Endoscopic Ultrasonography for the Upper Gastrointestinal Tract

Policy Number: MP-712

Latest Review Date: December 2023

Category: Surgical                                                                 

POLICY:

Effective for dates of service on or after January 21, 2021:

Endoscopic ultrasonography (EUS) or Endoscopic ultrasonography with fine needle aspiration (EUS-FNA) may be considered medically necessary for any of the following indications:

• Diagnosing common bile duct stones
• Evaluating abnormalities of the biliary tree
• Evaluating abnormalities of the gastrointestinal tract wall or adjacent structures
• Evaluating abnormalities of the pancreas, including masses, pseudocysts and chronic pancreatitis
• Evaluating adenopathy and masses of the posterior mediastinum (endoscopic ultrasonography with fine-needle aspiration)
• Evaluating idiopathic acute pancreatitis
• Gallbladder drainage for acute cholecystitis
• Pre-operative staging of esophageal cancer, or gastric cancer
• Providing endoscopic therapy under ultrasonographic guidance
• Sampling tissue of lesions within, or adjacent to, the wall of the gastrointestinal tract
• Staging tumors of the gastrointestinal tract (including the esophagus, the stomach, the rectum), pancreas and bile ducts
• Surveillance of certain gastric subepithelial masses (asymptomatic glomus tumors or small (less than 3 cm) gastrointestinal stromal tumors

Endoscopic ultrasonography guided biliary drainage (EUS-BD) may be considered medically necessary when ERCP cannot be performed as a result one or more of the following:

• Unsuccessful ERCP
• Surgically altered anatomy
• Gastric outlet obstruction
• Malignant distal biliary obstruction
• Duodenal obstruction
• Periampullary tumor infiltration

Endoscopic ultrasonography (EUS) is considered investigational for all other gastrointestinal indications.

Endoscopic ultrasonography incorporated high frequency ultrasound probe sonography (HFUPS) is considered investigational for all indications.

**For endobronchial ultrasound for the diagnosis and staging of lung cancer, please refer to medical policy #576.

DESCRIPTION OF PROCEDURE OR SERVICE:

Endoscopic ultrasound (EUS) is an imaging technique that provides information about the upper and lower digestive tract, surrounding tissue, and organs (e.g. pancreas, and liver). An endoscope with a small ultrasound device mounted on the tip is used to view the digestive tract.

EUS may be used to further evaluate known abnormalities that were detected previously from other x-rays or scans. It produces an image that is more detailed and can be used to stage tumors in the GI tract.  It has also been used for tissue sampling of lesions.

A recent advance of EUS is high-frequency ultrasound probe sonography (HFUPS). This has been researched as a method of providing ultrasound imaging of visible lesions without endoscope exchange as it can be performed through the biopsy channel of an endoscope.  Two commercially available probes, the Olympus UM-2R/UM-3R Ultrasonic Probes (Olympus Optical Co.) and the Fujinon Sonoprobe SP-701 (Fujinon, Inc.), have received 510(k) status from the Food and Drug Administration.

KEY POINTS:

The most recent literature update was performed through December 7, 2023.

Summary of Evidence

For individuals who receive EUS with or without FNA for evaluation of the GI tract, the evidence includes multiple meta-analyses and randomized trials. The relevant outcomes are overall survival, test accuracy and validity, and morbid events. Multiple studies have revealed a low rate of adverse events and few reinterventions in individuals who have received EUS. EUS with FNA has also exhibited improved accuracy of diagnoses with a relatively low incidence of adverse events.  Additionally, studies have indicated that it is a more accurate imaging modality for staging depth of tumor invasion, with pre-operative accuracy in the 80 % to 90 % range when compared with surgical pathology.  However, biopsy and histopathologic evaluation are needed to identify the specific histology. Endoscopic ultrasonography has proven to be a reliable and accurate diagnostic tool for the GI tract. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who receive EUS with high-frequency ultrasound probe sonography, the evidence includes a meta-analysis. The relevant outcomes are overall survival, test accuracy and validity, and morbid events. HFUPS has been used in the staging of esophageal, gastric, ampullary, pancreatobiliary, and colonic neoplasms, but widespread use of these probes have been limited. Further research and well-designed studies are needed to determine the benefits of this device.  The evidence is insufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements

The National Comprehensive Cancer Network

The National Comprehensive Cancer Network’s clinical practice guideline on gastric cancers (including cancer in the proximal 5 cm of the stomach) (NCCN, 2013) states that “clinical staging has greatly improved with the availability of diagnostic modalities such as endoscopic ultrasound (EUS) …. EUS performed prior to any treatment is important in the initial clinical staging of gastric cancer …. This is especially important in patients who are being considered for EMR [endoscopic mucosal resection]”.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

EUS, endoscopic ultrasonography, endoscopic ultrasound, GI ultrasound, gastrointestinal ultrasound, EUS with high-frequency ultrasound probe sonography, HFUPS

APPROVED BY GOVERNING BODIES:

In 2016, Boston Scientific received 510(k) endoscopic ultrasound – Boston Scientific

The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle received 510(k) in January 2017.  The SL needle is designed to sample targeted submucosal and extramural gi lesions through the accessory channel of a curvilinear echoendoscope.

In April 2017, the PENTAX Medical Endoscopic Ultrasound System is intended to provide optical visualization of ultrasonic visualization of, and therapeutic access to, the upper gi tract including but not restricted to organs, tissues, and subsystems: esophagus, stomach, duodenum, small bowel and underlying areas.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Adler JM, Sethi A. Interventional endoscopic ultrasonography in the pancreas. Gastrointest Endosc Clin N Am. 2018;28(4):569-578.
2. American Society for Gastrointestinal Endoscopy. Echoendoscopes. Available at: www.asge.org/docs/default-source/education/Technology_Reviews/doc-echoendoscopes_aip.pdf?sfvrsn=d6e4a51_4.
3. American Society for Gastrointestinal Endoscopy. Understanding EUS (endoscopic ultrasonography). Available at: www.asge.org/home/for-patients/patient-information/understanding-eus.
4. Banafea O, Mghanga FP, Zhao J, et al. Endoscopic ultrasonography with fine-needle aspiration for histological diagnosis of solid pancreatic masses: A meta-analysis of diagnostic accuracy studies. BMC Gastroenterol. 2016;16:108.
5. Choi JH, Lee SS. Endoscopic ultrasonography-guided gallbladder drainage for acute cholecystitis: From evidence to practice. Dig Endosc. 2015;27(1):1-7.
6. Dhir V, Shah R, Udawat P. Endoscopic Ultrasound-Guided Biliary Interventions. Gastrointest Endosc Clin N Am. 2022 Jul;32(3):507-525. doi: 10.1016/j.giec.2022.02.003. Epub 2022 May 11.
7. Feng X, Linghu E, Chai N, Li H. New treatment of the pancreatic cystic neoplasm: Endoscopic ultrasonography-guided radiofrequency ablation combined with lauromacrogol ablation. Turk J Gastroenterol. 2018;29(1):99-102.
8. Foley KG, Franklin J, Jones CM, Coles B, Roberts SA, Underwood TJ, Crosby T. The impact of endoscopic ultrasound on the management and outcome of patients with oesophageal cancer: an update of a systematic review. Clin Radiol. 2022 May;77(5):e346-e355. doi: 10.1016/j.crad.2022.02.001. Epub 2022 Mar 11.
9. Food and Drug Administration (FDA). www.accessdata.fda.gov/cdrh_docs/pdf16/K162447.pdf
10. Food and Drug Administration (FDA). www.accessdata.fda.gov/cdrh_docs/pdf16/K163058.pdf
11. Giljaca V, Gurusamy KS, Takwoingi Y, et al. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography for common bile duct stones. Cochrane Database Syst Rev. 2015;2:CD011549.
12. Han, Y., Sun, S., Guo, J., Ge, N., Wang, S., Liu, X., Wang, G., Hu, J., & Wang, S. (2016). Is endoscopic ultrasonography useful for endoscopic submucosal dissection?. Endoscopic ultrasound, 5(5), 284–290. doi.org/10.4103/2303-9027.191606
13. Hatamaru, K., & Kitano, M. (2019). EUS-guided biliary drainage for difficult cannulation. Endoscopic ultrasound, 8(Suppl 1), S67–S71. doi.org/10.4103/eus.eus_60_19
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. Ishihara R, Matsuura N, Hanaoka N, et al. Endoscopic imaging modalities for diagnosing invasion depth of superficial esophageal squamous cell carcinoma: A systematic review and meta-analysis. BMC Gastroenterol. 2017;17(1):24.
16. Jiang T, Chai W. Endoscopic ultrasonography (EUS)-guided laser ablation (LA) of adrenal metastasis from pancreatic adenocarcinoma. Lasers Med Sci. 2018;33(7):1613-1616.
17. Jovani, M., Ichkhanian, Y., Vosoughi, K., & Khashab, M. A. (2019). EUS-guided biliary drainage for postsurgical anatomy. Endoscopic ultrasound, 8(Suppl 1), S57–S66. doi.org/10.4103/eus.eus_53_19.
18. Kim S, Hamerski C, Ghassemi K, et al. The Clinical Utility of Evaluating the Luminal Upper Gastrointestinal Tract During Linear Endoscopic Ultrasonography. J Clin Gastroenterol. 2016 Aug;50(7):538-44.
19. Kim TH, Chon HK. [Endoscopic Ultrasound-guided Drainage in Pancreatobiliary Diseases]. Korean J Gastroenterol. 2022 May 25;79(5):203-209. Korean. doi: 10.4166/kjg.2022.064.
20. Kitano, M., Yoshida, T., Itonaga, M., Tamura, T., Hatamaru, K., & Yamashita, Y. (2019). Impact of endoscopic ultrasonography on diagnosis of pancreatic cancer. Journal of gastroenterology, 54(1), 19–32. doi.org/10.1007/s00535-018-1519-2
21. Klamt AL, Neyeloff JL, Santos LM, Mazzini GDS, Campos VJ, Gurski RR. Echoendoscopy in Preoperative Evaluation of Esophageal Adenocarcinoma and Gastroesophageal Junction: Systematic Review and Meta-analysis. Ultrasound Med Biol. 2021 Jul;47(7):1657-1669.
22. Lee MW, Kim GH, I H, et al. Predicting the invasion depth of esophageal squamous cell carcinoma: comparison of endoscopic ultrasonography and magnifying endoscopy. Scand J Gastroenterol. 2014;49(7):853-861.
23. Li JH, Qin SM, Liu TW, et al. The effect of endoscopic ultrasound on the precise selection of endoscopic treatment for submucosal tumors in the upper gastrointestinal tract. BMC Surg. 2023 Aug 27;23(1):255.
24. Manta R, Mutignani M, Galloro G, et al. Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis with a lumen-apposing metal stent: A systematic review of case series. Eur J Gastroenterol Hepatol. 2018;30(7):695-698.
25. National Comprehensive Cancer Network (NCCN). Esophageal and esophagogastric junction cancers. NCCN Clinical Practice Guidelines in Oncology, Version 2.2016. Fort Washington, PA: NCCN; 2016.
26. National Comprehensive Cancer Network (NCCN). Neuroendocrine tumors. NCCN Clinical Practice Guidelines in Oncology, Version 3.2017. Fort Washington, PA: NCCN; 2017.
27. National Comprehensive Cancer Network (NCCN). Pancreatic adenocarcinoma. NCCN Clinical Practice Guidelines in Oncology, Version 3.2017. Fort Washington, PA: NCCN; 2017
28. Nisenblat V, Bossuyt PM, Farquhar C, et al. Imaging modalities for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016;2:CD009591.
29. Oh SY, Irani S, Kozarek RA. What are the current and potential future roles for endoscopic ultrasound in the treatment of pancreatic cancer? World J Gastrointest Endosc. 2016;8(7):319-329.
30. Penas-Herrero I, de la Serna-Higuera C, Perez-Miranda M. Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video). J Hepatobiliary Pancreat Sci. 2015;22(1):35-43.
31. Serrani M, Calvanese C, Lisotti A, et al. Basics in endoscopic ultrasound part 2: EUS-guided sampling and therapeutic applications. Rev Recent Clin Trials. 2018;13(2):97-104.
32. Somani P, Sunkara T, Sharma M. Role of endoscopic ultrasound in idiopathic pancreatitis. World J Gastroenterol. 2017 23(38):6952-6961.
33. Su Q, Peng J, Chen X, et al. Role of endoscopic ultrasonography for differential diagnosis of upper gastrointestinal submucosal lesions. BMC Gastroenterol. 2021 Oct 7;21(1):365.
34. Sun X, Lu Z, Wu Y, et al. An endoscopic ultrasonography-guided interstitial brachytherapy based special treatment-planning system for unresectable pancreatic cancer. Oncotarget. 2017;8(45):79099-79110.
35. Tanaka H, Matsusaki S. The Utility of Endoscopic-Ultrasonography-Guided Tissue Acquisition for Solid Pancreatic Lesions. Diagnostics (Basel). 2022 Mar 19;12(3):753. doi: 10.3390/diagnostics12030753.
36. Teoh AYB, Dhir V, Kida M, et al. Consensus guidelines on the optimal management in interventional EUS procedures: Results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018;67(7):1209-1228.
37. Vedantam S, Amin S. Endoscopic Ultrasound-Guided Biliary Interventions in Liver Disease. Clin Liver Dis. 2022 Feb;26(1):101-114. doi: 10.1016/j.cld.2021.08.009. Epub 2021 Oct 22.
38. Vege SS. Etiology of acute pancreatitis. UpToDate [online serial]. Waltham, MA: NCCN; reviewed February 2019.
39. Wan J, Ouyang Y, Yu C, et al. Comparison of EUS with MRCP in idiopathic acute pancreatitis: A systematic review and meta-analysis. Gastrointest Endosc. 2018;87(5):1180-1188.
40. Wilcox CM, Seay T, Kim H, Varadarajulu S. Prospective endoscopic ultrasound-based approach to the evaluation of idiopathic pancreatitis: Causes, response to therapy, and long-term outcome. Am J Gastroenterol. 2016;111(9):1339-1348.
41. Yoshinaga S, Hilmi IN, Kwek BE, et al. Current status of endoscopic ultrasound for the upper gastrointestinal tract in Asia. Dig Endosc. 2015 Apr;27 Suppl 1:2-10.
42. Zilli A, Arcidiacono PG, Conte D, Massironi S. Clinical impact of endoscopic ultrasonography on the management of neuroendocrine tumors: Lights and shadows. Dig Liver Dis. 2018;50(1):6-14.

POLICY HISTORY:

Medical Policy Group, December 2020 (5): New policy created with full literature review. Medical Policy Administrative Committee: December 2020. Available for Comment: January 21, 2021 through March 7, 2021.

Medical Policy Group, January 2022 (5): Updates to Key Points, and References. Policy Statement updated to remove “not medically necessary.” No change to policy intent.

Medical Policy Group, December 2022 (5): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Group, December 2023 (11):  Reviewed by consensus. Update to Key Points, Benefit Application, and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.