National Medical Policy

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1 National Medical Policy Subject: Policy Number: Immunochemical Fecal Occult Blood Testing NMP286 Effective Date*: July 2006 Updated: June 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Colorectal Cancer Screening Tests (210.3): Fecal Occult Blood Test (190.34) National Coverage Manual Citation x Local Coverage Determination (LCD)* Colonoscopy and Sigmoidoscopy Diagnostic: Article (Local)* x Other Decision Memo for Screening Immunoassay Fecal-Occult Blood Test: ening+immunoassay+fecal- Occult+Blood+Test&SearchType=Advanced&Cov erageselection=both&ncselection=nca%7ccal %7cNCD%7cMEDCAC%7cTA%7cMCD&bc=AAAA AAAACAAAAA%3d%3d& MLN Matters Number: MM7184. January 3, New Waived Tests: Immunochemical Fecal Occult Blood Testing Jun 16 1

2 None Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/mm7184.pd f Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net Inc. considers Immunochemical Fecal Occult Blood Testing medically necessary as alternative to gfobt, guaiac-based test, for screening for colorectal cancer or for evaluation of symptoms suggestive of lower gastrointestinal bleeding. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Malignant neoplasm of the colon Malignant neoplasm of the rectum, rectosigmoid junction, and anus Benign neoplasm of the colon Benign neoplasm of rectum and anal canal Iron deficiency anemia, secondary to blood loss (chronic) Iron deficiency anemia, unspecified Anal and rectal polyp Hemorrhage of rectum and anus Blood in stool Hemorrhage of gastrointestinal tract, unspecified V10.05 Personal history of malignant neoplasm of the large intestine V10.06 Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus. Immunochemical Fecal Occult Blood Testing Jun 16 2

3 V12.72 Personal history of colonic polyps V16.0 Family history of malignant neoplasm of gastrointestinal tract (first-degree relative-sibling, parent, child) V76.41 Special screening for malignant neoplasms of rectum V76.50 Special screening for malignant neoplasms of intestine, unspecified V76.51 Special screening for malignant neoplasms of colon ICD-10 Codes C18.0-C18.9 Malignant neoplasm of colon C19 Malignant neoplasm of rectosigmoid junction C20 Malignant neoplasm of rectum C21.0-C21.8 Malignant neoplasm of anus and anal canal D12.Ø Benign neoplasm of cecum D12.2-D12.9 Benign neoplasm of colon, rectum, anus and anal canal D5Ø.Ø Iron deficiency anemia secondary to blood loss (chronic) K62.Ø Anal polyp K62.1 Rectal polyp K62.5 Hemorrhage of anus and rectum K92.1 Melena K92.2 Gastrointestinal hemorrhage, unspecified Z12.11-Z12.13 Encounter for screening for malignant neoplasm of intestinal tract Z Z Personal history of malignant neoplasm of large intestine Z Z Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus Z86.Ø1Ø Personal history of colonic polyps Z8Ø.Ø Family history of malignant neoplasm of digestive organs CPT Codes Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (ie, patient was provided three cards or single triple card for consecutive collection Blood, occult, by peroxidase activity (e.g., guaiac), qualitative, feces, single specimen (e.g., from digital rectal exam) Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations HCPCS Codes G0328 Colorectal cancer screening; fecal occult blood test, immunoassay, 1-3 simultaneous determinations Scientific Rationale Update June 2016 Hirai et al. (2016) completed a systematic review with a meta-analysis to assess the diagnostic accuracy of fecal occult blood testing (FOBT) for relative detection of colorectal cancer (CRC) according to its anatomical location. Diagnostic studies including both symptomatic and asymptomatic cohorts assessing performance of FOBTs for CRC were searched. Primary outcome was accuracy of FOBTs according to Immunochemical Fecal Occult Blood Testing Jun 16 3

4 the anatomical location of CRC. Bivariate random-effects model was used. Subgroup analyses were performed to evaluate test performance of guaiac-based FOBT (gfobt) and immunochemical-based FOBT (ifobt). Thirteen studies, with 17 cohorts, reporting performance of FOBT were included; a total of patients (mean age 58.9 years; 58.1% male) underwent both colonoscopy and FOBT. Pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of FOBTs for CRC detection in the proximal colon were 71.2% (95% CI %), 93.6% (95% CI %), 11.1 (95% CI ) and 0.3 (95% CI ) respectively. Corresponding findings for CRC detection in distal colon were 80.1% (95% CI %), 93.6% (95% CI %), 12.6 (95% CI ) and 0.2 (95% CI ). The area-under-curve for FOBT detection for proximal and distal CRC were 90% vs. 94% (P = ). Both gfobt and ifobt showed significantly lower sensitivity but comparable specificity for the detection of proximally located CRC compared with distal CRC. Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative detection of colorectal cancer in the distal colon than in the proximal bowel. Per the United States Preventive Services Task Force (USPSTF, updated July 2015) the summary of recommendations* for colorectal cancer screening include the following: 1. Adults, beginning at age 50 years and continuing until age 75 years 2. The USPSTF recommends screening for colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary. Recommended screening tests and intervals are as follows: High-sensitivity fecal occult blood test (FOBT), every year Flexible sigmoidoscopy, every five years with FOBT every 3 years Colonoscopy, every 10 years *Note: This recommendation was rated a Grade A by the USPSTF. This means that the USPSTF recommends this service and is high certainty that the net benefit is substantial. The National Comprehensive Care Network (NCCN, V2.2016) Clinical Practice Guidelines on Colorectal Cancer Screening do not mention immunochemical fecal occult blood testing. Scientific Rationale Update June 2015 Imperiale et al. (2014) completed the largest study of those at average risk for colon cancer. 9,989 were enrolled in an industry-sponsored cross-sectional study that compared the CologuardTM test, a noninvasive, multi-target stool DNA test with a fecal immunochemical test (FIT) in patients at average risk for colorectal cancer. The DNA test included quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and β-actin, plus a hemoglobin immunoassay. Of the 9989 participants who could be evaluated, 65 (0.7%) had colorectal cancer and 757 (7.6%) had advanced precancerous lesions on colonoscopy. The sensitivity for Immunochemical Fecal Occult Blood Testing Jun 16 4

5 detecting colorectal cancer was 92.3% with DNA testing and 73.8% with FIT (P=0.002). The sensitivity for detecting advanced precancerous lesions was 42.4% with DNA testing and 23.8% with FIT (P<0.001). The rate of detection of polyps with high-grade dysplasia was 69.2% with DNA testing and 46.2% with FIT (P=0.004); the rates of detection of serrated sessile polyps measuring 1 cm or more were 42.4% and 5.1%, respectively (P<0.001). Specificities with DNA testing and FIT were 86.6% and 94.9%, respectively, among participants with non-advanced or negative findings (P<0.001) and 89.8% and 96.4%, respectively, among those with negative results on colonoscopy (P<0.001). The authors concluded that in asymptomatic individuals at average risk for colorectal cancer, multi-target stool DNA testing detected significantly more cancers than FIT but had more false positive results. In this study, one limitation was the nonrandomized study design and lack of comparison to the standard of care, colonoscopy. Letters to the editor regarding this study by Imperiale and colleagues noted several issues with the interpretation of the study s results. Authors of the editorial letters suggested that the decreased sensitivity of FIT could have been due to the incorrect cutoff values included in the algorithm. In addition, the higher false positive rate may have contributed to the higher overall positive rate for the stool DNA test. The high number of false positives detected in this study limits the utility of the test. There continues to be no mention of immunochemical fecal occult blood testing (FOBT) in the NCCN (Version ) Guidelines on Colon Cancer. Scientific Rationale Update June 2013 There is no mention of immunochemical fecal occult blood testing (FOBT) in the 2013 National Cancer Comprehensive Guidelines on Colon Cancer. Scientific Rationale Update July 2010 Testing stool for occult blood by the chemical guaiac reagent (gfobt) has been available for decades and is effective at reducing mortality from colorectal cancer (CRC). However, because of limitations in sensitivity and specificity, newer fecal immunochemical tests (FITs) were developed that detect occult blood using enzyme immunoassays. Because of their improved sensitivity and specificity, FITs have replaced gfobt for screening in many settings. Hoffman et al (2010) investigated whether colorectal cancer screening adherence is greater with fecal immunochemical tests (FIT) or guaiac-based fecal occult blood tests (gfobt). Electronic health records were used to identify 3869 primary care patients due for screening for whom fecal blood testing was appropriate. 404 individuals were randomized to receive FIT (n=202) or gfobt (n=202) by mail. The investigators determined the proportion of individuals completing testing within 90 days of agreeing to participate in the study. They used multivariate logistic regression to evaluate screening completion, adjusting for age, gender, race/ethnicity, clinic site, previous gfobt testing, and co-morbidity. The authors reported screening adherence was higher with FIT than gfobt (61.4% vs. 50.5%, P=0.03). The adjusted odds ratio for completing FIT vs. gfobt was 1.56, 95% CI 1.04, The authors concluded in a clinic setting of patients who were due for colorectal cancer screening, adherence was significantly higher with FIT than gfobt. Tannous et al (2009) evaluated the analytical performance of 5 different FOBT methods (standard guaiac-based method and four immunochemical methods) using patient samples and spiked stool specimens. They reported the analytical sensitivity Immunochemical Fecal Occult Blood Testing Jun 16 5

6 measured using spiked stool samples varied from <8 to 1500 ug hemoglobin/gram of stool. In some cases the results differed significantly from the manufacturers reported analytical sensitivity. Analysis of 71 stool samples measured by all 5 methods showed a discrepant result in 31 cases (43.7%). The rate of positive samples varied by method from 8.5% to 42.2%. The authors concluded the results demonstrate significant differences in the analytical performance among FOBT methods. Careful method validation and selection of a method with appropriate sensitivity is essential when choosing an FOBT method for colorectal cancer screening or for the assessment of gastrointestinal bleeding in the emergency department and hospital inpatients. Graser et al (2009) compared the performance characteristics of five different screening tests in parallel for the detection of advanced colonic neoplasia: CT colonography (CTC), colonoscopy (OC), flexible sigmoidoscopy (FS), fecal immunochemical stool testing (FIT) and fecal occult blood testing (FOBT). Average risk adults provided stool specimens for FOBT and FIT, and underwent same-day low-dose 64-multidetector row CTC and OC using segmentally unblinded OC as the standard of reference. Sensitivities and specificities were calculated for each single test, and for combinations of FS and stool tests. CTC radiation exposure was measured, and patient comfort levels and preferences were assessed by questionnaire. The authors reported 221 adenomas were detected in 307 subjects who completed CTC (mean radiation dose, 4.5 msv) and OC; 269 patients provided stool samples for both FOBT and FIT. Sensitivities of OC, CTC, FS, FIT and FOBT for advanced colonic neoplasia were 100% (95% CI 88.4% to 100%), 96.7% (82.8% to 99.9%), 83.3% (95% CI 65.3% to 94.4%), 32% (95% CI 14.9% to 53.5) and 20% (95% CI 6.8% to 40.7%), respectively. Combination of FS with FOBT or FIT led to no relevant increase in sensitivity. 12 of 45 advanced adenomas were smaller than 10 mm. 46% of patients preferred CTC and 37% preferred OC (p<0.001). The authors concluded high-resolution and low-dose CTC is feasible for colorectal cancer screening and reaches sensitivities comparable with OC for polyps >5 mm. For patients who refuse full bowel preparation and OC or CTC, FS should be preferred over stool tests. However, in cases where stool tests are performed, FIT should be recommended rather than FOBT. Scientific Rationale Per the American Cancer Society colorectal cancer is the third most common cancer in both men and women. Screening for colorectal cancer in persons who are at average risk for developing colorectal cancer should begin at age 50. Earlier and more frequent screening has been recommended for high risk individuals. Screening methods for colorectal cancer currently available include fecal occult blood test (FOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy, double-contrast barium enema or the gold standard colonoscopy. Fecal occult blood testing (FOBT) is a noninvasive test that detects low levels of blood in the feces. FOBT as a screen for colorectal cancer continues to be the most widely used tool today. However, patient compliance with FOBT is low and this is one of the major barriers to colorectal cancer screening. Evidence from multiple wellconducted randomized trials supports the effectiveness of fecal occult blood testing (FOBT) in reducing colorectal cancer incidence and mortality rates compared with no screening for adults over age 50 who are at average risk. The U.S. Preventive Services Task Force (USPSTF) found good evidence that periodic fecal occult blood Immunochemical Fecal Occult Blood Testing Jun 16 6

7 testing (FOBT) reduces mortality from colorectal cancer and fair evidence that sigmoidoscopy alone or in combination with FOBT reduces mortality. FOBT are generally divided into two types: immunoassay and guaiac types. Guaiacbased fecal occult blood testing (FOBT) use a peroxidase reaction to indicate presence of the heme portion of hemoglobin. As some cancerous and precancerous lesions tend to bleed spontaneously, this test can detect low levels of blood in the feces. Most FOBTs use sticks to collect stool samples and may be developed in a physician s office or a laboratory. Disadvantages of FOBT screening include falsepositive results due to treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or consumption of peroxidase-rich foods such as red meat, turnips, or cabbage 3 days before the test. A false-positive result may also be related to bleeding hemorrhoid, gastrointestinal ulcer, or similar benign lesion. False negative results may occur if the patient has been taking Vitamin C. Immunochemical fecal occult blood tests (e.g., Flexsure OBT, InSure FOBT, Instant- View Fecal Occult Blood Rapid Test, Clearview Ultra FOB, Hemosure One-Step Fecal Occult Blood Test) are intended as an alternative to guaiac-based fecal occult blood testing. Immunological fecal occult blood tests (ifobt) detect blood in fecal samples using antibodies that bind to intact human hemoglobin. An ifobt may be less likely to give a false-positive result due to a bleeding ulcer in the upper gastrointestinal since blood from these ulcers should be at least partially degraded in the stomach and small intestine. One advantage of ifobt is the lack of required dietary restrictions, which make it a more patient-friendly test. While most ifobts use spatulas to collect stool samples, some use a brush to collect toilet water surrounding the stool. Most ifobts require laboratory processing. Upper GI bleeding will not be detected by this method & hemmocult guaiac methodology is recommended if bleeding is suspected from UGI tract. No randomized controlled trials of an immunochemical test have been conducted, but many case-control studies or studies comparing an immunochemical test with hemoccult have been conducted. Studies indicate that ifobts have either comparable or greater sensitivity than conventional guaiac-based FOBTs for detection of cancers in average-risk populations, with similar specificity, however, sensitivity for adenomas was much lower and similar for both types of tests. Immunochemical FOBT may be used as an alternative to conventional guiac based FOBTs. Li et al. reported a multicenter study of 324 patients comparing results of guaiacbased chemical FOBT (CFOBT) to ifobt (Hemosure IFOBT) as well as hypothetical sequential method (SFOBT), in which IFOBT was used only as a confirmatory test for CFOBT. Three consecutive stool samples were collected from each patient for simultaneous testing with each method, followed by colonoscopic examination. The sensitivity and specificity of the 3 methods (CFOBT, IFOBT and SFOBT) were compared in two settings, with the first 2 consecutive samples versus all 3 samples. Although the sensitivity for the detection of cancer and large (>20 mm) or multiple adenoma was similar for all 3 methods in the three-sample setting, in the twosample setting IFOBT had higher sensitivity than SFOBT for detecting cancer (87.8% vs. 75.5%, respectively,) and large (>20 mm) or multiple adenomas (65.4% vs. 42.3%, respectively). The IFOBT also had a higher specificity than the CFOBT (89.2% vs. 75.5%, respectively,) in "normal" individuals defined by colonoscopy in the three-sample setting. Comparing two-sample setting to the three-sample setting, both CFOBT and SFOBT showed significant loss of sensitivity for the detection of Immunochemical Fecal Occult Blood Testing Jun 16 7

8 cancer as well as adenoma, whereas the sensitivity for IFOBT did not change significantly. Overall, IFOBT with two-sample testing showed compatible sensitivity and specificity to the three-sample testing. Centers for Medicare and Medicaid Services (CMS) has concluded that there is adequate evidence to determine that the immunoassay fecal occult blood test (ifobt) is an appropriate and effective colorectal cancer screening test in patients who are appropriate candidates for colon cancer screening. The American Cancer Society (ACS) concluded that, in comparison with conventional guaiac-based FOBTs, the immunochemical tests are more patient-friendly and are likely to be equal or better in sensitivity and specificity. Unfortunately, both conventional and ifobts will give a false-negative result for a colorectal adenoma or tumor that does not bleed sufficiently. In an effort to increase the likelihood of detecting a tumor that bleeds intermittently, samples for an FOBT can be collected on 2 or 3 consecutive days. Patients with a positive test on any specimen should be followed up with colonoscopy. Review History July 2006 March 2007 July 2010 June 2011 June 2012 June 2013 June 2014 June 2015 June 2016 Medical Advisory Council, initial approval Coding Update Update no revisions Update no revisions. Medicare table added. Update. No Revisions. Update. No Revisions. Codes updated. Update. No revisions. Codes updated. Update. No revisions. Codes updated. Update. No revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. American Gastroenterological Association. Colorectal cancer screening and surveillance: Clinical guidelines and rationale Update based on new evidence. Gastroenterology Feb; Volume 124 (2) 2. Hayes Medical Technology Directory. Immunochemical Fecal Occult Blood Testing. December 5, Updated January 17, Archived November National Cancer Institute. Colorectal Cancer (PDQ): Screening. Last Modified. Mar U.S. Preventive Services Task Force. Screening for colorectal cancer: recommendations and rationale. Ann Intern Med 2002 Jul 16;137(2): U.S. Preventive Services Task Force. Screening for colorectal cancer: Recommendation Statement. October Updated July National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology. Colorectal Cancer Screening. V.I Updated Version Updated Version Updated Version Updated Version Updated Version Hayes. News Government. News Government. CMS Coverage Decision on Screening DNA Stool Test for Colorectal Cancer. May 6, American College of Gastroenterology. Clinical Guidelines. April References Update June Cabebe EC. Colorectal Cancer Guidelines. Colorectal Cancer Screening. Medscape. March 12, Immunochemical Fecal Occult Blood Testing Jun 16 8

9 2. Hirai HW, Tsoi KK, Chan JY, et al. Systematic review with meta-analysis: faecal occult blood tests show lower colorectal cancer detection rates in the proximal colon in colonoscopy-verified diagnostic studies. Aliment Pharmacol Ther Apr;43(7): doi: /apt Epub 2016 Feb Plumb AA, Ghanouni A, Rainbow S, et al. Patient factors associated with nonattendance at colonoscopy after a positive screening faecal occult blood test. J Med Screen May 22. pii: [Epub ahead of print]. References Update June Brenner, H, Werner, S, Chen, H. Multitarget stool DNA testing for colorectalcancer screening. N Engl J Med Jul 10;371(2): Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14): Lee JK, Terdiman JP, Corley DA. Multitarget stool DNA testing for colorectalcancer screening. N Engl J Med Jul 10;371(2): Robertson DJ, Dominitz JA. Stool DNA and colorectal-cancer screening. N Engl J Med. 2014;370(14): Senore, C, Segnan, N. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med Jul 10;371(2): Souverijn, JH. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med Jul 10;371(2):187. References Update June Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013;369(12):1106. References Update June Travis AC, Saltzman JR. Evaluation of occult gastrointestinal bleeding. UpToDate. November 21, van Roon AH, Goede SL, van Ballegooijen M, et al. Random comparison of repeated faecal immunochemical testing at different intervals for populationbased colorectal cancer screening. Gut 2013; 62:409. References Update June Duffy MJ, van Rossum LG, van Turenhout ST, et al. Use of faecal markers in screening for colorectal neoplasia: a European group on tumor markers position paper. Int J Cancer 2011; 128:3. 2. Fletcher RH. Tests for screening for colorectal cancer: Stool tests, radiologic imaging and endoscopy. UpToDate. March 13, Updated April 22, Haug U, Kuntz KM, Knudsen AB, et al. Sensitivity of immunochemical faecal occult blood testing for detecting left- vs right-sided colorectal neoplasia. Br J Cancer 2011; 104: van Rossum LG, van Rijn AF, Verbeek AL, et al. Colorectal cancer screening comparing no screening, immunochemical and guaiac fecal occult blood tests: A cost-effectiveness analysis. Int J Cancer. 2011; 128(8): References Update June Lane JM, Chow E, Young GP, et al. Interval fecal immunochemical testing in a colonoscopic surveillance program speeds detection of colorectal neoplasia. Gastroenterology Dec;139(6): van Dam L, Kuipers EJ, van Leerdam ME. Performance improvements of stoolbased screening tests. Best Pract Res Clin Gastroenterol Aug;24(4): Immunochemical Fecal Occult Blood Testing Jun 16 9

10 References Update July Centers for Medicaid and Medicare Services. NCD for Colorectal Cancer Screening Tests (210.3). Effective May Available at: cd%3a210%2e3%3a3%3acolorectal+cancer+screening+tests 2. Graser A, Stieber P, Nagel D, et al. Comparison of CT colonography, colonoscopy, sigmoidoscopy and fecal occult blood tests for the detection of advanced adenoma in an average risk population. Gut Feb;58(2): Haug U, Hundt S, Brenner H. Quantitative immunochemical fecal occult blood testing for colorectal adenoma detection: evaluation in the target population of screening and comparison with qualitative tests. Am J Gastroenterol Mar;105(3): Hoffman RM, Steel S, Yee EF, et al. Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial. Prev Med May-Jun;50(5-6): Hundt S, Haug U, Brenner H. 5.Comparative evaluation of immunochemical fecal occult blood tests for colorectal adenoma detection. Ann Intern Med Feb 3;150(3): Lohsiriwat V, Thavichaigarn P, Awapittaya B. A multicenter prospective study of immunochemical fecal occult blood testing for colorectal cancer detection. A multicenter prospective study of immunochemical fecal occult blood testing for colorectal cancer detection. 7. Oono Y, Iriguchi Y, Doi Y, et al. A retrospective study of immunochemical fecal occult blood testing for colorectal cancer detection. Clin Chim Acta Jun 3;411(11-12): Park DI, Ryu S, Kim YH, et al. Comparison of Guaiac-Based and Quantitative Immunochemical Fecal Occult Blood Testing in a Population at Average Risk Undergoing Colorectal Cancer Screening. Am J Gastroenterol May Potack J, Itzkowitz SH. Practical advances in stool screening for colorectal cancer. J Natl Compr Canc Netw Jan;8(1): Tannous B, Lee-Lewandrowski E, Sharples C, et al. Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: implications for clinical practice in hospital and outpatient settings. Clin Chim Acta Feb;400(1-2): Whitlock EP, Lin JS, Liles E, et al. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med Nov 4;149(9): References 1. Agrawal J, Syngal S. Colon cancer screening strategies. Curr Opin Gastroenterol Jan;21(1): Centers for Disease Control and Prevention (CDC). Increased use of colorectal cancer tests--united States, 2002 and MMWR Morb Mortal Wkly Rep Mar 24;55(11): Greenwald B. From guaiac to immune fecal occult blood tests: the emergence of technology in colorectal cancer screening. Gastroenterol Nurs Mar- Apr;28(2): Harford WV. Colorectal cancer screening and surveillance. Surg Oncol Clin N Am Jan;15(1):1-20, v. 5. Hayes Alert. CMS National Coverage for ifobt Takes Effect. Available at: Immunochemical Fecal Occult Blood Testing Jun 16 10

11 6. Hilsden RJ, McGregor E, Murray A, et al. Colorectal cancer screening: practices and attitudes of gastroenterologists, internists and surgeons. Can J Surg Dec;48(6): Launoy G, Berchi C. Advantage of immunochemical fecal occult blood test in screening for colorectal cancer. Bull Cancer Oct 1;92(10): Launoy GD, Bertrand HJ, Berchi C, et al. Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average-risk population. Int J Cancer Jun 20;115(3): Li S, Wang H, Hu J, et al. New immunochemical fecal occult blood test with twoconsecutive stool sample testing is a cost-effective approach for colon cancer screening: results of a prospective multicenter study in Chinese patients. Int J Cancer Jun 15;118(12): Mandel JS, Screening of patients at average risk for colon cancer. Med Clin North Am 2005 Jan ; 89(1): 43-59, vii 11. Moayyedi P, Achkar E. Does fecal occult blood testing really reduce mortality? A reanalysis of systematic review data. Am J Gastroenterol Feb;101(2): Morikawa T, Kato J, Yamaji Y, et al. A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology Aug;129(2): Nakama H, Zhang B, Kamijo N. Sensitivity of immunochemical fecal occult blood test for colorectal flat adenomas. Hepatogastroenterology Sep- Oct;51(59): Nease D, Colorectal Cancer Screening. Clin Fam Pract Sep; 6 (3); Ouyang DL, Chen JJ, Getzenberg RH, et al. Noninvasive testing for colorectal cancer: a review. Am J Gastroenterol Jun;100(6): Saidel-Odes L, Odes HS. Strategy for colorectal cancer screening. Isr Med Assoc J Apr;7(4): Stokamer CL, Tenner CT, Chaudhuri J, et al. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med Mar;20(3): Weber C. Screening and prevention of carcinoma of the colon and rectum Ther Umsch May;63(5): Woo HY, Mok RS, Park YN, et al. A prospective study of a new immunochemical fecal occult blood test in Korean patients referred for colonoscopy. Clin Biochem Apr;38(4): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are Immunochemical Fecal Occult Blood Testing Jun 16 11

12 any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy Immunochemical Fecal Occult Blood Testing Jun 16 12

13 California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Immunochemical Fecal Occult Blood Testing Jun 16 13