Bracco Diagnostics Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Oct. 6 -- Viviane Guay, senior director for market access at Bracco Diagnostics Inc., Monroe Township, New Jersey, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program; CY 2021 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.". The comment was written and posted on Sept. 30, 2020:

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Bracco Diagnostics Inc. is a leader in innovative contrast imaging agents offering a product and solution portfolio for all key diagnostic imaging modalities: X-Ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS) and Nuclear Medicine through radioactive tracers. As a key stakeholder in diagnostic imaging, we are submitting commentary on the Centers for Medicare & Medicaid Services Proposed Rule on National Coverage Determinations under the Physician Fee Schedule (PFS).

In this proposed rule, CMS identifies several criteria under which an older National Coverage Determination (NCD) may be retired and proposed to retire the NCDs for several medical services.

We believe that the NCD for computed tomography colonography (CT colonography), Chapter 1, Part 4 #210.3, should be added to the list and retired, enabling local Medicare contractors to make their own coverage decisions.

As per Federal Register document 78 FR 48164 Section E, CMS established an administrative process to periodically review the inventory of NCDs that are older than 10 years since their most recent review./1

The most recent review of this National Coverage Determination was August 7, 2009./2

It is critical to offer more screening options as Colorectal Cancer (CRC) remains the second most common cancer diagnosed in the United States and the third leading cause of cancer death even though it has a roughly 90% 5-year survival rate when detected early./3

In a study conducted by the Cancer Intervention and Surveillance Modeling Network (CISNET) models showed that per 1000 individuals screened with CT colonography every 5 years, the middle model estimate was 248 life-years gained and 22 colorectal cancer deaths would be avoided./4

Table omitted: https://www.regulations.gov/contentStreamer?documentId=CMS-2020-0088-17530&attachmentNumber=1&contentType=pdf

Less than half of adults 50 years of age and older remain compliant with recommended screening in the United States/5 with existing USPSTF recommended screening options.

Greater use of alternative CRC screening methods have been proposed as one strategy to improve screening rates./6,/7

It has been suggested that the common practice in the United States of recommending OC (optical colonoscopy) as the only preventative, visual exam to all CRC screening aged individuals may contribute to lower screening rates by not recognizing substantial variation in patient preferences and the invasiveness of OC./8,/9

Following are some of the key considerations that we believe warrant the NCD for CT colonography to enable local Medicare Administrative Contractors to make their own coverage decisions with respect to CT colonography procedures.

1. CT colonography is well-studied with clinical results aligned with Optical Colonoscopy (OC).

CT colonography consists of low-dose standard abdomen and pelvis computed tomography (CT) imaging combined with display protocols to optimally visualize the colon./10,/11,/12,/13,/14,/15,/16,/17,/18,/19,/20

Since its introduction into clinical practice around the year 2000, CT colonography has been implemented by over 1,000 radiology facilities in the US. In the past two years, there have been two significant meta-analysis comparing CT colonography with OC. A study completed in 2019 found that CT colonography and OC had similar results with findings of polyps and masses./21

While a metaanalysis specifically for Medicare age patients (65 years and older) published in 2018 found that CT colonography sensitivity for CRC was 93.0% in senior-age patients compared to 92.0% for younger adults./22

In June 2016, the United States Preventive Services Task Force (USPSTF) endorsed screening for CRC, awarding it an "A" grade and identifying a number of valid exams, including CT colonography, under the principle that the best test is the one that gets done./23

Further, the USPSTF has recognized that CT colonography is at least as sensitive as OC in identifying colorectal cancers and large adenomas./24

CT colonography has significantly higher sensitivity and specificity in identifying precursor polyps compared to stool-based tests./25

Metaanalyses performed have demonstrated that the sensitivity to detect cancer at CT colonography with optical colonoscopy and histologic validation is greater than 95%./26,/27

Most recently published in 2011, in 49 studies of 11,151 patients with a cumulative colorectal cancer prevalence of 3.6%, sensitivity to detect cancer at CT colonography was 96.1%./28

2. CT colonography is less invasive and more patient-friendly than other traditional CRC screening exams.

In general, CT colonography is a significantly less invasive and more patient-friendly procedure than traditional OC. Optical colonoscopy carries a far greater risk of perforation, bleeding, and infection than CT colonography. Unlike colonoscopy in which a colonoscope is inserted into the colon, CT colonography is minimally invasive, requiring only mild colonic insufflation.

Further, CT colonography patients do not receive anesthesia, thereby eliminating the risks inherent to sedation and eliminating the need for an escort to drive the patient home. Patient exams are completed in 10-15 minutes, and the patient can immediately return to normal daily activities. This simple, accurate, and patient-friendly test comports well with classic characteristics of what a good screening exam should be.

This is particularly relevant in patients who--for anatomic or other reasons--cannot tolerate insertion of a colonoscope and helps to characterize the difference in "penetration". When a patient's colon is penetrated by a colonoscope, there is serious risk of infection; whereas when there is "penetration" during a CT colonography procedure, it amounts to a small amount of air escaping from the colon into the peritoneal cavity. A recent study found that 16.3 per 1000 outpatient colonoscopies among Medicare beneficiaries resulted in unplanned hospital visits after the procedure. The most common reasons for these unplanned hospital visits were hemorrhage, abdominal pain, and perforation./29

3. CT colonography detects pre-cancerous lesions which are missed by Stool tests (i.e. gFOBT, FIT and FIT-DNA). Although their use has grown in popularity, stool tests for CRC screening only detect tumor markers when they are circulating in the blood at a more advanced stage of cancer, whereas CT colonography finds clinically relevant pre-cancerous polyps. Early detection of polyps enables the excision, via polypectomy, of clinically relevant lesions (i.e. polyps which are of a size and shape known to put a patient at risk of colon cancer, before they become cancer). Using a polyp size threshold for referral to treatment, CT colonography avoids unnecessary polypectomy in patients who do have polyps which might have been excised during OC but unnecessarily so.

4. CT colonography is well covered among commercial payors. In fact, commercial payers provide insurance to 75% of the approximately 61 million US adults aged 50 to 64./30

A study published in 2017 in the journal Radiology by Smith, et. al makes clear that people who have access to CT colonography via coverage by private insurers are almost 50% more likely to get screened than those who do not have such coverage./31

5. In the time of this pandemic-induced National Health Emergency, CT colonography offers additional administrative benefits versus OC. OC requires additional administration personnel as well as close patient contact. During this procedure, there are often times an anesthesiologist, gastroenterologist, nurse, and surgical technician. However, during a CT colonography procedure a patient is in the CT scanner while a radiology technologist is protected by glass in a different room and an offsite radiologist interprets the results. Now more than ever, it is important to keep medical professionals safe and with as minimum exposure as possible.

6. At this time, the public is more aware of the risks of CRC than ever. Actor Chadwick Boseman recently passed away from colorectal cancer at the age of 43. Boseman was under the traditional screening age upon his stage 3 diagnosis. With the increasing awareness, giving the Medicare age population more options for screening would help contribute to greater screening rates overall. CT colonography is an effective screening modality for AfricanAmerican adults and could potentially improve rates of colorectal screening in this under-served population./32

7. The best test is the one that gets done. As the USPSTF clearly stated in its latest CRC screening recommendation, the best test is the one that gets done. This means that patients should have access to as many medically sound screening tests as possible. In its recommendation statement, the Task Force endorsed screening for CRC, awarding it an "A" grade and identifying a number of valid exams, including CT colonography./33

A study done in 2018 by Duarte et al invited 8,104 patients to undergo a CT colonography and 7,310 patients to undergo an OC. Of these patients, 2,333 participated in the study involving CT colonographies (28.79%) and 1,486 (20.32%) participated in the study involving OCs. CT colonography is better accepted than colonoscopy by the population, and the option to perform this examination can increase the rate of participation in CT colonography screening programs./34

Due to the great risks undetected colorectal cancer poses, the positive prognosis opportunity that exists if detected early, and the importance of increasing public awareness, we respectfully request that CMS retire the National Coverage Determination for CT colonography. Given that eleven years have passed since this National Coverage Determination was last reviewed, it is eligible for retirement. In the intervening decade, a significant volume of favorable peer-reviewed literature has been published, the USPSTF endorsed CT colonography with an "A" grade, and public health statistics reinforce the fact that Colorectal Cancer continues to have a devastating impact on our citizens, given it has surged to be the third leading cause of cancer deaths despite the 90% 5-year survival rate when detected early. All of these data points are consistent with the bases to retire this policy. We believe, therefore, that it is in the best interest of the Medicare population to retire this policy and allow the Medicare Administrative Contractors the opportunity to make their own local coverage decisions.

Sincerely,

Viviane Guay

Sr. Director, Market Access

Bracco Diagnostics Inc.

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References

1. https://www.federalregister.gov/documents/2013/08/07/2013-19060/medicare-program-revised-processfor-making-national-coverage-determinations

2. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R105NCD.pdf

3. http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-survival-rates

4. https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/colorect al-cancer-screening

5. American Cancer Society. Colorectal cancer facts & figures 2011-2013. Atlanta, GA: American Cancer Society, 2011

6. Inadomi JM, Vijan S, Janz NK et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med 2012;172(7):575-582

7. McQueen A, Bartholomew LK, Greisinger AJ et al. Behind closed doors: physician-patient discussions about colorectal cancer screening. J Gen Intern Med 2009;24(11):1228-1235

8. Marshall DA, Johnson FR, Phillips KA, Marshall JK, Thabane L, Kulin NA. Measuring patient preferences for colorectal cancer screening using a choice-format survey. Value Health 2007;10(5):415-430.

9. DeBourcy AC, Lichtenberger S, Felton S, Butterfield KT, Ahnen DJ, Denberg TD. Community-based preferences for stool cards versus colonoscopy in colorectal cancer screening. J Gen Intern Med 2008;23(2):169-174.

10. Chang KJ, Heisler MA, Mahesh M, Baird GL, Mayo-Smith WW. CT colonography at low tube potential: using iterative reconstruction to decrease noise. Clin Radiol. 2015;70(9):981-988.

11. Lambert L, Danes J, Jahoda J, Masek M, Lisy J, Ourednicek P. Submilisievert ultralow-dose CT colonography using iterative reconstruction technique: a feasibility study. Acta Radiol. 2015; 56(5):517525.

12. http://jamanetwork.com/journals/jama/fullarticle/2529486

13. Lambert L, Ourednicek P, Jahoda J, Lambertova A, Danes J. Model-based vs hybrid iterative reconstruction technique in ultralow-dose submillisievert CT colonography.Br J Radiol. 2015; Apr;88 (1048) :20140667.

14. Lubner MG, Pickhardt PJ, Kim DH, Tang J, del Rio AM, Chen GH. Prospective evaluation of prior image constrained compressed sensing (PICCS) algorithm in abdominal CT: a comparison of reduced dose with standard dose imaging. Abdom Imaging.

15. Lubner MG, Pooler BD, Kitchin DR, et al. Sub-milliSievert (sub-mSv) CT colonography: a prospective comparison of image quality and polyp conspicuity at reduced-dose versus standard-dose imaging. Eur Radiol. 2015;25(7):2089-2102.

16. Millerd PJ, Paden RG, Lund JT, et al. Reducing the radiation dose for computed tomography colonography using model-based iterative reconstruction. Abdom Imaging. 2015;40 (5):1183-1189.

17. Nagata K, Fujiwara M, Kanazawa H, et al. Evaluation of dose reduction and image quality in CT colonography: comparison oflow-dose CT with iterative reconstruction and routine-dose CT with filtered back projection. Eur Radiol. 2015;25(1):221-229.

18. Shen H, Liang D, Luo M, et al. Pilot study on image quality and radiation dose of CT colonography with adaptive iterative dose reduction three-dimensional. PloS one. 2015;10(1):e0117116.

19. Shin CI, Kim SH, Lee ES, et al. Ultra-low peak voltage CT colonography: effect of iterative reconstruction algorithms on performance of radiologists who use anthropomorphic colonic phantoms. Radiology.2014;273(3):759-771.

20. Yamamura S, Oda S, Imuta M, et al. Reducing the Radiation Dose for CT Colonography: Effect of Low Tube Voltage and Iterative Reconstruction. Acad Radiol. 2015 Apr 11. pii: S1076-6332(15)00130-0. doi: 10.1016/j.acra.2015.03.009.

21. Positive Predictive Value for Colorectal Lesions at CT Colonography: Analysis of Factors Impacting Results in a Large Screening Cohort. Perry J. Pickhardt, Loredana Correale, and Cesare Hassan. American Journal of Roentgenology 2019 213:1, W1-W8.

22. Pickhardt PJ, Correale L, Delsanto S, Regge D, Hassan C. CT colonography performance for the detection of polyps and cancer in adults 65 years old: systematic review and meta-analysis. AJR 2018;211:40-51

23. US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989

24. US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989

25. Levin B, Lieberman D, McFarland B, et al. Screening and Surveillance for the Early Detection of Colorectal and Adenomatous Polyps, 2008. CA Cancer J Clin 2008;58:1-31

26. Halligan S, Altman DG, Taylor SA, et al. CT colonography in the detection of colorectal polyps and cancer: systematic review, meta-analysis, and proposed minimum data set for study level reporting.Radiology 2005;237:893-904

27. Pickhardt P, Hassan C, Halligan S et al; Colorectal cancer: CT colonography and colonoscopy for detection- systematic review and meta-analysis. Radiology 2011;259:393-405

28. Pickhardt P, Hassan C, Halligan S et al; Colorectal cancer: CT colonography and colonoscopy for detection- systematic review and meta-analysis. Radiology 2011;259:393-405

29. Ranasinghe, et al., Differences in Colonoscopy Quality Among Facilities: Development of a PostColonoscopy Risk-Standardized Rate of Unplanned Hospital Visits. Gastroenterology 2016;150:103-113

30. Sawhney TG, Pyenson BS, Rotter D, Berrios M, Yee J. Computed Tomography Colonography Less Costly Than Colonoscopy for Colorectal Cancer Screening of Commercially Insured Patients. Am Health Drug Benefits. 2018;11(7):353-361.

31. Smith MA, Weiss JM, Potvien A,et al. Insurance coverage for CT colonography screening: impact on overall colorectal cancer screening rates. Radiology 2017;284:717-724

32. Moreno, et al. Addressing Racial Disparity in Colorectal Cancer Screening With CT Colonography: Experience in an African-American Cohort. Clin Colorectal Cancer. 2018 Jun;17(2):e363-e367.

33. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening

34. Duarte RB, Bernardo WM, Sakai CM, et al. Computed tomography colonography versus colonoscopy for the diagnosis of colorectal cancer: a systematic review and meta-analysis. Ther Clin Risk Manag.2018;14:349-360. Published 2018 Feb 21. doi:10.2147/TCRM.S152147

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0088-1604

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