Bariatric Surgery Form

1

Bariatric Surgery - Medical Policy
Updated Revision Effective: July 1, 2024 Policy Number:

UM061POL

Approval Date: 4/29/2024

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Bariatric surgical procedures affect weight loss through three fundamental mechanisms, i.e., malabsorption, restriction, and the neurohormonal response that regulates hunger and energy balance. Some procedures have both a restrictive and malabsorptive component.

Restrictive procedures limit caloric intake by reducing the stomach's reservoir capacity via resection, bypass, or creation of a proximal gastric outlet. The sleeve gastrectomy has become the main restrictive procedure, but it is probably more successful due to its hormonal effects on hunger control.

Malabsorptive procedures decrease the effectiveness of nutrient absorption by shortening the absorption length of the functional small intestine, either through bypass of the small bowel absorptive surface area or diversion of the biliopancreatic secretions that facilitate absorption. Jejunoileal bypass (JIB) and the biliopancreatic diversion (BPD) are examples of malabsorptive procedures. Profound weight loss can be achieved by a malabsorptive operation, depending upon the effective length of the functional small bowel segment. However, the benefit of superior weight loss can be offset by significant metabolic complications, such as protein calorie malnutrition and various micronutrient deficiencies.

Restrictive and malabsorptive procedures include the Roux-en-Y gastric bypass (RYGB), the BPD with duodenal switch (BPD/DS), and the single-anastomosis duodenal ileal bypass with sleeve gastrectomy (SADI-S). In the RYGB, a small gastric pouch limits oral intake. However, the small bowel reconfiguration provides additional mechanisms favoring weight loss, including dumping physiology, positive hormonal changes, and mild malabsorption. There is an effect on hunger as well, likely due to the hormonal changes. The one-anastomosis gastric bypass (OAGB) also works by restriction and malabsorption as well as hormonal modulation.

2

 Line of Business

Commercial:
Refer to criteria under Policy section in this medical policy.

Medicaid – BeHealthy:
Health New England follows MassHealth Medical necessity guidelines for Bariatric surgery: https://www.mass.gov/lists/masshealth-guidelines-for-medical-necessity-determination

Medicare:
Health New England follows Local Coverage Determination (NCD) 100.1 Bariatric Surgery for Treatment of Co- morbid Conditions Related to Morbid Obesity. https://www.cms.gov/medicare-coverage-database/search.aspx

Policy

I. A. Initial Bariatric Surgery is considered medically necessary for members age 18 years and older when ALL of the following criteria are met:

1. Body mass index (BMI) greater than or equal to 35 kg/m2 (as documented prior to any pre-op interventions), regardless of presence, absence, or severity of co-morbidities; AND

2. Member has failed previous behavioral modification approaches to long-term weight loss. Surgeon must use their discretion on the different approaches tried by member including diet with exercise programs, behavioral changes, etc., and duration; AND

3. The member has participated in a multidisciplinary structured preoperative surgical program supervised by a physician or other professional health care provider; must directly precede the surgical procedure. Documentation must reflect all of the following:

   a. Adherence to preoperative care plan and program participation, including weight-loss history and progress toward diet and exercise goals in order to improve surgical outcomes, reduce the potential for surgical complications, and establish the member’s ability to comply with postoperative medical care and dietary restrictions. Note: A physician summary letter is not considered sufficient documentation. Medical and program records documenting progress, participation, and specific behavioral changes must be included; AND

   b. Tobacco cessation or significant attempt to decrease smoking

   c. Evidence that reversible endocrine or metabolic causes of obesity have been ruled out; and

   d. Evidence that diabetes when present is under control or, if difficult to control, evidence that the condition is under supervision and management; and

   e. Evidence that symptoms of gastroesophageal reflux disease (GERD) have been assessed and have been evaluated in the context of the chosen bariatric surgical intervention (e.g., GERD is a relative contraindication to sleeve gastrectomy); and

3

f. Female candidates for bariatric surgery have been counseled to avoid pregnancy preoperatively and for at least 12 months postoperatively; and

AND

4. Psychological or psychiatric evaluation has been performed within the past year that ruled out uncontrolled mental health disorders (e.g., chemical dependency, eating disorders, major depression or schizophrenia) that would contraindicate surgery and/or impair adherence with pre- and postoperative regimen, dietary instructions and impair ability to provide informed consent for the procedure; AND

   B. When criteria and requirements are met, the following bariatric surgical procedures for the initial treatment of obesity for members age 18 and older are considered medically necessary:

5. Sleeve gastrectomy

6. Open or laparoscopic Roux-en-Y gastric bypass (RYGB) (up to 150cm)

7. Laparoscopic adjustable gastric banding (LAGB)

8. Open or laparoscopic biliopancreatic diversion with or without duodenal switch

   C. Individual plan benefits and limitations will apply.

   II. Bariatric Surgery is considered medically necessary for Adolescents Ages 13-17 when members meet Criteria (A.) AND (B. or C.) AND (D.) below.

   A. Growth and Development: Achieved greater than 95% of estimated adult height based on documented individual growth pattern, or a minimum Tanner stage of 4; AND

   B. Patients with BMI equal to or > 35 - 39.9 kg/m2 must have one or more of the following major medical comorbidities:

9. Type 2 diabetes mellitus OR

10. Moderate-to-severe sleep apnea (AHI>15 - Apnea Hypopnea Index) OR

11. Pseudotumor cerebri OR

12. Severe NASH (Non-alcoholic Steatohepatitis) OR

13. Coronary artery disease OR

14. Idiopathic intracranial hypertension OR

15. Poorly controlled hypertension (systolic blood pressure at least 140 Hg or diastolic blood pressure 90 mmHg or greater, despite optimal medical management)

    OR

4

C. Patients with BMI equal to or > 40 kg/m2

AND

D. The member has shown a motivated attempt of weight loss through participation in structured program(s) before bariatric surgery for at least 3 months within a year before the request for the procedure. Among structured programs, participation in a preoperative surgical program supervised by a physician or other professional health care provider is required; must directly precede the surgical procedure; and may be included in the 3 months. Documentation must reflect all of the following:

1. Adherence to surgical preoperative care plan and program participation, including weight-loss history and progress toward diet and exercise goals in order to improve surgical outcomes, reduce the potential for surgical complications, and establish the member’s ability to comply with postoperative medical care and dietary restrictions. (A physician summary letter is not sufficient documentation.) Medical and program records documenting progress, participation, and specific behavioral changes must be included; and

2. Tobacco cessation or significant attempt to decrease smoking; and

3. Evidence that reversible endocrine or metabolic causes of obesity have been ruled out; and

4. Evidence that diabetes when present is under control or, if difficult to control, evidence that the condition is under supervision and management; and

5. Evidence that symptoms of gastroesophageal reflux disease (GERD) have been assessed and have been evaluated in the context of the chosen bariatric surgical intervention (e.g., GERD is a relative contraindication to sleeve gastrectomy); and

6. Female candidates for bariatric surgery have been counseled to avoid pregnancy preoperatively and for at least 12 months postoperatively; and

7. Psychological or psychiatric evaluation has been performed within the past year that ruled out uncontrolled mental health disorders (e.g. chemical dependency, eating disorders, major depression or schizophrenia) that would contraindicate surgery and/or impair adherence with pre- and postoperative regimen, dietary instructions and impair ability to provide informed consent for the procedure.

   E. When criteria and requirements are met, the following bariatric surgical procedures for the initial treatment of obesity for members under the age of 18 are considered medically necessary:

8. Sleeve gastrectomy

9. Open or laparoscopic Roux-en-Y gastric bypass (RYGB) (up to 150cm)

   III. Repeat Bariatric Surgery and Gastric Band Adjustments:

   A. Conversion to a sleeve gastrectomy, RYGB or BPD/DS is considered medically necessary for members who have not had adequate success (defined as loss of more than 50% of excess body weight) 2 years following the primary bariatric surgery procedure and the member has been compliant with a prescribed nutrition and exercise program following the procedure; or

5

B. Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch, dilated gastrojejunal stoma, or dilation of the gastrojejunostomy anastomosis is considered medically necessary if the primary procedure was successful in inducing weight loss and the member has been compliant with a prescribed nutrition and exercise program following the procedure; or

C. Conversion from an adjustable band to a sleeve gastrectomy, RYGB or BPD/DS is considered medically necessary for members who have been compliant with a prescribed nutrition and exercise program following the band procedure, and there are complications that cannot be corrected with band manipulation, adjustments or replacement.

D. Adjustment, revision, replacement of gastric bands is considered medically necessary when it is used to control the rate of weight loss or symptoms caused by restriction from the band.

E. Required documentation for revision should reflect adherence to postoperative care plan and program participation, including detailed records of postoperative weight loss, strict diet, and exercise regimen.

Note: A physician summary letter is not sufficient documentation. Medical and program records documenting progress, participation, and specific behavioral changes must be included.

IV. Medicare: NCD is followed as per below guideline:

NCD 100.1 Bariatric Surgery for Treatment of Co-morbid Conditions Related to Morbid Obesity.
https://www.cms.gov/medicare-coverage-database/search.aspx

V. Required Documentation

Clinical notes documenting all of the above

VI. Any bariatric procedure not listed as covered is considered experimental and investigational, including but not limited to:

 Fobi-Pouch (limiting proximal gastric pouch)
 Gastroplasty (stomach stapling)
 Intestinal bypass (jejunoileal bypass)
 Intragastric balloon (e.g., Orbera Intragastric Balloon System, ReShape Integrated Dual Balloon System)
 Loop gastric bypass
 Mini-gastric bypass
 Natural Orifice Transluminal Endoscopic Surgery™ (NOTES™) (e.g., StomaphyX™)  EndoBarrier™ Gastrointestinal Liner  Stomach aspiration therapy (e.g., Aspire Assist)  Vagus nerve blocking (e.g., VLOB device, also known as the Maestro Implant or Maestro Rechargeable System)
 Vertical Banded Gastroplasty (VBG)
 Biliopancreatic diversion (BPD) without duodenal switch  Laparoscopic gastric plication or laparoscopic greater curvature plication
 Roux-en-Y gastric bypass (short limb or long limb) combined with simultaneous gastric banding  When used for GERD
 Parietal cell separating gastrojejunostomy

6

 Two stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time).

Policy Guidelines and Definitions

Adjustable Gastric Banding (AGB) – AGB achieves weight loss through gastric restriction only by an inflatable doughnut-shaped balloon band. This band creates a small gastric pouch. The pouch is located in the uppermost part of the stomach. The band can be adjusted by adding or removing saline through a port. AGB procedures are laparoscopic only.

Biliopancreatic Diversion with Duodenal Switch (BPD/DS) – BPD/DS partially resects the stomach with weight loss through gastric restriction and malabsorption. Meal size is not restricted and one can eat relatively normal- sized meals because of the malabsorption with bypass of the jejunum and duodenum. Partial BPD/DS involves resection of the greater curvature of the stomach. It preserves the pyloric sphincter and transects the duodenum with a duodeno-ileal anastomosis and a lower ileo-ileal anastomosis. BPD/DS can be open or laparoscopic.

Roux-en-Y Gastric Bypass (RYGBP) – RYGBP reduces the stomach to a small gastric pouch (30 cc). By doing this, it results in feelings of satiety after meals (small). Weight loss is achieved through gastric restriction and malabsorption. This pouch is joined to a segment of the jejunum, bypassing the duodenum and very proximal small intestine. This reduces absorption. RYGBP can be open or laparoscopic.

Sleeve Gastrectomy – Resection of the greater curvature of the stomach is done and by doing this, it results in a tube or sleeve shaped stomach. Since the pyloric sphincter is preserved, it results in a more physiologic transit of food from the stomach to the duodenum and avoids the dumping syndrome. Dumping syndrome occurs when there is an overly rapid transport of food through the stomach into the intestines.

Bariatric Surgery – Also known as weight-loss surgery: Performed on the gastrointestinal tract of obese people to alter the digestive process and induce weight loss

Pickwickian Syndrome – Obesity hypoventilation syndrome that changes the balances of oxygen and carbon dioxide in the lungs

Pseudotumor Cerebri – Disorder with elevated spinal fluid pressure in the brain (aka: idiopathic intracranial hypertension)

Coding Guidance

CPT Codes

PA Requirement 43644
Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less)
Yes 43645
Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass
and small intestine reconstruction to limit absorption
Yes 43659 Unlisted laparoscopy procedure, stomach
Yes if related to a procedure listed in this policy

7

43770
Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric band (gastric band and subcutaneous port components)
Yes 43771
Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric band component only
No 43772
Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric band component only
No 43773
Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric band component only
No 43774
Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric band and subcutaneous port components
No 43775
Longitudinal gastrectomy (i.e., sleeve gastrectomy)
Yes 43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure) Yes 43860 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; without vagotomy Yes 43865 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; with vagotomy Yes 43886
Gastric restrictive procedure, open; revision of subcutaneous port component only No 43887
Gastric restrictive procedure, open; removal of subcutaneous port component only No 43888
Gastric restrictive procedure, open; removal and replacement of subcutaneous port component Only No 43999 Unlisted procedure, stomach
Yes if related to a procedure listed in this policy 43842
Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty
Yes 43843
Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty
Yes 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) Yes 43846
Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
Yes 43847
Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction
Yes 43290 Esophagogastroduodenoscopy, flexible, transoral; with deployment of intragastric bariatric balloon NOT COVERED 43291 Esophagogastroduodenoscopy, flexible, transoral; with removal of intragastric bariatric balloon(s) NOT COVERED 44799 Unlisted procedure, small intestine
Yes if related to a procedure listed in this policy

CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

8

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Eisenberg, Dan, et al. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) indications for metabolic and bariatric surgery.

2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery - Surgery for Obesity and Related Diseases (soard.org)

National Coverage Determination (NCD) for Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity (100.1).

https://www.cms.gov/medicare-coverage-database/search.aspx

MassHealth Medical necessity guidelines for Bariatric surgery: https://www.mass.gov/guides/masshealth- guidelines-for-medical-necessity-determination-for-bariatric-surgery

Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R).

https://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=160&ver=32&NcaName=Bariatric Surgery for the Treatment of Morbid Obesity (1st Recon)&bc=BEAAAAAAEAgA

Impact of Preoperative Supervised Weight Loss Programs on Bariatric Surgery Outcomes. (2017, December 19).

https://evidence.hayesinc.com/report/dir.impactpreopbariatric4174

Bariatric Surgery Guidelines and Recommendations. (Annual Review 1/18/2022).

https://asmbs.org/resources/bariatric-surgery-guidelines-and-recommendations

Comparative Effectiveness Review of Bariatric Surgeries for Treatment of Obesity in Adolescents (Annual Review January 20, 2022).

https://evidence.hayesinc.com/report/dir.bariatricadolescent4290

Lee, W, Almalki, O, Recent Advancements in bariatric/metabolic surgery. Annals of Gastroenterological Surgery (2017 Sept 10).

  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5881368/

Potential Candidates for Weight-loss Surgery, Who is a good adult candidate for bariatric surgery?

   https://www.niddk.nih.gov/health-information/weight-management/bariatric-surgery/potential-candidates

Turner, J, Puberty and the Tanner Stages.

https://childgrowthfoundation.org/wp-content/uploads/2018/05/Puberty-and-the-Tanner-Stages.pdf

9

Jawad, MD, M Why do some people need a second Bariatric Surgery? (Sept. 19, 2015).

https://www.orlandohealth.com/content-hub/why-do-some-people-need-a-second-bariatric-surgery

Obesity Surgery, Medical Clinical Policy Bulletins.

http://www.aetna.com/cpb/medical/data/100_199/0157.html

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 8/13/2002 Initial Policy Date 4/2023 Criteria re-ordered and clarified. No change to covered procedures.
1/2024 Added Line of Business Section 4/2024 MassHealth adults will use MassHealth criteria instead of HNE effective 7/1/2024. Other criteria clarified with no significant change.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.