- A body mass index of 35 or higher.
- At least one comorbidity related to obesity.
- Have been previously unsuccessful with medical treatment for obesity.
- Open and laparoscopic Roux-en-Y Gastric Bypass (RYGBP).
- Open and laparoscopic Biliopancreatic Diversion With Duodenal Switch (BPD/DS).
- Laparoscopic Adjustable Gastric Banding (LAGB).
- Open adjustable gastric banding.
- Open and laparoscopic-sleeve gastrectomy.
- Open and laparoscopic vertical-banded gastroplasty.
- Gastric balloon.
- Intestinal bypass.
- Mini-gastric bypass.
- Silastic ring vertical gastric bypass (Fobi pouch).
- 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 evidence of active inflammation.
- Physician-supervised nutrition and exercise program: Including dietitian consultation, appropriate calorie diet, increased physical activity and behavioral modification, documented in the medical record. This physician-supervised nutrition and exercise program must meet all of these criteria:
- Nutrition and exercise program must be supervised and monitored by a physician working in cooperation with appropriately trained dietitians and/or nutritionists.
- Nutrition and exercise program(s) must be for a minimum cumulative total of approximately six months, with participation in one program for at least three consecutive months,
- Within the two years prior to surgery, an attending physician who supervised the patient’s participation must document participation in a physician-supervised nutrition and exercise program in the medical record. The nutrition and exercise program may be administered as part of the surgical preparative regimen, and participation in the nutrition and exercise program may not be supervised by the surgeon who will perform the surgery. Note: A physician's summary letter is not sufficient documentation. Documentation should include medical records of the physician's contemporaneous assessment of the patient's progress throughout the course of the nutrition and exercise program and must include, at a minimum, summary statements of the patient’s course prepared by the nutritionist, dietitian and exercise program director. For patients who participate in a physician-administered nutrition and exercise program, program records documenting the patient’s participation and progress may substitute for physician medical records.
- Multidisciplinary surgical preparatory regimen: Proximate to the time of surgery, an organized multidisciplinary surgical preparatory regimen for a minimum of approximately three months’ duration meeting all of the following criteria to improve surgical outcomes, reduce the potential for surgical complications and establish the patient’s ability to comply with postoperative medical care and dietary restrictions:
- Consultation with a dietitian or nutritionist.
- Appropriately constructed, reduced-calorie diet program supervised by dietitian or nutritionist.
- Exercise regimen (unless contraindicated) to improve pulmonary reserve prior to surgery, supervised by an exercise therapist or other qualified professional.
- Behavior modification program supervised by a qualified professional.
- Smoking cessation.
- Documentation in the medical record of the patient’s participation in the multidisciplinary surgical preparatory regimen. A physician’s summary letter, without evidence of contemporaneous oversight, is not sufficient documentation. Documentation should include medical records of the physician’s initial patient assessment and the physician’s final patient assessment following completion of the multidisciplinary surgical preparatory regimen.
- Postoperative care by the operating surgeon immediately following surgery and throughout the global period for the surgery.
- At least three follow-up visits with the bariatric surgery team within the first year.
- Lifetime postoperative care for dietary issues (including vitamin, mineral and nutritional supplementation), exercise and lifestyle changes reinforced by counseling and/or support groups supervised by a physician knowledgeable in the long-term care of such patients.
- 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 condition.
- Failure to cease tobacco use.
- Psychological/psychiatric conditions:
- Schizophrenia, borderline personality disorder, suicidal ideation, severe or recurrent depression, or bipolar affective disorders.
- 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.
- 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).
- Hepatic disease with inflammation, portal hypertension or ascites.
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
- Furnished in a setting appropriate to the patient’s medical needs and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient’s medical need.
- At least as beneficial as an existing and available medically appropriate alternative.
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and CMS require the use of short CPT descriptors in policies published on the Web.
Lap gastric bypass/roux-en-y
Lap gastr bypass incl smll i
Laparoscope proc, stom
Note: Use CPT code 43659 when BOTH the gastric band and subcutaneous port components were removed AND replaced.
Lap place gastr adj device
Lap revise gastr adj device
Lap rmvl gastr adj device
Lap replace gastr adj device
Lap rmvl gastr adj all parts
Lap sleeve gastrectomy
Gastroplasty w/o v-band
Note: Use CPT code 43843 to identify open-sleeve gastrectomy.
Gastroplasty duodenal switch
Gastric bypass for obesity
Gastric bypass incl small i
Revise gastric port, open
Remove gastric port, open
Change gastric port, open
Stomach surgery procedure
Note: Use CPT code 43999 to identify: 1) laparoscopic vertical-banded gastroplasty; and 2) open adjustable gastric banding.
Diabetes mellitus without mention of complication, Type II or unspecified type, not stated as uncontrolled
Diabetes mellitus without mention of complication, Type II or unspecified type, uncontrolled
Diabetes with ketoacidosis, Type II or unspecified type, not stated as uncontrolled
Diabetes with ketoacidosis, Type II or unspecified type, uncontrolled
Diabetes with hyperosmolarity, Type II or unspecified type, not stated as uncontrolled
Diabetes with hyperosmolarity, Type II or unspecified type, uncontrolled
Diabetes with other coma, Type II or unspecified type, not stated as uncontrolled
Diabetes with other coma, Type II or unspecified type, uncontrolled
Diabetes with renal manifestations, Type II or unspecified type, not stated as uncontrolled
Diabetes with renal manifestations, Type II or unspecified type, uncontrolled
Diabetes with ophthalmic manifestations, Type II or unspecified type, not stated as uncontrolled
Diabetes with ophthalmic manifestations, Type II or unspecified type, uncontrolled
Diabetes with neurological manifestations, Type II or unspecified type, not stated as uncontrolled
Diabetes with neurological manifestations, Type II or unspecified type, uncontrolled
Diabetes with peripheral circulatory disorders, Type II or unspecified type, not stated as uncontrolled
Diabetes with peripheral circulatory disorders, Type II or unspecified type, uncontrolled
Diabetes with other specified manifestations, Type II or unspecified type, not stated as uncontrolled
Diabetes with other specified manifestations, Type II or unspecified type, uncontrolled
Diabetes with unspecified complication, Type II or unspecified type, not stated as uncontrolled
Diabetes with unspecified complication, Type II or unspecified type, uncontrolled
Disorders of lipoid metabolism
Obesity hypoventilation syndrome
Obstructive sleep apnea
Sleep related hypoventilation in conditions classified elsewhere
Benign intracranial hypertension
Benign essential hypertension
Other chronic pulmonary heart diseases (secondary pulmonary hypertension)
Cardiomyopathy in other diseases classified elsewhere (secondary cardiomyopathy)
Note: This diagnosis is not covered for CPT code 43770.
Other chronic non-alcoholic liver disease
Osteoarthrosis, localized, primary, pelvis and lower extremities
Osteoarthrosis, localized, secondary, pelvis and lower extremities
Osteoarthrosis, localized, not specified whether primary or secondary, pelvis and lower extremities
Osteoarthrosis, involving, or with multiple sites but not specified as generalized, multiple sites
Degeneration of lumbar or lumbosacral intervertebral disc
Intervertebral disc disorder with myelopathy lumbar region
Spinal stenosis, unspecified region
Body mass index 35.0–35.9, adult
Body mass index 36.0–36.9, adult
Body mass index 37.0–37.9, adult
Body mass index 38.0–38.9, adult
Body mass index 39.0–39.9, adult
Body Mass Index 40.0–44.9, adult
Body Mass Index 45.0–49.9, adult
Body Mass Index 50.0–59.9, adult
Body Mass Index 60.0–69.9, adult
Body Mass Index 70 and over, adult
Mechanical complication of other implant and internal device not elsewhere classified
Infection and inflammatory reaction due to unspecified device implant and graft
Other complications due to unspecified device implant and graft
- Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
- Each claim must be submitted with ICD-9-CM codes that reflect the condition of the patient and indicate the reason(s) for which the service was performed.
- The medical record must substantiate presence and severity of associated organic diseases requiring the treatment of obesity documented through appropriate physiologic testing and/or imaging.
- The patient’s medical record must include documentation of all required preoperative and postoperative evaluations and interventions and all other applicable coverage provisions required under both this LCD and prevailing National Coverage Determinations (NCDs).