiation — even more than a typical test, equal to about 1,050
conventional chest X-rays.
Given the radiation
risks, Dr. Ralph Brindis, another cardiologist, said
Dr. Hecht had erred. Because Mr. Franks had already taken a nuclear stress test
with normal results, he did not need a CT angiogram, said Dr. Brindis, vice president of the
“The biggest
problem we have with radiation is that the doses are cumulative and
additive,” Dr. Brindis said. “So the
concept of doing serial CT testing on asymptomatic patients, I think, is
abhorrent. I cannot justify that.”
Dr. Hecht said he sharply
disagreed with Dr. Brindis. The scan was appropriate
for Mr. Franks, despite his normal results from the nuclear stress test,
because of Mr. Franks’s other risk factors for
heart disease, including his higher-than-average calcium score, Dr. Hecht said.
And he said he recommended a follow-up scan next year so he could see how quickly
the plaque in Mr. Franks’s arteries was
thickening.
Otherwise, “how do
we know that our therapy is effective?” Dr. Hecht said. He acknowledged
that many cardiologists do not favor repeat scans but said long-term radiation
risks were a relatively minor issue for patients 60 and older.
Cardiologists like Dr. Brindis hurt their patients by being overly conservative
and setting unrealistic standards for the use of new technology, Dr. Hecht
said.
“It’s
incumbent on the community to dispense with the need for evidence-based
medicine,” he said. “Thousands of people are dying
unnecessarily.”
Medicare’s
Scrutiny
The Centers for Medicare
and Medicaid Services
had decided to push back.
The agency, which this
year will spend more than $800 billion on health care, rarely questions the
need to pay for new treatments. But last June, Medicare said it was considering
paying for CT heart scans only on the condition that studies be
done to show they had value for patients.
Concerned about the
overall proliferation of imaging tests, Medicare said it might require a
large-scale study to determine the scans’ value.
The plan met with fierce
resistance, particularly from a relatively new organization of specialists, the
Society of Cardiovascular Computed Tomography. The society has 4,700 physician
members and one purpose — to promote CT angiograms.
“For the CT
society, this was life or death,” said Dr. Daniel S. Berman, the
group’s president-elect. “This decision could essentially put them
out of business.”
Galvanized, at a meeting
in November in
“We didn’t
need to be talking about registries and the research,” Dr. Berman said.
“We needed to be questioning the wisdom of the Medicare decision
itself.”
The next month, Medicare issued
the draft of its proposal, saying that it would pay for the scans only if a
large-scale study were conducted. The CT society, along with other prominent
medical groups whose members performed scans, set to work lobbying the agency
and members of Congress.
One group marshaled the
evidence the doctors would take to Medicare, arguing that the agency had
ignored some studies, including those of the new 64-slice CT scans. Another
group visited Congressional offices. Defenders of the technology argued that
Medicare had agreed to pay for other tests, like mammograms,
without requiring proof that they improved patient care. Breakthrough
technologies, they said, need time to prove themselves.
Medicare “set the
bar so high, no new technology would be able to survive,” said Dr.
Michael Poon, a
Cardiologists met with
Representative Carolyn McCarthy, a New York
Democrat. In March, she and other members of Congress wrote to Medicare, urging
it to reconsider its plan. Eventually, a dozen or so senators and 79
representatives lined up to support the society’s efforts.
And Medicare gave way.
“There are a lot of
technologies, services and treatments that have not been unequivocally shown to
improve health outcomes in a definitive manner,” Dr. Barry Straube, Medicare’s chief medical officer, explained
when announcing that the agency would keep covering the tests.
In other words, the lack
of evidence that the CT scans provide measurable medical benefit would not stop
Medicare from paying for them.
Heavy lobbying makes it
virtually impossible for the agency to insist on more evidence before agreeing
to pay for a new technology, said Dr. James Adamson, chief medical officer for
Arkansas Blue Cross and Blue Shield. “Medicare,” he said,
“does not make a lot of really hard decisions.”
In a subsequent
interview, Marcel Salive, a Medicare official, said
the agency still hoped for large-scale studies to demonstrate the value of CT
scans.
The technology’s
proponents say they understand the need to prove its value. “It’s
incumbent on us to do more work,” said Gene Saragnese,
vice president for molecular imaging and CT at General Electric.
Doctors are also
discussing the creation of registries to track patients who have had CT
angiograms. But now that Medicare has backed down, skeptics say it is unlikely
that anyone will conduct a major clinical trial to determine if patients who
receive CT heart scans have better medical outcomes than those who do not.
“It’s clearly
going to be much more difficult, given the Medicare decision,” said Dr.
Sean Tunis, a former Medicare official who directs the Center for Medical
Technology Policy, a nonprofit group.
Industry consultants say
that now that Medicare has agreed to pay for the tests, resistance among
commercial insurers is likely to disappear. “I believe the holdouts will
be paying within 12 months,” said Michelle Boston, the chief executive of
Partners Imaging, a