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.
Bariatric surgical procedures are covered only when performed at facilities that are:
(1) certified by the American College
(2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006). Approved facilities and their approval dates are listed and maintained on the CMS coverage Web site:
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 and laparoscopic-sleeve gastrectomy.
- Open and laparoscopic vertical-banded gastroplasty.
- Gastric balloon.
TrailBlazer Local Coverage Policy
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
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 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
This standard applies to the surgical management of obesity when performed as an adjunct treatment of comorbid conditions. For the purposes of this LCD, a patient will have been unsuccessful with medical treatment of obesity if he meets BMI requirements stated in national policy (at the time of surgery) and he or she has made a diligent effort to achieve healthy body weight, as evidenced in the medical record.
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. Sincere pre-operative participation in either a physician-supervised nutrition and exercise program or a multidisciplinary surgical preparatory regimen as described below demonstrates patient understanding and commitment and should provide patients with necessary skills required to achieve and maintain healthy weight, thus, unless contraindicated, is necessary for Medicare coverage of bariatric surgery procedures. Medicare expects that contraindications to some degree of participation in nutrition program and/or exercise program are exceptionally rare and that patients deemed to have such a contraindication will have very clear medical record documentation, by the supervising physician, of such.
Because most individuals are able to lose weight by following healthy eating and exercise regimens, Medicare expects a diligent effort to result in weight loss of (the lesser of) at least 20 pounds or at least 10% of body weight. Medicare expects patient failure to achieve this weight loss will have been caused by plausible circumstances and the medical record will clearly explain those circumstances.
Acceptable nutrition and exercise programs are numerous and varied. Medicare expects that patients will have participated in a program with features described by one of the following:
- 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.
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.
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.
Other Preoperative Evaluation
A patient undergoing bariatric surgical procedures should undergo preoperative evaluation that is medically reasonable and necessary based upon his comorbid medical conditions and medical/surgical history. All underlying medical conditions that will likely impact or complicate the patient’s surgical and postoperative course must be adequately controlled before surgery. Routine preoperative testing (including upper gastrointestinal endoscopy) in the absence of signs/symptoms or personal history of a disease that could be negatively impacted by anesthesia or surgery is excluded from Medicare coverage by law.
Postoperative Care
Appropriate postoperative care for the bariatric surgery patient is required for Medicare coverage of bariatric surgical procedures. Follow-up must include but not be limited to:
- 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.
Contraindications to Bariatric Surgery
Surgery for severe obesity is a major surgical intervention with a risk of significant early and late morbidity and perioperative mortality. Surgery for severe obesity is not covered in the presence of absolute contraindications, including the following:
- 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.
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.
- 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.
Incidental Cholecystectomy
Incidental cholecystectomy is covered in the presence of signs and/or symptoms of gallbladder disease, finding of a grossly diseased gallbladder at the time of operation or a history of metabolic derangements that will result in symptomatic gallbladder disease following bariatric procedures.
Repeat Bariatric Procedures
Repeat bariatric surgery is generally not reasonable and necessary. Claims for more than one bariatric surgical procedure may be submitted for LCD 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).
See the related LCD article for instructions regarding requests for LCD Individual Consideration.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- 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.
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.
11X
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.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all the CPT/HCPCS codes listed can be billed with all the Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
0360
CPT/HCPCS Codes
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Note:
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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.
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43644©
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Lap gastric bypass/roux-en-y
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43645©
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Lap gastr bypass incl smll i
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43659©+
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Laparoscope proc, stom
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Note: Use CPT code 43659 when BOTH the gastric band and subcutaneous port components were removed AND replaced.
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43770©
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Lap place gastr adj device
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43771©**
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Lap revise gastr adj device
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43772©
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Lap rmvl gastr adj device
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43773©**
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Lap replace gastr adj device
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43774©
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Lap rmvl gastr adj all parts
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43775©*
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Lap sleeve gastrectomy
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43842©*
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V-band gastroplasty
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43843©*
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Gastroplasty w/o v-band
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Note: Use CPT code 43843 to identify open-sleeve gastrectomy.
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43845©
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Gastroplasty duodenal switch
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43846©
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Gastric bypass for obesity
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43847©
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Gastric bypass incl small i
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43848©**
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Revision gastroplasty
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43886©**
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Revise gastric port, open
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43887©
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Remove gastric port, open
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43888©**
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Change gastric port, open
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43999©*
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Stomach surgery procedure
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Note: Use CPT code 43999 to identify: 1) laparoscopic vertical-banded gastroplasty; and 2) open adjustable gastric banding.
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* Non-covered services.
** Covered on LCD Individual Consideration only.
+ Medicare coverage for replacement of gastric restrictive devices is limited (see Indications and Limitations section regarding repeat bariatric surgical procedures). Use of CPT code 43659 to report removal and replacement of bothcomponents is covered with one of the following diagnoses: 996.59, 996.60 or 996.70.
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. Coverage for selected bariatric surgery procedures on patients who meet national and local coverage criteria set forth in this LCDrequires reporting three appropriate diagnoses. Report the primary diagnosis as 278.01 (morbid obesity). Report a secondary diagnosis from Table 1 and a tertiary diagnosis from Table 2 below. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 43644, 43645, 43770, 43845, 43846, 43847 and 43887:
Table 1: Secondary Diagnoses
Covered for:
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250.00
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Diabetes mellitus without mention of complication, Type II or unspecified type, not stated as uncontrolled
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250.02
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Diabetes mellitus without mention of complication, Type II or unspecified type, uncontrolled
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250.10
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Diabetes with ketoacidosis, Type II or unspecified type, not stated as uncontrolled
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250.12
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Diabetes with ketoacidosis, Type II or unspecified type, uncontrolled
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250.20
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Diabetes with hyperosmolarity, Type II or unspecified type, not stated as uncontrolled
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250.22
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Diabetes with hyperosmolarity, Type II or unspecified type, uncontrolled
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250.30
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Diabetes with other coma, Type II or unspecified type, not stated as uncontrolled
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250.32
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Diabetes with other coma, Type II or unspecified type, uncontrolled
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250.40
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Diabetes with renal manifestations, Type II or unspecified type, not stated as uncontrolled
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250.42
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Diabetes with renal manifestations, Type II or unspecified type, uncontrolled
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250.50
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Diabetes with ophthalmic manifestations, Type II or unspecified type, not stated as uncontrolled
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250.52
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Diabetes with ophthalmic manifestations, Type II or unspecified type, uncontrolled
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250.60
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Diabetes with neurological manifestations, Type II or unspecified type, not stated as uncontrolled
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250.62
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Diabetes with neurological manifestations, Type II or unspecified type, uncontrolled
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250.70
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Diabetes with peripheral circulatory disorders, Type II or unspecified type, not stated as uncontrolled
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250.72
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Diabetes with peripheral circulatory disorders, Type II or unspecified type, uncontrolled
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250.80
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Diabetes with other specified manifestations, Type II or unspecified type, not stated as uncontrolled
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250.82
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Diabetes with other specified manifestations, Type II or unspecified type, uncontrolled
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250.90
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Diabetes with unspecified complication, Type II or unspecified type, not stated as uncontrolled
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250.92
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Diabetes with unspecified complication, Type II or unspecified type, uncontrolled
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272.0–272.4
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Disorders of lipoid metabolism
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278.03
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Obesity hypoventilation syndrome
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327.23
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Obstructive sleep apnea
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327.26
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Sleep related hypoventilation in conditions classified elsewhere
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348.2
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Benign intracranial hypertension
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401.1
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Benign essential hypertension
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416.8
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Other chronic pulmonary heart diseases (secondary pulmonary hypertension)
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425.8
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Cardiomyopathy in other diseases classified elsewhere (secondary cardiomyopathy)
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530.11
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Reflux esophagitis
Note: This diagnosis is not covered for CPT code 43770.
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571.8
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Other chronic non-alcoholic liver disease
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715.15–715.17
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Osteoarthrosis, localized, primary, pelvis and lower extremities
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715.25–715.27
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Osteoarthrosis, localized, secondary, pelvis and lower extremities
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715.35–715.37
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Osteoarthrosis, localized, not specified whether primary or secondary, pelvis and lower extremities
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715.89
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Osteoarthrosis, involving, or with multiple sites but not specified as generalized, multiple sites
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722.52
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Degeneration of lumbar or lumbosacral intervertebral disc
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722.73
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Intervertebral disc disorder with myelopathy lumbar region
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724.02–724.03
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Spinal stenosis, unspecified region
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Table 2: Tertiary Diagnoses
Covered for:
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V85.35
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Body mass index 35.0–35.9, adult
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V85.36
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Body mass index 36.0–36.9, adult
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V85.37
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Body mass index 37.0–37.9, adult
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V85.38
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Body mass index 38.0–38.9, adult
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V85.39
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Body mass index 39.0–39.9, adult
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V85.41
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Body Mass Index 40.0–44.9, adult
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V85.42
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Body Mass Index 45.0–49.9, adult
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V85.43
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Body Mass Index 50.0–59.9, adult
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V85.44
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Body Mass Index 60.0–69.9, adult
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V85.45
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Body Mass Index 70 and over, adult
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Coverage for 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 requires reporting of one diagnosis. The following list includes only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 43772 and 43774:
Covered for:
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996.59
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Mechanical complication of other implant and internal device not elsewhere classified
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996.60
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Infection and inflammatory reaction due to unspecified device implant and graft
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996.70
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Other complications due to unspecified device implant and graft
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Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
- 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).
Appendices
N/A
Utilization Guidelines
Repeat bariatric surgery is generally not reasonable and necessary. Claims for more than one bariatric surgical procedure may be submitted for LCD 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).
See the related LCD article for instructions regarding requests for LCD Individual Consideration.
Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.
