Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity

Please note, sections 40.5, 100.8, 100.11, and 100.14 have been removed from the National Coverage Determination (NCD) Manual and incorporated into NCD 100.1

A. General

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.

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 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) 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.

3. 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.

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. 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.

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.

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) or Gastric Reduction Duodenal Switch (BPD/GRDS), 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.

Effective for dates of service on and after February 21, 2006, 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 dates of service on and after September 24, 2013, facilities are no longer required to be certified.

Effective for services performed on and 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 for services provided up to and including date of service September 23, 2013.

C. Nationally Non-Covered Indications

Treatments for obesity alone remain non-covered.

Supplemented fasting is not covered under the Medicare program as a general treatment for obesity (see section D. below for discretionary local coverage).

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

D. Other

Effective for services performed on and after June 27, 2012, Medicare Administrative Contractors (MACs) acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a.-c. are satisfied.

1. The beneficiary has a body-mass index (BMI) ≥ 35 kg/m²,
2. The beneficiary has at least one co-morbidity related to obesity, and,
3. The beneficiary has been previously unsuccessful with medical treatment for obesity.

The determination of coverage for any bariatric surgery procedures that are not specifically identified in an NCD as covered or non-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, is left to the local MACs.

Where weight loss is necessary before surgery in order to ameliorate the complications posed by obesity when it coexists with pathological conditions such as cardiac and respiratory diseases, diabetes, or hypertension (and other more conservative techniques to achieve this end are not regarded as appropriate), supplemented fasting with adequate monitoring of the patient is eligible for coverage on a case-by-case basis or pursuant to a local coverage determination. The risks associated with the achievement of rapid weight loss must be carefully balanced against the risk posed by the condition requiring surgical treatment.

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).

11/2012 - Effective for claims with dates of service on or after June 27, 2012, Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a-c are satisfied.

1. The beneficiary has a body-mass index (BMI) ≥ 35 kg/m2,
2. The beneficiary has at least one co-morbidity related to obesity, and,
3. The beneficiary has been previously unsuccessful with medical treatment for obesity. Effective date: 06/27/2012 Implementation date: 12/10/2012. (TN 148) (CR8028).

01/2013 - Transmittal 148, dated November 9, 2012 is rescinded and replaced by Transmittal 150, dated January 29, 2013. The Business Requirement 8028.1 has been updated to include the correct responsibility FI that was previously omitted. All other information remains the same. (TN 150) (CR8028).

11/2013 - Effective for dates of service on and after September 24, 2013, facility certification shall no longer be required for coverage of covered bariatric surgery procedures. (TN 157) (CR8484).

12/2013 - Transmittal 157, dated November 15, 2013, is being rescinded and replaced by Transmittal 158, dated December 23, 2013 to add omitted ICD codes in section 150.5.1, Pub. 100-04 Claims Processing Manual, and to make technical corrections in sections 40.5, 100.8, 100.11 & 100.14, Pub. 100-03 NCD Manual. All other information remains the same. (TN 158) (CR8484)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580 ) (CR9252)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1792) (CR9861)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1854) (CR10086)