LCD L35350

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for upper gastrointestinal endoscopy. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for upper gastrointestinal endoscopy and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.6 Requirements for Ordering and Following Orders for Diagnostic Tests

• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 100.2 Endoscopy, Section 100.10 Injection Sclerotherapy for Esophageal Variceal Bleeding

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,

• Chapter 12, Section 30.1 Digestive System (Codes 40000 – 49999), Section 40.6 Claims for Multiple Surgeries

• Chapter 14, Section 20 List of Covered Ambulatory Surgical Center Procedures

• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Indications and Limitations of Coverage

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

These endoscopic examinations may be used to evaluate symptoms, identify anatomic abnormalities, to obtain biopsies, or are employed for therapeutic reasons. Most often the procedure is performed by a fiber-optic endoscope (including video endoscopy), a flexible tube containing light transmitting glass fibers that return a magnified image directly or by video.

Covered Indications

Endoscopy procedures can only be allowed if abnormal signs or symptoms or known disease are present.

• Indications which support esophagogastroduodenoscopies (EGD[s]) for diagnostic purpose(s) are as follows:

• Upper abdominal distress which persists despite an appropriate trial of therapy;

• Upper abdominal distress associated with symptoms and/or signs suggesting serious organic disease (e.g., prolonged anorexia and weight loss);

• Dysphagia or odynophagia;

• 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. Examples include patients with a history of GI bleeding who are scheduled for organ transplantation; long term anticoagulation; and chronic non-steroidal therapy for arthritis;

• X-ray findings of:

• A suspected neoplastic lesion, for confirmation and specific histologic diagnosis;

• Gastric or esophageal ulcer; or

• Evidence of upper gastrointestinal tract stricture or obstruction.

• The presence of gastrointestinal bleeding:

• In most actively bleeding patients 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; or

• For presumed chronic blood loss and for iron deficiency anemia when colonoscopy is negative.

• When sampling of duodenal or jejunal tissue or fluid is indicated;

• To assess acute injury after caustic agent ingestion; or

• Intraoperative EGD when necessary to clarify location or pathology of a lesion.

• Indications which support EGD(s) for therapeutic purpose(s) are as follows:

• Treatment of bleeding from lesions such as ulcers, tumors, vascular malformations (e.g., electrocoagulation, heater probe, laser photocoagulation or injection therapy);

• Sclerotherapy for bleeding from esophageal or proximal gastric varices or banding of varices;

• Foreign body removal;

• 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); or

• Palliative therapy of stenosing neoplasms (e.g., laser, bipolar electrocoagulation, stent placement).

• Sequential or periodic diagnostic upper GI endoscopy may be indicated for an appropriate number of procedures for active or symptomatic conditions.

• For follow-up of selected esophageal, gastric or stomal ulcers to demonstrate healing (frequency of follow-up EGDs is variable, but every two to four months until healing is demonstrated is reasonable);

• For follow-up in patients with prior adenomatous gastric polyps (approximate frequency of follow-up EGDs would be every one to four years depending on the clinical circumstances, with occasional patients with sessile polyps requiring every six-month surveillance initially);

• For follow-up for adequacy of prior sclerotherapy or banding of esophageal varices (approximate frequency of follow-up EGDs is very variable depending on the state of the patient but every six to twenty-four months is reasonable after the initial sclerotherapy/banding sessions are completed);

• For follow-up of Barrett's esophagus (approximate frequency of follow-up EGDs is one to two years with biopsies, unless dysplasia or atypia is demonstrated, in which case a repeat biopsy in two to three months might be indicated); or

• For follow-up in patients with familial adenomatous polyposis (approximate frequency of follow-up EGDs 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).

• The endoscopic retrograde cholangiopancreatography (ERCP) procedure is generally indicated for certain biliary and pancreatic conditions.

• ERCP is generally not indicated for the diagnosis of pancreatitis except for gallstone pancreatitis;

• ERCP is not usually indicated in early stages or in acute pancreatitis and could possibly exacerbate it;

• ERCP may be useful in traumatic pancreatitis to accurately localize the injury and provide endoscopic drainage;

• ERCP may be useful in pancreatic duct stricture evaluation;

• ERCP may be useful for the extraction of bile duct stones in severe gallstone induced pancreatitis;

• ERCP may be useful in detecting 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;

• ERCP may be useful in detecting gallstones in symptomatic patients whose oral cholecystogram and gallbladder ultrasonograms are normal; and

• ERCP may be indicated in patients with radiologic imaging suggestive of common bile duct stones or other potential pathology.

Limitations

• Indications for which EGD(s) are generally not covered by Medicare are as follows:

• Distress which is chronic, non-progressive, atypical for known organic disease, and is considered functional in origin (there are occasional exceptions in which an endoscopic examination may be done once to rule out organic disease, especially if symptoms are unresponsive to therapy);

• Uncomplicated heartburn responding to medical therapy;

• Metastatic adenocarcinoma of unknown primary site when the results will not alter management;

• X-ray findings of:

• asymptomatic or uncomplicated sliding hiatal 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;

• Patients without current gastrointestinal symptoms about to undergo elective surgery for non-upper gastrointestinal disease; or

• When lower G.I. 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 is not indicated for:

• Surveillance for malignancy in patients with gastric atrophy, pernicious anemia, treated achalasia, or prior gastric operation;

• Surveillance of healed benign disease such as esophagitis, gastric or duodenal ulcer; or

• Surveillance during chronic repeated dilations of benign strictures unless there is a change in status.

Place of Services (POS)

These services may be performed in a physician's office, or in a hospital inpatient or outpatient, or an ASC.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Refer to the Local Coverage Article: Billing and Coding: Upper Gastrointestinal Endoscopy (Diagnostic and Therapeutic), A57414 for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient's medical record and made available to the contractor upon request.

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

• The medical record documentation must support the medical necessity of the services as stated in this policy.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Appropriate utilization guidelines are outlined in the Indications/Limitations area of the policy.

Bibliography

• ASGE Standards of Practice Committee. Guideline: Role of EUS for the evaluation of mediastinal adenopathy. Gastrointestinal Endoscopy. 2011; 74(2):239-245.

• Bosch J, Berzigotti A, Garcia-Pagan JC, et al. The management of portal hypertension: rational basis available treatments and future options. Journal of Hepatology. 2008; 48: S68-S92.

• Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010; 362(9): 823-832.

• Garcia-Tsao G, Sanyal AJ, Grace ND, et al. Practice Guidelines: Prevention and Management of Gastroesophageal Varices and Variceal Hemorrhage in Cirrhosis. American Journal of Gastroenterology. 2007; 102:2086-2102.

• Graham DY, Smith L. The course of patients after variceal hemorrhage. Gastroenterology. 1981; 80(4): 800-809.

• Hwang JH, Shergill AK, Acosta RD, et al. American Society for Gastrointestinal Endoscopy Guideline: The role of endoscopy in the management of variceal hemorrhage. Gastrointestinal Endoscopy. 2014; 80(2): 221-227.

• Krige JEJ, Kotze UK, Bornman PC, et al. Variceal Recurrence, Rebleeding, and Survival After Endoscopic Injection Sclerotherapy in 287 Alcoholic Cirrhotic Patients With Bleeding Esophageal Varices. Annals of Surgery. 2006; 244(5): 764-770.

• LaBrecque D, Khan AG, Sarin SK, et al. Esophageal Varices. World Gastroenterology Organisation Global Guidelines. 2014; 1-14.

• Reverter E, Tandon P, Augustin S, et al. A MELD-based model to determine risk of mortality among patients with acute variceal bleeding. Gastroenterology. 2014; 146(2): 412-419.

• Silvestri, GA et al. Methods of Staging Non-small Cell Lung Cancer. Chest. 2013; 143(5)(Suppl): e211S-e250S.