The front page of the New York Times Sunday morning had a don’t miss article on the financial incentives behind using CT scans to look for heart disease. Medicare’s decided in March to begin paying for the test despite no evidence that it saves lives (see this GoozNews post). The lobbying campaign by a newly created physicians guild that invests in CT scanning clinics is discussed in the last few paragraphs of the story. That campaign was aided by "entrepreneurial guidelines" touting the procedure, discussed in this GoozNews post.
Here are the two key quotes from the story:
"It’s incumbent on the community to dispense with the need for evidence-based medicine." –Dr. Harvey Hecht, Manhattan cardiologist and CT scan advocate
"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, chief medical officer, Medicare
Alas, the article does not clearly describe the option that Straube and the Center for Medicare and Medicaid Services rejected in agreeing to pay for the scans. During Mark McClellan’s tenure at the agency, he instituted a "coverage with evidence development" program. That in-between option would require physicians using heart CT scans to send in results and monitor their patients over time, sending that follow-up data into the agency, too. This would create a database that could be analyzed to see if CT scans for heart disease and subsequent follow-up care actually reduced the incidence of heart disease mortality.
"We didn’t need to be talking about registries and the research," said Daniel S. Berman, president of Society of Cardiovascular Computed Tomography, a society of 4,700 physicians whose sole purpose is to promote CT angiograms, according to the article.
We don’t need no stinkin’ evidence. We don’t need no stinkin’ registries. We don’t need no stinkin’ research.
New leadership at CMS in the next administration at a minimum must insist on creating electronic registries for every new technology that it pays for where there is not yet clear cut evidence that it works. It also should set firm deadlines for manufacturers to submit well-controlled clinical trials offering definitive proof — or the payments authorized under the coverage-with-evidence-development policy should be revoked.
Merrill Goozner has been writing about economics and health care for many years. The former chief economics correspondent for the Chicago Tribune, Merrill has written for a long list of publications including the New York Times, The American Prospect and The Washington Post. His most recent book, "The $800 Million Dollar Pill – The Truth Behind the Cost of New Drugs " (University of California Press, 2004) has won acclaim from critics for its treatment of the issues facing the health care system and the pharmaceutical industry in particular. Today he has something to say about a familiar topic : the relationship between public sector R&D investment and innovation in the pharmaceutical and biotech industries. You can read more pieces by Merrill at Gooznews.com
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Rate cuts in medical imaging do not distinguish between appropriate tests and unneeded ones. Radiology benefits managers such as National Imaging Associates offers a cost control service that evaluates whether physicians are following guidelines when ordering tests and works with doctors if any corrections are needed.
A study, published last year in the Journal of the American College of Radiology, found that use of CT scans dropped by about a third after the introduction of pre-authorization based on American College of Radiology guidelines.
The process seems tedious at times but it can help to distinguish self-referral arrangements that are corrupting medical decision-making by creating a financial incentive for physicians to refer patients who don’t really need procedures.
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
http://www.medicalimaging.org/
Serial radiographic imaging studies are very expensive tests. In cancer medicine, the idea of their use is 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. No wonder health care costs keep exploding!
As a former clinical cardiologist who read cardiac CTs for a living, I must comment that both sides have valid arguments. Does everyone need a cardiac CT? NO. Does it save lives? Not necessarily. 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. I regrettable admit that many colleagues throughout the world probably overuse the test. It is yet another tool in our arsenal that must be used properly. It is clear from some of the comments made that there are those physicians who behave to the contrary.
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. In oncology for instance, 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.
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. It must be noted that all types of diagnostic tests are just that, “tests” and not treatment.
That’s why ASCO needs to update their tech assessment on cell-based profiling assays. And do it transparently this time!