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Esophagogastroduodenoscopy (EGD) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
07.02.22j

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.​

MEDICALLY NECESSARY

ESOPHAGOGASTRODUODENOSCOPY (EGD)
Esophagogastroduodenoscopy (EGD) is considered medically necessary and, therefore, covered in the following situations when any of the medical necessity criteria listed below under diagnostic, therapeutic, or surveillance/periodic EGD are met:
  • As the initial method of evaluation of symptoms as an alternative to radiographic studies
  • Following an unsuccessful empirical trial of therapy for a suspected benign digestive disorder
  • If a change in management is probable based on results of EGD
  • When a primary therapeutic procedure is contemplated
Diagnostic EGD
  • ​Upper abdominal distress (pain or discomfort) that persists despite an appropriate trial of therapy (e.g., acid suppression with proton-pump inhibitors [PPIs])​ 
  • Upper abdominal distress (pain or discomfort) associated with symptoms and/or signs suggesting structural disease​ (e.g., prolonged anorexia and weight loss)​ or new-onset symptoms in individuals older than 50 years of age
  • Dysphagia (difficulty or discomfort in swallowing) or odynophagia (painful swallowing)
  • Esophageal reflux symptoms that persist or recur despite appropriate therapy
  • Persistent vomiting of unknown cause
  • Other systemic diseases in which the presence of upper gastrointestinal (GI) pathology might modify other planned management (e.g., individuals with a history of GI bleeding who are scheduled for organ transplantation, long-term anticoagulation, and chronic nonsteroidal therapy for arthritis, and those with cancer of the head and neck)
  • Familial adenomatous polyposis syndromes
  • Confirmation and specific histologic diagnosis of radiologically demonstrated lesions:
    • Suspected neoplastic lesion
    • Gastric or esophageal ulcer
    • Upper tract stricture or obstruction
  • ​The presence of GI bleeding for any of the following:​
    • ​In individuals actively bleeding or those recently stopped
    • When surgical therapy is contemplated
    • When re-bleeding occurs after acute self-limited blood loss or after endoscopic therapy
    • When portal hypertension or aortoenteric fistula is suspected
    • Presumed chronic blood loss and iron deficiency anemia when the clinical situation suggests an upper GI source or when colonoscopy does not provide an explanation​
  • When sampling of duodenal or jejunal tissue or fluid is indicated
  • ​To assess acute injury after caustic agent ingestion 
  • Diarrhea in individuals suspected of having small-bowel disease (e.g., celiac disease)
  • Intraoperative evaluation of anatomic reconstructions typical of modern foregut surgery (e.g., evaluation of anastomotic leak and patency, fundoplication formation, pouch configuration during bariatric surgery)
  • Pernicious anemia 6 months after diagnosis or at the development of upper GI symptoms
Therapeutic EGD
  • Suspected portal hypertension or cirrhosis to document or treat esophageal varices
  • Bleeding lesions such as ulcers, tumors, vascular abnormalities (e.g., electrocoagulation, heater probe, laser photocoagulation, or injection therapy)
  • Removal of foreign bodies
  • Removal of selected lesions​​
  • Esophageal stricture dilation/management of achalasia (e.g., botulinum toxin, balloon dilation)
  • Placement of feeding or drainage tubes (e.g., peroral, percutaneous endoscopic gastrostomy, percutaneous endoscopic jejunostomy)
  • Dilation and stenting of stenotic lesions (e.g., with transendoscopic balloon dilators or dilation systems using guidewires)
  • Palliative treatment of stenosing neoplasms (e.g., laser, multipolar electrocoagulation, stent placement)
  • Endoscopic therapy of intestinal metaplasia
  • Management of operative complications (e.g., dilation of anastomotic strictures, stenting of anastomotic disruption, fistula, or leak in selected circumstances)
SURVEILLANCE/PERIODIC EGD
Premalignant Condition
  • Barrett esophagus (BE):
    • Without dysplasia, every 3 to 5 years
    • Indeterminate for dysplasia, a repeat EGD to clarify presence and grade of dysplasia
    • Low-grade dysplasia (LGD), a repeat EGD in 6 months to confirm LGD, then yearly
    • High-grade dysplasia (HGD), every 3 months for 1 year; after 1 year of no cancer detection, repeat EGD at lengthened intervals.
  • Caustic ingestion: beginning at 15 to 20 years following the acute injury, at an interval of every 1 to 3 years
  • Tylosis: beginning at 30 years of age, at an interval of every 1 to 3 years
  • Gastric epithelial polyps:
    • Beginning at 1 year after removal of adenomatous gastric polyps to assess recurrence at the prior excision site, new or previously missed polyps, and/or supervening early carcinoma:
      • If the results of this examination are negative, every 3 to 5 years
      • High-grade dysplasia and early gastric cancer, EGD at individualized intervals
  • Familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC):
    • Beginning at the time of a colectomy or after 30 years of age:
      • If no adenomas, repeat EGD in 5 years
      • Duodenal and periampullary adenomas, at intervals based on stage of disease
      • Papillary adenomas in individuals with advanced adenomas or dysplasia after complete excision, EGD with multiple biopsies every 6 months for a minimum of 2 years; thereafter every 3 years
    • HNPCC, EGD surveillance will be covered
  • Gastric intestinal metaplasia:
    • Confirmed gastric intestinal metaplasia with high-grade dysplasia
  • Mucosa-associated lymphoid tissue (MALT) lymphoma:
    • Every 3 to 6 months for the first 2 years after Helicobacter pylori eradication; after the first 2 years, every 6 to 12 months.
Esophageal Varices
  • Compensated cirrhosis with no varices on initial screening EGD, another EGD every 2 to 3 years. If the individual has small varices, another endoscopy every 1 to 2 years.
  • Cirrhosis secondary to alcohol abuse or decompensated liver disease with no findings of varices on the initial screening endoscopy, periodic EGD yearly for the screening of development of esophageal varices.
  • A yearly endoscopy for small varices accompanied by high-risk stigmata (red wale marks or red spots) on screening endoscopy.
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)
Endoscopic retrograde cholangiopancreatography (ERCP) is considered medically necessary and, therefore, covered in the following situations when any of the medical necessity criteria listed below are met:
  • As the initial method of evaluation of symptoms as an alternative to radiographic studies
  • Following an unsuccessful empirical trial of therapy for a suspected benign digestive disorder
  • If a change in management is probable based on results of ERCP
  • When a primary therapeutic procedure is contemplated
Indications
  • Acute biliary pancreatitis with concomitant cholangitis or biliary obstruction
  • Benign biliary strictures requiring dilation and stent placement
  • First-line therapy for postoperative biliary leaks
  • Type I sphincter of Oddi dysfunction (SOD) requiring a sphincterotomy
  • Pancreatic divisum
  • Tissue sampling from the papilla or from the bile or pancreatic ducts to check for cancer
  • Clinical and biochemical or imaging results suggestive of pancreatic duct disease or biliary tract without jaundice
  • Signs or symptoms suggesting pancreatic malignancy when results of direct imaging (e.g., endoscopic ultrasound, ultrasound, computed tomography, magnetic resonance imaging) are equivocal or normal
  • Pancreatitis of unknown etiology
  • Preoperative evaluation of an individual with chronic pancreatitis and/or pseudocyst
  • Evaluation of the sphincter of Oddi by manometry
  • When an endoscopic sphincterotomy is required for any of the following indications:
    • Choledocholithiasis
    • Papillary stenosis or type 1 SOD
    • Facilitate placement of biliary stents or dilation of biliary strictures
    • Sump syndrome
    • Choledochocele involving the major papilla
    • Ampullary carcinoma in individuals who are not candidates for surgery
    • Facilitate access to pancreatic duct
  • When dilation and/or stent placement is required across benign or malignant strictures, fistulae, postoperative bile leak, or in high-risk individuals with large unremovable common duct stones
  • When balloon dilation of the papilla is required
  • When nasobiliary drain placement is required
  • When pancreatic pseudocyst drainage is required
  • Ampullectomy of adenomatous neoplasms of the major papilla
  • Therapy of disorders of the biliary and pancreatic ducts
  • Facilitation of cholangioscopy and/or pancreatoscopy
NOT MEDICALLY NECESSARY

ESOPHAGOGASTRODUODENOSCOPY (EGD)
Diagnostic EGD

An EGD is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of conditions such as the following:
  • For the evaluation of symptoms that are considered functional in origin (i.e., no physiologic cause for GI complaints is found, even after extensive evaluation)
  • Metastatic adenocarcinoma of unknown primary site when the results will not alter management.
  • Radiographic findings of:
    • Asymptomatic or uncomplicated sliding hiatal hernia
    • Uncomplicated duodenal bulb ulcer that has responded to therapy
    • Deformed duodenal bulb when symptoms are absent or respond adequately to ulcer therapy
  • Prior to bariatric surgery in asymptomatic individuals
  • Routine screening in asymptomatic individuals
  • Screening or evaluation of colorectal cancer not associated with familial adenomatous polyposis (FAP) syndrome
SURVEILLANCE OR PERIODIC EGD
Sequential or periodic EGD is considered not medically necessary and, therefore, not covered for the following indications because the available published peer-reviewed literature does not support its use in the treatment of illness or injury.
  • Surveillance for malignancy in individuals with gastric atrophy, pernicious anemia, fundic gland or hyperplastic polyps, gastric intestinal metaplasia, or previous gastric operations for benign disease 
  • Surveillance of healed benign disease, such as esophagitis and gastric or duodenal ulcer ​
  • Repeat EGD for individuals with a prior normal or negative EGD, if symptoms remain unchanged
  • Surveillance EGD for individuals with adequate sampling or removal of nondysplastic gastric polyps
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)
An ERCP is considered not medically necessary and, therefore, not covered for the following indications because the available published peer-reviewed literature does not support its use:
  • For the evaluation of pancreaticobiliary-type pain in the absence of objective abnormalities on other pancreaticobiliary imaging or laboratory studies
  • Before a laparoscopic cholecystectomy in the absence of objective signs (e.g., biliary colic, obstructive jaundice, pancreatitis, cholangitis) of biliary obstruction or stone
  • For the evaluation or treatment of type III SOD
  • For further evaluation of documented pancreatic malignancy unless management will be altered
  • Empirical biliary sphincterotomy without sphincter of Oddi manometry in individuals with suspected type III SOD
EXPERIMENTAL/INVESTIGATIONAL

Transesophageal radiofrequency ablation and transesophageal endoscopic fundoplication for the treatment of gastroesophageal reflux disease (GERD) are considered experimental/investigational and, therefore, not covered because the safety and effectiveness of these procedures cannot be established by review of the available published peer-reviewed literature. Refer to medical policy 11.03.11, Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD), for additional information.

Confocal laser endomicroscopy, including but not limited to as an adjunct to standard endoscopy with random four-quadrant biopsy in BE surveillance, is considered experimental/investigational and, therefore, not covered because the safety and effectiveness of these procedures 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.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, upper gastrointestinal endoscopy is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Cellvizio (Mauna Kea Technologies) was approved by the FDA through the 510(k) process on October 23, 2015, for imaging of the internal microstructure of tissues during an endoscopic and laparoscopic surgical procedures.

Optiscan confocal endoscopic imaging system was approved by the FDA through the 510(k) process on March 5, 2010, for imaging of the internal microstructure of tissues in the anatomical track access by video endoscope, during endoscopic medical examination procedures.

Description

ESOPHAGOGASTRODUODENOSCOPY

Esophagogastroduodenoscopy (EGD), also known as an upper gastrointestinal (GI) endoscopy, involves examining the lining of the upper part of the GI tract, which includes the esophagus, stomach, and duodenum (first portion of the small intestine). EGD involves the use of a thin, flexible tube called an endoscope, which has its own lens and light source and projects images on a video monitor.

An EGD is often indicated for evaluation and treatment of abdominal symptoms. Some diagnostic indications may include abdominal symptoms, difficult and/or painful swallowing, GI bleed, esophageal reflux, and suspected neoplasm. Therapeutic indications may include stricture dilation, removal of foreign body, treatment of bleeding lesions, sclerotherapy of varices, and removal of selected lesions.

An EGD can evaluate, diagnose, and manage various GI problems, including difficult or painful swallowing, pain in the stomach or abdomen, GI bleed, ulcers, and tumors. Tiny instruments can be passed through an opening in the endoscope to obtain tissue samples, coagulate bleeding sites, dilate or stretch a narrowed area, or perform other treatments.

EGD can be used to periodically monitor individuals with esophageal varices or premalignant conditions (i.e., Barrett esophagus, caustic ingestion, tylosis, gastric epithelial polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

An ERCP is a procedure that combines upper GI endoscopy and x-rays to treat problems of the gallbladder, bile, and pancreatic ducts.

An ERCP is used to diagnose, evaluate, and treat problems that affect the pancreas and bile duct system, and to study the ducts that drain the liver and pancreas. Ducts are drainage routes into the bowel. The bile or biliary ducts drain the liver and gallbladder, and the pancreatic duct drains the pancreas. The bile and pancreatic ducts join together just before they drain into the upper bowel, about 3 inches from the stomach. The drainage opening is called the papilla. The papilla is surrounded by a circular muscle, called the sphincter of Oddi.

An ERCP can be used when there is a blockage of the bile ducts by gallstones, tumors, scarring or other conditions that cause obstruction or narrowing of the ducts. Similarly, blockage of the pancreatic ducts from stones, tumors, or stricture can also be evaluated or treated by ERCP, which is useful in assessing causes of pancreatitis.

There are several risk factors and complications that can develop from having an ERCP. Pancreatitis is the most common serious complication, also known as post-ERCP pancreatitis (PEP). This condition consists of worsened abdominal pain and elevated serum amylase resulting in a hospitalization.

PROCEDURES PERFORMED WITH ERCP
Sphincterotomy

Sphincterotomy is a procedure that incorporates the use of endoscopic as well as fluoroscopic guidance. The technique involves deep cannulation of the bile duct followed by severance of the sphincter of Oddi with the electrocautery, a small wire on a specialized catheter that uses electric current to cut the tissue. The actual cut is quite small, usually less than a half inch. This small cut, or sphincterotomy, allows various treatments in the ducts.

Stone Removal​

The most common treatment through an ERCP scope is removal of bile duct stones. These stones may form in the gallbladder and travel into the bile duct or may form in the duct itself years after the gallbladder has been removed. After a sphincterotomy is performed to enlarge the opening of the bile duct, stones can be pulled from the duct into the bowel. A variety of balloons and baskets attached to specialized catheters can be passed through the ERCP scope into the ducts allowing stone removal. Very large stones may require crushing in the duct with a specialized basket so the fragments can be pulled out through the sphincterotomy.

Stent Placement

Stents are placed into the bile or pancreatic ducts to bypass strictures, or narrowed parts of the duct. These narrowed areas of the bile or pancreatic duct are caused by scar tissue or tumors that cause blockage of normal duct drainage. There are two types of stents that are commonly used. The first is made of plastic and looks like a small straw. A plastic stent can be pushed through the ERCP scope into a blocked duct to allow normal drainage. The second type of stent is made of metal wires, appearing like the cross wires of a fence. The metal stent is flexible and springs open to a larger diameter than plastic stents. Both plastic and metal stents tend to clog up after several months, and another ERCP may be required to place a new stent. Metal stents are permanent, while plastic stents are easily removed at a repeat procedure.

Balloon Dilation

Balloon dilation involves the use of catheters fitted with dilating balloons that can be placed across a narrowed area or stricture. The balloon is then inflated to stretch out the narrowing. Dilation with balloons is often performed when the cause of the narrowing is benign (not a cancer). After balloon dilation, a temporary stent may be placed for a few months to help maintain the dilation.

Tissue Sampling

Tissue sampling from the papilla or from the bile or pancreatic ducts via the ERCP scope is commonly performed. There are several different sampling techniques, although the most common is to brush the area with subsequent examination of the cells obtained. Tissue samples can be used to decide whether a stricture or narrowing is caused by cancer. Positive results for cancer are very accurate; however, negative results may not be accurate.

CONFOCAL LASER ENDOMICROSCOPY 

Confocal laser endomicroscopy (CLE) (also known as confocal fluorescent endomicroscopy and optic endomicroscopy) is an in vivo microscopic imaging of the mucosal epithelium during endoscopy to assess the GI mucosal histology. A light for a low-power laser illuminates the tissue. The same lens detects light reflected from the tissue through a pinhole. The term confocal refers to having both illumination and collection systems in the same focal plan. Light reflected and scattered that is not reflected through the pinhole is excluded from detection. This dramatically increases the resolution of the CLE images.

There are two CLE devices that have been cleared for marketing by the US Food and Drug Administration (FDA) through the 510k process. One is an endoscope-based system with a confocal probe incorporated onto the tip of a conventional endoscope. The other is a probe-based system where the probe is placed through the biopsy channel of a conventional endoscope. The depth of view with the endoscopic system is up to 250 µm and about 120 µm with the probe-based system CLE (pCLE).

BARRETT ESOPHAGUS (BE)
For individuals with BE who are undergoing surveillance and receive CLE with targeted biopsy, the evidence includes several randomized controlled trials (RCTs), observational studies, systematic reviews, and meta-analyses. Evidence from RCTs has suggested that CLE has similar or higher sensitivity than standard endoscopy for identifying areas of dysplasia. More prospective RCTs and high-quality meta-analyses are needed. The evidence is insufficient to determine that this technology results in an improvement in the net health outcome. 

A single-center crossover RCT was published by Dunbar et al. (2009). Forty-six individuals with BE were enrolled, and 39 (95%) completed the study protocol. Of these, 23 were undergoing BE surveillance, and 16 had BE with suspected neoplasia. All individuals received endoscopy-based CLE and standard endoscopy, in random order. One endoscopist performed all CLE procedures, and another endoscopist performed all standard endoscopy procedures; endoscopists were blinded to the finding of the other procedure. During the standard endoscopy procedure, biopsy specimens were taken of any discrete lesions followed by four-quadrant random biopsy (every 1 cm for suspected neoplasia, every 2 cm for BE surveillance). During the CLE procedure, only lesions suspicious of neoplasia were biopsied. Endoscopists interpreted CLE images using the Confocal Barrett's Classification system, developed in a previous research study. Histopathologic analysis was the reference standard. Among the 16 study completers with suspected high-risk dysplasia, there were significantly fewer biopsies per individual with CLE (mean, 9.8 biopsies per individual) than with standard endoscopy (mean, 23.9 biopsies per individual; P=0.002). Although there were fewer biopsies, the mean number of biopsy specimens showing HGD or cancer was similar in the two groups (3.1 during CLE vs 3.7 during standard endoscopy). The diagnostic yield for neoplasia was 33.7% with CLE and 17.2% with standard endoscopy. None of the 23 individuals undergoing BE for surveillance had HGD or cancer. The mean number of mucosal specimens obtained for individuals in this group was 12.6 with white-light endoscopy and 1.7 with CLE (P<0.001). 


Sharma et al. (2011) published an international, multicenter RCT that included 122 consecutive individuals presenting for surveillance of BE or endoscopic treatment of HGD or early carcinoma. Individuals were randomly assigned to both standard white-light endoscopy and narrow-band imaging. Following these two examinations, done in a blinded fashion, the location of lesions was unblinded and, subsequently, all individuals underwent pCLE. All examinations involved a presumptive diagnosis of suspicious lesions. Also, in both groups, after all evaluations were performed, all suspicious lesions were biopsied, as well as random locations (four quadrants every 2 cm). The histopathologic analysis was the reference standard. Twenty-one individuals were excluded from the analysis. Of the remaining 101 individuals, 66 (65%) were found on histopathologic analysis to have no dysplasia, four (4%) had low-grade dysplasia, six (6%) had HGD, and 25 (25%) had early carcinoma. Sensitivity of CLE plus white-light endoscopy for detecting HGD or early carcinoma was 68.3% (95% CI, 60.0%–76.7%), which was significantly higher than white-light endoscopy alone (34.2%; 95% CI, 25.7%–42.7%; P=0.002). However, specificity of CLE plus white-light endoscopy was significantly lower (87.8%; 95% CI, 85.5%–90.1%) than white-light endoscopy alone (92.7%; 95% CI, 90.8%–94.6%; P<0.001). For white-light endoscopy alone, the PPV was 42.7% (95% CI, 32.8%–52.6%) and NPV was 89.8% (95% CI, 87.7%–92.0%). For white-light endoscopy with pCLE, the PPV was 47.1% (95% CI, 39.7%–54.5%) and NPV was 94.6% (95% CI, 92.9%–​​96.2%). White-light endoscopy alone missed 79 (66%) of 120 areas with HGD or early carcinoma, and white-light endoscopy plus CLE missed 38 (32%) of 120 areas. On a per-individual basis, 31 individuals were diagnosed with HGD or early carcinoma. White-light endoscopy alone failed to identify four of these individuals (sensitivity, 87%), whereas white-light endoscopy plus CLE failed to identify two individuals (sensitivity, 93.5%). 


The single RCT in a systematic review by Ypsilantis et al. published by Wallace et al. (2012) included individuals with BE who were undergoing ablation. After an initial attempt at ablation, individuals were randomly assigned to follow up with high-definition white-light endoscopy or high-definition white-light endoscopy plus CLE. The primary outcome was the proportion of optimally treated individuals, defined as those with no evidence of disease at follow-up, and those with residual disease who were identified and treated. Trial enrollment was halted after an interim analysis showed no difference between groups and higher than expected residual BE in both arms. Among the 119 individuals enrolled at the interim analysis, 15 (26%) of 57 in the high-definition white-light endoscopy group and 17 (27%) of 62 in the high-definition white-light endoscopy plus CLE group were optimally treated; the difference was not statistically significant. Moreover, other outcomes were similar in the two groups. 

Canto et al. (2014) reported on a single-blind, multicenter trial conducted at academic centers with experienced endoscopists. It included consecutive individuals undergoing endoscopy for routine BE surveillance or for suspected or known neoplasia. Individuals were randomly assigned to high-definition white-light endoscopy with random biopsy (n=98) or white-light endoscopy with endoscopy-based CLE and targeted biopsy (n=94). In the white-light endoscopy-only group, four-quadrant random biopsy samples were taken every 1 to 2 cm over the entire length of the BE for individuals undergoing surveillance and every 1 cm for individuals with suspected neoplasia. In the CLE group, biopsy specimens were obtained only when there was CLE evidence of neoplasia. Final pathologic diagnosis was the reference standard. A per-individual analysis of diagnostic accuracy for diagnosing BE-related neoplasia found a sensitivity of 40% with white-light endoscopy only and 95% with white-light endoscopy plus CLE. Specificity was 98% with white-light endoscopy only and 92% with white-light endoscopy plus CLE. When the analysis was done on a per-biopsy specimen basis and when CLE was added, sensitivity was substantially higher, and specificity was slightly lower. The median number of biopsies per individual was significantly higher in the white-light endoscopy group (four biopsies) compared with the CLE group (two biopsies; P<0.001). 


The investigators analyzed the number of cases in which CLE resulted in a different diagnosis. Thirty-two (34%) of 94 individuals in the white-light plus CLE group had a correct change in dysplasia grade after CLE compared with initial endoscopic findings. Six (19%) of the 32 individuals had lesions, and the remaining 26 did not. In 21 of the 26 individuals without lesions, CLE changed the plan from biopsy to no biopsy. The remaining 62 (65%) of 94 individuals in the white-light endoscopy plus CLE group had concordant diagnoses with both techniques. Because the trial was conducted at academic centers and used endoscopy-based CLE, findings may not be generalizable to other clinical settings or to pCLE. 


In a meta-analysis, Gupta et al. (2014) evaluated the diagnostic accuracy of the CLE-based targeted biopsies detecting high-grade dysplasia (HGD)/adenocarcinoma compared with four-quadrant random biopsies. Seven studies with 345 individuals and 3080 lesions were included in the meta-analysis. For the diagnosis of HGD/adenocarcinoma, the pooled sensitivity was 68% (95% confidence interval [CI], 64%–73%), and pooled specificity was 88% (95% CI, 87%–89%). The per-individual analysis among four studies was a pooled sensitivity of 86% (95% CI, 74%–96%) and a pooled specificity of 83% (95% CI, 77%–88%). The meta-analysis concluded that CLE is not an acceptable replacement for biopsy techniques for the diagnosis of HGD/esophageal adenocarcinoma in BE.

In a meta-analysis, Xiong et al. (2016) evaluated the accuracy of CLE for diagnosis of neoplasia in BE. Fourteen studies were included covering 789 with 4047 lesions. The per-individual analysis among seven studies was a pooled sensitivity of 89% (95% CI, 82%–94%) and a pooled specificity of 83% (95% CI, 78%–86%). The per-lesion analysis among 10 studies was a pooled sensitivity of 77% (95% CI, 73%–81%) and a pooled specificity of 89% (95% CI, 87%–​90%). Richardson et al. (2019) conducted a prospective study at eight centers in the United States to compare pCLE to conventional histology using the Seattle Protocol (random four-quadrant biopsy) to identify intestinal metaplasia among 172 individuals undergoing screening or surveillance endoscopy for BE. Endoscopists recruited for the study were early users of CLE with less than 2 years of experience and no formal pathology training. All individuals underwent a standardized endoscopy with white light and narrow band imaging evaluation, identification of landmarks, and recording of columnar-lined esophagus visualized according to the Prague classification. Individuals then received fluorescein followed by optical biopsy; images were interpreted both in real time and immediately following the procedure. After CLE images were acquired, esophageal biopsies were taken via the Seattle Protocol. Endoscopists were able to identify intestinal metaplasia among 99 individuals (57.6%) using CLE compared to 46 individuals (27%) using the Seattle Protocol (P<0.0001). Dysplasia was identified in six individuals using CLE compared with two individuals using the Seattle Protocol (both of which were also identified via CLE). Confocal laser endomicroscopy also identified significantly more individuals with intestinal metaplasia compared to the Seattle Protocol among those with visible columnar lined esophagus (75 vs. 31 individuals, respectively; P<0.0001), but not among those without columnar lined esophagus (24 vs. 15 individuals; P=0.067). Identification of intestinal metaplasia was not found to be significantly different when comparing CLE with expert review. 


Vithayathil et al. (2022) conducted a randomized crossover trial of standard high-resolution white-light Seattle protocol endoscopy or autofluorescence imaging-guided pCLE in individuals referred for surveillance of nondysplastic BE or flat dysplasia at two high-volume tertiary centers in the United Kingdom. A total of 154 individuals were recruited, of whom eight were excluded based on presence of clear macroscopic lesions consistent with BE-related neoplasia upon first endoscopy. An additional individual was excluded due to a protocol breach (use of chromoendoscopy) and 11 individuals withdrew consent. A total of 134 individuals completed both arms of the study, with crossover occurring after a 6- to 12-week interval. Endoscopists were blinded to the endoscopy and histology results of the pretrial endoscopy and other study arm. In the per-lesion analysis, optical diagnosis by CLE had a sensitivity and specificity for HGD/intramucosal cancer (IMC) of 69.2% and 73.2%, respectively. In the per-individual analysis, there was no difference in the sensitivity of CLE for dysplasia compared with Seattle protocol for HGD/IMC (76.5% for both; P=1.00) or all grades of dysplasia (74.3% vs. 80.0%, respectively; P=0.48). The specificity of CLE was 60.7% for HGD and 66.7% for all grades of dysplasia. Use of a three-biomarker panel consisting of one or more of optical dysplasia on CLE, aberrant p53 on immunohistochemistry, and/or aneuploidy on flow cytometry was associated with a per-individual sensitivity and specificity of 94.1% and 49.6% for HGD and 91.4% and 56.6% for all grades of dysplasia, respectively. The authors concluded that CLE has similar diagnostic accuracy for dysplasia compared with standard Seattle protocol endoscopy. In addition, the use of molecular biomarkers can further improve diagnostic accuracy. Several study limitations were noted: (1) it cannot be excluded that prior biopsy sites may have appeared as irregularities on second endoscopy due to the crossover study design, (2) sensitivity for detecting dysplasia was inconsistent across endoscopists, and (3) results may not be generalizable to general practice centers. 


In the American Society for Gastrointestinal Endoscopy (ASGE) technology status evaluation report, confocal laser endomicroscopy is considered an emerging technology with the potential to significantly reduce the number of biopsies in BE and irritable bowel disorder. Confocal laser endomicroscopy can provide surrogate real-time histological information of the bile duct and within the pancreatic cysts. ASGE concluded, "Before the technology can be widely accepted, many further studies are needed to determine its clinical efficacy and evaluate its cost-effectiveness and its utilization in both academic and community settings."

Confocal Laser Endomicroscopy as an Adjunct to Random Four-Quadrant Biopsy in BE Surveillance

In a meta-analysis, DeMeester et al. (2022) assessed pCLE benefit as an adjunct to random four-quadrant biopsies in the surveillance of individuals with BE for dysplasia and early esophageal cancer detection. Three meta-analyses were performed to estimate pooled sensitivities (SEs), specificities (SPs), negative predictive values (NPVs), and per-individual pooled absolute and relative detection rate of neoplasia with 95% CIs to compare pCLE detection rate with that of random four-quadrant biopsies. Nine studies (including Sharma et al., 2011; Wallace et al., 2012; Richardson et al., 2019; which are discussed above), with 688 individuals and 1299 lesions were included in the meta-analysis. Per-individual pCLE pooled SEs, SPs, and NPVs were 96% (95% CI, 65%–100%), 93% (95% CI, 71%–99%), and 98% (95% CI, 93%–100%), respectively. Per-lesion pCLE pooled SEs, SPs, and NPVs were 82% (95% CI, 63%–92%), 90% (95% CI, 84%–94%), and 95% (95% CI, 94%–97%), respectively. Compared with random biopsies, the per-individual pooled absolute and relative detection rate increases of neoplasia with pCLE were significant and equal to 5% (95% CI, 1%–9%) and 243% (95% CI, 122%–482%), respectively. 


Any improvements reported in the diagnostic yields by DeMeester et al. (2022) were derived from limited clinical investigations. Any clinical impact of these SEs, SPs, and NPVs from this meta-analysis cannot be elucidated, because reliable data for direct impact on clinical decision-making and management of indications, (e.g., dysplasia, cancer), have not been investigated and documented in high-quality studies with appropriate endpoints. Therefore, currently, any purported added clinical value for CLE when added to the standard of care surveillance cannot be established. 

Practice Guidelines 

National guidelines continue to recommend four-quadrant random biopsies for individuals with BE undergoing surveillance. 

In 2016, the American Gastroenterological Association (AGA) published a clinical practice update expert review on the diagnosis and management of low-grade dysplasia in BE. Regarding the use of other advanced endoscopic imaging techniques, the guideline stated that the use of confocal laser endomicroscopy "cannot be recommended in the routine clinical management" of individuals undergoing surveillance.


In 2019, the ASGE published a guideline on screening and surveillance of BE that recommends against routine use of CLE compared with white-light endoscopy with Seattle protocol biopsy sampling in individuals with BE undergoing surveillance.  


In 2022, the American College of Gastroenterology (ACG) published an updated clinical guideline for the diagnosis and management of BE and noted that in centers with a high prevalence of neoplasia or dysplasia, confocal endomicroscopy may be helpful in targeting biopsies and guiding therapy, although the value above that of high-definition white light is unclear.  The guidelines did not include a recommendation for white light endoscopy plus CLE.​

References

Al-Mansour MR, Caycedo-Marulanda A, Davis BR, et al. SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy. Surg Endosc. 2020;35(5):2091-2103. 


American Gastroenterological Association. American Gastroenterological Association Institute Guideline on the Role of Upper Gastrointestinal Biopsy to Evaluate Dyspepsia in the Adult Patient in the Absence of Visible Mucosal Lesions. Gastroenterology. 2015;149:1082-1087. 

American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the Management of Barrett's Esophagus. Gastroenterology. 2011;140:1084-1091. 


American Society for Gastrointestinal Endoscopy. Confocal laser endomicroscopy. Technology Status Evaluation Report. Gastrointest Endosc. 2014;80(6):928-938. 

American Society for Gastrointestinal Endoscopy (ASGE) guidelines. Appropriate use of GI endoscopy. Gastrointest Endosc. 2012;75(6):11-27-1131. 

American Society for Gastrointestinal Endoscopy (ASGE) guidelines. Quality indicators for EGD. Gastrointest Endosc. 2015;81(1):17-30. 

American Society for Gastrointestinal Endoscopy (ASGE). The role of endoscopy in Barrett's esophagus and other premalignant conditions of the esophagus. Gastrointest Endosc. 2012;76(6):1087-1094. 

American Society for Gastrointestinal Endoscopy (ASGE). The role of endoscopy in the evaluation and management of dysphagia. Gastrointest Endosc. 2014;79(2):191-201. 

American Society for Gastrointestinal Endoscopy (ASGE). The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. Gastrointest Endosc. 2013;77(2):167-174. 


American Society for Gastrointestinal Endoscopy (ASGE). The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010;71(1):1-9. 

American Society for Gastrointestinal Endoscopy (ASGE) guidelines. The role of endoscopy in the management of GERD. Gastrointest Endosc. 2015;81(6):1305-1310. 


American Society for Gastrointestinal Endoscopy (ASGE) guidelines. The role of endoscopy in the management of premalignant and malignant conditions of the stomach. Gastrointest Endosc. 2015;82(1):1-8.

American Society for Gastrointestinal Endoscopy (ASGE) guidelines. The role of endoscopy in the management of variceal hemorrhage. Gastrointest Endosc. 2014;80(2):221-227. 

American Society for Gastrointestinal Endoscopy (ASGE) guidelines. The role of ERCP in benign disease of the biliary tract. Gastrointest Endosc. 2015;81(4):795-803. 


Ayyad M, Gala D, Albandak M, et al. Probe-based confocal laser endomicroscopy: progress, challenges, and emerging applications. Surg Endosc. 2025;39(12):7958-7972.

Badillo R, Francis D. Diagnosis and treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther. 2014;5(3):105-112. 

Baron T, Petersen B, Mergener K, et. al. Quality indicators for endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 2006;63(4):S29-S38.

Baucom R, Wise P. Endoscopic and surgical management of hereditary non-polyposis colorectal cancer. Clin Colon Rectal Surg. 2012;25(2):90-96. 

Bazaldua O, Schneider D. Evaluation and management of dyspepsia. Am Fam Physician. 1999;60(6):1773-1784. 


Canto MI, Anandasabapathy S, Brugge W, et al. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014;79(2):211-221.

Cohen D. Esophagoscopy. [Medscape Web site]. Updated 11/28/2022. Available at: http://emedicine.medscape.com/article/1891879-overview [via subscription only]. Accessed February 17, 2026.

Cohen J, Safdi M, Deal S, et. al. Quality indicators for esophagogastroduodenoscopy. Am J Gastroenterology. 2006;101:886-891.


DeMeester S, Wang K, Ayub K, et al. High-definition Probe-based Confocal Laser Endomicroscopy Review and Meta-analysis for Neoplasia Detection in Barrett's Esophagus. Techniques and Innovations in Gastrointestinal Endoscopy. 2022;24(4):340-350. 


Desai M, Ruan W, Thosani N, et al. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: summary and recommendations. Gastrointest Endosc. 2025;101(2):267-284.


Dunbar KB, Okolo P, Montgomery E, et al. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009; 70(4):645-654.


Ellis A, Risk JM, Maruthappu T, Kelsell DP. Tylosis with oesophageal cancer: Diagnosis, management and molecular mechanisms. Orphanet J Rare Dis. 2015;10:126. 


Fujii-Lau LL, Thosani NC, Al-Haddad M, et al. American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: summary and recommendations. Gastrointest Endosc. 2023;98(5):685-693.

Gupta A, Attar BM, Koduru P, et al. Utility of confocal laser endomicroscopy in identifying high-grade dysplasia and adenocarcinoma in Barrett's esophagus: a systemic review and meta-analysis. Eur J Gastroenterol Hepatol. 2014;26(4):367-377.

Kapetanos DJ. ERCP in acute biliary pancreatitis. World J Gastrointest Endosc. 2010;2(1):25-28. 

Katz P, Gerson L, Vela M. Diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108:308-328. 


Mastoi MG, Karim A, Jaslok F, et al. Advances in endoscopic techniques for early detection and treatment of gastrointestinal cancers: A systematic review. Medicine (Baltimore). 2025;104(42):e45315.


Munoz J. Hereditary nonpolyposis colorectal cancer. Updated 03/03/2025. [Medscape website]. Available at: http://emedicine.medscape.com/article/188613-overview. Accessed February 17, 2026.


Qumseya B, Sultan S, Bain P, et al. ASGE guideline on screening and surveillance of Barrett's esophagus. Gastrointest Endosc. 2019;90(3):335-359.


Richardson C, Colavita P, Dunst C, et al. Real-time diagnosis of Barrett's esophagus: a prospective, multicenter study comparing confocal laser endomicroscopy with conventional histology for the identification of intestinal metaplasia in new users. Surg Endosc. 2019;33(5):1585-1591.


Ruan W, Yang J, Hou Y, Yv A, Ding Q, Zhou Y. Clinical Application of Confocal Laser Endomicroscopy in the Diagnosis of Gastrointestinal Diseases. Digestion. Published online September 18, 2025.


Schlosser W, Rau BM, Beger HG. Surgical treatment of pancreas divisum causing chronic pancreatitis: the outcome benefits of duodenum-preserving pancreatic head resection. J Gastrointest Surg. 2005.9(5):710-715.


Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. Am J Gastroenterol. 2022;117(4):559-587.


Sharma P, Meining AR, Coron E, et al. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011;74(3):465-472. 


Sheth SG, Machicado JD, Chhoda A, et al. American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the management of chronic pancreatitis: methodology and review of evidence. Gastrointest Endosc. 2025;101(1):e1-e53.


Spechler SJ, Sharma P, Souza RF, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011;140(3):1084-1091.

Triadafilopoulos G. Caustic esophageal injury in adults. Feb 2025. [Uptodate website]. Available at:
http://www.uptodate.com/contents/caustic-esophageal-injury-in-adults [via subscription only]. Accessed February 17, 2026.

US National Library of Medicine. Genetics Home Reference [website]. Familial adenomatous polyposis. Updated 10/2013. Available at: https://medlineplus.gov/genetics/condition/familial-adenomatous-polyposis/. Accessed February 17, 2026.

US Food and Drug Administration. Optiscan Pty Ltd. 510(k) Summary of Safety and Effectiveness Optiscan Confocal Endoscopic Imaging System. 3/5/2010. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093624.pdf. Accessed February 17, 2026.


Vithayathil M, Modolell I, Ortiz-Fernandez-Sordo J, et al. Image-Enhanced Endoscopy and Molecular Biomarkers Vs Seattle Protocol to Diagnose Dysplasia in Barrett's Esophagus. Clin Gastroenterol Hepatol. 2022;20(11):2514-2523.e3.

Wallace MB, Crook JE, Saunders M, et al. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012;76(3):539-547.


Wani S, Zhou MJ, Sawas T, et al. AGA Clinical Practice Guideline on Surveillance of Barrett's Esophagus. Gastroenterology. 2025;169(6):1184-1231.

Wani S, Rubenstein JH, Vieth M, et al. Diagnosis and Management of Low-Grade Dysplasia in Barrett's Esophagus: Expert Review From the Clinical Practice Updates Committee of the American Gastroenterological Association. Gastroenterology. 2016;151(5):822-835.


Xiong YQ, MA SJ, Zhou JH, et. al. A meta-analysis of confocal laser endomicroscopy for the detection of neoplasia in patients with Barrett's esophagus. J Gastroenterol Hepatol. 2016;31(6):1102-1110.


Ypsilantis E, Pissas D, Papagrigoriadis S, et al. Use of confocal laser endomicroscopy to assess the adequacy of endoscopic treatment of gastrointestinal neoplasia: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2015;25(1):1-5.​

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

ESOPHAGOGASTRODUODENOSCOPY (EGD)

43233, 43235, 43236, 43237, 43238, 43239, 43240, 43241, 43242, 43243, 43244, 43245, 43246, 43247, 43248, 43249, 43250, 43251, 43253, 43254, 43255, 43259, 43266, 43270

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

43260, 43261, 43262, 43263, 43264, 43265, 43274, 43275, 43276, 43277, 43278

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT TRANSESOPHAGEAL RADIOFREQUENCY ABLATION:

43257

THE FOLLOWING CODE IS USED TO REPRESENT TRANSORAL INCISIONLESS FUNDOPLICATION (TIF):

43210

THE FOLLOWING CODES ARE USED TO REPRESENT CONFOCAL LASER ENDOMICROSCOPY:

43252, 0397T
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
NOT MEDICALLY NECESSARY

ESOPHAGOGASTRODUODENOSCOPY (EGD)

Screening or evaluation of colorectal cancer not associated with Familial Adenomatous Polyposis (FAP) syndrome is considered not medically necessary.

B18.1           Chronic viral hepatitis b without delta-agent
B37.5           Candidal meningitis
C09.9           Malignant neoplasm of tonsil, unspecified
C10.9           Malignant neoplasm of oropharynx, unspecified
C17.1           Malignant neoplasm of jejunum
C18.0           Malignant neoplasm of cecum
C18.1           Malignant neoplasm of appendix
C18.2           Malignant neoplasm of ascending colon
C18.3           Malignant neoplasm of hepatic flexure
C18.4           Malignant neoplasm of transverse colon
C18.5           Malignant neoplasm of splenic flexure
C18.6           Malignant neoplasm of descending colon
C18.7           Malignant neoplasm of sigmoid colon
C18.8           Malignant neoplasm of overlapping sites of colon
C18.9           Malignant neoplasm of colon, unspecified
C19              Malignant neoplasm of rectosigmoid junction
C20              Malignant neoplasm of rectum
C67.9           Malignant neoplasm of bladder, unspecified
C7A.020      Malignant carcinoid tumor of the appendix
D09.8           Carcinoma in situ of other specified sites
D12.0           Benign neoplasm of cecum
D12.2           Benign neoplasm of ascending colon
D12.3           Benign neoplasm of transverse colon
D12.4           Benign neoplasm of descending colon
D12.5           Benign neoplasm of sigmoid colon
D12.7           Benign neoplasm of rectosigmoid junction
D12.8           Benign neoplasm of rectum
D12.9           Benign neoplasm of anus and anal canal
D13.6           Benign neoplasm of pancreas
D17.5           Benign lipomatous neoplasm of intra-abdominal organs
D37.8           Neoplasm of uncertain behavior of other specified digestive organs
D49.1           Neoplasm of unspecified behavior of respiratory system
D64.89         Other specified anemias
E04.9           Nontoxic goiter, unspecified
E16.4           Increased secretion of gastrin
E80.6           Other disorders of bilirubin metabolism
G04.81         Other encephalitis and encephalomyelitis
G47.33         Obstructive sleep apnea (adult) (pediatric)
G93.40         Encephalopathy, unspecified
I20.81           Angina pectoris with coronary microvascular dysfunction
I20.89           Other forms of angina pectoris
I61.0             Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
I63.81      Other cerebral infarction due to occlusion or stenosis of small artery
I63.89      Other cerebral infarction
I63.9             Cerebral infarction, unspecified
I86.8             Varicose veins of other specified sites
I87.2             Venous insufficiency (chronic) (peripheral)
J02.9            Acute pharyngitis, unspecified
J31.2            Chronic pharyngitis
J38.01          Paralysis of vocal cords and larynx, unilateral
J39.1            Other abscess of pharynx
J39.2            Other diseases of pharynx
J69.0            Pneumonitis due to inhalation of food and vomit
J84.9            Interstitial pulmonary disease, unspecified
J95.821        Acute postprocedural respiratory failure
J96.00          Acute respiratory failure, unspecified whether with hypoxia or hypercapnia
J96.01          Acute respiratory failure with hypoxia
K44.9           Diaphragmatic hernia without obstruction or gangrene
K52.9           Noninfective gastroenteritis and colitis, unspecified
K56.1           Intussusception
K56.41         Fecal impaction
K57.30         Diverticulosis of large intestine without perforation or abscess without bleeding
K58.9           Irritable bowel syndrome, unspecified
K59.00         Constipation, unspecified
K59.03         Drug induced constipation
K59.09         Other constipation
K62.1           Rectal polyp
K62.3           Rectal prolapse
K62.5           Hemorrhage of anus and rectum
K62.89         Other specified diseases of anus and rectum
K63.5           Polyp of colon
K64.0           First degree hemorrhoids
K64.1           Second degree hemorrhoids
K64.2           Third degree hemorrhoids
K64.4           Residual hemorrhoidal skin tags
K64.8           Other hemorrhoids
K64.9           Unspecified hemorrhoids
K75.9           Inflammatory liver disease, unspecified
K76.89         Other specified diseases of liver
K86.9           Disease of pancreas, unspecified
N18.9           Chronic kidney disease, unspecified
Q44.6           Cystic disease of liver
Q45.3           Other congenital malformations of pancreas and pancreatic duct
Q85.89         Other phakomatoses, not elsewhere classified
R06.02         Shortness of breath
R06.83         Snoring
R07.0           Pain in throat
R09.89         Other specified symptoms and signs involving the circulatory and respiratory systems
R10.21         Pelvic and perineal pain right side
R10.22         Pelvic and perineal pain left side
R10.23         Pelvic and perineal pain bilateral
R10.24         Suprapubic pain
R10.85         Abdominal pain of multiple sites
R10.8A1      Right flank tenderness
R10.8A2      Left flank tenderness
R10.8A3      Suprapubic tenderness
R10.8A9      Flank tenderness, unspecified
R10.A1        Flank pain, right side
R10.A2        Flank pain, left side
R10.A3        Flank pain, bilateral
R10.30         Lower abdominal pain, unspecified
R10.31         Right lower quadrant pain
R10.32         Left lower quadrant pain
R14.0           Abdominal distension (gaseous)
R15.0           Incomplete defecation
R15.2           Fecal urgency
R16.0           Hepatomegaly, not elsewhere classified
R18.8           Other ascites
R19.4           Change in bowel habit
R19.5           Other fecal abnormalities
R53.1           Weakness
R58              Hemorrhage, not elsewhere classified
R74.01         Elevation of levels of liver transaminase levels
R74.02         Elevation of levels of lactic acid dehydrogenase [LDH]
R74.8           Abnormal levels of other serum enzymes
R76.0           Raised antibody titer
R76.89         Other specified abnormal immunological findings in serum
R79.89         Other specified abnormal findings of blood chemistry
R88.0           Cloudy (hemodialysis) (peritoneal) dialysis effluent
R89.4            Abnormal immunological findings in specimens from other organs, systems and tissues
R91.1           Solitary pulmonary nodule
R91.8           Other nonspecific abnormal finding of lung field
R93.2           Abnormal findings on diagnostic imaging of liver and biliary tract
R93.6           Abnormal findings on diagnostic imaging of limbs
R94.5           Abnormal results of liver function studies
R94.8           Abnormal results of function studies of other organs and systems
S06.5X9A    Traumatic subdural hemorrhage with loss of consciousness of unspecified duration, initial encounter
S06.9X0A    Unspecified intracranial injury without loss of consciousness, initial encounter
​T14.90XA    Injury, unspecified, initial encounter
T14.90XD    Injury, unspecified, subsequent encounter
T14.90XS    Injury, unspecified, sequela
Z00.00         Encounter for general adult medical examination without abnormal findings
Z11.1           Encounter for screening for respiratory tuberculosis
Z12.10         Encounter for screening for malignant neoplasm of intestinal tract, unspecified
Z12.11         Encounter for screening for malignant neoplasm of colon
Z15.01         Genetic susceptibility to malignant neoplasm of breast
Z68.43         Body mass index [BMI] 50.0-59.9, adult
Z84.89         Family history of other specified conditions
Z85.038       Personal history of other malignant neoplasm of large intestine
Z86.0100     Personal history of colon polyps, unspecified
Z86.0101     Personal history of adenomatous and serrated colon polyps
Z86.0102     Personal history of hyperplastic colon polyps
Z86.0109     Personal history of other colon polyps       
HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

C7541 Diagnostic endoscopic retrograde cholangiopancreatography (ercp), including collection of specimen(s) by brushing or washing, when performed, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)

C7542 Endoscopic retrograde cholangiopancreatography (ercp) with biopsy, single or multiple, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)

C7543 Endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy/papillotomy, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)

C7544 Endoscopic retrograde cholangiopancreatography (ercp) with removal of calculi/debris from biliary/pancreatic duct(s), with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)

C7560 Endoscopic retrograde cholangiopancreatography (ercp) with removal of foreign body(s) or stent(s) from biliary/pancreatic duct(s) and endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s)​

Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From 07.02.22j:​
​04/01/2026

​This policy has been reviewed and reissued to communicate the Company's continuing position on esophagogastroduodenoscopy (EGD) and endoscopic retrograde cholangiopancreatography (ERCP)​.
10/01/2025
​This version of the policy will become effective 10/01/2025.
 
Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.
 
The following ICD-10 codes have been added to this policy attachment A as not medically necessary:
R10.21 Pelvic and perineal pain right side
R10.22 Pelvic and perineal pain left side
R10.23 Pelvic and perineal pain bilateral
R10.24 Suprapubic pain
R10.85 Abdominal pain of multiple sites
R10.8A1 Right flank tenderness
R10.8A2 Left flank tenderness
R10.8A3 Suprapubic tenderness
R10.8A9 Flank tenderness, unspecified
R10.A1 Flank pain, right side
R10.A2 Flank pain, left side
R10.A3 Flank pain, bilateral
R76.89 Other specified abnormal immunological findings in serum

The following ICD-10 codes have been deleted from this policy attachment A:
R10.2 Pelvic and perineal pain
R76.8 Other specified abnormal immunological findings in serum​

Revisions From 07.02.22​i:
07/01/2025

This version of the policy will become effective 07/01/2025.


The intent of this policy remains unchanged; however, the policy language has been updated to further clarify Medicare guidelines. In addition, changes have been made to diagnostic esophagogastroduodenoscopy (EGD). The applicable sources include peer-reviewed literature, including the American Society for Gastrointestinal Endoscopy (ASGE) and American Gastroenterological Association (AGA).​


Revisions From 07.02.22h:

10/16​/2024​
​This policy has been reissued in accordance with the Company's annual review process.​
10/01/2024
​​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the ICD-10 code update, effective 10/01/2024. 


The following ICD-10 code has been termed and removed from this policy:

Z86.010 Personal history of colonic polyps


The following ICD-10 code has been revised in this policy:

Changed from:

K58.9 Irritable bowel syndrome without diarrhea

​​Changed to:

K58.9 Irritable bowel syndrome, unspecified


The following ICD-10 codes have been added to this policy:

Z86.0100 Personal history of colon polyps, unspecified

Z86.0101 Personal history of adenomatous and serrated colon polyps

Z86.0102 Personal history of hyperplastic colon polyps

Z86.0109 Personal history of other colon polyps


​Revisions From 07.02.22g:

01/02/2024
​​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the HCPCS code update, effective 01/02/2024. 


The following HCPCS code has been added to this policy:

C7560 Endoscopic retrograde cholangiopancreatography (ercp) with removal of foreign body(s) or stent(s) from biliary/pancreatic duct(s) and endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s)​


Revisions From 07.02.22f:

10/01/2023
​​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the ICD-10 code update, effective 10/01/2023. 


The following ICD-10 code has been termed and removed from this policy:

I20.8 Other forms of angina pectoris


The following ICD-10 codes have been added to this policy:

I20.81 Angina pectoris with coronary microvascular dysfunction

I20.89 Other forms of angina pectoris​​


Revisions From 07.02.22e:

05/08/2023

This version of the policy will become effective 05/08/2023​.  

The intent of this policy remains unchanged; however, the experimental/investigational policy statement for confocal laser endomicroscopy was revised to include when used as an adjunct to standard endoscopy with random 4-quadrant biopsy in surveillance of Barrett's Esophagus. ​

​In addition, the description section was updated with literature regarding confocal laser endomicroscopy. ​

The following ICD-10 codes have been added to the policy:
I63.81 Other cerebral infarction due to occlusion or stenosis of small artery
I63.89 Other cerebral infarction
T14.90XA  Injury, unspecified, initial encounter
T14.90XD  Injury, unspecified, subsequent encounter
T14.90XS  Injury, unspecified, sequela

The following ICD-10 codes have been deleted from the policy:
I63.8  Other cerebral infarction
T14.90  Injury, unspecified​​


Revisions From 07.02.22d:

01/01/2023
I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the HCPCS code update, effective 01/01/2023.


The following HCPCS codes have been added to this policy:

C7541  Diagnostic endoscopic retrograde cholangiopancreatography (ercp), including collection of specimen(s) by brushing or washing, when performed, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)


C7542  Endoscopic retrograde cholangiopancreatography (ercp) with biopsy, single or multiple, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)


C7543  Endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy/papillotomy, with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)


C7544  Endoscopic retrograde cholangiopancreatography (ercp) with removal of calculi/debris from biliary/pancreatic duct(s), with endoscopic cannulation of papilla with direct visualization of pancreatic/common bile ducts(s)​​


Revisions From 07.02.22c:

10/01/2022
​​I​nclusion of a policy in a Code Update memo does not imply that a full review of

the policy was completed at this time.

 

This policy has been identified for the ICD-10 code update, effective 10/01/2022. 


The following ICD-10 code has been termed and removed from this policy:

Q85.8 Other phakomatoses, not elsewhere classified


The following ICD-10 code has been added to this policy:

Q85.89 Other phakomatoses, not elsewhere classified​


Revisions From 07.02.22b:

11/17/2021

This policy has been reissued in accordance with the Company's annual review process.​

​12/16/2020
​This policy has been reissued in accordance with the Company's annual review process.
10/01/2020​

​​This version of the policy is a result of code updates effective 10/01/2020. 

Diagnosis code R74.0 was deleted. 
 
The following diagnsis codes were added:
R74.01
R74.02

Code narrative of diagnosis code Z68.43​ was revised.
​
Revisions From 07.02.22a:
12/31/2019This policy has been reissued in accordance with the Company's annual review process.
10/01/2019This version of the policy went through a code update process effective 10/01/2019, and narrative for Z68.43 was revised in this policy on that date.

Revisions From 07.02.22:
01/14/2019This version of the policy will become effective 01/14/2019.

The following new policy has been developed to communicate the Company’s coverage criteria for EGD and ERCP.

10/1/2025
10/1/2025
4/1/2026
07.02.22
Medical Policy Bulletin
Commercial
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.