ACR, Patient Groups, Industry Make Case for CTC Coverage

Despite significant evidence of CT colonography’s effectiveness as a screening tool for colorectal cancer, on Feb. 11, the Centers for Medicare and Medicaid Services (CMS) announced a proposed decision not to cover the exam, stating that the evidence was inadequate to conclude that CTC would provide health benefits to the average Medicare beneficiary.

In the CMS proposed decision memo, opponents to coverage cited unknown effects from radiation exposure associated with the exam, questions as to the amount of training necessary to properly read the exam, and concern that it would be difficult to generalize the results of the ACRIN CT Colonography Trial to the average practice setting and specifically to the Medicare population.

The ACR and other societies have been working together to reverse CMS’s proposal by educating members of Congress that using CTC as a screening method for colorectal cancer will help more people to get screened, aid in early detection and ultimately help save lives.

At a Capitol Hill briefing last Monday, Elizabeth McFarland, M.D., chair of the ACR Colon Cancer Committee, made a presentation to congressional and regulatory staff members on behalf of the College as to the effectiveness and importance of this exam. In response to these efforts, several lawmakers have signed on to letters written to CMS urging them to cover CTC.

In a letter to the editor published in Saturday’s New York Times, Andrew R. Spiegel, chief executive of the Colon Cancer Alliance, Ilyse Schuman, managing director of the Medical Imaging and Technology Alliance, and myself, reinforced the proven cost-effectiveness of CTC as well as its “potential to enhance colon cancer screening compliance.”

The 30-day public comment period for the proposal ended on Friday, CMS is expected to make a final (at least for the immediate future) decision on coverage by May 12.

For those of you who currently offer/perform CTC:

• Has your practice seen an increase in CTC volume since the results of the ACRIN study were published in the New England Journal of Medicine last fall or a decrease since CMS proposed not to cover the exam?

And if you do not currently offer/perform CTC:

• Will Medicare’s final coverage decision determine whether or not you add this exam to your practice or seek out training?
  
  

I look forward to your thoughts.

Comments

[William A. Ladd]

CTC is an example of "the emperor's new clothes". I see nothing particularly attractive about it. You still need a bowel prep, you still need to have a tube stuck through your anus, you still need to have your colon inflated like a balloon, and if anything is found, you need a real colonoscopy to evaluate or remove it. On top of that, you get a nice radiation dose to you entire abdomen and pelvis. I do not believe that a screening test should carry an abdominal CT-level radiation dose. (Screening chest CT is different, because the dose can be much lower due to the reduced soft tissue in the path, and these are advocated only for those at elevated risk, not the general population.) Remind me about what the supposed advantage of CTC is over conventional colonoscopy, please. I somehow forgot.

All of the radiologists I know have gotten a regular colonoscopy, and that is the recommendation I give to all my non-medical friends. One of the smartest people I've ever known was a subject in a Harvard study comparing virtual and real colonoscopy. He said he would in the future only have real colonoscopy, mainly because the VC was so uncomfortable. But people don't equate its discomfort level to that of conventional colonoscopy, so you don't get conscious sedation for VC like you do with real colonoscopy.

It is interesting that radiologists are enthusiastically embracing CTC, because not only is it a bad test, but it will unavoidably throw radiologists and gastroenterologists into a turf battle. Just what we need! Most of the support for this comes from academic radiologists, who generally get excited about anything new, since it makes for easy publication fodder for their CV's. And they don't care that the reimbursement per unit radiologist time is much lower than for a conventional abdominal and pelvic CT scan. (Again, somebody please tell me the good points.)

[Abraham Dachman, MD, FACR]

The comments by William Ladd are important in showing that the radiology community has not succeeded in eliminating misconceptions and inaccurate information within the medical community.

The advantages of CTC are as follows: CTC is minimally invasive (if not non-invasive), can be done in an outpatient setting, and does not require sedation (a patient can come alone and drive themselves home or to work). Only half (at best) of those 50 and older who should be tested for CRC opt to be screened due to the discomfort, inability to work or drive after sedation, wait times and safety concerns associated with colonoscopy and other CMS covered exams. All of these factors make CTC attractive to patients who otherwise would not be tested at all.

Regarding the need for colonoscopy after CTC, in a screening CTC cohort the referral rate to optical colonoscopy (OC) is about 8% so a patient has a 92% chance of not needing an additional test. At OC every tiny polyp is removed which often results - from a CTC screening perspective - in many unnecessary charges and complications from the exam or from a biopsy that may show hyperplastic polyps (or even normal mucosa), or result in bleeding or perforation from the OC or biopsy (1/1000 normal OCs without polypectomy and 1/500 with polypectomy).

In our practice the radiation dose is 1-2mGy/series and even higher rates of 4-6mGy are well below the radiation that patients get every year without having any radiologic tests. In the recent ACRIN Trial, CTC used only half the radiation dose of the average abdominal CT scan (and equal to double contrast barium enema - already covered by Medicare). With increased training and advancing technology, even that low CT dose is likely to decrease.

Let's not forget that CRC screening is effective in reducing cancer rates and deaths, that CRC screening rates in the US are still poor, that CRC is the second most common cause of cancer deaths in the USA (combined date for men and women) and that the number of endoscopists is insufficient to fill this need. Also, many patients have barriers to undergoing colonoscopy (e.g. incomplete colonoscopy, anticoagulated, etc.). CTC is a more viable option for these patients.

There are MANY, many advantages to using CTC for wider screening of CRC. I encourage all radiologists to attend any of several CTC courses available to learn the truth about CTC.

[William A. Ladd]

The comments by my esteemed colleague Dr. Dachman indicate that I should have more clearly identified myself. My apologies.

I am a diagnostic radiologist, trained at MGH, with BS and MS degrees in physics from MIT, and a former graduate student in the Harvard-MIT Health Science and Technology program. I am in a large prestigious private practice and am a Voluntary Associate Clinical Professor at a top University. I have been reading CTC's for 4-5 years.

I stand by my previous comments. Many radiologists are enthused about CTC. I am not one of them. I strongly support its use for patients who have contraindications for conventional colonoscopy or "failed colonoscopy", but I do not believe it should be used as a screening tool. When used not for screening, this places us in the position of helping the gastroenterologists when they need us, but not competing with them.

In capable hands, colonoscopy is very safe and the risk of an unnecessary biopsy is virtually zero. Naturally, there are those who are more dangerous, less skilled, practitioners, and those who will biopsy anything in order to get paid extra. I guess one drawback of colonoscopy is that the general public has a hard time finding out who these people are.

A drawback of CTC I didn't mention before is the existence of flat lesions. Another is the frequent discovery of clinically insignificant incidental findings without the requisite confident dismissal by the radiologist, resulting in frightening, unnecessary, and expensive workups. This problem has been discussed and condemned in the context of screening body CT's done for cash.

I recently had an optical colonoscopy. The only problem was the prep, which I would have had anyway for a CTC. I was awake, not uncomfortable, and it only took a few minutes. I never even considered having a CTC.