Coverage Indications, Limitations, and/or Medical Necessity
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

CMS National Coverage Policy
Surgical treatment for primary obesity is not a covered Medicare service. CMS national policy dictates that surgery for morbid obesity is covered for Medicare beneficiaries who have all of the following:
•    A body mass index of 35 or higher.
•    At least one comorbidity related to obesity.
•    Have been previously unsuccessful with medical treatment for obesity.
Surgical procedures for morbid obesity that are covered under national policy for qualifying Medicare beneficiaries include:
•    Open and laparoscopic Roux-en-Y Gastric Bypass (RYGBP).
•    Open and laparoscopic Biliopancreatic Diversion With Duodenal Switch (BPD/DS).
•    Laparoscopic Adjustable Gastric Banding (LAGB).
Surgical procedures for morbid obesity that are not covered under national policy for all Medicare beneficiaries include:
•    Open adjustable gastric banding.
•    Open sleeve gastrectomy.
•    Open and laparoscopic vertical-banded gastroplasty.
•    Gastric balloon.

Contractor Local Coverage Policy
Bariatric surgery procedures must be performed by a surgeon trained and substantially experienced with surgery of the digestive tract. Services will be considered reasonable and necessary only if performed by appropriately trained providers. This training and expertise must have been acquired within the framework of a completed accredited residency training program and reflect ongoing continued medical education activities and board certification by the appropriate ABMS. It is expected that these services would be performed as indicated by current medical literature and accepted standards of practice of the American College of Surgeons, and the American Society for Metabolic and Bariatric Disease. Surgeons performing these services for Medicare beneficiaries shall be appropriately trained Medical Physicians (MD or DO) certified or eligible for certification by the American Board of Surgery, American Osteopathic Board of (General) Surgery and/or is a Fellow of the American or Royal College of Surgeons, or Regular Member of the American Society of Metabolic and Bariatric Surgery.

Laparoscopic Sleeve Gastrectomy for morbid obesity is covered under Local Coverage Determination by this contractor to include patients with the three above criteria (BMI 35 or greater, at least one comorbidity related to obesity and previous unsuccessful medical treatment for obesity) as the following:
•    Laparoscopic Sleeve Gastrectomy for a ‘stand-alone’ procedure (i.e., not as part of staged procedure or part of failed attempt that moves to an open procedure)

Under provisions of this LCD, the following procedures are also not covered:
•    Intestinal bypass.
•    Mini-gastric bypass.
•    Silastic ring vertical gastric bypass (Fobi pouch).
Comorbid Conditions
Severe obesity is known to aggravate numerous medical conditions. Comorbid conditions for which bariatric surgery is covered include the following:
•    Type II diabetes mellitus (by American Diabetes Association diagnostic criteria).
•    Refractory 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).
•    Hepatic steatosis without prior evidence of active inflammation.

Though the conditions listed above need not be immediately life-threatening for Medicare to cover bariatric surgery, the condition must not be trivial or easily controlled with non-invasive means (such as medication) and must be of sufficient severity as to pose considerable short- or long-term risk to function and/or survival. 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.

Previous 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 meets BMI requirements stated in national policy (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 is 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:
o    Physician (MD or DO).
o    Registered dietician (RD).
o    Board certified specialist in pediatric nutrition (CSP).
o    Board certified specialist in renal nutrition (CSR).
o    Fellow of the American Dietetic Association (FADA).

Preoperative Psychological/Psychiatric Evaluation

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 Medicare-covered service. A diagnostic session is appropriate, and treatment sessions are appropriate if the patient has a diagnosable disorder that is likely to respond to psychotherapy. The mental health professional, the surgeon and the patient should be in agreement that the patient is an appropriate candidate for the surgery. Screening of patients who do not meet these criteria would not be reasonable and necessary and therefore not covered.

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.