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HumanaCommercial Clinical Policy

Humana Capsule Endoscopy Form


Capsule Endoscopy of the Small Bowel

Indications

(503803) Is the patient two years of age or older, or an adult 18 years of age or older for the CapsoCam Plus system? 
(503804) Is the procedure to aid in the diagnosis of celiac disease with positive celiac-specific serology, and the patient is unable to undergo esophagogastroduodenoscopy (EGD) with biopsy? 
(503805) Is the patient undergoing evaluation for obscure gastrointestinal bleeding and has had an EGD and colonoscopy in the previous 12 months without identification of the bleeding source, along with laboratory proven iron deficiency anemia? 
(503806) Is the procedure for the initial diagnosis of suspected Crohn's disease with no evidence found on standard diagnostic tests? 
(503807) Is it for re-evaluating known celiac or Crohn's disease in a symptomatic individual despite adherence to prescribed therapy? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

08/24/2023

Last Reviewed

NA

Original Document

  Reference



Description

Capsule endoscopy (CE), also known as wireless capsule endoscopy or video capsule endoscopy, is a noninvasive diagnostic procedure that is designed to visualize the esophagus, stomach, small bowel or colon. To perform this procedure, a small digestible capsule (approximately the size of a large vitamin) containing a video camera and a light source is swallowed. The camera takes multiple pictures per second and sends electronic signals wirelessly to a data recorder worn around the individual’s waist. The data is then downloaded into a computer program that captures the images to be analyzed by a physician. The body typically excretes the capsule naturally within 8 to 72 hours after ingestion.

Currently, CE is only utilized for diagnostic purposes; an individual who requires a biopsy or therapeutic intervention must undergo a conventional endoscopic procedure.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Examples of commercially available capsule endoscopy systems include, but may not be limited to:
  • CapsoCam Plus (SV-3) capsule endoscope system is intended for visualization and detection of abnormalities of the small bowel mucosa in adults.
  • Capsule delivery devices reportedly introduce the capsule, endoscopically, into the small bowel in an individual who cannot swallow the capsule, who has gastroparesis or some other impediment that may prevent passage of the capsule into the small bowel in a reasonable time. Examples of these devices include, but may not be limited to, the AdvanCE endoscopy delivery system and the PillCam Express. (Refer to Coverage Limitations section)
  • MiroCam capsule endoscope system is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 2 years of age or older.
  • Patency capsule systems (e.g., Agile Patency Capsule, PillCam Patency Capsule) are intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in an individual with known or suspected strictures.
  • PillCam COLON 2 is intended for visualization of the colon and detection of colon polyps ONLY in an individual who had an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. The device is also indicated for the detection of colon polyps in an individual with evidence of gastrointestinal (GI) bleeding of lower GI origin. This only applies to an individual with major risks for colonoscopy or moderate risk factors for colorectal cancer. (Refer to Coverage Limitations section)

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Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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  • PillCam Crohn’s Capsule is intended to visualize both the small bowel and the colon in an individual with Crohn’s disease via a capsule that has two camera heads. It is designed to provide a broader view of the intestinal mucosa. (Refer to Coverage Limitations section)
  • PillCam ESO is intended for the visualization of the esophageal mucosa to detect abnormalities such as gastroesophageal reflux disease (GERD), Barrett’s esophagus or varices. (Refer to Coverage Limitations section)
  • PillCam UGI capsule endoscopy system is intended for visualization of the upper GI tract (esophagus, stomach, duodenum) in a hemodynamically stable individual who is 18 years of age or older. (Refer to Coverage Limitations section)
  • Pill Cam SB 3 and the Olympus small intestinal capsule endoscope system (eg, Endocapsule EC-10) are intended for the visualization of the small intestinal mucosa.
  • An ingestible gastrointestinal blood detection capsule is also being investigated. This capsule (eg, Pill Sense System) utilizes an optical sensor that purportedly measures the presence of blood by measuring the absorption of wavelengths of light. The data gathered is transmitted to an external receiver where an algorithm is used to process the presence of blood or no blood. No images are sent from the capsule. (Refer to Coverage Limitations section)
  • Artificial intelligence (AI) is under investigation to purportedly reduce the amount of time required to read and increase the accuracy of the interpretation of CE studies. AI reportedly utilizes a deep-learning convolutional neural network (CNN), which is a type of artificial neural network used in image recognition. CNN is designed to enable the identification of abnormal small bowel mucosa and bleeding, increase sensitivity and reduce reading times. An example of a device that utilizes AI is the NaviCam SB – with ProScan, which is not yet available in the US. (Refer to Coverage Limitations section)

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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Coverage Determination

Humana members may be eligible under the Plan for capsule endoscopy of the small bowel for the following indications:

  • Two years of age or older (with the exception of the CapsoCam Plus system, which is indicated for an adult, 18 years of age or older);
  • AND ANY of the following:
    • Aid in the diagnosis of celiac disease in an individual with positive celiac-specific serology who is unable to undergo esophagogastroduodenoscopy (EGD) with biopsy (eg, medically unstable, presence of known or suspected perforated viscus); OR
    • Evaluation of an individual with suspicion of obscure (hidden or indistinct) GI bleeding in the small bowel with the following:
      • EGD and colonoscopy within the previous 12 months that failed to identify bleeding source; AND
      • Laboratory proven iron deficiency anemia; OR
    • Initial diagnosis of suspected Crohn’s disease when there is no evidence of the disease found via standard diagnostic tests such as upper and lower endoscopy (EGD and colonoscopy), computed tomography (CT) enterography, magnetic resonance (MR) enterography or small bowel follow-through (SBFT); OR
    • Re-evaluate known celiac or Crohn’s disease in an individual remaining symptomatic despite adherence to prescribed therapy; OR
    • Surveillance in an individual with Peutz-Jeghers syndrome for the following:
      • A baseline test at 8 years of age or older (depending on age at diagnosis); AND
      • If polyps are present, repeat every 3 years; AND
  • If no polyps are present, repeat at 18 years of age and then every 3 years or earlier if symptoms are present (eg, abdominal pain, intestinal obstruction, nausea/vomiting, rectal bleeding); OR
  • Suspected small bowel tumors with the following:
    • Persistent clinical symptoms (eg, abdominal pain, anemia, gastrointestinal bleeding, unexplained weight loss); AND
    • Standard diagnostic testing within the previous 12 months have failed to determine the etiology of symptoms (testing includes, but may not be limited to, upper and lower endoscopies [EGD and colonoscopy], upper gastrointestinal series, advanced imaging [eg, CT scan/MRI enteroscopy])

Coverage Limitations

Humana members may NOT be eligible under the Plan for CE for any indications other than those listed above including, but may not be limited to, the following indications and/or devices:

  • Capsule delivery devices (eg, AdvanCE capsule delivery system, PillCam Express) for any indication; OR
  • Evaluation of the colon for any indication including screening for colorectal cancer (eg, PillCam COLON 2, PillCam Crohn’s Capsule); OR
  • Evaluation of the esophagus for any indication including screening for Barrett’s esophagus or esophageal varices (eg, PillCam ESO); OR
  • Individual with a known or suspected GI obstruction, strictures or fistulas based on the clinical picture or pre-procedure testing and profile;
  • Ingestible gastrointestinal blood detection capsules (eg, Pill Sense System); OR
  • Magnetic guided capsule endoscopy systems (eg, NaviCam capsule endoscope system) for any indication; OR

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Patency capsule (eg, Agile Patency Capsule, PillCam Patency System) for any indication; OR
  • Small bowel monitoring or surveillance of any conditions not included in Coverage Determination section (eg, PillCam SB 3, Olympus small intestinal capsule endoscope system); OR
  • Upper gastrointestinal tract CE (eg, PillCam UGI) for any indication

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for artificial intelligence (AI). This is considered experimental/investigational as is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about GI conditions may be found from the following websites:

Background

  • American College of Gastroenterology
  • American Gastroenterological Association
  • National Library of Medicine

Alternatives to CE for the colon include, but may not be limited to, the following:

Medical Alternatives
  • Barium enema
  • Colonoscopy
  • Computed tomographic colonography (CTC)
  • Fecal immunochemical test (FIT)
  • Fecal occult blood test (FOBT)
  • Flexible sigmoidoscopy

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

For information regarding colorectal cancer screening tests, please refer to Colorectal Cancer Screening and Surveillance Medical Coverage Policy.

Alternatives to CE for the esophagus or small bowel include, but may not be limited to:

  • Angiography
  • Enteroclysis
  • Intraoperative enteroscopy
  • Nuclear medicine scan
  • Push enteroscopy
  • Small bowel follow through (SBFT) x-ray series
  • Sonde enteroscopy
  • Upper GI endoscopy

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Provider Claims Codes
  • CPT® Category Ill Code(s) - Description - Comments
  • 91299 - Unlisted diagnostic gastroenterology procedure - report any procedure outlined in Coverage Limitations section
  • 0651T - Magnetically controlled capsule endoscopy, esophagus through stomach, including intraprocedural positioning of capsule, with interpretation and report - Not Covered
References
  1. Agency for Healthcare Research and Quality (AHRQ). Clinician Summary (ARCHIVED). Diagnosis of celiac disease: current state of the evidence. https://www.ahrq.gov. Published July 2016. Accessed July 26, 2023.
  2. American College of Gastroenterology (ACG). ACG clinical guideline: colorectal cancer screening 2021. https://www.gi.org. Published March 2021. Accessed August 1, 2023.
  3. American College of Gastroenterology (ACG). ACG clinical guideline: diagnosis and management of small bowel bleeding. https://www.gi.org. Published 2015. Accessed August 4, 2023.
  4. American College of Gastroenterology (ACG). ACG clinical guideline: management of Crohn's disease in adults. https://www.gi.org. Published April 2018. Accessed August 1, 2023.
  5. American College of Gastroenterology (ACG). Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. https://www.gi.org. Published July 2017. Accessed August 1, 2023.
  6. American College of Gastroenterology (ACG). Quality indicators for capsule endoscopy and deep enteroscopy. https://www.gi.org. Published November 2022. Accessed August 1, 2023.
  7. American College of Gastroenterology (ACG). American College of Gastroenterology guidelines update: diagnosis and management of celiac disease. https://www.gi.org. Published January 2023. Accessed August 1, 2023.
  8. American College of Physicians (ACP). Clinical Guideline. Screening for colorectal cancer in asymptomatic average-risk adults: a guidance statement from the American College of Physicians. https://www.acponline.org. Published August 1, 2023. Accessed August 2, 2023.
  9. American College of Radiology (ACR). ACR Appropriateness Criteria. Nonvariceal upper gastrointestinal bleeding. https://www.acr.org. Published 2016. Accessed August 3, 2023.
  10. American Gastroenterological Association (AGA). AGA clinical practice guidelines on the gastrointestinal evaluation of iron deficiency anemia. https://www.gastro.org. Published August 15, 2020. Accessed August 1, 2023.
  11. American Gastroenterological Association (AGA). AGA clinical practice update on management of refractory celiac disease: expert review. https://www.gastro.org. Published September 19, 2022. Accessed August 1, 2023.
  12. American Gastroenterological Association (AGA). Diagnosis and management of cancer risk in the gastrointestinal hamartomatous polyposis syndrome: recommendations from the US Multi-Society Task Force on colorectal cancer. https://www.gastro.org. Published June 1, 2022. Accessed August 1, 2023.
  13. American Society for Gastrointestinal Endoscopy (ASGE). American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in familial adenomatous polyposis syndromes. https://www.asge.org. Published May 2020.

Accessed August 2, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. American Society for Gastrointestinal Endoscopy (ASGE). Guideline. Appropriate use of GI endoscopy. https://www.asge.org. Published 2012. Accessed August 2, 2023.
  2. American Society for Gastrointestinal Endoscopy (ASGE). Guideline. Modification in endoscopic practice in pediatric patients. https://www.asge.org. Published 2014. Accessed August 2, 2023.
  3. American Society for Gastrointestinal Endoscopy (ASGE). Guideline. Modification in endoscopic practice in the elderly. https://www.asge.org. Published 2013. Accessed August 2, 2023.
  4. American Society for Gastrointestinal Endoscopy (ASGE). Guideline. The role of endoscopy in inflammatory bowel disease. https://www.asge.org. Published 2015. Accessed August 2, 2023.
  5. American Society for Gastrointestinal Endoscopy (ASGE). Guideline. The role of endoscopy in the management of suspected small bowel bleeding. https://www.asge.org. Published 2017. Accessed August 2, 2023.
  6. American Society for Gastrointestinal Endoscopy (ASGE). Position statement on priorities for artificial intelligence in GI endoscopy: a report by the ASGE task force. https://www.asge.org. Published 2020. Accessed August 2, 2023.
  7. American Society for Gastrointestinal Endoscopy (ASGE). Report on Emerging Technology (ARCHIVED). Magnets in the GI tract. https://www.asge.org. Published 2013. Accessed August 2, 2023.
  8. American Society for Gastrointestinal Endoscopy (ASGE). Technology Status Evaluation Report. Video capsule endoscopy. https://www.asge.org. Published 2021. Accessed August 2, 2023.
  9. ClinicalKey. Clinical Overview. Celiac disease. https://www.clinicalkey.com. Updated August 16, 2022. Accessed July 26, 2023.
  10. ClinicalKey. Clinical Overview. Peutz-Jeghers syndrome. https://www.clinicalkey.com. Updated May 28, 2021. Accessed July 26, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. Capsule endoscopy for the diagnosis of small bowel disease in children. https://evidence.hayesinc.com. Published September 27, 2011. Updated September 1, 2015. Accessed July 25, 2023.
  2. Hayes, Inc. Medical Technology Directory (ARCHIVED). Capsule endoscopy of the small bowel for obscure gastrointestinal bleeding. https://evidence.hayesinc.com. Published June 20, 2013. Updated May 14, 2017. Accessed July 25, 2023.
  3. MCG Health. Capsule endoscopy. 27th edition. https://www.mcg.com. Accessed June 28, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. Merck Manual: Professional Version. Crohn disease.https://www.merckmanuals.com. Updated January 2021. Updated September 2022. Accessed July 26, 2023.
  2. Merck Manual: Professional Version. Endoscopy.https://www.merckmanuals.com. Updated March 2023. Accessed July 26, 2023.
  3. Merck Manual: Professional Version. Small-bowel tumors. https://www.merckmanuals.com. Updated March 2021. Updated September 2022. Accessed July 26, 2023.
  4. National Cancer Institute (NCI). Childhood colorectal cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated June 28, 2023. Accessed August 2, 2023.
  5. National Cancer Institute (NCI). Gastrointestinal carcinoid tumors treatment (PDQ) – health professional version. https://www.cancer.gov. Updated March 15, 2023. Accessed August 2, 2023.
  6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Colorectal cancer screening. https://www.nccn.org. Updated May 17, 2023. Accessed August 2, 2023.
  7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Genetic/familial high-risk assessment: colorectal. https://www.nccn.org. Updated May 30, 2023. Accessed August 2, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Clinical Report. Differentiating ulcerative colitis from Crohn’s disease in children and young adults: report of a working group of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the Crohn’s and Colitis Foundation of America. https://naspghan.org. Published May 2007. Accessed August 2, 2023.
  2. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Consensus Statement. Health supervision in the management of children and adolescents with IBD: NASPGHAN recommendations. https://naspghan.org. Published July 2012. Accessed August 2, 2023.
  3. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Society Paper. NASPGHAN capsule endoscopy clinical report. https://naspghan.org. Published March 2017. Accessed August 2, 2023.
  4. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). Society Paper. NASPGHAN clinical report on postoperative recurrence in pediatric Crohn disease. https://naspghan.org. Published October 2017. Accessed August 2, 2023.
  5. UpToDate, Inc. Angiodysplasia of the gastrointestinal tract. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  6. UpToDate, Inc. Approach to acute upper gastrointestinal bleeding in adults.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. UpToDate, Inc. Clinical manifestations, diagnosis and prognosis of Crohn disease in adults. https://www.uptodate.com. Updated June 2023. Accessed July 26, 2023.
  2. UpToDate, Inc. Clinical presentation and diagnosis of inflammatory bowel disease in children. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  3. UpToDate, Inc. Clinical presentation and diagnosis of primary gastrointestinal lymphomas. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  4. UpToDate, Inc. Clinical presentation, diagnosis and staging of colorectal cancer. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. UpToDate, Inc. Diagnosis and staging of small bowel neoplasms. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  2. UpToDate, Inc. Diagnosis of celiac disease in adults. https://www.uptodate.com. Updated June 2023. Accessed July 26, 2023.
  3. UpToDate, Inc. Endoscopic diagnosis of inflammatory bowel disease in adults. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  4. UpToDate, Inc. Evaluation of occult gastrointestinal bleeding. https://www.uptodate.com. Updated June 22, 2023. Accessed July 25, 2023.
  5. UpToDate, Inc. Evaluation of suspected small bowel bleeding (formerly obscure gastrointestinal bleeding). https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  6. UpToDate, Inc. Lynch syndrome (hereditary nonpolyposis colorectal cancer): cancer screening and management. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  7. UpToDate, Inc. Peutz-Jeghers syndrome: clinical manifestations, diagnosis and management. https://www.uptodate.com. Updated June 2023. Accessed July 26, 2023.
  8. UpToDate, Inc. Tests for screening for colorectal cancer. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.
  9. UpToDate, Inc. Wireless video capsule endoscopy. https://www.uptodate.com. Updated June 2023. Accessed July 25, 2023.

Capsule Endoscopy Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. US Food & Drug Administration (FDA). 510(k) summary: AdvanCE capsule endoscope delivery device. https://www.fda.gov. Published March 10, 2017. Accessed July 29, 2019.
  2. US Food & Drug Administration (FDA). 510(k) summary: AGILE patency system. https://www.fda.gov. Published May 8, 2006. Accessed August 23, 2013.
  3. US Food & Drug Administration (FDA). 510(k) summary: CapsoCam (SV-1). https://www.fda.gov. Published February 9, 2016. Accessed August 24, 2016.
  4. US Food & Drug Administration (FDA). 510(k) summary: CapsoCam Plus (SV-3). https://www.fda.gov. Published October 21, 2016. Updated February 14, 2020. Accessed July 27, 2020.
  5. US Food & Drug Administration (FDA). 510(k) summary: MiroCam capsule endoscope system. https://www.fda.gov. Published March 4, 2015. Accessed September 2, 2016.
  6. US Food & Drug Administration (FDA). 510(k) summary: Olympus small intestinal capsule endoscope system. https://www.fda.gov. Published March 13, 2018. Accessed August 26, 2018.
  7. US Food & Drug Administration (FDA). 510(k) summary: PillCam Colon 2 capsule endoscopy system. https://www.fda.gov.

Capsule Endoscopy Effective Date: 08/24/2023

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Review Date: 08/24/2023

Policy Number: HUM-0376-022

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. US Food & Drug Administration (FDA). 510(k) summary: PillCam ESO capsule. https://www.fda.gov. Published November 24, 2004. Accessed August 23, 2013.
  2. US Food & Drug Administration (FDA). 510(k) summary: PillCam Express. https://www.fda.gov. Published September 30, 2010. Accessed August 23, 2013.
  3. US Food & Drug Administration (FDA). 510(k) summary: PillCam patency system. https://www.fda.gov. Published March 8, 2018. Accessed July 29, 2019.
  4. US Food & Drug Administration (FDA). 510(k) summary: PillCam SB 3. https://www.fda.gov. Published August 12, 2013. Accessed September 4, 2014.

Capsule Endoscopy Effective Date: 08/24/2023

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  1. US Food & Drug Administration (FDA). 510(k) summary: PillCam UGI capsule endoscopy system. https://www.fda.gov. Published December 16, 2014. Accessed September 2, 2015.
  2. US Food & Drug Administration (FDA). De novo summary: NaviCam capsule endoscopy system. https://www.fda.gov. Published May 22, 2020. Accessed July 27, 2020.
  3. US Food & Drug Administration (FDA). De novo summary: Pill Sense system. https://www.fda.gov. Published February 24, 2023. Accessed July 31, 2023.
  4. US Preventive Services Task Force (USPSTF). Recommendation Statement. Screening for colorectal cancer. https://www.uspreventiveservicestaskforce.org. Published May 18, 2021. Accessed August 2, 2023.