Note: Many Aetna plan benefit descriptions specifically exclude services and supplies for or related to treatment of obesity or for diet and weight control. Under these plans, claims for weight reduction medications and for physician supervision of weight reduction programs will be denied based on that exclusion. Please check benefit plan descriptions for details.

Aetna considers the following medically necessary treatment of obesity when criteria are met:

1. Weight reduction medications, and
2. Physician supervision of weight reduction programs.

Weight Reduction Medications:

Note: Many Aetna benefit plans specifically exclude coverage of weight reduction medications under the pharmacy benefit and/or under the health benefits plan. The medical necessity criteria set forth below do not apply to health plans that specifically exclude services and supplies for or related to treatment of obesity or for diet or weight control. Under these plans, claims for weight loss drugs will be denied based on this exclusion.  For members whose medical policies do not exclude weight reduction medications or services and supplies for or related to weight reduction programs, Aetna covers these drugs under the medical benefit, not the pharmacy benefit. Please check benefit plan descriptions for details.

Weight reduction medications are considered medically necessary for members who have failed to lose at least one pound per week after at least 6 months on a weight loss regimen that includes a low calorie diet, increased physical activity, and behavioral therapy, and who meet either of the following selection criteria below:

1. Member has a body mass index** (BMI) greater than or equal to 30 kg/m²; or

2. Member has a BMI greater than or equal to 27 kg/m² with any of the following obesity-related risk factors considered serious enough to warrant pharmacotherapy:

   1. Hypertension (systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg on more than one occasion)

   2. Dyslipidemia:

      1. LDL cholesterol greater than or equal to 160 mg/dL, or
      2. HDL cholesterol less than 35 mg/dL, or

      3. Triglycerides greater than or equal to 400 mg/dL

   3. Coronary heart disease
   4. Type 2 diabetes mellitus

   5. Obstructive sleep apnea.

Weight reduction medications are considered experimental and investigational when these criteria are not met.

**BMI = weight (kg) ¸ [height (m)]²

The following medications have been approved by the FDA for weight reduction:

• phendimetrazine [Bontril, Melfiat, Prelu-2, etc.],
• phentermine [Ionamin, Phentride, Fastin, Obe-Nex, Oby-Trim, Pro-Fast, Adipex-P, etc.],
• diethylpropion [Tenuate],
• mazindol [Mazanor, Sanorex],
• benzphetamine [Didrex]
• sibutramine [Meridia], and
• orlistat [Xenical].

For Aetna’s clinical policy on surgical management of obesity, see CPB 157 - Obesity Surgery.

Physician Supervision of Weight Reduction Programs:

Note: Some plans exclude services and supplies for or related to treatment of obesity or for diet and weight control.

Aetna considers medically necessary physician supervision of weight reduction programs (i.e., effective, appropriate, and essential diagnostic and therapeutic services) for members who have a documented history of failure to maintain their weight at 20 % or less above ideal or at or below a BMI of 27 when the following criteria are met:

1. Member has a BMI** greater than or equal to 30 kg/m²; or

2. Member has a BMI greater than or equal to 27 and less than 30 kg/m² and one or more of the following comorbid conditions:

   1. Coronary artery disease
   2. Diabetes mellitus type 2
   3. Obstructive sleep apnea
   4. Obesity-hypoventilation syndrome (Pickwickian syndrome)
   5. Hypertension (systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg on more than one occasion)

   6. Dyslipidemia:

      • LDL cholesterol greater than or equal to 160 mg/dL; or
      • HDL cholesterol less than 35 mg/dL; or
      • Serum triglyceride levels greater than or equal to 400 mg/dL.

Physician supervision of weight reduction programs is considered experimental and investigational when these criteria are not met.

** For a simple and rapid calculation of BMI, please click below and it will take you to the Obesity Education Initiative:

BMI = weight (kg) ¸ [height (m)]²

The following physician services are considered medically necessary for the evaluation of overweight or obese individuals:

• Comprehensive history and physical examination
• Electrocardiogram (EKG) - adult
• Metabolic and chemistry profile (serum chemistries, liver tests, uric acid) (SMA 20)
• Glucose tolerance test (GTT)
• Complete blood count
• Urinalysis
• Hand x-ray for bone age -- child
• Thyroid function tests (T3, T4, TSH)
• Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
• Dexamethasone suppression test and 24-hour urinary free cortisol measures if symptoms suggest Cushing's syndrome.

Note: Office visits are considered medically necessary every two weeks for the first month, and monthly thereafter up to one year. For members with comorbid conditions or who have been prescribed weight reduction medication, weekly office visits are considered medically necessary for the first month, then monthly thereafter up to one year. More frequent office visits are considered medically necessary if the person has been prescribed a very low calorie diet (see below). Requests for office visits extending beyond one year are subject to medical review to determine whether continued physician supervision is considered medically necessary. Factors to consider in determining whether continued physician supervision is medically necessary include whether the person continues to receive weight reduction medication, whether the person is currently on a very low calorie diet, whether the person has received or will receive surgical intervention for weight control, and whether there is ongoing treatment of modifiable comorbid medical conditions.

Physician Supervision of Very Low Calorie Diets (VLCD):

For members at high or very high health risk (BMI greater than or equal to 35 or BMI greater than or equal to 30 kg/m² plus a comorbid condition) who have been prescribed a very low calorie diet (VLCD) (less than 799 Kcal/day) (e.g., Optifast, Medifast), the following services are considered medically necessary for up to 16 weeks after initiation of the VLCD:

1. Weekly physician visits during the rapid weight loss phase of the VLCD, then every 2 weeks thereafter up to 16 weeks; and
2. Serum chemistries and liver function tests (SMA 20) at each physician visit; and
3. EKG after 50 lbs. of weight loss; and
4. Lipid profile at the beginning and end of the VLCD program.

Note: VLCDs extending beyond 16 weeks are subject to medical review to determine if additional services are medically necessary.

Notes: Prepackaged food supplements or substitutes and grocery items are generally excluded from coverage under most benefit plans.  Diagnostic tests required by, for or as a result of non-covered weight loss programs (e.g., those not requiring physician supervision) are not covered.  Please check benefit plan descriptions for details.

Excluded Services:

The following interventions are considered experimental and investigational for weight reduction:

• Human chorionic gonadotropin (HCG) or vitamin injections for weight loss
• Acupuncture for weight loss
• Psychiatric treatment for weight loss, including behavior modification, biofeedback, counseling (individual or group), hypnosis, etc.
• Whole body calorimetry (diagnostic study)
• Dual-energy X-ray (DEXA) body composition (diagnostic study)
• Body plethysmography (diagnostic study)
• Gastric electrical stimulation (see CPB 678 - Gastric Pacing and Gastric Electrical Stimulation).

Hospital confinement is considered not medically necessary for a weight reduction program.

Note: Under most benefit plans, the following services and supplies for weight reduction are specifically excluded from coverage (please check benefit plan descriptions for details)

• Rice diet or other special diet supplements (e.g., amino acid supplements, Optifast liquid protein meals, or NutriSystem pre-packaged foods), see CPB 061 - Nutritional Support
• Weight Watchers, Jenny Craig, Diet Center, Zone diet, or similar programs
• Exercise programs or use of exercise equipment.

This policy is supported by NHLBI Guidelines on Diagnosis and Management of Obesity.

Weight reduction medications should be used as an adjunct to caloric restriction, exercise, and behavioral modification, when these measures alone have not resulted in adequate weight loss. Factors influencing successful weight loss are: weight loss during dieting alone, adherence to diet, eating habits, motivation and personality.

Weight loss due to weight reduction medication use is generally temporary. In addition, the potential for development of physical dependence and addiction is high. Because of this, their use to aid in weight loss is not regarded as therapeutic, but rather involves a risk/benefit ratio, which makes it medically inappropriate in most cases.

Individuals who cannot maintain weight loss through behavioral weight loss therapy and are at risk of medical complications of obesity are an exception to this; for these persons, the risk of physical dependence or other adverse effects may present less of a risk than continued obesity. For such individuals, use of weight reduction medication may need to be chronic.

Tests with weight loss drugs have shown that initial responders tend to continue to respond, while initial non-responders are less likely to respond even with an increase in dosage. If a person does not lose 2 kg (4.4 lb) in the first four weeks after initiating therapy, the likelihood of long-term response is very low. If weight is lost in the initial 6 months of therapy or is maintained after the initial weight loss phase, this should be considered a success and the drug may be continued.

Other than orlistat (Xenical), which is approved for use in adolescents aged 12 years or older, weight reduction medications have not been proven to be safe and effective for treatment of obesity in children and adolescents.  All drugs listed in this policy except orlistat (Xenical) are contraindicated in the following conditions: hypertension, atherosclerosis, coronary artery disease, and stroke.  Orlistat (Xenical) is contraindicated in persons with chronic malabsorption syndromes and cholestasis.

Ioannides-Demos et al (2006) stated that there is limited safety and effectiveness data for amfepramone (diethylpropion) and phentermine and their approvals for the management of obesity are limited to short-term use.  Orlistat and sibutramine are the only currently approved medications for long-term management of obesity.  Although the benefit-risk profiles of sibutramine and orlistat appear positive, sibutramine continues to be monitored because of long-term safety concerns.  The safety and effectiveness of currently approved drug therapies have not been evaluated in children and elderly patient populations.

Appendix

Ideal Weight Chart:

The following indicates maximum ideal weight in shoes with one-inch heels based on body frame and height:

Ideal weights for adult men:

Ideal weights for adult women: