LCD L33411: Surgical Management of Morbid Obesity

Please refer to the CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual , Chapter 1, Part 2, Section 100.1 Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity for nationally covered indications and limitations.

Covered Indications

Gastrointestinal surgery for obesity, also called bariatric surgery, promotes weight loss by closing off parts of the stomach to make it smaller. Program payment may not be made for treatment of obesity alone since this treatment cannot be considered reasonable and necessary for the diagnosis or treatment of an illness or injury.

Laparoscopic sleeve gastrectomy (LSG)

The surgical management for the treatment of morbid obesity is considered reasonable and necessary for all nationally covered bariatric surgical procedures and Laproscopic sleeve gastrectomy when ALL of the following conditions are met and recorded in the medical record:

• The patient meets the definition of morbid obesity which is defined as a body mass index (BMI) > 35 and comorbid conditions exist (e.g., hypertensive cardiovascular disease, pulmonary/respiratory disease, diabetes, sleep apnea or degenerative arthritis of weight-bearing joints). Documentation of the level of severity of the comorbid existing condition must be included in the patient’s medical record; AND

• The patient has been previously unsuccessful with medical treatment for obesity; AND

• Treatable metabolic causes for obesity (e.g., adrenal or thyroid disorders) have been ruled out or have been clinically treated if present.

Unsuccessful Medical Treatment for Obesity

With or without bariatric surgery, successful obesity management requires adoption and lifelong practice of healthy eating and physical exercise (i.e. lifestyle modification) by the obese patient. Without adequate patient motivation and/or skills needed to make such lifestyle modifications, the benefit of bariatric surgical procedures is severely jeopardized and not medically reasonable or necessary. Patients considering bariatric surgical options must have been provided with knowledge and tools needed to achieve such lifelong lifestyle changes and must be capable and willing to undergo the changes.

For the purposes of this LCD, a patient will be deemed to have been unsuccessful with medical treatment of obesity if all of the following minimal requirements are met per documentation in the medical record:

• The patient has BMI ≥ 35 at the time of surgery.

• The patient has been provided with knowledge and tools needed to achieve such lifelong lifestyle changes, exhibits understanding of the needed changes and has demonstrated to clinicians involved in his or her care to be capable and willing to undergo the changes.

• The patient has made a diligent effort to achieve healthy body weight with such efforts described in the medical record and certified by the operating surgeon.

• The patient has failed to maintain a healthy weight despite adequate participation in a structured dietary program overseen by one of the following:

• Physician (MD or DO).

• Registered dietician (RD).

• Board certified specialist in pediatric nutrition (CSP).

• Board certified specialist in renal nutrition (CSR).

• Fellow of the American Dietetic Association (FADA).

Preoperative Psychological/Psychiatric Evaluation

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.

An objective examination by a mental health professional (psychiatrist or psychologist) experienced in the evaluation and management of bariatric surgery candidates to exclude patients who are unable to personally provide informed consent, who are unable to comply with a reasonable pre- and postoperative regimen, or who have a significant risk of postoperative decompensation is recommended. Such evaluation is a covered service. A diagnostic session is appropriate, and treatment sessions are appropriate if the patient has a diagnosable disorder that is likely to adversely impact the surgical outcome including post –operative compliance. The mental health professional, the surgeon and the patient should be in agreement that the patient is an appropriate candidate for the surgery.

Comorbid Conditions

Severe obesity (BMI) ≥ 35 kg/m2 is known to exacerbate numerous medical conditions. Comorbid conditions for which bariatric surgery is covered include the following:

• Type II diabetes mellitus (by American Diabetes Association diagnostic criteria).

• Resistant hypertension (defined as blood pressure of 140 mmHg systolic and/or 90 mmHg diastolic despite medical treatment with maximal doses of three antihypertensive medications).

• Refractory hyperlipidemia (acceptable levels of lipids unachievable with diet and maximum doses of lipid lowering medications).

• Obesity-induced cardiomyopathy.

• Clinically significant obstructive sleep apnea.

• Obesity-related hypoventilation.

• Pseudotumor cerebri (documented idiopathic intracerebral hypertension).

• Severe arthropathy of spine and/or weight-bearing joints (when obesity prohibits appropriate surgical management of joint dysfunction treatable but for the obesity).

• Nonalcoholic fatty liver disease (NAFLD) as confirmed by physician with expertise in liver disease. Consideration of the risk-benefit for each individual patient must be used to determine that surgery for obesity is the best option for treatment for that patient and no contraindications to bariatric surgery may exist.

Limitations

Contraindications to Bariatric Surgery

Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient. To meet reasonable and necessary (R&N) threshold for covered surgeries in the treatment of morbid obesity, the physician’s documentation for the case should clearly support the indication and the medical need (the procedure does not exceed the medical need) and is at least as beneficial as existing alternatives. The following list includes contraindications to surgery to treat morbid obesity and lacking compelling arguments for an exception in the supporting documentation, the hospital and physician services can be denied if reviewed.

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

• Severe chronic obstructive airway disease or respiratory dysfunction.

• Non-compliance with medical treatment of obesity or treatment of other chronic medical conditions.

• History of significant eating disorders, including anorexia nervosa, bulimia and pica (sand, clay or other abnormal substance).

• Severe hiatal hernia/gastroesophageal reflux (for purely restrictive procedures such as LAGB).

• Autoimmune and rheumatological disorders (including inflammatory bowel diseases and vasculitides) that will be exacerbated by the presence of intra-abdominal foreign bodies (for LAGB procedure).

• Active hepatic disease with inflammation, portal hypertension or ascites.

• Failure to cease tobacco use at least 6 weeks prior to surgery or documentation in the medical record that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation.

• Psychological/psychiatric conditions:

• 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).

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

• 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.

Note: A history of or presence of mild, uncomplicated and adequately treated depression due to obesity is not normally considered a contraindication to obesity surgery.

Under provisions of this LCD, the following procedures are not considered reasonable and necessary and will be denied:

• Mini-gastric bypass

• Long limb gastric bypass (i.e., more than 150 cm)

• Silastic ring vertical gastric bypass (Fobi pouch)

The open port replacement procedures are non-covered since they are associated with the non-covered open gastric restrictive procedures.

Note: Any service associated with noncovered services are also noncovered.

Repeat bariatric surgery is generally not reasonable and necessary. Claims for more than one bariatric surgical procedure may be submitted for individual consideration, and potentially covered when clinical circumstances demonstrate reasonability and necessity (such as replacing a defective device or correcting a complication in a patient who had met medical necessity for the original procedure and has achieved acceptable weight loss).

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual , Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications

Bariatric surgery procedures must be performed by a surgeon trained and substantially experienced with surgery of the digestive tract, working in a clinical setting with adequate support for all aspects of management, assessment and follow-up. The American College of Surgeons (ACS) and American Society for Bariatric Surgery (ASBS) certification requirements for physician credentialing satisfy this requirement. Physicians who do not meet ACS or ASBS certification criteria for performing bariatric procedures do not qualify for payment for bariatric surgery procedures.

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