Effective Date: 9/1/2018 Section: SUR Policy No: 139 Medical Officer 9/1/2018 Date Technology Assessment Committee Approved Date: 3/04; 3/05; 3/06; 4/12; 4/16 Medical Policy Committee Approved Date: 11/08; 5/09; 7/09; 8/10; 10/10; 10/12; 8/13; 10/13; 3/14; 6/14; 1/15; 11/15; 12/15; 12/16; 1/18; 6/18 APPLIES TO: Medicare Only See Policy CPT CODE section below for any prior authorization requirements CRITERIA This policy is based on the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 100.1 for for Treatment of Morbid Obesity (effective 09/24/2013) and Local Coverage Article A53028 Coverage (effective 10/01/2018) which were last accessed on 1/16/2019. 1,2 Indications and Limitations of Coverage I. Nationally Covered Indications A. Effective for services performed on and after February 21, 2006, open and laparoscopic Rouxen-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 bodymass index 35, have at least one co-morbidity related to obesity (Link to LCA for a complete list of comorbid conditions), and have been previously unsuccessful with medical treatment for obesity. B. 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 Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for as a 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. C. 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. D. 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- Page 1 of 10
Information/MedicareApprovedFacilitie/Bariatric-Surgery.html, and published in the Federal Register for services provided up to and including date of service September 23, 2013. II. Per the CMS LCA 2 : A. Documentation must clearly demonstrate the failure of reasonable non-invasive/non-surgical treatments for obesity with which the beneficiary has been compliant. B. Noridian considers the following, based on national guidelines for bariatric care, to be the minimum specifications to be documented in the patient record in order to demonstrate the beneficiary has been previously unsuccessful with medical treatment for obesity as required by the NCD: 1. The beneficiary has been previously unsuccessful with medical treatments for obesity. The latter includes but is not limited to: active participation within the last 12 months prior to bariatric surgery in a weight-management program that is supervised by a physician or other health care professionals for a minimum of four consecutive months. The weightmanagement program must include monthly documentation of patient s weight and BMI, current dietary regimen and physical activity (e.g. exercise program). 2. Physician-supervised programs consisting exclusively of pharmacological management are not sufficient to meet this requirement. 3. A thorough multidisciplinary evaluation is required within the previous six months which includes ALL of the following: a. an evaluation by a bariatric surgeon recommending surgical treatment, including a description of the proposed procedure(s) b. a separate medical evaluation from a physician other than a surgeon and preferably the beneficiary s primary care physician that includes both a recommendation for bariatric surgery as well as a medical clearance for the proposed bariatric surgery c. mental health and psychosocial clearance for bariatric surgery by a mental health provider including a statement regarding motivation and ability to follow post-surgical requirements d. a nutritional evaluation by a physician or registered dietician. III. Nationally Non-Covered Indications (Per CMS NCD) 1 : A. Treatments for obesity alone remain non-covered. (Link to LCA for a complete list of comorbid conditions) B. Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section III. below for discretionary local coverage). C. The following bariatric surgery procedures are non-covered for all Medicare beneficiaries: 1. Open adjustable gastric banding; 2. Open sleeve gastrectomy; 3. Laparoscopic sleeve gastrectomy (prior to June 27, 2012); 4. Open and laparoscopic vertical banded gastroplasty; 5. Intestinal bypass surgery; and 6. Gastric balloon for treatment of obesity. Page 2 of 10
IV. Other A. Effective for services performed on and after June 27, 2012, Medicare Administrative Contractors (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. 1. The beneficiary has a body-mass index (BMI) 35 kg/m², 2. The beneficiary has at least one co-morbidity related to obesity (Link to LCA for a complete list of comorbid conditions), and, 3. The beneficiary has been previously unsuccessful with medical treatment for obesity. B. 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 bodymass index 35, have at least one co-morbidity related to obesity (Link to LCA for a complete list of comorbid conditions), and have been previously unsuccessful with medical treatment for obesity, is left to the local MACs. C. 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 techniques 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. V. Per the Non-Covered Services LCD 3 A. Vagus nerve blocking therapy for morbid obesity is considered not proven effective, not medically reasonable and necessary. The Providence Health Plan (PHP) CMS Medical Policy Manual (UM382) hierarchy of coverage indicates that in the absence of an NCD, LCD, LCA, or other coverage guideline, CMS allows coverage determinations to be based on an objective, evidenced-based process. Therefore, the PHP commercial medical policy criteria may be applied to the following service: Repeat or revision of bariatric surgery Repeat Due to Inadequate Weight Loss VI. A repeat bariatric surgery, following an initial, primary bariatric procedure, may be considered medically necessary and covered due to inadequate weight loss when all of the following (A.-D.) criteria are met: A. There is documentation of full compliance with the previously prescribed postoperative dietary and exercise program; and B. There is technical failure of the original bariatric surgical procedure (e.g., pouch dilatation) Page 3 of 10
documented by imaging or an endoscope; and C. The patient has failed to achieve adequate weight loss, which is defined as failure within two (2) years to lose at least 50% of excess body weight due to technical failure; and D. The proposed repeat bariatric procedure is considered medically necessary. Note: Repeat bariatric surgeries are limited to once per life time. A third, bariatric procedure following an initial, primary procedure and a secondary, repeat procedure is not covered. Revision or Conversion Due to Complications NOT Related to an Adjustable Gastric Band VII. Surgical repair, reversal (i.e., take down), or conversion to a different, medically necessary bariatric surgery may be considered medically necessary and covered as treatment of any one or more of the following (A.-M.) documented major complication related to the primary bariatric procedure: A. Barrett s Esophagus B. Bleeding C. Fistula D. Internal hernia or ventral hernia E. Gastric prolapse F. Infection G. Leak/perforation H. Metabolic derangement I. Obstruction J. Stricture K. Stomal Stenosis L. Ulcer M. Excess weight loss to 80% or less of ideal body weight Revision or Conversion Due to Complications Related to the Adjustable Band Major Complications Related to Band Placement VIII. Surgical repair or removal of an adjustable gastric or surgical conversion of an adjustable gastric band to a sleeve gastrectomy or bypass may be considered medically necessary and covered as a treatment of any one or more of the following (A.-D.) documented major complication related to band placement, which cannot be corrected with manipulation or adjustment (i.e., deflation): A. Any one or more of the major complications listed in criterion II.; or B. Band or balloon rupture; or C. Image documentation of erosion, perforation, or slippage; or D. Port malfunction. Symptoms Related to Band Placement in the Absence of Major Complications Page 4 of 10
Note: if major complication is present in conjunction with any of the symptoms noted below, please apply criterion III. IX. Surgical repair or removal of an adjustable gastric band or surgical conversion of an adjustable gastric band to a sleeve gastrectomy or bypass may be considered medically necessary and covered as a treatment of symptoms related to band placement, when endoscopic imaging indicates no major complications are present and any one of the following criteria (A.-C.) are met: Gastroesophageal Reflux Disease (GERD) and/or Respiratory Symptoms of Coughing and/or Aspiration A. Treatment of GERD when all of the following (1.-3.) criteria are met: 1. There is documentation of full compliance with the previously prescribed postoperative dietary and exercise program; and 2. If patient has respiratory symptoms, documents must indicate patient has refrained from smoking for three (3) months; and 3. GERD symptoms are refractory to both of the following (a.-b.) initial treatments: a. Band manipulation or adjustment, which includes band deflation; and b. Anti-reflux medication Vomiting B. Treatment of vomiting when both of the following (1.-2.) criteria are met: 1. There is documentation of full compliance with the previously prescribed postoperative dietary and exercise program; and 2. Vomiting is persistent despite band manipulation or adjustment, which includes band deflation. Dilation of the Esophagus or Stomach or Esophageal Dysmotility C. Treatment of esophageal or stomach dilation when both of the following (1.-2.) criteria are met: 1. There is documentation of full compliance with the previously prescribed postoperative dietary and exercise program; and 2. Esophageal or stomach dilation or esophageal dysmotility is persistent despite band manipulation or adjustment, which includes band deflation. Non-covered Repeat Procedures X. Repeat bariatric surgery or surgical repair, revision, or conversion is considered not medically necessary and is not covered when any of the above criteria (V.-VIII.) are not met, including, but not limited to, any of the following: A. Dissatisfaction with a previous bariatric procedure Page 5 of 10
B. Early satiety C. Weight gain after weight loss of 50% or more of excess body weight in the absence of any complications or symptoms as described above in criteria II.-IV. XI. Transoral outlet reduction (TORe) following bariatric surgery is considered investigational and is not covered following bariatric surgery to treat dilated gastrojejunostomy (GJ) outlet. BILLING GUIDELINES Only the codes listed on this policy may be used for reporting bariatric procedures. Codes 43631-43634 are specific to gastrectomy and should not be used to report bariatric procedures. Code 43843 should not be used when there is a procedure-specific bariatric surgery code. CPT CODES Medicare Only Prior Authorization Required Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than 43843 vertical-banded gastroplasty Roux-en-Y Gastric Bypass 43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less) 43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption 43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy 43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption Adjustable Gastric Banding (e.g., LAP-BAND ) 43770 Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (eg, gastric band and subcutaneous port components) Sleeve Gastrectomy 43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy) Biliopancreatic Bypass with Duodenal Switch 43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch) Removal/Revision of Page 6 of 10
43771 Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device component only 43772 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only 43773 Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only 43774 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components 43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure) 43850 Revision of gastroduodenal anastomosis (gastroduodenostomy) with reconstruction; without vagotomy 43855 Revision of gastroduodenal anastomosis (gastroduodenostomy) with reconstruction; with vagotomy 43860 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; without vagotomy 43865 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; with vagotomy 43886 Gastric restrictive procedure, open; revision of subcutaneous port component only 43887 Gastric restrictive procedure, open; removal of subcutaneous port component only 43888 Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only Not Covered 0312T 0313T 0316T 0317T Vagus nerve blocking therapy (morbid obesity); laparoscopic implantation of neurostimulator electrode array, anterior and posterior vagal trunks adjacent to esophagogastric junction (EGJ), with implantation of pulse generator, includes programming Vagus nerve blocking therapy (morbid obesity); laparoscopic revision or replacement of vagal trunk neurostimulator electrode array, including connection to existing pulse generator Vagus nerve blocking therapy (morbid obesity); replacement of pulse generator Vagus nerve blocking therapy (morbid obesity); neurostimulator pulse generator electronic analysis, includes reprogramming when performed Gastric restrictive procedure, without gastric bypass, for morbid obesity; verticalbanded gastroplasty Unlisted Codes All unlisted codes will be reviewed for medical necessity, correct coding, and pricing at the claim level. If an unlisted code is billed related to services addressed in this policy then priorauthorization is required. 43842 43659 Unlisted laparoscopy procedure, stomach 43999 Unlisted procedure, stomach DESCRIPTION Page 7 of 10
Per the Centers for Medicare & Medicaid Services NCD regarding bariatric surgery as a treatment of obesity: Obesity may be caused by medical conditions such as hypothyroidism, Cushing's disease, and hypothalamic lesions, or can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Non-surgical services in connection with the treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of these medical conditions. In addition, supplemented fasting is a type of very low calorie weight reduction regimen used to achieve rapid weight loss. The reduced calorie intake is supplemented by a mixture of protein, carbohydrates, vitamins, and minerals. Serious questions exist about the safety of prolonged adherence for 2 months or more to a very low calorie weight reduction regimen as a general treatment for obesity, because of instances of cardiopathology and sudden death, as well as possible loss of body protein. Bariatric surgery procedures are performed to treat comorbid conditions associated with morbid obesity. Two types of surgical procedures are employed. Malabsorptive procedures divert food from the stomach to a lower part of the digestive tract where the normal mixing of digestive fluids and absorption of nutrients cannot occur. Restrictive procedures restrict the size of the stomach and decrease intake. Surgery can combine both types of procedures. The following are descriptions of bariatric surgery procedures: 1. Roux-en-Y Gastric Bypass (RYGBP) The RYGBP achieves weight loss by gastric restriction and malabsorption. Reduction of the stomach to a small gastric pouch (30 cc) results in feelings of satiety following even small meals. This small pouch is connected to a segment of the jejunum, bypassing the duodenum and very proximal small intestine, thereby reducing absorption. RYGBP procedures can be open or laparoscopic. 2. Biliopancreatic Diversion with Duodenal Switch (BPD/DS) or Gastric Reduction Duodenal Switch (BPD/GRDS) The BPD achieves weight loss by gastric restriction and malabsorption. The stomach is partially resected, but the remaining capacity is generous compared to that achieved with RYGBP. As such, patients eat relatively normal-sized meals and do not need to restrict intake radically, since the most proximal areas of the small intestine (i.e., the duodenum and jejunum) are bypassed, and substantial malabsorption occurs. The partial BPD/DS or BPD/GRDS is a variant of the BPD procedure. It involves resection of the greater curvature of the stomach, preservation of the pyloric sphincter, and transection of the duodenum above the ampulla of Vater with a duodeno-ileal anastomosis and a lower ileo-ileal anastomosis. BPD/DS or BPD/GRDS procedures can be open or laparoscopic. 3. Adjustable Gastric Banding (AGB) Page 8 of 10
The AGB achieves weight loss by gastric restriction only. A band creating a gastric pouch with a capacity of approximately 15 to 30 cc's 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 patient s 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 no longer performed. 1 INSTRUCTIONS FOR USE Providence Health Assurance (PHA) Medical Policies serve as guidance for the administration of plan benefits. Medical policies do not constitute medical advice nor a guarantee of coverage. PHA Medical Policies are reviewed annually and are based upon Centers for Medicare & Medicaid (CMS) coverage guidance available as of the last policy update. PHA reserves the right to determine the application of Medical Policies and make revisions to its Medical Policies at any time. Providers will be given at least 60-days notice of policy changes that are restrictive in nature. The scope and availability of all plan benefits are determined in accordance with the applicable coverage agreement. Any conflict or variance between the terms of the coverage agreement and PHA Medical Policy will be resolved in favor of the coverage agreement. REGULATORY STATUS Mental Health Parity Statement Coverage decisions are made on the basis of individualized determinations of medical necessity and the experimental or investigational character of the treatment in the individual case. Page 9 of 10
REFERENCES 4 1. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) 100.1for for Treatment of Morbid Obesity. 2013; https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=57&ncdver=5&searchtype=advanced&coverageselection=both&ncselecti on=nca%7ccal%7cncd%7cmedcac%7cta%7cmcd&articletype=sad%7ced&policytype=both &r=r10&keyword=bariatric+surgery&keywordlookup=doc&keywordsearchtype=exact&kq=tr ue&bc=iaaaacaaaaaa&. Accessed 01/16/2019. 2. Centers for Medicare & Medicaid Services (CMS) Local Coverage Article (LCA) A53028 Bariatric Surgery Coverage. 2018; https://www.cms.gov/medicare-coverage-database/details/articledetails.aspx?articleid=53028&ver=33&date=01%2f16%2f2019&docid=a53028&bc=haaaabaaa AAA&. Accessed 01/16/2019. 3. Centers for Medicare & Medicaid Services Local Coverage Determination (LCD): Non-Covered Services (L35008). 2019; https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=35008&ver=93&date=01%2f16%2f2019&docid=l35008&bc=iaaaabaaaaa A&. Accessed 01/16/2019. 4. Medicare Claims Processing Manual: Chapter 32- Billing Requirements for Special Services. 2018; https://www.cms.gov/regulations-and- Guidance/Guidance/Manuals/Downloads/clm104c32.pdf. Accessed 3/26/2018. Page 10 of 10