Clinical Medical Policy Department Clinical Affairs Division DESCRIPTION. Original Effective Date: June 12, 2008 Reviewed: Revised: September 20, 2013

Transcription

1 Endoscopic Ultrasonography (EUS) [For the list of services and procedures that need preauthorization, please refer to Go to Comunicados a Proveedores, and click Cartas Circulares.] Medical Policy: MP-SU Original Effective Date: June 12, 2008 Reviewed: Revised: September 20, 2013 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION Endoscopy Ultrasound (EUS) combines endoscopy and ultrasound in order to obtain images and information about the digestive tract and the surrounding tissue and organ. Endoscopy procedure is the insertion of a long flexible tube via the mouth or the rectum to visualize the digestive tract. Whereas ultrasound uses high frequency sound waves to produce images of the organs and structures inside the body such as ovaries, uterus, liver, gall bladder, pancreas and aorta, etc. Traditional ultrasound sends sound waves to the organ(s) and back with a transducer placed on the skin overlying the organs(s) of interest. Images obtained by traditional ultrasound are not always on high quality. In EUS a small ultrasound transducer is installed on the tip of the endoscope into the upper or the lower digestive tract and one can obtain high quality ultrasound images of the organs inside the body (MedicineNet, Inc., 2013). EUS provides more detailed pictures of the digestive tract anatomy. It can be used to evaluate an abnormality below the surface of the inner lining (mucosa) such as a growth that was detected at a prior endoscopy or by X-ray. EUS, because of its ability to examine the wall layers of the GI tract, provides a detailed picture of the growth, which can help the doctor determine its nature and decide on the best treatment (ASGE, 2010). EUS can also be used to diagnose diseases of the pancreas, bile duct, and gallbladder when other tests are inconclusive, and EUS can be used to determine the stage of cancers. More importantly, EUS provides a minimally invasive method for acquiring tissue samples from gastrointestinal tumors and lymph nodes that may not be easily accessible by other methods (i.e. radiographic or surgical guidance). Fine Needle Aspiration (FNA) can be performed by passing a biopsy needle down the channel of the endoscope and across the intestinal wall under ultrasound guidance to obtain tissue for the diagnosis and staging of cancer. More recently, EUS has emerged as a therapeutic tool for treating both solid and cystic tumors of the pancreas, alleviating intractable abdominal pain secondary to advanced pancreatic cancer, and obtaining access to the bile ducts and pancreatic duct in cases of failed Endoscopic Retrograde Cholangiopancreatography (ERCP) (ASGE, 2010). EUS technology and related interventions have evolved dramatically over the past 2 decades. More recently, interventional EUS has become more central to the field of minimally invasive endosurgery. 1

2 The combination of modern, large-channel echoendoscopes with high-quality imaging transducers and dedicated accessories has been critical for the development of transluminal procedures. Further progress in device technology and well-designed clinical studies are needed to clarify the role of interventional EUS in clinical practice (ASGE, 2010). COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS I. Medical Card System (MCS) considers Endoscopic Ultrasonography (EUS) medically reasonable and necessary for ANY of the following indications: 1. Staging tumors of the gastrointestinal tract, pancreas, bile ducts, and mediastinum, including lung cancer. 2. Evaluation of masses of the gastrointestinal tract wall or adjacent structures only in clinical situations in which the EUS results will avoid an invasive diagnostic procedure, or in which the EUS results may assist in determining the optimal anatomical location to perform an invasive diagnostic procedure. 3. Evaluation of abnormalities of the pancreas, including masses, pseudo cysts, cysts and chronic pancreatitis. 4. Evaluation of abnormalities of the biliary tree. 5. Providing endoscopic therapy under ultrasonographic guidance. 6. Evaluation of adenopathy and masses of the posterior mediastinum with Endoscopic Ultrasonography-Fine Needle Aspiration (EUS-FNA). 7. Staging of patients with non-small cell lung cancer without definitive adenopathy on cross sectional imaging. 8. Placement of fiducials into tumors within or adjacent to the wall of the GI tract. 9. Treatment of symptomatic pseudocysts by creating an enteral-cyst communication. 10. To perform Celiac Plexus Blockade (CPB) or Celiac Plexus Neurolysis (CPN) as a means of achieving analgesia (i.e. Drug Delivery). 2

3 11. Providing access into the bile ducts or pancreatic duct, either independently or as an adjunct to Retrograde Cholangiopancreatography (ERCP). 12. Evaluation for chronic pancreatitis. 13. Evaluation of acute pancreatitis of unknown etiology. 14. Evaluation for perianal and perirectal disorders (anal sphincter injuries, fistulae, abscesses). 15. Evaluation of patients at increased risk of pancreatic cancer. II. (MCS) considers Experimental, Investigational or Unproven Endoscopic Ultrasonography (EUS) for the following indications: 1. EUS guided pancreaticobiliary technique to access biliary and pancreatic ducts via EUS guided needle puncture through the gastric or duodenal wall (ASGE, 2013). 2. EUS-guided drainage procedures (i.e. Pelvic abscesses, proximal pelvic collections, multiloculated collections, and stent clogging) (ASGE, 2010). 3. Interventional biliary access procedures including EUS guided transpapillary rendezvous, choledochoduodenostomy, and hepaticogastrostomy techniques (ASGE, 2010). 4. EUS-guided oncologic interventions (i.e. cancer cytoreductive therapies including EUS-guided fineneedle injection of chemotherapeutics, and brachytherapy) (ASGE, 2010). 5. EUS-guided pancreatic cyst ablation (ASGE, 2010). 6. EUS-guided vascular interventions (i.e. access intra-abdominal vascular structures for both diagnostic and therapeutic applications for GI bleeding) (ASGE, 2010). 7. EUS-guided endosurgical interventions (i.e. EUS-guided luminal anastomoses, antireflux therapy, and lymphadenectomy; also Tissue-anchoring and apposition systems in performing transluminal EUS-guided NOTES (Natural Orifice Transluminal Endoscopic Surgery) interventions) (ASGE, 2010). CONTRAINDICATIONS/LIMITATIONS 1. Known or suspected perforated viscus. 2. Acute diverticulitis. 3. Fulminant Colitis. 3

4 4. Unstable cardiac or pulmonary conditions. 5. For Staging of tumors, (e.g. of the GI tract, pulmonary, etc.) when prior imaging methods have confirmed metastasis (Unless the results are the basis for therapeutic decisions). 6. When the risks to patient health or life are judged to outweigh the most favorable benefits of the procedure. 7. When adequate patient cooperation or consent cannot be obtained. 8. When the results will not contribute to a management choice. 9. For periodic follow-up of healed benign disease unless surveillance of a premalignant condition is warranted. CODING INFORMATION CPT Codes (List may not be all inclusive) CPT Codes Description Esophagoscopy, rigid or flexible; with endoscopic ultrasound examination Esophagoscopy, rigid or flexible; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with endoscopic ultrasound examination limited to the esophagus Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s), esophagus (includes endoscopic ultrasound examination limited to the esophagus) Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum and/or jejunum as appropriate) Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with endoscopic ultrasound examination, including the esophagus, stomach, and either the duodenum and/or jejunum as appropriate Sigmoidoscopy, flexible; with endoscopic ultrasound examination Sigmoidoscopy, flexible; with transendoscopic ultrasound guided intramural or transmural fine needle aspiration/biopsy(s) Colonoscopy, flexible, proximal to splenic flexure; with endoscopic ultrasound examination 4

5 Colonoscopy, flexible, proximal to splenic flexure; with transendoscopic ultrasound guided intramural or transmural fine needle aspiration/biopsy(s) Injection, anesthetic agent; celiac plexus, with or without radiologic monitoring Destruction by neurolytic agent, with or without radiologic monitoring; celiac plexus Gastrointestinal endoscopic ultrasound, supervision and interpretation *Current Procedural Terminology (CPT ) 2013 American Medical Association: Chicago, IL. Note 1 : Do not report CPT Code in conjunction with the following CPT Codes: 43231, 43232, 43237, 43238, 43242, 43259, 45341, 45342, or (AMA CPT Manual, 2013). ICD-9 CM Diagnosis Codes (List may not be all inclusive) ICD-9 CM Codes Description Malignant Neoplasm of Cervical Esophagus Malignant neoplasm of thoracic esophagus Malignant neoplasm of abdominal esophagus Malignant neoplasm of upper third of esophagus Malignant neoplasm of middle third of esophagus Malignant neoplasm of lower third of esophagus Malignant neoplasm of other specified part Malignant neoplasm of esophagus, unspecified Malignant neoplasm of cardia Malignant neoplasm of pylorus Malignant neoplasm of pyloric antrum Malignant neoplasm of fundus of stomach Malignant neoplasm of body of stomach Malignant neoplasm of lesser curvature, unspecified Malignant neoplasm of greater curvature, unspecified Malignant neoplasm of other specified sites of stomach Malignant neoplasm, unspecified site Malignant neoplasm of duodenum Malignant neoplasm of jejunum Malignant neoplasm of ileum Malignant neoplasm of Meckel's diverticulum Malignant neoplasm of other specified sites of small intestine Malignant neoplasm of small intestine, unspecified Malignant neoplasm of hepatic flexure Malignant neoplasm of transverse colon Malignant neoplasm of descending colon Malignant neoplasm of sigmoid colon Malignant neoplasm of cecum Malignant neoplasm of appendix Malignant neoplasm of ascending colon 5

6 153.7 Malignant neoplasm of splenic flexure Malignant neoplasm of other specified sites of large intestine Malignant neoplasm of colon, unspecified Malignant neoplasm of rectosigmoid junction Malignant neoplasm of rectum Malignant neoplasm of anal canal Malignant neoplasm of anus, unspecified Malignant neoplasm of other sites of rectum, rectosigmoid junction, and anus Malignant neoplasm of intrahepatic bile ducts Malignant neoplasm of extrahepatic bile ducts Malignant neoplasm of ampulla of vater Malignant neoplasm of other specified sites of gallbladder and extrahepatic bile ducts Malignant neoplasm of biliary tract, part unspecified Malignant neoplasm of head pancreas Malignant neoplasm of body of pancreas Malignant neoplasm of tail of pancreas Malignant neoplasm of pancreatic duct Malignant neoplasm of islets of langerhans Malignant neoplasm of other specified sites of pancreas Malignant neoplasm of pancreas, part unspecified Malignant neoplasm of retroperitoneum Malignant neoplasm of specified parts of peritoneum Malignant neoplasm of peritoneum, unspecified Malignant neoplasm of intestinal tract, part unspecified Malignant neoplasm of spleen, not elsewhere classified Malignant neoplasm of other sites of digestive system and intra-abdominal organs Malignant neoplasm of ill-defined sites within the digestive organs and peritoneum Malignant neoplasm of trachea Malignant neoplasm of main bronchus Malignant neoplasm of upper lobe, bronchus or lung Malignant neoplasm of middle lobe, bronchus or lung Malignant neoplasm of lower lobe, bronchus or lung Malignant neoplasm of other parts of bronchus or lung Malignant neoplasm of bronchus and lung, unspecified Malignant neoplasm of anterior mediastinum Malignant neoplasm of posterior mediastinum Malignant neoplasm of other parts of thymus, heart and mediastinum Malignant neoplasm of mediastinum, part unspecified Malignant neoplasm of connective & other soft tissue of thorax 6

7 171.5 Malignant neoplasm of connective tissue and other soft tissue of abdomen Malignant neoplasm of other specified sites of connective & other soft tissue Malignant neoplasm of connective & other soft tissue site unspecified Secondary malignant neoplasm of lung Secondary malignant neoplasm of mediastinum Secondary malignant neoplasm of pleura Secondary malignant neoplasm of other respiratory organs Secondary malignant neoplasm of small intestine including duodenum Secondary malignant neoplasm of large intestine and rectum Secondary malignant neoplasm of retroperitoneum and peritoneum Secondary malignant neoplasm of liver, specified as secondary Secondary malignant neoplasm of other digestive organs and spleen Malignant neoplasm of reticulosarcoma involving intra-abdominal lymph nodes Malignant neoplasm of lymphosarcoma involving intra-abdominal lymph nodes Malignant neoplasm of marginal zone lymphoma, unspecified site, extranodal & solid organ sites Malignant neoplasm of marginal zone lymphoma,intra-thoracic lymph nodes Malignant neoplasm of marginal zone lymphoma, intra-abdominal lymph nodes Malignant neoplasm of mantle cell lymphoma, intra-abdominal lymph nodes Malignant neoplasm of primary central nervous system lymphoma, intraabdominal lymph nodes Malignant neoplasm of large cell lymphoma, intra-abdominal lymph nodes Other malignant neoplasms of other lymphomas unspecified site, extranodal and solid organ sites Malignant neoplasm of other lymphomas, lymph nodes of head, face, and neck Malignant neoplasm of other malignant lymphomas involving intra-thoracic lymph nodes Malignant neoplasm of other malignant lymphomas intra-abdominal lymph nodes Malignant neoplasm of other malignant lymphomas, lymph nodes of axilla, & upper limb Malignant neoplasm of other malignant lymphomas, lymph nodes of inguinal region, & lower limb Malignant neoplasm of other malignant lymphomas, intra-pelvic lymph nodes Malignant neoplasm of other malignant lymphomas, spleen 7

8 Malignant neoplasm of other malignant lymphomas, lymph nodes of multiple sites Malignant carcinoid tumor of the small intestine, unspecified portion Malignant carcinoid tumor of the duodenum Malignant carcinoid tumor of the large intestine, unspecified portion Malignant carcinoid tumor of the cecum Malignant carcinoid tumor of the ascending colon Malignant carcinoid tumor of the transverse colon Malignant carcinoid tumor of the descending colon Malignant carcinoid tumor of the sigmoid colon Malignant carcinoid tumor of unknown primary site Malignant carcinoid tumor of the bronchus & lung Malignant carcinoid tumor of the thymus Malignant carcinoid tumor of the stomach Malignant carcinoid tumor of foregut, Not Otherwise Specified (NOS) Malignant carcinoid tumor of the midgut, Not Otherwise Specified (NOS) Malignant carcinoid tumor of hindgut, Not Otherwise Specified (NOS) Malignant carcinoid tumor of other sites Malignant poorly differentiated neuroendocrine carcinoma, any site Merkel cell carcinoma of other sites Benign carcinoid tumor of the small intestine, unspecified portion Benign carcinoid tumor of the duodenum Benign carcinoid tumor of the jejunum Benign carcinoid tumor of the stomach Benign carcinoid tumor of foregut, Not Otherwise Specified (NOS) Benign carcinoid tumor of midgut, Not Otherwise Specified (NOS) Benign carcinoid tumor of other sites Secondary merkel cell carcinoma Secondary neuroendocrine tumor of other sites Benign neoplasm of esophagus Benign neoplasm of stomach Benign neoplasm of duodenum, jejunum, and ileum Benign neoplasm of colon Benign neoplasm of rectum and anal canal Benign neoplasm of liver and biliary passages Benign neoplasm of pancreas, except islets of Langerhans Benign neoplasm of islets of Langerhans Benign neoplasm of retroperitoneum and peritoneum Benign neoplasm of other and unspecified site in the digestive system Benign neoplasm of larynx Benign neoplasm of trachea Benign neoplasm of bronchus and lung 8

9 212.4 Benign neoplasm of pleura Benign neoplasm of mediastinum Lipoma of intra-abdominal organs Other benign neoplasm of connective and other soft tissue of abdomen Hemangioma of intra-abdominal structures Carcinoma in situ of esophagus Carcinoma in situ of stomach Carcinoma in situ of colon Carcinoma in situ of rectum Carcinoma in situ of anal canal Carcinoma in situ of anus, unspecified Carcinoma in situ of other and unspecified parts of intestine Carcinoma in situ of liver and biliary system Carcinoma in situ of other and unspecified digestive organs Neoplasm of uncertain behavior of stomach, intestines, and rectum Neoplasm of uncertain behavior of liver and biliary passages Neoplasm of uncertain behavior of retroperitoneum and peritoneum Neoplasm of uncertain behavior of other and unspecified digestive organs Neoplasm of uncertain behavior of larynx Neoplasm of uncertain behavior of trachea, bronchus, and lung Neoplasm of uncertain behavior of pleura, thymus, and mediastinum Neoplasm of uncertain behavior of connective and soft tissue Neoplasm of unspecified nature of digestive system Other disorders of abnormality of secretion of gastrin Other disorders of nonspecific mesenteric lymphadenitis Lymphadenitis unspecified except mesenteric Esophageal varices without mention of bleeding Varices of other sites Diseases of achalasia & cardiospasm Diseases of ulcer of esophagus without bleeding Diseases of ulcer of esophagus with bleeding Diseases of stricture & stenosis of esophagus Other specified disorders of Barrett's esophagus Other diseases of esophagus Unspecified disorder of esophagus Chronic gastric ulcer without hemorrhage or perforation without mention of obstruction Chronic gastric ulcer without hemorrhage or perforation with obstruction Gastric ulcer unspecified as acute or chronic without mention of hemorrhage or perforation without obstruction Gastric ulcer unspecified as acute or chronic without hemorrhage or perforation with obstruction 9

10 Gastrojejunal ulcer unspecified as acute or chronic without hemorrhage or perforation without obstruction Gastrojejunal ulcer unspecified as acute or chronic without hemorrhage or perforation with obstruction Acute gastritis (without hemorrhage) Acute gastritis with hemorrhage Dieulafoy lesion (hemorrhagic) of stomach & duodenum Other specified disorders of stomach & duodenum Unspecified disorder of stomach & duodenum Abscess of intestine Dieulafoy lesion (hemorrhagic) of intestine Other specified disorders of intestines Unspecified disorder of liver Chronic pancreatitis Cyst & pseudocyst of pancreas Other specified diseases of pancreas Unspecified disease of pancreas Gastrointestinal vessel anomaly Other congenital anomalies of gallbladder bile ducts & liver Congenital anomalies of pancreas Enlargement of lymph nodes Swelling, mass or lump in chest Abdominal or pelvic swelling, mass, or lump, unspecified site Abdominal or pelvic swelling, mass, or lump, right upper quadrant Abdominal or pelvic swelling, mass, or lump, left upper quadrant Abdominal or pelvic swelling, mass, or lump, right lower quadrant Abdominal or pelvic swelling, mass, or lump, left lower quadrant Abdominal or pelvic swelling, mass, or lump, periumbilic Abdominal or pelvic swelling, mass, or lump, epigastric Abdominal or pelvic swelling, mass, or lump, generalized Abdominal or pelvic swelling, mass, or lump, other specified site Solitary pulmonary nodule Other nonspecific abnormal finding of lung field Nonspecific (abnormal) findings on radiological and other examination of other intrathoracic organs Nonspecific (abnormal) findings on radiological and other examination of biliary tract Nonspecific (abnormal) findings on radiological and other examination of gastrointestinal tract Nonspecific (abnormal) findings on radiological and other examination of abdominal area, including retroperitoneum V55.1 Attention to gastrostomy *2013 ICD-9-CM For Physicians, VOLUMES I & II, Professional Edition (American Medical Association). 10

11 When using endoscopic ultrasound (CPT code 76975) to guide celiac plexus block/neurolysis, ICD-9-CM diagnosis codes through , and through may be covered: ICD-9 CM Codes Description Abdominal pain, unspecified site Abdominal pain, right upper quadrant Abdominal pain, left upper quadrant Abdominal pain, right lower quadrant Abdominal pain, left lower quadrant Abdominal pain, periumbilic Abdominal pain, epigastric Abdominal pain, generalized Abdominal pain, other specified site (multiple sites) Malignant ascites Other ascites Abdominal tenderness, unspecified site Abdominal tenderness, right upper quadrant Abdominal tenderness, left upper quadrant Abdominal tenderness, right lower quadrant Abdominal tenderness, left lower quadrant Abdominal tenderness, periumbilic Abdominal tenderness, epigastric Abdominal tenderness, generalized Abdominal tenderness, other specified site (multiple sites) Other symptoms involving abdomen and pelvis *2013 ICD-9-CM For Physicians, VOLUMES I & II, Professional Edition (American Medical Association). HCPCS CODES (List may not be all inclusive) HCPCS CODES N/A DESCRIPTION N/A *2013 HCPCS LEVEL II Professional Edition (American Medical Association). REFERENCES 1. American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology (2006). Jacobson BC, Chak A, Hoffman B, Baron TH, Cohen J, Deal SE, Mergener K, Petersen BT, Petrini JL, Safdi MA, Faigel DO, Pike IM. Quality indicators for endoscopic ultrasonography. Gastrointestinal Endoscopy 2006 Apr; 63 (4 Suppl):S35-8. Accessed September 20, Available at URL address: 11

12 2. American Gastroenterological Association (AGA) Institute Medical Position Statement on the Management of Gastric Subepithelial Masses. Hwang JH, Kimmey MB. Gastroenterology. 2006; 130(7): Accessed September 20, Available at URL address: or at URL address: 3. American Society for Gastrointestinal Endoscopy (ASGE) (2013) CPT Coding Changes. Accessed September 20, Available at URL address: 4. American Society for Gastrointestinal Endoscopy (ASGE) (2013). Adverse events associated with EUS and EUS with FNA. Gastrointestinal Endoscopy 2013: Vol. 77; Pages Accessed September 20, Available at URL address: ts%20associated%20with%20eus%20and%20eus%20with%20fna.pdf 5. American Society for Gastrointestinal Endoscopy (ASGE) (2012). Appropriate Use of Gastrointestinal Endoscopy. Gastrointestinal Endoscopy 2012; Vol. 75; Pages Accessed September 20, Available at URL address: 6. American Society for Gastrointestinal Endoscopy (ASGE) (2000). Appropriate Use of Gastrointestinal Endoscopy. A consensus statement from the American Society for Gastrointestinal Endoscopy. Initially prepared by the Committee on Endoscopic Utilization. Revised by the Standards of Practice Committee and approved by the Governing Board. Vol. 52; No.6, Pages Accessed September 20, Available at URL address: ppropriate.pdf 7. American Society for Gastrointestinal Endoscopy (ASGE) (2013). Guideline: Modifications in endoscopic practice for the elderly. Gastrointestinal Endoscopy 2013: Vol. 78: Pages 1-7. Accessed September 20, Available at URL address: 0in%20endoscopic%20practice%20for%20the%20elderly.pdf 8. American Society for Gastrointestinal Endoscopy (ASGE) (2001). Guidelines for credentialing and granting privileges for endoscopic ultrasound. Reviewed and reapproved: 1/2011. Gastrointestinal Endoscopy, Vol. 54, No.6. Accessed September 20, Available at URL address: 61ECBC72CA39.pdf 9. American Society for Gastrointestinal Endoscopy (ASGE) (2010, November). Media Backgrounder Endoscopic Procedures: Endoscopic Ultrasound (EUS). Accessed September 20, Available at URL address: 12

13 10. American Society for Gastrointestinal Endoscopy (ASGE) (2013). Patient Information: Understanding EUS (Endoscopic Ultrasonography). Accessed September 20, Available at URL address: American Society for Gastrointestinal Endoscopy (ASGE) (2010). Report on Emerging Technology: Interventional EUS. Gastrointestinal Endoscopy 2010; Vol. 72; No. 1; Pages 1-4. Accessed September 20, Available at URL address: 12. American Society for Gastrointestinal Endoscopy (ASGE) (2000). Role of Endoscopic Ultrasonography. Gastrointestinal Endoscopy, Vol. 52, No. 6. Accessed September 20, Available at URL address: American Society for Gastrointestinal Endoscopy (ASGE) (2011). Role of the EUS for the evaluation of mediastinal adenopathy. Gastrointestinal Endoscopy 2011; Vol. 74; Pages Accessed September 20, Available at URL address: American Society for Gastrointestinal Endoscopy (ASGE) (2006). Technology Status Evaluation Report: Endoscopic ultrasound probes. Gastrointestinal Endoscopy 2006; Vol. 63; No. 6; Pages Accessed September 20, Available at URL address: American Society for Gastrointestinal Endoscopy (ASGE) (2007). Technology Status Evaluation Report: EUS accessories. Gastrointestinal Endoscopy 2007; Vol. 66; No. 6; Pages Table 2. List of relevant EUS CPT codes. Accessed September 20, Available at URL address: 22D163E637DF.pdf 16. American Society for Gastrointestinal Endoscopy (ASGE) (2013). The role of endoscopy in the assessment and treatment of esophageal cancer. Gastrointestinal Endoscopy 2013; Vol. 77; Pages Accessed September 20, Available at URL address: f%20endoscopy%20in%20the%20assessment%20and%20treatment%20of%20esophageal%20ca ncer.pdf 17. American Society for Gastrointestinal Endoscopy (ASGE) (2013). The role of endoscopy in the evaluation and treatment of patients with biliary neoplasia. Gastrointestinal Endoscopy 2013:Vol. 77; No.2; Pages Accessed September 20, Available at URL address: f%20endoscopy%20in%20the%20evaluation%20and%20treatment%20of%20patients%20with% 20biliary%20neoplasia.pdf 18. Annema JT, Versteegh MI, Veselic M. et al. Endoscopic ultrasound added to mediastinoscopy improves preoperative staging of patients with lung cancer. JAMA 2005; 294: Accessed September 20, Available at URL address: 13

14 and at URL address: Bjorkman, DJ, Popp, JW. Measuring the quality of endoscopy. Gastrointest Endosc 2006 Apr; 63(4Suppl):S1-2. Available in Portable Document Format (PDF) from the American Society forgastrointestinal Endoscopy Website. Accessed September 20, Available at URL address: 006_quality.pdf 20. Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 12 Physicians/Nonphysician Practitioners. Section Digestive System. Rev. 2714, 5/24/2013. Accessed September 20, Available at URL address: Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network (MLN): Medicare Quarterly Provider Compliance Newsletter Guidance to Address Billing Errors. Volume 3, Issue 3 April 2013 (Revised). Page 13: Finding for Endoscopic Ultrasound (EUS). Accessed September 20, Available at URL address: Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/MedQtrlyComp- Newsletter-ICN pdf 22. Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination (LCD) for Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy (L26404). Contractor Name: National Government Services, Inc. Contract Number: Geographical Jurisdiction: Illinois. Original Effective Date: For services performed on or after 04/01/2008. Revision Effective Date: For services performed on or after 09/07/2013. Accessed September 20, Available at URL address: 273&name=National+Government+Services%2c+Inc.+(06102%2c+MAC+- +Part+B)&s=19&DocType=Active&bc=AggAAAIAAAAAAA%3d%3d& 23. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Endoscopy (100.2). Effective Date of this Version: This is a longstanding national coverage determination. The effective date of this version has not been posted. Accessed September 20, Available at URL address: Centers for Medicare & Medicaid Services (CMS). Retired Local Coverage Determination (LCD) for Esophagogastroduodenoscopy (EGD) (L26394). Contractor Name: National Government Services, Inc. Contractor Number: Primary Geographic Jurisdiction: Indiana. Original Determination Effective Date: For services performed on or after 04/01/2008. Original Determination Ending Date: 12/31/2011. Accessed September 20, Available at URL address: 14

15 25. Dancygier H. Endoscopy ultrasonography of the upper gastrointestinal tract. Bailliries Clin Gastroenterology Mar; 5(1): Accessed September 20, Available at URL address: Faigel, DO, Pike, IM, Baron, TH, Chak, A, Cohen, J, Deal, SE, Hoffman, B, Jacobson, BC, Mergener, K, Petersen, BT, Petrini, JL, Rex, DK, Safdi, MA. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Gastrointest Endosc 2006 Apr; 63(4 Suppl):S3-9. Accessed September 20, Available at URL address: Hunerbein M, Dophmoto M, Rau B, Schlag P. Endosonography and endosonography guided biopsy for upper GI tract tumors using a curved array echoendoscope. Accessed September 20, Available at URL address: Kramer H, van Putten JW, Post WJ, et al. Oesophageal endoscopic ultrasound with fine needle aspiration improves and simplifies the staging of lung cancer. Thorax 2004; 59(7): Accessed September 20, Available at URL address: MedicineNet, Inc. (2013). Endoscopic Ultrasound (EUS): What is Endoscopic Ultrasound? Accessed September 20, Available at URL address: MedicineNet, Inc. (2013). Endoscopic Ultrasound (EUS): When is EUS useful? Accessed September 20, Available at URL address: Mortesen MB, Pless T, Durup J, Aisworth AP, Plagborg GJ, Hovendal C. Clinical impact of endoscopy ultrasound guided fine needle aspiration biopsy in upper gastrointestinal tract malignancies. A prospective study. Endoscopy Jun; 33 (6): , Accessed September 20, Available at URL address: National Guideline Clearinghouse. Quality indicators for endoscopic ultrasonography. This guideline summary has been withdrawn from NGC. Searched September 20, No longer available at URL address: NHIC, Corp. A CMS Contractor (2009). Local Coverage Determination (LCD) for Esophagogastroduodenoscopy (EGD) (L26394). Contractor Name: National Government Services, Inc. Contractor Number: Geographical Jurisdiction: Massachusetts & Maine. Original Determination Effective Date: For services performed on or after 04/01/2008. Revision Effective Date: For services performed on or after 12/01/2008. Accessed September 20, Available at URL address: 4).pdf 15

16 34. Ryozawa S, Kitoh H, Gondo T, Urayama N, Yamashita H, Ozawa H, and Yanai K. Usefulness of endoscopic ultrasound guided fine needle aspiration biopsy for the diagnosis of pancreatic cancer. J.Gastroenterology Sep; 40 (9): , Accessed September 20, Available at URL address: Shirakawa T, Imamura F, Hamamoto J, et al. Usefulness of endobronchial ultrasonography for transbronchial lung biopsies of peripheral lung lesions. Respiration. 2004; 71(3): Accessed September 20, Available at URL address: Vander Noot MR 3rd, Eloubedei M, Chen V, Eltoum I, Jhala D, Jhala N, Syed S, Chhieng D. Diagnosis of Gastrointestinal tract lesions by Endoscopic ultrasound guided fine needle aspiration biopsy. Cancer Jun 25; 102 (3): Accessed September 20, Available at URL address: Wallace MB, Fritscher-Ravens A, Savides TJ. Endoscopic Ultrasound for the staging of Non-small cell lung cancer. Endoscopy 2003; 35: Accessed September 20, Available at URL address: POLICY HISTORY DATE ACTION COMMENT June 12, 2008 Origination of Policy August 11, 2009 Yearly Review August 24, 2010 Yearly Review August 23, 2011 Yearly Review References updated. July 13, 2012 Yearly Review References updated. December 10, 2012 Reviewed Policy was reviewed and approved by the Medical Card System (MCS) Medical Advisory Committee (MAC) on December 10, February 20, 2013 Revised Coding information Revised: Added ICD-9 Codes September 20, 2013 Revised References updated. Added new references, numbers 3-17, 21-24, 29, 30, & 33. To the Descriptions Section Added: EUS provides more detailed pictures of the digestive tract anatomy. It can be used to evaluate an abnormality below the surface of the inner lining (mucosa) such as a growth that was detected at a prior endoscopy or by X-ray. EUS, because of its ability to examine the wall layers of the GI tract, provides a detailed picture of the growth, which can help the doctor determine its nature and decide on the best treatment (ASGE, 2010). EUS can also be used to diagnose diseases of the pancreas, bile duct, and gallbladder when other tests are inconclusive, and EUS can be used to determine the stage of cancers. More importantly, EUS provides a minimally invasive method for acquiring tissue samples from gastrointestinal tumors and lymph nodes that may not be easily accessible by other methods (i.e. radiographic or surgical guidance). Fine Needle Aspiration (FNA) can be performed by passing a biopsy needle down the channel of the endoscope and across the intestinal wall under ultrasound guidance to obtain tissue for the diagnosis and staging of cancer. More recently, EUS has emerged as a therapeutic tool for treating both solid and cystic tumors of the pancreas, alleviating intractable abdominal pain secondary to advanced pancreatic cancer, and obtaining access to the bile ducts and pancreatic duct in cases of failed Endoscopic 16

17 Retrograde Cholangiopancreatography (ERCP) (ASGE, 2010). EUS technology and related interventions have evolved dramatically over the past 2 decades. More recently, interventional EUS has become more central to the field of minimally invasive endosurgery. The combination of modern, large-channel echoendoscopes with high-quality imaging transducers and dedicated accessories has been critical for the development of transluminal procedures. Further progress in device technology and well-designed clinical studies are needed to clarify the role of interventional EUS in clinical practice (ASGE, 2010). To the Indications Section: To Indication #1 added: including lung cancer. To Indication #3 added: cysts. Added new indications: # Added new Experimental, Investigational or Unproven indications Section: 1. EUS guided pancreaticobiliary technique to access biliary and pancreatic ducts via EUS guided needle puncture through the gastric or duodenal wall (ASGE, 2013). 2. EUS-guided drainage procedures (i.e. Pelvic abscesses, proximal pelvic collections, multiloculated collections, and stent clogging) (ASGE, 2010). 3. Interventional biliary access procedures including EUS guided transpapillary rendezvous, choledochoduodenostomy, and hepaticogastrostomy techniques (ASGE, 2010). 4. EUS-guided oncologic interventions (i.e. cancer cytoreductive therapies including EUS-guided fineneedle injection of chemotherapeutics, and brachytherapy) (ASGE, 2010). 5. EUS-guided pancreatic cyst ablation (ASGE, 2010). 6. EUS-guided vascular interventions (i.e. access intraabdominal vascular structures for both diagnostic and therapeutic applications for GI bleeding) (ASGE, 2010). 7. EUSguided endosurgical interventions (i.e. EUS-guided luminal anastomoses, antireflux therapy, and lymphadenectomy; also Tissue-anchoring and apposition systems in performing transluminal EUS-guided NOTES (Natural Orifice Transluminal Endoscopic Surgery) interventions) (ASGE, 2010). To the Contraindications/ Limitations Section: Eliminated the Contraindication: High grade esophageal structure. Added new Contraindications: #6-9. To the Coding Information: Added new CPT Codes: & Added: Note1: Do not report CPT Code in conjunction with the following CPT Codes: 43231, 43232, 43237, 43238, 43242, 43259, 45341, 45342, or (AMA CPT Manual, 2013). Added new ICD-9 Codes: , 171.9, , , & V55.1. Added: When using endoscopic ultrasound (CPT code 76975) to guide celiac plexus block/neurolysis, ICD-9-CM diagnosis codes through , and through may be covered. To this Section added ICD-9 Codes:

18 This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member s plan in effect as of the date services are rendered., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion., (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide. 18