Bariatric Surgery - BMC HealthNet Plan/media/f07b2236de3c48c0b59... · Bariatric Surgery + Plan...

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Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 37 bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy Bariatric Surgery Policy Number: OCA 3.49 Version Number: 18 Version Effective Date: 11/01/16 Product Applicability All Plan + Products Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊ Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options. Policy Summary The Plan considers specific bariatric procedures for the treatment of morbid obesity to be medically necessary when the Plan’s medical criteria are met (as specified in the Medical Policy Statement section). Other procedures for the treatment of morbid obesity are considered experimental and investigational. Prior authorization is required for all bariatric procedures. It will be determined during the Plan’s prior authorization process if the procedure is considered experimental and investigational for the requested indication. See the Plan’s policy, Experimental and Investigational Treatment (policy number OCA 3.12), for the product-specific definitions of experimental or investigational treatment.

Transcript of Bariatric Surgery - BMC HealthNet Plan/media/f07b2236de3c48c0b59... · Bariatric Surgery + Plan...

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy

Bariatric Surgery Policy Number: OCA 3.49 Version Number: 18 Version Effective Date: 11/01/16

Product Applicability

All Plan+ Products

Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program

Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options

only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary

The Plan considers specific bariatric procedures for the treatment of morbid obesity to be medically necessary when the Plan’s medical criteria are met (as specified in the Medical Policy Statement section). Other procedures for the treatment of morbid obesity are considered experimental and investigational. Prior authorization is required for all bariatric procedures. It will be determined during the Plan’s prior authorization process if the procedure is considered experimental and investigational for the requested indication. See the Plan’s policy, Experimental and Investigational Treatment (policy number OCA 3.12), for the product-specific definitions of experimental or investigational treatment.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Description of Item or Service

Bariatric Surgery: Surgical procedures that promote weight loss for the treatment of morbid obesity. Bariatric procedures are based on two (2) primary principles to promote weight loss: Gastric restriction (defined below in item A) and intestinal malabsorption (summarized below in item B).

A. Gastric Restriction: Gastric restrictive procedures involve reducing the size of the stomach to restrict the amount of food ingested, producing a feeling of fullness. Examples of gastric restrictive procedures include adjustable silicone gastric banding (ASGB) and the vertical banded gastroplasty (VBG).

B. Intestinal Malabsorption: Intestinal malabsorption procedures involve the creation of a small

stomach pouch to restrict food intake and rerouting or bypassing parts of the small intestine to create malabsorption. Examples of intestinal malabsorption combined with gastric restrictive procedures include the Roux-en-Y gastrojejunostomy or Roux-en-Y gastric bypass (RYGB), and the biliopancreatic diversion (BPD) with or without duodenal switch (DS). Specific examples of bariatric surgery procedures include but are not limited to the following, as specified below in items 1 through 13:

1. Adjustable Silicone Gastric Banding (ASGB): A gastric restrictive procedure by which a

silicone band is inserted to create a small gastric pouch. Saline is injected into the balloon of the silicone band to adjust the diameter of the stomal opening. Weight loss is promoted by limiting food intake. Complications can include band erosion, gastric perforation, food intolerance, and/or band migration. This procedure is performed using a minimally invasive laparoscope or with an open technique if unable to perform the procedure laparoscopically. (Examples include the Lap-Band® System or the REALIZE™ Adjustable Gastric Band.)

2. Biliopancreatic Diversion (BPD) or Scopinaro Procedure: A restrictive and malabsorption

procedure where a partial gastrectomy is done to create a small pouch that is connected directly to the final segment of the small intestine, diverting bile and pancreatic juice into the distal ileum. Weight loss is promoted by the malabsorption of fat and protein. Nutritional deficiencies, severe iron deficiency anemia, lactose intolerance, and/or vitamin deficiencies are common. According to the peer reviewed published scientific literature, the evidence is not sufficient to support conclusions on the benefit/risk ratio for BPD compared with gastric bypass. The studies do not distinguish small differences in weight loss between the two (2) procedures, and the data does not support the hypothesis that BPD results in greater weight loss than gastric bypass. Complication rates are poorly reported in these trials. Limited data suggests that long-term nutritional and vitamin deficiencies occur at a high rate following BPD. The rates of nutritional deficiencies and the consequences of these deficiencies require further investigation.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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3. Biliopancreatic Diversion with Duodenal Switch (BPDDS): This procedure is a variant of the BPD where instead of a partial gastrectomy, a “sleeve” gastrectomy is performed along the vertical axis of the stomach to decrease the volume, and the small intestine is then divided with one end attached to the stomach to create an “alimentary limb.” All the food moves through this segment but not much is absorbed. Weight loss is promoted through the principles of malabsorption and the reduction of the stomach volume. The potential for metabolic complications is less with the BPDDS than with the BPD procedure; however, individuals who undergo BPDDS need life-long supplementation of fat-soluble vitamins, vitamin B12, iron, and calcium.

4. Fobi-Pouch: A limiting proximal gastric pouch procedure that involves a small (less than 25

ml) vertical banded pouch, a Silastic ring around the stomach creating a stoma, and a gastroenterostomy to a Roux-en-Y limb.

5. Jejunoileal Bypass: Also known as intestinal bypass, the proximal jejunum is joined to the

distal ileum, bypassing a large segment of the small bowel. 6. Loop Gastric Bypass: A gastric pouch in the shape of a tube created by dividing the

stomach at the junction of the body and the antrum, parallel to the lesser curve. A loop of jejunum is then anastomosed to the gastric pouch.

7. Mini Gastric Bypass: Using a laparoscopic approach, the stomach is pouched and a loop of

the jejunum is anastamosed directly to the stomach pouch. 8. ROSE Procedure: The ROSE procedure is also referred to as revision obesity surgery

endoscopic; restorative obesity surgery endoscopic; restorative obesity surgery, endoluminal; and peroral endoscopic surgery. The ROSE procedure involves the application of an endoscope into the esophagus to provide access to the stomach so that the size of the gastric pouch and/or nearby structures can be reduced. This procedure is primarily reserved for when a patient regains weight following gastric bypass surgery.

9. Roux-en-Y Gastrojejunostomy or Roux-en-Y Gastric Bypass (RYGB): The gastric bypass or

RYGB is considered the gold standard for bariatric surgery and the most common. It is a restrictive and malabsorptive procedure that surgically alters the stomach’s capacity using surgical staples to create a small pouch that restricts food intake. A Y-shaped section of the small intestine is anastamosed to the pouch to allow food to bypass the duodenum and jejunum to limit the body’s ability to digest food. A short limb RYGB is 150 cm or less and a long limb RYGB is greater than 150 cm. Weight loss is promoted by restriction of the amount of food and limitation of the digestion of food. RYGB can cause nutritional deficiencies due to the malabsorption of nutrients; for example, iron deficiency resulting in anemia is common.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Dumping syndrome is a common side effect. Symptoms include nausea, abdominal cramps, diarrhea, rapid heart rate, sweating, weakness, headache, faintness, hunger, shakiness, difficulty concentrating, and/or dizziness. Because the pylorus sphincter is bypassed, food is allowed to pass rapidly into the intestines.

10. Roux-en-Y Gastric Bypass (RYGB) Combined with Gastric Banding: This combination is

being investigated as a strategy to enhance weight loss and avoid weight regain. The evidence supporting use of this combined procedure is currently limited.

11. Sleeve Gastrectomy or Vertical Sleeve Gastrectomy: A variant of the vertical banded

gastroplasty involving a subtotal gastric resection for the creation of a long lesser-curve-based gastric conduit. The operation preserves the pyloric sphincter and function of the stomach while drastically reducing stomach volume; the gastric restriction reduces the amount of food that can be eaten. It is postulated that weight loss occurs since the removed section of the stomach produces most of the hormone ghrelin, which is responsible for appetite and hunger. Sleeve gastrectomy procedures may be performed as either laparoscopic or open, but the procedure is most often performed laparoscopically. The sleeve gastrectomy is the first part of the surgical process for BPDDS; however, the sleeve gastrectomy may be all that is needed for the patient to lose a sufficient amount of weight and the BPDDS is not necessary. The sleeve gastrectomy has also been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk, super-obese patients with a BMI > 50 kg/m2. Laparoscopic sleeve gastrectomy may be technically easier and a faster procedure than either open or laparoscopic Roux-en-Y gastric bypass and less complex than BPDDS.

12. StomaphyX: The StomaphyX is a sterile, single-use device for use in endoluminal transoral

tissue approximation and ligation in the GI tract. It is used for endoscopic plication and revision of the gastric pouch (EPRGP) in patients who underwent gastric bypass surgery.

13. Vertical Banded Gastroplasty (VBG): A gastric restrictive procedure that can be performed

either laparoscopically or open whereby a small stomach pouch is created by placing staples in a vertical segment of the stomach. Weight loss is promoted by restriction of the amount of food intake. The most common complication is persistent esophageal reflux disease. This procedure has been largely abandoned because long-term weight loss is not achieved.

Revisional Bariatric Surgery (RBS): A wide assortment of complex abdominal operations performed to treat patients who have experienced complications, insufficient amelioration of comorbid conditions, failure of weight loss, and/or weight regain after bariatric surgery for severe obesity.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Medical Policy Statement

The Plan considers the following open or laparoscopic bariatric procedures to be medically necessary when medical record documentation supports that the applicable Plan criteria have been met, as specified below in item I for all members and item II for age-specific criteria. Applicable criteria must be met in item III ONLY for a revision to a prior bariatric procedure or a reversal. I. Criteria for All Members (Adults and Adolescents):

ALL of the following criteria must be met for each adult and adolescent member, as specified below in items A through H:

A. Persistent obesity despite previous attempts to lose weight with non-surgical, clinician-

supervised weight reduction methods (such as diet, exercise, behavioral modification, exercise, and/or pharmaceutical interventions), and these efforts have been fully appraised by the physician requesting authorization for bariatric surgery; AND

B. Successful completion of a psychological assessment demonstrating readiness for surgery; AND C. Preoperative nutritional assessment demonstrating motivation and willingness to make

necessary changes in eating and drinking habits, both before and after surgery; AND

D. Ability to participate in pre and post-surgical treatment with long-term follow-up; AND E. Presurgical identification and treatment of all metabolic causes for obesity, such as adrenal or

thyroid disorders; AND F. Strict abstention from pregnancy and breast-feeding from the time of surgery through the

postoperative period of rapid weight loss which is expected during the first year after gastric bypass (not applicable for the banding procedure); AND

G. A separate medical evaluation, within the previous six (6) months of the scheduled surgery from a physician other than the requesting surgeon, that includes a risk assessment and recommendations for perioperative management, as indicated; AND

H. Member meets ALL applicable age and procedure-specific clinical criteria specified below in

item II and item III; AND

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II. Age-Specific Criteria (Adult or Adolescent Members):

ONE (1) of the following sets of age-specific criteria must be met, as specified below in item A for an adult member or item B for an adolescent member.

A. Criteria for Adult Members (Age 18 or Older on the Date of Service):

ALL of the following criteria must be met for an adult member, as specified below in items 1 through 5: 1. ALL criteria must be met in item I, as specified above; AND 2. The surgery is to be performed by an appropriately privileged bariatric surgeon in

association with a recognized formal obesity surgery program accredited by the Metabolic

and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP);∞ AND

∞ Note: Resource to identify MBSAQIP accreditation available at: https://www.facs.org/search/bariatric-surgery-centers?allresults=

3. The bariatric surgeon has notified the Plan of the surgical treatment plan established for the member and meets ONE (1) of the following criteria, as specified below in item a or item b:

a. The surgery is a single, stand-alone bariatric procedure; OR b. The procedure is part of a multi-staged bariatric surgical approach to treatment;** AND

**Note: Notification of a treatment plan which includes a multi-staged bariatric

procedure is required at the time of the first bariatric surgery and before each additional procedure. A separate prior authorization is required before each bariatric procedure.

4. Member must attend support group to learn about bariatric surgery from other patients;

AND 5. Criteria are met for a stand-alone procedure or a multi-staged procedure, as specified

below in item a or item b:

a. Single, Stand-Alone Bariatric Procedure for Adults:

BOTH of the following criteria are met, as specified below in item (1) and item (2):

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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(1) Bariatric surgery is a single, stand-alone procedure and ONE (1) of the following procedures will be performed, as specified below in items (a) through (d):

(a) Laparoscopic adjustable silicone gastric banding (LASGB);*** OR

***Note: A request for a scheduled, open adjustable silicone gastric banding

(ASGB) requires Medical Director review with supporting documentation which specifies why the member is a candidate for an open ASGB rather than a LASGB, as stated in the Limitations section of this policy.

(b) Open or laparoscopic biliopancreatic diversion with duodenal switch

(BPDDS); OR (c) Open or laparoscopic Roux-en-Y gastric bypass; OR (d) Open or laparoscopic sleeve gastrectomy; AND

(2) Bariatric surgery is a single, stand-alone procedure and ONE (1) of the following criteria is met, as specified in item (a) or item (b) below:

(a) Member has a BMI of 40 kg/m2 or higher with a strong desire for substantial

weight loss for improvement in quality of life; OR (b) Member has a BMI of 35 kg/m2 or higher with at least ONE (1) of the

following high-risk comorbidities, as specified below in items i through ix:

i. Coronary artery disease; OR

ii. Diabetes mellitus type 2; OR iii. Hypertension meeting Stage I JNC-7 criteria which require

pharmacologic control with at least two (2) antihypertensive medications; OR

iv. Joint disease of weight bearing joints, treatable but for the obesity; OR v. Obesity-related cardiomyopathy; OR vi. Obesity-related pulmonary hypertension; OR vii. Obstructive sleep apnea; OR viii. Pickwickian syndrome; OR

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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ix. Pseudotumor cerebri; OR

b. Bariatric Procedure is First in a Planned, Multi-Staged Procedure for Adults:

The following TWO (2) criteria must be met, as specified below in item (1) and item (2): €

(1) Member has a BMI of 40 kg/m2 or higher; AND (2) The first procedure is a sleeve gastrectomy; OR € Note: Notification of a treatment plan which includes a multi-staged bariatric

procedure is required at the time of the first bariatric surgery and before each additional procedure. A separate prior authorization is required before each bariatric procedure.

B. Criteria for Adolescent Members (Under Age 18 on the Date of Service):

ALL of the following criteria must be met for an adolescent member under the age of 18 on the date of service, as specified below in items 1 through 10: 1. ALL criteria in Section I above must be met; AND 2. The surgery is to be performed by an appropriately privileged bariatric surgeon in

association with a recognized formal obesity surgery program accredited by the Metabolic

and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)¥ that has experience treating adolescent patients for bariatric surgery; AND

¥ Note: Resource to identify MBSAQIP accreditation available at:

https://www.facs.org/search/bariatric-surgery-centers?allresults=

3. The bariatric surgeon has notified the Plan of the surgical treatment plan established for the adolescent member and BOTH of the following criteria are met, as specified below in item a and item b:

a. The surgery is a single, stand-alone bariatric procedure and is not part of a multi-staged

bariatric procedure; AND b. Bariatric surgery is a single, stand-alone procedure† and ONE (1) of the following

procedures will be performed, as specified below in item (1) or item (2):

(1) Roux-en-Y gastric bypass (open or laparoscopic); OR

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(2) Sleeve gastrectomy (open or laparoscopic);‡ AND Notes: † Notification of a treatment plan which includes a multi-staged bariatric procedure is

required at the time of the first bariatric surgery and before each additional procedure. A separate prior authorization is required before each bariatric procedure. Any multi-staged bariatric procedure for an adolescent member, including a Roux-en-Y gastric bypass or sleeve gastrectomy, requires Medical Director review.

‡ American Society for Metabolic and Bariatric Surgery (ASMBS) states that long-term

adolescent outcomes data are required for adolescents undergoing sleeve gastrectomy, but the preliminary results from ongoing studies appear to demonstrate excellent weight reduction, reversal of associated co-morbid diseases, and morbidity outcomes similar to those of the adult population. (Source: ASMBS Pediatric Best Practice Guidelines.)

4. The member’s age meets ONE (1) of the following criteria, as specified below in item a or

item b:

a. 15 years of age or older on the date of service if the member is a boy (including an adolescent member born with male reproductive organs and/or with typical male karyotype with only one [1] X chromosome, if known); OR

b. 13 years of age or older on the date of service if the member is a girl (including an

adolescent member born with female reproductive organs and/or with typical female karyotype with two [2] X chromosomes, if known); AND

5. ONE (1) of the following BMI requirements must be met, as specified below in item a or

item b:

a. BMI of 35 kg/m2 or higher with at least ONE (1) of the following serious comorbidities, as specified below in items (1) through (6):

(1) Diabetes mellitus type 2; OR (2) Moderate or severe obstructive sleep apnea (apnea hypopnea index [AHI] 15

events/hour); OR (3) Nonalcoholic steatohepatitis (NASH); OR (4) Pseudotumor cerebri; OR

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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(5) Severe or complicated hypertension; OR (6) Other documented, serious comorbidity related to the member’s obesity; OR

b. BMI of 40 kg/m2 or higher with at least ONE (1) of the following obesity-related

comorbidities, as specified below in items (1) through (12):

(1) Dyslipidemia; OR (2) Gastroesophageal reflux; OR (3) Hypertension; OR (4) Moderate to severe nonalcoholic fatty liver disease; OR (5) Obstructive sleep apnea (apnea hypopnea index [AHI] 5 events/hour); OR (6) Panniculitis; OR (7) Significant impairment in activities of daily living; OR (8) Urinary incontinence; OR (9) Venous stasis disease; OR (10) Severe psychosocial distress; OR (11) Significantly impaired quality of life; OR (12) Weight-related arthropathies

6. Attainment of Tanner sexual maturity stage IV with written documentation provided to the Plan; AND

7. Member is has completed bone growth and is at least 95% of predicted adult height, as

estimated by bone age, with written documentation provided to the Plan; AND

8. Support group attendance accompanied by a family member or guardian to learn about surgery from other patients; AND

9. Documentation by a psychologist regarding psychological suitability and willingness to

undergo surgery; AND

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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10. Documentation by a licensed social worker to determine whether the degree of support

available in the home environment appears sufficient for post-operative care and compliance; AND

III. Guidelines for Revisional Bariatric Surgery or Reversals:

The following applicable criteria must be met ONLY when the member is a candidate for either a revision to a prior bariatric procedure (and all criteria in item A must be met) or a reversal (and the criterion specified in item B must be met).

A. Revision to a Prior Bariatric Procedure (Revisional Bariatric Surgery):

ALL of the following criteria must be met, as specified below in items 1 through 4: 1. ALL criteria must be met in item I listed above for all members, and ALL appropriate age-

specific criteria listed in item II must be met (i.e., item IIA for adult members or item IIB for adolescent members); AND

2. The prior bariatric procedure has been performed at least one (1) year before the scheduled

revision (unless otherwise specified in the Limitations section of this Plan policy); AND 3. Surgical evaluation must have occurred within four (4) months of the planned surgery; AND 4. At least ONE (1) of the following criteria is met, as specified below in item (a), item (b), or

item (c):

(a) Documentation of compliance with the previously prescribed postoperative dietary and exercise program; OR

(b) Anatomic failure of the prior bariatric surgery with persistent or recurrent obesity; OR (c) Secondary complications such as stricture, obstruction, erosion, or band slippage.

B. Reversals:

Reversals for bariatric procedures may be considered medically necessary on a case-by-case basis. See the Plan policy, Medically Necessary (policy number OCA 3.14), for the product-specific definitions of medically necessary treatment.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Limitations

A. Open adjustable silicone gastric banding (ASGB) is not considered medically necessary for an

adult member unless at least ONE (1) of the following criteria is met, as specified below in item 1 or item 2: 1. A laparoscopic ASGB procedure was unsuccessfully attempted by the attending surgeon and

an unscheduled, open ASGB is medically required for the member’s safety; OR 2. A request for a scheduled, open ASGB is reviewed prospectively by a Plan Medical Director

and is determined to be medically necessary by the Plan Medical Director based on the member’s medical condition; see Plan medical policy, Medically Necessary (policy number OCA 3.14).

B. The Plan requires Medical Director review to determine the medical necessity of a request for

ANY of the following bariatric procedures for adolescent members, as specified below in items 1 through 6 (and all other applicable limitations listed in this section also apply):

1. Adjustable gastric banding for an adolescent member under age 18 on the date of service

(since the implanted device is FDA approved for adult patients only); OR 2. Biliopancreatic diversion (BPD) with or without duodenal switch (DS) for an adolescent

member under age 18 on the date of service; OR 3. Sleeve gastrectomy for an adolescent member under age 18 on the date of service when

Plan medical criteria are NOT met; OR 4. Bariatric surgery for an adolescent boy (including an adolescent boy born with male

reproductive organs and/or with typical male karyotype with only one [1] X chromosome, if known) who is less than 15 years of age on the date of service; OR

5. Bariatric surgery for an adolescent girl (including an adolescent member born with female

reproductive organs and/or with typical female karyotype with two [2] X chromosomes, if known) who is less than 13 years of age on the date of service; OR

6. Any staged bariatric procedure for an adolescent member under age 18 on the date of

service (including the first procedure).

C. The Plan considers ANY of the following procedures experimental and investigational for ALL members, as specified below in items 1 through 10: 1. Biliopancreatic diversion (BPD) without a duodenal switch for all members;**** OR

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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****Note: According to the Society of American Gastrointestinal and Endoscopic Surgeons

(SAGES), the duodenal switch diminishes the most severe complications of BPD, including dumping syndrome and peptic ulceration of the anastomosis.

2. Fobi-pouch; OR 3. Endoscopic bariatric procedures, gastric plication, and pouch reduction; examples include

but are not limited to the ROSE procedure, EndoCinch, and StomaphyX™; OR 4. Intragastric balloon system; examples include but are not limited to the Orbera System

(formerly known as BIB; Apollo Endosurgery Inc.), the Spatz Adjustable Balloon (Spatz FGIA Inc.), the Obalon Balloon (Obalon Therapeutics), the Heliosphere BAG (Santé Actions Group), and the ReShape Duo (ReShape Medical Inc.); OR

5. Jejunoileal bypass; OR 6 Loop gastric bypass; OR 7. Mini-gastric bypass (i.e., gastric bypass using Billroth II type of anastomosis); OR 8. Roux-en-Y gastric bypass combined with simultaneous gastric banding; OR 9. Vertical banded gastroplasty (VBG); OR 10. Other bariatric procedure not specified in this Plan policy.

D. The Plan considers bariatric surgery to be experimental and investigational for all members

when used for an indication that does not meet Plan criteria, including but not limited to ANY of the following, as specified below in items 1 through 3:

1. A cure for type 2 diabetes; OR

2 Gastroesophageal reflux disease (GERD); OR

3. Infertility.

E. The Plan considers the bariatric surgery to be experimental and investigational for all members when a device is used for the bariatric procedure that is not FDA approved for the specified indication, for the member’s age, and/or member’s medical condition.

F. Contraindications for bariatric surgery for all members include any ONE (1) of the following

(and a member with one of these contraindications requires individual consideration by a Plan

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Medical Director, as specified in the Plan’s Clinical Criteria policy, policy number OCA 3.201), as specified below in items 1 through 9:

1. Advanced cancer; OR

2. Current substance abuse; OR 3. End-stage cardiopulmonary disease; OR 4. End-stage liver disease; OR 5. End-stage renal disease; OR 6. Lack of comprehension of the risks–benefits, expected outcomes, alternatives, and lifestyle

changes required with bariatric surgery; OR 7. Pregnancy or planned pregnancy during expected weight loss; OR 8. Noncompliance with previous medical care that severely impacted the member’s health

and safety; OR 9. Uncontrolled psychiatric illness.

G. The second procedure (and any additional procedure beyond the first procedure) for all members in a multi-staged bariatric procedure requires Medical Director review.

H. The first bariatric surgery in a planned, multi-staged bariatric procedure requires Medical

Director review when ANY of the following criteria is met, as specified below in items 1 through 3: 1. The first procedure is not a sleeve gastrectomy for an adult; OR 2. Any staged bariatric procedure for an adolescent (including the first procedure); OR 3. Other Plan criteria are not met.

I. Any revisional bariatric procedure where the prior bariatric procedure was performed less than one (1) year before the scheduled revision requires Plan Medical Director review; this may be due to a complication that may require more immediate surgical intervention.

J. Plan Medical Director review is required for requests for bariatric surgery when applicable Plan criteria are not met, as specified in the Medical Policy Statement section.

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Definitions

Apnea Hypopnea Index (AHI): Criterion used for diagnosis or to determine treatment for obstructive sleep apnea (OSA); the measurement represents the average of the combined number of apnea and hypopnea episodes that occur per hour of sleep. Types include mild OSA (AHI of 5-15 per hour), moderate OSA (AHI of 15-30 per hour), or severe OSA (AHI of more than 30 per hour).

Body Mass Index (BMI): Body mass index describes relative weight for height and correlates with total fat content. BMI is calculated as weight (kg)/height squared (m2). The classification of BMI is specified in the table below. To estimate BMI using pounds and inches, use the following formula: Weight (pounds)/height (inches) x 703.

Description Classification BMI (kg/m2)

Underweight <18.5

Normal 18.5-24.0

Overweight 25.0-29.9

Obesity I 30.0-34.9

II 35.0-39.9

Extreme Obesity III >40

Super Obesity >50

Super Super Obesity >60

Morbid Obesity (Clinically Severe Obesity): A disease of excess energy stores in the form of fat. Clinically severe obesity correlates with a body mass index (BMI) of greater than or equal to 40 kg/m2 or a BMI of greater than or equal to 35 kg/m2 accompanied by comorbid conditions that include but are not limited to: coronary artery disease, clinically refractory hypertension, severe obstructive sleep apnea, type 2 diabetes, Pickwickian syndrome, obesity related cardiomyopathy, and/or pulmonary hypertension. Nonalcoholic Steatohepatitis (NASH): A common and often silent liver disease. It resembles alcoholic liver disease, but occurs in individuals who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. Most individuals with NASH feel well and are not aware that they have a liver problem. Nevertheless, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to work properly. (Source: National Institute of Diabetes and Digestive and Kidney Disease)

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Applicable Coding

The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service. Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

CPT Codes Description: Codes Covered When Medically Necessary

43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less)

43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption

43659 Unlisted laparoscopy procedure, stomach (Plan note: Use to report removal and replacement of both gastric restrictive device and subcutaneous port components)

43770 Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (e.g., gastric band and subcutaneous port components)

43771 Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device component only

43772 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only

43773 Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only

43774 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (i.e., sleeve gastrectomy)

43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty

43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)

43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy

43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption

43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)

43886 Gastric restrictive procedure, open; revision of subcutaneous port component only

43887 Gastric restrictive procedure, open; removal of subcutaneous port component only

43888 Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only

CPT Code Description: Code Considered Experimental and Investigational

43842 Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty

Clinical Background Information

Obesity is a major health problem in the United States and is increasing to epidemic proportions. It is the second most common preventable cause of morbidity and mortality after smoking. The comorbidities associated with obesity substantially raise the health risk of individuals with obesity. The diseases associated with obesity include hypertension, type 2 diabetes, coronary heart disease, dyslipidemia, gallbladder disease, stroke, osteoarthritis, sleep apnea, and certain cancers. The National Heart Lung Blood Institute (NHLBI) defines overweight as a body mass index (BMI) of 25 to 29.9 kg/m2 and obesity as a BMI of 30 kg/m2 or higher. Recently, statistics show that over 2% of the United States population has a BMI over 40 kg/m2. The goal of weight loss treatment is to improve the comorbidities and decrease the future complications related to obesity. The initial weight loss goal should be to reduce body weight by approximately 10% from baseline. According to the American Gastroenterological Association, a stepwise approach is recommended for the treatment of obesity based on the National Institutes of Health (NIH) panel on the identification, evaluation, and treatment of overweight and obese adults. The stepwise principles of obesity therapy include interventions in the following order: dietary strategies that promote loss of weight and an increase in physical activity, behavior modification therapy to facilitate changes in eating habits, pharmacotherapy, and finally bariatric surgery. Surgical therapy is recommended in patients with a BMI of 40kg/m2 or greater, or those individuals with a BMI 35.0 - 39.9 kg/m2 with one or more severe

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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obesity-related medical complications (e.g., hypertension, type 2 diabetes, heart failure, or sleep apnea) if they have been unsuccessful in achieving weight loss with conventional therapy based on the stepwise approach. Candidates for surgery must have acceptable operative risks and be able to comply with long-term treatment and follow-up. The type of surgical procedure depends on the expertise of the surgeon and the individual’s BMI. Gastric bypass is the most common procedure. All gastric restrictive and intestinal malabsorption procedures can be performed with the open or minimally invasive laparoscopic technique. Weight loss is similar with either laparoscopic or open procedure, but the laparoscopic approach is associated with fewer post-operative complications, shorter hospital stay, and earlier return to functional status. According to the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), laparoscopic surgery may be difficult or impossible in patients with giant ventral hernias, severe intra-abdominal adhesions, large liver, high BMI with central obesity or physiological intolerance of pneumo-peritoneum. Surgeons performing bariatric surgery should possess the necessary skills to perform open bariatric surgery in the event it becomes necessary to convert to an open procedure. Malabsorptive procedures should be considered in individuals with a BMI of 50 kg/m2 or higher. Complications following gastric restrictive and malabsorption procedures can include: peritonitis secondary to anastomic leak or perforation, gastric pouch dilatation, band erosion, stricture, reflux esophagitis, anastomatic ulcer, incisional hernia, internal abdominal wall hernias and nutritional deficiencies. Patients who lose a large amount of weight following bariatric surgery often form gallstones or sludge during the first year. Other complications can include deep vein thrombosis (DVT), pulmonary embolism, and/or wound infections. Reversal or revisional surgery may be necessary in some patients. There are multiple comorbid conditions associated with severe obesity in youths, including metabolic disorders, hypertension, non-alcoholic fatty liver disease, musculoskeletal problems and/or obstructive sleep apnea syndrome. Severely obese youths are much more likely to become severely obese adults with associated health risks and adverse outcomes. Bariatric surgery is appropriate and available for only some adolescents with severe obesity. Currently, the most common operations being performed in children affected by severe obesity are the Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and sleeve gastrectomy. There is good evidence that RYGB is reasonably safe and highly effective compared with lifestyle modification for the treatment of severe obesity with adolescents who are skeletally mature. Relatively good safety and efficacy data for LAGB in adolescents have been reported, although a high rate of reoperation and sparse long-term data, along with a lack of FDA approval for the device, hamper recommendations for usage before adulthood. Sleeve gastrectomy has been performed less often in adolescents than the RYGB or the adjustable gastric banding, but has been performed in increasing numbers throughout the past few years. Long-term data is not yet available on sleeve gastrectomy performed on adolescents, but preliminary results from on-going studies of adolescents undergoing the procedure demonstrate excellent weight reduction, reversal of co-morbidities, and complication rates similar to those of the adult population. Advantages of the gastric sleeve for

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adolescents include the following: there is no foreign body left to erode or require removal, no adjustments are needed, malabsorption should be less with a reduction in ghrelin (reducing hunger satiety signals), bowel obstruction later in life is unlikely, the pylorus is preserved, and the biliary tract is not excluded. According to SAGES, laparoscopic sleeve gastrectomy in the pediatric age group is as safe and effective as it is in adults. Pediatric patients had fewer serious complications and were more compliant with follow-up than adults. Nevertheless, long-term results are required to further clarify the safety and efficacy of LSG in pediatric patients Specific dietary guidelines follow bariatric surgery. The postoperative diet is started with frequent small servings of water and ice chips for the first few days. The progression of the diet to solid foods begins with liquids and pureed foods to soft textured food and can be advanced slowly over several weeks as tolerated. Generally, the initial gastric capacity is 30 to 60 mL with a progression up to 120 to 150 mL. Individuals should understand that they need to eat for 20 minutes or more to avoid bolus feeding and allow the feeling of fullness to occur. Liquids should be ingested well before meals or at least 30 minutes afterwards. Proteins should be eaten first followed by fats and carbohydrates. Lifelong vitamin B12 injections and daily multivitamin therapy may be necessary in some patients. At the time of the Plan’s most recent policy review, the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) 100.1 includes the following clinical guidelines for bariatric surgery for the treatment of morbid obesity for Medicare beneficiaries and specifies that type 2 diabetes mellitus is an applicable comorbidity: “…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…; or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence.” Verify CMS criteria in the applicable NCD, local coverage determination (LCD), and/or coverage guidelines in in effect on the date of the prior authorization request for bariatric surgery for a Senior Care Options member. Services related to bariatric surgery may or may not include intensive behavioral therapy for obesity. According to CMS NCD 210.12, CMS covers intensive behavioral therapy for obesity, defined as a body mass index (BMI) ≥ 30 kg/m2, for the prevention or early detection of illness or disability. Intensive behavioral therapy for obesity consists of the following: (1) Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed kg/m2); (2) dietary (nutritional) assessment; and (3) intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise. Additional administrative guidelines for covered behavioral therapy for obesity are included in NCD 210.12. Medical nutrition services (MNT) may or may not also be necessary for individuals who will receive or have had bariatric surgery. CMS NCD 180.1 includes medically necessary indications for MNT for a

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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beneficiary with a diagnosis of renal disease and/or diabetes according to CMS established criteria based on duration of treatment, episode of care, date of service, and number of units administered per day. As stated in NCD 180.1, additional treatment may be considered medically necessary and covered if the treating physician determines that there is a change in the beneficiary’s medical condition, diagnosis, and/or treatment regimen that requires a change in MNT and physician orders additional MNT during that episode of care. See the Plan medical policy, Medical Nutrition Therapy in the Outpatient or Office Setting (policy number OCA 3.66), for additional Plan guidelines related to this service.

References

Abdemur A et al. Laparoscopic conversion of laparoscopic sleeve gastrectomy to gastric bypass for intractable gastroesophageal reflux disease. September/October 2012. Volume 8. Issue 5. Page 654. Abeles D, Kim JJ, Tarnoff ME, Shah S, Shikora SA. Primary laparoscopic gastric bypass can be performed safely in patients with BMI >or= 60. J Am Coll Surg. 2009 Feb;208(2):236-40. Epub 2008 Dec 18. doi:10.1016/j.jamcollsurg.2008.10.020. Alexander JW, Goodman H. Gastric bypass in chronic renal failure and renal transplant. Nutr Clin Pract. 2007 Feb;22(1):16-21. Alqahtani A, Alamri H, Elahmedi M, Mohammed R. Laparoscopic sleeve gastrectomy in adult and pediatric obese patients: a comparative study. Surg Endosc. 2012 Nov;26(11):3094-100. Alqahtani AR, Antonisamy B, Alamri H, Elahmedi M, Zimmerman VA. Laparoscopic sleeve gastrectomy in 108 obese children and adolescents aged 5 to 21 years. Ann Surg. 2012 Aug;25(2):266-73. Alqahtani AR, Elahmedi MO, Al Qahtani AR, Lee J, Butler MG. Laparoscopic sleeve gastrectomy in children and adolescents with Prader-Willi syndrome: a matched-control study. Surg Obes Relat Dis. 2015 Jul 22. pii: S1550-7289(15)00301-9. doi: 10.1016/j.soard.2015.07.014. [Epub ahead of print] Al-Sabah SK, Almazeedi SM, Dashti SA, Al-Mulla AY, Ali DA, Jumaa TH. The efficacy of laparoscopic sleeve gastrectomy in treating adolescent obesity. Obes Surg. 2015 Jan;25(1):50-4. doi: 10.1007/s11695-014-1340-9. American Academy of Sleep Medicine (AASM). Obstructive Sleep Apnea. 2008. Accessed at: http://www.aasmnet.org/resources/factsheets/sleepapnea.pdf

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. 2008 Jul-Aug. NGC:006716. Accessed at: http://www.guideline.gov/content.aspx?id=47785 American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient – 2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Rel Dis. 2013;9:159-191. Accessed at: http://www.guideline.gov/content.aspx?id=47785 The American College of Obstetricians and Gynecologists (ACOG). Bariatric surgery and pregnancy. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2009 Jun. 9 p. Accessed at: http://www.guideline.gov/content.aspx?id=14683&search=bariatric The American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Obesity in Pregnancy. Number 549, January 2013. Accessed at: http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Obesity-in-Pregnancy American College of Surgeons. Massachusetts Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. MBSAQIP Accredited Bariatric Surgery Centers. Accessed at: https://www.facs.org/search/bariatric-surgery-centers?page=1&n=25&state=MA American College of Surgeons. Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). MBSAQIP Accredited Bariatric Surgery Centers. Search by Name of Institution, State, City, Zip, Country, Distance. Accessed at: https://www.facs.org/search/bariatric-surgery-centers?allresults= American College of Surgeons. Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Resources for Optimal Care of the Metabolic and Bariatric Surgery Patient 2014. Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Standards and Pathways Manual. Effective May 1, 2014. Accessed at: http://www.mbsaqip.org/docs/Resources%20for%20Optimal%20Care%20of%20the%20MBS%20Patient.pdf American College of Surgeons. New Hampshire Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. MBSAQIP Accredited Bariatric Surgery Centers. Accessed at: https://www.facs.org/search/bariatric-surgery-centers?page=1&n=25&state=NH American Society for Metabolic and Bariatric Surgery (ASMBS). Pediatric Best Practice Guidelines. Comorbities. Patient Selection. Team Member Qualifications. Risks and Outcomes (Types of Bariatric Surgery). January 2012. Accessed at: https://asmbs.org/resources/pediatric-best-practice-guidelines

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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American Society for Metabolic and Bariatric Surgery (ASMBS). Childhood and Adolescent Obesity. Who Should Be Considered for Bariatric Surgery? Accessed at: http://asmbs.org/patients/adolescent-obesity American Society for Metabolic and Bariatric Surgery (ASMBS). Policy Statement on Gastric Plication. May 2011. Accessed at: http://asmbs.org/resources/policy-statement-on-gastric-plication

American Society for Metabolic and Bariatric Surgery (ASMBS). ASMBS Position Statement. Emergency Care of Patients with Complications Related to Bariatric Surgery. March 2010. Accessed at: http://asmbs.org/wp/uploads/2014/05/ASMBS_Position_Statement_on_Emergency_Care_of_Ptients_with_Complications_Related_to_Bariatric_Surgery_Mar_2010.pdf American Society for Metabolic and Bariatric Surgery (ASMBS). ASMBS Position Statement. Preoperative Supervised Weight Loss Requirements. March 23, 2011. American Society for Metabolic and Bariatric Surgery (ASMBS). Bariatric Surgery in Class 1 Obesity. September 2012. Accessed at: http://asmbs.org/resources/bariatric-surgery-in-class-i-obesity American Society for Metabolic and Bariatric Surgery (ASMBS). Bariatric Surgery Procedures. Gastric Bypass, Sleeve Gastrectomy, Adjustable Gastric Band, Biliopancreatic Diversion with Duodenal Switch (BPD/DS). Accessed at: http://asmbs.org/patients/bariatric-surgery-procedures American Society for Metabolic and Bariatric Surgery (ASMBS). Michalsky M, Reichared K, Inge T, Pratt J, Lenders C. ASMBS Pediatric Best Practice Guidelines. January 2012. Accessed at: https://asmbs.org/resources/pediatric-best-practice-guidelines American Society for Metabolic and Bariatric Surgery (ASMBS). Updated Position Statement on Sleeve Gastrectomy as a Bariatric Procedure. Revised March 14, 2012. Accessed at: http://asmbs.org/wp/uploads/2012/03/UpdatedPositionSleeveGastrectomyMar142012.pdf Apovian CA et al. Best Practice Guidelines in Pediatric/Adolescent Weight Loss Surgery Obesity Research (2005) 13, 274282. Arterburn DE, Olsen MK, Smith VA, Livingston EH, Van Scoyoc L, Yancy WS Jr, Eid G, Weidenbacher H, Maciejewski ML. Association between bariatric surgery and long-term survival. JAMA. 2015 Jan 6;313(1):62-70. doi: 10.1001/jama.2014.16968. Baltasar A, Serra C, Pérez N, Bou R, Bengochea M, Ferri L. Laparoscopic Sleeve Gastrectomy: A Multi-purpose Bariatric Operation. Obesity Surg 2005;15:1124-1128. Bandealy A, Stahl C. Obesity, reproductive health, and bariatric surgery in adolescents and young adults. J Pediatr Adoles Gynecol 2012;25:277-279.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Blackburn GL, Hutter MM, Harvey AM, Apovian CM, Boulton HR, Cummings S, Fallon JA, Greenberg I, Jiser ME, Jones DB, Jones SB, Kaplan LM, Kelly JJ, Kruger RS Jr, Lautz DB, Lenders CM, Lonigro R, Luce H, McNamara A, Mulligan AT, Paasche-Orlow MK, Perna FM, Pratt JS, Riley SM Jr, Robinson MK, Romanelli JR, Saltzman E, Schumann R, Shikora SA, Snow RL, Sogg S, Sullivan MA, Tarnoff M, Thompson CC, Wee CC, Ridley N, Auerbach J, Hu FB, Kirle L, Buckley RB, Annas CL. Expert panel on weight loss surgery: executive report update. Obesity (Silver Spring). 2009 May; 17(5):842-62. doi: 10.1038/oby.2008.578. Epub 2009 Feb 19. BlueCross BlueShield Association (BCBSA) Technology Evaluation Center (TEC). Newer Techniques in Bariatric Surgery. TEC Assessment Program. Vol 20, No 5. Chicago, IL: BCBSA 2005 August. Bowne WB, Julliard K, Castro AE, et al. Laparoscopic Gastric Bypass is Superior to Adjustable Gastric Band in Super Morbidly Obese Patients. Arch Surg. 2006;141(7):683-689. Brolin RE. Long limb Roux en Y gastric bypass revisited. Surg Clin North Am. 2005 Aug;85(4):807-17, vii. Censani M, Stein EM, Shane E, Oberfield SE, McMahon DJ, Lerner S, Fennoy I. Vitamin D Deficiency Is Prevalent in Morbidly Obese Adolescents Prior to Bariatric Surgery. ISRN Obes. 2013;2013. doi: 284516. Centers for Medicare & Medicaid Services (CMS). Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R2). June 27, 2012. Accessed at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=258&fromdb=true Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Bariatric Surgery for Treatment of Morbid Obesity (100.1). Effective February 12, 2009. Accessed at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=57&ncdver=3&bc=AAAAgAAAAAAA& Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Intensive Behavioral Therapy for Obesity (210.12). November 29, 2011. Accessed at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=353&ncdver=1&NCAId=253&ver=6&NcaName=Intensive+Behavioral+Therapy+for+Obesity&bc=AiAAAAAAIAAA& Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Medical Nutrition Therapy (180.1). Effective Date October 1, 2002. Accessed at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=252&ncdver=1&DocID=180.1&SearchType=Advanced&bc=IAAAAAgAAAAAAA%3d%3d&

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Centers for Medicare & Medicaid Services (CMS). Welcome to the Medicare Coverage Database. Accessed at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx Chiapaikeo D, Schultheis M, Protyniak B, Pearce P, Borao FJ, Binenbaum SJ. Analysis of reoperations after laparoscopic adjustable gastric banding. JSLS. 2014 Oct;18(4). pii: e2014.00210. Childerhose JE, Tarini BA. Understanding Outcomes in Adolescent Bariatric Surgery. Pediatrics. 2015 Aug;136(2):e312-4. Commonwealth of Massachusetts Betsy Lehman Center for Patient Safety and Medical Error Reduction Expert Panel on Weight Loss Surgery: executive report. Lehman Center Weight Loss Surgery Expert Panel. Obes Res. 2005 Feb;13(2):205-26. Commonwealth of Massachusetts MassHealth Guidelines for Medical Necessity Determination for Bariatric Surgery. Accessed at: http://www.mass.gov/portal/ Cottam D et al. Laparoscopic Sleeve Gastrectomy as an Initial Weight-Loss Procedure for High-Risk Patients with Morbid Obesity. Surgical Endoscopy. 2006;20:859. Cozacov Y, Roy M, Moon S, Marin P, Lo Menzo E, Szomstein S, Rosenthal R. Mid-term results of laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass in adolescent patients. Obes Surg. 2014 May;24(5):747-52. doi: 10.1007/s11695-013-1169-7. De Castro ML. Efficacy, safety, and tolerance of two types of intragastric balloons placed in obese subjects: a double-blind comparative study. Obesity Surgery 2010 Dec;20(12):1642-6. Delko T, Kostler T, Peev M, Oertli D, Zingg U. Influence of additional resection of the gastric fundus on excessive weight loss in laparoscopic very long limb Roux-en-Y gastric bypass. Obes Surg. 2013 Mar;23(3):279-86. Dorman RB, Rasmus NF, al-Haddad BJ, Serrot FJ, Slusarek BM, Sampson BK, Buchwald H, Leslie DB, Ikramuddin S. Benefits and complications of the duodenal switch/biliopancreatic diversion compared to the Roux-en-Y gastric bypass. Surgery. 2012 Oct;152(4):758-65; discussion 765-7. doi: 10.1016/j.surg.2012.07.023. Epub 2012 Sep 6. Dumonceau JM. Single vs. repeated treatment with the intragastric balloon: a 5-year weight loss study. Obesity Surgery. 2010 Jun;20(6):692-7. Eldar SM, Heneghan HM, Brethauer SA, Khwaja HA, Singh M, Rogula T, Schauer PR. Laparoscopic bariatric surgery for those with body mass index of 70-125 kg/m2. Surg Obes Relat Dis. 2012 Nov-Dec;8(6):736-40. doi: 10.1016/j.soard.2011.09.024. Epub 2011 Oct 14.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Fridley J, Foroozan R, Sherman V, Brandt ML, Yoshor D. Bariatric surgery for the treatment of idiopathic intracranial hypertension. J Neurosurg. 2011. Jan;114(1):34-9. doi: 10.3171/2009.12.JNS09953. Epub 2010 Jan 22. Review. PubMed PMID: 20095788. Fullmer MA, Abrams SH, Hrovat K, Mooney L, Scheimann AO, Hillman JB, Suskind DL. National Association of Children's Hospitals and Related Institutions, North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Nutritional strategy for adolescents undergoing bariatric surgery: report of a working group of the Nutrition Committee of NASPGHAN/NACHRI. J Pediatric Gastroenterology Nutr. 2012 Jan;54(1):125-35. doi: 10.1097/MPG.0b013e318231db79. Gagne DJ, Dovec E, Urbandt JE. Laparoscopic revision of vertical banded gastroplasty to Roux-en-Y gastric bypass: outcomes of 105 patients. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):493-9. Gehrer S et al. Fewer nutrient deficiencies after laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB)-a prospective study. Obes Surg. 2010 Apr;20(4):447-53. Gidon A et al. Longitudinal Gastrectomy as a Treatment for the High-Risk Super Obese Patient. Obesity Surg 2004;14:492-497. Gleysteen JJ. Five-year outcome with gastric bypass: Roux limb length makes a difference. Surg Obes Relat Dis. 2009 Mar-Apr;5(2):242-7; discussion 247-9. doi: 10.1016/j.soard.2008.08.005. Epub 2008 Aug 19. Gonzalez-Heredia R, Masrur M, Patton K, Bindal V, Sarvepalli S, Elli E. Revisions after failed gastric band: sleeve gastrectomy and Roux-en-Y gastric bypass. Surg Endosc. 2014 Nov 27. Gravante G et al. Laparoscopic adjustable gastric bandings, a prospective randomized study of 400 operations performed with 2 different devices. Arch Surg. 2007;142(10):958-961. Hall TC, Pellen MG, Sedman PC, Jain PK. Preoperative factors predicting remission of type 2 diabetes mellitus after Roux-en-Y gastric bypass surgery for obesity. Obes Surg. 2010 Sep;20(9):1245-50. Hayes Medical Technology Directory. Laparoscopic Sleeve Gastrectomy for Super Obesity in Adults. Winifred Hayes, Inc. October 19, 2012. Annual Review September 15, 2015. Hayes Medical Technology Directory. Revisional Surgery for Treatment of Complications After Bariatric Surgery. Winifred Hayes, Inc. July 24, 2014. Annual Review July 21, 2015. Hayes Medical Technology Directory. Roux-en-Y Gastric Bypass for Diabetes in Obese or Severely Obese Patients. Winifred Hayes, Inc. August 7, 2014. Annual Review July 21, 2015. Hayes Medical Technology Directory. Roux-en-Y Gastric Bypass for Gastroesophageal Reflux Disease in Obese or Severely Obese Patients. Winifred Hayes, Inc. July 10, 2013. Annual Review June 17, 2015.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Hayes News - Clinical Study. Bariatric Surgery an Effective Treatment for Type 2 Diabetes? Winifred Hayes, Inc. April 11, 2014. Hayes News - Clinical Study. Bariatric Surgery No Bargain Over the Long Term. February 22, 2013. Hayes News - Clinical Study. Can Bariatric Surgery “Cure” Diabetes? Winifred Hayes, Inc. April 2, 2012. Hayes News - Clinical Study. Gastric Bypass Surgery Appears to Improve Diabetes Risk Factors. Winifred Hayes, Inc. June 5, 2013. Hayes News - Clinical Study. Three-Year Outcomes Following Bariatric Surgery Suggest Sustained Weight Loss. Winifred Hayes, Inc. November 5, 2013. Hayes News - Government. CMS Decision Related to Bariatric Surgical Procedures to Treat Type 2 Diabetes. Winifred Hayes, Inc. February 17, 2009. Hayes News – Government. CMS Issues Decision Memo for Laparoscopic Sleeve Gastrectomy. Winifred Hayes, Inc. June 28, 2012. Hayes News - Government. Proposed Decision Memo Regarding CMS Coverage for Bariatric Surgery. Winifred Hayes, Inc. July 23, 2013. Hayes News - Medical Association/Organization. Updated Guidelines for Bariatric Surgery. Winifred Hayes, Inc. April 26, 2013. Hayes Search & Summary. Preoperative Supervised Weight Loss Prior to Adult Bariatric Surgery. Winifred Hayes, Inc. February 5, 2015. Hayes Search & Summary. Sleeve Gastrectomy for Treatment of Obesity in Children. Winifred Hayes, Inc. February 12, 2015. Heneghan HM, Cetin D, Navaneethan SD, Orzech N, Brethauer SA, Schauer PR. Effects of Bariatric Surgery on Diabetic Nephropathy After 5 Years of Follow-Up. Surg Obes Relat Dis. 2012 Oct 12. doi:pii: S1550-7289(12)00349-8. Holterman AX, Holterman M, Browne A, Henriques S, Guzman G, Fantuzzi G. Patterns of surgical weight loss and resolution of metabolic abnormalities in superobese bariatric adolescents. J Pediatr Surg. 2012 Sep;47(9):1633-9. Hsia DS et al. Adolescent bariatric surgery. Arch Pediatr Adolesc Med. 2012 Aug;166(8):757-66.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011 Sep;254(3):410-20; discussion 420-2. doi: 10.1097/SLA.0b013e31822c9dac. Inabnet WB, Quinn T, Gagner M, Urban M, Pomp A. Laparoscopic Roux-en-Y gastric bypass in patients with BMI <50: a prospective randomized trial comparing short and long limb lengths. Obes Surg. 2005 Jan;15(1):51-7. PMID: 15760498. Inge TH, King WC, Jenkins TM, Courcoulas AP, Mitsnefes M, Flum DR, Wolfe BM, Pomp A, Dakin GF, Khandelwal S, Zeller MH, Horlick M, Pender JR, Chen JY, Daniels SR. The effect of obesity in adolescence on adult health status. Pediatrics. 2013 Dec;132(6):1098-104. Inge TH, Krebs NF, Garcia VF, Skelton JA, Guice KS, Strauss RS, Albanese CT, Brandt ML, Hammer LD, Harmon CM, Kane TD, Klish WJ, Oldham KT, Rudolph CD, Helmrath MA, Donovan E, Daniels SR. Bariatric surgery for severely overweight adolescents: concerns and recommendations. Pediatrics. 2004; 114;217. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/15231931 Inge TH, Xanthakos SA, Zeller MH. Bariatric surgery for pediatric extreme obesity: now or later? Int J Obes (Lond) 2007;31:1–14. Inge TH, Zeller MH, Jenkins TM, Helmrath M, Brandt ML, Michalsky MP, Harmon CM, Courcoulas A, Horlick M, Xanthakos SA, Dolan L, Mitsnefes M, Barnett SJ, Buncher R; for the Teen-LABS Consortium. Perioperative Outcomes of Adolescents Undergoing Bariatric Surgery: The Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study. JAMA Pediatr. 2013 Nov 4. doi: 10.1001/jamapediatrics.2013.4296. [Epub ahead of print] Inge TH, Zeller MH, Lawson L, Daniels SR. Critical appraisal of the evidence supporting bariatric surgery for weight management in adolescence. J Pediatr 2005;147:10 –9. International Pediatric Endosurgery Group (IPEG). IPEG Guidelines for Surgical Treatment of Extremely Obese Adolescents. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:xiv-xvi. doi: 10.1089/lap.2009.9981.supp. Jain-Spangler K, Portenier D, Torquati A, Sudan R. Conversion of vertical banded gastroplasty to stand-alone sleeve gastrectomy or biliopancreatic diversion with duodenal switch. J Gastrointest Surg. 2013 Apr;17(4):805-8. Jamal MH, Corcelles R, Daigle CR, Rogula T, Kroh M, Schauer PR, Brethauer SA. Safety and effectiveness of bariatric surgery in dialysis patients and kidney transplantation candidates. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):419-23. doi: 10.1016/j.soard.2014.09.022. Epub 2014 Oct 2. PMID: 25813752.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent National Trends in the Use of Adolescent Inpatient Bariatric Surgery: 2000 Through 2009. Arch Pediatr Adolesc Med. 2012 Dec 17:1-7. doi: 10.1001/2013.jamapediatrics.286. Kiraikopoulos A et al. Laparoscopic sleeve gastrectomy in morbidly obese patients. Technique and short term results. Hormones (Athens). 2009 Apr-Jun;8(2):138-43. Koeck ES, Barefoot LC, Hamrick M, Owens JA, Qureshi FG, Nadler EP. Predicting sleep apnea in morbidly obese adolescents undergoing bariatric surgery. Surg Endosc. 2014 Apr;28(4):1146-52. Krispel CM, Keltner JL, Smith W, Chu DG, Ali MR. Undiagnosed papilledema in a morbidly obese patient population: a prospective study. J Neuroophthalmol. 2011 Dec;31(4):310-5. doi: 10.1097/WNO.0b013e3182269910. Kuwada TS, Richardson S, El Chaar M, Norton HJ, Cleek J, Tomcho J, Stefanidis D. Insurance-mandated medical programs before bariatric surgery: do good things come to those who wait? Surg Obes Relat Dis. 2011 Jul-Aug;7(4):526-30. doi: 10.1016/j.soard.2010.08.017. Epub 2010 Sep 19. Laffin M et al. Sleeve Gastrectomy and Gastroesophageal Reflux Disease. J Obes. 2013; 2013: 741097. Langer FB et al. Does Gastric Dilatation Limit the Success of Sleeve Gastrectomy as a Sole Operation for Morbid Obesity? Obesity Surg 2006;16:166-171. Lee W et al. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. Leitman IM et al. Early results of trans-oral endoscopic plication and revision of the gastric pouch and stoma following Roux-en-Y gastric bypass surgery. JSLS. 2010 Apr-Jun;14(2):217-20. Lennerz BS, Wabitsch M, Lippert H, Wolff S, Knoll C, Weiner R, Manger T, Kiess W, Stroh C. Bariatric surgery in adolescents and young adults-safety and effectiveness in a cohort of 345 patients. Int J Obes (Lond). 2013 Sep 19. doi: 10.1038/ijo.2013.182. [Epub ahead of print] Levin AA, Hess D, Hohler AD. Treatment of idiopathic intracranial hypertension with gastric bypass surgery. Int J Neurosci. 2015 Jan;125(1):78-80. doi: 10.3109/00207454.2014.898144. Epub 2014 Mar 25. PMID: 24579748. Mann JP, Jakes AD, Hayden JD, Barth JH. Systematic Review of Definitions of Failure in Revisional Bariatric Surgery. Obes Surg. 2014 Dec 17. [Epub ahead of print] Marcason W. What are the Dietary Guidelines following Bariatric Surgery? Journal of the American Dietetic Association, March 2004 104:3 487-488.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Marceau P, Biron S, Hould FS, Lebel S, Marceau S, Lescelleur O, Biertho L, Simard S. Duodenal switch improved standard biliopancreatic diversion: a retrospective study. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):43-7. doi: 10.1016/j.soard.2008.03.244. Epub 2008 Apr 28. PMID: 18440876. Messiah SE, Lopez-Mitnik G, Winegar D, Sherif B, Arheart KL, Reichard KW, Michalsky MP, Lipshultz SE, Miller TL, Livingstone AS, de la Cruz-Muoz N. Changes in weight and co-morbidities among adolescents undergoing bariatric surgery: 1-year results from the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis. 2012 Mar 28. Mognol P et al. Laparoscopic Sleeve Gastrectomy as an Initial Bariatric Operation for High-Risk Patients: Initial Results in 10 Patients. Obesity Surg 2005;15:1030-1033. Nadler EP, Barefoot LC, Qureshi FG. Early results after laparoscopic sleeve gastrectomy in adolescents with morbid obesity. Surgery. 2012 Aug;152(2):212-7. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/22828142 Nadler EP, Youn HA, Ren CJ, Fielding GA. An update on 73 US obese pediatric patients treated with laparoscopic adjustable gastric banding: comorbidity resolution and compliance data. J Pediatr Surg. 2008 Jan;43(1):141-6. doi: 10.1016/j.jpedsurg.2007.09.035. National Guideline Clearinghouse (NGC). Guideline synthesis: Management of overweight and obesity in children and adolescents. Agency for Healthcare Research and Quality (AHRQ); 2005 Apr 29 (revised 2013 Jan). Accessed at: http://www.guideline.gov/content.aspx?id=15489 National Institute of Diabetes and Digestive and Kidney Disease. U.S. Department of Health and Human Services. Nonalcoholic Steatohepatitis. May 28, 2014. Accessed at: http://www.niddk.nih.gov/health-information/health-topics/liver-disease/nonalcoholic-steatohepatitis/Pages/facts.aspx National Institute of Health and Clinical Excellence (NICE). CG43 Obesity: Full Guideline. December 2006. Updated 26 January 2011. Accessed at: http://guidance.nice.org.uk/CG43/Guidance National Institute of Health and Clinical Excellence (NICE). Specifying a bariatric surgical service for the treatment of people with severe obesity. May 10, 2010. Updated March 02, 2012. Accessed at: http://www.nice.org.uk/guidance/cg189 Nergaard BJ, Leifsson BG, Hedenbro J, Gislason H. Gastric bypass with long alimentary limb or long pancreato-biliary limb--long-term results on weight loss, resolution of co-morbidities and metabolic parameters. Obes Surg. 2014 Oct;24(10):1595-602. doi: 10.1007/s11695-014-1245-7. PMID: 24744188. Nguyen NT, Karipineni F, Masoomi H, Laugenour K, Reavis K, Hohmann S, Varela E. Increasing utilization of laparoscopic gastric banding in the adolescent: data from academic medical centers, 2002-2009. Am Surg. 2011 Nov;77(11):1510-4.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the superobese with massively enlarged liver. Obes Surg. 2005;15:1077-1081. Nguyen NQ, Game P, Bessell J, Debreceni TL, Neo M, Burgstad CM, Taylor P, Wittert GA. Outcomes of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. World J Gastroenterol. 2013 Sep 28;19(36):6035-43. doi: 10.3748/wjg.v19.i36.6035. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785625/ Nobili V, Vajro P, Dezsofi A, Fischler B, Hadzic N, Jahnel J, Lamireau T, McKiernan P, McLin V, Socha P, Tizzard S, Baumann U. Indications and limitations of bariatric intervention in severely obese children and adolescents with and without nonalcoholic steatohepatitis: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):550-61. doi: 10.1097/MPG.0000000000000715. Oberbach A, Neuhaus J, Inge T, Kirsch K, Schlichting N, Blher S, Kullnick Y, Kugler J, Baumann S, Till H. Bariatric surgery in severely obese adolescents improves major comorbidities including hyperuricemia. Metabolism. 2013 Nov 22. pii: S0026-0495(13)00394-6. doi: 10.1016/j.metabol.2013.11.012. Ochner CN, Dambkowski CL, Yeomans BL, Teixeira J, Xavier Pi-Sunyer F. Pre-bariatric surgery weight loss requirements and the effect of preoperative weight loss on postoperative outcome. Int J Obes (Lond). 2012 Nov;36(11):1380-7. doi: 10.1038/ijo.2012.60. Epub 2012 Apr 17. Review. Osorio A, Moreira-Pinto J, Pereira J, Silva G, Bonet B, Cidade-Rodrigues JA, Ferreira-de-Sousa JA, Enes C, Mansilha H. 9 Years after the first laparoscopic adjusted gastric banding (LAGB) in adolescents: the Portuguese experience. Eur J Pediatr Surg. 2011 Oct;21(5):331-4. Ou Yang O, Loi K, Liew V, Talbot M, Jorgensen J. Staged laparoscopic sleeve gastrectomy followed by Roux-en-Y gastric bypass for morbidly obese patients: a risk reduction strategy. Obes Surg. 2008 Dec;18(12):1575-80. doi: 10.1007/s11695-008-9554-3. Epub 2008 May 28. Pagé MP, Kastenmeier A, Goldblatt M, Frelich M, Bosler M, Wallace J, Gould J. Medically refractory gastroesophageal reflux disease in the obese: what is the best surgical approach? Surg Endosc. 2014 May;28(5):1500-4. doi: 10.1007/s00464-013-3343-3. Epub 2013 Dec 6. PMID: 24310740. Pallati P, Buettner S, Simorov A, Meyer A, Shaligram A, Oleynikov D. Trends in adolescent bariatric surgery evaluated by UHC database collection. Surg Endosc. 2012 Nov;26(11):3077-81. Papadia FS, Adami GF, Marinari GM, Camerini G, Scopinaro N. Bariatric surgery in adolescents: a long-term follow-up study. Surg Obes Relat Dis 2007;3:465–8.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Pech N, Meyer F, Lippert H, Manger T, Stroh C. Complications, reoperations, and nutrient deficiencies two years after sleeve gastrectomy. J Obes. 2012;2012:828737. Peterli R, Borbly Y, Kern B, Gass M, Peters T, Thurnheer M, Schultes B, Laederach K, Bueter M, Schiesser M. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Ann Surg. 2013 Nov;258(5):690-4. Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess. 2009 Sep;13(41):1-190, 215-357, iii-iv. doi: 10.3310/hta13410. Review. PMID: 19726018. Pratt JS, Lenders CM, Dionne EA, Hoppin AG, Hsu GL, Inge TH, Lawlor DF, Marino MF, Meyers AF, Rosenblum JL, Sanchez VM. Best practice updates for pediatric/adolescent weight loss surgery. Obesity (Silver Spring). 2009 May;17(5):901-10. doi: 10.1038/oby.2008.577. Epub 2009 Feb 19. Review. PMID: 19396070; PubMed Central PMCID: PMC3235623. Rebibo L, Dhahri A, Verhaeghe P, Regimbeau JM. What to do when it is technically impossible to perform laparoscopic sleeve gastrectomy. Obes Surg. 2014 Dec;24(12):2069-74. doi: 10.1007/s11695-014-1320-0. PMID: 24952633. Sachdev P, Makaya T, Marven SS, Ackroyd R, Wales JK, Wright NP. Bariatric surgery in severely obese adolescents: a single-centre experience. Arch Dis Child. 2014 Oct;99(10):894-8. doi: 10.1136/archdischild-2013-305583. Epub 2014 Jun 30. Sanchez-Santos R et al. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg. 2009 Sep;19(9):1203-10. Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. Schmitt F, Riquin E, Beaumesnil M, Dinomais M, Topart P, Weil D, Malka J, Coutant R, Podevin G, Bouhours-Nouet N. Laparoscopic adjustable gastric banding in adolescents: Results at two years including psychosocial aspects. J Pediatr Surg. 2015 Sep 14. pii: S0022-3468(15)00577-1. Shah S et al. Prospective controlled study of effect of laparoscopic sleeve gastrectomy on small bowel transit time and gastric emptying half-time in morbidly obese patients with type 2 diabetes mellitus. Surg Obes Relat Dis. 2010 Mar 4;6(2):152-7.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Sinha M, Stanley TL, Webb J, Scirica C, Corey K, Pratt J, Boepple PA, Hoppin A, Misra M. Metabolic effects of Roux-en-Y gastric bypass in obese adolescents and young adults. J Pediatr Gastroenterol Nutr. 2013 May;56(5):528-31. Smith M. Experts Debate Sleeve Gastrectomy as Gold Standard for Teens. Procedure Is Growing in Popularity, But Long-term Efficacy Remains Unknown. Obesity Care. September 2012, Volume: 39:9. Accessed at: http://www.generalsurgerynews.com/ViewArticle.aspx?d=Obesity+Care&d_id=410&i=September+2012&i_id=883&a_id=21630 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Alqahtani AR, Mohamed Elahmedi M, Alamri H. Saud K. Laparoscopic Sleeve Gastrectomy in Adult and Pediatric Obese Patients: A Comparative Study. Accessed at: http://www.sages.org/meetings/annual-meeting/abstracts-archive/laparoscopic-sleeve-gastrectomy-in-adult-and-pediatric-obese-patients-a-comparative-study/ Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Guidelines for Clinical Application of Laparoscopic Bariatric Surgery. 2008. Accessed at: http://www.sages.org/publications/guidelines/guidelines-for-clinical-application-of-laparoscopic-bariatric-surgery/ Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD. Guidelines for surgical treatment of gastroesophageal reflux disease. SAGES Guidelines Committee. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. Review. No abstract available. PMID: 20725747. Sugerman, H. Summary: Consensus Conference on Surgery for Severe Obesity. Surgery for Obesity and Related Diseases 1. 2005. 369-370. Sugerman, HJ, Sugerman EL, DeMaria EJ, et al. Bariatric surgery for severely obese adolescents. J Gastrointest Surg. 7: 102107. 2003. Tafti BA, Haghdoost M, Alvarez L, Curet M, Melcher ML. Recovery of renal function in a dialysis-dependent patient following gastric bypass surgery. Obes Surg. 2009 Sep;19(9):1335-9. doi: 10.1007/s11695-009-9907-6. Epub 2009 Jul 15. Tevis S, Garren MJ, Gould JC. Revisional surgery for failed vertical-banded gastroplasty. Obes Surg 2011 Aug;21(8):1220-4. doi: 10.1007/s11695-011-0358-5. Thakkar RK, Michalsky MP. Update on bariatric surgery in adolescence. Curr Opin Pediatr. 2015 Jun;27(3):370-6.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Thurnheer M, Bisang P, Ernst B, Schultes B. A novel distal very long Roux-en Y gastric bypass (DVLRYGB) as a primary bariatric procedure--complication rates, weight loss, and nutritional/metabolic changes in the first 355 patients. Obes Surg. 2012 Sep;22(9):1427-36. Tian HL, Tian JH, Yang KH, Yi K, Li L. The effects of laparoscopic vs. open gastric bypass for morbid obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2011 Apr;12(4):254-60. doi: 10.1111/j.1467-789X.2010.00757.x. PMID: 20546145. Till H, Blüher S, Hirsch W, Kiess W. Efficacy of laparoscopic sleeve gastrectomy (LSG) as a stand-alone technique for children with morbid obesity. Obes Surg 2008;18:1047–9. Topart P, Becouarn G, Salle A. Five-year follow-up after biliopancreatic diversion with duodenal switch. Surg Obes Relat Dis. 2011 Mar-Apr;7(2):199-205. Epub 2010 Nov 13. Treadwell JR. Systematic review and meta-analysis of bariatric surgery for pediatric obesity. Ann Surg 2008 Nov;248(5):763-76. Tsai WS, Inge TH, Burd RS. Bariatric surgery in adolescents: recent national trends in use and in-hospital outcome. Arch Pediatr Adolesc Med 2007;161:217–21. U.S. Food and Drug Administration (FDA) Medical Devices. LAP-BAND® Adjustable Gastric Banding (LAGB®) System - P000008. Approval Date June 5, 2001. Accessed at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm088965.htm Woolford SJ, Clark SJ, Gebremariam A, Davis MM, Freed GL. To cut or not to cut: physicians' perspectives on referring adolescents for bariatric surgery. Obes Surg. 2010 Jul;20(7):937-42. doi: 10.1007/s11695-010-0152-9. Xanthakos SA, Schwimmer JB. Paediatric gastroenterology. On a knife-edge--weight-loss surgery for NAFLD in adolescents. Nat Rev Gastroenterol Hepatol. 2015 Jun;12(6):316-8. Zeinoddini A, Heidari R, Talebpour M. Laparoscopic gastric plication in morbidly obese adolescents: a prospective study. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1135-9. Zeller MH, Reiter-Purtill J, Ratcliff MB, Inge TH, Noll JG. Surg Obes Relat Dis. 2011 Nov-Dec;7(6):727-32. doi: 10.1016/j.soard.2011.01.034. Epub 2011 Mar 5. Zwintscher NP, Azarow KS, Horton JD, Newton CR, Martin MJ. The increasing incidence of adolescent bariatric surgery. J Pediatr Surg. 2013 Dec;48(12):2401-7.

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Original Approval Date

Original Effective Date* and Version

Number Policy Owner Approved by

Regulatory Approval: N/A Internal Approval: 11/01/14

01/01/05 Version 1

Medical Policy Manager as Chair of Medical Policy, Criteria, and Technology Assessment Committee (MPCTAC) and member of Quality Improvement Committee (QIC)

Quality and Clinical Management Committee (Q&CMC)

*Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date for the Well Sense Heath Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for the Senior Care Options Product(s): 01/01/16

Policy Revisions History

Review Date Summary of Revisions

Revision Effective Date and Version

Number

Approved by

12/06/05 Updated clinical coverage criteria. Version 2 12/06/05: Q&CMC

02/06/07 Updated references, added CMS and other payer coverage information.

Version 3 02/06/07: Q&CMC

06/01/07 Revised template. Version 4

01/08/08 Clinical criteria revised, vertical banded gastroplasty and sleeve gastrectomy are considered investigational. Revisions effective 07/01/08.

07/01/08 Version 5

01/08/08: MPCTAC 01/22/08: Utilization Management Committee (UMC) 02/19/08: QIC

11/11/08 No changes. Version 6 11/25/08: MPCTAC 11/25/08: UMC 12/16/08: QIC

11/24/09 No changes.

Version 7 11/24/09: MPCTAC 12/23/09: QIC

12/01/10 Added criteria for the revision of prior bariatric surgery, the sleeve gastrectomy, BPD procedures and bariatric reversal procedures. Added the StomaphyX and ROSE procedures as investigational. Updated references.

Version 8 12/28/10: MPCTAC 01/26/11: QIC

12/01/11 Updated definitions, clinical criteria and limitations sections with additional procedures that are considered investigational. Updated the criteria for sleeve gastrectomy.

Version 9 12/12/11: MPCTAC 12/20/11: QIC

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History

07/01/12 Off cycle review for Well Sense Health Plan. Revised Summary statement, revised and reformatted Clinical Guideline Statement, revised Limitations, updated code list, deleted reference to MassHealth medical necessity guidelines.

Version 10 08/03/12: MPCTAC 09/05/12: QIC

02/01/13 Review for effective date 06/01/13. Revised Summary section, reformatted and revised clinical criteria in Medical Policy Statement section (formerly named the Clinical Guideline Statement section), reformatted and added limitations and contraindications, revised language in Applicable Coding section and updated code list, text added to Clinical Background Information section, and revised and added references.

06/01/13 Version 11

02/20/13: MPCTAC 03/21/13: QIC

07/01/13 Review for effective date 11/01/13. Revised criteria in Medical Policy Statement section requiring medical evaluation with risk assessment for bariatric surgery. Revised Description of Item or Service section.

11/01/13 Version 12

07/17/13: MPCTAC 08/15/13: QIC

11/01/13 Review for effective date 03/01/14. Added CPT code 43842 (for vertical-banded gastroplasty) as an experimental and investigational code.

03/01/14 Version 13

11/20/13: MPCTAC 12/19/13: QIC

02/01/14 Review for effective date 06/01/14. Updated Description of Item or Service, Clinical Background Information, and References section. Updated criteria in the Medical Policy Statement section and Limitation section.

06/01/14 Version 14

02/19/14: MPCTAC 02/26/14: QIC

01/01/15 Review for effective date 06/01/15. Updated Description of Item or Service, Definitions, Clinical Background Information, and References sections. Revised medical criteria in the Medical Policy Statement section and Limitations section. Added sleeve gastrectomy as a medically necessary procedure for adolescent members

06/01/15 Version 15

02/18/15: MPCTAC 03/11/15: QIC

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History

when applicable medical criteria are met. Removed Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available.

11/01/15 Review for effective date 01/01/16. Updated template with list of applicable products and corresponding notes. Revised language in the Applicable Coding section.

01/01/16 Version 16

11/18/15: MPCTAC 11/25/15: MPCTAC (electronic vote) 12/09/15: QIC

11/25/15 Review for effective date 03/01/16. Revised criteria in the Medical Policy Statement and Limitations sections. Revised the Definitions and References sections.

03/01/16 Version 17

11/18/15: MPCTAC 11/25/15: MPCTAC (electronic vote) 12/09/15: QIC

09/01/16 and 09/28/16

Review for effective date 11/01/16. Updated Description of Item or Service, Clinical Background Information, References, and Reference to Applicable Laws and Regulations. Administrative changes made to clarify language related to gender.

11/01/16 Version 18

09/21/16: MPCTAC 09/28/16: MPCTAC (electronic vote) 10/12/16: QIC

Last Review Date

09/28/16

Next Review Date

11/01/16

Authorizing Entity

QIC

Other Applicable Policies

Medical Policy - Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy - Medical Nutrition Therapy in the Outpatient or Office Setting (policy number OCA 3.66) Medical Policy - Medically Necessary, policy number OCA 3.14 Reimbursement Policy - Anesthesia, policy number 4.103 Reimbursement Policy - Anesthesia, policy number SCO 4.103

Bariatric Surgery + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Reimbursement Policy - Anesthesia, policy number WS 4.11 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number SCO 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number WS 4.108 Reimbursement Policy - General Billing and Coding Guidelines, policy number 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number SCO 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number WS 4.31 Reimbursement Policy - Hospital, policy number WS 4.21 Reimbursement Policy - Inpatient Hospital, policy number, policy number 4.110 Reimbursement Policy - Inpatient Hospital, policy number, policy number SCO 4.110 Reimbursement Policy - Outpatient Hospital, policy number 4.17 Reimbursement Policy - Outpatient Hospital, policy number SCO 4.17

Reference to Applicable Laws and Regulations

78 FR 48164-69. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. August 7, 2013. Accessed at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

Disclaimer Information: +

Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs.

Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members.

The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.