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L.7.01.444
Vagus nerve blocking therapy for obesity consists of an implantable device that delivers electrical stimulation to branches of the vagus nerve on the anterior abdominal wall. The intent is to intermittently block signals to the intra-abdominal vagus nerve to disrupt hunger sensations and induce feelings of satiety.
Obesity
Obesity is a common condition in the United States. A large nationally representative survey conducted in 2009 to 2010 found that 36% of American adults aged 20 years and older were obese, defined as a body mass index (BMI) of 30 kg/m² or more. Fifteen percent of these adults had a BMI of 35 kg/m² or more and 6% had a BMI of 40 kg/m² or more. Among 2- to 19-year olds, 17% were obese, which is defined in this population as being at or above the 95% percentile in sex-specific BMI for corresponding age (based on the U.S. Centers for Disease Control and Prevention age growth charts).
Obesity is a major cause of premature death and is linked to serious illnesses including heart disease, type 2 diabetes, sleep apnea, osteoarthritis, and certain types of cancer. In a 2013 systematic review, being obese has been associated with higher all-cause mortality and death from cardiovascular disease. In that same year, the American Medical Association officially recognized obesity itself as a disease.
Management and Treatment
Weight loss (bariatric) surgery is a potential option for obese patients who have failed conservative treatments. Common procedures include gastric bypass surgery (open or laparoscopic approaches), sleeve gastrectomy, and laparoscopic adjustable gastric banding. Certain types of bariatric surgery have improved outcomes in select patients who choose that treatment.
Vagus nerve blocking therapy is another potential treatment option for obese patients. The vagus nerve consists of two long cranial nerves that extend from the brainstem to the viscera. The term vagus is Latin for wandering, and the vagus nerve winds through the abdomen and has branches that come into contact with the heart, lung, stomach, and other body parts. The vagus nerve plays a major role in autonomic and sympathetic nervous system functioning, including regulation of heartbeat and breathing. It is also involved in regulation of the digestive system, although its exact role in controlling appetite and feelings of satiety is unknown. Vagus nerve blocking therapy involves intermittent blocking of signals to the intra-abdominal vagus nerve, with the intent disrupting hunger sensations and inducing feelings of satiety.
In January 2015, the FDA approved a medical device specifically designed to provide vagal nerve blocking therapy for regulation of weight in obese patients. This device, the Maestro Rechargeable System, includes a neuroblocking pulse generator that is implanted subcutaneously on the thoracic sidewall and flexible leads approximately 47 cm in length that are placed on the abdominal anterior and posterior vagal nerve trunks. External components include a mobile charger, a transmit coil, a programmable microprocessor, and customized software. The system delivers high-frequency pulses of electrical current to vagus nerve trunks; therapy parameters and the treatment schedule can be customized by a clinician. Like other surgical interventions, there is the potential for adverse effects. In addition, there may be other unintended consequences of disrupting signals to a particular portion of the vagus nerve.
Stimulation of the vagus nerve via a device implanted within the carotid artery sheath has also been evaluated as a treatment for obesity and is addressed in the Vagus Nerve Stimulation medical policy. Vagus nerve stimulation is FDA-approved to treat epilepsy and depression, but not obesity.
Outcomes
To assess obesity treatments, a double-blind randomized controlled trial is optimal because these interventions require changes to patient behavior (ie, diet, exercise) that are subject to the placebo effect. Health outcomes such as mortality, cardiovascular events, and rates of type 2 diabetes would be optimal, but are difficult to use as study endpoints due to the need for a large sample size and long follow-up period. Cardiovascular risk factors, such as changes in blood pressure, glucose, and lipid levels, are good intermediate measures because they have been linked with these health outcomes and would require smaller sample sizes. Weight-loss outcomes, reported as an absolute change in weight or BMI, or as percent excess weight loss or percent BMI are acceptable intermediate outcome measures and are commonly used in obesity studies. Weight loss has been linked to improvements in cardiovascular risk factors. While no generally accepted threshold of percent excess weight loss is considered clinically significant, bariatric surgery trials generally define clinical success as at least 50% excess weight loss. The amount of weight loss is expected to be lower for other, less dramatic weight-loss interventions.
Sham controls are useful for establishing the efficacy of intervention beyond the placebo effect and for controlling other nonspecific effects of interventions including disease natural history and regression to the mean. Because there are so many existing treatment options for weight loss, if sham-controlled weight loss intervention studies are positive, trials using an active comparator, such as medication or other types of surgery, are desirable.
In January 2015, the Maestro® Rechargeable System (EnteroMedics, St. Paul, MN) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for use in adults ages 18 years and older who have a BMI of 40 to 45 kg/m² or a BMI of 35 to 39.9 kg/m² with one or more obesity-related conditions such as high blood pressure or high cholesterol and have failed at least one supervised weight management program within the past 5 years. Implantable components are incompatible with magnetic resonance imaging. Additional contraindications to use of the device include conditions such as cirrhosis of the liver, portal hypertension, clinically significant hiatal hernia, and the presence of a previously implanted medical device. FDA product code: PIM.
The commercial availability of the Maestro® System is unclear. On the FDA's Weight-Loss and Weight-Management Devices webpage (content noted as current as of 09/05/2019), the Maestro® Rechargeable System is described as "no longer marketed as of September 2018." Additionally, on the ReShape Lifesciences™ website (previously EnteroMedics), the Maestro® Rechargeable System, is not listed among their current portfolio of medical devices to treat obesity and metabolic disease. However, updates to the Maestro® Rechargeable System were noted in the FDA Premarket Approval database (P130019) subsequent to September 2018, including updates to the circuit assembly and application firmware of the mobile charger (01/25/2019) and approval of modifications to the follow-up schedule for the post-approval study protocol.
Related medical policies –
Intra-abdominal vagus nerve blocking therapy is considered investigational in all situations, including but not limited to the treatment of obesity.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
07/16/2015: Approved by Medical Policy Advisory Committee.
04/13/2016: Policy description updated. Policy statement unchanged.
06/01/2016: Policy number A.7.01.150 added.
03/01/2017: Policy title, description, and statement updated to change "vagal" to "vagus."
03/08/2018: Policy description updated regarding outcomes of obesity treatments. Policy statement unchanged.
03/25/2019: Policy description updated regarding management and treatment of obesity. Policy statement unchanged.
03/12/2020: Policy description updated regarding devices. Policy statement unchanged.
06/10/2021: Policy reviewed; no changes.
12/28/2022: Code Reference section updated to add CPT code 64999, effective 01/01/2023.
09/01/2023: Medical policy number changed from "A.7.01.150" to "L.7.01.444." Policy reviewed. Policy statement unchanged.
06/26/2024: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT codes 0312T, 0313T, 0314T, 0315T, 0316T, and 0317T.
Blue Cross and Blue Shield Association Policy # 7.01.150
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
64999 | Unlisted procedure, nervous system |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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