Endoscopy by Capsule

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title 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 chapter

CMS Publications:

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 23:

10.1 - 10.1.7 ICD-9-CM Coding for Diagnostic Tests.

Abstract:

Endooscopy by capsule is carried out by a wireless video capsule that is swallowed and ultimately passed from the rectum. Two capsules are available, one designed for the small bowel and one for the esophagus. This LCD outlines coverage guidelines for conditions involving the small bowel where small bowel capsule use may be helpful for diagnosis. This LCD also defines coverage for the esophageal capsule in a subgroup of patients with hepatic cirrhosis to identify medium-large esophageal varices.

Indications:

The indications below were derived in part from The American Society for Gastrointestinal Endoscopy (ASGE) Technology Status Evaluation Report:Wireless Capsule Endoscopy

Endoscopy by Capsule of the Esophagus
The esophageal capsule is a wireless diagnostic video capsule specifically designed for visualization of the esophagus. The device acquires video images via camera ports at both ends as it travels through the esophagus. No sedation is required for the procedure.

There is a high mortality associated with bleeding from esophageal varices. Treatment with beta blockers or variceal ligation is generally accepted to reduce the incidence of first bleeding in patients with medium to large varices. Consequently triage of cirrhotics into those with medium-large varices or none-small varices is reasonable to determine who should be treated. Capsule endoscopy of the esophagus is an alternative to conventional endoscopy in cirrhotic patients who are anticipated to tolerate adequate doses of beta-blockers (see documentation requirements). Cirrhotic patients unlikely to tolerate beta-blockers should be examined with conventional endoscopy so that variceal ligation may be performed if indicated. Since variceal size estimates should be comparable to estimates made by conventional endoscopy the capsule endoscopist should use a previously validated algorithm to estimate variceal size. The recommended algorithm to estimate variceal size by capsule endoscopy was developed from the initial pilot data (Eisen et al. Endoscopy 2006) and subsequently used and validated (compared to conventional endoscopy) in a multi-center international trial (De Franchis et al. presented at Digestive Disease Week 2007). In this algorithm a varix is considered small if the diameter is greater than zero and less than 1/4 of the video circumference for the frame that shows its largest diameter. It is considered medium/large if this measurement is greater than or equal to 1/4 of the circumference.

Evaluation for esophageal varices is reasonable in patients with cirrhosis and portal hypertension and no prior variceal bleeding. Cirrhosis and portal hypertension is defined for this policy as a Child's class B or C stage or a class A with a low platelet count (<140,000), an enlarged portal vein diameter (> 13 mm), or evidence of collateral circulation on ultrasound (see Grace ND et al).

For those patients diagnosed with medium to large varices subsequent capsule endoscopy would not be reasonable. However, coverage for conventional flexible endoscopy would be available when reasonable and necessary.

The American Society for Gastrointestinal Endoscopy suggests repeat evaluation in 3-year intervals for those without varices and in 1 to 2 years for those with small varices.

Endoscopy by Capsule of the Small Intestine
It may be an adjunctive tool used in the detection of abnormalities of the small bowel, which is not accessible to standard upper endoscopy and colonoscopy. A small capsule is swallowed and moves through the GI tract propelled by peristalsis, transmitting video pictures. The video images are transmitted to sensors taped to the body and stored on a portable recorder. The strength of the signal is used to calculate the position of the capsule as it passes through the GI tract. Video images are stored on a portable recorder and later downloaded to a computer, from which they may be viewed. The capsule passes naturally from the body with the stool, and since it is disposable, it is not recovered.

Gastrointestinal Bleeding
The test is indicated for the diagnosis of occult gastrointestinal bleeding, the site of which has not been identified previously by any of the following: upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging, or radiological procedures. The test is especially helpful in the diagnosis of angiodysplasias of the gastrointestinal tract.

Endoscopy by capsule is limited to those patients who have generally undergone both upper GI endoscopy and colonoscopy, and when these tests have failed to reveal a source of bleeding. In rare situations where hemotemesis occurs repeatedly and upper GI endoscopy is repeatedly negative capsule endoscopy may be indicated.

Small Bowel Neoplasm
The test is indicated for the detection of neoplasms of the small bowel, when the diagnosis has not been previously confirmed by other studies (e.g., upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging, or radiological procedures). The patient must be symptomatic for a neoplasm (e.g., GI bleeding) or have a documented polyposis syndrome that is associated with small bowel neoplasia or there is other history suggesting the presence of small bowel neoplasia and other diagnostic testing to assess these symptoms (i.e., upper GI endoscopy and/or colonoscopy) must have been performed. Endoscopy by capsule may be indicated for the detection of small bowel neoplasm in those patients with documented intussusception of the small bowel, without established etiology. In such instances the requirement for prior examination by upper and lower endoscopies may be waived.

Crohn's Disease
Endoscopy by capsule is indicated for the diagnosis of Crohn's disease when the condition has not been previously confirmed or gastrointestinal capsule imaging is indicated when a diagnosis of colitis of an indeterminate type affecting the colon is known, and a more specific diagnosis is sought by evaluating for possible small bowel involvement. Endoscopy by capsule is reasonable in those patients in whom there is strong clinical suspicion of Crohn's disease (with abdominal pain, weight loss, diarrhea, anorexia, bleeding and biochemical indicators of inflammation) and in whom, in the physician's judgment, there is no intestinal stricture. In these patients with a strong clinical suspicion of Crohn's disease, negative colonoscopy is a prerequisite to the performance of the capsule endoscopy.

Other Conditions
Evaluation of malabsorption syndrome, chronic diarrhea, or protein-losing enteropathy of obscure origin is reasonable when it is suspected to originate in the small intestinal mucosa. Appropriate prior negative or non-diagnostic evaluations of the esophagus, stomach, duodenum/small intestine, and colon by flexible endoscopy, and complementary radiologic procedures and/or microbiologic studies must be documented.

Evaluation Prior to Surgery
Evaluation of extent of small bowel involvement with arteriovenous malformations or lymphangiectasia for patients who are contemplated for surgical resection of the small bowel to control recurrent bleeding or protein loss is reasonable.

Limitations:

Endoscopy by Capsule of the Esophagus

Medicare contractor local coverage determinations (LCDs) generally cover esophagoscopy in patients with Gastroesophageal Reflux Disease (GERD) symptoms that persist despite appropriate therapy. The American College of Gastroenterology (ACGE) states in regard to empirical therapy for GERD: "Further diagnostic testing should be considered if the patient does not respond to therapy, when there are alarm symptoms suggesting complicated disease (dysphagia, odynophagia, bleeding, weight loss, or anemia) and when patients have a sufficient duration of symptoms to put them at risk for Barrett's esophagus."

The American Society for Gastrointestinal Endoscopy states "When there are clinical clues that suggest that reflux may be severe or that other diseases may be present, endoscopy is the diagnostic procedure of choice."

The reported frequency of Barrett's esophagus in those with reflux symptoms ranges from 5% to 15%, and these patients without significant inflammatory changes undergo biopsy at the time of endoscopy.

Indications for endoscopy in GERD assume that endoscopy has the potential to obtain tissue samples and to examine the stomach and duodenum. Since the capsule does not have these capabilities, the above recommendations cannot be carried over to the capsule.

Until a clear description of the population who would benefit from endoscopy by capsule (patients who do not need evaluation of the stomach and duodenum and who do not need initial biopsies) becomes available, endoscopy by capsule is not covered for GERD evaluation.

Patency Capsule Testing
Patency Capsule Testing will also not be covered. Sufficient peer-reviewed literature supporting its use is not currently available. On occasion Patency Capsule has been reported to cause obstruction requiring urgent intervention.

The ASGE Technology Status Evaluation Report Wireless Capsule Endoscopy lists, "Patients with known or suspected gastrointestinal (GI) obstruction, strictures, or fistulas based on the clinical picture or preprocedure testing" under contraindications for the small bowel capsule.

Endoscopy by Capsule of the Small Intestine
ICD-10-CM codes K58.0 or K58.9 and R10.11-R10.13, R10.2, R10.31-R10.33, or R10.84 for irritable bowel syndrome and abdominal pain have been placed on the list of covered diagnoses for use when a capsule endoscopy exam is normal in the face of compelling symptoms. When representing chronic stable symptoms, these conditions rarely represent reasonable indications for endoscopy by capsule. When these diagnostic codes are used, the codes must be applicable and the rationale for capsule endoscopy must be carefully documented in the medical record.

The ingestion of the capsule is part of the test and an evaluation & management (E&M) service may not be billed for this purpose.

Endoscopy by capsule of the small intestine is not covered in the following situations:

• Colorectal cancer screening
• When carried out by FDA non-approved devices
• Confirmation of lesions or pathology normally within the reach of upper or lower endoscopy (lesions proximal to the ligament of Treitz or distal to the ileum) or for the confirmation of lesions or pathology discovered by prior endoscopy (including push enteroscopy), colonoscopy, or radiology
• When performed by physicians not trained in endoscopy or for independent diagnostic testing facilities, which are not under the general supervision of a physician trained in endoscopy procedures.
  
  Endoscopy by capsule performed to diagnose obscure gastrointestinal bleeding, is only covered if it is documented that the beneficiary had continuing GI blood loss or anemia secondary to bleeding or iron deficiency anemia.
  
  Endoscopy by capsule is not generally reimbursable when used for management of patients with a confirmed diagnosis of Crohn's disease. Onset of new symptoms suggestive of Crohn's disease at an undiagnosed small bowel region may make endoscopy by capsule reasonable.
  
  Endoscopy by capsule for the detection of small bowel malignancies, in the absence of obscure gastrointestinal bleeding, or symptoms suggesting Crohn's disease, or the presence of a polyposis syndrome associated with small bowel neoplasia or other history suggesting the presence of small bowel neoplasia is not covered.
  
  Endoscopy by capsule of the esophagus is not covered in patients with a current history of dysphagia suggestive of esophageal stricture.
  
  Other Comments:
  
  For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims.
  
  Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.
  
  For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.
  
  Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

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The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Medical record documentation must be available to Medicare upon request. Photographic copies of the video images, with the beneficiary's name and the date of service included in the picture, must be available for review.

Additional documentation is required according to the specific indication for performing endoscopy by capsule:

• If the beneficiary has GI blood loss or iron deficiency anemia or anemia secondary to the bleeding, the medical record must document that the prior upper GI endoscopy or colonoscopy failed to adequately reveal the source of bleeding.
• If the provisional diagnosis is occult gastrointestinal bleeding without iron deficiency anemia, the medical record must document the presence of occult blood in fecal samples.
• If the provisional diagnosis is Crohn's disease, the medical record must document the signs, symptoms, and previous diagnostic work supporting this diagnosis.
• If the provisional diagnosis is Crohn's the medical record must document that, in the physicians's judgment, the patient does not have an intestinal stricture.
• If small bowel involvement is suspected in a patient with known Crohn's disease or other colitis, the medical record must document the signs, symptoms, and previous diagnostic work supporting this hypothesis.
• The medical record must document the need for capsule endoscopy and contain reports or reference to the previous appropriate negative endoscopies performed prior to endoscopy by capsule.
  
  For capsule endoscopy of the esophagus the record must document that the patient does not have a contraindication for nonselective beta-blocker use. The presence of this documentation must be indicated with claim submission by use of the KX modifier. Examples of likely contraindications would be bronchial asthma, sinus bradycardia and greater than first degree heart block and overt congestive heart failure.
  
  Not applicable
  
  Endoscopy by capsule of the small intestine will be covered once per episode of illness. Services exceeding this parameter will be considered not medically necessary.
  
  Claims for additional tests will be denied as not medically necessary in the absence of supportive documentation.

This bibliography presents those sources that were obtained during the development of this policy. CGS Administrators, LLC is not responsible for the continuing viability of Web site addresses listed below.

Appleyard M, Fireman Z, Glukhovsky A, et al. A randomized trial comparing wireless capsule endoscopy with push enteroscopy for the detection of small-bowel lesions. Gastroenterology. 2000;119:1431-1438.

Appleyard M, Glukhovsky A, Swain P. Wireless-capsule diagnostic endoscopy for recurrent small-bowel bleeding. N Engl J Med. 2001;344:232-233.

Armstrong D, Marshall JK, Chiba N, et al. Canadian Consensus Conference on the management of gastroesophageal reflux disease in adults - update 2004. Can J Gastroenterol. 2005;19:15-35.

Barkay O, Moshkowitz M, Fireman Z, et al. Initial experience of videocapsule endoscopy for diagnosing small-bowel tumors in patients with GI polyposis syndromes. Gastrointest Endosc. 2005;62:448-452.

Boivin ML, Lochs H, Voderholzer WA. Does passage of a patency capsule indicate small-bowel patency? A prospective clinical trial? Endoscopy. 2005;37:808-815.

Catanzaro A, Faulx A, Isenberg GA, et al. Prospective evaluation of 4-mm diameter endoscopes for esophagoscopy in sedated and unsedated patients. Gastrointest Endosc. 2003;57:300-304.

D'Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis. 1999;19:475-505.

De Franchis R, Eisen GM, Eliakim R, et al. Esophageal capsule endoscopy (Pillcam ESO) is comparable to traditional endoscopy for detection of esophageal varices-An international Multi-center trial. 2007. Ref Type: (Unpublished Work). Presented at 2007 Digestive Week Scientific Meeting, Washington, D.C.

Dellon ES, Shaheen NJ. Does screening for Barrett's esophagus and adenocarcinoma of the esophagus prolong survival? J Clin Oncol. 2005;23:4478-4482.

Desmond AN, O'Regan K, Curran C, et al. Crohn's disease: factors associated with exposure to high levels of diagnostic radiation. Gut. 2008;57(11):1489-1490.

DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005;100:190-200.

Eisen GM, Baron TH, Dominitz JA, et al. Complications of upper GI endoscopy. Gastrointest Endosc. 2002;55:784-793.

Eisen GM, Eliakim R, Zaman A, et al. The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endoscopy. 2006;38:31-35.

Eliakim R, Sharma VK, Yassin K, et al. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005;39:572-578.

Gay G, Delvaux M, Laurent V, et al. Temporary intestinal occlusion induced by a "patency capsule" in a patient with Crohn's disease. Endoscopy. 2005;37:174-177.

Goldfarb NI, Pizzi LT, Fuhr JP, et al. Diagnosing crohn's disease: an economic analysis comparing wireless capsule endoscopy with traditional diagnostic procedures. Disease Management. 7(4):292-304.

Grace ND, Groszmann RJ, Garcia-Tsao G, et al. Portal hypertension and variceal bleeding: an AASLD single topic symposium. Hepatology. 1998;28:868-880.

Hahne M, Adamek HE, Schilling D, Riemann JF. Wireless capsule endoscopy in a patient with obscure occult bleeding. Endoscopy. 2002;34:588-590.

Hampel H, Abraham NS, El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005;143:199-211.

Herrerias JM, Leighton JA, Costamanga, G, et al. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointestinal Endoscopy. 2008:1-8.

Idezuki Y. General rules for recording endoscopic findings of esophagogastric varices (1991). Japanese Society for Portal Hypertension. World J Surg. 1995;19:420-422.

Kamath PS. Esophageal variceal bleeding: primary prophylaxis. Clin Gastroenterol Hepatol. 2005;3:90-93.

Leighton JA, Goldstein J, Hirota W, et al. Obscure gastrointestinal bleeding. Gastrointest Endosc. 2003;58:650-655.

Leighton JA, Shen B, Baron TH, et al. ASGE guideline: endoscopy in the diagnosis and treatment of inflammatory bowel disease. Gastrointest Endosc. 2006;63:558-565.

Lewis, BS. Expanding role of capsule endoscopy in inflammatory bowel disease. World J Gastroenterol. 2008;14(26):4137-4141.

Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005;37(10):960-965.

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Marmo R, Rotondano G, Piscopo R, et al. Capsule endoscopy versus enteroclysis in the detection of small-bowel involvement in Crohn's disease: a prospective trial. Clin Gastroenterol Hepatol. 2005;3:772-776.

Marmo R, Rotondano G, Piscopo R, Bianco MA, Cipolletta L. Meta-analysis: capsule endoscopy vs. conventional modalities in diagnosis of small bowel diseases. Ailment Pharmcol Ther. 2005;22:595-604.

Mata A, Bordas JM, Feu F, et al. Wireless capsule endoscopy in patients with obscure gastrointestinal bleeding: a comparative study with push enteroscopy. Aliment Pharmacol Ther. 2004;20:189-194.

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Sampliner RE. Updated guidelines for the diagnosis, surveillance, and therapy of Barrett's esophagus. Am J Gastroenterol. 2002;97:1888-1895.

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Tatar EL, Shen EH, Palance AL, Sun JH, Pitchumoni CS. Clinical utility of wireless capsule endoscopy: experience with 200 cases. J Clin Gastroenterol. 2006;40:140-144.

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Zoli M, Merkel C, Magalotti D, Marchesini G, Gatta A, Pisi E. Evaluation of a new endoscopic index to predict first bleeding from the upper gastrointestinal tract in patients with cirrhosis. Hepatology. 1996;24:1047-1052.

Other Medicare contractor policies consulted in development of the draft:

• AdminaStar Federal fiscal intermediary LCD (Illinois [L13708], Indiana [L13707], Kentucky [L13709], Ohio [L13710])
• Associated Hospital Services fiscal intermediary LCDs (Maine [L23048], Massachusetts [L23050])
• Anthem Health Plans of New Hampshire fiscal intermediary LCD [L22853]
• Empire Medicare Services carrier LCD (New Jersey [L4244], New York [L3589])

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