HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Sunday, June 29, 2008

CT Scans and New Health Technologies: A Cost/Benefit Analysis

The New York Times has a long front page article today on the value of CT scans and other new technologies that doctors feel they need to use for patient health without much proof that they promote and health.  There is also that little problem of the financial incentives involved with the use of such technologies.  Alex Berenson and Reed Abelson report,

A group of cardiologists recently had a proposition for Dr. Andrew Rosenblatt, who runs a busy heart clinic in San Francisco: Would he join them in buying a CT scanner, a $1 million machine that produces detailed images of the heart? 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. . . .

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. . . .

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What struck me in The New York Times article “Weighing the Costs of a CT Scan Inside the Heart” was what the story omitted: peer-reviewed and emerging clinical trial data showing that CTA scans produce cost savings and improve patient outcomes. Also, for a story of this length to leave out any discussion of appropriateness criteria – even though cardiology and radiology medical societies already have programs in place, and both criteria are part of the current policy discussion – is curious. In my estimation, it fails to offer readers balanced information to help inform their decisions.

There are numerous peer-reviewed studies demonstrating that CT scans detect heart disease and help patients avoid cardiac catheterization. For example, the article could have cited a 2007 study in the Journal of the American College of Cardiology, which found that multi-slice heart scans significantly reduced diagnostic time and produced cost savings. It could have also cited a recent study demonstrating how CT heart scans are an effective and cost-saving tool in selecting patients for cardiac catheterization. The selective catheterization resulted in average cost savings of $1,454 per patient.

Proper utilization of any medical technology is important, and the majority of doctors do use medical imaging appropriately, without standing to realize any financial gain from doing so. In fact, according to 2005 Medicare claims data, an average of 94% of CT, MRI, PET and SPECT referrals are made to physicians who do not order the tests, and that percentage is even higher for cardiac imaging. To address the small minority of instances when imaging is improperly used, policymakers and medical societies are embracing appropriateness criteria and accreditation requirements as effective solutions that allow health decisions to remain in the domain of physicians and patients rather than insurance companies. Unfortunately, The Times story made no mention of this either.

CT heart scans eliminate the need for an invasive and expensive procedure to diagnose coronary artery disease by providing precise and comprehensive information on heart ailments without surgery and within seconds. Yes, a CT heart scan may seem expensive when viewed in isolation, but compare the price tag of a one time scan to the cumulative, long-term costs that will come with its regrettable alternatives: repetitive consultation and progression of disease and inappropriate treatment. Talk about penny wise and pound foolish—especially considering that coronary artery disease is the most common type of heart disease, and the number one killer for both men and women.

Thankfully, Medicare’s recent heart CT scan coverage decision allowed continued patient access to these tremendously valuable scans, which have revolutionized the way doctors diagnose heart disease, and become the standard of care for cardiac disease throughout the country and the world. I am certain that patients across America are benefiting as a result, and in this vein, it is incumbent upon us and our healthcare system to ensure that physicians are continually armed with improved resources for diagnosing and treating disease more precisely, effectively and efficiently – not restricted in their ability to save lives.

Andrew Whitman
Vice President, Medical Imaging & Technology Alliance

Posted by: Andrew Whitman | Jul 2, 2008 11:31:13 AM

Is there evidence that a CT saves lives? No. No diagnostic/laboratory test ever has. This is not what it does.

What is the appropriate standard to judge medical tests?

1. Efficacy (use of tests improves clinical outcomes)

2. Accuracy (the test accurately measures what they are purported to measure)

Diagnostic/laboratory tests are judged by accuracy and reproducibility and never by their effect upon treatment outcomes. Most tests used today have comparable "sensitivities" and "specificities."

Pet Scans were not approved because they saved lives in a controlled clinical trial that compared the outcome of patients who received care with or without the benefit of a Pet Scan. They were approved because their performance characteristics (sensitivity/specificity) are reproducible, favorable and provide information to treating physicians.

In cancer medicine, no test in oncology has ever been shown in prospective randomized clinical trials to improve patient outcomes. The existing standard has always been the "accuracy" of the test. This is true for every single test used in cancer medicine, from estrogen receptors to panels of immunohistochemical stains (IHC) to diagnosing and classifying tumor to Her2/neu and CA-125 to cell culture assays to MRI's, CT Scans, Pet Scans and so on.

Even when you get to the new genetic/molecular tests, the validation standard that private insurance companies is accepting is "accuracy" and not "efficacy." The essential "proof" is that all they have to do for these tests is that the test has a useful degree of "accuracy," not that the use of the diagnostic test improves clinical outcomes.

However, that's not the validation standard the American Society of Clinical Oncology (ASCO) wants for cell-based profiling tests. It looked at "efficacy" in their 2004 tech assessment. The cell-based profiling tests have the same entitlement to be judged by the same validation standard as genetic/molecular profiling and all other diagnostic tests. ASCO needs to update their tech assessment on cell-based profiling assays. And do it transparently this time!

A cardiac CT provides anatomic information regarding the presence or absence of blockages in coronary arteries. Such findings alone do not determine whether or not a patient requires an invasive procedure such as an angiogram or angioplasty/stent. Such decisions should be based on physiologic indicators such as presence of angina or, more importantly, an abnormal stress test. A cardiac CT by itself will never be proven to save lives. However, it is yet another tool in the arsenal that must be used properly.

In cancer medicine, the CT is used to follow the size of the patient's tumor while the patient is receiving repeated courses of chemotherapy to determine whether or not the treatment is working and whether or not different drugs should be given, instead. This is an entirely unproven benefit, and were appropriate studies ever to be performed, there wouldn't be any measurable benefit at all, in terms of improving patient response to chemotherapy or patient survival with chemotherapy.

One reason medical costs are getting way out of control: GE employs too many good salesmen.

Posted by: Gregory D. Pawelski | Jul 2, 2008 12:55:17 PM

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