Background and Rationale for Gipson bill AB The imperative for colonoscopy after a positive FOBT (Fecal Occult Blood Test)

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1 Background and Rationale for Gipson bill AB 1763 The imperative for colonoscopy after a positive FOBT (Fecal Occult Blood Test) The Affordable Care Act (ACA) requires all private insurers (except grandfathered plans) to cover preventive services that receive an A or B rating from the United States Preventive Services Task Force (USPSTF) without any patient cost sharing (e.g. copayments, coinsurance, and deductibles). (1) The USPSTSF is an independent, volunteer panel of national prevention and evidence based medicine experts who provide evidence based recommendations about clinical preventive services (e.g. screenings, preventive medications, and counseling services). (2) In 2008 (the most recent recommendation), the USPSTF gave an A rating to several colorectal cancer screening tests, including colonoscopy, flexible sigmoidoscopy, and fecal occult blood testing (FOBT). The Task Force did not recommend any one of these tests as the best. Screening for colorectal cancer by a high sensitivity FOBT is inexpensive and effective, but it requires a two step screening process if the test is positive. The USPSTF clearly states in its screening guidelines follow up of positive screening test results requires colonoscopy regardless of the screening test used. (2) Screening is not complete until patients with positive results receive follow up by colonoscopy to rule out the presence of cancer or precancerous polyps (abnormal growths in the lining of the colon). The percent of screened patients with a positive stool test ranges from 4 8% depending on positivity thresholds and the tests used. (3) (4) Health plans must waive cost sharing for colonoscopies in patients with a positive test to eliminate a financial disincentive for patients to choose stool testing

2 as a first line screening option just as they are required to do for an initial screening colonoscopy. Problems Solved by AB Missed cancers and precancerous polyps Patients with a positive fecal occult blood test (FOBT) are at high risk to have colon cancer or a polyp with an increased chance of becoming cancer over time. In a large California study, a patient with a + FOBT had a 3.4% chance of already having a colon cancer and a 51.5% chance of having a polyp. (11) The ACA as it is presently written, provides a free colonoscopy to individuals at low risk for colon cancer 0.7%, (17) but denies it to individuals with a positive FIT at higher risk of having a colon cancer 3.4%. 2. Missed screening opportunities in patients who prefer other less invasive tests Research has shown that limiting colorectal cancer screening choices to only colonoscopy can result in a lower colorectal cancer screening completion rates compared to providing a choice between colonoscopy and a stool based test, particularly among racial and ethnic minorities. (12)(16). The co pay for the necessary colonoscopy after a positive FOBT effectively limits the low income patient and their provider to only recommending a colonoscopy since it is the only colon cancer screening test that does not have a co pay under the ACA. 3. Cost Considerations Colon cancer screening is cost effective. The mathematical modeling used by the USPSTF has shown that screening with a sensitive FOBT saves $191 for every individual who undergoes the recommended FOBT screening from 50 to 75 years old. This is the only cancer screening testing program that results in cost savings to the health system. The colonoscopy colon cancer screening program is cost effective but not cost saving as FOBT has been shown to be. Colonoscopy screening costs $296 for each 50 to 75 year old screened compared to $191 saved for every person screened with

3 FOBT.(13) Presently California uses the FOBT to screen 20% of its screening eligible population (50 to 75 year old individuals). (14) Removing the costsharing barrier to FOBT colon cancer screening will result in a saving of $487 for California s health care system for every person who chooses the FIT screening program over a colonoscopy screening program. (13) 4. Screening colonoscopy cost sharing when a polyp is found and removed Despite the changes made by the Affordable Care Act, California health plans continue to require beneficiaries to pay co insurance (patient cost could be more than $300) when a polyp or abnormal growth is removed during the screening colonoscopy. This co pay charge is generally received unexpectedly after having a screening colonoscopy in which a polyp is discovered. This co pay can act as a serious disincentive for future screening for colon cancer. Finding an adenomatous polyp during a screening colonoscopy is not a rare event. During a good quality colonoscopy exam, an adenomatous polyp will be found in at least 25% of the screening colonoscopies. (15) Passing the Gipson Bill AB 1763 would eliminate this unexpected cost, and remove the financial disincentives, which prevent people from getting their colon cancer screening. By removing this financial barrier, California s legislature would help increase screening rates among individuals age 50 to 75 and reduce death and suffering from colorectal cancer.

4 1. Patient Protection and the Affordable Care Act, P.L , 1800 (codified at U.S.C (1)(1)(2010). 2. Screening for colorectal cancer: U.S, Preventive Services Task Force recommendation statement. Ann Intern Med. 2008;149: Grazzini G, Visioli CB, Zorzi M, Ciatto S, Banovich F, Bonanomi AG, et al. Immunochemical faecal occult blood test: number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening? Br J Cancer. 2009;100(2): Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta analysis. Ann Intern Med. 2014;160(3): The Kaiser Family Foundation, the American Cancer Society, and the National Colorectal Cancer Roundtable. Coverage of colonoscopies under the Affordable Care Act s prevention benefit. Published September costs/report/coverage ofcolonoscopies under the affordable care/. 6. National Colorectal Cancer Roundtable. The importance of waiving cost sharing for follow up colonoscopies: Action steps for health plans. Published November 10, Accessed January 15, content/uploads/crc Screemomg Continuum Coverage Issues Brief Private Health Plans Nov2015.pdf. 7. 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 J Clin.2008;58: Solanki G, Schauffler HH, Miller LS. The direct and indirect effects of cost sharing on the use of preventive services. Health Services Research. 2000;34: Wharam JF,Graves AJ, Landon BE, Zhang F,Soumerai SB, Ross Degnan D. Two year trends in colorectal cancer screening after switch to a high deductible health plan. Med Care. 2011;49: Trivedi AN, Rakowsi W,Ayanian JA. Effect of cost sharing on screening mammography in Medicare health plans. N Eng J Med. 2008;358:

5 11. Jensen CD, Corley DA, Quinn, VP. Fecal Immunochemical Test Program Performance Over 4 Rounds of Annual Screening. AnnInternMed. doi: /m Inadomi JM, Vigan S, Janz NK, Fagerlin A, Thomas JP, Lin YV,et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012; 172(7): doi: /archinternmed Iris Lansdorp-Vogelaar, Marjolein van Ballegooijen, Ann G. Zauber, Effect of Rising Chemotherapy Costs on the Cost savings of Colorectal Cancer Screening. J Natl Cancer Inst 2009;101: MMWR / November 8, 2013 / Vol. 62 / No Douglas A. Corley, M.D., Ph.D., Christopher D. Jensen, Ph.D., Amy R. Marks, MD, et al. Adenoma detection rate and the risk of colon cancer and death. N Engl J Med 2014;370: Samir Gupta MD, Ethan Halm MD et al Comparative Effectiveness of Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal Cancer screening Among the Underserved. JAMA Intern Med doi: /jamainternmed Thomas Imperiale MD, David Ransohoff, et al. Multitarget Stool DNA Testing for Colorectal Cancer Screening, N Engl J Med 2014;370: