Treatment of obesity (278.00) is excluded from medical coverage.  However, covered services for the medical treatment for morbid obesity (278.01) are eligible for reimbursement.  Coverage for the medical treatment of morbid obesity is determined according to individual or group customer benefits.

Surgical Treatment

There are a variety of surgeries intended for the treatment of morbid obesity.  All procedures fall into one of these two categories:

1. Gastric restrictive surgical procedures (e.g., vertical banded gastroplasty, gastric stapling, laparoscopic adjustable gastric banding, mini-gastric bypass, gastric bypass with Roux-en-Y) create a small gastric pouch, resulting in weight loss from early satiety and decreased dietary intake.  The decreased capacity of the stomach reduces the volume of food an individual consumes before feeling full.
2. Malabsorptive surgical procedures (e. g., biliopancreatic diversion, biliopancreatic diversion with duodenal switch, long-limb gastric bypass, intestinal gastric bypass) bypass a section of the small intestines.  Weight loss results from intestinal malabsorption without dietary modification.

The following procedures are covered for the surgical treatment of morbid obesity when all of the patient selection criteria are met.  (Note:  Coverage for the surgical treatment of morbid obesity is determined according to individual or group customer benefits.)

• Laparoscopic adjustable gastric banding using an FDA-approved adjustable gastric band (43770)
  
  Laparoscopic adjustable gastric banding involves creating a gastric pouch by placing a gastric band around the exterior of the stomach.  The band is attached to a reservoir that is implanted subcutaneously in the abdominal fascia in the patient’s upper abdomen.  Injecting the reservoir with saline will alter the diameter of the gastric band.  This limits food consumption and creates an earlier feeling of fullness.  Subsequent adjustments can be made either to tighten or loosen the band to meet individual patient needs.

• Roux-en-Y gastric bypass (RY-GBP) {open (43846) or laparoscopic (43644)}

The open Roux-en-Y gastric bypass is considered the gold standard for bariatric surgery.  A small (30 cc) proximal gastric pouch is constructed which is then divided from the remainder of the stomach just below the cardia with a short (150 cm or less) Roux-en-Y gastrojejunostomy performed between the proximal gastric pouch and a Roux-en-Y jejunal limb.

• Vertical banded gastroplasty and gastric stapling (open) (43842, 43843)
  
  Vertical banded gastroplasty is a type of gastric restrictive procedure, which consists of constructing a small pouch with a restricted outlet along the lesser curvature of the stomach.  The outlet may be externally reinforced to prevent disruption or dilation.
  
  Gastric stapling is accomplished by stapling the upper stomach to create a small pouch into which food flows after it’s swallowed.  The outlet of this pouch is restricted by a band of synthetic mesh, which slows its emptying, so that the person feels full after only a few bites of food.

Patient Selection Criteria

• The patient is morbidly obese;

Morbid obesity is defined as a condition of consistent and uncontrollable weight gain that is characterized by a weight which is at least 100 lbs. or 100% over ideal weight or a BMI of at least 40 (V85.4) or a BMI of 35 (V85.35-V85.39) with comorbidities (e.g., hypertension, cardiovascular heart disease, dyslipidemia, diabetes mellitus type II, sleep apnea).

• The patient is at least 18 years old; and

• The patient has received non-surgical treatment (e.g., dietitian/nutritionist consultation, low calorie diet, exercise program, and behavior modification) and attempts at weight loss have failed.

• The patient must participate in and meet the criteria of a structured nutrition and exercise program.  This includes dietitian/nutritionist consultation, low calorie diet, increased physical activity, behavioral modification, and/or pharmacologic therapy, documented in the medical record.  This structured nutrition and exercise program must meet all of the following criteria:

1. The nutrition and exercise program must be supervised and monitored by a physician working in cooperation with dieticians and/or nutritionists; and
2. The nutrition and exercise program(s) must be for a cumulative total of 6 months or longer in duration; and
3. The nutritional and exercise program must occur within two years prior to the surgery; and
4. The patient's participation in a structured nutrition and exercise program must be documented in the medical record by an attending physician who supervised the patient's progress.  A physician's summary letter is not sufficient documentation.  Documentation should include medical records of the physician's on-going assessments of the patient's progress throughout the course of the nutrition and exercise program.  For patients who participate in a structured nutrition and exercise program, medical records documenting the patient's participation and progress must be available for review.

• The patient must complete a psychological evaluation performed by a licensed mental health care professional and be recommended for bariatric surgery.  The patient's medical record documentation should indicate that all psychosocial issues have been identified and addressed.
  
  
• Patient selection is a critical process requiring psychiatric evaluation and a multidisciplinary team approach.  The member's understanding of the procedure, and ability to participate and comply with life-long follow-up and the life-style changes (e.g., changes in dietary habits, and beginning an exercise program) are necessary to the success of the procedure.

If the patient does not meet all of the patient selection criteria for bariatric surgery, the procedure will be denied as not medically necessary. 

Gastric stapling and gastric bypass surgery reported for the treatment of "morbid obesity" should be processed under the appropriate procedure code 43644, 43842, 43843, 43846, or 43848respectively.  Claims for "vertical banded gastroplasty" should be processed under code 43842.(See Medical Policy Bulletin S-96 for additional information on laparoscopic surgery.)

In addition, itemized charges reported for gastroduodenostomy and/or surgery should be combined with the stapling, vertical banded gastroplasty or bypass surgery.  The gastrojejunostomy in conjunction with gastric stapling, vertical banded gastroplasty or gastric bypass claim should be processed under the appropriate code 43644, 43842, 43843, 43846, or 43848.  Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

A liver biopsy (10021, 10022, 47001, 47100, 47120, 47122, and 47379), upper gastrointestinal endoscopy and esophagogastroduodenoscopy (EGD) (43234-43239, 43241, and 43259) are considered an inherent part of all bariatric surgical procedures (43644, 43645, 43770-43774, 43842-43848, 43886-43888, and S2083).  These services are not eligible for separate payment when reported on the same day as a bariatric surgical procedure.  When a doctor reports a liver biopsy, upper gastrointestinal endoscopy  or EGD with a bariatric surgical procedure, the charges should be combined under the appropriate bariatric surgery procedure code.  A participating, preferred, or network provider cannot bill the member for the liver biopsy, upper gastrointestinal endoscopy, or EGD.  Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day.  When modifier 59 is reported, the patient’s records must support its use in accordance with CPT guidelines.

Repeat or Revised Bariatric Surgical Procedures (43771-43774, 43848, and 43886-43888)

• Conversion of a gastric restrictive procedure without gastric bypass (e.g., laparoscopic adjustable gastric banding, or vertical banded gastroplasty) to a gastric restrictive procedure with gastric bypass (e.g., for morbid obesity)
  
  
• Revision of a failed gastric restrictive procedure (e.g., restapling of dehisced vertical banded gastroplasty staple line, severe adhesions of the gastric pouch, stenosis of stoma, dilation of stoma)
  
  A Roux-en-Y gastric bypass (43644, 43846) may be considered medically necessary for patients who have not had adequate weight loss (defined as loss of more than 50 percent of excess body weight) from the primary bariatric surgery (e.g. laparoscopic adjustable gastric banding (43770), vertical banded gastroplasty (43842).  Since, maximal weight loss is not typically achieved until 1 to 2 years of the primary bariatric surgery (e.g., laparoscopic adjustable gastric banding, or vertical banded gastroplasty), a Roux-en-Y gastric bypass is considered not medically necessary and not covered if performed within two years of the primary bariatric surgery.  In addition, a Roux-en-Y gastric bypass following laparoscopic adjustable gastric banding or vertical banded gastroplasty is considered not medically necessary and not covered for patients who have been substantially noncompliant with a prescribed nutrition and exercise program following the primary bariatric surgery.  More than one laparoscopic adjustable gastric banding, vertical banded gastroplasty or Roux-en-Y gastric bypass procedure is considered not medically necessary.
  
  Reoperation may be required to either “take-down” or revise the original bariatric procedure.  Surgical revision or reversal (i.e., take-down) is covered for members who have complications from the primary procedure demonstrated by diagnostic study (e.g., obstruction, stricture, dilation of the gastric pouch).  A reoperation or reversal is considered not medically necessary unless the primary bariatric surgery has resulted in complications, and therefore, it is not covered.  (See Medical Policy Bulletin Z-35 for additional information on repeat surgical procedures.)
  
  Codes 43771-43774, 43886-43888 represent open or laparoscopic revisions, repairs or removal of the components of laparoscopic adjustable gastric banding.  These procedures would be indicated if there was a complication (e.g., infection in the area of the subcutaneous port).

Services that do not meet the medical necessity guidelines outlined in this policy will be considered not medically necessary. Effective January 26, 2009, a participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement should be maintained in the provider's records.

Endoscopic procedures (43999) (e.g., insertion of the StomaphyX™ device) to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches are considered experimental/investigational. Well-designed large population, multicenter, controlled clinical trials with long-term follow-up are needed. A participating, preferred, or network provider can bill the member for the denied service. The StomaphyX™ device was approved in March 2007 by the FDA through the 510(k) process. It is being used in endoluminal transoral tissue approximation and ligation in the gastrointestinal tract.

The StomaphyX device is also used in the treatment of gastroesophageal reflux disease. See Medical Policy S-145 for information on endoscopic/endoluminal gastroplasty or gastroplication with suturing of the esophagogastric junction in the treatment of GERD.

Date Last Reviewed: 05/2008

The following procedures are considered experimental/investigational, and therefore, they are not covered.  A participating, preferred or network provider can bill the member for the denied service.

• Biliopancreatic bypass (the Scopinaro procedure) (43847) or laparoscopic (43645)

The biliopancreatic diversion (BPD) was first reported by Scopinaro, et al, in 1976 as a procedure that combined both gastric restriction and malabsorption.  The technique includes a partial gastrectomy to create a 200-300 cc pouch followed by division and anastomosis of the terminal ileum to the stomach.  The jejunum is totally excluded from digestive continuity with the distal end anastomosed to the terminal ileum, creating a “common channel” of ileum approximately 50 cm from the ileocecal valve.  A high incidence and the severity of complications following BPD have led many surgeons to restrict its use as an operation for the treatment of super obese patients.

Date Last Reviewed:  08/2007

Biliopancreatic bypass with duodenal switch (43845)

The biliopancreatic bypass with duodenal switch is a modification of the biliopancreatic bypass.  The most significant difference from the biliopancreatic bypass to the duodenal switch procedure is utilization of a sleeve gastrectomy of the greater curvature rather than a distal gastrectomy and anastomosis of the ileum to the duodenum instead of the stomach.

Date Last Reviewed:  08/2007

Long-limb gastric bypass (i.e., > 150cm) (43847) or laparoscopic (43645)

The long-limb gastric bypass differs from the conventional gastric bypass only in the length of defunctionalized jejunum.  The long-limb gastric bypass was designed to induce greater malabsorption by diverting bile and pancreatic secretions distally in the digestive tract.  This was felt to produce a greater malabsorption of fats without the protein malabsorption associated with intestinal bypass.

Date Last Reviewed:  06/2009

• Mini-gastric bypass

A mini-gastric bypass is a variation of the gastric bypass.  Using a laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y anastomosis, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure.

Date Last Reviewed:  06/2009

• Sleeve Gastrectomy

A sleeve gastrectomy is an alternative approach to gastrectomy that can be performed on its own, or in combination with malabsorptive procedures (most commonly biliopancreatic diversion with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum, and avoiding the dumping syndrome (overly rapid transport of food through stomach into intestines) that is seen with distal gastrectomy. This procedure is relatively simple to perform, and can be done by the open or laparoscopic technique. Some surgeons have proposed this as the first in a 2-stage procedure for very high-risk patients.

Date Last Reviewed: 09/2008

• Two-Staged Procedure for Morbid Obesity

In the two-staged procedure, the greater curve of the stomach is removed in the initial procedure, and then a Roux-en-Y technique is used to anastomose the small bowel to the stomach remnant.  Bariatric procedures are usually completed in one operative procedure.  At this time, multi-staged bariatric procedures are considered experimental/investigational.

Date Last Reviewed:  09/2008

There is a lack of peer reviewed medical literature that contains comparative data that demonstrates the above mentioned procedures are equivalent to or offer any advantage over the accepted alternatives, particularly Roux-en-Y gastric bypass. 

Intestinal bypass

The intestinal (e.g., jejunoileal) bypass is created by dividing the small bowel 30 cm distal to the ligament of Treitz.  The proximal cut end of the small bowel is anastomosed to the terminal ileum 50 cm proximal to the ileocecal valve.  The rest of the small bowel remains a blind loop.

When intestinal bypass surgery is reported, the claim should be processed in accordance with Medical Policy Bulletin G-21 (procedures of questionable current usefulness). 

For information on gastric electrical stimulation/gastric pacing for treatment of obesity, please refer to Medical Policy Bulletin S-155.

Description

Obesity is an increase in body weight beyond the limitation of skeletal and physical requirements, as a result of excessive accumulation of fat in the body. In general, 20% to 30% above "ideal" bodyweight, according to standard life insurance tables, constitutes obesity. Morbid obesity is further defined as a condition of consistent and uncontrollable weight gain that is characterized by a weight which is at least 100 lbs. or 100% over ideal weight or a body mass index (BMI) of at least 40 or a BMI of 35 with comorbidities (e.g., hypertension, cardiovascular heart disease, dyslipidemia, diabetes mellitus type II, sleep apnea).

Body mass index (BMI) is a method used to quantitatively evaluate body fat by reflecting the presence of excess adipose tissue. BMI is calculated by dividing measured bodyweight in kilograms by the patient's height in meters squared. The normal BMI is 20-25 kg/meters squared.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

FEP will cover gastric restrictive procedures, gastric malabsorptive procedures, and combination restrictive and malabsorptive procedures to treat morbid obesity.  Morbid obesity is described as a condition in which an individual has a Body Mass Index (BMI) of 40 or more, or an individual with a BMI of 35 or more with co-morbidities who has failed conservative treatment.  All eligible members must be age 18 years or over. 

Benefits are also available for diagnostic studies and a psychological examination performed prior to the procedure to determine if the patient is a candidate for the procedure. 

PRN References

02/1993, Obesity 04/2003, Obesity defined
06/2003, Highmark considers laparoscopic adjustable gastric banding investigational
10/2003, Obesity guidelines revised
06/2004, Guidelines on liver biopsy, upper gastrointestinal endoscopy (UGI) and esophagogastroduodenoscopy (EGD) when reported with a bariatric surgical procedure
08/2004, Clarification on patient selection criteria for bariatric surgery
10/2004, Sapala-Wood Micropouch Roux-en-Y gastric bypass
06/2006, Patient selection criteria for bariatric surgery explained
02/2007, Sleeve gastrectomy considered investigational
04/2007, Laparoscopic adjustable gastric banding now eligible for reimbursement
10/2008, StomaphyX not covered

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