Surgical Management of Clinically Severe Obesity (Ie, Bariatric Surgery)

Clinical Medical Policy Department Clinical Affairs Division

Surgical Management of Clinically Severe Obesity (i.e., Bariatric Surgery) [For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr. Go to “Comunicados a Proveedores”, and click “Cartas Circulares”.]

Medical Policy: MP-SU-01-04 Original Effective Date: May 15, 2004 Revised: March 04, 2020 Next Revision: March, 2021

This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member’s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION

Patients are classified as being affected by Clinically Severe Obesity (previously called “morbid” obesity) when their Body Mass Index (BMI) is greater than 40, or they are more than a 100 pounds over their ideal body weight. Additionally, patients who have a BMI of 35 or greater with an existing comorbidity (e.g., diabetes, hypertension, etc.) are also classified as Clinically Severe Obese.

TheSurgical Management of Clinically Severe Obesity refers to the surgical procedures that are performed to manage obesity and, are collectively referred to as Metabolic or Bariatric Surgery (UpToDate®/Lim1, 2018). These procedures for weight loss include a combination of volume restrictive and nutrient malabsorptive procedures that affect satiety, absorption, and insulin sensitivity hormonal or enteric derived factors, in conjunction with behavior modification to achieve and sustain weight loss (UpToDate®/Lim2, 2020).

Examples ofContemporary Bariatric Surgery Proceduresinclude, but are not limited to, the following:

 Roux-en-Y-Gastric Bypass (RYGB)– RYGB remains one of the most commonly performed bariatric procedure and, it involves the creation of a small gastric pouch, thereby restricting food and limiting caloric absorption;

 Laparoscopic Adjustable Gastric Banding (LAGB) – Adjustable Gastric Banding (AGB) is a purely restrictive procedure that compartmentalizes the upper stomach by placing a tight, adjustable prosthetic band around the entrance to the stomach. While AGB can be performed by an open approach, it is most commonly performed Laparoscopically (LAGB);

 Sleeve gastrectomy (SG) – SG is a partial gastrectomy, in which the majority of the greater curvature of the stomach is removed and, a tubular stomach is created. SG is technically easier to perform than the RYGB, as it does not require multiple anastomoses. It is also safer, as it reduces the risks of internal herniation and protein and mineral malabsorption;

 Bilio-Pancreatic Diversion with Duodenal Switch (BPD/DS) –The BPD/DS is a variant of the Bilio- Pancreatic Diversion (BPD). The original BPD procedure involves dividing the duodenum from the pylorus, removing the pylorus, and dividing the ileum. The distal ileum is then anastomosed

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 1 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 1 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division to the stomach and the proximal ileum, with the output from the liver, pancreas, and duodenum (or biliopancreatic limb) is anastomosed to the terminal ileum some 50-100 cm away from the ileocecal valve. The BPD/DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and creation of a Roux limb with a short common channel. The BPD/DS procedure differs from the BPD in the portion of the stomach that is removed, as well as preservation of the pylorus. It is associated with a lower incidence of stomal ulceration and diarrhea than with BPD alone (UpToDate®/Lim2, 2020).

Examples of Experimental/Investigational/Not Covered Bariatric Surgery Procedures include, but are not limited to, the following:

 Mini-Gastric Bypass (MGB) – The MGB, a modification of the loop gastric bypass and technically easier to perform than a RYGB, is performed laparoscopically. The MGB has not been universally accepted as a metabolic and bariatric procedure due to higher rates of alkaline bile reflux and limited data documenting effective long-term outcomes;

 Intra-Gastric Balloon (IGB) – The IGB consists of a soft, saline-filled balloon that promotes a feeling of satiety and restriction. An IGB is typically inserted endoscopically and filled with 400 to 700 mL of saline, generally for a maximum of six months, beyond which time the leak rate increases significantly. Weight loss is dependent on adherence to lifestyle changes and patient compliance. The US Food and Drug Administration (FDA) has issued updates in August 2017 and June 2018 to alert health care providers of 12 reported deaths worldwide from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Seven of these 12 deaths involved United States patients;

 Endoluminal Vertical Gastroplasty (EVG) – EVG is an endoscopic approach for suturing the stomach that offers the potential to perform gastric-restrictive procedures endoluminally. Similar to an endoscopic device that created a fundoplication, there has been an issue with durability as a significant amount of staples and fasteners may not be holding the stomach tissue after 1 year;

 Implantable Gastric Pacing (IGP) – IGP involves surgically placing electric pacers into the stomach wall and then attaching the pacing wires to a generator placed in the subcutaneous tissue of the abdominal wall. How IGP works is not entirely understood. The increased stimulation is thought to increase gastric motility but, it may also change fundic tone and alter gut hormone secretions;

 Endoscopic Gastrointestinal Bypass Devices (EGIBD) – In EGIBD, a barrier device is deployed to prevent luminal contents from being absorbed in the proximal small intestine. Data are still lacking about the longevity of endobarriers and their outcomes once the barrier is removed (UpToDate®/Lim2, 2020).

Examples of Obsolete Bariatric Surgery Procedures, which are no longer or only rarely performed, include the following:

 JejunoIleal Bypass (JIB)–JIB was one of the first bariatric operations. The procedure was performed by dividing the jejunum close to the ligament of Treitz, and connecting it a short

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 2 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 2 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division distance proximal to the ileocecal valve, thereby diverting a long segment of small bowel, resulting in malabsorption. The use of JIB has been abandoned due to the high complication rate and frequent need for revisional surgery;

 Gastroplasties–A gastroplasty narrows the area of food passage between the proximal and the distal stomach. This procedure did not result in significant weight loss, and the Vertical Banded Gastroplasty (VBG) was subsequently created to put a more permanent restrictive barrier between the proximal and distal stomach. VBG has been replaced largely by other procedures and is rarely performed due to lack of sustained/desired weight loss, as well as the high incidence of complications requiring revision (UpToDate®/Lim2, 2020).

The scope of this medical policy is to establish the medical coverage criteria for the Commercial Line of Business (LOB) only, since for the Classicare (Advantage) LOB, Medicare established a Local Coverage Determination, addressed later on in this medical policy.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage.

INDICATIONS

I. For the Commercial Line of Business (LOB) Only: Medical Card System, Inc., (MCS) considers medically necessary the Surgical Management of Clinically Severe Obesity (i.e. Bariatric Surgery), when All of the following criteria are met:

1. Patient is 18 years of age or more, or has reach full expected skeletal growth; and

2. Patient has a body mass index(BMI) ≥ 35 kg/m2 or greater; and

3. Patient has been previously unsuccessful with a recent treatment of six (6)consecutive months of medical treatment for obesity (documentation must be submitted by a licensed physician and/or licensed nutritionist, including: diet plan used and reason for failure); and

4. Patient’s treatable metabolic causes for obesity (e.g., adrenal or thyroid disorders) have been ruled out, or have been clinically treated, if present; and

5. Patients who have a history of psychiatric or psychological disorder, or are currently under the care of a psychologist/psychiatrist, or are on psychotropic medications, must undergo preoperative psychological evaluation and clearance, and the patient’s record must include documentation of the evaluation and assessment; and

6. In the absence of psychiatric/psychological disorder, the patient’s psychological evaluation, screening for mental conditions and willingness to comply with the treatment, must be documented in medical record.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 3 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 3 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

II. For the Classicare (Advantage) LOB: Medical Card System, Inc., (MCS) considers medically necessary the Surgical Management of Clinically Severe Obesity (i.e. Bariatric Surgery), under the criteria established within the Medicare:

 Local Coverage Determination (LCD) for Surgical Management of Morbid Obesity (L33411), which corresponds to the geographical jurisdiction of Puerto Rico. Please refer to the afore mentioned PR LCD for further details.

CONTRAINDICATIONS FOR THE COMMERCIAL LOB ONLY

1. Prohibitive perioperative risk of cardiac complications due to cardiac ischemia or myocardial dysfunction.

2. Significant chronic obstructive airways disease or respiratory dysfunction.

3. Non-compliance with medical treatment of obesity.

4. Psychological disorders of a significant degree that, a psychologist/psychiatrist would have thought would be exacerbated or interfere with the long-term management of the patient after the operation.

5. Significant eating disorders.

6. Severe Hiatal Hernia/Gastro-Esophageal Reflux (GERD) for purely restrictive procedures such as Laparoscopic Adjustable Gastric Banding (LAGB).

LIMITATIONS FOR THE COMMERCIAL LOB ONLY.

1. Under provisions of this medical policy, All the following procedures are considered Not reasonable and medically necessary, and hence, Not Covered:

a. Mini-Gastric Bypass (CPT® code 43999); and

b. Long limb gastric bypass (i.e. than 150 cm) (CPT® code 43999); and

c. Silastic ring vertical gastric bypass (FobiPouch) (CPT® code 43999); and

d. Intra-Gastric Balloon (IGB) (CPT® 43999 code).

2. Procedure codes 43886, 43887 and 43888 are for open port replacement. The open port replacement procedures are non-covered, since they are associated with the non-covered open gastric restrictive procedures.

3. For covered laparoscopic restrictive procedures that require port replacements, use CPT® codes 43771, 43772, or 43773.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 4 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 4 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

FOR CONTRAINDICATIONS AND LIMITATIONS FOR CLASSICARE LOB PLEASE REFER TO PR LCD

 Local Coverage Determination (LCD) for Surgical Management of Morbid Obesity (L33411), which corresponds to the geographical jurisdiction of Puerto Rico.

CODING INFORMATION FOR BOTH THE COMMERCIAL & CLASSICARE (ADVANTAGE) LOB CPT® Codes (List may not be all inclusive) CPT® Codes Description 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 43770 Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (eg, 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 43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (i.e. sleeve gastrectomy) 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) Current Procedural Terminology (CPT®) 2020 American Medical Association: Chicago, IL.

Note1: For procedure codes 43644, 43645, 43770, 43775, 43845 43846, and 43847: Report the primary diagnosis as E66.01 then an additional secondary diagnosis for body mass index (BMI) and a third diagnosis for the comorbidities as appropriate.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 5 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 5 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

CPT® Codes Not Covered (List may not be all inclusive) CPT® Codes Description 43659 Unlisted laparoscopy procedure, stomach 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 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 43999 Unlisted procedure, stomach 44799 Unlisted procedure, small intestine Current Procedural Terminology (CPT®) 2020 American Medical Association: Chicago, IL.

ICD-10 Codes (List may not be all inclusive) ICD-10-Codes Description A18.84 Tuberculosis of heart E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic- hyperosmolar coma (NKHHC) E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma E11.10 Type 2 diabetes mellitus with ketoacidosis without coma E11.11 Type 2 diabetes mellitus with ketoacidosis with coma E11.21 Type 2 diabetes mellitus with diabetic nephropathy E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease E11.29 Type 2 diabetes mellitus with other diabetic kidney complication E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema E11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E11.3291 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E11.3292 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 6 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 6 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E11.3293 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E11.3391 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E11.3392 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E11.3393 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E11.3491 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E11.3492 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E11.3493 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E11.3521 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E11.3522 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E11.3523 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E11.3531 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E11.3532 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 7 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 7 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E11.3533 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E11.3541 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E11.3542 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye E11.3543 Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E11.3551 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye E11.3552 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye E11.3553 Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E11.36 Type 2 diabetes mellitus with diabetic cataract E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complication E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy E11.44 Type 2 diabetes mellitus with diabetic amyotrophy E11.49 Type 2 diabetes mellitus with other diabetic neurological complication E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene E11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene E11.59 Type 2 diabetes mellitus with other circulatory complications E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy E11.618 Type 2 diabetes mellitus with other diabetic arthropathy E11.620 Type 2 diabetes mellitus with diabetic dermatitis E11.621 Type 2 diabetes mellitus with foot ulcer

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 8 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 8 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E11.622 Type 2 diabetes mellitus with other skin ulcer E11.628 Type 2 diabetes mellitus with other skin complications E11.630 Type 2 diabetes mellitus with periodontal disease E11.638 Type 2 diabetes mellitus with other oral complications E11.641 Type 2 diabetes mellitus with hypoglycemia with coma E11.649 Type 2 diabetes mellitus with hypoglycemia without coma E11.65 Type 2 diabetes mellitus with hyperglycemia E11.69 Type 2 diabetes mellitus with other specified complication E11.8 Type 2 diabetes mellitus with unspecified complications E11.9 Type 2 diabetes mellitus without complications E13.00 Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E13.01 Other specified diabetes mellitus with hyperosmolarity with coma E13.10 Other specified diabetes mellitus with ketoacidosis without coma E13.11 Other specified diabetes mellitus with ketoacidosis with coma E13.21 Other specified diabetes mellitus with diabetic nephropathy E13.22 Other specified diabetes mellitus with diabetic chronic kidney disease E13.29 Other specified diabetes mellitus with other diabetic kidney complication E13.311 Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E13.319 Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema E13.3211 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E13.3212 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E13.3213 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E13.3291 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E13.3292 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E13.3293 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E13.3311 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E13.3312 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 9 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 9 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E13.3313 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E13.3391 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E13.3392 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E13.3393 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E13.3411 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E13.3412 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E13.3413 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E13.3491 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E13.3492 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E13.3493 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E13.3511 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E13.3512 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E13.3513 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E13.3521 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E13.3522 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E13.3523 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E13.3531 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E13.3532 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E13.3533 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E13.3541 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E13.3542 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 10 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 10 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division eye E13.3543 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E13.3551 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye E13.3552 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye E13.3553 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E13.3591 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E13.3592 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E13.3593 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E13.36 Other specified diabetes mellitus with diabetic cataract E13.37X1 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E13.37X2 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E13.37X3 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E13.39 Other specified diabetes mellitus with other diabetic ophthalmic complication E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication E13.51 Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene E13.52 Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene E13.59 Other specified diabetes mellitus with other circulatory complications E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy E13.618 Other specified diabetes mellitus with other diabetic arthropathy E13.620 Other specified diabetes mellitus with diabetic dermatitis E13.621 Other specified diabetes mellitus with foot ulcer E13.622 Other specified diabetes mellitus with other skin ulcer

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 11 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 11 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E13.628 Other specified diabetes mellitus with other skin complications E13.630 Other specified diabetes mellitus with periodontal disease E13.638 Other specified diabetes mellitus with other oral complications E13.641 Other specified diabetes mellitus with hypoglycemia with coma E13.649 Other specified diabetes mellitus with hypoglycemia without coma E13.65 Other specified diabetes mellitus with hyperglycemia E13.69 Other specified diabetes mellitus with other specified complication - (Use additional code to identify complication) E13.8 Other specified diabetes mellitus with unspecified complications E13.9 Other specified diabetes mellitus without complications E66.01 Morbid (severe) obesity due to excess calories E66.2 Morbid (severe) obesity with alveolar hypoventilation E78.00 Pure hypercholesterolemia, unspecified E78.01 Familial hypercholesterolemia E78.1 Pure hyperglyceridemia E78.2 Mixed hyperlipidemia E78.3 Hyperchylomicronemia E78.41 Elevated Lipoprotein(a) E78.49 Other hyperlipidemia E78.5 Hyperlipidemia, unspecified G47.33 Obstructive sleep apnea (adult) (pediatric) G47.36* Sleep related hypoventilation in conditions classified elsewhere G93.2 Benign intracranial hypertension I10 Essential (primary) hypertension I27.21 Secondary pulmonary arterial hypertension I27.22 Pulmonary hypertension due to left heart disease I27.23 Pulmonary hypertension due to lung diseases and hypoxia I27.24 Chronic thromboembolic pulmonary hypertension I27.29 Other secondary pulmonary hypertension I27.83 Eisenmenger's syndrome I27.89 Other specified pulmonary heart diseases I43* Cardiomyopathy in diseases classified elsewhere K21.0 Gastro-esophageal reflux disease with esophagitis K75.81 Nonalcoholic steatohepatitis (NASH)

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 12 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 12 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division K76.0 Fatty (change of) liver, not elsewhere classified K76.89 Other specified diseases of liver M15.3 Secondary multiple arthritis M15.8 Other polyosteoarthritis M16.0 Bilateral primary osteoarthritis of hip M16.10 Unilateral primary osteoarthritis, unspecified hip M16.11 Unilateral primary osteoarthritis, right hip M16.12 Unilateral primary osteoarthritis, left hip M16.2 Bilateral osteoarthritis resulting from hip dysplasia M16.30 Unilateral osteoarthritis resulting from hip dysplasia, unspecified hip M16.31 Unilateral osteoarthritis resulting from hip dysplasia, right hip M16.32 Unilateral osteoarthritis resulting from hip dysplasia, left hip M16.4 Bilateral post-traumatic osteoarthritis of hip M16.50 Unilateral post-traumatic osteoarthritis, unspecified hip M16.51 Unilateral post-traumatic osteoarthritis, right hip M16.52 Unilateral post-traumatic osteoarthritis, left hip M16.6 Other bilateral secondary osteoarthritis of hip M16.7 Other unilateral secondary osteoarthritis of hip M16.9 Osteoarthritis of hip, unspecified M17.0 Bilateral primary osteoarthritis of knee M17.10 Unilateral primary osteoarthritis, unspecified knee M17.11 Unilateral primary osteoarthritis, right knee M17.12 Unilateral primary osteoarthritis, left knee M17.2 Bilateral post-traumatic osteoarthritis of knee M17.30 Unilateral post-traumatic osteoarthritis, unspecified knee M17.31 Unilateral post-traumatic osteoarthritis, right knee M17.32 Unilateral post-traumatic osteoarthritis, left knee M17.4 Other bilateral secondary osteoarthritis of knee M17.5 Other unilateral secondary osteoarthritis of knee M17.9 Osteoarthritis of knee, unspecified M19.071 Primary osteoarthritis, right ankle and foot M19.072 Primary osteoarthritis, left ankle and foot M19.079 Primary osteoarthritis, unspecified ankle and foot M19.171 Post-traumatic osteoarthritis, right ankle and foot

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 13 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 13 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division M19.172 Post-traumatic osteoarthritis, left ankle and foot M19.179 Post-traumatic osteoarthritis, unspecified ankle and foot M19.271 Secondary osteoarthritis, right ankle and foot M19.272 Secondary osteoarthritis, left ankle and foot M19.279 Secondary osteoarthritis, unspecified ankle and foot M19.90 Unspecified osteoarthritis, unspecified site M48.061 Spinal stenosis, lumbar region without neurogenic claudication M48.062 Spinal stenosis, lumbar region with neurogenic claudication M48.07 Spinal stenosis, lumbosacral region M51.06 Intervertebral disc disorders with myelopathy, lumbar region M51.36 Other intervertebral disc degeneration, lumbar region M51.37 Other intervertebral disc degeneration, lumbosacral region M99.23 Subluxation stenosis of neural canal of lumbar region M99.33 Osseous stenosis of neural canal of lumbar region M99.43 Connective tissue stenosis of neural canal of lumbar region M99.53 Intervertebral disc stenosis of neural canal of lumbar region M99.63 Osseous and subluxation stenosis of intervertebral foramina of lumbar region M99.73 Connective tissue and disc stenosis of intervertebral foramina of lumbar region Z68.35* Body mass index (BMI) 35.0 -35.9, adult Z68.36* Body mass index (BMI) 36.0 -36.9, adult Z68.37* Body mass index (BMI) 37.0 -37.9, adult Z68.38* Body mass index (BMI) 38.0 -38.9, adult Z68.39* Body mass index (BMI) 39.0 -39.9, adult 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

Note2*: Diagnosis codes identified with asterisks should not be billed as the primary diagnosis code.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 14 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 14 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

REFERENCES

1. American Association of Clinical Endocrinologists (AACE), the Obesity Society (TOS) & American Society for Metabolic & Bariatric Surgery (ASMBS) Guidelines. (2013, April 15). Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Non-surgical Support of the Bariatric Surgery Patient—2013 Update: Cosponsored by AACE, TOS, and ASMBS. Surgery for Obesity and Related Diseases, 9: 159–191. Accessed March 2, 2020. Available at URL address: https://asmbs.org/app/uploads/2014/05/AACE_TOS_ASMBS_Clinical_Practice_Guidlines_3.201 3.pdf

2. American Heart Association (AHA) / American College of Cardiology (ACC) / The Obesity Society (TOS). (2014). 2013 AHA/ACC/TOS Prevention Guideline for the Management of Overweight and Obesity in Adults: A Report of the ACC/AHA Task Force on Practice Guidelines and TOS. Erratum published in AHA Circulation (2014, June 24): 129, 25 Supp2, S102-S138. DOI: 10.1161/01.cir.0000437739.71477. Originally E-published (2013, November 12). Accessed March 2, 2020. Available at URL address: https://www.ahajournals.org/doi/full/10.1161/01.cir.0000437739.71477.ee, and at URL address: https://www.ahajournals.org/doi/pdf/10.1161/01.cir.0000437739.71477.ee

3. American Society for Metabolic and Bariatric Surgery (ASMBS). (n.d.). Bariatric Surgery Procedures. Accessed March 2, 2020. Available at URL address: https://asmbs.org/patients/bariatric-surgery-procedures

4. American Society for Metabolic and Bariatric Surgery (ASMBS). (2013). Position Statement on Emerging Endosurgical Interventions for Treatment of Obesity. Published: May 2009. Reviewed: November 2013. Accessed March 2, 2020. Available at URL address: https://asmbs.org/resources/emerging-endosurgical-interventions-for-treatment-of-obesity, and at URL address: https://asmbs.org/app/uploads/2009/01/ASMBS-Positions-Statement-on- Emerging-Endosurgical-Interventions-for-treatment-of-obesity-2009.pdf

5. American Society for Metabolic and Bariatric Surgery (ASMBS). (2016, June). ASMBS updated position statement on insurance mandated preoperative weight loss requirements. Surg. Obes. Relat. Dis., 12(5), 955-959. Epub 2016 Apr 22. DOI: 10.1016/j.soard.2016.04.019. Accessed March 2, 2020. Available at URL address: https://asmbs.org/app/uploads/2011/03/2016- Preoperative-Weight-Loss.pdf

6. American Society for Metabolic and Bariatric Surgery (ASMBS). (2016, May). Guidelines & Recommendations: Pre-Surgical Psychological Assessment. Surg. Obes. Rel. Dis. 12(4) 731-749. DOI: 10.1016/j.soard.2016.02.008. Accessed March 2, 2020. Available at URL address: https://asmbs.org/resources/recommendations-for-the-presurgical-psychosocial-evaluation-of- bariatric-surgery-patients?%2Fresources%2Fpre-surgical-psychological-assessment, and at URL Address: https://asmbs.org/app/uploads/2016/06/2016-Psych-Guidelines-published.pdf

7. “Cámara de Representantes del Estado Libre Asociado (ELA) de Puerto Rico. R. de la C. 36 del 12 de febrero de 2013. Resolución: investigación sobre la implementación de la Ley 212-2008, para

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 15 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 15 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division el tratamiento de la obesidad mórbida y el síndrome metabólico con la cirugía bariátrica.” Searched March 2, 2020. Available at MCS Document Library.

8. Centers for Medicare & Medicaid Services (CMS). Local Coverage Article: Billing and Coding: Surgical Management of Morbid Obesity (A57145). Contractor Name: First Coast Service Options, Inc. Contract Number: 09202. Geographic Jurisdiction: Puerto Rico. Original Determination Effective Date: 10/03/2018. Accessed March 2, 2020. Available at URL address:https://www.cms.gov/medicare-coverage-database/details/article- details.aspx?articleId=57145&ver=3&LCDId=33411&DocType=2&s=46&bc=AgIAAAAAgAAA&

9. Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination (LCD) for Surgical Management of Morbid Obesity (L33411). Contractor Name: First Coast Service Options, Inc. Contract Number: 09202. Geographic Jurisdiction: Puerto Rico. Original Determination Effective Date: For services performed on or after 10/01/2015. Revision Effective Date: For services performed on or after 10/1/2019. Accessed March 2, 2020. Available at URL address:https://www.cms.gov/medicare-coverage-database/details/lcd- details.aspx?LCDId=33411&ver=29&DocType=2&s=46&bc=AgIAAAAAgAAA&

10. Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual (CPM) Chapter 32 – Billing requirements for Special Services. Section 150: Billing Requirements for Bariatric Surgery for Morbid Obesity. Rev. 4237, 2/08/2019. Accessed March 2, 2020. Available at URL address: https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/clm104c32.pdf

11. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Bariatric Surgery for Treatment of Morbid Obesity (100.1). Version Number 5. Effective Date of this Version: 9/24/2013. Implementation Date: 12/17/2013. Accessed March 2, 2020. Available at URL address: https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=57&ncdver=5&bc=AgAAQAAAAAAAAA%3d%3d&

12. Darabi, S.,Talebpour, M., Zeinoddini, A., & Heidari, R. (2013, December). Laparoscopic gastric plication versus mini-gastric bypass surgery in the treatment of morbid obesity: A randomized clinical trial. Surg. Obes. Relat. Dis., 9 (6), 914-919. DOI: 10.1016/j.soard.2013.07.012. Epub 2013, July 25. Accessed March 2, 2020. Available at URL address: https://pubmed.ncbi.nlm.nih.gov/24321569/, or https://pubmed.ncbi.nlm.nih.gov/24321569- laparoscopic-gastric-plication-versus-mini-gastric-bypass-surgery-in-the-treatment-of-morbid- obesity-a-randomized-clinical-trial/

13. Kaul A. & Sharma J. (2011, December). Impact of bariatric surgery on comorbidities. Surg. Clin. North Am. 91 (6):1295-312. Accessed March 2, 2020. Available at URL address: https://pubmed.ncbi.nlm.nih.gov/22054155/, or https://pubmed.ncbi.nlm.nih.gov/22054155- impact-of-bariatric-surgery-on-comorbidities/

14. Lal, N., Livemore, S., Dunne, D., & Khan, I. (2015, January). Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterology Research and Practice, Vol.2015, Article ID 762972, 9 pages. Accessed March 2, 2020. Available at URL address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4515290/pdf/GRP2015-762972.pdf

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 16 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 16 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 15. Noria, S., & Grantcharov, T. (2013, February). Biological effects of bariatric surgery on obesity- related comorbidities. Canadian Journal of Surgery. Can. J. Surg., 56 (1), 47-57. DOI:10.1503/cjs.036111. PMCID: PMC3569476. Accessed March 2, 2020. Available at URL address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3569476/, or at URL Address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3569476/pdf/cjs-56-47.pdf

16. Obesity Action Coalition (OAC) (2016). What is Obesity? Accessed March 2, 2020. Available at URL address: https://www.obesityaction.org/get-educated/understanding-your-weight-and- health/what-is-obesity/

17. Office of the Commisioner of Insurance of the Commonwealth of Puerto Rico (n.d.). RequiredBenefits for Health Insurance Companies: Bariatric Surgery. Accessed March 2, 2020. Available at URL address: http://www.ocs.gobierno.pr/ocspr/documents/asuntoslegales/resoluciones/pr-state-requiredbenefits.pdf

18. “Oficina de Servicios Legislativos de Puerto Rico (PR) (2008). Ley Núm. 212 del año 2008 (P. del S. 2401) de PR”. (PR Law Number 212 of the year 2008). Published: August 9, 2008. Accessed March 2, 2020. Available at URL address: http://www.lexjuris.com/lexlex/Leyes2008/lexl2008212.htm

19. Salinas, A., Salinas, H.M., Santiago, E., García, W., Ferro, Q., & Antor, M. (2009, August). Silastic ring vertical gastric bypass: cohort study with 83% rate of 5-year follow-up. Surg. Obes. Relat. Dis. 2009 Jul-Aug; 5 (4), 455-8. DOI: 10.1016/j.soard.2008.10.002. E-pub: 2008, Nov 1. Accessed March 2, 2020. Available at URL address:https://pubmed.ncbi.nlm.nih.gov/19136311/, or https://pubmed.ncbi.nlm.nih.gov/19136311-silastic-ring-vertical-gastric-bypass-cohort-study- with-83-rate-of-5-year-follow-up/

20. The National Institutes of Health (NIH) & the National Institute of Diabetes and Digestive and Kidney Diseases (2016, July). Bariatric Surgery. Accessed March 2, 2020. Available at URL address: https://www.niddk.nih.gov/health-information/weight-management/bariatric-surgery, or at URL address: https://www.niddk.nih.gov/health-information/weight- management/bariatric-surgery/all-content

21. UpToDate®/ Lim, R.B (2018). Bariatric operations for management of obesity: Indications and preoperative preparation. Topic last updated: April 23, 2018. Accessed March 2, 2020. Available at URL address: https://www.uptodate.com/contents/bariatric-operations-for- management-of-obesity-indications-and-preoperative-preparation

22. UpToDate®/ Lim, R.B. (2020). Bariatric surgical operations for the management of severe obesity: Descriptions. Topic last updated: Feb 3, 2020. Accessed March 2, 2020. Available at URL address: https://www.uptodate.com/contents/bariatric-procedures-for-the-management- of-severe-obesity-descriptions

23. UpToDate®/ Lim, R.B. (2020). Intragastric balloon therapy for weight loss. Topic last updated: February 24, 2020. Accessed March 2, 2020. Available at URL

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 17 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 17 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division address:https://www.uptodate.com/contents/intragastric-balloon-therapy-for-weight- loss?topicRef=88536&source=see_link

24. U.S. Food & Drug Administration (FDA). (2018, June). Update: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers. Accessed March 2, 2020. Available at URL address: https://www.fda.gov/medical-devices/letters-health-care-providers/update-potential- risks-liquid-filled-intragastric-balloons-letter-health-care-providers-0

POLICY HISTORY DATE ACTION COMMENT May 15, 2004 Origination of Policy August 2008 Revised December 17, 2009 Revised The following indications were added: . Member is 18 years of age or more or has reach full expected skeletal growth, . Treatable metabolic causes for obesity (e.g., adrenal or thyroid disorders) have been ruled out or have been clinically treated if present The following contraindications were added: . Perioperative risk of cardiac complications . Poor myocardial reserve . Significant chronic obstructive airways disease or respiratory dysfunction . Non-compliance of medical treatment . Psychological disorders of a significant degree that a psychologist/psychiatrist would have thought would be exacerbated or interfere with the long term management of the patients after the operation . Significant eating disorders Severe hiatal hernia/gastroesophageal reflux

The following limitations were added: . The following surgical techniques are considered investigational and non-covered when performed for severe obesity (BMI of 40 or more) : o Adjustable gastric banding (i.e., Lap band adjustable gastric banding system) o Long limb gastric bypass o Mini gastric bypass o Open sleeve gastrectomy, laparoscopic sleeve gastrectomy, laparoscopic vertical banded gastroplasty and open adjustable gastric banding Note: CPT code 43999 is not covered when is use to report above procedures.

. CPT code 43842 (Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical banded gastroplasty) is noncovered.

. Bariatric Surgery coverage is limited to the following surgery techniques: o Open Roux en Y gastric bypass (RYGBP) o Laparoscopic Roux en Y gastricbypass (RYGBP) o Laparoscopic adjustable gastric banding (LAGB) o Open biliopancreatic diversion with duodenal switch (BPD/DS) o Laparoscopic biliopancreatic diversion with duodenal switch (BPD/D) . Treatment for obesity plan should be approved by a physician specialized in bariatric medicine or bariatric surgery, including the following: o Member written commitment detailing that he/she is willing to o comply with the treatment o Psychological evaluation and screening for mental

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 18 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 18 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division conditions o Risks, complications and benefits of bariatric surgery o Long term changes in members life style

March 11, 2010 Revised Policy revised to delete the following limitations: . Only one bariatric surgery is covered per lifetime for MCS Commercial and MCS HMO. This restriction does not apply to revision procedure code 43848, 43886, 43887 and 43888. . Reconstructive surgeries after bariatric surgery will be covered if the physician certifies that is medically necessary to remove the excess skin because it affects the functioning of a body part.

. The following surgical techniques are considered investigational and non-covered when performed for severe obesity (BMI of 40 or more) :

o Adjustable gastric banding (i.e., Lap band adjustable gastric banding system) o Long limb gastric bypass o Mini gastric bypass o Open sleeve gastrectomy, laparoscopic sleeve gastrectomy, laparoscopic vertical banded gastroplasty and open adjustable gastric banding Note: CPT code 43999 is not covered when is use to report above procedures. . CPT code 43842 (Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical banded gastroplasty) is non-covered.

. Bariatric Surgery coverage is limited to the following surgery techniques:

o Open Roux en Y gastric bypass (RYGBP) o Laparoscopic Roux en Y gastricbypass (RYGBP) o Laparoscopic adjustable gastric banding (LAGB) o Open biliopancreatic diversion with duodenal switch (BPD/DS) o Laparoscopic biliopancreatic diversion with duodenal switch (BPD/D)

. Treatment for obesity plan should be approved by a physician specialized in bariatric surgery, including the following: (This will apply to HMO/Commercial line of business) o Member written commitment detailing that he/she is willing to comply with the treatment o Psychological evaluation and screening for mental conditions o Risks, complications and benefits of bariatric surgery o Long term changes in members life style

The following code was added to the policy: CPT Code 43999 Unlisted procedure, stomach July 15, 2010 Revised 1. Coverage only for MCS Life and MCS HMO for MCS Classicare refer to CMS LCD. 2. Policy reviewed to add under indication type of diabetes for co morbidity (it was not specified before) to Type II. 3. Consideration to surgery added again to policy (it was deleted in the last revision) 4. Under Coding Information the following codes were deleted from the policy: 43659, 43843,43848,43886,43887, 43888 and 43999, 43842 remain non- covered. 5. Lists of non-covered codes were added to the policy.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 19 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 19 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 6. ICD9 list updated to reflect type 2 diabetes and other co morbidities. 7. Policy reviewed to assure that MCS is compliant with Puerto Rico Law # 212 see link:

Ley Núm_ 212 de 2008 Bariatric.mht

The law contemplates 3 techniques and suggests that insurance companies comply with one. Our policy is compliant with at least two of the techniques suggested by the law.

March 11, 2011 Revised I. The following Indications were deleted from the medical policy: . a body mass index (BMI) 40 (Severe Obesity) or above or

. a body mass index(BMI) ≥ 35 and any of the following co-morbidities exist: o hypertensive cardiovascular disease, o pulmonary/respiratory disease, o diabetes type II, o sleep apnea or o degenerative arthritis of weight bearing joints; and . Co-morbidities should be documented in the history andphysical examination of the patient’s attending physician II. Under the section of Consideration for surgery the following were deleted from the medical policy: . Treatment for obesity plan should be approved by a physician specialized in bariatric surgery

. Member written commitment detailing their willingness to comply with the treatment

August 2, 2012 Revised NHLBI definition of Obesity added to the description section. CMS LCD Link updated: http://www.cms.gov/medicare-coverage-database/details/lcd- details.aspx?LCDId=29477&ContrId=198&ver=8&ContrVer=1&CntrctrSelected=19 8*1&Cntrctr=198&name=First+Coast+Service+Options%2c+Inc.+%2809202%2c+M AC+-+Part+B%29&s=46&bc=AggAAAIAAAAA& April 2, 2013 Revised References updated. New added references, numbers 2 – 6, 10, 14 – 16, 20 – 24.

To the Description Section: Revised and updated information for the list of surgical procedures for gastric reduction, and added Notes 1 & 2.

To the Indications Section: Added 2 new indications: 1.Patients with a BMI ≥ 40 kg/m2 without co-existing medical problems and for whom bariatric surgery would not be associated with excessive risk should be eligible for 1 of the procedures; or

2. Patients with a BMI ≥ 35 kg/m2 and 1 or more severe obesity related comorbidities, including Type 2 Diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS), Pick-wickian syndrome (a combination of OSA and OHS), non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis(NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life, may also be offered a bariatric procedure.

To the Contraindications Section: Revised and modified Contraindications 1, 6 & 7. Added new Contraindications, numbers 8 – 10, and Note 5.

To the Limitations Section: Added new Limitations. Numbers 2 – 6.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 20 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 20 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

To the Coding Information: Added new CPT Code 43848. Also, added the following new ICD-9 Codes: V85.41 – V85-45, 250.10, 272.0, 272.1, 272.3, 272.4, 278.03, 327.26, 348.2, 425.8, 530.11, 571.8, 715.15 – 715.89, 722.52, 722.73, 724.02, & 724.03. Also added a clarification sub-title for the ICD-9 Codes: Additional Diagnosis Codes for Comorbidity; and Notes 6 -8.

July 29, 2013 Revised References updated. Added new references: numbers 17 & 21.

Moved the following Limitation to the Contraindications Section: Psychological/psychiatric conditions:

c. Schizophrenia, borderline personality disorder, suicidal ideation, severe or recurrent depression, or bipolar affective disorders with difficult-to- control manifestations (e.g., history of recurrent lapses in control or recurrent failure to comply with management regimen).

b. Mental retardation that prevents personally provided informed consent or the ability to understand and comply with a reasonable pre- and postoperative regimen.

c. Any other psychological/psychiatric disorder that, in the opinion of a psychologist/psychiatrist, imparts a significant risk of psychological/psychiatric decompensation or interference with the long-term postoperative management. January 21, 2014 Revised All changes from April & July of 2013 were reviewed, modified and approved by the MCS Medical Advisory Committee (MAC) on January 21, 2014.

The MCS MAC also took the following determinations:

To the Description Section:  Added Note 1: The American Society of Clinical Endocrinologists (AACE), the Obesity Society (TOS) and the American Society for Metabolic and Bariatric Surgery (ASMBS) (2013) made the following statements concerning the procedures for the bariatric surgery: Laparoscopic sleeve gastrectomy joins laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass and laparoscopic biliopancreatic diversion BPD, BPD/duodenal switch as primary bariatric and metabolic procedures for patients requiring weight loss and/or metabolic control. Research demonstrates sleeve gastrectomy has benefits comparable to these other procedures in terms of weight loss, resolution of obesity-related conditions and rate of complications; The AACE, TOS & ASMBS (2013) guidelines do not recommend one primary procedure over another as each procedure poses different risks and benefits; It is recommended that the surgical method chosen should be based on specific patient goals and motivations, and surgeon and institutional expertise and experience. However, laparoscopic procedures are preferred over open procedures due to lower early postoperative morbidity and mortal; Data have emerged on other procedures including gastric plication, electrical neuromodulation, and endoscopic sleeves, but the guidelines continue to classify them as investigational because of a lack of sufficient outcomes evidence.  Added Note 2: The FDA (2013) has approved two gastric bands: Lap- Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight. Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, and have a body mass index (BMI) of at least 40 or, a BMI of at least 35, and at least one health condition linked to obesity (FDA, 2013).

To the Indications Section:

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 21 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 21 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division  Changed the word “member” to “patient”.  Reaffirmed validity for Indications 1, 2 & 4.  Revised Indication #3, in order to read: Patient has been previously unsuccessful with a recent treatment of six (6) consecutive months (Hopkins, 2010) of medical treatment for obesity (documentation must be submitted by a licensed physician and/or licensed nutritionist, including: diet plan used and reason for failure).  Added new Indication #5: Patients who have a history of psychiatric or psychological disorder or are currently under the care of a psychologist/psychiatrist, or are on psychotropic medications, must undergo preoperative psychological evaluation and clearance and the patient’s record must include documentation of the evaluation and assessment.  No further Indications were approved to be added.

To the Contraindications Section:  Revised contraindication #1 to read: Prohibitive perioperative risk of cardiac complications due to cardiac ischemia or myocardial dysfunction.  Revised contraindication #6 to read: Significant eating disorders.  Revised contraindication #7 to read: Severe hiatal hernia/gastroesophageal reflux (for purely restrictive procedures such as LAGB).  No further contraindications were approved to be added.

To the Limitations Section:  Added Limitation #2: Under provisions of this medical policy, the following procedures are not considered reasonable and necessary and will be denied: a. Mini-gastric bypass (CPT code 43999); b. Long limb gastric bypass (i.e. more than 150 cm) (CPT code 43999); & c. Silastic ring vertical gastric bypass (Fobi pouch) (CPT code 43999).  Added Limitation #3: Procedure codes 43886, 43887and 43888 are for open port replacement. The open port replacement procedures are non-covered since they are associated with the non-covered open gastric restrictive procedures.  Added Limitation #4: covered laparoscopic restrictive procedures that require port replacements use 43771, 43772, or 43773.

To the Coding Information:  CPT®Code 43775 was removed from the NOT Covered Section, and moved to Covered codes.  New CPT ® Code 44799 was added as NOT covered.  Deleted: ICD-9-CM Sub-title: Additional Diagnosis Codes for Comorbidity.  Deleted Note: *According to the ICD-9-CM book, diagnosis codes identified with asterisks are secondary diagnosis codes and should not be billed as the primary code.  Deleted Note: Additional diagnosis for comorbidity to be reported in addition to the primary diagnosis of 278.01 and the secondary diagnosis for the BMI.  Added Note 7: For ICD-9-CM Code 278.01, please use additional code to identify Body Mass Index (BMI), if it is known (V85.0 – V85.54).  Added Note 8: According to the ICD-9-CM book, diagnosis codes *327.26 and *425.8 are secondary diagnosis codes and should not be billed as the primary diagnosis.

February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy.

June 25, 2014 Revised Revised and made the following modifications:  Restructured Notes throughout medical policy as Notes 1-5.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 22 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 22 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

To the Indications Section:  To opening statement added the following coverage phrase: for the Commercial Line of Business (LOB) ONLY.  Added Note 3: For MCS Classicare (Advantage) LOB patients, please refer to the following First Coast Service Options, Inc.’s Local Coverage Determination (LCD): LCD for Surgical Management of Morbid Obesity (L29477).

To the Limitations Section:  Deleted #1: Bariatric procedures for all other MCS Lines of Business (LOB) will be covered according to the member’s contract specifications, limitations, exclusions and/or exceptions. June 25, 2015 Revised To title of medical policy:  Added at the end of title: (i.e., Bariatric Surgery).

To the References Section:  References updated.  Deleted obsolete and non-used references for 2015 revision.  Added new references, numbers 2, 5, 10, 14, 20 & 24.

To the Description Section:  Deleted entire previous information.  Added: Patients are classified as being affected by Clinically Severe Obesity (previously called “morbid” obesity) when their Body Mass Index (BMI) is greater than 40, or they are more than a 100 pounds over their ideal body weight. Additionally, patients who have a BMI of 35 or greater with an existing comorbidity (e.g., diabetes, hypertension, etc.) are also classified as Clinically Severe Obese (OAC, 2015).  Added: The Surgical Management of Clinically Severe Obesity refers to the surgical procedures that are performed to manage obesity and, are collectively referred to as Metabolic or Bariatric Surgery (UpToDate®/Lim1, 2015). These procedures for weight loss include a combination of volume restrictive and nutrient malabsorptive procedures that affect satiety, absorption, and insulin sensitivity hormonal or enteric derived factors, in conjunction with behavior modification to achieve and sustain weight loss (UpToDate®/Lim2, 2015).  Added: Examples of Contemporary Bariatric Surgery Procedures include, but are not limited to, the following: •Roux-en-Y-Gastric Bypass (RYGB) – RYGB remains the most commonly performed bariatric procedure and, it involves the creation of a small gastric pouch, thereby restricting food and limiting caloric absorption; •Laparoscopic Adjustable Gastric Banding (LAGB) – Adjustable Gastric Banding (AGB) is a purely restrictive procedure that compartmentalizes the upper stomach by placing a tight, adjustable prosthetic band around the entrance to the stomach. While AGB can be performed by an open approach, it is most commonly performed Laparoscopically (LAGB); •Sleeve gastrectomy (SG) – SG is a partial gastrectomy, in which the majority of the greater curvature of the stomach is removed and, a tubular stomach is created. SG is technically easier to perform than the RYGB, as it does not require multiple anastomoses. It is also safer, as it reduces the risks of internal herniation and protein & mineral malabsorption; •Bilio-Pancreatic Diversion with Duodenal Switch (BPD/DS) – The BPD/DS is a variant of the Bilio-Pancreatic Diversion (BPD). The original BPD procedure involves dividing the duodenum from the pylorus, removing the pylorus, and dividing the ileum. The distal ileum is then anastomosed to the stomach and the proximal ileum, with the output from the liver, pancreas, and duodenum (or biliopancreatic limb) is anastomosed to the terminal ileum some 50- 100 cm away from the ileocecal valve. The BPD/DS procedure involves creating a sleeve gastrectomy with preservation of the pylorus, and

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 23 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 23 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division creation of a Roux limb with a short common channel. The BPD/DS procedure differs from the BPD in the portion of the stomach that is removed, as well as preservation of the pylorus. It is associated with a lower incidence of stomal ulceration and diarrhea than with BPD alone (UpToDate®/Lim2, 2015).  Added: Examples of Experimental/Investigational/Not Covered Bariatric Surgery Procedures include, but are not limited to, the following: •Mini-Gastric Bypass (MGB) – The MGB, a modification of the loop gastric bypass & technically easier to perform than a RYGB, is performed laparoscopically. The MGB has not been universally accepted as a metabolic & bariatric procedure due to higher rates of alkaline bile reflux and limited data documenting effective long-term outcomes; •Intra-Gastric Balloon (IGB) – The IGB consists of a soft, saline-filled balloon that promotes a feeling of satiety and restriction. The IGB is not available for use in the United States, outside of clinical trials; •Endoluminal Vertical Gastroplasty (EVG) – EVG is an endoscopic approach for suturing the stomach that offers the potential to perform gastric-restrictive procedures endoluminally. Similar to an endoscopic device that created a fundoplication, there has been an issue with durability as a significant amount of staples and fasteners may not be holding the stomach tissue after 1 year; •Implantable Gastric Pacing (IGP) – IGP involves surgically placing electric pacers into the stomach wall and then attaching the pacing wires to a generator placed in the subcutaneous tissue of the abdominal wall. How IGP works is not entirely understood. The increased stimulation is thought to increase gastric motility but, it may also change fundic tone and alter gut hormone secretions; •Endoscopic Gastrointestinal Bypass Devices (EGIBD) – In EGIBD, a device is deployed to prevent luminal contents from being absorbed in the proximal small intestine. Data are still lacking about the longevity of endobarriers and their outcomes once the barrier is removed (UpToDate®/Lim2, 2015).  Added: Examples of Obsolete Bariatric Surgery Procedures, which are no longer or only rarely performed, include the following: •Jejuno-Ileal Bypass (JIB) – JIB was one of the first bariatric operations. The procedure was performed by dividing the jejunum close to the ligament of Treitz, and connecting it a short distance proximal to the ileocecal valve, thereby diverting a long segment of small bowel, resulting in malabsorption. The use of JIB has been abandoned due to the high complication rate and frequent need for revisional surgery; •Gastroplasties – A gastroplasty narrows the area of food passage between the proximal and the distal stomach. This procedure did not result in significant weight loss, and the Vertical Banded Gastroplasty (VBG) was subsequently created to put a more permanent restrictive barrier between the proximal and distal stomach. VBG has been replaced largely by other procedures and is rarely performed due to lack of sustained/desired weight loss, as well as the high incidence of complications requiring revision (UpToDate®/Lim2, 2015).  Added: The scope of this medical policy is to establish the medical criteria for the Commercial Line of Business (LOB) only, since for the Classicare (Advantage) LOB, Medicare established a Local Coverage Determination, addressed later on in this medical policy.

To the Indications Section:  Divided Indications into 2 parts: Part I for Commercial LOB and Part II for Classicare (Advantage) LOB.  To Part I, modified coverage statement to read as follows: For the Commercial Line of Business (LOB) Only: Medical Card System, Inc., (MCS) considers medically necessary the Surgical Management of Clinically Severe Obesity (i.e. Bariatric Surgery), when the All of the following criteria are met.  To Part I, Indication #1, added at the beginning: ‘patient is’.  To Part I, Indication #2, added at the beginning: ‘patient has’.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 24 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 24 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division  To Part I, Indication #4, added at the beginning: ‘patient’s’.  To Part I, added new indication #6 located in previous section: Considerations of Surgery, but modified wording to read as follows: In the absence of psychiatric/psychological disorder, the patient’s psychological evaluation, screening for mental conditions and willingness to comply with the treatment, must be documented in medical record  Deleted previous Note 2: For MCS Classicare (Advantage) LOB patients, please refer to the following First Coast Service Options, Inc.’s Local Coverage Determination (LCD): LCD for Surgical Management of Morbid Obesity (L29477).  To new Part II, added new coverage statement as follows: For the Classicare (Advantage) LOB: Medical Card System, Inc., (MCS) considers medically necessary the Surgical Management of Clinically Severe Obesity (i.e. Bariatric Surgery), under the criteria established within the Medicare: •Local Coverage Determination (LCD) for Surgical Management of Morbid Obesity (L29477), which corresponds to the geographical jurisdiction of Puerto Rico. Please refer to the aforementioned PR LCD for further details.

To the Contraindications Section:  Specified in title that section applies to: the Commercial LOB Only. For Classicare LOB Please Refer To PR LCD 29477.  Deleted Contraindication 2: Poor myocardial reserve.

To the Considerations of Surgery Section:  Deleted Section, but only: 2. Risks, complications and benefits of bariatric surgery; & 3. Long term changes in life style.  Moved # 1 (i.e., Psychological evaluation and screening for mental conditions and willingness to comply with the treatment) to the Indications Section as new # 6.

To the Limitations Section:  Specified in title that section applies to: the Commercial LOB Only. For Classicare LOB Please Refer To PR LCD 29477.  To Limitation 1, modified structure of content to read as follows: Under provisions of this medical policy, All the following procedures are considered Not reasonable & medically necessary, and hence, Not Covered.  To Limitation 1, added letter ‘d’: Intra-Gastric Balloon (IGB) (CPT® 43999 code).

To the Coding Information Section:  Specified in title that section applies to Both the Commercial &Classicare (Advantage) LOB.  No new codes were added. November 23, 2015 Revised To the coding section:  Eliminate ICD-9 codes since they are no longer valid for diagnosis classification.  Add new section of ICD-10 codes which are the valid diagnosis classification system since October 1, 2015. March 16, 2016 Revised References were Updated

To the Contraindications Section:  To the Contraindication #3 for Commercial LOB; The Phrase “of Obesity” was added at the end of this premise.

To the Coding Section:

 New ICD-10 Codes were added to the Policy: A18.84, E11.329, E11.339, E11.349, E11.359, E11.42, E13.00, E13.11, E13.620, E13.621, E13.622, E13.628, E13.638, E13.641, E13.649,

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 25 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 25 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E13.65, E13.69, E13.8, andE13.9.

 New Note1 was added to the ICD-10 Codes at the end of the series of Code section.

To the References Section: New Reference #13 was added to the Policy. January 23, 2019 Revised References updated. Added #3, 24 & 25. Deleted # 19, 23, 24 &25.

To the Description Section:  To 1st paragraph: Deleted citation (OAC, 2016).  To 2ndparagraph: Updated citation’s years (2018).  To 3rd paragraph, under Examples of Contemporary Bariatric Surgery Procedures, first bullet: Roux-en-Y-Gastric Bypass (RYGB) – Added phrase “one of” to sentence.  To 2nd bullet of Examples of Experimental/Investigational/Not Covered Bariatric Surgery ProceduresIntra-Gastric Balloon (IGB) –Deleted sentence: The IGB is not available for use in the United States, outside of clinical trials. Added: An IGB is typically inserted endoscopically and filled with 400 to 700 mL of saline, generally for a maximum of six months, beyond which time the leak rate increases significantly. Weight loss is dependent on adherence to lifestyle changes and patient compliance. The US Food and Drug Administration (FDA) has issued updates in August 2017 and June 2018 to alert health care providers of 12 reported deaths worldwide from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Seven of these 12 deaths involved United States patients;  To 5th bullet: Endoscopic Gastrointestinal Bypass Devices (EGIBD) – added term “barrier” to sentence. Also updated citation year to 2018.  To the 2nd bullet of Examples of Obsolete Bariatric Surgery Procedures, which are no longer or only rarely performed: Updated citation year to 2018.

To the Indications Section:  To section #2: updated link for Local Coverage (LCD) for Surgical Management of Morbid Obesity (L33411).

To the Contraindications and Limitations for Classicare Section:  Updated link for updated link for Local Coverage (LCD) for Surgical Management of Morbid Obesity (L33411).

To the Coding Information Section:  To the CPT Codes table: Added New Note 1 which reads: For procedure codes 43644, 43645, 43770, 43775, 43845 43846, and 43847: Report the primary diagnosis as E66.01 then an additional secondary diagnosis for body mass index (BMI) and a third diagnosis for the comorbidities as appropriate.  Changed former note 1 to note 2.  Deleted ICD-10 Codes: E11.319,E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351,E13.359, E13.59, I27.2, M14.80, M14.819, M14.829, M14.839, M14.849, M14.859, M14.869, M14.879, M483.06, M51.07.  Added new ICD-10 codes: E11.10, E11.11, E11.3211, E11.3212, E11.3213, E11.3291, E11.3292, E11.3293, E11.3311, E11.3312, E11.3313, E11.3391, E11.3392, E11.3393, E11.3411, E11.3412, E11.3413, E11.3491, E11.3492, E11.3493, E11.3511, E11.3512, E11.3513, E11.3521, E11.3522, E11.3523, E11.3531, E11.3532, E11.3533, E11.3541, E11.3542, E11.3543, E11.3551, E11.3552, E11.3553, E11.3591, E11.3592, E11.3593, E11.37X1, E11.37X2, E11.37X3, E13.3211, E13.3212, E13.3213, E13.3291, E13.3292, E13.3293, E13.3511, E13.3512, E13.3513, E13.521, E13.3522, E13.3523,

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 26 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 26 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division E13.3531, E13.3532, E13.3533, E13.3541, E13.3542, E13.3543, E13.3551, E13.3552, E13.3553, E13.3591, E13.3592, E13.3593, E13.36, E13.37X1, E13.37X2, E13.37X3, E13.3311, E13.39, E13.40, E13.41, E13.42, E13.43, E13.44, E13.49, E13.59, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I15.0, I15.1, I15.2, I15.8, I15.9, M48.061, M48.062.

March 4, 2020 Revised References updated. Added #8.

To the Description Section:  Updated citation year to UpToDate, Lim2 to 2020, where applicable.

To the Indications Section:  To Indications Set II: Updated link to CMS LCD L33411.

To the Contraindications/ Limitations Section for Classicare LOB Section:  Updated link to CMS LCD L33411.

To the Coding Information Section:  Corrected descriptor for ICD-10 Code E13.3411.  Corrected ICD-10 Code to E13.3521, thus deleting code E13.521.  Deleted ICD-10 Codes E78.0, E78.4, I11.0, I11.9, I12.0, I12.9, I13.0, I13.10, I13.11, I13.2, I15.0, I15.1, I15.2, I15.8, I15.9, I25.10, I25.110, I25.111, I25.118, I125.119, I27.0, I27.20, I12.9, M14.811, M14.812, M14.821, M14.822, M14.831, M14.832, M14.841, M14.842, M14.851, M14.852, M14.861, M14.862, M14.871, M14.872, M14.88, M14.89, M36.1, N26.2.  Added ICD-Codes E78.00, E78.01, E78.41, E78.49, I27.89.  Added asterisks to ICD-10 Codes which should not be billed as primary diagnosis: Z68.35, Z68.36, Z68.37, Z68.38, Z68.39, Z68.41, Z68.42, Z68.43, Z68.44, Z68.45  To Note 2: Deleted: Diagnosis codes G47.36 and I43 should not be billed as the primary diagnosis. Replaced with note: Diagnosis codes identified with asterisks should not be billed as the primary diagnosis code.

This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member’s plan in effect as of the date services are rendered. Medical Card System, Inc., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. Medical Card System, Inc., (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan’s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 27 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 27 All Rights Reserved®