1 Clinical Policy Title: Upper gastrointestinal endoscopy Clinical Policy Number: 08.01.13 Effective Date: August 1, 2018 Initial Review Date: June 5, 2018 Most Recent Review Date: July 3, 2018 Next Review Date: July 2019 Related policies: CP# 08.01.01 Capsule endoscopy CP# 08.01.11 Gastroparesis evaluations ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer- reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina’s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers the use of upper gastrointestinal endoscopy to be clinically proven and, therefore, medically necessary when any of the following criteria are met (Cohen, 2006; Early, 2012; Hirota, 2006): For diagnostic purposes, in the following situations: Persistent upper abdominal distress despite an appropriate trial of therapy. Upper abdominal distress associated with signs or symptoms suggestive of serious organic disease (such as weight loss and prolonged anorexia) or in members over age 45. Dysphagia or odynophagia of unknown cause. New onset of dyspepsia in members age 50 and older. Persistent or recurrent esophageal reflux signs or symptoms despite appropriate therapy. Persistent vomiting of unknown cause. Postoperative bariatric surgery with persistent nausea, vomiting, or abdominal distress despite counseling and behavior modification regarding diet. Policy contains: Esophagogastroduodenoscopy. Upper endoscopy. Gastroscopy. Gastroesophageal reflux disease. Hematemesis. Gastrointestinal bleeding.
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ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select
Health of South Carolina’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina’s clinical policies are not guarantees of payment.
Coverage policy
Select Health of South Carolina considers the use of upper gastrointestinal endoscopy to be clinically
proven and, therefore, medically necessary when any of the following criteria are met (Cohen, 2006;
Early, 2012; Hirota, 2006):
For diagnostic purposes, in the following situations:
Persistent upper abdominal distress despite an appropriate trial of therapy.
Upper abdominal distress associated with signs or symptoms suggestive of serious organic
disease (such as weight loss and prolonged anorexia) or in members over age 45.
Dysphagia or odynophagia of unknown cause.
New onset of dyspepsia in members age 50 and older.
Persistent or recurrent esophageal reflux signs or symptoms despite appropriate therapy.
Persistent vomiting of unknown cause.
Postoperative bariatric surgery with persistent nausea, vomiting, or abdominal distress despite
counseling and behavior modification regarding diet.
Policy contains:
Esophagogastroduodenoscopy.
Upper endoscopy.
Gastroscopy.
Gastroesophageal reflux
disease.
Hematemesis.
Gastrointestinal bleeding.
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Presence of systemic disease, the treatment of which would potentially be modified based on
upper gastrointestinal pathology. Examples include patients with a history of gastrointestinal
bleeding who are scheduled for organ transplantation; long-term anticoagulation; chronic
nonsteroidal therapy for arthritis; or with cancer of the head or neck.
Findings on X-ray of any of the following:
A suspected neoplasm, for confirmation and biopsy for histology.
Esophageal or gastric ulcer.
Evidence of upper gastrointestinal tract obstruction or stricture.
Presence of gastrointestinal bleeding, under any of the following conditions:
When bleeding is active or recent.
When surgical therapy is under consideration.
When portal hypertension or aorto-enteric fistula is suspected.
For presumed chronic blood loss and for iron deficiency anemia when colonoscopy
findings are negative.
When the sampling of tissue or fluid is indicated.
After caustic agent ingestion, to assess acute injury.
During surgery, to identify the location or clarify the pathology of a lesion or to evaluate
anatomic reconstructions.
In members with a familial adenomatous polyposis syndrome.
To evaluate potential upper gastrointestinal role in suspected lower gastrointestinal disorders
such as celiac disease or in pediatric inflammatory bowel disease.
For therapeutic purposes, in any of the following conditions:
To treat bleeding from lesions including ulcers, tumors, vascular malformations (for example,
electrocoagulation, heater probe, injection therapy, or laser photocoagulation).
To perform sclerotherapy for bleeding from esophageal or proximal gastric varices or banding of
varices.
To remove a foreign body.
To remove selected polypoid or submucosal lesions.
For placement of feeding tubes (oral, percutaneous endoscopy gastrostomy, percutaneous
endoscopic jejunostomy).
For dilation of stenotic lesions (e.g., with dilating systems employing guidewires or with
transendoscopic balloon dilators).
To provide palliative therapy of stenosing neoplasms (such as laser, stent placement, and bipolar
electrocoagulation).
For management of gastroduodenal dysmotility when symptoms persist despite optimal medical
and dietary management.
For treatment of achalasia.
For dilation in adult members with eosinophilic esophagitis who have a dominant esophageal
stricture or ring and remain symptomatic despite medical therapy.
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Endoscopic resection for members with Barrett’s esophagus, in the absence of life-limiting
comorbidities, is medically necessary with any of the following findings:
Low-grade dysplasia.
Flat high-grade dysplasia.
Intestinal metaplasia.
Endoscopic resection or radiofrequency ablation for members without life-limiting comorbidities
and stage T1a esophageal adenocarcinoma.
Screening (periodic diagnostic) upper gastrointestinal endoscopy may be indicated for a medically
appropriate number of procedures in the following active or symptomatic conditions:
For follow up of members with portal hypertension or compensated cirrhosis if any of the
following criteria are met:
Finding of small varices and high-risk stigmata, follow-up every one to two years.
With no finding of varices, follow up every two to three years.
In members with history of alcohol abuse or decompensated liver disease, follow-up
annually.
For follow up of selected esophageal, gastric, or stomal ulcers to demonstrate healing. The
frequency of follow-up examinations is variable, but every two to four months until healing is
demonstrated is reasonable.
For follow up in members with prior adenomatous gastric polyps. The approximate frequency of
follow-up examinations would be every one to four years, depending on the clinical
circumstances. Some members with sessile polyps would initially require surveillance every six
months initially).
For follow up for adequacy of prior sclerotherapy or banding of esophageal varices. The
approximate frequency of follow-up procedures varies widely depending on the state of the
member. Every six to 24 months is reasonable after completion of the initial
sclerotherapy/banding sessions have been completed.
For follow up of Barrett's esophagus, approximately every one to two years with biopsies, unless
dysplasia or atypia is demonstrated, in which case a repeat biopsy in two to three months may
be indicated.
For follow up in members with familial adenomatous polyposis, the recommended approximate
frequency of follow up is every two to four years. However, the presence of gastric adenomas or
adenomas of the duodenum may indicate more frequent follow up of every six to 12 months.
Limitations:
Upper gastrointestinal endoscopy is not medically necessary for the following:
Screening of asymptomatic upper gastrointestinal tracts of members at average risk.
Follow-up screening for Barrett’s esophagus after the previous examination findings were
negative for Barrett’s esophagus.
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Screening for aerodigestive cancer.
Follow-up of any of the following:
Healed benign disease, such as gastric or duodenal ulcer, or esophagitis.
Gastric atrophy.
Pernicious anemia.
Fundic gland or hyperplastic polyps.
After radiographic findings of any of the following:
Sliding hiatal hernia, asymptomatic or uncomplicated.
Uncomplicated duodenal ulcer that has responded to treatment.
Deformed duodenal bulb in the absence of symptoms or when symptoms respond to
ulcer therapy.
Confirming eradication of Helicobacter pylori eradication.
To evaluate isolated pylorospasm, known congenital hypertrophic pyloric stenosis, constipation and encopresis, or inflammatory bowel disease responding to therapy.
Prior to bariatric or non-gastroesophageal surgery in asymptomatic individuals.
Metastatic adenocarcinoma of unknown primary site when the results will not alter management.
To obtain tissue samples from endoscopically normal tissue to diagnose reflux disease or exclude Barrett’s esophagus in adults.
To evaluate symptoms considered functional in origin.
To evaluate benign-appearing, uncomplicated duodenal ulcers identified on radiologic imaging.
When there is clinical evidence of acute perforation.
Upper gastrointestinal endoscopy is contraindicated in conditions including shock, peritonitis, fulminant
is an active life-threatening hemorrhage), and severe cardiac decompensation. Additionally, relative
contraindications include individuals who are not fully conscious, alert, and cooperative, and who have
cardiac arrhythmias or recent myocardial ischemia (Chan, 2017).
Alternative covered services:
X-ray.
Ultrasound.
Capsule endoscopy.
Ambulatory esophageal pH monitoring.
Background
Upper gastrointestinal endoscopy, also known as esophagogastroduodenoscopy, upper endoscopy, or
gastroscopy, is a procedure in which a flexible tube known as a fiberoptic endoscope, which may have
video capacity, is introduced into the upper gastrointestinal system (National Institute of Diabetes and
Digestive and Kidney Diseases, 2017). This transmits a magnified image that is used to examine tissue,
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visualize the area while extracting biopsies, or perform a therapeutic procedure. The areas that can be
visualized during the procedure are the esophagus, stomach, and upper intestine (duodenum). The
procedure can be performed on an outpatient basis, usually while a patient is sedated. It is generally a
brief procedure lasting 15 to 30 minutes. The risks from the procedure, which are considered low,
include bleeding, perforation of the lining of the upper gastrointestinal tract, and a reaction to the
sedative.
Gastrointestinal endoscopy is a keystone of the evaluation and management of gastrointestinal disease
(Sivak, 2006). Upper gastrointestinal endoscopy is used to identify the causes of symptoms such as
abdominal pain or bleeding, discomfort eating or swallowing, heartburn, nausea, vomiting, and
indigestion. Upper gastrointestinal endoscopy is useful in diagnosing conditions including esophagitis,
Schatzki’s ring (lower esophageal ring or esophagastric ring), inflammation of the stomach or
duodenum, ulcer, polyps, diverticula, and other abnormalities — including mucosal tears, obstructions,
strictures, and tumors. The procedure can also be used therapeutically to treat conditions such as
bleeding due to ulcers, to remove foreign objects, polyps, or growths, to widen strictures with a small
balloon, and to place feeding tubes. In addition, the procedure is used to screen for possible disease in
symptomatic individuals or individuals at risk for gastrointestinal disease, and to follow up on treated
conditions.
Searches
Select Health of South Carolina searched PubMed and the databases of:
UK National Health Services Centre for Reviews and Dissemination.
Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other
evidence-based practice centers.
The Centers for Medicare & Medicaid Services.
We conducted searches on April 30, 2018. Search terms were: “upper gastrointestinal endoscopy,”
“esophagogastroduodenoscopy,” “upper endoscopy,” and “gastroscopy.”
We included:
Systematic reviews, which pool results from multiple studies to achieve larger sample sizes
and greater precision of effect estimation than in smaller primary studies. Systematic
reviews use predetermined transparent methods to minimize bias, effectively treating the
review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.
Guidelines based on systematic reviews.
Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple
cost studies), reporting both costs and outcomes — sometimes referred to as efficiency
studies — which also rank near the top of evidence hierarchies.
Findings
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We were unable to identify many publications on the comparative efficacy of upper gastrointestinal
endoscopy for the multiple indications for which it is commonly used, or on safety of the procedure. The
coverage indications for this policy are based on several professional guidelines, primarily developed by
the American Society of Gastrointestinal Endoscopists. Their publication on the indications for
gastrointestinal endoscopy (Early, 2012) is the main source for the coverage policy, along with earlier
publications on quality indicators (Cohen, 2006) and premalignant conditions (Hirota, 2006).
The need for effective screening and diagnostic tools evolve as disease trends shift. Increases in obesity
and gastroestophageal reflux disease are provoking some shifts in how upper gastrointestinal
endoscopy is used. Upper gastrointestinal endoscopy is of limited value in diagnosing gastroesophageal
reflux disease. Instead, ambulatory esophageal pH monitoring is more sensitive since it estimates distal
esophageal acid exposure and can show the relationship between acid reflux and its symptoms.
A cost-effectiveness analysis examined the clinical and economic impact of performing upper
gastrointestinal endoscopies in patients with indications suggesting they should have the procedure in
comparison with those without an indication for the procedure (DiGiulio, 2009). The results showed
that to detect one case of cancer among those with appropriate indications, 41 procedures had to be
performed, while 753 had to be performed in those without an indication in order to find one case of
cancer. To prevent one death related to gastroesophageal cancer, 571 procedures had to be carried out
in those with indications, while 11,111 procedures had to be carried out in those without indications for
the procedure. Per life-year gained, the incremental cost-effectiveness ratios of appropriate and
inappropriate upper endoscopies, as compared to a policy of not referring patients for endoscopy, were
$16,577 in those with an indication for the procedure and $301,203 in those without an indication for
the procedure. This analysis does not take into account the risk of procedures in those without an
indication.
Policy updates:
None.
Summary of clinical evidence:
Citation Content, Methods, Recommendations
Pimenta-Melo (2016)
Missing rate for gastric
cancer
Key points:
A total of 22 studies were included in this meta-analysis.
The pooled negative predictive value was 99.7% (95% confidence interval 99.6-99.9%).
The missed gastric cancer proportion was 9.4% (95% confidence interval 5.7 – 13.1%),
and was 10.0% in studies including patients with negative findings followed over time.
The proportion was 8.3% in studies including patients with gastric cancer, and 23.3% in
studies evaluating the proportion of missed synchronous lesions.
Missed cancers were mainly located in the gastric body and most were
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Citation Content, Methods, Recommendations
adenocarcinomas. Predictors of diagnostic failure were younger age (<55 years), female
sex, marked gastric atrophy, gastric adenoma or ulcer, and inadequate number of
biopsy fragments.
The authors conclude that upper gastrointestinal endoscopy is a very effective method
to rule out gastric cancer, but that one in 10 cancers are potentially missed.
Interestingly, lesions were more often missed in the body and, therefore, a more
rigorous protocol for endoscopy and biopsy should be implemented worldwide.
American Society for
Gastrointestinal Endoscopy
(2014)
Endoscopy in evaluation
and management of
dysphagia
Key points:
Endoscopy is indicated in patients with dysphagia to determine the underlying etiology,
exclude malignant and premalignant conditions, assess the need for therapy, and
perform therapy, such as dilation.
Esophageal dilation is a therapeutic procedure performed for the management of
dysphagia. The primary indication for dilation is to provide immediate and durable
symptomatic relief of dysphagia.
Safety and efficacy have been confirmed in both adults and the pediatric population.
Ford (2010)
Prevalence of clinically
significant endoscopic
findings in dyspepsia
Key points:
This systematic review and meta-analysis identified 151 publications that reported the
prevalence of dyspepsia. Of these, nine reported prevalence of endoscopic findings
among 5,389 total participants.
Erosive esophagitis was the most common abnormality encountered (pooled prevalence
13.4%) followed by peptic ulcer (pooled prevalence 8.0%). The only finding encountered
more frequently in individuals with dyspepsia, compared with those without, was peptic
ulcer (odds ratio, 2.07; 95% confidence interval, 1.52-2.82). The prevalence of erosive
esophagitis was lower when the Rome criteria were used to define dyspepsia compared
with a broad definition (6% versus 20%).
Erosive esophagitis was the most common finding encountered at endoscopy for
dyspepsia. The prevalence was lower when the Rome criteria were used to define
dyspepsia. Only peptic ulcer was found to be more common in individuals with
dyspepsia.
DiGiulio (2009)
Cost-effectiveness of upper
gastrointestinal endoscopy
according to
appropriateness of the
indication
Key points:
The authors constructed a decision analysis model to compare a strategy of not referring patients for upper endoscopy (with either an appropriate or inappropriate indication) with a policy of carrying out the requested upper endoscopy. Cancer prevalence in appropriate and inappropriate procedures was estimated using a systematic review of the literature. Costs of the procedure and cancer care were estimated from Medicare reimbursement data.
The number of appropriate and inappropriate procedures required to detect one case of cancer was 41 and 753, respectively. To prevent one gastroesophageal cancer-related death, the numbers were 571 and 11,111, respectively.
The incremental cost-effectiveness ratios of appropriate and inappropriate upper endoscopies as compared to a policy of not referring patients for endoscopy were $16,577 and $301,203, respectively, per life-year gained.
The authors conclude that for inappropriate upper endoscopies, the very low likelihood of cancer and the relatively high costs associated with this procedure argue against endoscopic referral.
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References
Professional society guidelines/other:
American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee. The role of
endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9.
doi: 10.1016/j.gie.2009.09.041.
ASGE Standards of Practice Committee, Pasha SF, Acosta RD, et al. The role of endoscopy in the evaluation and management of dysphagia. Gastrointest Endosc. 2014;79(2):191-201. Chan, WW. Endoscopy. Merck Manual Professional Version. Updated February, 2017. https://www.merckmanuals.com/professional/gastrointestinal-disorders/diagnostic-and-therapeutic-gi-procedures/endoscopy. Accessed April 30, 2018. Cohen J, Safdi MA, Deal SE, et al. Quality indicators for esophagogastroduodenoscopy. Gastrointest
Endosc. 2006;63(4):S10-S15.
Early DS, Ben-Menachem T, Decker GA, et al. Appropriate use of GI endoscopy. Gastrointest Endosc. 2012;75(6):1127-1131.
Faigel DO, Pike IM, Baron TH, et al. Quality indicators for gastrointestinal endoscopic procedures: an
Hirota WK, Zuckerman MJ, Adler DG, et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: The role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. Gastrointest Endosc. 2006;63(4):570-580. National Institute of Diabetes and Digestive and Kidney Diseases. Upper GI endoscopy. National
Institutes of Health website. July, 2017. https://www.niddk.nih.gov/health-information/diagnostic-
tests/upper-gi-endoscopy. Accessed April 30, 2018.
Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ. American Gastroenterological Association
Technical Review on the Management of Barrett’s Esophagus. Gastroenterology. 2011;140(3):e18-e13.
doi:10.1053/j.gastro.2011.01.031.
Peer-reviewed references:
Cena M, Gomez J, Alyousef T, Trohman RG, Pierko K, Agarwal R. Safety of endoscopic procedures after
acute myocardial infarction: a systematic review. Cardiol J. 2012;19(5):447-452.
Di Giulio E, Hassan C, Pickhardt PJ, et al. Cost-effectiveness of upper gastrointestinal endoscopy
according to the appropriateness of the indication. Scand J Gastroenterol. 2009;44(4):491-498.