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COVERAGE POLICY BULLETIN

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Number: 157

Subject: Obesity: Surgical Treatment

Policy

Aetna U.S. Healthcare® covers the surgical treatment of obesity when

the following criteria are met:

(These criteria were adapted from the NIH Consensus Conference on

Surgical Treatment of Morbid Obesity.)

Presence of morbid obesity, defined as a body mass index (BMI)*

exceeding 40 or greater than 35 in conjunction with severe co -

morbidities such as cardiopulmonary complications or severe diabetes;

AND documented history of repeated failure of physician - supervised

medical/dietary therapies.

*BMI is calculated by dividing a patient's weight (in kilograms) by

height (in meters) squared.

To convert pounds to kilograms, multiply pounds by 0.45

To convert inches to meters, multiply inches by .0254

Candidates for revision of gastric restrictive surgery must have a

complication of the original procedure, such as obstruction or

stricture. In addition, revision of gastric restrictive or bypass

surgery, which has failed due to dilation of the gastric pouch, is

appropriate if the original procedure resulted in weight loss prior

to the pouch dilation.

Aetna U.S. Healthcare does not cover ANY of the following procedures

because the peer reviewed medical literature shows them to be either

unsafe or inadequately studied:

Loop gastric bypass

Gastroplasty using staples to create a small pouch

Duodenal switch operation

Biliopancreatic bypass

Laparoscopic adjustable silicone gastric banding using the LAP - BAND

Note: As a high incidence of gallbladder disease (28%) has been

documented after surgery for morbid obesity, Aetna U.S. Healthcare

covers routine cholecystectomy in concert with elective bariatric

procedures.

Background

Accepted surgery for morbid obesity, termed bariatric surgery,

includes gastric restrictive procedures and gastric bypass. The

gastric restrictive procedures include vertical banded gastroplasty

and gastric banding which attempt to induce weight loss by creating

an intake - limiting gastric pouch by segmenting the stomach along

its vertical axis. The process of digestion is more or less normal.

Gastric bypass combines gastric segmentation along its horizontal or

vertical axis with a Roux - en - Y procedure, such that the food

bypasses the duodenum and proximal small bowel.

Because the normal flow of food is disrupted, there are more

metabolic complications compared to gastric restrictive surgeries,

including iron deficiency anemia, vitamin B - 12 deficiency and

hypocalcemia, all of which can be corrected by oral supplementation.

Several studies have suggested that gastric bypass is a more

effective weight loss procedure than vertical banded gastroplasty,

offering the best combination of maximum weight control, and minimum

nutritional risk.

While appropriate surgical procedures for morbid obesity primarily

produce weight loss by restricting intake, intestinal bypass

procedures produce weight loss by inducing a malabsorptive effect.

Biliopancreatic bypass (also called jejunoileal bypass or the

Scopinaro procedure) consists of a subtotal gastrectomy and diversion

of the biliopancreatic juices into the distal ileum by a long Roux -

en - Y procedure; the result is a 200 cm long alimentary tract, a 300

to 400 cm biliary tract, and after these two tracts are joined at the

distal anastomosis, there is only a 50 cm common absorptive

alimentary tract.

It was designed to address some of the drawbacks of the original

intestinal bypass procedures which resulted in unacceptable metabolic

complications of diarrhea, hyperoxaluria, nephrolithiasis,

cholelithiasis and liver failure. Although this procedure is reported

to have a higher rate of weight loss, it is rarely performed in the

United States due to the high risk of various metabolic complications.

Gastroplasty, not to be confused with vertical banded gastroplasty,

is a technically simple operation, accomplished by stapling the upper

stomach to create a small pouch into which food flows after it is

swallowed. The outlet of this pouch is restricted by a band of

synthetic mesh, which slows its emptying, so that the person having

it feels full after only a few bites of food. Patients who have this

procedure seldom experience any satisfaction from eating, and tend to

seek ways to get around the operation by eating more.

This causes vomiting, which can tear out the staple line and destroy

the operation. Overall, about 40% of persons who have this operation

never achieve loss of more than half of their excess body weight. In

the long - term, five or more years after surgery, only about 30% of

patients have maintained a successful weight loss. Many patients must

undergo another, revisional operation, to obtain the results they

seek.

Although the basic concept of gastric bypass remains intact, numerous

variations are being performed at this time. Recent data demonstrate

that surgeons are moving from simple gastroplasty procedures,

favoring the more complex gastric bypass procedures as the surgical

treatment of choice for the morbidly obese patient. The gastric

bypass operation can be modified, to alter absorption of food, by

moving the Roux - en - Y - connection distally down the jejunum,

effectively shortening the bowel available for absorption of food.

The weight loss effect is then a combination of the very small

stomach, which limits intake of food, with malabsorption of the

nutrients which are eaten, reducing caloric intake even further. In a

sense, this procedure combines the least - desirable features of the

gastric bypass with the most troublesome aspects of the

biliopancreatic diversion. Although patients can have increased

frequency of bowel movements, increased fat in their stools, and

impaired absorption of vitamins, recent studies have reported good

results.

The loop gastric bypass developed years ago has generally been

abandoned by most bariatric surgeons as unsafe.

Although easier to perform than the Roux en - Y, it creates a severe

hazard in the event of any leakage after surgery, and seriously

increases the risk of ulcer formation, and irritation of the stomach

pouch by bile.

Recent advances in laparoscopy have renewed the interest in gastric

banding techniques for the control of severe obesity. Recently,

laparoscopic adjustable silicone gastric banding (LASGB) using the

adjustable LAP - BAND has become an attractive method because it is

minimally invasive and allows modulation of weight loss. Their

advantage is the adjustability of the band, which can be inflated or

deflated percutaneously according to weight loss without altering the

anatomy of the stomach.

This method entails encircling the upper part of the stomach using

bands made of synthetic materials, creating a small upper pouch that

empties into the lower stomach through a narrow, non - stretchable

stoma. The reduced capacity of the pouch and the restriction caused

by the band diminish caloric intake, depending on important technical

details, thus producing weight loss comparable to vertical

gastroplasties, without the possibility of staple - line disruption

and lesser incidence of infectious complications.

However, distension of the pouch, slippage of the band and entrapment

of the foreign material by the stomach have been described and are

worrisome. The FDA has not yet approved this device and procedure for

use in the United States, and so it still is considered

investigational.

Application to products:

Unless indicated otherwise above, this policy applies to all fully

insured Aetna U.S. Healthcare HMO, POS and PPO plans and to all other

plans, unless a specific limitation or exception exists. For self -

funded plans, consult individual plan sponsor benefit descriptions.

If there is a discrepancy between this policy and a self - funded

customer's plan of benefits, the provisions of the benefits plan will

govern.

With respect to fully insured plans and self - funded non - ERISA

(e.g., government, school boards, church) plans, applicable state

mandates will take precedence over either. Unless otherwise

specifically excluded, Federal mandates will apply to all plans.

With respect to Medicare and Medicaid members, this policy will apply

unless Medicare and Medicaid policies extend coverage beyond this

Coverage Policy Bulletin. HCFA's Coverage Issues Manual can be found

on the following website:

http://www.hcfa.gov/pubforms/06_cim/ci00.htm

Exceptions and Special Notes:

Coverage of the surgical treatment of obesity may be subject to prior

review in plans which have such provisions.