Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic)
Policy #:MA07.023e

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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.

ESOPHAGOGASTRODUODENOSCOPY (EGD)

MEDICALLY NECESSARY
Diagnostic EGD

A diagnostic esophagogastroduodenoscopy (EGD) is considered medically necessary and, therefore, covered for any of the following:
  • Upper abdominal distress (pain or discomfort) which persists despite an appropriate trial of therapy (e.g., acid suppression with proton-pump inhibitors (PPI)
  • Upper abdominal distress (pain or discomfort) associated with symptoms and/or signs suggesting serious organic disease (e.g., prolonged anorexia and weight loss)
  • Dysphagia (difficulty or discomfort in swallowing) or odynophagia (painful swallowing)
  • Esophageal reflux symptoms which are persistent or recurrent despite appropriate therapy
  • Persistent vomiting of unknown cause
  • Other systemic diseases in which the presence of upper 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 non-steroidal therapy for arthritis; Barrett's esophagus)
  • X-ray findings for any of the following:
    • A suspected neoplastic lesion, for confirmation and specific histologic diagnosis
    • Gastric or esophageal ulcer
    • Evidence of upper gastrointestinal tract stricture or obstruction
  • The presence of gastrointestinal 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 aorto-enteric fistula is suspected
    • For presumed chronic blood loss and for iron deficiency anemia when a colonoscopy is negative
  • When sampling of duodenal or jejunal tissue or fluid is indicated
  • To assess acute injury after caustic agent ingestion
  • To clarify a location or pathology of a lesion; intraoperatively

Therapeutic EGD

A therapeutic EGD is considered medically necessary and, therefore, covered for any of the following indications:
  • Treatment of bleeding lesions, such as ulcers, tumors, vascular malformations (e.g., electrocoagulation, heater probe, laser photocoagulation or injection therapy)
  • Treatment of bleeding from esophageal or proximal gastric varices or banding of varices; using sclerotherapy
  • Removal of a foreign body
  • Removal of selected polypoid lesions
  • Placement of feeding tubes (oral, percutaneous endoscopic gastrostomy, percutaneous endoscopic jejunostomy)
  • Dilation of stenotic lesions (e.g., with transendoscopic balloon dilators or dilating systems employing guidewires)
  • Palliative therapy of stenosing neoplasms (e.g., laser, bipolar electrocoagulation, stent placement)

NOT MEDICALLY NECESSARY
All other indications for EGD, such as but not limited to the following, are considered not medically necessary and, therefore, not covered:
  • Gastric distress which is chronic, non-progressive, atypical for known organic disease, and considered functional in origin (there are occasional exceptions in which an endoscopic examination may be necessary once to rule out organic disease, especially if symptoms are unresponsive to therapy)
  • Uncomplicated heartburn responsive to medical therapy
  • Metastatic adenocarcinoma of unknown primary site when the results will not alter management
  • X-ray findings of:
    • Asymptomatic or uncomplicated sliding hiatus hernia;
    • Uncomplicated duodenal bulb ulcer which has responded to therapy; or
    • Deformed duodenal bulb when symptoms are absent or respond adequately to ulcer therapy;
  • Routine screening of the upper gastrointestinal tract
  • For planned elective surgery for non-upper GI disease in individuals without current GI symptoms or
  • When a lower GI endoscopy reveals the cause of symptoms, abnormal signs or laboratory tests (e.g., colonic neoplasm with iron deficiency anemia). Exceptions can be considered if medical necessity for this procedure can be demonstrated.
  • Sequential or periodic diagnostic EGD for the following:
    • Surveillance for malignancy in individuals with gastric atrophy, pernicious anemia, treated achalasia, or prior gastric operation
    • Surveillance of healed benign disease such as esophagitis, gastric or duodenal ulcer
    • Surveillance during chronic repeated dilations of benign strictures unless there is a change in status

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

MEDICALLY NECESSARY
Endoscopic retrograde cholangiopancreatography (ERCP) is considered medically necessary and, therefore, covered for any of the following indications:
  • For individuals with traumatic pancreatitis to accurately localize the injury and provide endoscopic drainage
  • For pancreatic duct stricture evaluation
  • For the extraction of bile duct stones in severe gallstone-induced pancreatitis
  • For the detection of pancreatic ductal changes in chronic pancreatitis and also the presence of calcified stones in the ductal system. A pancreatogram may be performed and is likely to be abnormal in chronic alcoholic pancreatitis, but less so in non-alcoholic--induced types.
  • For detecting gallstones in symptomatic individuals whose oral cholecystogram and gallbladder ultrasonograms are normal
  • For individuals with radiologic imaging that is suggestive of common bile duct stones or other potential pathology

An ERCP is typically not indicated for the following conditions:
  • For the diagnosis of pancreatitis except for suspected gallstone pancreatitis
  • For use in early stages or in acute pancreatitis, because of the possibility of exacerbation

EXPERIMENTAL/INVESTIGATIONAL
Confocal laser endomicrosopy to evaluate the pancreas and bile duct system 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.
Policy Guidelines

SEQUENTIAL OR PERIODIC DIAGNOSTIC UPPER ENDOSCOPIES MAY BE INDICATED FOR THE FOLLOWING:

Esophageal, gastric or stomal ulcers
  • Frequency of follow-up EGD is variable, but every two to four months until healing is demonstrated.

Prior adenomatous gastric polyps
  • Approximate frequency of follow-up EGD would be every one to four years depending on the clinical circumstances, with select individuals with sessile polyps initially requiring every six-month surveillance

Esophageal varices
  • Approximate frequency of follow-up EGD is very variable depending on the state of the individual, although, every six to twenty-four months is reasonable after the initial sclerotherapy/banding sessions are completed.

Barrett's esophagus
  • Approximate frequency of follow-up EGD with biopsies is one to two years, unless dysplasia or atypia is demonstrated, in which case a repeat biopsy in two to three months might be indicated.

Familial adenomatous polyposis
  • Approximate frequency of follow-up EGD would be every two to four years, but might be more frequent, such as every six to twelve months if gastric adenomas or adenomas of the duodenum were demonstrated.

BENEFIT APPLICATION

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

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

Description

ENDOSCOPY

An upper gastrointestinal endoscopy involves examining the lining of the upper part of the gastrointestinal (GI) tract, which includes the esophagus, stomach, and duodenum (first portion of the small intestine). The procedure involves the use of a thin, flexible tube called an endoscope, which has its own lens and light source, and will view the images on a video monitor.

Several procedures may fall under the category of an upper endoscopy, including gastroscopy, esophagogastroduodenoscopy (EGD), and enteroscopy.

ESOPHAGOSCOPY

Esophagoscopy is a procedure in which an endoscope is inserted through the mouth or, very rarely, through the nares and into the esophagus. The endoscope uses a video chip to display magnified images on a video screen. The procedure allows visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).

ESOPHAGOGASTRODUODENOSCOPY (EGD)

Esophagogastroduodenoscopy (EGD), also known as upper gastrointestinal (GI) endoscopy, upper endoscopy, or gastroscopy, refers to examination of the esophagus, stomach, and upper duodenum (first part of the small intestine) by means of a flexible fiber-optic endoscope with a tiny video camera and light on the end.

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.

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

An endoscopic retrograde cholangiopancreatography (ERCP) is used to diagnose, evaluate, and treat problems that affect the pancreas and bile duct system. 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.

CONFOCAL LASER ENDOMICROSCOPY
Confocal laser endomicrosopy (also known as confocal fluorescent endomicrosopy and optic endomicrosopy) is an in vivo microscopic imaging of the mucosal epithelium during endoscopy to assess the gastrointestinal mucosal histology. Light from 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 confocal laser endomicroscopy (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 m and about 120m with the probe-based system.

There are limited studies evaluating confocal laser endomicroscopy for diagnosing pancreatic and biliary conditions.
References

American Society for Gastrointestinal Endoscopy (ASGE). Confocal laser endomicroscopy. Gastrointestinal Endoscopy. 2014;80(6):928-938. Available at: https://www.asge.org/docs/default-source/education/Technology_Reviews/doc-confocal_laser_endomicroscopy.pdf?sfvrsn=6. Accessed March 12, 2019.

ASGE guidelines. Appropriate use of GI endoscopy. Gastro Endosc J. 2012;75:6. Available at: http://www.giejournal.org/article/S0016-5107(12)00033-8/pdf. Accessed March 12, 2019.

Cohen D.Esophagoscopy. [Medscape Web site]. Updated 09/20/2017. Available at: http://emedicine.medscape.com/article/1891879-overview [via subscription only]. Accessed March 12, 2019.

Kapetanos D.J. ERCP in acute biliary pancreatitis. World J Gastrointest Endosc. 2010 Jan 16; 2(1): 25–28.Published online 2010 Jan 16. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2999082/ Accessed March 12, 2019.

Karia K, Waxman I, Konda VJ, et al. Needle-based confocal endomicroscopy for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc. 2016;83(5):924-927.

Novitas, Inc. Medicare Services. Local Coverage Determination (LCD). L35350: Upper Endoscopy (Diagnostic and Therapeutic). (original effective 10/01/2015, revised 10/01/2018 . Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35350&ver=47&name=314*1&UpdatePeriod=749&bc=AAAAEAABAAAA&. Accessed March 12, 2019.

Slivka A, Gan I, Jamidar P, et al. Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc. 2015;81(2):282-290.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


43191, 43192, 43193, 43194, 43195, 43196, 43197, 43198, 43200, 43201, 43202, 43204, 43205, 43206, 43211, 43212, 43213, 43214, 43215, 43216, 43217, 43220, 43226, 43227, 43229, 43231, 43232, 43233, 43235, 43236, 43237, 43238, 43239, 43240, 43241, 43242, 43243, 43244, 43245, 43246, 43247, 43248, 43249, 43250, 43251, 43252, 43253, 43254, 43255, 43259, 43260, 43261, 43262, 43263, 43264, 43265, 43266, 43270, 43274, 43275, 43276, 43277, 43278

EXPERIMENTAL/INVESTIGATIONAL

0397T



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Please see Attachment A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic)
Description: ICD-10 Coding







Policy History

MA07.023e
12/31/2019This policy has been reissued in accordance with the Company's annual review process.
05/20/2019This version of the policy will become effective 05/20/2019. This policy was updated to include the Company's current experimental/investigational position for confocal laser endomicroscopy for the pancreas and bile duct system.

The following CPT / HCPCS code has been added to this policy: 0397T (experimental/investigational)

MA07.023d
10/01/2018This policy has been identified for the ICD-10 CM code update, effective 10/01/2018.

The following ICD-10 CM code has been termed from this policy:
    K83.0 Cholangitis

The following ICD-10 CM codes have been added to this policy:
    K83.01 Primary sclerosing cholangitis
    K83.09 Other cholangitis

MA07.023c
01/31/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic).
10/01/2017This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 code has been termed from this policy:
  • K91.3

The following ICD-10 CM codes have been added to this policy:
  • K91.30 Postprocedural intestinal obstruction, unspecified as to partial versus complete
  • K91.31 Postprocedural partial intestinal obstruction
  • K91.32 Postprocedural complete intestinal obstruction

MA07.023b
06/07/2017This policy has been reissued in accordance with the Company's annual review process.
12/28/2016 In accordance with Medicare, the policy was updated with the following changes:

Attachment A:
  • The following ICD-10 diagnosis codes: I86.4,K70.30. K70.31, K71.7, K74.3, K74.4, K74.5, K74.60, K74.69, K76.6 and K94.23 were added as medically necessary to the following CPT Codes: 43200, 43201, 43202, 43204, 43205, 43206, 43212, 43215, 43216, 43217, 43220, 43226, 43227, 43229, 43231, 43232, 43235, 43236, 43237, 43238, 43239, 43240, 43241, 43242, 43243, 43244, 43245, 43246, 43247, 43248, 43249, 43250, 43251, 43252, 43255, 43259, 43260, 43261, 43262, 43263, 43264, 43265, 43266, 43270, 43274, 43275, 43276, 43277, AND 43278
  • The following diagnosis R93.2 is no longer eligible when reported with CPT codes 43275 and 43276.

MA07.023a
10/01/2016This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.
The following ICD-10 CM been deleted from this policy:
    K85.0, K85.1, K 85.2, K 85.3, K85.8, K85.9 K86.8

The following ICD-10 CM codes have been added to this policy:
    K85.00 , K85.01, K85.02, K85.10, K85.11, K85.12, K85.20, K85.21, K85.22, K85.30, K85.31, K85.32, K85.80, K85.81, K85.82, K85.90, K85.91, K85.92, K86.81, K86.89.

MA07.023
07/05/2016This new policy has been developed to communicate the Medicare Advantage coverage criteria for upper gastrointestinal endoscopy (Diagnostic and Therapeutic).





Version Effective Date: 05/20/2019
Version Issued Date: 05/20/2019
Version Reissued Date: 01/09/2020