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CT Colonography: Medicare Failed to Meet Challenge

by Dr. Len May 12, 2009

We now have the “final answer” from Centers for Medicare and Medicaid Services as to whether or not they will provide coverage for colorectal cancer screening with CT colonography under the Medicare program.  And the answer is: no.


To say the least, I am personally very disappointed.  Not that my opinion should be the driving force on a decision that may affect the lives of thousands of people.  But this is something that became a bit of a “cause” for me, in no small part because I felt it represented an opportunity to advance our medical science and knowledge at a time when lives could be saved.  It was an opportunity in my view to start setting the stage on how we can do things the right way in health care going forward, which will be a critical part of any reform effort.


In my opinion, we have failed to meet the challenge.


For me, the issue was reasonably straight forward.  We lose close to 50,000 people every year in this country from colorectal cancer.  We could save thousands of lives if we were able to get people screened for this disease.  The American Cancer Society believes that we should favor tests that prevent cancer, and has endorsed CT colonography as a reasonable test for this purpose.


For the most part, colorectal cancer is a disease of the Medicare population.  We can’t cheat death forever, but we could prevent needless suffering and deaths from colorectal cancer if we were able to screen more Medicare beneficiaries.


We aren’t making the grade with the screening tests we already have, for a variety of reasons.  If we were going to embrace a “prevention strategy” for colorectal cancer through the use of routine colonoscopy, research has shown that it would us years to have everyone screened.  There are simply not enough gastroenterologists around to get the job done nationwide.


CT colonography isn’t perfect, but it certainly appears to be a very reasonable test.  It is my opinion and the opinion of others that it would expand the opportunity for colorectal cancer prevention and early detection strategy to more people throughout the country.


Yes, there are questions as pointed out by CMS in their decision about detection of small polyps.  And there are questions about what happens if the scan shows an abnormality elsewhere, such as an unexpected lesion in the kidney or an aneurysm in the aorta.  And there are questions about radiation dosage.


Perhaps the most significant question as to what to do if a polyp is found and the patient has to undergo a se cond bowel prep for a colonoscopy on another date.  Not a pleasant thought, for sure.


How to solve the dilemma on what to do when opinions among respected experts differ?


We made a proposal to CMS that they consider a “coverage with evidence” decision (CED).  This would have allowed CMS and respected professional organizations perhaps along with the American Cancer Society to set up strict rules to follow patients who got screened for colorectal cancer with CT colonography so we could get the data, measure the effectiveness of the test, and answer the questions that have been raised.


CMS said repeatedly they couldn’t do a CED for CT colonography because it is a screening test.  They did have such a program for PET scans, but that was OK in their opinion because PET scans are used in the diagnosis and treatment of disease.


So much for preventing cancer as opposed to treating it.


There were other issues, such as how much CT colonography costs.  Truth be told, CMS knows there is no answer to that question, because they haven’t established a payment for the test.  That process is currently underway, and may now be stalled because of the agency’s decision not to cover the test.  And, more gastroenterologists are requiring their patients to have general anesthesia for a routine screening colonoscopy, which can substantially increase the costs for the procedure.


So any statements about the cost of CT colonography in comparison to routine colonoscopy is a pure guess in my opinion.


And when the experts looked at the costs of treating colorectal cancer in their cost-effectiveness analysis, they used old data that didn’t use the expense of the newer targeted therapies and other chemotherapy drugs used in treating advanced colorectal cancer.  These newer costs can quickly run into the hundreds of thousands of dollars, tilting the balance clearly in favor of screening and prevention as opposed to treatment of advanced disease.


So the argument goes on. 


In its comments released today, CMS frequently cites the lack of medical data on the use of this test in patients aged 65 and over.  With this decision today, it is likely we will never develop such data.


We need a better way in this country to find out what works and what doesn’t in medical care.  When it comes to saving lives, we have a problem when we can’t get the answers we need.  We need a system that can look at procedures that could have a major impact on saving lives and answer the questions that have been asked, rather than just dumping it on the heap of “non-coverage” to hopefully be reexamined another day, maybe within the next ten or fifteen years.


If I seem a bit angry, maybe I am.  I thought this would be the opportunity to do something right, to answer the questions that have been asked, and address a major public health need.


Goodness knows I don’t have all the answers, but I do hope that I have the common sense to understand that when there are significant disagreements by respected experts, and when the issue at hand is saving lives and saving people, that we would look beyond questionable assessments and find a path to get to the right conclusion, whatever that may be.


It’s ok to say “no,” but it is much better to say “how do we resolve the questions for our better health?” Here was a chance to do just that, and we have failed to meet the challenge.


Unfortunately, if this is a harbinger of things to come this is not a good sign for the future of reforming healthcare in this country.

Filed Under:

Colon Cancer | Prevention | Screening


5/13/2009 10:08:22 AM #


You stated: “[M]ore gastroenterologists are requiring their patients to have general anesthesia for a routine screening colonoscopy, which can substantially increase the costs for the procedure.”  Do you really mean “general anesthesia”?  If you did then this alarms me more than the main point of your blog.  This is a screening test not surgery.  I’m less worried about the cost than I am about the risks.  In my opinion conscious sedation is risky enough but general anesthesia for a screening test adds even more risk.  Colonoscopy screening already has a 1 in 1700 risk of bowel perforation which goes to 1 in 700 if there is polyp removal.  Plus there have been problems reported with the bowel prep.  A virtual CT colonoscopy might be OK if you take the position that it’s better than nothing but I personally don’t like the radiation exposure it would inflict and you still need the bowel prep and if they find something you’ve got to come back again for a real colonoscopy.  And if you were to open up CT colonography to “lots” of people then these machines will be less available for diagnostic use.  And finally, what about DNA based stool testing?  Who’s looking into this potential method of screening?  If it’s proven to work at least as well as colonoscopy then it would probably be cheaper and it wouldn’t tie up expensive diagnostic equipment.  So the bottom line for me is maybe Medicare saying no to CT colonagraphy is a good thing in that it will keep the motivation going for researching other ways of colon cancer screening.


5/13/2009 10:21:43 AM #

Len Lichtenfeld

Yes, i meant general anesthesia with a drug called propofol administered in the ouptatient facility.

As to stool dna tests, the American Cancer Society includes this as a choice for screening, but because it detects cancer and does not prevent it, it was not a "preferred" test.

Len Lichtenfeld

5/18/2009 4:16:42 PM #


But would virtual colonoscopy prevent cancer or just detect cancer?  In my view it would do neither.  If polyps are found on a virtual colonoscopy a real colonoscopy would have to be done to remove and test the polyp.  And there is a limit on the smallest polyp that can be detected with virtual colonoscopy.  And not all potential or real cancers present as polyps that can be easily seen on a virtual colonoscopy..  Based on my view I don’t see how virtual colonoscopy could ever become a “preferred” test.


5/28/2009 9:01:03 AM #

Gregory D. Pawelski

Radiologist groups and manufacturers of the equipment launched a write-in campaign and persuaded some members of Congress to sign letters urging CMS to reconsider. They claim that the agency lacked the authority to consider data on cost-effectiveness in its decisions. The industry lobbying ignored the evidence that had been thoroughly documented by the Agency for Healthcare Quality and Research technology assessment. And authors of an article in this week's New England Journal of Medicine noted that screening for colorectal cancer is one of the few medical procedures where Medicare is allowed to consider costs when considering coverage decisions. "Given the economic realities facing Medicare, health care reform must include explicit authority for the CMS to consider costs in all its coverage decisions in order to assess the true value of a given procedure."

Gregory D. Pawelski

5/28/2009 9:57:21 AM #

Len Lichtenfeld

I want to emphasize that the ACS did not participate in a write in campaign to Congress, nor have we contacted Congressional staff on this issue.  I would also point out that the cost effectiveness decision was based on "replacing" optical colonoscopy patients with the virtual test.  There is evidence that CT colonography actually increases the number of people screened, and in that scenario the "cost effectiveness" argument loses some of its steam.  The cost effectiveness analysis also failed to include the much higher costs of treatment associated with the newer targeted therapies now widely used in treating metastatic colorectal cancer.

The reality is that a minority of patients have polyps, and in the CT screened population the number of polypectomies was substantially less than in the optical group.  Yes, people with larger polyps would need a routine colonoscopy, but a significant majority of patients would not.

Recognizing that questions remained, we did argue that CMS could have chosen a "coverage with evidence development" approach, where the various organizations would have worked with CMS to put together an analytic program to carefully follow patients who chose CT colonoscopy and compared outcomes and costs to those who chose traditional colonoscopy.

Although knowledgeable experts familiar with CMS rules and regulations thought this was an option, CMS staff rejected it as beyond their scope.  Their justification was that this was a screening test, and in their opinion they could only do CED programs for treatment-oriented tests, such as PET scans.  The potential for saving lives--which I consider to be a significant element in this debate--did not enter into the discussion.

Going forward, we are going to have to have a better means of developing evidence and policy when it comes to saving lives and reducing costs.  Continually looking backwards at studies that someone else has completed will not always answer the legitimate coverage questions that will inevitably arise as we move (for better or worse, depending on your opinion) to a more centralized health care system.


Len Lichtenfeld

About Dr. Len

Dr. Len

J. Leonard Lichtenfeld, MD, MACP - Dr. Lichtenfeld is Deputy Chief Medical Officer for the national office of the American Cancer Society.