(Medicare National Coverage Determinations Manual)

3. Adjustable Gastric Banding (AGB)   The AGB achieves weight loss by gastric restriction only. A band creating a gastric pouch with a capacity of approximately 15 to 30 ccs encircles the uppermost portion of the stomach. The band is an inflatable doughnut-shaped balloon, the diameter of which can be adjusted in the clinic by adding or removing saline via a port that is positioned beneath the skin. The bands are adjustable, allowing the size of the gastric outlet to be modified as needed, depending on the rate of a patients weight loss. AGB procedures are laparoscopic only.   4. Sleeve Gastrectomy   Sleeve gastrectomy is a 70% -80% greater curvature gastrectomy (sleeve resection of the stomach) with continuity of the gastric lesser curve being maintained while simultaneously reducing stomach volume. In the past, sleeve gastrectomy was the first step in  a two -stage procedure when performing RYGBP, but more recently has been offered as a stand -alone surgery. Sleeve gastrectomy procedures can be open or laparoscopic.   5. Vertical Gastric Banding (VGB)   The VGB achieves weight loss by gastric restriction only. The upper part of the stomach is stapled, creating a narrow gastric inlet or pouch that remains connected with the remainder of the stomach. In addition, a non-adjustable band is placed around this new inlet in an attempt to prevent future enlargement of the stoma (opening). As a result, patients experience a sense of fullness after eating small meals. Weight loss from this procedure results entirely from eating less. VGB procedures are essentially n o longer performed.   B. Nationally Covered Indications  Effective for services performed on and after February 21, 2006, Open and laparoscopic Roux- en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS) or Gastric Reduction Duodenal Switch (BPD/GRDS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a body -mass index  35, have at least one co- morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.   Effective for dates of service on and after February 21, 2006, these procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006).  Effective for dates of service on and after September 24, 2013, facilities are no longer required to be certified.  Effective for services performed on and after February 12, 2009, the Centers for Medicare & Medicaid Services (CMS) determines that Type 2 diabetes mellitus is a co -morbidity for purposes of this NCD.   A list of approved facilities and their approval dates are listed and maintained on the CMS Coverage Web site at http://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/Bariatric -Surgery.html  , and published in the Federal  Register  for services provided up to and including date of service September 23, 2013.  C. Nationally Non-Covered Indications  Treatments for obesity alone remain non- covered.   Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section D. below for discretionary local coverage).  The following bariatric surgery procedures are non- covered for all Medicare beneficiaries:   Open adjustable gastric banding;   Open sleeve gastrectomy;    Laparoscopic sleeve gastrectomy (prior to June 27, 2012);   Open and laparoscopic vertical banded gastroplasty;   Intestinal bypass surgery; and,   Gastric balloon for treatment of obesity.  D. Other  Effective for services performed on and after June 27, 2012, A/B Medicare Administrative Contractors (A/B MACs) acting within their respective jurisdictions may determine coverage of stand -alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co -morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a.- c. are satisfied.   a. The beneficiary has a body-mass index (BMI)  35 kg/m2,   b. The beneficiary has at least one co -morbidity related to obesity, and,   c. The beneficiary has been previously unsuccessful with medical treatment for obesity.   The determination of coverage for any bariatric surgery procedures that are not specifically identified in an NCD as covered or non-covered, for Medicare beneficiaries who have a body -mass index  35, have at least one co -morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity, is left to the local MACs.   Where weight loss is necessary before surgery in order to ameliorate the complications posed by obesity when it coexists with pathological conditions such as cardiac and respiratory diseases, diabetes, or hypertension (and other more conservative technique s to achieve this end are not regarded as appropriate), supplemented fasting with adequate monitoring of the patient is eligible for coverage on a case-by- case basis or pursuant to a local coverage determination. The risks associated with the achievement of rapid weight loss must be carefully balanced against the risk posed by the condition requiring surgical treatment.  100.2 - Endoscopy  (Rev. 1, 10-03-03) CIM 35 -59  Endoscopy is a technique in which a long flexible tube-like instrument is inserted into the body orally or rectally, permitting visual inspection of the gastrointestinal tract.  Although primarily a diagnostic tool, endoscopy includes certain therapeutic procedures such as removal of polyps, and endoscopic papillotomy, by which stones are removed from the bile duct.   Endoscopic procedures are covered when reasonable and necessary for the individual patient.  100.3 - 24-Hour Ambulatory Esophegeal pH Monitoring  (Rev. 1, 10- 03-03) CIM 35 -83  Twenty -four hour ambulatory esophageal pH monitoring is a diagnostic procedure involving the placement of an indwelling electrode into the lower esophagus of a patient for the purpose of determining the presence of gastric reflux and measuring abnormal esophageal acid exposure.   Twenty -four hour ambulatory pH monitoring is covered by Medicare for patients who are suspected of having gastric reflux, but only if the patient presents diagnostic problems associated with atypical symptoms or the patients symptoms are suggestive of ref lux, but conventional tests have not confirmed the presence of reflux.   100.4 - Esophageal Manometry  (Rev. 1, 10- 03-03) CIM 50 -25  Esophageal manometry is covered under Medicare where it is determined to be reasonable and necessary for the individual patient.  The major use of esophageal manometry is to measure pressure within the esophagus to assist in the diagnosis of esophageal pat hology including aperistalsis, spasm, achalasia, esophagitis, esophageal ulcer, esophageal congenital webs, diverticuli, scleroderma, hiatus hernia, congenital cysts, benign and malignant tumors, hypermobility, hypomobility, and extrinsic lesions.  Esophageal manometry is mostly used in difficult diagnostic cases and as an adjunct to x- rays and direct visualization of the esophagus (endoscopy) through the fiberscope.   100.5 - Diagnostic Breath Analyses  (Rev. 1, 10- 03-03) CIM 50 -51  Diagnostic breath analyses are tests performed to measure either the hydrogen or carbon dioxide content of the breath after the ingestion of certain compounds. The analyses are performed to diagnose certain gastrointestinal disease states.   The Following Breath Test Is Covered:   Lactose breath hydrogen to detect lactose malabsorption.  The Following Breath Tests Are Excluded From Coverage:   Lactulose breath hydrogen for diagnosing small bowel bacterial overgrowth and measuring small bowel transit time.   CO2  for diagnosing bile acid malabsorption.   CO2  for diagnosing fat malabsorption.  100.6 - Gastric Freezing  (Rev. 1, 10- 03-03) CIM 35 -65  Gastric freezing for chronic peptic ulcer disease is a non -surgical treatment which was popular about 20 years ago but now is seldom done.  It has been abandoned due to a high complication rate, only temporary improvement experienced by patients, and lack of effectiveness when tested by double-blind, controlled clinical trials.  Since the procedure is now considered obsolete, it is not covered.  100.7 - Colonic Irrigation  CIM 35 -1  Not Covered  Colonic irrigation is a procedure to wash out or lavage material on the walls of the bowel to an unlimited distance without inducing defecation.  This procedure is distinguished from all types of enemas which are primarily used to induce defecation.  There are no conditions for which colonic irrigation is medically indicated and no evidence of therapeutic value.  Accordingly, colonic irrigation cannot be considered reasonable and necessary within the meaning of 1862(a)(1) of the Act.   100.8  Intestinal Bypass Surgery  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Please note section  100.8 has  been  removed  from  the NCD Manual  and incorporated into  NCD 100.1 effective September 24, 2013.    100.9 - Implantation of Anti-Gastroesophageal Reflux Device  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04 -10-23)    Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that no national coverage determination  (NCD)  is appropriate at  this time for FDG  PET for Implantation  of Gastrointestinal Reflux Devices. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.  100.10 - Injection Sclerotherapy for Esophageal Variceal Bleeding  (Rev. 1, 10-03-03) CIM 35 -73  Injection sclerotherapy is a technique involving insertion of a flexible fiberoptic endoscope into the esophagus, and the injection of a sclerosing agent or solution into the varicosities to control bleeding.  This procedure is covered under Medicare.  100.11  Gastric Balloon for Treatment of Obesity  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Please note section  100.11 has been  removed  from  the NCD Manual  and incorporated into  NCD 100.1 effective September 24, 2013.    100.12 - Gastrophotography  (Rev. 1, 10-03-03) CIM 50 -9  Gastrophotography is an accepted procedure for diagnosis and treatment of gastrointestinal disorders.  The photographic record provided by this procedure is often necessary for consultation and/or follow-up purposes and when required for such purposes, is more valuable than a conventional gastroscopic examination.  Such a record facilitates the documentation and evaluation (healing or worsening) of lesions such as the gastric ulcer, facilitates consultation b etween physicians concerning difficult -to-interpret lesions, provides preoperative characterization for the surgeon, and permits better diagnosis of postoperative gastric bleeding to help determine whether there is a need for another operation.  Therefore, program reimbursement may be made for this procedure.   100.13 - Laproscopic Cholecystectomy  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Laparoscopic cholecystectomy is a covered surgical procedure in which a diseased gall bladder is removed through the use of instruments introduced via cannulae, with vision of the operative field maintained by use of a high- resolution television camera -monitor system (video laparoscope).  For inpatient claims, report the diagnosis code for laparoscopic cholecystectomy.  For all other claims, report the appropriate CPT code for laparoscopy, surgical; cholecystectomy (any method), and the appropriate CPT code  for laparoscopy, surgical: cholecystectomy with cholangiography.   100.14  Surgery for Diabetes  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section  100.14 has been  removed  from  the NCD Manual  and incorporated into  NCD 100.1 effective September 24, 2013.   110 - Hematology/Immunology/Oncology  (Rev. 1, 10- 03-03)