Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Treatment of Obesity and Bariatric Surgery for Treatment of Morbid Obesity
Policy #:MA11.051a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Bariatric surgery procedures for morbid obesity are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a BMI of 35 or higher.
  • The individual has at least one comorbidity related to obesity (e.g., refractory hypertension, refractory hyperlipidemia, obesity induced cardiomyopathy, type 2 diabetes mellitus, clinically significant obstructive sleep apnea, obesity related hypoventilation, pseudotumor cerebri, severe arthropathy of spine and/or weight-bearing joints, hepatic steatosis without prior evidence of active inflammation).
  • The individual has a documented failed history of medical treatment for obesity.
  • The individual is scheduled for one of the following operations:
    • Adjustable gastric banding (laparoscopic only [CPT code 43770])
    • Roux-en-Y gastric bypass with short limb (proximal) (150 cm or less) (laparoscopic [CPT code 43644] or open [CPT code 43846])
    • Roux-en-Y gastric bypass with long limb (distal) (greater than 150 cm) (laparoscopic [CPT code 43645] or open [CPT code 43847])
    • Sleeve gastrectomy (laparoscopic only [CPT code 43775] as part of a stand-alone procedure
    • Biliopancreatic bypass with duodenal switch (CPT code 43845) or Gastric Reduction Duodenal Switch (BPD/GRDS)

CONCURRENT CHOLECYSTECTOMY

Cholecystectomy performed in conjunction with bariatric surgery is considered medically necessary and, therefore, covered when the individual has any of the following:
  • Signs and/or symptoms of gallbladder disease
  • Finding of a grossly diseased gallbladder at the time of bariatric surgery
  • A history of metabolic derangements that will result in symptomatic gallbladder disease following bariatric procedures


NOT MEDICALLY NECESSARY

Bariatric surgery is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • Prohibitive perioperative risk of cardiac complications due to cardiac ischemia or myocardial dysfunction
  • Severe chronic obstructive airway disease or respiratory dysfunction
  • Failure to cease tobacco use
  • Noncompliance with medical treatment of obesity or treatment of other chronic medical conditions.
  • Psychological/psychiatric condition
    • Schizophrenia, borderline personality disorder, suicidal ideation, severe or recurrent depression, or bipolar affective disorders with difficult-to-control manifestations (e.g., history of recurrent lapses in control or recurrent failure to comply with management regimen)
    • Intellectual disability that prevents personally provided informed consent or the ability to understand and comply with a reasonable pre- and post-operative regimen
    • Any other psychological/psychiatric disorder that, in the opinion of a psychologist/psychiatrist, imparts a significant risk of psychological/psychiatric decompensation or interference with long-term postoperative management
  • History of significant eating disorders, including anorexia nervosa, bulimia, and pica (i.e., ingesting sand, clay, or other abnormal substances)
  • Hepatic disease with prior documented inflammation, portal hypertension, or ascites (i.e., fluid accumulation in the peritoneal cavity)
  • Severe hiatal hernia/gastroesophageal reflux (for purely restrictive procedures such as laparoscopic adjustable gastric banding)
  • Autoimmune and rheumatological disorders (including inflammatory bowel diseases and vasculitides) that will be exacerbated by the presence of intra-abdominal foreign bodies (for the laparoscopic adjustable gastric banding procedure)

Note: A history or presence of mild, uncomplicated, and adequately treated depression due to obesity is not normally considered an absolute contraindication to bariatric surgery.

REPEAT BARIATRIC SURGERY

In accordance with Medicare, repeat bariatric surgery is generally considered not medically necessary, and therefore not covered.


NON-COVERED

For the surgical intervention of morbid obesity or morbid obesity and type 2 diabetes mellitus in individuals, all other bariatric procedures other than those outlined above as medically necessary are considered not medically necessary, and therefore not covered. These include, but are not limited to, the following procedures:
  • Sleeve gastrectomy as an open (CPT code 43843) stand-alone procedure or as part of a two-stage procedure; laparoscopic (CPT code 43775) or open (CPT code 43843).
  • Adjustable gastric banding as an open (CPT code 43843) procedure
  • Vertical-banded gastroplasty: laparoscopic (CPT code 43659) or open (CPT code 43842) procedure
  • Gastric balloon (CPT code 43999)
  • Intestinal bypass Surgery
  • Mini-Gastric bypass
  • Silastic Ring Vertical Gastric Bypass (Fobi pouch)


Supplemental Fasting

In accordance with Medicare, supplemented fasting is not covered by the Company, because it is not considered as a general treatment for obesity.

PLACE OF SERVICE

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

At the time of precertification of the services listed below, the surgeon must submit a letter of medical necessity (LOMN), attesting that the member has been compliant with a prescribed nutrition and exercise program following the initial procedure.

Services for which the LOMN is required:
  1. Conversion (e.g., to a Roux-en-Y gastric bypass or vertical gastrectomy) for members who have not had adequate success (defined as loss of more than 50 percent of excess body weight) two years following the initial bariatric surgery procedure.
  2. Revision of a primary bariatric surgery procedure that has failed due to dilation of the gastric pouch where the primary procedure was successful in inducing weight loss prior to the pouch dilation.

Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, treatment of obesity and bariatric surgery for treatment of morbid obesity are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary or not covered are not eligible for coverage or reimbursement by the Company.


COMPLICATIONS

Complications of a bariatric surgery procedure may include those associated with any major surgery such as bleeding or infection, but may also include those specific to the bariatric procedure itself or the method (e.g., laparoscopic, open) used. Complications associated with bariatric surgery (including those resulting from a technical failure) usually occur during the 30-day period following the operation. The most common complications include, but are not limited to:
  • Band erosion
  • Band slippage
  • Internal hernia requiring further surgery
  • Leaks from or dehiscence of anastomoses or staple lines
  • Separation of stapled/sutured areas
  • Wound separations
  • Strictures
  • Ulcers
  • Nutritional deficiencies


Description

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:
  • 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.
  • 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. The degree of malabsorption depends on the length of the common tract. Due to the high incidence of cholelithiasis (stone formation in the gallbladder) that results from BPD, cholecystectomy is commonly performed with this procedure.
  • 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 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.
  • 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.
  • 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.
  • Gastric balloon procedure: is a medical device developed for use as a temporary adjunct to diet and behavior modification to reduce the weight of patients who fail to lose weight with those measures alone. It is inserted into the stomach to reduce the capacity of the stomach and to affect early satiety.
  • Jejunoileal Bypass or Jejunoileal Intestinal Bypass (JIB); The jejunoileal bypass (also called the intestinal bypass) is performed by dividing the jejunum close to the ligament of Treitz and connecting it a short distance proximal to the ileocecal valve, thereby diverting a long segment of small bowel, resulting in malabsorption. This procedure is no longer performed due to the high complication
    rate and frequent need for revisional surgery. Per the ‘American Society for Metabolic & Bariatric Surgery’, the JIB is no longer a recommended bariatric surgical procedure. The lessons learned from the JIB include the crucial importance of longterm follow-up and the dangers of a permanent, severe and global malabsorption.
  • Loop Gastric Bypass (Mini Gastric Bypass); The mini gastric bypass procedure was first developed, as a modification of the standard Billroth II procedure. Using a laparoscopic approach, the stomach is segmented, similar to a traditional gastric bypass. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cms from the start of the intestine.
  • Silastic Ring Vertical Gastric Bypass (Fobi pouch); The silastic ring vertical gastric bypass (SRVGBP) consists of a proximal vertical gastric pouch < 30 cc in size. The pouch is banded with a 5.5-cm SILASTIC ring, and this functions as the stoma which does not stretch and is large enough to allow individuals to eat all varieties of food, including vegetables and meats, with minimal incidence of postprandial emesis

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. Certain designated surgical services for the treatment of obesity are covered for members who have a BMI ≥35, have at least one comorbidity related to obesity and have been previously unsuccessful with the medical treatment of obesity.

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 sleeve gastrectomy (SG) involves excision of the lateral aspect of the stomach, leaving a much reduced, lesser-curve based, tubular stomach. When this procedure is performed laparoscopically the term laparoscopic sleeve gastrectomy (LSG) is used. Presently, LSG is commonly used as a stand-alone approach to bariatric surgery; however, initially, the procedure served to reduce gastric capacity and initiate short-term weight loss while the malabsorptive component of the operation (biliopancreatic diversion) provided the long-term weight loss. A stand-alone sleeve gastrectomy is sometimes referred to as an isolated sleeve gastrectomy. A laparoscopic approach to sleeve gastrectomy was later developed. There are variations in the detail of the sleeve gastrectomy procedure itself.

The safety of intestinal bypass surgery for treatment of obesity has not been demonstrated. Severe adverse reactions such as steatorrhea, electrolyte depletion, liver failure, arthralgia, hypoplasia of bone marrow, and avitaminosis have sometimes occurred as a result of this procedure.
References

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Bariatric Surgery for Treatment of Morbid Obesity (100.1). [CMS website]. Effective date: 9/24/2013. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=57&ncdver=5&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=obesity&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d&. Accessed May 21, 2014.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Gastric Balloon for Treatment of OBESITY (100.11). 9/18/1987. [CMS website]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=111&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=obesity&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d& Accessed January 3, 2014.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Treatment of Obesity (40.5). 2/21/2006. [CMS website]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=38&ncdver=3&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=obesity&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d&. Accessed January 3, 2014.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Surgery for Diabetes (100.14). 2/12/2009. [CMS website]. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=326&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=diabetes&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d& Accessed January 3, 2014.

National Coverage Determination (NCD) for Intestinal Bypass Surgery (100.8). [CMS website]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=50&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=bypass&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d&. Accessed January 3, 2014.

Novitas Solutions, Inc. Local Coverage Determination (LCD) L34495.Bariatric Surgical Management of Morbid Obesity (L34495) effective 12/5/2013. Available at:
http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34495&ContrId=170&ver=4&ContrVer=2&CntrctrSelected=170*2&Cntrctr=170&name=Novitas+Solutions%2c+Inc.+%2812502%2c+MAC+-+Part+B%29&s=All&DocType=Active|Future&bc=AggAAAIAAAAAAA%3d%3d&. Accessed January 3, 2014.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

43644, 43645, 43770, 43775, 43845, 43846, 43847

TO REPORT REVISIONS TO BARIATRIC SURGERY OR REMOVAL/REPLACEMENT OF BARIATRIC SURGERY COMPONENTS, USE THE FOLLOWING CODES
43771, 43772, 43773, 43774, 43848, 43886, 43887, 43888

FOR REMOVAL AND REPLACEMENT OF BOTH GASTRIC BAND AND SUBCUTANEOUS PORT COMPONENTS, USE THE FOLLOWING CODE
43659


NON-COVERED
43842, 43843

TO REPORT VERTICAL-BANDED GASTROPLASTY: LAPROSCOPIC, OR MINI-GASTRIC BYPASS USE THE FOLLOWING CODE
43659

TO REPORT GASTRIC BALLOON OR SILASTIC RING VERTICAL GASTRIC BYPASS (FOBI POUCH) USE THE FOLLOWING CODE
43999

TO REPORT INTESTINAL BYPASS SURGERY, USE THE FOLLOWING CODE
44799



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



S2083 Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.051a
12/31/2019This policy has been reissued in accordance with the Company’s annual review process
12/19/2018This policy has been reissued in accordance with the Company’s annual review process
12/09/2016This policy has been reissued in accordance with the Company’s annual review process
12/30/2015This policy has been reissued in accordance with the Company's annual review process.
01/01/2016This policy has been identified for the HCPCS code update, effective 01/01/2016.
The following HCPCS code has been deleted from this policy: G6021

MA11.051
01/01/2015This is a new policy.
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Note: This policy has been identified for the CPT and HCPCS code updates, effective 01/01/2015:
On 12/30/2014, the following CPT narrative for a NOC code has been revised in this policy:
44799
The following HCPCS code has been added to this policy: G6021





Version Effective Date: 01/01/2016
Version Issued Date: 01/05/2016
Version Reissued Date: 01/09/2020