Highmark Commercial Medical Policy - Pennsylvania


 
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Medical Policy: G-24-047
Topic: Obesity
Section: Miscellaneous
Effective Date: January 1, 2016
Issue Date: January 4, 2016
Last Reviewed: September 2015

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.

Gastric restrictive surgical procedures (e.g., vertical banded gastroplasty, gastric stapling, laparoscopic adjustable gastric banding, vertical sleeve gastrectomy (VSG), 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.

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.

Gastric restrictive and malabsorptive procedure: Roux-en Y gastric bypass combines both restrictive and malabsorptive elements. The restrictive elements can be achieved by stapling the stomach into two sections. The top section becomes a small pouch that serves as the “new” stomach. The small size of this newly formed stomach is so reduced that it “restricts” or limits the amount of food intake. It also provides a feeling of fullness and satisfaction with smaller portions of food. The lower section of the stomach no longer receives stores and mixes food but remains functional by continuing to secrete digestive juices.

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.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

The following bariatric procedures may be considered medically necessary for the surgical treatment of morbid obesity when ALL of the patient selection criteria are met. Bariatric surgery should be performed in appropriately selected patients by surgeons who are adequately trained and experienced in the specific techniques used and in institutions that support a comprehensive bariatric surgery program, including long-term monitoring and follow-up post-surgery.  

  • Laparoscopic adjustable gastric banding using an FDA-approved adjustable gastric band for adults greater than 18-55 years of age; or
  • Biliopancreatic bypass with duodenal switch or open procedure (for members with a BMI of 50≥ kg/m2 or greater; or
  • Roux-en-Y gastric bypass (RY-GBP) (aka gastric bypass surgery) open procedure or laparoscopic; or
  • Laparoscopic Sleeve Gastrectomy or open procedure
    • Sleeve gastrectomy is an eligible procedure as a first stage of a two-stage procedure; or as a sole definitive procedure.
    • For high BMI patients in whom the duodenal switch may be difficult, it is reasonable to do a sleeve gastrectomy as the first stage of an intended two-stage duodenal switch. This does permit subsequent assessment of both the efficacy of the sleeve (to see whether the second stage is really needed), or assessment of the compliance of the patient (to see whether the more complicated procedure is justified), or to examine the metabolic and nutritional effects of the sleeve (to see whether potential further metabolic derangements of the duodenal switch would make it unadvisable). 

Patient Selection Criteria for Adults

  • The patient is morbidly obese and is at least 18 years of age.
    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 or a BMI of 35 with ONE or more of the following comorbidities:
    • Medically refractory hypertension (blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes); or
    • Cardiovascular heart disease (with objective documentation by exercise stress test, radionuclide stress test, pharmacologic stress test, stress echocardiography, CT angiography, coronary angiography, heart failure or prior myocardial infarction); or
    • Hyperlipidemia; or
    • Diabetes mellitus type II; or
    • Obstructive sleep apnea (OSA); or
    • Obesity-hypoventilation syndrome (OHS); or
    • Pickwickian syndrome ( a combination of OSA and OHS); or
    • Nonalcoholic fatty liver disease (NAFLD); or
    • Nonalcoholic steatohepatitis (NASH)
  • The patient has participated in a non-surgical treatment (e.g., dietitian/nutritionist consultation, low calorie diet, exercise program, and behavior modification) and attempts at weight loss have failed; and
  • The patient must participate in and meet the criteria of a structured nutrition (commonly available diet programs, such as Weight Watchers or Jenny Craig, are considered acceptable structured diet programs) and exercise program. This includes dietitian/nutritionist consultation, low calorie diet, increased physical activity, behavioral modification, documented in the medical record.  This structured nutrition and exercise program must meet ALL of the following criteria:
    • The nutrition and exercise program must be supervised and monitored by a physician or other designated licensed provider, (e.g. registered dietician, nurse practitioner, physician’s assistant); and
    • The nutrition and exercise program(s) must total six (6) visits or more during a period of six (6) consecutive months; and
    • The nutritional and exercise program must occur within two (2) years prior to the surgery to enable both behavioral changes and adequate assessment of anticipated postoperative dietary maintenance; and
    • The patient's participation in a structured nutrition and exercise program must be documented in the medical record by an attending physician or other designated  licensed provider; (e.g. registered dietician, nurse practitioner, physician’s assistant  who supervised the patient's progress. A physician’s or the designated licensed provider’s summary letter is not sufficient documentation.  Documentation should include medical records of the physician’s or the designated licensed provider’s (as listed above) 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; and
  • 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.

Procedure Codes
43644, 43770, 43775, 43843, 43845, 43846



Patient Selection Criteria for Adolescents

The eligible bariatric surgical procedures listed above unless otherwise specified are covered for members under the age of 18 years when they meet ALL of the following patient selection criteria:

  • Attainment or near-attainment of physiologic/skeletal maturity at approximately, age 13 in girls and 15 for boys. (The patient has attained Tanner 4 pubertal development and final or near-final adult height (e.g., ≥ 95 %) of adult stature); and
  • The patient is morbidly obese defined as a BMI of > 50 or severely obese defined as a BMI > 40 with ONE or more less serious obesity-related comorbidities:
    • Hypertension; or
    • insulin resistance; or
    • glucose intolerance; or
    • dyslipidemia; or
    • clinically significant obstructive sleep apnea; or  
    • substantially impaired quality of life or activities of daily living;  or
  • A BMI between 35-40 in addition to ONE or more serious obesity related comorbidities;
    • type II  diabetes; or
    • moderate to severe obstructive sleep apnea (apnea-hypopnea index >15); or
    • pseudotumor cerebri; or
    • severe nonalcoholic steatohepatitis (NASH)
  • 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; and ALL of the following:
    • 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, and behavioral modification, documented in the medical record. This structured nutrition and exercise program must meet ALL of the following criteria:
      • The nutrition and exercise program must be supervised and monitored by a physician, registered dietician, nurse practitioner or physician’s assistant; and
      • The nutrition and exercise program(s) must total six (6) visits or more during a period of six (6) consecutive months; and
      • The nutritional and exercise program must occur within two (2) years prior to the surgery; and
      • The patient's participation in a structured nutrition and exercise program must be documented in the medical record by an attending physician or a designated licensed provider e.g. (registered dietician, nurse practitioner, physician’s assistant) who supervised the patient's progress. A physician’s or the designated licensed provider’s summary letter is not sufficient documentation. Documentation should include medical records of the physician's or the licensed provider, e.g. (registered dietician, nurse practitioner, physician’s assistant) 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; and
  • The patient must be able to show decisional capacity and maturity in the psychological evaluation and provide informed assent for surgical management; and
  • The patient must be capable and willing to adhere to nutritional guidelines postoperatively; and
  • The patient must have a supportive and committed family environment; and
  • 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.

Procedure Codes
43644, 43770 , 43775 , 43843 , 43845 , 43846



Repeat or Revised Bariatric Surgical Procedures

Surgical repair to correct perioperative or late chronic complications of a bariatric procedure may be considered medically necessary when there is documentation of a surgical complication related to the perioperative or late chronic complications of a bariatric procedure. These include but are not limited to:

  • Enteric fistula that does not close with bowel rest and nutritional support; or
  • Gastrogastric fistula associated with ulcers, GERD and weight gain; or
  • Band erosion; or
  • Disruption/anastomotic leakage of a suture/staple line; or
  • Tubing  leak or port  dislocation; or
  • Small bowel obstruction; or
  • Band intolerance with obstructive symptoms (e.g. vomiting, esophageal spasm); or
  • Band slippage and/or prolapse that cannot be corrected with manipulation or adjustment; or
  • Stricture/stenosis with dysphagia, solid food intolerance  and/or severe reflux; or
  • Stomal stenosis; or
  • Refractory marginal ulcers; or
  • Non-absorption resulting  in hypocalcemia  or malnutrition; or
  • Weight loss of 20% or more below ideal body weight  

Repeat surgical procedures for revision or conversion to another surgical procedure may be considered medically necessary when the initial bariatric surgery was medically necessary (and the individual continues to meet all the medical necessity criteria for bariatric surgery); and when ANY ONE of the following criteria is met:

  • A conversion to a sleeve gastrectomy, RYGB or BPD/DS for individuals who have not had adequate weight loss 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  (standard tables for adult weight ranges based on height, body frame, gender and age), an example is available from the National Heart Lung and Blood Institute [NHLBI.]
  • A revision of a primary bariatric surgery procedure that has failed due to dilatation of the gastric pouch, dilated gastrojejunal stoma, or dilation of the gastrojejunostomy anastomosis if the primary procedure was successful in inducing weight loss prior to the dilation of the pouch or GJ anastomosis, and the member has been compliant with a prescribed nutrition and exercise program following the procedure; or
  • Replacement of an adjustable band  if there are complications (e.g., port leakage, slippage) that cannot be corrected with band manipulation or adjustments; or
  • A conversion from an adjustable band to a sleeve gastrectomy, RYGB or BPD/DS for individuals 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. 

Inadequate weight loss due to individual noncompliance with postoperative nutrition and exercise recommendations is considered not medically necessary for revision or conversion surgery and is non-covered. 

Repeat procedures for repair, revision, or conversion to another surgical procedure following a gastric bypass or gastric restrictive procedure are considered not medically necessary when the criteria listed above are not met.

Procedure Codes
43644, 43771, 43772, 43773, 43774, 43775, 43845, 43846, 43848, 43886, 43887, 43888



Gastric stapling and gastric bypass surgery reported for the treatment of "morbid obesity" should be processed under the appropriate procedure codes. 

Itemized charges reported for gastroduodenostomy and/or surgery should be combined with the stapling or bypass surgery. 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. A liver biopsy upper gastrointestinal endoscopy and esophagogastroduodenoscopy (EGD) are considered an inherent part of all bariatric surgical procedures. 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. 

Procedure Codes
10021, 10022, 43235, 43236, 43237, 43238, 43239, 43241, 43253, 43259, 43644, 43645, 43770, 43771, 43772, 43773, 43774, 43775, 43843 , 43845 , 43846 , 43847, 43848, 43886, 43887, 43888 , 47001, 47100, 47120, 47122 , 47379



The following bariatric procedures are considered experimental/investigational, and therefore, non-covered.  There is insufficient evidence in the peer-reviewed published medical literature regarding effectiveness and safety of these procedures. 

  • Endoscopic procedures; StomaphyX™ device, or  ROSE procedure;
  • Biliopancreatic bypass (the Scopinaro procedure) or laparoscopic;
  • The long-limb gastric bypass;
  • Intestinal bypass;
  • Laparoscopic gastric plication;
  • Vagal nerve blocking (VBLOC) therapy (neuromodulation non-metabolic), also known as the Maestro implant or Maestro rechargeable system;
  • Mini-gastric bypass;
  • Vertical banded gastroplasty;
  • ReShape Integrated Dual Balloon System;
  • ORBERA Intragastric Balloon System
Procedure Codes
43645, 43842, 43847, 43999 , 0312T, 0313T, 0314T , 0315T, 0316T, 0317T



Refer to Medical Policy Bulletin S-96 for additional information on laparoscopic surgery.

Refer to Medical Policy Bulletin, S-155 for additional information on Gastric electrical stimulation/gastric pacing for treatment of obesity.



Place of Service: Inpatient/Outpatient

The following procedures are typically considered inpatient procedures: Bariatric primary: Biliopancreatic Diversion with Duodenal switch, Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy and Bariatric Revisional Surgery.

The treatment of obesity is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


FEP Guidelines

Gastric restrictive procedures, gastric malabsorptive procedures, and combination restrictive and malabsorptive procedures to treat morbid obesity - 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; eligible members must be age 18 or over.

NOTE:
Here are some things to keep in mind about surgery for morbid obesity:
  • Prior approval is required for outpatient surgery for morbid obesity.
  • Benefits for the surgical treatment of morbid obesity, performed on an inpatient or outpatient basis, are subject to the following pre-surgical requirements:
    • Diagnosis of morbid obesity for a period of 2 years prior to surgery
    • Participation in a medically supervised weight loss program, including nutritional counseling, for at least 3 months prior to the date of surgery. (Note: Benefits are not available for commercial weight loss programs.)
    • Pre-operative nutritional assessment and nutritional counseling about pre- and post-operative nutrition, eating, and exercise
    • Evidence that attempts at weight loss in the 1 year period prior to surgery have been ineffective
    • Psychological assessment of the member’s ability to understand and adhere to the pre- and post-operative program, performed by a psychiatrist, clinical psychologist, psychiatric social worker, or psychiatric nurse
    • Patient has not smoked in the 6 months prior to surgery
    • Patient has not been treated for substance abuse for 1 year prior to surgery
  • Benefits for subsequent surgery for morbid obesity, performed on an inpatient or outpatient basis, are subject to the following additional pre-surgical requirements:
    • All criteria listed above for the initial procedure must be met again
    • Previous surgery for morbid obesity was at least 2 years prior to repeat procedure
    • Weight loss from the initial procedure was less than 50% of the member’s excess body weight at the time of the initial procedure
    • Member complied with previously prescribed postoperative nutrition and exercise program
  • Claims for the surgical treatment of morbid obesity must include documentation from the patient’s provider(s) that all pre-surgical requirements have been met

Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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