Medicare Will Keep Covering CT Heart Scans After All
Posted by Jacob Goldstein (March 13 2008)
High-tech scans are one of the fastest growing areas of health-care spending, and the feds have been trying for a while to figure out how to slow the growth. But Medicare just gave up on one cost-control measure.
The Centers for Medicare and Medicaid Services yesterday reversed an earlier plan to deny coverage of cardiac CT scans used to diagnose heart disease, the New York Times reports.
Medical societies that would have been hurt by cuts complained early and often about the proposed change. A letter from a bunch of doctors’ groups including the American College of Cardiology and the American College of Radiology said the “policy would have a profoundly negative impact on Medicare beneficiaries by limiting needed access to this technology for clinically appropriate indications.”
Medicare officials are still lukewarm on the tests. “We found that the evidence is not black and white either way” said Barry Straube, chief medical officer for CMS, told the Times. But given all the opposition, the agency thought it best to defer coverage decisions to the Medicare carriers that make decisions on a regional level. The carriers tend to cover the test; Medicare paid for roughly 70,000 of the heart scans in 2006, at a cost of $40 million to $50 million.
The scans can serve a purpose similar to conventional angiography, in which X-ray images of the coronary vessels heart are enhanced with a dye injected by a catheter. A set of guidelines, created by several medical societies, recommends using the scans only on certain patients who have some evidence of heart disease, such as those with chest pain and a hard-to-evaluate stress test.
But because the CT scans are less invasive than angiography, there is some concern that they might be used for screening patients who don’t show symptoms of disease, inappropriately driving up costs and subjecting patients to the radiation risks associated with the tests.
Posted by Jacob Goldstein (March 13 2008)
High-tech scans are one of the fastest growing areas of health-care spending, and the feds have been trying for a while to figure out how to slow the growth. But Medicare just gave up on one cost-control measure.
The Centers for Medicare and Medicaid Services yesterday reversed an earlier plan to deny coverage of cardiac CT scans used to diagnose heart disease, the New York Times reports.
Medical societies that would have been hurt by cuts complained early and often about the proposed change. A letter from a bunch of doctors’ groups including the American College of Cardiology and the American College of Radiology said the “policy would have a profoundly negative impact on Medicare beneficiaries by limiting needed access to this technology for clinically appropriate indications.”
Medicare officials are still lukewarm on the tests. “We found that the evidence is not black and white either way” said Barry Straube, chief medical officer for CMS, told the Times. But given all the opposition, the agency thought it best to defer coverage decisions to the Medicare carriers that make decisions on a regional level. The carriers tend to cover the test; Medicare paid for roughly 70,000 of the heart scans in 2006, at a cost of $40 million to $50 million.
The scans can serve a purpose similar to conventional angiography, in which X-ray images of the coronary vessels heart are enhanced with a dye injected by a catheter. A set of guidelines, created by several medical societies, recommends using the scans only on certain patients who have some evidence of heart disease, such as those with chest pain and a hard-to-evaluate stress test.
But because the CT scans are less invasive than angiography, there is some concern that they might be used for screening patients who don’t show symptoms of disease, inappropriately driving up costs and subjecting patients to the radiation risks associated with the tests.
American College of Cardiology Guidelines For Appropriate Use.
Boston Globe
On the Take
How Medicine's Complicity with Big Business Can Endanger Your Health
Jerome P. Kassirer
How Medicine's Complicity with Big Business Can Endanger Your Health
Jerome P. Kassirer
We all know that doctors accept gifts from drug companies, ranging from pens and coffee mugs to free vacations at luxurious resorts. But as the former Editor-in-Chief of The New England Journal of Medicine reveals in this shocking expose, these innocuous-seeming gifts are just the tip of an iceberg that is distorting the practice of medicine and jeopardizing the health of millions of Americans today. In On the Take , Dr. Jerome Kassirer offers an unsettling look at the pervasive payoffs that physicians take from big drug companies and other medical suppliers, arguing that the billion-dollar onslaught of industry money has deflected many physicians' moral compasses and directly impacted the everyday care we receive from the doctors and institutions we trust most. Underscored by countless chilling untold stories, the book illuminates the financial connections between the wealthy companies that make drugs and the doctors who prescribe them. Kassirer details the shocking extent of these financial enticements and explains how they encourage bias, promote dangerously misleading medical information, raise the cost of medical care, and breed distrust.
October 8, 2007, 9:52 am
Tangled Web of Conflicts Over Lung Cancer Screening
Posted by David Armstrong
Tangled Web of Conflicts Over Lung Cancer Screening
Posted by David Armstrong
A spat is developing over the moonlighting of researchers leading a big government study of lung cancer screening as expert witnesses in tobacco litigation, the WSJ reports.
Two of the researchers, including study co-director Denise Aberle of UCLA, have testified for tobacco companies sued by smokers seeking to have the cigarette makers pay for annual CT scans to screen for lung cancer. That has upset some patient groups and pro-screening advocates who were already concerned that the government study is tilted against screening.
While screening advocates point to the tobacco company work as a troubling conflict of interest, scientists who have been among the biggest promoters of screening have their own conflicts.
No group has been more active in the study and promotion of screening than the one at Cornell Medical/New York-Presbyterian led by Claudia Henschke. Henschke and collaborator David Yankelevitz have published some of the most promising studies demonstrating a benefit to screening for lung cancer with CT scans.
In a study published in the New England Journal of Medicine last year, the Cornell group reported that CT screening of more than 30,000 smokers discovered first-stage lung cancer in 412 of them. Of those, all but eight received some kind of treatment. The overall survival rate for those found to have early stage cancer was 88% after 10 years. The eight patients who declined treatment all died within five years of diagnosis. Currently, the five-year survival rate for lung cancer is just 16%, mainly because the disease is often detected too late for treatment to work. That article concluded by noting “no potential conflict of interest relevant to this article was reported.”
But Henschke and Yankelevitz, however, receive royalty payments from General Electric, a big maker of CT scanners, for a computer algorithm they developed to detect lung cancer on diagnostic images.
Henschke told the Health Blog that the licensing agreement with GE was struck after the medical journal Lancet published a paper from the Cornell group in 1999. She said the royalties are small and declining. She couldn’t specify the money amounts. Yankelevitz said most of the royalties go to Cornell. He also was unable to provide a specific amount paid to him by GE.
A GE spokesman said the company has “an agreement in place to license Cornell patents around lung cancer screening.” Henschke says she informed the NEJM of the GE royalty agreement but that the journal decided not to disclose it. The NEJM didn’t immediately return a call for comment.
Yankelevitz owns shares in and consults for PneumRx, a company that makes needles used to biopsy suspected cancer tissue in the lung. The company would likely benefit from any uptick in screening as further tests are ordered. PneumRx CEO Erin McGurk says Yankelevitz was given stock in exchange for licensing some intellectual property he had developed. Yankelevitz said he has consulted for PneumRx for about a year and a half but doesn’t consider the work to be a conflict because “it isn’t a screening company.”
Two of the researchers, including study co-director Denise Aberle of UCLA, have testified for tobacco companies sued by smokers seeking to have the cigarette makers pay for annual CT scans to screen for lung cancer. That has upset some patient groups and pro-screening advocates who were already concerned that the government study is tilted against screening.
While screening advocates point to the tobacco company work as a troubling conflict of interest, scientists who have been among the biggest promoters of screening have their own conflicts.
No group has been more active in the study and promotion of screening than the one at Cornell Medical/New York-Presbyterian led by Claudia Henschke. Henschke and collaborator David Yankelevitz have published some of the most promising studies demonstrating a benefit to screening for lung cancer with CT scans.
In a study published in the New England Journal of Medicine last year, the Cornell group reported that CT screening of more than 30,000 smokers discovered first-stage lung cancer in 412 of them. Of those, all but eight received some kind of treatment. The overall survival rate for those found to have early stage cancer was 88% after 10 years. The eight patients who declined treatment all died within five years of diagnosis. Currently, the five-year survival rate for lung cancer is just 16%, mainly because the disease is often detected too late for treatment to work. That article concluded by noting “no potential conflict of interest relevant to this article was reported.”
But Henschke and Yankelevitz, however, receive royalty payments from General Electric, a big maker of CT scanners, for a computer algorithm they developed to detect lung cancer on diagnostic images.
Henschke told the Health Blog that the licensing agreement with GE was struck after the medical journal Lancet published a paper from the Cornell group in 1999. She said the royalties are small and declining. She couldn’t specify the money amounts. Yankelevitz said most of the royalties go to Cornell. He also was unable to provide a specific amount paid to him by GE.
A GE spokesman said the company has “an agreement in place to license Cornell patents around lung cancer screening.” Henschke says she informed the NEJM of the GE royalty agreement but that the journal decided not to disclose it. The NEJM didn’t immediately return a call for comment.
Yankelevitz owns shares in and consults for PneumRx, a company that makes needles used to biopsy suspected cancer tissue in the lung. The company would likely benefit from any uptick in screening as further tests are ordered. PneumRx CEO Erin McGurk says Yankelevitz was given stock in exchange for licensing some intellectual property he had developed. Yankelevitz said he has consulted for PneumRx for about a year and a half but doesn’t consider the work to be a conflict because “it isn’t a screening company.”
Boston Globe
JEROME P. KASSIRER
Stemming the craze on CT scans
February 8, 2008
IN MEDICINE, not everything that makes sense is sensible. Because smoking predisposes to lung cancer, and because advanced lung cancer is incurable, it seems to make sense to screen all smokers for early cancers and treat them while they are treatable. And because coronary disease is common, it seems to make sense to screen middle-age people so some preventative measure can be taken before a heart attack strikes them down. The wide availability of ultrasensitive CT scans makes such screening possible, and two groups are promoting the tests. Yet the medical establishment disagrees. Why?
One proposal, the Screening for Heart Attack Prevention and Education guidelines, was issued in 2006 by an independent, self-selected group of cardiologists. By screening, the group's spokesmen said, 90,000 deaths could be prevented and billions of dollars saved.
Around the same time, a self-selected consortium of radiologists called the International Early Lung Cancer Action Program published an uncontrolled study of early detection in which they claimed to cure more than 90 percent of lung cancers; an astonishing rate.
Despite these claims and observations, major professional organizations did not go along with the recommendations of these two groups. The American Heart Association, the American College of Cardiology, the American College of Chest Physicians, and the American Cancer Society, among others, had examined the evidence on screening, and had identified its well-known problems.
Studies such as the early lung cancer program were uncontrolled; screening often detects lesions that may never become clinically important; many discovered abnormalities, especially spots on the lung, are not cancers; and many patients end up having to undergo invasive procedures when some abnormality is found even when the finding is insignificant in terms of the patient's ultimate well-being.
Both the Screening for Heart Attack Prevention and Education group and the International Early Lung Cancer Action Program were undeterred.
The heart attack prevention group's investigators and their collaborators in the so-called Association for Eradication of Heart Attack convinced a Texas state representative to introduce legislation that would mandate reimbursement for tests to detect asymptomatic arteriosclerosis. The lung cancer group investigators and their collaborators in the so-called Lung Cancer Alliance went further.
They not only called for payment for CT-guided screening of smokers, but they declared publicly that the ongoing controlled, blinded clinical trial of screening centered at the National Institutes of Health was unethical. They complained to Elias Zerhouni, the head of the NIH, and they stirred up the leadership of the House Committee on Energy and Commerce to investigate the principal investigators of the NIH study for alleged financial conflicts, accusations that proved unfounded.
Why all the fuss? Why were the organizations pushing so hard, not only bucking the recommendations of major organizations, but going directly to legislatures to get their policies implemented? Why not go through the usual channels in their own professional organizations, offering their evidence and opinion and getting the official policies changed? Perhaps they were true believers, convinced that their interpretation of the evidence would provide a great benefit for humanity, and impatient with the sluggishness of the big professional societies as well as the snail's pace by which physicians often change their practices. Perhaps.
But given the expansion of privately owned CT scanners in the country, and the possibility of a reimbursement bonanza for such procedures, another more sinister explanation is possible, namely a profit motive. Such a motive became more credible when Paul Goldberg, a reporter who covers the cancer field, found that the two lead investigators of the lung cancer study held 27 patents on procedures for CT screening and lung biopsy procedures. Information also surfaced that the heart attack prevention guidelines were sponsored by Pfizer, a company likely to benefit from the use of its drugs if extensive cardiac screening were implemented.
How do we know whether these screening recommendations are motivated by concern for patients' welfare or money, or perhaps both? We don't. But widespread screening for lung cancer and heart disease can be risky and will be expensive. Experience shows that every time we approve a screening procedure, it is used more widely than the indications for which it was originally approved. More screening machines invariably lead to more tests; more tests yield more false positive results, more risk to screened patients, and more expense.
Testing decisions must be made by organizations that sort through all the evidence. They must appoint guideline committees that are not influenced by how much their colleagues make or how many pills the companies sell that pay them to speak or consult. We are nearly at the limit of our expenditures on medical care; we don't need more expenses for tests that have been tainted by possible financial bias. We must remember who will pay for all these additional tests: you and me.
Dr. Jerome P. Kassirer is a professor at Tufts University School of Medicine.
