Source: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=220&NcaName=Screening+Computed+Tomography+Colonography+(CTC)+for+Colorectal+Cancer&TAId=58&IsPopup=y&bc=AAAAAAAAEAgA
Timestamp: 2014-03-08 23:07:36
Document Index: 112886879

Matched Legal Cases: ['§1861', '§ 1862', '§1862', '§ 1861', '§ 1861', '§ 1861', '§ 410', '§1862', '§ 1862', '§1861', '§ 410', '§1861', 'art4']

Back to Coding Analysis for Labs (CAL) Tracking Sheet Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)
The Centers for Medicare and Medicaid Services (CMS) concludes the following: The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under §1861(pp)(1) of the Social Security Act. CT colonography for colorectal cancer screening remains noncovered.
To: Administrative File CAG-00396N
From: Tamara Syrek Jensen, JD
Subject: Coverage Decision Memorandum for Screening Computed Tomographic (CT) Colonography for Colorectal Cancer
Medicare is a defined benefit program. An item or service must fall within a benefit category under Part A or Part B as a prerequisite to Medicare coverage. Congress has specifically authorized coverage of certain colorectal cancer screening tests under Part B of the Medicare program and has consistently made necessary conforming changes in order to ensure that payments are made. Subject to certain frequency limits, certain colorectal cancer screening tests are payable under the Medicare statute even if the tests would not satisfy the “reasonable and necessary” provision of § 1862(a)(1)(A) of the Social Security Act. §1862(a)(1)(H). Colorectal Cancer Screening Tests have a benefit category under § 1861(s)(2)(R) and § 1861(pp) of the Social Security Act. Specifically, CMS is using the authority under § 1861(pp)(1)(D) and 42 C.F.R. § 410.37(a)(1)(v) to determine whether the scope of the CRC screening benefit should be expanded to include coverage of the CT colonography screening test. IV. Timeline of Recent Activities
CMS initiates this national coverage analysis for the use of screening CTC for colorectal cancer. The public has 30 days to submit comments on this topic. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information related to the technology under review. We are especially interested as to the types of studies needed if the evidence is determined to be premature for coverage or if the appropriate frequency interval is uncertain. November 19, 2008 CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to review the available evidence on the use of CTC as a screening test for colorectal cancer for average risk individuals, including test characteristics, screening frequency, cost effectiveness, safety and training requirements. February 11, 2009
CMS posts a proposed decision memorandum and the 30 day public comment period begins.
CMS met with representatives of the American Cancer Society, the American College of Radiology, and the American Gastroenterological Association and listened to their concerns regarding the proposed decision memorandum and asked them to reflect those concerns in the written comments they submit during the public comment period.
CMS met with representatives of the Medical Imaging and Technology Alliance and listened to their concerns regarding the proposed decision memorandum and asked them to reflect those concerns in the written comments they submit during the public comment period.
CMS searched PubMed from January 2003 to October 2008. General keywords included screening computed tomographic colonography and virtual colonoscopy. Initially, we searched for studies on asymptomatic, average risk individuals that presented original data using multislice CT, examined health outcomes and were published in peer-reviewed English language journals. Since no study met the criteria for health outcomes, the search was expanded to include technology assessments, meta-analysis, reviews, and studies that reported only test characteristics compared to optical colonoscopy. Abstracts were excluded. Using these general parameters, 6 original studies and 6 reviews were found. B. Discussion of evidence reviewed
Zauber AG, Knudsen AM, Rutter CM, Lansdorp-Vogelaar I, Savarino JE, van Ballegooijen M, Kuntz KM. Cost-effectiveness of CT colonography to screen for colorectal cancer. Report to AHRQ from the Cancer Intervention and Surveillance Modeling Network (CISNET) for MISCAN, SimCRC, and CRC-SPIN Models, 2009. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id58TA.pdf
Comments from Professional Societies and Organizations CMS received comments from the following: American Cancer Society (ACS), American College of Gastroenterology (ACG), American College of Preventive Medicine (ACPM), American College of Radiology (ACR) (combined comments with the Society of Gastrointestinal Radiology and the Society of Computed Tomography and Magnetic Resonance), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), Advanced Medical Technology Association (AMTA), American’s Health Insurance Plans (AHIP), Medical Imaging and Technology Alliance (MITA), and United Health Care (UHC).
Several commenters referenced these studies and unpublished results that were obtained from a subgroup analysis of the resulting data, which were presented to CMS at a meeting in Baltimore on March 3, 2009, in asserting that data are available for the 65 year old and older cohort on the clinical effectiveness of the CTC test in the older Medicare population. Based on these results, one commenter suggested that (1) the referral rate to colonoscopy from a positive CTC (14.4 per cent) (83/577) was reasonable in this subgroup, (2) the advanced neoplasia rate was also in an acceptable range, and (3) the CTC performance was more than adequate. CMS Response: As noted in our proposed decision, we are seeking data and evidence on the performance of screening CT colonography for individuals ≥ 65 years. The information presented provided an estimate on referral rates but did not include estimates on test characteristics such as sensitivity and specificity due to the parallel study design. We encourage publication of these data and other data on test characteristics for the Medicare aged population in peer reviewed journals for full consideration. In general, CMS does not take into account unpublished data since they are not available for full review publicly.
A number of commenters expressed their concerns and disagreements with several assumptions used in the AHRQ Technology Assessment titled, “Cost-Effectiveness of CT Colonography to Screen for Colorectal Cancer,” which was published on January 22, 2009. One commenter questioned an assumption that they indicate was made in the assessment that “the number of polypectomies projected for CT and optical colonoscopy (OC) were nearly equal (Tables 8A-8C in the AHRQ Technology Assessment).” The commenter also disagreed with assumptions that were made in the assessment relative to the transition rates for the progression of polyps to cancers.” The same commenter expressed the view that “an analysis of the cost-effectiveness of CTC must take into account the impact of extracolonic findings, especially the ability of CTC to detect asymptomatic abdominal aortic aneurysms as well as undiagnosed cancer at an early stage.” This commenter added, “In response to the concerns of cost effectiveness of CT colonography in the Medicare population, a recent study was published (Pickhardt et al., 2009),” and that “The conclusion reached in this analysis was that CTC represents a highly cost-effective and clinically efficacious strategy for the Medicare population given its ability to simultaneously screen for both CRC (Colorectal Cancer) and AAA.” Another commenter asserted that the Zauber et al., 2009, analysis “does not include cost of anesthesia for colonoscopy, which may impose a significant burden on patients in both time and expense.” The same commenter also asserts that the Zauber study “did not look at costs that can be saved in the screening and follow-up process if a positive CTC is immediately followed by an optical colonoscopy on the same day.” Where such access is available, the commenter suggested that this may increase adherence to follow-up after diagnosis and increase the cost-effectiveness of CTC.” CMS Response: As with the majority of cost effectiveness analyses, the parameters and assumptions of the model are important and depend on the available evidence. We agree that all models including the Pickhardt model are subject to the available data on history and follow-up. The assumptions of specific models are usually mentioned in the report, as Zauber and colleagues did, and may influence the interpretation and generalizability of the findings. The assumptions may also help explain different conclusions by various authors. We believe the analysis by Zauber provided a balanced set of assumptions. The analysis by Pickhardt included an additional test for abdominal aortic aneurysms. This model has not been used before and is not as well tested.
Several commenters asked CMS to reconsider its proposed decision to non-cover the CTC screening test and cover it as a Medicare option that would be available to beneficiaries through the Coverage with Evidence Development (CED) process. One recommended that CTC be covered as a colorectal cancer screening benefit for Medicare beneficiaries as long as certain enumerated conditions of coverage are met. Specifically, the commenter believes that the final coverage policy “should mandate the training, technology, quality standards and reporting prerequisites necessary to increase the likelihood that screening CTC will improve detection and that the CRC burden will not increase as a result of the false negative results associated with inadequate training or inappropriate technology.” In addition, the commenter recommended “standard reporting of all polyps in order to develop the evidence as to the appropriate use of referrals from CTC to colonoscopy and polypectomy, and the screening interval for CTC should be based on analysis of the implications of the published literature.” A second commenter urged CMS to cover CTC screening generally for average risk beneficiaries, or “at the very least apply a CED approach” to the test. In view of CMS’concerns about the inadequacy of the evidence on the usefulness of CTC screening for the Medicare population, a third commenter “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.” CMS Response: CED is a coverage option based on the reasonable and necessary authorities set forth in §§1862(a)(1)(A), and (a)(1)(E). Colorectal cancer screening benefits are covered as an exception to § 1862(a)(1)(A). This NCD is a scope of benefits determination based on the authority set forth at §1861(pp), and 42 C.F.R. § 410.37(a)(1)(v). §1861(s)(2)(R). Thus, CED is not applicable in this context.
One commenter, a consumer representative to the MEDCAC and a panel member of the California Technology Assessment Forum (CTAF), which also recently reviewed the CTC screening test, recommended “that Medicare deny a NCD for CTC at this time, or cover it only within a Coverage with Evidence Development (CED) framework …” The commenter noted that “the CTAF panel concurred with CMS and the USPSTF that there is insufficient evidence that CTC is an appropriate screening mechanism for colorectal cancer, particularly in a population that is of average risk.” Specifically, the commenter indicated that “Most elderly patients are not fully informed of the fact that bowel preparation is still required for CTCs, as it is for conventional colonoscopy and that sedation is not administered with CTC, resulting in acute discomfort for some patients.” CMS Response: We appreciate the comment and the position of the CTAF. The CTAF panel concurred with the USPSTF I statement and supports our decision.
Many commenters believe that compared to the optical colonoscopy (OC) the CTC test would encourage more beneficiaries who are concerned about the use of sedation with OC and the possibility of an accidental perforation of the colon. CMS Response: As noted in the decision, CT colonography requires a bowel prep that is similar to the prep for colonoscopy and while considered less invasive, complications may also occur with CT colonography as with any procedure. Also if polyps are detected, colonoscopy is still needed to remove the polyps. There also are no published studies on the impact of adding CT colonography on CRC screening rates in older individuals.
Cost. The cost and cost-effectiveness of screening tests are important to consider especially in environments with limited resources, increasing expenditures, and the availability of alternatives. The consideration of cost in screening is widely accepted, especially when considering whether an additional colorectal cancer screening test is appropriate. The cost effectiveness of CT colonography was specifically evaluated by Zauber and colleagues (2008) who reported: “Based on the analyses from three microsimulation models, screening for CRC with CT colonography every 5 years with referral of individuals with a 6 mm or larger lesion to colonoscopy provides a benefit in terms of life-years gained that is comparable to that of five-year flexible sigmoidoscopy with annual FOBT and slightly lower than colonoscopy screening every 10 years. The cost of CT colonography relative to the benefit derived and to the availability and costs of other CRC screening tests, would need to be in the range of $108 to $205 to be a cost-effective alternative to all other available screening modalities, and in the range of $179 to $237 to be cost-effective compared to colonoscopy screening with CMS payment of approximately $500 for colonoscopy without polypectomy and $650 for colonoscopy with polypectomy.” The initial analysis did not include the cost of general anesthesia use in some colonoscopies or the cost of evaluation of extracolonic findings from CT colonography. These factors will be considered in a later report. Vijan and colleagues (2007) found similar results and concluded: “CT colonography is an effective screening test for colorectal neoplasia. However, it is more expensive and generally less effective than optical colonoscopy. CT colonography can be reasonably cost-effective when the diagnostic accuracy of CT colonography is high, as with primary 3-dimensional technology, and if costs are about 60% of those of optical colonoscopy. Overall, CT colonography technology will need to improve its accuracy and reliability to be a cost-effective screening option.”
Based on these main studies and the consideration of the above factors, CT colonography using at least 8-16 slice CT scanners has sensitivity and specificity that are comparable to optical colonoscopy for polyps ≥ 10mm, and is cost effective when reimbursed at an amount in the range of $179 to $237 for representative populations. For polyps 6-9mm, the evidence is suggestive but less convincing given the lower sensitivity and specificity. CT colonography does not appear to have the ability to reliably detect small polyps < 6mm. This position is consistent with the MedCAC voting results. However, a pivotal, overarching concern is the generalizability of these main study results to the Medicare population (Appendix A). The mean age of participants in these studies (57.8 years, 57 years and 58.3 years in the Pickhardt, Kim and Johnson studies, respectively) was considerably younger than the Medicare aged population (mean age of 75.5 years in 2007, not including disabled beneficiaries, available at: http://www.cms.hhs.gov/DataCompendium/16_2008_Data_Compendium.asp#TopOfPage). Specific subgroup analyses of participants ≥ 65 years of age were not reported in the published reports so other participant characteristics may also be different. No published study has focused on a population more representative of the Medicare population. Without specific data and evidence, it is unclear if the determination of the above factors would result in a similar conclusion. It is also unclear if the published study results are generalizable. Thus there is insufficient evidence to determine that CT colonography is a valuable screening test for colorectal cancer for average risk Medicare individuals compared to optical colonoscopy. Estimates of test parameters for older participants ≥ 65 years of age from published studies and/or new studies are needed to address this critical concern. One commenter noted that there are ongoing subgroup analyses that focus on older individuals. When these results are published and publicly available, we will closely review them.
In deciding whether or not to add CT colonography to the list of covered CRC screening tests, CMS evaluated the test characteristics and performance of CT colonography and the impact on health outcomes for individuals aged 65 years and older. We have determined that there is insufficient evidence on the test characteristics and performance of screening CT colonography in Medicare aged individuals and that the evidence is not sufficient to conclude that screening CT colonography improves health benefits for asymptomatic, average risk Medicare beneficiaries. While it is a promising technology, many questions on the use of CT colonography need to be answered with well designed clinical studies that focus on health outcomes for the Medicare population. Until the evidence is sufficient, CMS strongly encourages physicians and beneficiaries to participate in CRC screening by selecting one of the several CRC screening tests that are currently covered under Medicare (Section 210.3 – Colorectal Cancer Screening Tests, available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf).
[ii] Individuals at high risk for colorectal cancer means an individual with (1) a close relative who has had colorectal cancer or adenomatous polyp; (2) family history of familial adenomatous polyposis; (3) family history of hereditary nonpolyposis colorectal cancer; (4) personal history of adenomatous polyps; (5) personal history of colorectal cancer; or (6) inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Back to Top
Zauber AG, Knudsen AM, Rutter CM, Lansdorp-Vogelaar I, Savarino JE, van Ballegooijen M, Kuntz KM. Cost-effectiveness of CT colonography to screen for colorectal cancer. Report to AHRQ from the Cancer Intervention and Surveillance Modeling Network (CISNET) for MISCAN, SimCRC, and CRC-SPIN Models. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id58TA.pdf