C3: Colorectal Cancer Coalition Comments Regarding the Centers for Medicare and Medicaid Services National Coverage Analysis on Computed Tomography Colonography and the Proposed Decision Memo for Screening Computed Tomography Colonography for Colorectal Cancer (CAG-00396N)
March 9, 2009
These comments are submitted by C3: Colorectal Cancer Coalition (C3), a non-profit, nonpartisan advocacy organization committed to the fight against colon and rectal cancer. We appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis (NCA) on Computed Tomography Colonography (CTC) and the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N).
After careful review of the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)[i], our past comment on this issue[ii], and the many references available, C3 believes that there is sufficient evidence to recommend CTC to screen for colorectal cancer in the Medicare population. While we agree with CMS that there is limited data in the Medicare population, we believe that the existing data supports coverage of CTC by CMS.
No one disputes that colorectal cancer screening saves lives and saves money. At the same time, almost every article about screening acknowledges that it is under-utilized. CTC provides the unique option of a whole-bowel, non-invasive visualization of the colon and rectum. This option is important for people who will not or cannot undergo optical colonoscopy[iii].
C3 recognizes that CMS and the US Preventive Services Task Force[iv] (USPSTF) disagree with our conclusion. Both CMS and USPSTF want to see additional supportive data prior to adopting CTC for screening.
Therefore, C3 strongly urges CMS to gather the evidence by approving coverage of CTC, and implement the new coverage through a Coverage with Evidence Development (CED) process. A CED will generate additional safety and efficacy data in people over the age of 65, a population that is typically under-represented in clinical research. CED can also generate information that will help to identify patients who can benefit from CTC as opposed to optical colonoscopy.
A complete denial of coverage is akin to “throwing the baby out with the bathwater.” Thus, we urge CMS to use its unique ability to generate data from its consumer base, and determine whether CTC is appropriate for people over age 65.
Background for C3 Recommendation
Evidence that CTC is an Effective Colorectal Cancer Screening Tool
In March 2008, the American Cancer Society in collaboration with the Multi-Society Task Force on Colorectal Cancer and the American College of Radiology consensus guidelines (ACS-MSTFCC-ACR consensus[v]) found that “Based on the accumulation of evidence . . . the expert panel concludes that there are sufficient data to include CTC as an acceptable option for [colorectal cancer] screening.” CTC is included in their recommendations as one of the “tests that are effective at detecting cancer and premalignant adenomatous polyps.”
Since the release of the ACS-MSTFCC-ACR consensus guidelines, results from the American College of Radiology Imaging Network (ACRIN) National CT Colonography Trial have been published[vi]. These results found similar sensitivity between CTC and optical colonoscopy to find polyps over 1 cm. CTC in the National CT Colonography trial found 90 percent of larger polyps over 1 cm and 78 percent of those 6 to 9 mm. The nationwide, 15-site study supported earlier research with similar results.[vii] [viii][ix]
In October 2008, we believe that the USPSTF confused the screening issue for patients and advocates by dissenting from the ACS-MSTFCC-ACR consensus. They concluded, “The evidence is insufficient to assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer. (I statement)”. As a result, their recommendations for screening methods include only fecal occult blood testing, sigmoidoscopy and colonoscopy.
However, neither FOBT nor sigmoidoscopy has the single-test sensitivity of CTC, and false positives from FOBT lead to unnecessary colonoscopy in about one-third of cases[x]. Furthermore, sigmoidoscopy alone offers only partial bowel screening, and misses proximal polyps and tumors. Women are significantly more likely to have proximal polyps (42.2% vs 31.5%, P < 0.001)[xi], further limiting the usefulness of sigmoidoscopy.
As C3 reviewed the material supporting the CMS national coverage decision, we found that the USPSTF recommendations and the computer simulations that supported it were strongly influential at the MEDCAC meeting. We urge fuller reconsideration of the supporting evidence for the ACS-MSTFCC-ACR guidelines and the results of the ACRIN trial.
Reaching Screening Candidates Who Refuse Optical Colonoscopy
We regularly hear from people who adamantly refuse colonoscopy screening. They relate personal stories of family or friends who experienced excessive pain or perforation of the colon. Some worry that surgery or heart conditions might make them more vulnerable to colonoscopy complications. While bowel preparation is the most frequently given reason for avoiding colonoscopy, patients also are concerned about the invasiveness of the procedure, the size and length of the scope, being sedated, having to miss work, and needing a ride home.
While anecdotal information has limited usefulness, we believe that the relatively low uptake of colorectal cancer screening illustrates public concern with existing methods of screening.
The ACS-MSTFCC-ACR consensus guidelines point out that, “CTC surveillance could be offered to those patients who would benefit from screening but either decline CSPY (colonoscopy) or are not good candidates for CSPY for one or more reasons.”
The American Society for Gastrointestinal Endoscopy, a member of the US Multi-Society Task Force on Colorectal Cancer, does not recommend CTC for “widespread screening” but points out in their 2008 Screening Recommendations, “However, it may be useful for patients who refuse colonoscopy or who have had an incomplete colonoscopic examination.”
Patients Need Clear Guidance
C3 is concerned that there is an important difference in the screening recommendations between ACS in collaboration with the Multi-Society Task Force on Colorectal Cancer and the American College of Radiology and the guidelines from the US Preventive Services Task Force. While the ACS-MSTFCC-ACR consensus includes CTC as a screening option to prevent colorectal cancer, the USPSTF does not. In an environment where several different screening options are available, choices with varying benefits, risks, and payment coverage can confuse patients and physicians.
CMS coverage with evidence development of CTC will generate data that can resolve this confusion and provide significant public benefit.
C3 urges reconsideration of the non-coverage decision by CMS, and strongly urges CMS to gather the evidence by approving coverage of CTC, and implementing the new coverage through a Coverage with Evidence Development (CED) process.
C3 pushes for research to improve screening, diagnosis, and treatment of colorectal cancer; for policy decisions that make the most effective colorectal cancer prevention and treatment available to all; and for increased awareness that colorectal cancer is preventable, treatable, and beatable. More information can be found at www.FightColorectalCancer.org.
C3 believes in fully disclosing sources of financial support, per our disclosure policy which can be viewed at www.FightColorectalCancer.org/sponsors. C3 has received no financial or in-kind support from manufacturers of CTCs. None of our other corporate supporters have influenced our comments on this issue.
[iii] Levin B, Lieberman DA, McFarland, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Published online March 5, 2008. CA Cancer J Clin. 2008;58:
“CTC surveillance could be offered to those patients who would benefit from screening but either decline CSPY (colonoscopy) or are not good candidates for CSPY for one or more reasons.”
The American Society for Gastrointestinal Endoscopy, a member of the US Multi-Society Task Force on Colorectal Cancer does not recommend CTC for “widespread screening” but points out in their 2008 Screening Recommendations, “However, it may be useful for patients who refuse colonoscopy or who have had an incomplete colonoscopic examination.”
[iv] U.S. Preventive Services Task Force (USPSTF). Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2008;149:627-637. Available at http://www.ahrq.gov/clinic/uspstf08/colocancer/coloartwhit.htm
[v] Levin B, Lieberman DA, McFarland, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Published online March 5, 2008. CA Cancer J Clin. 2008;58
[vi] Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, et al. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med 2008;359:1207-17.
[vii] Johnson CD, MacCarty RL, Welch TJ, Wilson LA, Harmsen WS, Ilstrup DM, Ahlquist DA. Comparison of the relative sensitivity of CT colonography and double-contrast barium enema for screen detection of colorectal polyps. Clin Gastroenterol Hepatol 2004;4:314-321.
[viii] Kim DH, Pickhardt PJ, Taylor AJ, Leung WK, Winter TC, Hinshaw JL, et al. CT Colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med 2007;357:1403-12.
[ix] Pickhardt PJ, ChoiRJ, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003;349:2191-200.
[x] Ronsohoff DF, Lang CA. Screening for colorectal cancer with the fecal occult blood test: a background paper. Ann Intern Med. 1997;126:811-22.
[xi] Koo et al. Improved Survival in Young Women With Colorectal Cancer. The American Journal of Gastroenterology (2008) 103, 1488-1495