Local Coverage Determination (LCD): Laparoscopic Sleeve Gastrectomy (L34157)

Transcription

1 Local Coverage Determination (LCD): Laparoscopic Sleeve Gastrectomy (L34157) Contractor Information Contractor Name Noridian Healthcare Solutions, LLC LCD Information Document Information LCD ID L34157 Original ICD-9 LCD ID L32866 LCD Title Laparoscopic Sleeve Gastrectomy AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 10/01/2015 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A

2 American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary. Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. IOM , NCD Manual Section Bariatric Surgery for Treatment of Co-morbid Conditions Related to Morbid Obesity. In 2006, CMS released a final National Coverage Determination (NCD) on Bariatric Surgery for the Treatment of Morbid Obesity. This NCD is revised and titled Bariatric Surgery for Treatment of Co-morbid Conditions Related to Morbid Obesity (Effective September 24, 2013). For Medicare beneficiaries who have a BMI 35, have at least one co-morbidity related to obesity, and who have been previously unsuccessful with medical treatment for obesity, the following procedures were determined to be reasonable and necessary: open and laparoscopic Roux-en-Y gastric bypass (RYGBP); laparoscopic adjustable gastric banding (LAGB); and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) or gastric reduction duodenal switch (BPD/GRDS). In addition, the NCD stipulates that the above Bariatric procedures be covered only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (BSCOE) (Program Standards and requirements in effect on February 15, 2006). The CMS has determined that the evidence is sufficient to conclude that continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries and this requirement is removed

3 effective 09/24/2013. The 2006 NCD specifically non-covered open vertical banded gastroplasty, laparoscopic vertical banded gastroplasty, open sleeve gastrectomy, laparoscopic sleeve gastrectomy, and open adjustable gastric banding because there was a paucity of evidence to support claims of improved health outcomes from those procedures. In 2009, CMS reconsidered the NCD to include type 2 diabetes mellitus as a comorbidity. Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity, 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. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity The sleeve gastrectomy (SG) involves excision of the lateral aspect of the stomach, leaving a much reduced, lesser-curve based, tubular stomach (Hutter, 2011). When this procedure is performed laparoscopically the term laparoscopic sleeve gastrectomy (LSG) is used. Presently, LSG is commonly used as a stand-alone approach to bariatric surgery; however, initially, the procedure served to reduce gastric capacity and initiate short-term weight loss while the malabsorptive component of the operation (biliopancreatic diversion) provided the long-term weight loss (Brethauer, 2010). A stand-alone sleeve gastrectomy is sometimes referred to as an isolated sleeve gastrectomy. A laparoscopic approach to sleeve gastrectomy was later developed. There are variations in the detail of the sleeve gastrectomy procedure itself. Although LSG has been gaining popularity over the last few years and the number of bariatric surgery units that offer it is increasing, there is not yet a standard technique for this procedure (Ferrer-Márquez, 2011). LSG is not commonly considered for older patients, which is reflected in the lack of older subjects in the reported clinical studies. We found no RCTs that compared LSG to medical management or another bariatric surgical approach that focused solely on adults who were 65 years old or allowed us to discriminate subpopulation findings. As Flum noted, age is an important factor in adverse outcomes from bariatric surgery. DeMaria noted that the role of bariatric procedures in patients outside the commonly defined age range (18 to 60 years) is not well established and reported advanced patient age as a major contributor to mortality. The VA/DoD clinical practice guideline for screening and management of overweight and

4 obesity does not include LSG in its bariatric surgery recommendations and states, there is insufficient evidence to recommend for or against the routine use of bariatric surgery [any surgery] in those over 65 years of age and patients with a substantial surgical risk. Indications & Limitations of Coverage: 1. Effective for dates of service before January 01, 2014, laparoscopic sleeve gastrectomy will be covered in patients less than 61 years old if all the requirements of the NCD, including the June 2012 Decision Memo and all diagnoses, which are coded in the Noridian LCD are met. These requirements include, but are not limited to: 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. For dates of service January 01, 2014 the age restriction is changed to include age less than 65 years. This change is made to bring consistency in policy across Noridian s Medicare Parts A and B jurisdictions. The other requirements mentioned above remain in effect other than the date of service. 2. Patients 61 years and older (before January 01, 2014) may be considered for laparoscopic sleeve gastrectomy on an individual case basis. If a reconsideration request is made on a denied claim, the Medical Directors will review all evidence submitted by the provider supporting the treatment in the individual patient. (Please note the Medical Directors have reviewed all references cited in the CMS Decision Memo.) Laparoscopic sleeve gastrectomy was specifically not approved under past NCDs. Recently, under a national coverage analysis (Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity CAG-00250R2) CMS has made the decision for stand-alone LGS coverage to be at the discretion of the local Medicare contractor. Open sleeve gastrectomy is specifically not covered in the CMS NCD and as such remains non-covered. In the past, Noridian was concerned that there were no randomized controlled trials (RCTs) that adequately evaluated adults 65 years. Subsequently, based on a valid reconsideration request, additional scientific literature was presently that showed several studies that supported the safety and efficacy of this procedure in the age 65 year old population when same are carefully screened. Effective January 01, 2015, Noridian will cover laparoscopic sleeve gastrectomy when all of the following criteria are met: Patients has a Body Mass Index 35.0 kg/m² Patient has at least one CMS approved co-morbidity related to obesity and The beneficiary has been previously unsuccessful with medical treatments for obesity. The latter includes but is not limited to: active participation within the last 12 months prior to bariatric surgery in a weight-management program that is supervised by a physician or other health care professionals for a minimum of four consecutive months. The weight-management program must include monthly documentation of patient s weight and BMI, current dietary regimen and physical activity (e.g. exercise program).

5 Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 011x Hospital Inpatient (Including Medicare Part A) Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. 036X Operating Room Services - General Classification 049X Ambulatory Surgical Care - General Classification 075X Gastro-Intestinal (GI) Services - General Classification 096X Professional Fees - General Classification CPT/HCPCS Codes Group 1 Paragraph: Covered CPT/HCPCS codes: Group 1 Codes: LAPAROSCOPY, SURGICAL, GASTRIC RESTRICTIVE PROCEDURE; LONGITUDINAL GASTRECTOMY (IE, SLEEVE GASTRECTOMY) ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: <b *In-patient claims will also require ICD-10-CM Procedure Code 0DB64Z3 laparoscopic vertical sleeve gastrectomy. Primary/Principle Diagnosis: </b

6 Group 1 Codes: Group 1Codes ICD-10 Code Description E66.01 Morbid (severe) obesity due to excess calories Showing 1 to 1 of 1 entries in Group 1 Group 2 Paragraph: Co-morbid condition necessitating the condition: Group 2 Codes: ICD-10 Code E08.00 Group 2Codes Description Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E08.01 Diabetes mellitus due to underlying condition with hyperosmolarity with coma E08.10 Diabetes mellitus due to underlying condition with ketoacidosis without coma E08.11 Diabetes mellitus due to underlying condition with ketoacidosis with coma E08.36 Diabetes mellitus due to underlying condition with diabetic cataract E08.39 Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication E08.41 Diabetes mellitus due to underlying condition with diabetic mononeuropathy E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy E08.43 Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy E08.44 Diabetes mellitus due to underlying condition with diabetic amyotrophy E08.49 Diabetes mellitus due to underlying condition with other diabetic neurological complication E08.59 Diabetes mellitus due to underlying condition with other circulatory complications E Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy E Diabetes mellitus due to underlying condition with diabetic dermatitis E Diabetes mellitus due to underlying condition with foot ulcer E Diabetes mellitus due to underlying condition with other skin ulcer E Diabetes mellitus due to underlying condition with hypoglycemia with coma E08.65 Diabetes mellitus due to underlying condition with hyperglycemia E08.69 Diabetes mellitus due to underlying condition with other specified complication E08.9 Diabetes mellitus due to underlying condition without complications E09.00 Drug or chemical induced diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)

7 E09.01 Drug or chemical induced diabetes mellitus with hyperosmolarity with coma E09.10 Drug or chemical induced diabetes mellitus with ketoacidosis without coma E09.11 Drug or chemical induced diabetes mellitus with ketoacidosis with coma E09.36 Drug or chemical induced diabetes mellitus with diabetic cataract E09.39 Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complication E09.41 Drug or chemical induced diabetes mellitus with neurological complications with diabetic mononeuropathy E09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy E09.43 Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy E09.44 Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy E09.49 Drug or chemical induced diabetes mellitus with neurological complications with other diabetic neurological complication E09.59 Drug or chemical induced diabetes mellitus with other circulatory complications E Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy E Drug or chemical induced diabetes mellitus with diabetic dermatitis E Drug or chemical induced diabetes mellitus with foot ulcer E Drug or chemical induced diabetes mellitus with other skin ulcer E Drug or chemical induced diabetes mellitus with hypoglycemia with coma E Drug or chemical induced diabetes mellitus with hypoglycemia without coma E09.65 Drug or chemical induced diabetes mellitus with hyperglycemia E09.69 Drug or chemical induced diabetes mellitus with other specified complication E09.9 Drug or chemical induced diabetes mellitus without complications E10.10 Type 1 diabetes mellitus with ketoacidosis without coma E10.11 Type 1 diabetes mellitus with ketoacidosis with coma E10.21 Type 1 diabetes mellitus with diabetic nephropathy E10.22 Type 1 diabetes mellitus with diabetic chronic kidney disease E10.29 Type 1 diabetes mellitus with other diabetic kidney complication E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.59 Type 1 diabetes mellitus with other circulatory complications E Type 1 diabetes mellitus with diabetic dermatitis E Type 1 diabetes mellitus with foot ulcer E Type 1 diabetes mellitus with other skin ulcer E Type 1 diabetes mellitus with other skin complications E Type 1 diabetes mellitus with other oral complications E Type 1 diabetes mellitus with hypoglycemia with coma E Type 1 diabetes mellitus with hypoglycemia without coma E10.65 Type 1 diabetes mellitus with hyperglycemia

8 E10.69 Type 1 diabetes mellitus with other specified complication E10.9 Type 1 diabetes mellitus without complications E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemichyperosmolar coma (NKHHC) E11.01 Type 2 diabetes mellitus with hyperosmolarity 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 E Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema E Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema E Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema E11.36 Type 2 diabetes mellitus with diabetic cataract 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 E Type 2 diabetes mellitus with diabetic neuropathic arthropathy E Type 2 diabetes mellitus with other diabetic arthropathy E Type 2 diabetes mellitus with diabetic dermatitis E Type 2 diabetes mellitus with foot ulcer E Type 2 diabetes mellitus with other skin ulcer E Type 2 diabetes mellitus with other skin complications

9 E Type 2 diabetes mellitus with periodontal disease E Type 2 diabetes mellitus with other oral complications E Type 2 diabetes mellitus with hypoglycemia with coma E 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 E Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema E Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema E Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema E13.36 Other specified diabetes mellitus with diabetic cataract 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

10 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 E Other specified diabetes mellitus with diabetic neuropathic arthropathy E Other specified diabetes mellitus with other diabetic arthropathy E Other specified diabetes mellitus with diabetic dermatitis E Other specified diabetes mellitus with foot ulcer E Other specified diabetes mellitus with other skin ulcer E Other specified diabetes mellitus with other skin complications E Other specified diabetes mellitus with periodontal disease E Other specified diabetes mellitus with other oral complications E Other specified diabetes mellitus with hypoglycemia with coma E 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 E13.8 Other specified diabetes mellitus with unspecified complications E13.9 Other specified diabetes mellitus without complications E28.2 Polycystic ovarian syndrome E28.39 Other primary ovarian failure E28.8 Other ovarian dysfunction E66.01 Morbid (severe) obesity due to excess calories G47.33 Obstructive sleep apnea (adult) (pediatric) G93.2 Benign intracranial hypertension I10 Essential (primary) hypertension I11.0 Hypertensive heart disease with heart failure I11.9 Hypertensive heart disease without heart failure I12.0 Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease I12.9 Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.10 Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.11 Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease I15.2 Hypertension secondary to endocrine disorders I15.8 Other secondary hypertension I27.2 Other secondary pulmonary hypertension I27.89 Other specified pulmonary heart diseases

11 I50.1 Left ventricular failure I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.31 Acute diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.33 Acute on chronic diastolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I67.4 Hypertensive encephalopathy I Varicose veins of right lower extremity with ulcer of thigh I Varicose veins of right lower extremity with ulcer of calf I Varicose veins of right lower extremity with ulcer of ankle I Varicose veins of right lower extremity with ulcer of heel and midfoot I Varicose veins of right lower extremity with ulcer other part of foot I Varicose veins of right lower extremity with ulcer other part of lower leg I Varicose veins of left lower extremity with ulcer of thigh I Varicose veins of left lower extremity with ulcer of calf I Varicose veins of left lower extremity with ulcer of ankle I Varicose veins of left lower extremity with ulcer of heel and midfoot I Varicose veins of left lower extremity with ulcer other part of foot I Varicose veins of left lower extremity with ulcer other part of lower leg I Varicose veins of right lower extremity with both ulcer of thigh and inflammation I Varicose veins of right lower extremity with both ulcer of calf and inflammation I Varicose veins of right lower extremity with both ulcer of ankle and inflammation I Varicose veins of right lower extremity with both ulcer of heel and midfoot and inflammation I Varicose veins of right lower extremity with both ulcer other part of foot and inflammation I Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation I Varicose veins of left lower extremity with both ulcer of thigh and inflammation I Varicose veins of left lower extremity with both ulcer of calf and inflammation I Varicose veins of left lower extremity with both ulcer of ankle and inflammation I Varicose veins of left lower extremity with both ulcer of heel and midfoot and inflammation I Varicose veins of left lower extremity with both ulcer other part of foot and inflammation I Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation I Varicose veins of right lower extremities with pain

12 I Varicose veins of left lower extremities with pain I Varicose veins of bilateral lower extremities with pain I Varicose veins of right lower extremities with other complications I Varicose veins of left lower extremities with other complications I Varicose veins of bilateral lower extremities with other complications K21.0 Gastro-esophageal reflux disease with esophagitis K21.9 Gastro-esophageal reflux disease without esophagitis M Other specific arthropathies, not elsewhere classified, right hip M Other specific arthropathies, not elsewhere classified, left hip M Other specific arthropathies, not elsewhere classified, right knee M Other specific arthropathies, not elsewhere classified, left knee M Other specific arthropathies, not elsewhere classified, right ankle and foot M Other specific arthropathies, not elsewhere classified, left ankle and foot M12.88 Other specific arthropathies, not elsewhere classified, other specified site M16.0 Bilateral primary osteoarthritis of hip M16.11 Unilateral primary osteoarthritis, right hip M16.12 Unilateral primary osteoarthritis, left hip M16.2 Bilateral osteoarthritis resulting from hip dysplasia 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 M16.51 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 M17.0 Bilateral primary osteoarthritis of knee M17.11 Unilateral primary osteoarthritis, right knee M17.12 Unilateral primary osteoarthritis, left knee M17.2 Bilateral post-traumatic osteoarthritis of 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 M Primary osteoarthritis, right ankle and foot M Primary osteoarthritis, left ankle and foot M Post-traumatic osteoarthritis, right ankle and foot M Post-traumatic osteoarthritis, left ankle and foot M Secondary osteoarthritis, right ankle and foot M Secondary osteoarthritis, left ankle and foot M Other articular cartilage disorders, right hip M Other articular cartilage disorders, left hip M Other articular cartilage disorders, right ankle

13 M Other articular cartilage disorders, left ankle M Other articular cartilage disorders, right foot M Other articular cartilage disorders, left foot M Fistula, right hip M Fistula, left hip M Fistula, right knee M Fistula, left knee M Fistula, right ankle M Fistula, left ankle M Fistula, right foot M Fistula, left foot M25.18 Fistula, other specified site M Other specified joint disorders, right hip M Other specified joint disorders, left hip M Other specified joint disorders, right knee M Other specified joint disorders, left knee M Other specified joint disorders, right ankle and foot M43.21 Fusion of spine, occipito-atlanto-axial region M43.22 Fusion of spine, cervical region M43.23 Fusion of spine, cervicothoracic region M43.24 Fusion of spine, thoracic region M43.25 Fusion of spine, thoracolumbar region M43.26 Fusion of spine, lumbar region M43.27 Fusion of spine, lumbosacral region M43.28 Fusion of spine, sacral and sacrococcygeal region M51.04 Intervertebral disc disorders with myelopathy, thoracic region M51.05 Intervertebral disc disorders with myelopathy, thoracolumbar region M51.06 Intervertebral disc disorders with myelopathy, lumbar region M51.14 Intervertebral disc disorders with radiculopathy, thoracic region M51.15 Intervertebral disc disorders with radiculopathy, thoracolumbar region M51.16 Intervertebral disc disorders with radiculopathy, lumbar region M51.17 Intervertebral disc disorders with radiculopathy, lumbosacral region M51.34 Other intervertebral disc degeneration, thoracic region M51.35 Other intervertebral disc degeneration, thoracolumbar region M51.36 Other intervertebral disc degeneration, lumbar region M51.37 Other intervertebral disc degeneration, lumbosacral region M51.86 Other intervertebral disc disorders, lumbar region M51.87 Other intervertebral disc disorders, lumbosacral region M53.2X7 Spinal instabilities, lumbosacral region M53.2X8 Spinal instabilities, sacral and sacrococcygeal region M53.3 Sacrococcygeal disorders, not elsewhere classified M53.84 Other specified dorsopathies, thoracic region

14 M53.85 Other specified dorsopathies, thoracolumbar region M53.86 Other specified dorsopathies, lumbar region M53.87 Other specified dorsopathies, lumbosacral region M53.88 Other specified dorsopathies, sacral and sacrococcygeal region M54.03 Panniculitis affecting regions of neck and back, cervicothoracic region M54.04 Panniculitis affecting regions of neck and back, thoracic region M54.05 Panniculitis affecting regions of neck and back, thoracolumbar region M54.06 Panniculitis affecting regions of neck and back, lumbar region M54.07 Panniculitis affecting regions of neck and back, lumbosacral region M54.08 Panniculitis affecting regions of neck and back, sacral and sacrococcygeal region M54.09 Panniculitis affecting regions, neck and back, multiple sites in spine M54.14 Radiculopathy, thoracic region M54.15 Radiculopathy, thoracolumbar region M54.16 Radiculopathy, lumbar region M54.17 Radiculopathy, lumbosacral region M54.31 Sciatica, right side M54.32 Sciatica, left side M54.41 Lumbago with sciatica, right side M54.42 Lumbago with sciatica, left side M54.5 Low back pain M54.89 Other dorsalgia M Muscle spasm of back N39.3 Stress incontinence (female) (male) N39.41 Urge incontinence N39.46 Mixed incontinence R06.00 Dyspnea, unspecified R06.09 Other forms of dyspnea R06.83 Snoring R06.89 Other abnormalities of breathing R26.2 Difficulty in walking, not elsewhere classified Showing 1 to 309 of 309 entries in Group 2 Group 3 Paragraph: ICD-10 Diagnosis Codes for BMI 35 are: Group 3 Codes: Group 3Codes ICD-10 Code Description Z68.35 Body mass index (BMI) , adult Z68.36 Body mass index (BMI) , adult Z68.37 Body mass index (BMI) , adult

15 Z68.38 Body mass index (BMI) , adult Z68.39 Body mass index (BMI) , adult Z68.41 Body mass index (BMI) , adult Z68.42 Body mass index (BMI) , adult Z68.43 Body mass index (BMI) , adult Z68.44 Body mass index (BMI) , adult Z68.45 Body mass index (BMI) 70 or greater, adult Showing 1 to 10 of 10 entries in Group 3 ICD-10 Codes that DO NOT Support Medical Necessity Group 1 Paragraph: All ICD-10-CM codes not listed in this policy under ICD-10-CM Codes that Support Medical Necessity above. Group 1 Codes: N/A Additional ICD-10 Information N/A General Information Associated Information Documentation in the patient's medical records must support: all requirements of the NCD on Bariatric surgery are met as well as those of this LCD. 1. The reasonable and necessary requirements as outlined under the Indications and Limitations of Coverage and/or Medical Necessity section of this policy and must be available to Medicare for review upon request. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits in addition to guidance in this LCD. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare. Whichever guidance is more restrictive should be adhered to. When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.

16 Sources of Information and Basis for Decision American Society for Metabolic & Bariatric Surgery. Updated Position Statement on Sleeve Gastrectomy as a Bariatric Procedure Available at: SLEEVE-STATEMENT-2011_10_28.pdf. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64: Epub 2011 Jan 5. Birkmeyer NJ, Dimick JB, Share D, Hawasli A, English WJ, Genaw J, Finks JF, Carlin AM, Birkmeyer JD; Michigan Bariatric Surgery Collaborative. Hospital complication rates with bariatric surgery in Michigan. JAMA 2010;304: Brethauer SA. Sleeve gastrectomy. Surg Clin North Am 2011;91(6): Centers for Medicare & Medicaid Services. Change Request 8028 Centers for Medicare & Medicaid Services. NCD Manual (available at: aspx?ncdid=57&ncdver=3&ncaid=160&ver=40&ncaname=bariatric+surgery+for+the+tre atment+of+morbid+obesity+(1st+recon)&bc=aiaaaaaaiaaa&). Centers for Medicare & Medicaid Services. NCD Manual (available at: aspx?ncdid=353&ncdver=1&ncaid=253&ver=6&ncaname=intensive+behavioral+therapy +for+obesity&bc=aiaaaaaaiaaa&). Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2010;6:1-5. Epub 2009 Nov 17. Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev 2009;2:CD Delaet D, Schauer D. Obesity in adults. Clinical Evidence 2011;03(604):1-25. DeMaria EJ, Pate V, Warthen M, Winegar DA. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis 2010;6: Epub Diehr P, O'Meara ES, Fitzpatrick A, Newman AB, Kuller L, Burke G. Weight, mortality, years of healthy life, and active life expectancy in older adults. J Am Geriatr Soc Jan;56(1): Epub 2007 Nov 20. Dorman RB, Abraham AA, Al-Refaie WB, Parsons HM, Ikramuddin S, Habermann EB.

17 Bariatric Surgery Outcomes in the Elderly: An ACS NSQIP Study. J Gastrointest Surg 2011 Oct 27. PMID: [Epub ahead of print]. ECRI Institute Health Technology Assessment Information Service. Emerging Technology. Evidence Report: Laparoscopic sleeve gastrectomy for obesity. Plymouth Meeting (PA): ECRI Institute; 2011 October. Available at: Summary at: aged_care)_october2011.pdf. Ferrer-Marquez M, Belda-Lozano R, Ferrer-Ayza M. Technical controversies in Laparoscopic Sleeve Gastrectomy. Obes Surg Jan;22(1): Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, JAMA 2010;303: Flum DR, Kwon S, MacLeod K, Wang B, Alfonso-Cristancho R, Garrison LP, Sullivan SD. Bariatric Obesity Outcome Modeling Collaborative. The use, safety and cost of bariatric surgery before and after Medicare's national coverage decision. Ann Surg 2011;254: Flum DR, Salem L, Elrod JA, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005;294: Food and Drug Administration. Summary of Pediatric Advisory Committee Meeting Clinical Trial Design Issues for Pediatric Obesity Devices. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, Alderson P, Glasziou P, Falck- Ytter Y, Schünemann HJ. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64: Epub 2010 Dec 30. Helmiö M, Victorzon M, Ovaska J, Leivonen M, Juuti A, Jaser N, Peromaa P, Tolonen P, Hurme S, Salminen P. SLEEVEPASS: A randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surg Endosc Apr 5. [Epub ahead of print] Heneghan HM, Meron-Eldar S, Brethauer SA, Schauer PR, Young JB. Effect of bariatric surgery on cardiovascular risk profile. Am J Cardiol 2011;108: Himpens J, Dapri G, Cadière GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006 Nov;16: Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann

18 Surg 2011;254: Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-yy levels after Rouxen-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg 2008;247: Klarenbach S, Padwal R, Wiebe N, Hazel M, Birch D, Manns B, Karmali S, Sharma A, Tonelli M. Bariatric Surgery for Severe Obesity: Systematic Review and Economic Evaluation [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010 (Technology report;no. 129). [cited ]. Available from: Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med Apr 26;366(17): Epub 2012 Mar 26. Nagai M, Kuriyama S, Kakizaki M, Ohmori-Matsuda K, Sone T, Hozawa A, Kawado M, Hashimoto S, Tsuji I. Impact of obesity, overweight and underweight on life expectancy and lifetime medical expenditures: the Ohsaki Cohort Study. BMJ Open May 11;2(3). pii: e doi: /bmjopen Print National Institutes of Health, National Heart, Lung and Blood Institute: Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risks. Accessed via Nienhuijs SW, de Zoete JP, Berende CA, de Hingh IH, Smulders JF. Evaluation of laparoscopic sleeve gastrectomy on weight loss and co-morbidity. Int J Surg. 2010;8(4): Epub 2010 Mar 19. Padwal R, Klarenbach S, Wiebe N, Birch D, Karmali S, Manns B, Hazel M, Sharma AM, Tonelli M. Bariatric surgery: a systematic review and network meta-analysis of randomized trials. Obes Rev 2011;12: doi: /j X x. Epub 2011 Mar 28. Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess 2009;13:1-190, , iii-iv. Reuser M, Bonneux LG, Willekens FJ. Smoking kills, obesity disables: a multistate approach of the US Health and Retirement Survey. Obesity (Silver Spring) Apr;17(4): Epub 2009 Jan 22. Printed on 7/31/2012. Page 37 of 38 Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 2012 Apr

19 26;366(17): Stroh C, Weiner R, Horbach T, Ludwig K, Dressler M, Wolff S, Lippert H, Büsing M, Schmidt U, Manger T. Results of sleeve gastrectomy in Germany Data on Nationwide Survey on quality assurance in bariatric surgery in Germany. Surgical Science, 2012, 3, Walsh J. Sleeve gastrectomy as a stand alone bariatric procedure for obesity. California Technology Assessment Forum. October 13,2010. Available at Revision History Information Please note: Most Revision History entries effective on or before 01/24/2013 display with a Revision History Number of "R1" at the bottom of this table. However, there may be LCDs where these entries will display as a separate and distinct row. Revision History Date 10/01/2015 R3 10/01/2015 R2 10/01/2015 R1 Revision History Number Revision History Explanation This LCD is revised to remove the paragraph, When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and any pertinent peerreviewed literature that supports the request. At a minimum two (2) Phase II studies (human studies of efficacy, pivotal) or one (1) Phase III study (evidence of safety and efficacy, pivotal) must be submitted for the Medical Director s review. from the Associated Information field. Coverage Indications, Limitations and/or Medical Necessity is revised to remove age restriction from coverage criteria. ICD-10 code M51.07 is deleted per ICD-10 code updates and M51.04 and M51.05 are added. Reason(s) for Change Other (Removed the paragraph, When requesting an individual consideration through the written redetermination (formerly appeal) process, providers must include all relevant medical records and any pertinent peer-reviewed literature that supports the request. At a minimum two (2) Phase II studies (human studies of efficacy, pivotal) or one (1) Phase III study (evidence of safety and efficacy, pivotal) must be submitted for the Medical Director s review.") Reconsideration Request Revisions Due To ICD-10-CM Code Changes

20 Associated Documents Attachments N/A Related Local Coverage Documents N/A Related National Coverage Documents N/A Public Version(s) Updated on 03/27/2015 with effective dates 10/01/ N/A Updated on 12/15/2014 with effective dates 10/01/ N/A Updated on 07/25/2014 with effective dates 10/01/ N/A Updated on 03/31/2014 with effective dates 10/01/ N/A