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National Coverage Determination (NCD) for Bariatric Surgery for Treatment of Morbid OBESITY (100.1)

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Benefit Category
Incident to a physician's professional Service
Inpatient Hospital Services
Physicians' Services

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

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:

1. 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.

2. Biliopancreatic Diversion with Duodenal Switch (BPD/DS)

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 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 anastamosis and a lower ileo-ileal anastamosis. BPD/DS procedures can be open or laparoscopic.

3. Adjustable Gastric Banding (AGB)

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.

4. 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. It may be the first step in a two-stage procedure when performing RYGBP. Sleeve gastrectomy procedures can be open or laparoscopic.

5. 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.


Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for services performed on and after February 21, 2006, Open and laparoscopic Roux-en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a body-mass index > 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. These procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006).

Effective for services performed on or after February 12, 2009, the Centers for Medicare & Medicaid Services (CMS) determines that Type 2 diabetes mellitus is a co-morbidity for purposes of this NCD.

A list of approved facilities and their approval dates are listed and maintained on the CMS Coverage Web site at http://www.cms.gov/Medicare/Medicare-General-Information/MedicareApprovedFacilitie/Bariatric-Surgery.html, and published in the Federal Register.

C. Nationally Non-Covered Indications

The following bariatric surgery procedures are non-covered for all Medicare beneficiaries:

  • Open adjustable gastric banding;
  • Open and laparoscopic sleeve gastrectomy; and,
  • Open and laparoscopic vertical banded gastroplasty.

The two previous non-coverage determinations remain unchanged - Gastric Balloon (Section 100.11) and Intestinal Bypass (Section 100.8).

D. Other

N/A

(This NCD last reviewed February 2009.)


Cross Reference

See §§40.5, 100.8, and 100.11.


Transmittal Number

100

Revision History

04/2006 - Medicare will cover open and laparoscopic Roux-en Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB) and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) if certain criteria are met and the procedure is performed in an approved facility. Effective date: 02/21/2006 (TN 54) (CR5013).

Implementation Dates:

  • 05/30/2006 for physician claims billed to the carrier
  • 10/02/2006 for hospital claims billed to the FI

04/2009 - Effective for services performed on and after February 12, 2009, CMS determines that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) in Medicare beneficiaries who have type 2 diabetes mellitus (T2DM) and a BMI less than 35 are not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act, and therefore are not covered. Effective date: 02/12/2009 Implementation date: 05/18/2009 (TN 100) (CR6419).


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

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