Bariatric Surgery Hs-006

Home , Gastric bypass surgery

BARIATRIC SURGERY HS-006

Easy Choice Health Plan, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Inc.

‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc.

WellCare Health Insurance of Illinois, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare Health Insurance of Arizona, Inc.

WellCare of Florida, Inc.

WellCare of Connecticut, Inc.

WellCare of Georgia, Inc.

WellCare of Kentucky, Inc. Bariatric Surgery

WellCare of Louisiana, Inc. Policy Number: HS-006 WellCare of New York, Inc. Original Effective Date: 4/1/2007 WellCare of South Carolina, Inc.

WellCare of Texas, Inc. Revised Date(s): 6/19/2008; 7/2/2009;

WellCare Prescription Insurance, Inc. 7/16/2009; 8/18/2009; 9/23/2010; 7/18/2011; 2/2/2012; 2/7/2013; 2/19/2013; 8/1/2013; Windsor Health Plan 11/7/2013; 3/17/2014; 5/30/2014; 10/2/2014; Windsor Rx Medicare Prescription Drug Plan 3/19/2015; 4/2/2015

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

BARIATRIC SURGERY HS-006

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.

BACKGROUND

Gastric bypass surgery and gastroplasty cause weight reduction in morbidly obese patients. Gastroplasty reduces the capacity of the stomach and the size of the gastric outlet. Gastric bypass reduces stomach capacity and diverts partially digested food past the duodenum to the jejunum. Morbid or clinically severe obesity correlates with a Body Mass Index (BMI) of 40 kg/m2 or with being greater than or equal to 100 pounds over ideal body weight.

The Lap-Band Adjustable Gastric Banding System (LAGBS) received FDA approval in June 2001 and is currently available as a weight reduction surgery in obese patients. The system consists of a band with a sutureless locking mechanism. The band is placed via a laparoscopic approach around the upper part of the stomach to form a small pouch and is connected by tubing to an access port that is positioned in the upper abdomen directly under the skin. The surgeon adjusts the size of the band around the stomach by percutaneously injecting or removing saline as needed through the access port.

Adolescents and Young Adults

The National Heart, Lung, and Blood Institute published evidence-based recommendations for the management of obesity among 12 to 21 year olds:17

 Identify adolescents at increased risk for obesity because of parental obesity, change in physical activity +/– excess gain in BMI for focused diet and/or physical activity (PA) education x 6 months.

BMI/BMI%ile stable → reinforce current program, 6 month follow-up Increasing BMI/BMI%ile → Registered Dietician (RD) counseling for energy-balanced CHILD 1, intensified physical activity x 3 months

 BMI 85th - 95th%ile: Excess weight gain prevention with adolescent as change agent for energy-balanced CHILD 1, reinforced physical activity recommendations x 6 months.

Improvement in BMI%ile → continue current program Increasing BMI%ile → RD counseling for energy- balanced weight control diet, intensified physical activity, 3 month follow-up

 BMI ≥ 95th%ile: Specific assessment for comorbidities (hypertension, dyslipidemia, type 2 diabetes mellitus.

 BMI ≥ 95th%ile with no comorbidities: Office-based weight loss plan: Family-centered Grade B with adolescent as change agent for behavior Strongly recommend modification counseling, RD counseling for (-) energy-balanced diet, Rx for increased MVPA, decreased sedentary time x 6 months. o Improvement in BMI/BMI%ile → continue current program o No improvement in BMI/BMI%ile → referral to comprehensive multidisciplinary weight loss program with peers o No improvement in BMI/BMI%ile → consider initiation of medication (orlistat) under care of experienced MD x 6-12 months

 BMI ≥ 95th%ile with comorbidities or BMI > 35 kg/m2: Refer to comprehensive lifestyle weight loss program for intensive management x 6-12 months. o Improvement in BMI/BMI%ile → continue present program

Clinical Coverage Guideline page 2

Original Effective Date: 4/1/2007 - Revised: 6/19/2008, 7/2/2009, 8/18/2009, 9/23/2010, 7/18/2011, 2/2/2012, 2/7/2013, 8/1/2013, 11/7/2013, 3/17/2014, 5/30/2014, 9/4/2014, 10/2/2014, 3/19/2015, 4/2/2015

BARIATRIC SURGERY HS-006

o No improvement in BMI/BMI%ile → consider initiation of orlistat under care of experienced clinician x 6- 12 months o BMI far above 35 kg/m2 and comorbidities unresponsive to lifestyle therapy for > 1 y, consider bariatric surgery/referral to center with experience/expertise in procedures

Pediatric and adolescent bariatric surgery specialty programs should include the following components:18

1. Institutional commitment involves a commitment to excellence in the care of pediatric patients undergoing bariatric surgery. Evidence includes ongoing in-service education programs in adolescent bariatric surgery and regular administrative review of the program. Direct caregivers should be able to recognize the early signs of common clinical complications so that they can be managed promptly (e.g., pulmonary embolus, anastomotic leak, infection, bowel obstruction, and other specific device- or procedure-related complications).

2. Medical home of the adolescent bariatric care team must demonstrate direct and regular communication with a primary care physician defined as the patient’s “medical home” before surgical weight-loss procedures can be considered and/or executed.

3. Routine experience involves being routinely engaged in advanced open and laparoscopic abdominal procedures and be staffed with allied health workers who are familiar with the perioperative care of adolescents with complex abdominal conditions.

4. Program staffing should include a surgical director, medical director, child and adolescent psychologist / psychiatrist, allied health workers, social worker, dietician, exercise specialist and consultants (e.g., anesthesiologist, pulmonologist, cardiologist, interventional radiologist, endocrinologist, infectious disease specialist, and respiratory therapist. Flexible endoscopy (experienced surgeon or gastroenterologist) should be readily available.

5. Multidisciplinary review should consist of a committee that includes pediatric and adolescent bariatric surgery providers to review each surgery candidate. Activity should reflect involvement of the surgical director, medical director, program coordinator, behavioral health practitioner, physical activity specialist, and nutritionist or dietician. Additional membership of the care team could include other specialists such as a pulmonologist, endocrinologist, cardiologist, gastroenterologist, otolaryngologist, orthopedist, and/or ethicist (or ethics committee).

6. Specialized equipment should be maintained by the institution including specific instrumentation designed for the care of morbidly obese patients throughout the patient care environment. This includes, but is not limited to: hospital beds, gurneys, gowns, blood pressure cuffs, walkers, clinic examination room and waiting room furniture, scales, wheelchairs, toilets, operating room tables and surgical equipment. In addition, patient-transfer systems for morbidly obese patients must be in place wherever care is provided. Staff must also receive training in the handling of morbidly obese patients to avoid injury to self and/or the patient. Computed-tomography units, fluoroscopy tables, and nuclear medicine equipment should have sufficient weight capacity, as well.

7. Standardized care should use clinical pathways (ambulatory and inpatient) that facilitate the standardization of care for the relevant bariatric procedure. It is the responsibility and duty of the surgeon to select which primary operation(s) he or she will perform. The expectation is that the procedure(s), regardless of the choice, will be performed in a standardized manner. Details should be documented so that each member of the surgeon’s team is aware of the care plan and is prepared to follow the outlined process.

8. Follow-up care compliance with long-term postoperative follow-up care is critical for appropriate monitoring of weight-loss velocity and to provide anticipatory guidance and goal-setting for both the patient and his or her family. Specific areas of concern include weight regain, pregnancy, and malnutrition.

Clinical Coverage Guideline page 3

BARIATRIC SURGERY HS-006

9. Support groups should use in-person and/or electronic formats for those who have undergone or are considering undergoing bariatric surgery.

10. Transition care should include a plan for long-term monitoring and care.

American Society for Metabolic & Bariatric Surgery

Preoperative weight loss can reduce liver volume and may help improve the technical aspects of surgery in patients with an enlarged liver or fatty liver disease and is therefore encouraged before bariatric surgery (Grade B; BEL 1; downgraded due to inconsistent results). Preoperative weight loss or medical nutritional therapy may also be used in selected cases to improve co-morbidities, such as reasonable preoperative glycemic targets (Grade D).19

American Diabetes Association21

The ADA notes that the incidence and prevalence of type 2 diabetes in adolescents has increased dramatically over the past decade, especially in ethnic populations. In addition, recent studies question the validity of A1C in the pediatric population, especially among certain ethnicities, and suggest OGTT or FPG as more suitable diagnostic tests. The study authors note that most studies do not recognize that diabetes diagnostic criteria are based on long- term health outcomes, and validations are not currently available in the pediatric population. The ADA acknowledges the limited data supporting A1C for diagnosing diabetes in children and adolescents. However, aside from rare instances, such as cystic fibrosis and hemoglobinopathies, the ADA continues to recommend A1C in this cohort.

POSITION STATEMENT

Applicable To: Medicaid Medicare

Adult

Bariatric Surgery for the treatment of morbid obesity is considered medically necessary for members age 18 and older when the following is met:

1. Presence of morbid obesity, defined as either: a. Body mass index (BMI)* > 40; OR, b. BMI* greater than 35 in conjunction with ANY of the following severe comorbidities: 1) Established coronary heart disease (based on Cardiologist medical records, known intervention by catheterization or positive stress tests, etc.); OR, 2) Type 2 diabetes mellitus as defined below:20  A1C>6.5%. The test should be performed in a laboratory setting using a method that is NGSP certified and standardized to the DCCT assay;# OR  FPG > 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours; # OR  2-h plasma glucose > 200 mg/dl (11.1 mmol/l during an OGTT). The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water; # OR  In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > 200 mg/dl (11.1 mmol/l). # In the absence of unequivocal hyperglycemia, criteria 1-3 should be confirmed by repeat testing.

OR,

3) Clinically significant obstructive sleep apnea ( i.e., member meets the criteria for treatment of obstructive sleep apnea; OR,

Clinical Coverage Guideline page 4

BARIATRIC SURGERY HS-006

4) Medically refractory hypertension (blood pressure greater than 140 mmHg systolic and/or 90 mmHg diastolic despite optimal medical management);

* NOTE: BMI is calculated by dividing the patient’s weight (in kilograms) by the height (in meters) squared: *BMI = weight (kg) / [height (m)] 2 (To convert pounds to kilograms, multiply pounds by 0.45. To convert inches to meters, multiply inches by 0.0254).

AND;

2. Enrollment in a program with significant experience, a multi-disciplinary team and approach, and agreement to participate in post-operative dietary counseling and education15,16 AND;

3. Member has participated in a physician-supervised nutrition and exercise program (including a low calorie diet, increased physical activity, and behavioral modification). This physician-supervised nutrition and exercise program must meet ALL of the following criteria:

a. Participation in nutrition and exercise program must be supervised and monitored by a physician; AND, b. Nutrition and exercise program must occur within the two years prior to surgery; AND, c. Participation in physician-supervised nutrition and exercise program must be documented in the medical record by an attending physician. Note: A physician’s summary letter is not sufficient documentation.

The program must be overseen by one of the following:  Physician (MD or DO); OR,  Registered dietician (RD); OR,  Board certified specialist in pediatric nutrition (CSP); OR,  Board certified specialist in renal nutrition (CSR); OR,  Fellow of the American Dietetic Association (FADA).

Programs such as Weight Watchers®, Jenny Craig® and Optifast® are acceptable alternatives if done in conjunction with physician supervision and detailed documentation of participation is available for review. However, physician-supervised programs consisting exclusively of pharmacological management are not sufficient to meet this requirement.

AND;

4. Mental health evaluation by a psychiatrist or psychologist to determine any relative contraindications as listed below, mental competency and understanding of the nature, extent and possible complications of the surgery and ability to sustain dietary behavioral modifications needed to ensure a successful outcome of surgery.

A clinical assessment is appropriate to screen for relative contraindicated conditions. If psychological testing is used as a component of the assessment, a total of 2 hours of psychological testing will be approved. For additional information, please reference HS: 203 Use and Approval Of Psychological Testing.

Relative contraindicated diagnoses include:

a. Active drug abuse b. Active suicidal ideation c. Borderline personality disorder d. Schizophrenia e. Psychotic disorder f. Uncontrolled depression g. Defined non-compliance with previous medical care h. Self-destructive or suicidal behavior (e.g., ideation, plan, attempt) i. Psychiatric hospitalizations

Clinical Coverage Guideline page 5

BARIATRIC SURGERY HS-006

Current outpatient psychotherapy (including medications) should also be reviewed with respect to the member’s length of stability, frequency of follow up visits, and/or the need for possible titration or reevaluation of the current medication regimen prior to the surgical procedure.

Information should be obtained from the member’s provider(s) regarding the member’s emotional stability, coping skills, psychological resources and ability to manage life stressors, impulse control issues and compulsions, as well as the client’s capacity to follow directions and adhere to self-management guidelines. The fact that weight loss will positively affect self-esteem or depression, may not be sufficient grounds to proceed with surgery.

In addition, the impact of surgery should also be discussed in terms of symptom resolution and potential exacerbation. Medication issues post-surgery should be taken into consideration as some medications may affect appetite and weight gain.19

Adolescents

Bariatric Surgery for the treatment of morbid obesity is considered medically necessary for adolescent members (age 12 through age 17) when the following criteria are met:

1. Presence of morbid obesity, defined as either: a. Body mass index (BMI)* exceeding 40; OR, b. BMI* greater than 35 in conjunction with ANY of the following severe comorbidities: 1) Coronary heart disease; OR, 2) Type 2 diabetes mellitus;^ OR, 3) Clinically significant obstructive sleep apnea ( i.e., member meets the criteria for treatment of obstructive sleep apnea; OR, 4) Medically refractory hypertension (blood pressure greater than 140 mmHg systolic and/or 90 mmHg diastolic despite optimal medical management);

^ Criteria for Type 2 diabetes mellitus is defined below:20  A1C>6.5%. The test should be performed in a laboratory setting using a method that is NGSP certified and standardized to the DCCT assay;* OR  FPG > 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours;# OR  2-h plasma glucose > 200 mg/dl (11.1 mmol/l (during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water;* OR  In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > 200 mg/dl (11.1 mmol/l).

# In the absence of unequivocal hyperglycemia, criteria 1-3 should be confirmed by repeat testing. NOTE: The validity of A1C levels in minority populations may not be accurate. OGTT or FPG may be more suitable for diagnostic purposes. The ADA continues to recommend A1C in this cohort, aside from rare instances (e.g., cystic fibrosis)21

AND;

2. Member has completed growth (Tanner Stage IV or completing 95 percent of the predicted adult stature based on bone age); AND;

3. Enrollment in a program with significant experience, a multi-disciplinary team and approach, and agreement to participate in post-operative dietary counseling and education15,16; AND;

4. Member has participated in a physician-supervised nutrition and exercise program (including a low calorie diet, increased physical activity, and behavioral modification). This physician-supervised nutrition and exercise program must meet ALL of the following criteria:

Clinical Coverage Guideline page 6

BARIATRIC SURGERY HS-006

a. Participation in nutrition and exercise program must be supervised and monitored by a physician; AND, b. Nutrition and exercise program must be 6 months or longer in duration; AND, c. Nutrition and exercise program must occur within the two years prior to surgery; AND, d. Participation in physician-supervised nutrition and exercise program must be documented in the medical record by an attending physician. Note: A physician’s summary letter is not sufficient documentation.

The program must be overseen by one of the following:

 Physician (MD or DO); OR,  Registered dietician (RD); OR,  Board certified specialist in pediatric nutrition (CSP); OR,  Board certified specialist in renal nutrition (CSR); OR,  Fellow of the American Dietetic Association (FADA).

AND;

5. Mental health evaluation by a psychiatrist or psychologist to determine any relative contraindications as listed below, mental competency and understanding of the nature, extent and possible complications of the surgery and ability to sustain dietary behavioral modifications needed to ensure a successful outcome of surgery.

Relative contraindicated diagnoses include:

In addition, the impact of surgery should also be discussed in terms of symptom resolution and potential

Clinical Coverage Guideline page 7

BARIATRIC SURGERY HS-006

exacerbation. Medication issues post-surgery should be taken into consideration as some medications may affect appetite and weight gain.19

General Notes

Only the following surgical procedures are covered: a. Gastric segmentation along its vertical axis with a Roux-en-Y bypass with distal anastomosis placed in the jejunum (Open - CPT 43846 or 43847 and Laparoscopic -CPT 43644)^ b. Laparoscopic adjustable silicone gastric banding (LASGB) (CPT 43770) c. Biliopancreatic Diversion with Duodenal Switch (Open -CPT 43847) d. Laparoscopic Longitudinal gastrectomy, i.e., Laparoscopic Sleeve Gastrectomy (CPT 43775)*

* Effective for services performed on and after June 27, 2012, Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions a.-c. are satisfied a. The beneficiary has a body-mass index (BMI) . 35 kg/m2., b. The beneficiary has at least one co-morbidity related to obesity, and, c. The beneficiary has been previously unsuccessful with medical treatment for obesity.

^ RYGB is supported in adult patients diagnosed with type 2 diabetes mellitus (DM) and severe obesity (BMI ≥ 35 kg/m2) for whom conventional medical treatment has failed and there is no contraindication to surgery. RYGB is not covered for adult patients with type 2 DM and moderate or mild obesity (BMI < 35 kg/m2).14

Repeat surgery is considered medically necessary ONLY when a complication has occurred associated with the original procedure.

NOTE: Inadequate weight loss due to individual noncompliance with postoperative nutrition and exercise recommendations is NOT considered medically necessary for revision or conversion surgery.

Recommended Facilities and Providers

1. Facilities should be limited to tertiary care centers equipped to perform pre and post-surgical interventions. The facility should have the following qualifications: a. Be accomplished in bariatric surgery with a demonstrated commitment to provide adequate facilities and equipment, as well as properly trained and funded appropriate bariatric surgery support staff. b. Be under the direction of a qualified surgeon who is in charge of an experienced and comprehensive bariatric surgery team that should include experienced surgeons and physicians, skilled nurses, specialty- trained nutritionists, experienced anesthesiologists, and, as needed, cardiologists, pulmonologists, rehabilitation therapists, and psychiatric staff.

2. The surgeon should be board certified by the American Board of Surgery or in the process of certification within 5 years after completion of an accredited residency program in general or gastrointestinal surgery, and recertification has been obtained by the American Board Surgery on an every 10-year basis, if applicable. Minimal qualifications for a bariatric surgeon include either fellowship training or extended mentoring by an experienced surgeon, preferably by members of international/national bariatric societies, in all aspects of bariatric surgery, advanced laparoscopic techniques, and additional training in re-operative techniques.

CODING

Covered CPT®* Codes 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

Clinical Coverage Guideline page 8

BARIATRIC SURGERY HS-006

43770 Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric band (gastric band and subcutaneous port components) Roux-en-Y gastroenterostomy (roux limb 150 cm or less) 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 43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy) 43842 Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty 43845 Open 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 Open Gastric restrictive procedure, with gastric bypass for morbid obesity; (Roux-en-Y gastroenterostomy) with short limb (150 cm or less) 43847 Open Gastric restrictive procedure, with gastric bypass for morbid obesity (Roux-en-Y gastroenterostomy); with small bowel reconstruction to limit absorption (greater than 150 cm) 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

Non-Covered Bariatric Surgery 43659 Unlisted laparoscopy procedure, stomach 43999 Unlisted procedure when billed for Open Sleeve Gastrectomy gastric band diameter via subcutaneous port by injection or aspiration of saline 76000 Fluoroscopy (separate procedure) up to 1 hour physician time 76705 Ultrasound, abdominal, limited (eg, single organ, quadrant, follow-up)

HCPCS Code S2083*+ Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline * S-Codes for MEDICAID must be billed secondary to CPT 43999 Outpatient Adjustment of gastric band

Covered ICD-9-CM Procedure Codes 44.38 Laparoscopic Gastroenterostomy; Roux-en Y Bypass 44.39 Open Gastroenterostomy, Roux-en Y Bypass 44.95 Laparoscopic gastric restrictive procedure (laparoscopic adjustable gastric band and port insertion). 44.98 Adjustment Gastric Restrictive Device

Covered ICD-9-CM Diagnosis Codes 250.00 Diabetes mellitus Type 2 without mention of complication, unspecified type, not stated as uncontrolled 250.02 Diabetes mellitus Type 2 without mention of complication, unspecified type, uncontrolled 278.01 Morbid obesity 327.23 Obstructive Sleep apnea (Adult) 401.0 - 401.9 Essential hypertension 414.01 Coronary atherosclerosis of native coronary artery V45.86 Bariatric surgery status

Clinical Coverage Guideline page 9

BARIATRIC SURGERY HS-006

Applicable V85 Category codes must be billed as secondary diagnosis. NOTE: Applicable co-morbidities must be billed as primary diagnosis with the appropriate V85 code. V85 Body Mass Index 40 and over, adult

Covered ICD-10-CM Diagnosis Codes NOTE: Applicable co-morbidities must be billed as primary diagnosis with the appropriate Z68 code E11.9 Type 2 diabetes mellitus without complications E13.9 Other specified diabetes mellitus without complications E11.65 Type 2 diabetes mellitus with hyperglycemia E66.01 Morbid (severe) obesity due to excess calories G47.33 Obstructive sleep apnea (adult) (pediatric) I10 Essential (primary) hypertension I10 Essential (primary) hypertension I10 Essential (primary) hypertension I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris I25.119 Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris Z68.41 Body mass index (BMI) 40.0-44.9, adult Z68.42 Body mass index (BMI) 45.0-49.9, adult Z68.43 Body mass index (BMI) 50-59.9 , adult Z68.44 Body mass index (BMI) 60.0-69.9, adult Z68.45 Body mass index (BMI) 70 or greater, adult Z98.84 Bariatric Surgery Status

DRAFT ICD-10-PCS Codes 0D16479 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Percutaneous Endoscopic 0D1647A BypassApproach Stomach to Jejunum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1647B Bypass Stomach to Ileum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1647L Bypass Stomach to Transverse Colon with Autologous Tissue Substitute, Percutaneous Endoscopic 0D164J9 BypassApproach Stomach to Duodenum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JA Bypass Stomach to Jejunum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JB Bypass Stomach to Ileum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164K9 Bypass Stomach to Duodenum with Nonautologous Tissue Substitute, Percutaneous Endoscopic 0D164KA BypassApproach Stomach to Jejunum with Nonautologous Tissue Substitute, Percutaneous Endoscopic 0D164KB BypassApproach Stomach to Ileum with Nonautologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164KL Bypass Stomach to Transverse Colon with Nonautologous Tissue Substitute, Percutaneous 0D164Z9 BypassEndoscopic Stomach Approach to Duodenum, Percutaneous Endoscopic Approach 0D164ZA Bypass Stomach to Jejunum, Percutaneous Endoscopic Approach 0D164ZB Bypass Stomach to Ileum, Percutaneous Endoscopic Approach 0D164ZL Bypass Stomach to Transverse Colon, Percutaneous Endoscopic Approach 0D16079 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Open Approach 0D1607A Bypass Stomach to Jejunum with Autologous Tissue Substitute, Open Approach 0D1607B Bypass Stomach to Ileum with Autologous Tissue Substitute, Open Approach 0D1607L Bypass Stomach to Transverse Colon with Autologous Tissue Substitute, Open Approach 0D160J9 Bypass Stomach to Duodenum with Synthetic Substitute, Open Approach 0D160JA Bypass Stomach to Jejunum with Synthetic Substitute, Open Approach 0D160JB Bypass Stomach to Ileum with Synthetic Substitute, Open Approach 0D160JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Open Approach 0D160K9 Bypass Stomach to Duodenum with Nonautologous Tissue Substitute, Open Approach

Clinical Coverage Guideline page 10

BARIATRIC SURGERY HS-006

0D160KA Bypass Stomach to Jejunum with Nonautologous Tissue Substitute, Open Approach 0D160KB Bypass Stomach to Ileum with Nonautologous Tissue Substitute, Open Approach 0D160KL Bypass Stomach to Transverse Colon with Nonautologous Tissue Substitute, Open Approach 0D160Z9 Bypass Stomach to Duodenum, Open Approach 0D160ZA Bypass Stomach to Jejunum, Open Approach 0D160ZB Bypass Stomach to Ileum, Open Approach 0D160ZL Bypass Stomach to Transverse Colon, Open Approach 0D16879 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Via Natural or Artificial Opening 0D1687A BypassEndoscopic Stomach to Jejunum with Autologous Tissue Substitute, Via Natural or Artificial Opening 0D1687B BypassEndoscopic Stomach to Ileum with Autologous Tissue Substitute, Via Natural or Artificial Opening 0D1687L BypassEndoscopic Stomach to Transverse Colon with Autologous Tissue Substitute, Via Natural or Artificial 0D168J9 BypassOpening Stomach Endoscopic to Duodenum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JA Bypass Stomach to Jejunum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JB Bypass Stomach to Ileum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Via Natural or Artificial Opening 0D168K9 BypassEndoscopic Stomach to Duodenum with Nonautologous Tissue Substitute, Via Natural or Artificial Opening 0D168KA BypassEndoscopic Stomach to Jejunum with Nonautologous Tissue Substitute, Via Natural or Artificial Opening 0D168KB BypassEndoscopic Stomach to Ileum with Nonautologous Tissue Substitute, Via Natural or Artificial Opening 0D168KL BypassEndoscopic Stomach to Transverse Colon with Nonautologous Tissue Substitute, Via Natural or Artificial 0D168Z9 BypassOpening Stomach Endoscopic to Duodenum, Via Natural or Artificial Opening Endoscopic 0D168ZA Bypass Stomach to Jejunum, Via Natural or Artificial Opening Endoscopic 0D168ZB Bypass Stomach to Ileum, Via Natural or Artificial Opening Endoscopic 0D168ZL Bypass Stomach to Transverse Colon, Via Natural or Artificial Opening Endoscopic 0DV64CZ Restriction of Stomach with Extraluminal Device, Percutaneous Endoscopic Approach

REFERENCES

1. Pre-surgical psychological assessment. American Society for Metabolic and Bariatric Surgery Web site. http://asmbs.org/2012/06/pre-surgical- psychological-assessment/. Published 2012. Accessed February 26, 2015. 2. Local coverage determination for laparoscopic sleeve gastrectomy (L32866) [Arizona]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published March 5, 2013. Accessed February 26, 2015. 3. Local coverage determination for laparoscopic sleeve gastrectomy (L32960) [California, Northern]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published February 4, 2013. Accessed February 26, 2015. 4. Local coverage determination for laparoscopic sleeve gastrectomy (L32969) [California]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published February 11, 2013. Accessed February 26, 2015. 5. Local coverage determination for laparoscopic sleeve gastrectomy (L32960) [California, Southern]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published February 4, 2013. Accessed February 26, 2015. 6. Local coverage determination for laparoscopic sleeve gastrectomy (L32960) [Hawaii]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published February 4, 2013. Accessed February 26, 2015. 7. Local coverage determination for laparoscopic sleeve gastrectomy (L32866) [South Carolina]. Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published March 8, 2013. Accessed February 26, 2015. 8. Local coverage determination: surgical management of morbid obesity (L33019). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published December 14, 2012. Accessed February 26, 2015. 9. Medicare national coverage determination manual: chapter 1, part 2 (sections 90 – 160.26) coverage determinations. Centers for Medicare and Medicaid Services Web site. https://www.cms.gov/manuals/downloads/ ncd103c1_Part2.pdf. Published January 6, 2012. Accessed February 26, 2015. 10. National coverage determination: bariatric surgery for the treatment of morbid obesity (100.1). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published 2009 [revised June 27, 2012]. Accessed February 26, 2015. 11. National Academy of Science, Institute of Medicine, Committee to Develop Criteria for Evaluating The Outcomes of Approaches to Prevent and Treat Obesity. Weighing the Options: Criteria for Evaluation Weight-Management Programs. PR Thomas, ed. Washington, D.C. National Academy Press; 1995. 12. National Institutes of Health Consensus Development Conference Statement. Gastrointestinal Surgery for Severe Obesity. Ann Intern Med. 1991; 115:956-961 13. U.S. Food and Drug Administration. Lap-Band Adjustable Gastric Banding (LABG) System Summary of Safety and Effectiveness Data. PMA No. p000008. Issues June 5, 2001. Rockville MD: FDA; June 3 2002. http://www.fda.gov/cdrh/pdf/p000008.html 14. Roux-en-Y gastric bypass for diabetes in obese or severely obese patients. Hayes Directory Web site. http://www.hayesinc.com. Published

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August 7, 2014. Accessed February 26, 2015. 15. Preoperative supervised weight loss prior to adult bariatric surgery. Hayes Directory Web site. http://www.hayesinc.com. Published February 5, 2015. Accessed February 25, 2015. 16. Arterburn DE, Olsen MK, Smith VA, Livingston EH, Van Scoyoc L, Yancy WS, et al. Association between bariatric surgery and long-term survival. 2015. JAMA;313(1):62-70. 17. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. National Heart, Lung, and Blood Institute Web site. http://www.nhlbi.nih.gov/health-pro/guidelines/current/cardiovascular-health-pediatric- guidelines/summary. Published October 2012. Accessed February 26, 2015. 18. Michalsky M, Kramer RE, Fullmer MA, Polfuss M, Porter R, Ward-Begnoche W, et al. Developing criteria for pediatric/adolescent bariatric surgery programs. Pediatrics 2011;128:S65–S70. www.pediatrics.org/cgi/doi/10.1542/peds.2011-0480F. doi:10.1542/peds.2011-0480F. Accessed February 26, 2015. 19. American Society for Metabolic & Bariatric Surgery Web site. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. http://asmbs.org/resources/clinical-practice-guidelines-for-the-perioperative-nutritional- metabolic-and-nonsurgical-support-of-the-bariatric-surgery-patient. Published March 2013. Accessed March 5, 2015. 20. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan; 35(Suppl 1): S64–S71. doi: 10.2337/dc12-s064. 21. American Diabetes Association. Classification and diagnosis of diabetes. Sec. 2. In Standards of Medical Care in Diabetes. 2015. Diabetes Care; 38(Suppl. 1):S8–S16. DOI: 10.2337/dc15-S005. http://care.diabetesjournals.org/content/38/Supplement_1/S8.full.pdf+html

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

4/2/2015  Approved by MPC. Updates to Pediatric criteria (skeletal maturity, BMI). 3/19/2015  Approved by MPC. Revision of requirement no.3 under Position Statement; included pediatric criteria. 10/2/2014  Approved by MPC. Clarified item no. 5 regarding clinical assessment and psychological evaluation. 5/30/2014  Approved by MPC. Included items from CMS LCD (referenced). 3/17/2014  Approved by MPC. Coding update re: adjustment of gastric restrictive device. 11/7/2013  Approved by MPC. Inserted additional items for pre-surgical psychological evaluation. 8/1/2013  Approved by MPC. Updated CMS references; no changes to coverage. 2/19/2013  Approved by MPC. Included coverage of CPT 43775 (laparoscopic longitudinal gastrectomy (e.g., laparoscopic sleeve gastrectomy). Effective June 2012, CMS allows contractors to determine coverage of stand-alone procedures. 2/7/2013  Approved by MPC. No changes. 2/2/2012  Approved by MPC. References to laparoscopic longitudinal gastrectomy (e.g., laparoscopic sleeve gastrectomy) removed due to change in CMS National Coverage Determination (date of revision 1/6/2012). Added reference. 12/1/2011  New template design approved by MPC. 7/18/2011  Approved by MPC. No changes.

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