**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.