C3: Colorectal Cancer Coalition Comments Regarding the Centers for Medicare andMedicaid Services National Coverage Analysis on Computed TomographyColonography and the Proposed Decision Memo for Screening Computed TomographyColonography 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. Weappreciate 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 TomographyColonography (CTC) for Colorectal Cancer (CAG-00396N)

, our past comment on thisissue

, and the many references available, C3 believes that there is sufficient evidence torecommend CTC to screen for colorectal cancer in the Medicare population. While we agreewith CMS that there is limited data in the Medicare population, we believe that the existingdata supports coverage of CTC by CMS. No one disputes that colorectal cancer screening saves lives and savesmoney. At the sametime, almostevery article about screening acknowledges that it is under-utilized. CTC provides theunique option of a whole-bowel, non-invasive visualization of the colon andrectum. This option is important for people who will not or cannot undergo opticalcolonoscopy

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.C3 recognizes that CMS and the US Preventive Services Task Force

(USPSTF) disagreewith our conclusion. Both CMS and USPSTF want to see additional supportive data prior toadopting CTC for screening.

C3 RecommendationTherefore, C3 strongly urges CMS to gather the evidenceby approving coverage of CTC, and implement the new coverage through a Coverage with Evidence Development(CED) process.

CED will generate additional safety and efficacy data in people over theage of 65, a population that is typically under-represented in clinical research. CED can alsogenerate information that will help to identify patients who can benefit from CTC as opposedto 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 determinewhether CTC is appropriate for people over age 65.

C3: Colorectal Cancer CoalitionComments to CMS regarding CTC, March 9, 2009Page 2 of 4Background 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 ColorectalCancer and the American College of Radiology consensus guidelines (ACS-MSTFCC-ACR consensus

) foundthat “

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 oneof the“

tests that are effective at detecting cancer and premalignant adenomatous polyps.”

Since the release of the ACS-MSTFCC-ACR consensus guidelines, results from theAmerican College of Radiology Imaging Network (ACRIN) National CT Colonography Trialhave been published

. These results found similar sensitivity between CTC and opticalcolonoscopy 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.

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In October 2008, we believe that the USPSTF confusedthe screening issue for patients andadvocates by dissenting from the ACS-MSTFCC-ACR consensus. They concluded, “

Theevidence is insufficient to assess the benefits and harms of computed tomographiccolonography and fecal DNA testing as screening modalities for colorectal cancer. (I statement)”.

As a result, their recommendations for screening methods include only fecaloccult 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

.Furthermore, sigmoidoscopy alone offers only partial bowel screening, and misses proximal polyps andtumors. Women are significantly more likely to have proximal polyps (42.2%

31.5%,

<0.001)

, further limiting the usefulness of sigmoidoscopy.As C3 reviewed the material supporting the CMS national coverage decision, we found thatthe USPSTF recommendations and the computer simulations that supported it were stronglyinfluential at the MEDCAC meeting. We urge fuller reconsideration of the supportingevidence 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

C3: Colorectal Cancer CoalitionComments to CMS regarding CTC, March 9, 2009Page 3 of 4

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 tocolonoscopy 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 ridehome.While anecdotal information has limited usefulness, we believe that the relatively low uptakeof colorectal cancer screening illustrates public concern with existing methods of screening.The ACS-MSTFCC-ACR consensus guidelines point out that, “

CTC surveillance could beoffered 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-SocietyTask 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 patientswho 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 andthe 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 differentscreening options are available, choices with varying benefits, risks, and payment coveragecan confuse patients and physicians.CMS coverage with evidence development of CTC will generate data that can resolve thisconfusion and provide significant public benefit.

Conclusion

C3 urges reconsideration of the non-coverage decision by CMS, and strongly urgesCMS to gather the evidence by approving coverage of CTC, and implementing thenew coverage through a Coverage with Evidence Development (CED) process.

About C3

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

C3: Colorectal Cancer CoalitionComments to CMS regarding CTC, March 9, 2009Page 4 of 4

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 whichcan 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