The AspireAssist device is a weight management tool that employs aspiration therapy. This system involves a gastrostomy tube surgically placed into the stomach, which connects to a skin-port on the abdomen. Approximately 20 to 30 minutes after eating a meal, the patient connects an external device to this port to drain about 30% of the stomach contents. This process reduces calorie absorption and is intended for long-term use, combined with a comprehensive lifestyle program and continuous medical monitoring.
Medicare’s Coverage Stance on AspireAssist
Medicare does not cover the AspireAssist device. As of current policy, the Centers for Medicare and Medicaid Services (CMS) has not issued a favorable National Coverage Determination (NCD) for the equipment. Medicare often classifies such novel devices as experimental or investigational, leading to their exclusion from payment.
This exclusion applies to Original Medicare (Part A and Part B), as well as most Medicare Advantage plans (Part C). While Medicare Advantage plans can offer additional benefits, they must adhere to the fundamental coverage rules of Original Medicare. Without a positive NCD or a supporting Local Coverage Determination (LCD) from a regional contractor, the device is considered a non-covered service under Part B.
Medicare Policy for Novel Weight Loss Devices
Most medical devices and procedures intended for weight loss are subjected to rigorous review under Medicare Part B, which covers services like Durable Medical Equipment (DME) and outpatient procedures. Devices like AspireAssist often do not satisfy the criteria for DME, which requires equipment to be medically necessary, durable, and used in the home. Medicare policy also distinguishes between treatments for obesity itself and treatments for conditions caused by obesity.
Original Medicare does not cover services whose primary purpose is solely weight reduction. Coverage is granted only when the treatment addresses a recognized obesity-related comorbidity, such as diabetes or sleep apnea. For a device to receive coverage, the manufacturer must provide substantial evidence that the treatment is effective and not experimental, often requiring years of data to achieve a positive NCD. Although the AspireAssist device is FDA-approved for patients with a Body Mass Index (BMI) of 35 to 55 who have failed other non-surgical therapies, it is still viewed as a non-surgical obesity treatment lacking the necessary long-term evidence for routine Medicare coverage.
Medicare Coverage for Traditional Bariatric Surgery
Medicare provides coverage for several established bariatric surgeries. These procedures include the Roux-en-Y Gastric Bypass, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Adjustable Gastric Banding. Coverage for these surgical alternatives is not automatic and is subject to strict eligibility criteria established by CMS.
To qualify for coverage, a patient must have a BMI of 35 or greater. Additionally, the patient must have at least one comorbidity related to their obesity, such as type 2 diabetes, severe hypertension, or obstructive sleep apnea. The purpose of the surgery must be to treat these associated medical conditions, not just to reduce weight.
A further requirement is that the patient must provide documentation proving they have been unsuccessful with previous medical treatment for obesity. This often involves evidence of participation in a medically supervised weight loss program that failed to achieve or maintain a healthy weight.