Proposed LCD - Colon Capsule Endoscopy (CCE) (DL38571)

CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Code of Federal Regulations:42 CFR 410.32 indicates that diagnostic tests may only be ordered by a treating physician (or other treating practitioner acting within the scope of their license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapterCMS Publications:CMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23: 10.1 - 10.1.7 ICD-10-CM Coding for Diagnostic Tests.Coverage Indications, Limitations, and/or Medical NecessityDiagnostic and/or surveillance* (performed for signs/symptoms of disease) colon capsule colonoscopy (CCE) is medically necessary for the detection of colon polyps when EITHER of the following criteria are met:Secondary procedure after an incomplete diagnostic optical colonoscopy (OC) with adequate preparation, and a complete evaluation of the colon was not technically possible (1,2) whenEITHERof the following criteria are metDetection or surveillance of colon polyp(s)ORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsPrimary procedure in patients with major risks for OC or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training whenEITHERof the following criteria are met:Surveillance of colon polyp(s) in previously diagnosed patientsORDiagnostic procedure whenANYof the following criteria are met (3):Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)ORMultitarget Stool DNA (sDNA) Test positiveORBlood-based biomarker colorectal cancer screening test positiveOROther evidence of lower GI bleed in hemodynamically stable patientsExclusion Criteria (NONE of the below are allowed)Known or suspected gastrointestinal obstruction, stricture, or fistulaCardiac pacemaker or another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency or other interfering signalSwallowing disorderKnown contraindication or allergy to any medication or preparation agent used before or during the procedureMay not be done in conjunction with CT Colonography (CTC)CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease* Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such.General InformationAssociated InformationN/ASources of InformationN/ABibliographyFDA approves PillCam COLON as follow-up test.Cancer Discov.2014;4(4):380-381.PillCam COLON 2 Capsule Endoscopy System (K153466). https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153466.pdf. Accessed 2/28/20.National Coverage Determination (NCD) for Colorectal Cancer Screening Tests (210.3).National Coverage Decision. Accessed 6/01/21.Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.Gastroenterology.2015;148(5):948-957 e942.Rondonotti E, Borghi C, Mandelli G, et al. 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