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Date: 05/23/2008
- CTC should NOT be approved. - There are multiple published studies indicating that it is an INFERIOR test compared to visual colonoscopy - it has missed polyps and it has missed colon cancers also when compared to visual colonoscopy. - The only studies that show some benefit were done at "expert" centers by "ctc experts" and hence that level of performance will not be duplicated by all radiologists - also the plan to "monitor" small polyps found on ctc as proposed by the radiology societies is simply bordering on malpractice as there is clear evidence that even small polyps can have cancer on pathology evaluation when removed and evaluated under microscope. - the patient also has to undergo colon preparation prior to ctc also just like in visual colonoscopy and ctc is done with no sedation hence the patient is in more discomfort -if a polyp is found on ctc then the patient and insurance company will have to incur ADDITIONAL EXPENSE and inconvenience to undergo regular visual colonoscopy to remove the polyp and that will likely be on a different day and hence after another colon prep. Wheras with visual colonoscopy the polyps are all removed out at the same time as the test. -the screening ctc repeat interval duration is also shorter at 5 years and hence there is additional expense in doing more tests. - it is yet unknown to what extent the body will be harmed by the massive doses of radiation during a ct scan - the radiation is multiple times that of any plain xray - hence to expose a patient to unecessary radiation is not good as visual colonoscopy can be done without any radiation exposure. - any new test should be approved only if there is clear benefit over existing tests and in this case ctc clearly has NO additional benefit over visual colonoscopy.
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Title: MD, PhD
Organization: Scottsdale Medical Imaging
Date: 05/23/2008
I would strongly urge Medicare to initiate reimbursement for CT
colonography. Results of the national multicenter CTC trial (ACRIN
6664) have shown that this an effective screening tool. Adding an
effective screening tool only improves our chances of preventing
colon cancer, and its associated morbidity and mortality. As with
all disease, early prevention is critical and ultimately cost effective.
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Title: Physician
Organization: Brigham and Women''s Hospital
Date: 06/10/2008
To whom it may concern, As a fellow in gastroenterology, I have used CTC in the evaluation of patients who have failed or difficult colonoscopies for a variety of indications and have found it useful. I also think it is an excellent tool for cancer detection (visualizing lesions that have already become advanced cancers). But I have been following the literature closely and have several reservations about the use of CTC in cancer prevention which is one of the goals of a colorectal cancer screening program. Cancer prevention relies on the ability to detect pre-cancerous lesions or "polyps." A well-publicized study by Soetikno and colleagues described the high malignant potential of flat polyps that by definition cannot be detected by CT (and are difficult even to see during colonoscopy). This study should be repeated and verified in other populations before the jury decides on flat polyps. In addition to flat polyps there is the issue of small polyps. Radiologists recognize the limited ability to detect lesions less than 6mm, and have agreed not to disclose these smaller polyps to patients and their providers even when these lesions are visualized! Aside from ethical concerns of this lack of disclosure, I feel that this diminishes the prevention aspect of screening. Interestingly, in less well-publicized research in Clinical Gastroenterology Hepatology, Gupta and colleagues showed that radiologist often underestimate the size of the polyps that they seen, which means that even larger polyps may go unreported and undetected. Finally, many of the large CTC studies cull out super-expert readers even from among groups of expert radiologists. I believe in the ACRIN study (the results to be released in December)...the investigators excluded 2 board certified radiologist because of poor performance on a reading exam; these results are therefore not generalizable to the abilities of the radiology community. Finally, CT scans, unlike MRIs and ultrasound, subject people to ionizing radiation. Repeated exposure (every 5 years) to radiation, would undoubtably increase cancer risk. In summary, with rapidly improving technology in the area of imaging, capsule tests, etc, I am confident that we will soon find a screening test for colorectal cancer that is noninvasive and accomplishes the goal of cancer prevention and detection without exposing patients to immeasurable risks like radiation. I look forward to the day when I can offer this type of test to my patients. I think adopting CTC as a screening test at this point is premature. Thank you kindly for allowing me to submit my opinion. Sincerely, Jaya Agrawal
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Date: 06/11/2008
CTC should NOT be approved as a standard
screening test for colorectal cancer.
This is an appropriate test for patients who have
failed conventional colonoscopy, and it should be
approved in those settings but it must not be
widely applied to the general public as a
frontline screening option due to extensive CT
associated radiation simply for ''screening'' and
the fact that any lesions found cannot be removed
even after so much radiation exposure any the
person would again need a second colonoscopy for
this. Lastly the test is not as good as a
conventional colonoscopy and many polyps may be
missed giving a false sense of security!
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Date: 06/11/2008
To Whom It May Concern:
I fully support virtual colonoscopy. According to what I have read, Virtual Colonoscopy has been clinically proven to be as effective as optical colonoscopy, the current gold standard, in several major studies. Virtual colonoscopy, being minimally invasive, drastically improves the chances that the majority of the recommended screening population (i.e. 50 years and older) will actually be screened for cancer, unlike the current estimates between 15-40% currently being screened with other procedures. Since virtual colonoscopy has been proven to be as effective, I believe Medicare and Medicaid patients should have the opportunity to use virtual colonoscopy as a screening choice.
The following are a list of some studies I base my opinion on:
The New England Journal of Medicine
"CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia", David H. Kim, M.D., Perry J. Pickhardt, M.D., Andrew J. Taylor, M.D., Winifred K. Leung, M.D., Thomas C. Winter, M.D., J. Louis Hinshaw, M.D., Deepak V. Gopal, M.D., Mark Reichelderfer, M.D., Richard H. Hsu, M.D., and Patrick R. Pfau, M.D., October 4, 2007, (Vol. 357, No. 14)
"Computed Tomographic Virtual Colonsocopy to Screen for Colorectal neoplasia in Asymptomoatic Adults", Perry J. Pickhardt, M.D., J. Richard Choi, Sc.D., M.D., Inku Hwang, M.D., James A. Butler, M.D., Michael L. Puckett, M.D., Hans A. Hildebrandt, M.D., Roy K. Wong, M.D., Pamela A. Nugent, M.D., Pauline A. Mysliwiec, M.D., M.P.H., and William R. Schindler, D.O., December 2003 issue (Vol. 349, No. 23)
American Gastroenterological Association
"AGA Supports New Guidelines Favoring Tests That Prevent Colorectal Cancer ", March 5, 2008
Alimentary Pharmacology & Therapeutics
"Virtual vs. optical colonoscopy in symptomatic gastroenterology out-patients: the case for virtual imaging followed by targeted diagnostic or therapeutic colonoscopy", M.Bose, J.Bell, L.Jackson, P.Casey, J.Saunders, O.Epstein Volume 26 Issue 5 Page 727-736, September 2007
American Cancer Society
"Prevention the Focus of New Colon Cancer Screening Guidelines", Article date: 2008/03/05
"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", Bernard Levin, MD, David A. Lieberman, MD, Beth McFarland, MD, Robert A. Smith, PhD, Durado Brooks, MD, MPH, Kimberly S. Andrews, Chiranjeev Dash, MD, MPH, Francis M. Giardiello, MD, Seth Glick, MD, Theodore R. Levin, MD, Perry Pickhardt, MD, Douglas K. Rex, MD, Alan Thorson, MD, Sidney J. Winawer, MD and for the American Cancer Society Colorectal Cancer Advisory Group, the US Multi-Society Task Force, and the American College of Radiology
American Journal of Roentgenology
" Primary 2D Versus Primary 3D Polyp Detection at Screening CT Colonography", Perry J. Pickhardt, Andrew D. Lee, Andrew J. Taylor, Steven J. Michel, Thomas C. Winter, Anthony Shadid, Ryan J. Meiners, Peter J. Chase, J. Louis Hinshaw, John G. Williams, Tyler M. Prout, S. Hamid Husain, David H. Kim, 189, December 2007
"Translucency Rendering in 3D Endoluminal CT Colonography: A Useful Tool for Increasing Polyp Specificity and Decreasing Interpretation Time", P. J. Pickhardt August 2004 AJR:183(2),429 - 436
"Three-Dimensional Endoluminal CT Colonography (Virtual Colonoscopy): Comparison on Three Commerically Available Systems", P. J. Pickhardt December 4, 2003 AJR: 181, 1599-1606
"Electronic Cleansing and Stool Tagging in CT Colonography: Advantages and Pitfalls with Primary Three Dimensional Evaluation", Perry J. Pickhardt, September 2003:181, 799-805
Annals of Internal Medicine
"Location of Adenomas Missed by Optical Colonoscopy", Perry J. Pickhardt, MD; Pamela A. Nugent, MD; Pauline A. Mysliweic, MD, MPH; J. Richard Choi, ScD, MD; and William R. Schnindler, DO, September 7, 2004 | Volume 141 Issue 5| Pages 352-359
Archives of Internal Medicine
"Computed Tomographic Colonography to Screen for Colorectal Cancer, Extracolonic Cancer, and Aortic Aneurysm", Model Simulation With Cost-effectiveness Analysis Cesare Hassan, MD; Perry Pickhardt, MD; Andrea Laghi, MD; Daniel Kim, MD; Angelo Zullo, MD; Franco Iafrate, MD; Lorenzo Di Giulio, MD; Sergio Morini, MD Arch Intern Med. 2008;168(7):696-705.
Gastroenterology
"Standards for Gastroenterologists for Performing and Interpreting Diagnostic Computed Tomographic Colonography", Don C. Rockey, Matthew Barish, Joel V. Brill, Brooks D. Cash, Joel G. Fletcher, Prateer Sharma, Sachin Wani, Maurits J. Wiersema, Laura E. Peterson, and Jennifer Conte, 2007;133:1005-10242-158
"Surface Visualization at 3D Endoluminal CT Colonography: Degree of Coverage and Implications for Polyp Detection", Perry J. Pickhardt, MD; Andrew J. Taylor, and Deepak V. Gopal, 2006 | 130: 1582-1587
"Computed Tomographic Virtual Colonoscopy Computer-Aided-Polyp-Detection in Screening", Ronald M. Summers, Jianhua Yao, Perry J. Pickhardt, Marek Franaszek, Ingmar Bitter, Daniel Brickman, Vamsi Krisna, and J. Richard Choi, 2005 | 129: 1832-1844
"Position of the American Gastroenterological Association (AGA) Institute on Computed Tomographic Colonography", 2006 | 131: 1627-1628
Radiology
"Screening for Colorectal Neoplasia with CT Colongraphy: Initial Experience from the 1st Year of Coverage by Third-Party Payers", Perry J. Pickhardt, MD, Andrew J. Taylor, MD, David H. Kim, MD, Mark Reicheldferfer, MD, Deepak V. Gopal, MD, and Patrick R. Pfau, MD, 2006. 0:2412052007
"Linear Polyp Measurement at CT Colonography: In Vitro and in Vivo Comparison of Two-Dimensional and Three-dimensional Displays", Perry J. Pickhardt, MD, Andrew D. Lee, MD, Elizabeth G. McFarland, MD, Andrew J. Taylor, MD, 2005; 236:872-878
"Building a CT Colonography Program: Necessary Ingredients for Reimbursement and Clinical Success", Perry J. Pickhardt, MD,Andrew J. Taylor, MD, Gary L. Johnson, MD, Lawrence A. Fleming, MD, Debra A. Jones, MD, Patrick R. Pfau, MD, Mark Reichelderfer, MD, 2005; 235:17-20
"Incidence of Colonic Perforation at CT Colonography: Review of Existing Data and Implications for Screening of Asymptomatic Adults", Perry J. Pickhardt, MD, 2006; 239: 313-316
I am sure there are other studies and data available. I hope you take all of this into consideration when making your final decision. I believe you will reach the same conclusion: virtual colonoscopy, in many cases, is equivalent to or more effective than some currently reimbursed procedures such as flexible sigmoidoscopy, fecal blood occult screening and barium enemas. Thank you for your consideration.
Yours truly,
Garrett Karl Andersen, M.D.
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Title: President
Organization: Association of Community Cancer Centers (ACCC)
Date: 06/18/2008
DRAFT CONFIDENTIAL DOCUMENT
June 18, 2008
BY ELECTRONIC DELIVERY
William Larson, MA
Lead Analyst
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Mail Stop C1-09-06
Baltimore, Maryland 21244
Re: NCA Tracking Sheet for Screening Computed Tomography
Colonography (CTC) for Colorectal Cancer (CAG-00396N)
Dear Mr. Larson:
The Association of Community Cancer Centers (ACCC)
appreciates that the Centers for Medicare and Medicaid Services
(CMS) has initiated a national coverage analysis (NCA) for computed
tomography colonography (CTC), also referred to as virtual
colonoscopy.1 ACCC agrees with the March 5, 2008 cancer screening
guidelines developed by the American Cancer Society (ACS), the US
Multi Society Task Force on Colorectal Cancer, and the American
College of Radiology recommending CTC as a prescribing option for
colon cancer screening and urges CMS to provide this option to
Medicare beneficiaries.
ACCC is a membership organization whose members
include hospitals, physicians, nurses, social workers, and oncology
team members who care for millions of patients and families fighting
cancer. ACCC’s more than 700 member institutions and
organizations treat 45% of all U.S. cancer patients. Combined with
our physician membership, ACCC represents the facilities and
providers responsible for treating over 60% of all U.S. cancer patients. We often are at the front line in preventing and fighting cancer and therefore look
forward to working with CMS to increase the available options of life-saving cancer
screening tests for Medicare beneficiaries, such as virtual colonoscopy.
ACCC applauds CMS for taking the initiative to cover this valuable
technology. Our members painfully understand the grim statistics regarding the
poor utilization of colorectal screening tests by Medicare beneficiaries. According to
the American Cancer Society (ACS), more than 148,000 new cases will be diagnosed
and more than 49,000 people will die from colorectal cancer in 2008.2
Unfortunately, by failing to have a colorectal screening test early, many Medicare
beneficiaries learn that they have the disease at its later stages, making it harder
for us to treat and for our patients to survive. We welcome the opportunity to have
more choices to detect this disease at its earlier stages.
As stated above, the Tracking Sheet references recently published
guidelines that recommend CTC as a screening test for colorectal cancer. These
guidelines were issued jointly by the American Cancer Society (ACS), the US Multi
Society Task Force on Colorectal Cancer, and the American College of Radiology
and are an update to current recommendations.3 ACCC believes that the updated
guidelines provide an accurate and fair assessment of the clinical benefits and
practical shortcomings of CTC. Specifically, virtual colonoscopy requires less time
to administer, provides better imaging of the colon and other organs, and is
minimally invasive for the patient. As an added benefit, CTC does not require the
patient to be anesthetized or stay in the hospital or surgical center for a significant
period of time. Although the preparation protocol is similar to other screening tests
and equally uncomfortable, we urge CMS to cover CTC because this will provide
physicians and their patients with another screening option.
In our fight against cancer, we often work with Congress to develop
policies to encourage appropriate access to a variety of screening tests for and
treatments of cancer. One such example occurred with the passage of the Balanced
Budget Act of 1997 (BBA). Within the BBA, Congress required CMS to cover
certain colorectal screening tests and provided CMS with the flexibility to cover new
technologies in the future.4 ACCC believes that by including the CTC as a covered
benefit, CMS will further Congressional intent to provide Medicare beneficiaries
with a variety of colorectal cancer screening options.
Our physicians rely on clinical guidelines and scientific journals to
remain current in our fight against cancer. We believe that the updated guidelines
recently issued are scientifically accurate and fairly portray the current state-of-theart
care relating to screening for colorectal cancer. The guidelines detail previous
and ongoing studies related to CTC, including the preliminary findings of the
American College of Radiology Imaging Network #6664 study (ACRIN). This study
followed approximately 2,500 patients across 15 institutions. Initial findings
demonstrated that CTC had a sensitivity of 90 percent for adenomatous colorectal
lesions of 1 cm or larger.5 The guidelines further describe other ongoing studies,
and we urge CMS to review the findings of those studies and the ACRIN trial once
completed.
ACCC greatly appreciates the efforts of CMS and hopes that by adding
CTC as a Medicare covered screening test for colorectal cancer more beneficiaries
will be screened. By detecting the disease earlier, we hope to save more lives. We
look forward to working with CMS to implement this valuable Medicare benefit and
would be pleased to answer any questions regarding these comments. Please
contact me at 301-984-9496 ext. 221 if ACCC can be of any assistance as CMS
continues to evaluate the coverage of screening CTC.
Sincerely,
Ernest Anderson, Jr., MS, RPh
President
Association of Community Cancer Centers (ACCC)
cc: Joseph Chin, MD
Steve Phurough, MD
1 The Tracking Sheet is available at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=220.
2 Jemal A, Siegel R, Ward E, et al. Cancer Statistics, 2008. CA Cancer J Clin 2008;58:71-96.
3 Levin B, Lieberman D, McFarland B, 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. CA Cancer J Clin 2008;58:130-160.
4 Section 4104(a)(2) of the Balanced Budget Act of 1997 (BBA), Pub. L. No. 105-33 (1997); codified at Social
Security Act § 1861(pp)(1)(D).
5 CA Cancer J Clin 2008 at 149.
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Title: Chairman and Professor, Department of Radiology
Organization: UCSF
Date: 06/18/2008
As Chair of Radiology at the University of California, San Francisco I am submitting my opinion that CT Colonography for colorectal carcinoma screening should be fully covered by CMS. CTC has evolved to become a test that is now shown by multiple large prospective trials to be as effective as colonoscopy for the detection of clinically significant polyps. The released results of the ACRIN 6664 National CTC Trial which is the largest prospective trial to date in a screening asymptomatic patient population demonstrates 90% per patient sensitivity and 86% specificity for large (10 mm or larger) colorectal neoplasia. The goal of CTC is to detect these significant precursor lesions and to prevent the development of cancer. The recently published joint collaborative guidelines from ACS (Americna Cancer Society) , USMSTF (United States MultiSociety Task Force) and ACR (Amercian College of Radiology) clearly shows that major organizations endorse CTC as a valuable test for colorectal cancer screening. In fact for the first time it is stated that tests that detect adenomatous polyps and cancer are preferred indicating decreased preference for FOBT (fecal occult blood test) and FIT (fecal immunochemical test). Note that FOBT is currently covered. Advantages of CTC include the lack of need for sedation, the relative ease of the test on the patient and a lower complication rate (including perforations). This test is ready to play a role in screening for colorectal carcinoma in this country. I strongly support approval of national coverage of screening CTC by CMS. 1.Kim DH, Pickhardt PJ, Taylor AJ, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med. 2007;357:1403-1412 2.Mulhall BP, Veerappan GR, Jackson JL. Meta-analysis: computed tomographic colonography. Ann Intern Med 2005; 142:635-650 3.Pickhardt PJ, Choi JR, Hwang I, et al. CT virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003;349:2191-2200 4.Yee J, Akerkar GA, Hung RK, Steinauer-Gebauer AM, Wall SD, McQuaid KR. Colorectal neoplasia: performance characteristics of CT colonography for detection in 300 patients. Radiology 2001; 219:685-692 5. Levin B, Lieberman DA, McFarland B, 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. CA Cancer J Clin 2008; 58:130-160.
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Title: Policy and Grassroots Manager
Organization: C3: Colorectal Cancer Coalition
Date: 06/17/2008
C3: Colorectal Cancer Coalition’s Comments Regarding National Coverage Analysis for CT-Colonography These comments are submitted on behalf of C3: Colorectal Cancer Coalition (C3), a non-profit, nonpartisan advocacy organization that is 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). 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. The American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology issued revised guidelines for colorectal cancer screening in March 2008 . Their rigorous, evidence-based evaluation of the various screening methods resulted in the addition of CTC to the screening guidelines. We believe that all Americans should have full access to credible colorectal cancer screening. Thus, C3 fully supports the coverage of CTC by Medicare. Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer death in the United States. This disease claims the lives of nearly 50,000 men and women annually. When it is diagnosed at an early stage, the 5 year survival rate is nearly 90 percent. However, when cancer is not diagnosed until it has spread to distant organs, the 5 year survival rate is only 5 percent. In addition, when precancerous polyps are discovered and removed, colorectal cancer can not only be detected early, it can be prevented. Since 90 percent of colorectal cancer diagnosis occurs after the age of 50 and the risk of developing colorectal cancer increases with each decade of life, routine screening for colorectal cancer is critical for Medicare’s consumers. Despite the passage of the Balanced Budget Act (BBA) of 1997, which authorized coverage for colorectal cancer screenings for Medicare recipients, colorectal cancer screenings are still very much under-used. The Centers for Disease Control and Prevention (CDC) estimates that as many 60 percent of deaths could be prevented if everyone age 50 and older were screened regularly . One of the barriers to screening is patient concern about an invasive procedure such as colonoscopy and flexible sigmoidoscopy. CT colonography (CTC) uses x-rays to produce two- and three-dimensional images of the colon. The exam takes around ten minutes, does not require a sedative, and is less expensive than optical colonoscopy. CTC is not invasive, and its sensitivity and specificity are acceptably high. From a patient’s perspective, these characteristics make CTC an attractive option. Thus, we feel that reimbursement of screening CTC by Medicare may increase screening rates by Medicare consumers. Recommendations: 1. Medicare should provide coverage for CTC that is consistent with all colorectal cancer screening tests recommended by the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Their recommendation includes tests such as fecal occult blood tests (FOBTs), barium enemas, flexible sigmoidoscopy and colonoscopy, which are already covered under Medicare. 2. Medicare should base payment for screening CTC on that for diagnostic CTC, which is already billable under several local coverage determinations under Medicare. A diagnostic CTC can be ordered in some Medicare areas when symptoms or signs of the disease are determined to be present by a physician. Screening CTC is appropriate when individuals have no signs or
symptoms of colorectal cancer. 3. CTC should be exempt from cuts to imaging services reimbursement under Medicare imposed by the Deficit Reduction Act (DRA) of 2006. C3 thanks you for the opportunity to comment on this national coverage analysis and appreciates your willingness to hear from patients and advocates who would be impacted by any future national coverage determination.
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Title: M.D.
Organization: n/a
Date: 06/11/2008
CTC for many different reasons in the correct
setting is a very valuable tool for screening and
surveillance and should be utilized. In my
particular case I have an "impossible" colon to
navigate and am at high risk and it would be
medically useful to CTC. am a retired GI doctor
and former Clinical Associate Professor Medicine
and in manyh cases I was frustrated in myh
practice to offer CTC, sometimes as first choice.
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Title: CEO
Organization: Colon Health Centers of America, LLC
Date: 06/13/2008
I strongly urge CMS to initiate national coverage for Virtual Colonoscopy (VC). However, I believe that the only appropriate way to provide VC is in the setting of a comprehensive colorectal cancer screening process, i.e., VC with the opportunity for a same-day, same-prep therapeutic colonoscopy (polypectomy) for those with discovered polyps. VC is now a proven screening test based on numerous regional and national randomized controlled trials, including ACRIN 6664. Further, VC is clearly more effective than three of the four covered CRC screening tests (FOBT, Flexible Sigmoidoscopy, and Barium Enema), and is as effective as Screening Colonoscopy. [There is a tendency to think of colonoscopy as the perfect “gold standard” test when in actuality it is only 90% sensitive in detecting significant polyps. With new technologies and reading techniques, VC at least matches this sensitivity, and may soon exceed it. For example, the VC studies demonstrate numerous polyps and cancers that were detected on VC, but missed on colonoscopy.] However, the major problem with VC is the lack of therapeutic options when polyps are discovered. In the setting of stand-alone VC, these patients will very likely be forced to make an appointment with a colonoscopist on a subsequent day—and even worse—be forced to take a second colon prep in order to have the polyps removed. This is not only an unacceptable inconvenience for Medicare beneficiaries, but will likely result in many patients refusing to perform the second prep and not getting their pre-cancerous polyps removed. Because of this, VC should be allowed only in an integrated program, whereby VC results are available immediately following the test and same-day therapeutic colonoscopy is definitively made available to all patients with significant polyps. Such comprehensive programs allow for all of the benefits of VC (easier, safer, no sedation, and less expensive) while overcoming the major deficit (lack of therapeutic option). Furthermore, these comprehensive programs allow for a progressive “episode-of-care” reimbursement strategy, i.e. a single bundled reimbursement for the entire screening process: VC for all, followed by same-day, same-prep therapeutic colonoscopy in those with significant polyps. I understand that CMS is moving in the direction of episode-of-care reimbursement strategies. In summary, I urge CMS to help save lives by covering VC in the Medicare program, but to do so in the only way that make sense for patients: within a comprehensive screening program that allows for same-day, same-prep therapeutic colonoscopy, and a bundled, episode-of-care reimbursement Thank you for your consideration.
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Date: 05/28/2008
To Whom It May Concern:
I fully support virtual colonoscopy. According to what I have read, Virtual Colonoscopy has been clinically proven to be as effective as optical colonoscopy, the current gold standard, in several major studies. Virtual colonoscopy, being minimally invasive, drastically improves the chances that the majority of the recommended screening population (i.e. 50 years and older) will actually be screened for cancer, unlike the current estimates between 15-40% currently being screened with other procedures. Since virtual colonoscopy has been proven to be as effective, I believe Medicare and Medicaid patients should have the opportunity to use virtual colonoscopy as a screening choice.
The following are a list of some studies I base my opinion on:
The New England Journal of Medicine
"CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia", David H. Kim, M.D., Perry J. Pickhardt, M.D., Andrew J. Taylor, M.D., Winifred K. Leung, M.D., Thomas C. Winter, M.D., J. Louis Hinshaw, M.D., Deepak V. Gopal, M.D., Mark Reichelderfer, M.D., Richard H. Hsu, M.D., and Patrick R. Pfau, M.D., October 4, 2007, (Vol. 357, No. 14)
"Computed Tomographic Virtual Colonsocopy to Screen for Colorectal neoplasia in Asymptomoatic Adults", Perry J. Pickhardt, M.D., J. Richard Choi, Sc.D., M.D., Inku Hwang, M.D., James A. Butler, M.D., Michael L. Puckett, M.D., Hans A. Hildebrandt, M.D., Roy K. Wong, M.D., Pamela A. Nugent, M.D., Pauline A. Mysliwiec, M.D., M.P.H., and William R. Schindler, D.O., December 2003 issue (Vol. 349, No. 23)
American Gastroenterological Association
"AGA Supports New Guidelines Favoring Tests That Prevent Colorectal Cancer ", March 5, 2008
Alimentary Pharmacology & Therapeutics
"Virtual vs. optical colonoscopy in symptomatic gastroenterology out-patients: the case for virtual imaging followed by targeted diagnostic or therapeutic colonoscopy", M.Bose, J.Bell, L.Jackson, P.Casey, J.Saunders, O.Epstein Volume 26 Issue 5 Page 727-736, September 2007
American Cancer Society
"Prevention the Focus of New Colon Cancer Screening Guidelines", Article date: 2008/03/05
"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", Bernard Levin, MD, David A. Lieberman, MD, Beth McFarland, MD, Robert A. Smith, PhD, Durado Brooks, MD, MPH, Kimberly S. Andrews, Chiranjeev Dash, MD, MPH, Francis M. Giardiello, MD, Seth Glick, MD, Theodore R. Levin, MD, Perry Pickhardt, MD, Douglas K. Rex, MD, Alan Thorson, MD, Sidney J. Winawer, MD and for the American Cancer Society Colorectal Cancer Advisory Group, the US Multi-Society Task Force, and the American College of Radiology
American Journal of Roentgenology
" Primary 2D Versus Primary 3D Polyp Detection at Screening CT Colonography",
Perry J. Pickhardt, Andrew D. Lee, Andrew J. Taylor, Steven J. Michel, Thomas C. Winter, Anthony Shadid, Ryan J. Meiners, Peter J. Chase, J. Louis Hinshaw, John G. Williams, Tyler M. Prout, S. Hamid Husain, David H. Kim, 189, December 2007
"Translucency Rendering in 3D Endoluminal CT Colonography: A Useful Tool for Increasing Polyp Specificity and Decreasing Interpretation Time", P. J. Pickhardt August 2004 AJR:183(2),429 - 436
"Three-Dimensional Endoluminal CT Colonography (Virtual Colonoscopy): Comparison on Three Commerically Available Systems", P. J. Pickhardt December 4, 2003 AJR: 181, 1599-1606
"Electronic Cleansing and Stool Tagging in CT Colonography: Advantages and Pitfalls with Primary Three Dimensional Evaluation", Perry J. Pickhardt, September 2003:181, 799-805
Annals of Internal Medicine
"Location of Adenomas Missed by Optical Colonoscopy", Perry J. Pickhardt, MD; Pamela A. Nugent, MD; Pauline A. Mysliweic, MD, MPH; J. Richard Choi, ScD, MD; and William R. Schnindler, DO, September 7, 2004 | Volume 141 Issue 5| Pages 352-359
Archives of Internal Medicine
"Computed Tomographic Colonography to Screen for Colorectal Cancer, Extracolonic Cancer, and Aortic Aneurysm", Model Simulation With Cost-effectiveness Analysis
Cesare Hassan, MD; Perry Pickhardt, MD; Andrea Laghi, MD; Daniel Kim, MD; Angelo Zullo, MD; Franco Iafrate, MD; Lorenzo Di Giulio, MD; Sergio Morini, MD
Arch Intern Med. 2008;168(7):696-705.
Gastroenterology
"Standards for Gastroenterologists for Performing and Interpreting Diagnostic Computed Tomographic Colonography", Don C. Rockey, Matthew Barish, Joel V. Brill, Brooks D. Cash, Joel G. Fletcher, Prateer Sharma, Sachin Wani, Maurits J. Wiersema, Laura E. Peterson, and Jennifer Conte, 2007;133:1005-10242-158
"Surface Visualization at 3D Endoluminal CT Colonography: Degree of Coverage and Implications for Polyp Detection", Perry J. Pickhardt, MD; Andrew J. Taylor, and Deepak V. Gopal, 2006 | 130: 1582-1587
"Computed Tomographic Virtual Colonoscopy Computer-Aided-Polyp-Detection in Screening", Ronald M. Summers, Jianhua Yao, Perry J. Pickhardt, Marek Franaszek, Ingmar Bitter, Daniel Brickman, Vamsi Krisna, and J. Richard Choi, 2005 | 129: 1832-1844
"Position of the American Gastroenterological Association (AGA) Institute on Computed Tomographic Colonography", 2006 | 131: 1627-1628
Radiology
"Screening for Colorectal Neoplasia with CT Colongraphy: Initial Experience from the 1st Year of Coverage by Third-Party Payers", Perry J. Pickhardt, MD, Andrew J. Taylor, MD, David H. Kim, MD, Mark Reicheldferfer, MD, Deepak V. Gopal, MD, and Patrick R. Pfau, MD, 2006. 0:2412052007
"Linear Polyp Measurement at CT Colonography: In Vitro and in Vivo Comparison of Two-Dimensional and Three-dimensional Displays", Perry J. Pickhardt, MD, Andrew D. Lee, MD, Elizabeth G. McFarland, MD, Andrew J. Taylor, MD, 2005; 236:872-878
"Building a CT Colonography Program: Necessary Ingredients for Reimbursement and Clinical Success", Perry J. Pickhardt, MD,Andrew J. Taylor, MD, Gary L. Johnson, MD, Lawrence A. Fleming, MD, Debra A. Jones, MD, Patrick R. Pfau, MD, Mark Reichelderfer, MD, 2005; 235:17-20
"Incidence of Colonic Perforation at CT Colonography: Review of Existing Data and Implications for Screening of Asymptomatic Adults", Perry J. Pickhardt, MD, 2006; 239: 313-31 6
I am sure there are other studies and data available. I hope you take all of this into consideration when making your final decision. I believe you will reach the same conclusion: virtual colonoscopy, in many cases, is equivalent to or more effective than some currently reimbursed procedures such as flexible sigmoidoscopy, fecal blood occult screening and barium enemas. Thank you for your consideration.
Yours truly,
Paul L. Bell, Jr.
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Title: EVP, Clinical Affairs and Strategic Planning
Organization: America’s Health Insurance Plans (AHIP)
Date: 06/18/2008
June 18, 2008
Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Dear Dr. Phurrough:
Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) call for a national coverage analysis on Screening Computer Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.
General Comments
AHIP supports CMS's efforts to ensure that all patients receive the most effective and appropriate treatments based on the latest scientific evidence. We believe that it would be reasonable for CMS to open a national coverage determination process in light of the recently released joint consensus guidelines for colorectal cancer screening put forth by the American Cancer Society and other groups. These consensus guidelines contain a recommendation that CTC be included as an accepted option for cancer screening. Some public insurers, such as the Washington State Health Care Authority, have recently decided not to provide coverage for CTC, indicating that the uncertainty in the current evidence regarding CTC would make it useful to have a national coverage determination process.
However, there are several caveats to beginning a national coverage analysis immediately. First, results from one important multi-institutional trial, the ACRIN study, have been submitted for publication but are not currently available in the peer-reviewed literature. Second, the U.S. Preventive Services Task Force is in the final stages of making new recommendations on colorectal cancer screening, and CMS may be well served in waiting for their evidence analysis and opinion prior to commencing its own process. And third, studies are underway on a version of CTC that does not require a cathartic bowel preparation. Should these studies demonstrate comparable diagnostic performance, the patient acceptability of a "prepless" CTC may weigh importantly on determinations of its net health benefit, both for individuals, and for the population.
Should the decision be taken to move forward on a national coverage analysis, AHIP urges CMS to follow its prior precedent and include the results of decision analytic modeling as a basis for evaluating both the clinical effectiveness and cost-effectiveness of any new screening strategy for colorectal cancer. In 2003, the National Coverage Determination (NCD) for Screening Immunoassay Fecal-Occult Blood Test (CAG-00180N) made it clear that cost-effectiveness was a core element of the approach to evaluating a screening strategy, and AHIP strongly supports this position. Results of decision analytic modeling should provide CMS with valuable insight into clinical health outcomes. In addition, this modeling will serve as a useful approach to informing decisions on a reimbursement level for a new test that would reflect a reasonable valuation of any marginal net health benefit in comparison to existing alternatives.
In searching for evidence on CTC, CMS should be aware of a prior systematic review of clinical effectiveness by the California Technology Assessment Forum (www.ctaf.org), and a January 2008 systematic review of the comparative clinical effectiveness and cost-effectiveness of CTC performed by the Institute for Clinical and Economic Review (ICER) at Massachusetts General Hospital and Harvard Medical School (www.icer-review.org). The Blue Cross Blue Shield Technology Evaluation Center (TEC) has an evaluation of the clinical effectiveness of CTC in process that will be forthcoming later this year.
ICER Review Results
From the ICER review, the following issues stand out as deserving particular attention:
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Impact of incidental extracolonic findings. A controversial feature of CTC is its concurrent ability to image and to detect abnormalities in extracolonic abdominal tissues. Particularly among otherwise healthy adults undergoing screening examination, incidental lesions present both a clinical and policy challenge. The potential clinical benefit of early detection of some significant lesions needs to be weighed against the overall likelihood that detection of such lesions will not prove clinically valuable and instead will engender unnecessary costs and risks that come with further investigation. A full review of the literature on this topic is available within the ICER final appraisal document.
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Impact of interpreter training. Guidelines for training interpreters for CTC are now available from the American College of Radiology and American College of Gastroenterology. As these guidelines suggest, training with a minimum of 30-50 CTC readings is now considered the minimum standard to ensure appropriate quality of CTC interpretation. An analysis of the published literature should recognize the potential role of poor training in some of the results from earlier studies of CTC; however, it is also reasonable for evidence reviews to question whether the published results from studies involving less well-trained readers will be more typical of results that would be achieved in community practice.
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Value of decision analytic modeling as part of evidence review. Given that there are no randomized trials of CTC with overall mortality or cancer-specific mortality as outcomes, decision analytic modeling studies should be viewed as valuable adjuncts to any systematic review of the clinical literature. Modeling can enable CMS to judge more fully the balance of potential harms and benefits provided by CTC to individual patients and to the population eligible for colorectal cancer screening. Should CTC be covered by Medicare, modeling can also provide insights into how reimbursement for CTC can be set at a level commensurate with its prospective benefits compared to other screening methods.
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Comparative cost considerations. In comparing the cost-effectiveness of CT colonography with optical colonoscopy, it is important to identify all of the associated costs for each technology. For optical colonoscopy, there are fees for the colonoscopy itself, accompanying facility fees, and anesthesiologist fees in a proportion of cases. There is a growing trend for the attendance of an anesthesiologist to provide sedation during the procedure. Given the variation in practice patterns nationally, the ICER analysis did not factor in the cost of attendance of an anesthesiologist but framed its cost-effectiveness results as a ratio of the reimbursed cost of CTC to optical colonoscopy. Approaching the comparative cost-effectiveness in this manner will allow CMS and others to use their local practice patterns as the basis for a comparative analysis.
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Impact on population screening rates for colorectal cancer. Since CTC is minimally invasive, many clinical experts believe that its adoption will spur higher population rates of colorectal cancer screening. The ICER review revealed that no study has been able to examine this hypothesis directly. Therefore, judgments of the potential value of CTC in increasing population screening rates among Medicare beneficiaries cannot be based on evidence.
Future Research Recommendations
If CMS determines that the evidence is premature for coverage, AHIP recommends that the specific identified evidence gaps be used to frame a justification for the type of study design that will best address several uncertainties. The ICER review identified several key areas of remaining uncertainty and recommended the following research agenda:
1) What is the impact on population screening rates of making CT colonography available?
A key uncertainty is whether CTC availability would increase population screening rates or would largely shift screening from colonoscopy or other methods to CTC. Several different study designs could be envisioned to address this question, including cluster randomized trials and before-after analyses of defined populations such as a health plan cohort. Both studies would be better performed in a health system where all patient screening can be evaluated over a several-year period, but a large and relatively cohesive health plan cohort, such as that within Kaiser Foundation Health Plans, or more broadly across the HMO Research Network, would provide very useful information.
2) What is the impact on cancer rates of CTC management of medium-sized polyps vs. traditional management with colonoscopy?
Although this is an area of uncertainty, a randomized trial of CTC screening vs. colonoscopy seems impractical. It is unclear whether patients in a large trial would accept randomization, and during the necessary 10-15 year follow-up it is extremely likely that both CTC and colonoscopy will change significantly enough that data will be uninterpretable.
3) What is the impact of extracolonic findings?
It should be feasible to launch studies of patients receiving CTC that will document more precisely the prevalence of extracolonic findings and ascertain their clinical impact and the costs associated with their follow-up. Such studies could potentially be done through passive retrospective claims database evaluation but would be better conducted as prospective cohort studies or patient registries.
4) What is the natural history of diminutive and medium-sized polyps?
Much of the current clinical consensus regarding the management of polyps 1-9mm is based on limited data of the natural history of these polyps. Some CTC advocates point to three fairly old and small colonoscopy studies that left polyps in place as providing evidence that many, if not most, diminutive polyps undergo regression. In these studies, some of the polyps were smaller at follow-up, some were unchanged, and some had grown. In one study, some were not seen at follow-up. A large, prospective study of patients undergoing either CTC or colonoscopy would help address the important uncertainty in this area. If there is substantial regression of polyps, then polypectomy with colonoscopy may be overzealous and the benefits of CTC might appear more substantial.
Colorectal cancer is the second leading cause of cancer death in the United States, with over 130,000 new cases diagnosed each year. There are several other accepted methods for screening for colorectal cancer, and AHIP believes that the decision to add another option merits a national coverage analysis that takes the full range of effects on health and on the Medicare system into consideration.
Thank you for the opportunity to comment on this important issue.
Sincerely,
Carmella Bocchino
Executive Vice President, Clinical Affairs and Strategic Planning
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Date: 05/20/2008
[PHI redacted] I strongly feel that it must be approved as a screening tool. It is non-invasive and has proven to be as sensetive as optical in
detecting potentially cancerous polyps. It far exceeds the other "screening" options and is cost effective.
CTC should be one of the patients'' options.
Thank you for your attention.
Bill Bond
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Date: 05/22/2008
I do not believe that CTC screening for colon cancer is ready for widespread application. Although some of the studies show good results, there is a great deal of inconsistency in the sensitivity of this test in detecting colon lesions when all studies are considered. In addition, the issue of radiation exposure over a lifetime of screening has yet to be satisfactorily addressed.
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Title: Chief, GI and Colon Health Initiative
Organization: National Naval Medical Center
Date: 06/03/2008
The fact that CMS has initiated a national
coverage analysis (NCA) for CT colonography
(CTC) screening indicates that there is a
growing realization of the value of this test as
a screening modality for CRC and I
wholeheartedly endorse its approval. In a
country in which adherence rates for screening
of the 2nd leading cause of (preventable) cancer
death it is clear that additional, valid options
are needed. As one of the larget CTC centers in
the country, we have proven that an integrated
model, with gastroenterology and radiology
working in concert can result in greater
penetration of CRC screening and make a real
difference in our patients'' lives. We have seen
our CRC screening adherence move beyond 70% of
our empanelled patients and our CRC screening
procedures increase by 90% over the 4 years that
we have been refining the process. Performance
characteristics of CTC in our institution is
equivalent to optical colonoscopy to a polyp
size of 6 mm.
The concern about diminutive polyps is a real
and valid one but clinicians and policy makers
must keep the big picture of other screening
alternatives in mind when considering these
issues surrounding new tests. CTC should not be
thought of as a colonoscopy replacement, but
rather an alternative test that intuitively is
superior to other non-colonoscopic CRC screening
tests commonly practiced (FOBT, FS, ACBE).
Moreover, this test, widely perceived as less
invasive and more convenient, is bringing in
people who would otherwise avoid screening for
accurate, whole-colon evaluations and saving
lives through pushing those who need polypectomy
to colonoscopy. The motivation here should
remain optimizing adherence with CRC screening
and if this additional test will help in that
goal then approval be pursued. Issues remain
with regards to training and clinical outcome
algorithms but CTC in its current form
deployable and feasible as a CRC screening test
with appropriate forethought and responsible
implementation.
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Title: Clinical Program Coordinator-Virtual Colonoscopy
Organization: Univirsity of Wisconsin Hospital and Clinics
Date: 06/11/2008
To Whom It May Concern: According to an overview on colorectal cancer screening found on the CMS website: "Medicare has covered colorectal cancer screening tests and procedures since 1998, but use of this benefit has been low. Medicare claims from 1998 - 2004 indicate that only about 52% of beneficiaries have had at least one claim for a colorectal cancer test during this window. There is clearly an opportunity to improve colorectal cancer screening rates in the Medicare population" (http://www.cms.hhs.gov/ColorectalCancerScreening/, retrieved June 11, 2008). We have shown at University of Wisconsin Hospital and Clinics that when virtual colonoscopy (VC) is offered as a screening tool, we screen twice as many patients as optical colonoscopy (OC) alone. In many cases, we are attracting these patients from a group that might not have ever had colon cancer screening had they not been presented with VC as an option. From our experience of performing over 5,000 screening exams it is easy to see that VC is an accepted option for colorectal cancer screening by both providers and patients and therefore could increase the overall compliance rate with colorectal cancer screening if offered to Medicare patients. An additional issue is that there does not appear to be enough endoscopists to accommodate the patients that do seek screening in a reasonable amount of time. VC offers a perfect first-line screening tool for our GI partners to refer them the patients that only need therapeutic intervention. This method ultimately allows GI to efficiently use their invasive, more costly services for patients that require polypectomy. As the "baby boomer" generation has mostly surpassed age 50, we are well aware that this population will further put a strain on endoscopy services. As this population continues to age, it would be prudent to have an additional test to meet their screening needs that is as good as OC, if not better. Gastroenterologists may feel the pressure from the back-log of patients, but CMS may also eventually feel the increasing financial burden to cover these necessary screening tests. VC is considerably less expensive than a regular colonoscopy. Although it is true that a percentage of patients that have VC will require subsequent OC for polypectomy, the overall cost long-term is still less for VC when this is added because most patients are going to have a normal exam. Not to mention the cost that OC generates when they have a complication from perforation, bleeding, or from the sedation. Furthermore, if a patient that would only consider VC as a screening option decides not to get any colon cancer screening because VC is not covered, and that person gets colon cancer, the cost of surgery and chemo, and potentially the cost of their life cannot compare to the potential benefit the VC could have had. Moreover, barium enema is a reimbursable exam for screening for colorectal cancer. This exam is more invasive and less comfortable for the patient. It is considerably less accurate than VC and could be said to have the same limitations (i.e. if a polyp is identified a subsequent OC would need to be performed for polypectomy). We are very fortunate to be the only center in the nation for the past four years to have third-party coverage for VC screening. Because of this, we have relevant experience in the application of VC and how we can impact patients'' lives everyday with technology that is as accurate and more sensitive than optical colonoscopy. I have chosen not to submit any published research results as I am sure you have already received several publications to review. Instead I implore you to not only consider the statistics and published results, but also take into consideration the realistic life saving impact VC could have for Medicare or Medicaid patients. The American Cancer Society already recognizes VC as an effective option. If medical providers/payers truly care about the fight to prevent colon cancer, then the time is now to include VC as an option for colon cancer screening so that patients have another effective option to detect this deadly, yet preventable disease. Sincerely, Holly Casson, RN, BSN University of Wisconsin Hospital and Clinics Clinical Program Coordinator-Virtual Colonoscopy
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Title: Assistant Professor
Organization: Warren Alpert Medical School of Brown University
Date: 05/29/2008
I strongly urge CMS to add CT colonography (CTC) as a screening option for colorectal cancer. For more than a decade now abundant research has been performed and CT techniques have evolved to the point where CTC, as it is now performed today, has convincingly proven itself as a valid and highly effective screening tool for colorectal neoplasia. Colon cancer is the 2nd leading cause of cancer deaths in this country. Americans have a 6% risk of developing colon cancer at some point in their lives. The good news is that over 95% of colon cancer deaths are preventable as the vast majority of colon cancers show a slow and indolent pattern of onset. The bad news is that only 40% of eligible patients undergo any form of screening at all with less than 15% undergoing the "gold" standard of traditional colonoscopy. Under these circumstances any new option for screening is better than no screening at all. Compared to traditional colonoscopy, CT colonography (CTC) is the cheaper, faster, and safer option. With CTC, there is no need for sedation, less manpower is required (no need for an anesthetist or nurse), less technical operator skill required, and examination time is quicker (table time ~ 15 mins). The risk of serious complications such as colonic perforation is also significantly lower with CTC. The risk of perforation is ten times lower than for traditional colonoscopy with a reported perforation rate between 0.02% and 0.04% (Pickhardt, P. J. Radiology 2006;239(2): 313-6.). The risk of radiation exposure with CT colonography is also relatively low with use of currently accepted low-dose techniques resulting in a radiation dose less than that of a double-contrast barium enema (< 5 mSv). The adenoma-carcinoma sequence accounts for the large majority of colon cancers. The natural history of colon cancers has been well documented and while many adenomas are found in the sub 5 mm size range, the vast majority of these adenomas remain stable or may even regress and are not likely to be clinically significant. Less than 1% of polyps in this size range progress to true malignancy. The few that do increase in size should be picked up on a 5-year follow-up study. There is a clear documented correlation between adenoma size and risk of malignancy raising the valid question of whether diminutive polyps are even worth resecting at all (much less mentioning in a CTC study). (O’Brien MJ et al. The National Polyp Study. Gastroenterol 1990;88:371-379.). When an economic comparison is made between CTC and other forms of colorectal screening (including traditional colonoscopy), CTC focused on detection of polyps greater than 5 mm in size has been shown to be the most cost-effective screening strategy (Pickhardt PJ et. al., Cancer 2007; 109:2213-2221. Arnesen R et. al., Acta Radiologica 2007; 48:259-266.). Numerous large multi-center randomized clinical trials performed in multiple countries around the globe in both an academic and community medical setting have shown sensitivity and specificity very comparable to that of traditional colonoscopy. These results have been especially convincing in the last few years with the use of modern multi-detector CT scanners and the increasing use of oral fecal/fluid tagging agents. These results seem to hold true not just in the hands of a few "expert" CTC readers, but across a wide variety of practice settings. (ACRIN National CT Colonography Trial, Munich Trial, IMPACT, SIGGAR, French Multi-center Trial, and others). It is interesting to note that Pickhardt''s New England Journal of Medicine study even suggested that CTC showed better sensitivity than traditional colonoscopy in the detection of larger polyps (using segmental unblinding of colonoscopy combined with CTC results as the gold standard). CTC has also shown equal efficacy compared to traditional colonoscopy in the detection of advanced neoplasia when compared to traditional colonoscopy (Kim DH, Pickhardt PJ, Taylor AJ, et al. N Engl J Med 2007; 357:1403-1412.). A recent clinical trial involving over 6200 patients demonstrated that primary CTC for screening sent less than 8% of patients on to traditional colonoscopy with resection of less than 25% the number of polyps of traditional colonoscopy, yet resulting in an equivalent yield in the number of patients with advanced neoplasia. As for patient tolerance of the procedure itself, colonic distention in CTC is generally well tolerated without the use of sedation (which carries a real and significant concomitant risk). Unlike after a traditional colonoscopy, the unsedated CTC patient is able to return to work immediately following the procedure resulting in much less loss of productivity. Most surveys of patients that have had both traditional colonoscopy and CT colonography have also shown a greater patient preference for CT colonography with most patients preferring continued CTC surveillance over traditional colonoscopic
surveillance. When a viable alternative cancer screening option such as CTC has been shown to be equally or nearly equally as sensitive as the currently accepted "gold" standard, as efficacious in the detection of clinically significant polyps, not to mention safer, faster, cheaper, and better tolerated, then there should be no question that CT colonography deserves its place amongst the covered colon cancer screening options for Medicare patients. The U.S. Multi Society Task Force on Colorectal Cancer thinks so, the American College of Radiology thinks so, and the American Cancer Society thinks so as well.
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Date: 06/11/2008
i think it would be nice for this procedure to be
covered by cms. even though it is seen as another
layer( diagnostic only) of testing but better
than a barium enema some would benefit from its
inclusion, may be replace Barium enema as a
screening option.
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Date: 05/22/2008
CTC should not be used as a standard screening
test for colorectal cancer. This is an
appropriate test for patients who have failed
conventional colonoscopy, but should not be
widely applied to the general public.
Though this test does detect larger polyps it is
poor for small and medium sized lesions. The
argument from the proponents of this test is that
small and medium sized lesions don''t really
matter, when in fact almost ALL GI physicians
have removed cancers that are small in size. The
test would clearly lead to over-utilization of CT
scanning and increase the number of colonoscopies
as well. Radiologists in the community have a
strong tendency to "overcall" lesions on these
scans (the number of small, benign renal cysts is
just one example). The proponents of CTC
advocate essentially lying about findings and not
even mentioning that they saw a lesion on the
scan if it doesn''t meet a certain size in order
to try and prevent over-utilization and too many
colonoscopies after CTC. This will fail as soon
as 1 person in the community setting is sued for
missing a cancer.
In the end analysis- this test is not as
accurate, promotes over-utilization of resources,
offers no therapeutic benefits, and has had the
data surrounding the test and the criteria for
reading the test manipulated so heavily as to
make it appear reasonable.
CTC does have a role in limited cases where
patients are unable to have colonoscopy or have
for some reason failed colonoscopy.
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Title: RT (R) (CT) (M) (MR) BS
Organization: ARRT
Date: 05/21/2008
Besides limiting the chance of bowel perforation,
CTC is more thorough, hands down. There is an
image that can be reviewed multiple times that is
not subject to Dr skill with scope. There is not
sedation required that can put the patient at
higher risk and takes how many less staff to prep
and get the info? What about 5 or 6 less paid
professionals? As a patient and healthcare
professional, the biggest issue should be about
getting the most information with an exam with
the least stress or risk to the patient. I see
CTC as my professional and personal choice over
colonoscopy.
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Date: 05/31/2008
I have interpreted over 150 virtual colonoscopy cases and have discovered many clinically significant polyps in asymptomatic patients that have undergone incomplete optical colonoscopy. I have also had cases where incomplete optical colonoscopy was followed by VC, with VC identifying small polyps. Repeat optical colonoscopy in these patients failed to identify the polyps, but where again identified as true positive findings on blinded followup VC. I have many patients who would like to avoid the risk of and/or have fear of anesthesia associated with optical colonoscopy and would like the option of virtual colonosocpy, but cannot afford it. I argue that they cannot NOT afford to be screened for colon cancer! I fully support virtual colonoscopy. Virtual Colonoscopy has been clinically proven to be as effective as optical colonoscopy, the current gold standard, in several major studies. Optical colonoscopy is only considered the "gold standard" because an equal or better test has not existed until now. Virtual colonoscopy, being minimally invasive, drastically improves the chances that the majority of the recommended screening population (i.e. 50 years and older) will actually be screened for cancer, unlike the current estimates between 15-40% currently being screened with other procedures. Since virtual colonoscopy has been proven to be as effective, I believe Medicare and Medicaid patients should have the opportunity to use virtual colonoscopy as a screening choice. I base my opinion on personal experience and the following list of articles which I have read: The New England Journal of Medicine "CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia", David H. Kim, M.D., Perry J. Pickhardt, M.D., Andrew J. Taylor, M.D., Winifred K. Leung, M.D., Thomas C. Winter, M.D., J. Louis Hinshaw, M.D., Deepak V. Gopal, M.D., Mark Reichelderfer, M.D., Richard H. Hsu, M.D., and Patrick R. Pfau, M.D., October 4, 2007, (Vol. 357, No. 14) "Computed Tomographic Virtual Colonsocopy to Screen for Colorectal neoplasia in Asymptomoatic Adults", Perry J. Pickhardt, M.D., J. Richard Choi, Sc.D., M.D., Inku Hwang, M.D., James A. Butler, M.D., Michael L. Puckett, M.D., Hans A. Hildebrandt, M.D., Roy K. Wong, M.D., Pamela A. Nugent, M.D., Pauline A. Mysliwiec, M.D., M.P.H., and William R. Schindler, D.O., December 2003 issue (Vol. 349, No. 23) American Gastroenterological Association"AGA Supports New Guidelines Favoring Tests That Prevent Colorectal Cancer ", March 5, 2008 Alimentary Pharmacology & Therapeutics"Virtual vs. optical colonoscopy in symptomatic gastroenterology out-patients: the case for virtual imaging followed by targeted diagnostic or therapeutic colonoscopy", M.Bose, J.Bell, L.Jackson, P.Casey, J.Saunders, O.Epstein Volume 26 Issue 5 Page 727-736, September 2007 American Cancer Society"Prevention the Focus of New Colon Cancer Screening Guidelines", Article date: 2008/03/05 "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", Bernard Levin, MD, David A. Lieberman, MD, Beth McFarland, MD, Robert A. Smith, PhD, Durado Brooks, MD, MPH, Kimberly S. Andrews, Chiranjeev Dash, MD, MPH, Francis M. Giardiello, MD, Seth Glick, MD, Theodore R. Levin, MD, Perry Pickhardt, MD, Douglas K. Rex, MD, Alan Thorson, MD, Sidney J. Winawer, MD and for the American Cancer Society Colorectal Cancer Advisory Group, the US Multi-Society Task Force, and the American College of Radiology American Journal of Roentgenology" Primary 2D Versus Primary 3D Polyp Detection at Screening CT Colonography",Perry J. Pickhardt, Andrew D. Lee, Andrew J. Taylor, Steven J. Michel, Thomas C. Winter, Anthony Shadid, Ryan J. Meiners, Peter J. Chase, J. Louis Hinshaw, John G. Williams, Tyler M. Prout, S. Hamid Husain, David H. Kim, 189, December 2007 "Translucency Rendering in 3D Endoluminal CT Colonography: A Useful Tool for Increasing Polyp Specificity and Decreasing Interpretation Time", P. J. Pickhardt August 2004 AJR:183(2),429 - 436 "Three-Dimensional Endoluminal CT Colonography (Virtual Colonoscopy): Comparison on Three Commerically Available Systems", P. J. Pickhardt December 4, 2003 AJR: 181, 1599-1606 "Electronic Cleansing and Stool Tagging in CT Colonography: Advantages and Pitfalls with Primary Three Dimensional Evaluation", Perry J. Pickhardt, September 2003:181, 799-805 Annals of Internal Medicine"Location of Adenomas Missed by Optical Colonoscopy", Perry J. Pickhardt, MD; Pamela A. Nugent, MD; Pauline A. Mysliweic, MD, MPH; J. Richard Choi, ScD, MD; and William R. Schnindler, DO, September 7, 2004 | Volume 141 Issue 5| Pages 352-359 Archives of Internal Medicine "Computed Tomographic Colonography to Screen for Colorectal Cancer, Extracolonic Cancer, and Aortic Aneurysm", Model Simulation With Cost-effectiveness AnalysisCesare Hassan, MD; Perry Pickhardt, MD; Andrea Laghi, MD; Daniel Kim, MD; Angelo Zullo, MD; Franco Iafrate, MD; Lorenzo Di Giulio, MD; Sergio Morini, MD Arch Intern Med. 2008;168(7):696-705. Gastroenterology "Standards for Gastroenterologists for Performing and Interpreting Diagnostic Computed Tomographic Colonography", Don C. Rockey, Matthew Barish, Joel V. Brill, Brooks D. Cash, Joel G. Fletcher, Prateer Sharma, Sachin Wani, Maurits J. Wiersema, Laura E. Peterson, and Jennifer Conte, 2007;133:1005-10242-158 "Surface Visualization at 3D Endoluminal CT Colonography: Degree of Coverage and Implications for Polyp Detection", Perry J. Pickhardt, MD; Andrew J. Taylor, and Deepak V. Gopal, 2006 | 130: 1582-1587 "Computed Tomographic Virtual Colonoscopy Computer-Aided-Polyp-Detection in Screening", Ronald M. Summers, Jianhua Yao, Perry J. Pickhardt, Marek Franaszek, Ingmar Bitter, Daniel Brickman, Vamsi Krisna, and J. Richard Choi, 2005 | 129: 1832-1844 "Position of the American Gastroenterological Association (AGA) Institute on Computed Tomographic Colonography", 2006 | 131: 1627-1628 Radiology"Screening for Colorectal Neoplasia with CT Colongraphy: Initial Experience from the 1st Year of Coverage by Third-Party Payers", Perry J. Pickhardt, MD, Andrew J. Taylor, MD, David H. Kim, MD, Mark Reicheldferfer, MD, Deepak V. Gopal, MD, and Patrick R. Pfau, MD, 2006. 0:2412052007 "Linear Polyp Measurement at CT Colonography: In Vitro and in Vivo Comparison of Two-Dimensional and Three-dimensional Displays", Perry J. Pickhardt, MD, Andrew D. Lee, MD, Elizabeth G. McFarland, MD, Andrew J. Taylor, MD, 2005; 236:872-878 "Building a CT Colonography Program: Necessary Ingredients for Reimbursement and Clinical Success", Perry J. Pickhardt, MD,Andrew J. Taylor, MD, Gary L. Johnson, MD, Lawrence A. Fleming, MD, Debra A. Jones, MD, Patrick R. Pfau, MD, Mark Reichelderfer, MD, 2005; 235:17-20 "Incidence of Colonic Perforation at CT Colonography: Review of Existing Data and Implications for Screening of Asymptomatic Adults", Perry J. Pickhardt, MD, 2006; 239: 313-316 I hope you take all of this into consideration when making your final decision. I believe you will reach the same conclusion: Virtual colonoscopy is a safe, noninvasive, powerful, sensitive, and specific alternative to optical colonoscopy that should and must be made available to the general public as an effective screening method for colon cancer. Virtual colonoscopy has the power to become the NEW gold standard. It is certainly more effective than some currently reimbursed procedures such as flexible sigmoidoscopy, fecal blood occult screening and barium enemas. Thank you for your consideration. Yours truly, Ronald J. Costanzo, MDDepartment of RadiologyDoylestown HospitalDoylestown, PA
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Date: 06/17/2008
I work at NNMC and have been scheduling patients
for and assisting in completion of virtual
colonoscopies since Oct/04 - our patients like
having a 20 minute appointment that clears them
for 5 years. If they are on anticoaugulation, it
does not need to be stopped. Patients who are
too ill for sedation can safely have VC(s), no
driver/escort is needed. And it is nice to be
able to give healthy low risk screening patients
a choice in which screening modality is used.
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Title: President
Organization: Synergy Consulting Group, Ltd.
Date: 06/18/2008
I am strongly in favor of CMS extending coverage
to CTC for the simplest of reasons; all comments
from patients or family members of patients were
very positive in their opinion of CTC. Optical
colonoscopy has been the gold standard for at
least two decades and its practitioners have been
uniformly unsuccessful in increasing compliance
with CC screening guidelines. CTC clearly has the
potential to reach the 40 million Americans who
are eligible for CC screening but have not come
forward for the many reasons put forth in these
commentaries. As the previous Medical Director
for EZEM, I have spent the past 20 years in CC
screening and detection and have intimate
knowledge of the double contrast barium enema,
optical colonoscopy and CTC. It is clear to all
that asymptomatic individuals between the ages of
50 and 75 who have not as yet been screened are
clamoring for CTC to become part of their
healthcare benefit. You (CMS) can make it so.
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Date: 06/03/2008
May 28, 2008
Ref: CAG-00396N
Dear Centers for Medicare & Medicaid Services (CMS):
I fully support virtual colonoscopy screening for colon
cancer. According to my research and
readings, virtual colonoscopy has been clinically proven to be as effective as
optical colonoscopy, the current gold standard, in several major studies. Because virtual colonoscopy is less invasive,
it drastically improves the chances that the majority of the recommended
screening population (50 yrs +), will actually be screened for colon cancer,
unlike the current estimates between 15% - 40% being screened with other procedures.
Virtual colonoscopy has a very
high degree of sensitivity. Since
virtual colonoscopy has been proven to be as effective, I believe patients
should have the opportunity to use virtual colonoscopy as a screening
choice. I believe that patients are more
willing to lie in a CT scanner for a scan, there is no sedation required, they
can drive themselves home, and the scan takes a few minutes (especially in the
fast multi slice CT scanners). 70% to 75% of Americans are not getting screened for colon
cancer because most do not like the invasive optical colonoscopy. If they get screened with virtual
colonoscopy, just think of how many cases of colon cancer can be found early
and how many lives can be saved.
The American Cancer Society,
backed by American College of Radiology and
American Gastroenterology Association has endorsed this exam as a front line
exam for colon cancer screening. Some
of the currently reimbursed procedures are flexible sigmoidoscopy, fecal blood
occult screening, and of course the long time test of the barium enema. The virtual colonoscopy should be reimbursed
as well.
It is my hope that CMS will also
see this exquisite tool that is sitting in the palm of your hands, only waiting
for reimbursement to be approved to start saving more lives.
Thank you for your consideration
and your time in reading my email.
Below is a list of some of the studies that I
have based my opinion on. The list is as
follows:
The New England Journal of Medicine "CT Colonography versus Colonoscopy for the
Detection of Advanced Neoplasia", David H. Kim,
M.D., Perry J. Pickhardt, M.D., Andrew J. Taylor,
M.D., Winifred K. Leung, M.D., Thomas C. Winter,
M.D., J. Louis Hinshaw, M.D., Deepak V. Gopal,
M.D., Mark Reichelderfer, M.D., Richard H. Hsu,
M.D., and Patrick R. Pfau, M.D., October 4, 2007, (Vol. 357, No. 14)
"Computed Tomographic Virtual Colonsocopy to
Screen for Colorectal neoplasia in Asymptomatic
Adults", Perry J. Pickhardt, M.D., J. Richard
Choi, Sc.D., M.D., Inku Hwang, M.D., James A.
Butler, M.D., Michael L. Puckett, M.D., Hans A.
Hildebrandt, M.D., Roy K. Wong, M.D., Pamela A.
Nugent, M.D., Pauline A. Mysliwiec, M.D., M.P.H.,
and William R. Schindler, D.O., December 2003
issue (Vol. 349, No. 23)
American Gastroenterological Association "AGA Supports New Guidelines Favoring Tests That Prevent Colorectal Cancer ", March 5, 2008
Alimentary Pharmacology & Therapeutics
"Virtual vs. optical colonoscopy in symptomatic
gastroenterology out-patients: the case for
virtual imaging followed by targeted diagnostic
or therapeutic colonoscopy", M.Bose, J.Bell,
L.Jackson, P.Casey, J.Saunders, O.Epstein Volume
26 Issue 5 Page 727-736, September 2007
American Cancer Society
"Prevention the Focus of New Colon Cancer
Screening Guidelines", Article date: 2008/03/05
"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", Bernard Levin, MD, David A.
Lieberman, MD, Beth McFarland, MD, Robert A.
Smith, PhD, Durado Brooks, MD, MPH, Kimberly S.
Andrews, Chiranjeev Dash, MD, MPH, Francis M.
Giardiello, MD, Seth Glick, MD, Theodore R.
Levin, MD, Perry Pickhardt, MD, Douglas K. Rex,
MD, Alan Thorson, MD, Sidney J. Winawer, MD and
for the American Cancer Society Colorectal Cancer
Advisory Group, the US Multi-Society Task Force,
and the American College of Radiology
American Journal of Roentgenology
" Primary 2D Versus Primary 3D Polyp Detection at
Screening CT Colonography",
Perry J. Pickhardt, Andrew D. Lee, Andrew J.
Taylor, Steven J. Michel, Thomas C. Winter,
Anthony Shadid, Ryan J. Meiners, Peter J. Chase,
J. Louis Hinshaw, John G. Williams, Tyler M.
Prout, S. Hamid Husain, David H. Kim, 189,
December 2007
"Translucency Rendering in 3D Endoluminal CT
Colonography: A Useful Tool for Increasing Polyp
Specificity and Decreasing Interpretation Time",
P. J. Pickhardt August 2004 AJR:183(2),429 - 436
"Three-Dimensional Endoluminal CT Colonography
(Virtual Colonoscopy): Comparison on Three
Commerically Available Systems", P. J. Pickhardt
December 4, 2003 AJR: 181, 1599-1606
"Electronic Cleansing and Stool Tagging in CT
Colonography: Advantages and Pitfalls with
Primary Three Dimensional Evaluation", Perry J.
Pickhardt, September 2003:181, 799-805
Annals of Internal Medicine
"Location of Adenomas Missed by Optical
Colonoscopy", Perry J. Pickhardt, MD; Pamela A.
Nugent, MD; Pauline A. Mysliweic, MD, MPH; J.
Richard Choi, ScD, MD; and William R. Schnindler,
DO, September 7, 2004 | Volume 141 Issue 5|
Pages
352-359
Archives of Internal Medicine
"Computed Tomographic Colonography to Screen for
Colorectal Cancer, Extracolonic Cancer, and
Aortic Aneurysm", Model Simulation With Cost-
effectiveness Analysis
Cesare Hassan, MD; Perry Pickhardt, MD; Andrea
Laghi, MD; Daniel Kim, MD; Angelo Zullo, MD;
Franco Iafrate, MD; Lorenzo Di Giulio, MD; Sergio
Morini, MD Arch Intern Med. 2008;168(7):696-705.
Gastroenterology
"Standards for Gastroenterologists for Performing
and Interpreting Diagnostic Computed Tomographic
Colonography", Don C. Rockey, Matthew Barish,
Joel V. Brill, Brooks D. Cash, Joel G. Fletcher,
Prateer Sharma, Sachin Wani, Maurits J. Wiersema,
Laura E. Peterson, and Jennifer Conte,
2007;133:1005-10242-158
"Surface Visualization at 3D Endoluminal CT
Colonography: Degree of Coverage and Implications
for Polyp Detection", Perry J. Pickhardt, MD;
Andrew J. Taylor, and Deepak V. Gopal, 2006 |
130: 1582-1587
"Computed Tomographic Virtual Colonoscopy
Computer-Aided-Polyp-Detection in Screening",
Ronald M. Summers, Jianhua Yao, Perry J.
Pickhardt, Marek Franaszek, Ingmar Bitter, Daniel
Brickman, Vamsi Krisna, and J. Richard Choi, 2005
| 129: 1832-1844
"Position of the American Gastroenterological
Association (AGA) Institute on Computed
Tomographic Colonography", 2006 | 131: 1627-1628
Radiology
"Screening for Colorectal Neoplasia with CT
Colongraphy: Initial Experience from the 1st Year
of Coverage by Third-Party Payers", Perry J.
Pickhardt, MD, Andrew J. Taylor, MD, David H.
Kim, MD, Mark Reicheldferfer, MD, Deepak V.
Gopal, MD, and Patrick R. Pfau, MD, 2006.
0:2412052007
"Linear Polyp Measurement at CT Colonography: In
Vitro and in Vivo Comparison of Two-Dimensional
and Three-dimensional Displays", Perry J.
Pickhardt, MD, Andrew D. Lee, MD, Elizabeth G.
McFarland, MD, Andrew J. Taylor, MD, 2005;
236:872-878
"Building a CT Colonography Program: Necessary
Ingredients for Reimbursement and Clinical
Success", Perry J. Pickhardt, MD,Andrew J.
Taylor, MD, Gary L. Johnson, MD, Lawrence A.
Fleming, MD, Debra A. Jones, MD, Patrick R. Pfau,
MD, Mark Reichelderfer, MD, 2005; 235:17-20
"Incidence of Colonic Perforation at CT
Colonography: Review of Existing Data and
Implications for Screening of Asymptomatic
Adults", Perry J. Pickhardt, MD, 2006; 239: 313-316
Thank You.
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Title: Outpatient Radiology Consultant
Date: 05/27/2008
The cost effectiveness of adopting CTC as a Colorectal Ca screening tool is an important consideration when compared to the higher costs of optical colonoscopy. CTC has an increased patient acceptance that will in the long term lead to more screenings and eventual treatment of CA that would have otherwise not been diagnosed. The use of CAD and advanced fecal tagging technology will provide more diagnostic confidence to the radiologists and will improve the overall specificity and sensitivity of CTC.
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