Medicare Advantage

Medical Policy

Notification

Capsule Endoscopy

Notification Issued Date:

The policy has been reviewed and reissued to communicate the Company’s continuing position on Wireless Capsule Endoscopy.

Title:

Capsule Endoscopy

Policy #:

MA07.022e

Policy

WIRELESS CAPSULE ENDOSCOPY

MEDICALLY NECESSARY

Wireless capsule endoscopy (WCE) of the esophagus through the ileum using an FDA-approved device is considered medically necessary and, therefore, covered for any of the following indications:

For the diagnosis of occult gastrointestinal bleeding (i.e., likely involving the small intestine), the site of which has not been previously identified by any of the following: upper gastrointestinal (GI) endoscopy, colonoscopy, push enteroscopy, nuclear imaging or radiological procedures.

WCE is limited to those individuals who have undergone GI endoscopy and colonoscopy and these tests have failed to rev

eal a source of bleeding.

Appropriate differential diagnoses for the evaluation of suspected GI bleeding include:

Angiodysplasia
Neoplasm
Iron deficiency anemia, which is unexplained after upper and lower endoscopy
Zollinger-Ellison syndrome
Tuberculosis
Vasculitis
Radiation enteritis
Meckel's diverticulum
Jejunal diverticula
Chronic mesenteric ischemia

For the management of celiac disease (e.g., surveillance for small intestine cancer)
For suspected, undiagnosed Crohn’s disease or when colonic involvement of Crohn’s disease is known, and it is necessary to determine whether there is also involvement of the small bowel
When an indeterminate type of colitis exists and a more specific diagnosis is being sought from a small bowel evaluation

Wireless capsule endoscopy of the esophagus is considered medically necessary and, therefore, covered for the evaluation of esophageal varices in individuals with portal hypertension as an alternative to upper GI endoscopy.

LIMITATIONS

Typically, the administration of a second capsule would not be expected during the same examination, unless it was to ensure an adequate examination (e.g., the initial capsule does not penetrate the pylorus).

Any repeat use of the WCE for an individual must be considered medically necessary for coverage.

NOT MEDICALLY NECESSARY

Wireless capsule endoscopy is considered not medically necessary and, therefore, not covered for any the following indications:

Erosive esophagitis and Barrett’s esophagus
Colorectal cancer screening
The confirmation of lesions or pathology normally within the reach of upper or lower endoscopes (lesions proximal to the ligament of Treitz or distal to the ileum)
Swallowing disorders
Known or suspected gastrointestinal (GI) obstruction, strictures or fistulas based on clinical presentation or prior tests

All other uses for wireless capsule endoscopy are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis of illness or injury.

COLON CAPSULE ENDOSCOPY (CCE)

MEDICALLY NECESSARY

For diagnostic and/or surveillance purposes, Colon capsule endoscopy (CCE) is medically necessary when EITHER of the following criteria are met:

Primary procedure in individuals with major risks for Optical Colonoscopy (OC) or moderate sedation as indicated from an evaluation of the individual by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training and any of the following criteria:

Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)
Multitarget Stool DNA (sDNA) Test positive
Other evidence of lower GI bleeding in hemodynamically stable patient

Secondary procedure

For the detection or surveillance of colon polyp(s) if the diagnostic OC was incomplete OR
When an incomplete diagnostic OC was performed for any of the following criteria:

Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical)
Multitarget Stool DNA (sDNA) Test positive
Other evidence of lower GI bleeding in hemodynamically stable individuals

NOT MEDICALLY NECESSARY

Colon capsule endoscopy is considered not medically necessary and, therefore, not covered when any of the following conditions are present:

Known or suspected gastrointestinal obstruction, stricture, or fistula
Swallowing disorders
Cardiac pacemaker or another implanted electro-medical device that emits a radiofrequency or other interfering signal
Known contraindication or allergy to any medication or preparation agent used before or during the procedure
When performed in conjunction with CT Colonography (CTC)
Colorectal cancer screening

All other uses for colon capsule endoscopy are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis of illness or injury.

MAGNETIC CAPSULE ENDOSCOPY

EXPERIMENTAL/INVESTIGATIONAL

Magnetic capsule endoscopy (e.g., NaviCam™ Stomach Capsule Endoscopy System [AnX Robotica, Inc., Plano, Texas]) is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Documentation in the medical record must indicate that the individual has suspected GI blood loss with or without anemia.

Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

Subject to the terms and conditions of the applicable Evidence of Coverage, wireless capsule endoscopy is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

WIRELESS CAPSULE ENDOSCOPY (WCE)

Wireless capsule endoscopy (WCE) of the esophagus through the ileum is used for the diagnosis of occult gastrointestinal bleeding (likely involving the small intestine), the site of which has not previously been identified by any of the following: upper gastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging, or radiological procedures.

Wireless capsule endoscopy of the esophagus is used for the evaluation of esophageal varices in individuals with portal hypertension, and may be used as an alternative to upper GI endoscopy.

COLON CAPSULE ENDOSCOPY (CCE)

Colon Capsule Endoscopy (CCE) is a noninvasive procedure that does not require air inflation or sedation and allows for minimally invasive and painless colonic evaluation.

MAGNETIC CAPSULE ENDOSCOPY

Magnetic Capsule Endoscopy is a noninvasive procedure that allows for visualization of the gastric mucosa through remote magnetic manipulation without the need for sedation.

In May 2020, the U.S. Food and Drug Administration (FDA) approved a novel magnetically maneuvered CE system (NaviCam™; AnX Robotica, Inc.) This system consists of a single-use ingestible capsule and magnet linked to a physician-operated console. The capsule contains a camera that wirelessly captures images of the desired anatomy. The console allows the operator to control the motion and direction of the capsule, ensuring visualization of the entire stomach. The capsule leaves the body in 24 hours on average but may take as long as 2 weeks. The device is contraindicated for use in individuals with gastrointestinal obstruction, stenosis, fistula, or those with dysphagia. Other contraindications include individuals with cardiac pacemakers or other implantable electronic medical devices as well as pregnant women, those less than 22 years of age, and those with a body mass index 38 or greater.

For individuals who have unexplained upper abdominal complaints who receive magnetic capsule endoscopy (CE), the evidence includes diagnostic accuracy studies. Relevant outcomes are test validity, symptoms, change in disease status, and treatment-related morbidity. Studies evaluating the diagnostic characteristics of magnetic CE as compared to conventional gastroscopy in the target population have generally demonstrated similar accuracy, sensitivity, and specificity, with increases in individual preference and an acceptable safety profile with the magnetic CE approach. However, the diagnostic characteristics of magnetic CE are inadequate to substitute for other modalities or to triage individuals to other modalities based on the current literature. Direct evidence of improved outcomes or a strong chain of evidence to improved outcomes is lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

References

Cross A, Szoka N. SAGES NaviCam stomach capsule system. March 10, 2021. Available at: https://www.sages.org/publications/tavac/navicam-stomach-capsule-system/. Accessed October 4, 2022.

Denzer UW, Rosch T, Hoytat B, et al. Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study. J Clin Gastroenterol. 2015; 49(2): 101-7.

Liao Z, Hou X, Lin-Hu EQ, et al. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016; 14(9): 1266-1273.e1.

Novitas Solutions, Inc. Local Coverage Article (LCA).A58414: Billing and Coding: Colon Capsule Endoscopy (CCE). [Novitas Solutions, Inc. Web site]. 01/012022. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58414&ver=11. Accessed October 4, 2022.

Novitas Solutions, Inc. Local Coverage Determination (LCD).L38807: Colon Capsule Endoscopy (CCE). [Novitas Solutions, Inc. Web site]. 03/28/2021. Available at: Local Coverage Determination for Colon Capsule Endoscopy (CCE) (L38807) (cms.gov). Accessed October 4, 2022.

Novitas Solutions, Inc. Local Coverage Article (LCA).A57753: Billing and Coding: Wireless Capsule Endoscopy. [Novitas Solutions, Inc. Web site]. 01/01/2022. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57753&ver=12&bc=CAAAAAAAAAAA. Accessed October 4, 2022.

Novitas Solutions, Inc. Local Coverage Determination (LCD).L35089: Wireless Capsule Endoscopy. [Novitas Solutions, Inc. Web site]. 11/21/2019. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35089&ver=30&Keyword=wireless+capsule&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=BC|SAD|RTC|Reg&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA&. Accessed October 4, 2022.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. NaviCam Capsule Endoscope System with NaviCam Stomach Capsule. DEN190037. [FDA Web site]. Available at:
Microsoft Word - DEN190037.Letter.DENG.final.May22,2020.docx (fda.gov) . Accessed October 4, 2022.

Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

91110, 91111, 91113

EXPERIMENTAL/INVESTIGATIONAL

0651T

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

PROCEDURE CODE 91110 IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

A18.32 Tuberculous enteritis
A18.39 Retroperitoneal tuberculosis
A18.83 Tuberculosis of digestive tract organs, not elsewhere classified
C17.0 Malignant neoplasm of duodenum
C17.1 Malignant neoplasm of jejunum
C17.2 Malignant neoplasm of ileum
C17.3 Meckel's diverticulum, malignant
C17.8 Malignant neoplasm of overlapping sites of small intestine
C17.9 Malignant neoplasm of small intestine, unspecified
C49.A3 Gastrointestinal stromal tumor of small intestine
C49.A4 Gastrointestinal stromal tumor of large intestine
C78.4 Secondary malignant neoplasm of small intestine
D01.40 Carcinoma in situ of unspecified part of intestine
D01.49 Carcinoma in situ of other parts of intestine
D13.2 Benign neoplasm of duodenum
D13.30 Benign neoplasm of unspecified part of small intestine
D13.39 Benign neoplasm of other parts of small intestine
D37.2 Neoplasm of uncertain behavior of small intestine
D50.0 Iron deficiency anemia secondary to blood loss (chronic)
D50.9 Iron deficiency anemia, unspecified
E16.4 Increased secretion of gastrin
I77.6 Arteritis, unspecified
K31.811 Angiodysplasia of stomach and duodenum with bleeding
K31.82 Dieulafoy lesion (hemorrhagic) of stomach and duodenum
K50.00 Crohn's disease of small intestine without complications
K50.011 Crohn's disease of small intestine with rectal bleeding
K50.018 Crohn's disease of small intestine with other complication
K50.019 Crohn's disease of small intestine with unspecified complications
K50.10 Crohn's disease of large intestine without complications
K50.111 Crohn's disease of large intestine with rectal bleeding
K50.118 Crohn's disease of large intestine with other complication
K50.119 Crohn's disease of large intestine with unspecified complications

K50.80 Crohn's disease of both small and large intestine without complications
K50.811 Crohn's disease of both small and large intestine with rectal bleeding
K50.818 Crohn's disease of both small and large intestine with other complication
K50.819 Crohn's disease of both small and large intestine with unspecified complications
K50.90 Crohn's disease, unspecified, without complications
K50.911 Crohn's disease, unspecified, with rectal bleeding
K50.918 Crohn's disease, unspecified, with other complication
K50.919 Crohn's disease, unspecified, with unspecified complications
K52.0 Gastroenteritis and colitis due to radiation
K55.1 Chronic vascular disorders of intestine
K55.21 Angiodysplasia of colon with hemorrhage
K57.11 Diverticulosis of small intestine without perforation or abscess with bleeding
K57.13 Diverticulitis of small intestine without perforation or abscess with bleeding
K57.51 Diverticulosis of both small and large intestine without perforation or abscess with bleeding
K57.53 Diverticulitis of both small and large intestine without perforation or abscess with bleeding
K63.81 Dieulafoy lesion of intestine
K90.0 Celiac disease
K92.1 Melena
K92.2 Gastrointestinal hemorrhage, unspecified
R19.5 Other fecal abnormalities

PROCEDURE CODE 91111 IS MEDICALLY NECESSARY WHEN REPORTED WITH K76.6 (PORTAL HYPERTENSION) AND ANY OF THE FOLLOWING DIAGNOSIS CODES:

I85.10 Secondary esophageal varices without bleeding
I85.11 Secondary esophageal varices with bleeding

PROCEDURE CODE 91113 IS MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

K63.5 Polyp of colon
K92.1 Melena
K92.2 Gastrointestinal hemorrhage, unspecified
R19.5 Other fecal abnormalities

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

1/1/2023

Version Issued Date:

12/30/2022

Version Reissued Date:

2/7/2024