The following editorial by Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, is republished from Dr. Len's Cancer Blog, a source of news and commentary on topics of interest to the medical and oncology communities. It originally appeared on June 17, 2009.
A recent editorial in the New England Journal of Medicine praising the decision by the U.S. Centers for Medicare and Medicaid Services (CMS) not to cover CT colonography (also known as virtual colonoscopy) for the prevention and early detection of colon cancer for Medicare patients left me with a great deal of concern -- especially since it was written by some of the same people who made the decision in the first place.
I consider myself a fairly reasonable, experienced, and tolerant person when it comes to the legislative and regulatory decision-making processes. You win some, you lose some, you re-evaluate, and, generally, you move on to the next issue. But this time, for me at least, it's different.
The article, which was published online on May 27, 2009, in the New England Journal of Medicine, reviewed the basis for the decision denying coverage for CT colonography in the Medicare program.
Here are the opening paragraphs from that article. Remember, these are the words of the authors, some of whom had either participated in or written the final CMS regulation denying coverage for the test:
In an unprecedented endorsement of evidence-based medicine, the Centers for Medicare and Medicaid Services (CMS) recently decided to deny coverage of computed tomographic (CT) colonography for cancer screening, concluding that 'the evidence is inadequate.' The CMS emphasized that the 'pivotal, overarching concern' in its decision was the fact that the findings of trials showing a benefit of screening with this method were not necessarily generalizable from the study populations to other groups of patients. In particular, the CMS noted that the mean age of participants in the studies that were cited in support of coverage was significantly lower than that of Medicare beneficiaries. There were no studies evaluating this technology in the elderly, nor were there analyses of subgroups of participants over 65 years of age.
Does the CMS's strict application of evidence-based analysis herald a shift in its approach to national coverage decisions? We hope so.
My friends, these comments have serious implications. These are not the words of some outside experts or editorialists who are offering an opinion about how Medicare should make coverage decisions. These are words of the decision-makers themselves.
The key words here are "evidence-based analysis." Just remember that one person's conclusion about the results of such "evidence-based analysis" may not be the same as someone else's. Tweak the data inputs on the models and your evidence-based analysis may go right out the window if you don't have accurate, up-to-date information. An analysis is only as good as the quality, validity, and "timeliness" of the data you have to analyze. Sometimes you have to acknowledge that the data in your model may not be good enough.
In the case of CT colonography, I would argue (as I have previously) that the data used in this analysis was, shall we say, a bit dated. It included studies that looked at old technology, did not consider the new huge costs of treating advanced colorectal cancer with targeted therapies, and didn't address the question of what happens if more people end up getting effectively screened for colorectal cancer and prevent the disease, as opposed to simplistically concluding that CT colonography versus traditional colonoscopy is an either/or decision. And, it ignored the fact that you can't compute the cost of the test if you have not yet determined what the payment will be for that test in the Medicare fee schedule.
The authors go on to say that the quality of evidence for many of the treatments we use for Medicare patients is weak. That is a very true statement, and an unfortunate reality.
In fact, I would maintain that if we applied strict evidence criteria to the diagnosis and treatment of Medicare patients today -- as suggested by this article -- then we could solve the shortfall in the Medicare program tomorrow, because virtually no drug, no test, or any procedure would survive this rigorous "evidence-based analysis" that was applied to CT colonography.
I assure you I am no wild-haired doctor who thinks that the government should pay for anything I want to do for my patients, regardless of cost or other consideration. It is no secret that I believe we must carefully evaluate what we do for our patients, and that we must move to a paradigm where we provide the right care to the right patient in the right place at the right time. Simply stated, in the U.S. we spend way too much money on medical care and don't get sufficient benefit in return. I firmly believe that we need to address the overuse of tests and procedures of little or marginal value, if we are going to "bend the curve" of rising Medicare and medical expenditures.
But when it comes to saving lives, I think we need to be a bit more careful about the conclusions we draw from the evidence that we have, as well as the evidence we don't have.
When there are significant and substantive disagreements about the evidence and the impact of a particular screening test or treatment that is used in the Medicare population, we need to develop approaches that are designed to resolve those ambiguities before concluding that the test doesn't work. We must seek the answers to the questions we must ask. We can do that through the Medicare program, through the judicious use of a process called "coverage with evidence" or CED.
The American Cancer Society and the medical professional organizations that approached CMS about coverage for CT colonography recommended that such a CED process be used in this circumstance. The professional societies agreed to put a rigorous process in place to answer the very questions that CMS was asking. That wouldn't result in wide and unfettered use of the test. Rather, it would continue evaluation of the test while allowing the opportunity to get screened with the test under very controlled conditions. They have already done that with other radiology tests, specifically, PET scans.
CMS denied that request, although they didn't mention that in their "evidence-based" article. They claimed to us that they couldn't use CED under their regulatory procedures because -- unlike PET scans which are used in the treatment of cancer, and for which there is substantially less well-done evidence-based research -- CT colonography is used to prevent cancer.
Other very knowledgeable experts disagreed on their interpretation of the law and their regulations, but the CMS folks were -- in my personal opinion -- too anxious to "just say no" and prove their point that they could stand up to the "special interests" that were pressuring them to do otherwise. Their "article" in the NEJM -- which appeared surprisingly quickly in a journal that is known for very long lead times for publication of scientific articles -- suggests that there may indeed be some foundation to my opinion.
Here is another quote from the article:
These findings suggest that many previously approved interventions may lack evidence of benefit in the Medicare population -- the group for which U.S. taxpayers are footing the bill. We believe that the CMS's decision in the CT colonography case, therefore, is a long-overdue step toward meaningful validation of clinical-trial evidence in Medicare beneficiaries.
But here is what I would call the zinger paragraph, the one that gave me pause and the greatest concern. Remember, these authors are in part the "judges" of the decision. Some of them are or were employees of the agency at the time the decision was under consideration, and had influence on that decision:
Our optimism, however, is cautious. Powerful pressure will inevitably be applied to the CMS. Indeed, after the agency published its draft decision in February, proponents of CT colonography, in a now-familiar pattern, quickly mobilized. More than 350 comments were submitted to the CMS by interest groups, many with a financial stake in use of the technology. Radiologist groups and manufacturers of CT equipment, among others, launched a write-in campaign, conducted congressional briefings, and persuaded 56 members of the U.S. House of Representatives to sign letters urging the CMS to reconsider. Advocates for the medical device industry asserted that the agency lacked the authority to consider data on cost-effectiveness in its decisions. Already at least one representative, Kay Granger (R-TX), has issued a press release expressing the hope that the CMS will reconsider its decision.
Maybe this is the place where I should be grateful that the authors didn't offer full discussion of the events that went on prior to the final decision, but here is the fact: One of those groups who participated "in a now-familiar pattern" was the American Cancer Society. We submitted comments, we participated in public and private meetings with CMS, and we participated in a congressional briefing where I personally presented a discussion about colon cancer and the potential value of cancer prevention and early detection, which in our opinion includes CT colonography. But maybe mentioning the American Cancer Society would suggest that not everyone who promoted coverage of this test had a direct financial interest in the outcome. Maybe we aren't viewed to be as villainous as the others the regulators singled out in their article. Whatever the reason, we were there because we have come to the conclusion that this test would save lives from a preventable disease.
(By the way, to my knowledge, we have made no direct contact with any legislator about this issue, nor participated in any group which asked Congress to approach CMS on this issue.)
After all, we had published a guideline in March 2008 and came to the conclusion that CT colonography was a useful test -- in fact, a preferred test -- to prevent and detect colorectal cancer. We did so independently. We don't make CT scanners, we are not a medical device manufacturer, we have no patents on the technology, and we don't earn our living from doing the test. We just represent the ordinary person out there who may want to avoid a fatal disease.
One more thing -- you should not be singled out as a scoundrel for pleading your case to federal regulators.
Last time I checked, this is a democracy. You are allowed to let your elected representatives know your position, and you are allowed to submit your comments to regulators about pending regulation and even to speak to them about your concerns. It is not illegal, unethical, inappropriate, inconsiderate, or anything else. It is part of the way we make decisions in this country.
Here's more from the article:
Indeed, it is worth asking why the CMS has acted differently this time. Perhaps the agency is responding to the current economic reality: with the Medicare hospital insurance trust fund projected to become insolvent by 2017, the CMS no doubt recognizes the need to ensure that we are spending Medicare dollars, first and foremost, on improving the lives of Medicare beneficiaries. With Medicare expenditures increasing at an unsustainable pace, the CMS appropriately -- indeed, necessarily -- considered whether the procedure is effective in its beneficiaries.
I don't want to sound cynical here, but last time I checked, Medicare was supposed to provide coverage for reasonable and necessary medical care. The fiscal issues are nothing to sneeze at. They are very real, very legitimate, and, for many of us, immediate concerns. But that is a legislative issue. The key words for Medicare are "reasonable and necessary."
I would propose that we need to move forward with CT colonography under a CED process, and answer the legitimate disputed question about cost-effectiveness. The American Cancer Society obviously believes the test is "reasonable and necessary" and in fact considered it "preferred" as a means of finding colorectal polyps before cancer develops and invasive cancers at an early stage.
There is no question but that the costs of medical care are a real and pressing concern. We are in the midst of an intense debate about the financing of healthcare in this country. Part of that debate includes a discussion at the political/legislative level about what treatments and medical services we will pay for going forward, and how we will make those decisions. That is part of the public debate, as it should be. But now we have the regulators stepping out in front of everyone else in claiming they will solve the problem, even if the premises on which they base their decision may be subject to criticism.
What is the problem with their premises? The technology on which many of the effectiveness studies have been done was old technology. Assumptions regarding the use of the test may be flawed. The cost data was from a past era in the treatment of colorectal cancer.
Even President Obama acknowledged in his speech to the American Medical Association (AMA) the other day that one of the measures that will save us billions of dollars in healthcare costs over the next decade will be making biologic therapies -- read that "targeted therapies" in cancer care -- available as generics as soon as possible.
What you may not know is that the costs of biologics are rising, and rising quickly, in the Medicare program. And these drugs are used to treat advanced colorectal cancer. And the "cost-effective analysis" done by Medicare gave the costs of those drugs no consideration, since it was based on data from earlier in this decade before biologics were even available to treat this disease.
So, the president knows this issue. His regulators obviously do not. Prevent a colon cancer and you may just save the system a whole lot of money, not to mention someone's life.
As to CMS' cost-effectiveness analysis itself, I heard another presentation at the recent meeting of the American Society of Clinical Oncology (ASCO) that disputed the CMS' "definitive" conclusion. Although the presenter acknowledged the issue, he concluded that the data on the newer CT colonography technology is simply insufficient to draw meaningful, firm conclusions. And, my friends, he is not a gastroenterologist, a radiologist, or a medical device manufacturer. He is a highly respected chairman of a department of internal medicine at a major medical center.
Here is the concluding paragraph from the article:
We applaud this landmark decision, and we hope that the agency remains firm in its evidence-based approach and extends its application as healthcare reform proceeds.
Given the fact that two of the authors on this article were directly involved in the CMS decision, it sounds more like a pat on the back than applause from the audience.
My bottom-line concern? We need to fix this system and this process, but we need to do so in a way that is realistic and not absolutist.
Those of us who tried to work with CMS to get this done the right way (and offered concrete suggestions on how to do that) ended up being vilified in the pages of the world's leading medical journal. That is not a comfortable place to be.
If this is the attitude that we are going to have to deal with as we move forward in tackling these difficult issues, then that portends real difficulties as all of us try to work together to solve the very real problems we face when it comes to improving the quality and costs of our healthcare delivery system.
Simply stated, there has to be a better way. Publicly questioning and criticizing the motives of others in the pages of the New England Journal of Medicine is not going to get us where we need to be.
By Dr. J. Leonard Lichtenfeld
AuntMinnie.com contributing writer
June 24, 2009
Dr. Lichtenfeld is deputy chief medical officer for the American Cancer Society, and a board-certified medical oncologist and internist who was a practicing physician for more than 19 years. He is responsible for directing the society's Cancer Control Science Department, an internationally recognized group of experts who are responsible for producing the society's widely recognized guidelines for the prevention and early detection of cancer, including the role of nutrition and physical activity. Lichtenfeld also serves as a liaison for the society with many professional and public organizations. He is a member of the Relative Value Update Committee (RUC) of the AMA, which works with CMS to update the Medicare Physician Fee Schedule. Dr. Lichtenfeld is a member of CMS' Medicare Evidence Development and Coverage Advisory Committee. His regular commentary on topics of interest to the medical community can be found at Dr. Len's Cancer Blog.
Related Reading
NEJM editorial lauds CMS rejection of VC, May 28, 2009
CTC advocates urge CMS to scrap decision, May 14, 2009
CMS rejects Medicare coverage for virtual colonoscopy, May 12, 2009
CMS rejects case for virtual colonoscopy reimbursement, February 12, 2009
American Cancer Society recognizes virtual colonoscopy screening benefit, March 5, 2008
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