Medicare coverage for the AspireAssist device, a form of Aspiration Therapy, is complex and lacks a simple national answer. This weight management tool is not covered universally, and the determination depends heavily on your specific plan and geographic location. Because there is no uniform national policy, coverage is highly variable. Beneficiaries must investigate their specific plan and regional rules to determine potential out-of-pocket costs.
What AspireAssist Is and How It Is Classified
The AspireAssist device is a non-surgical weight management tool that uses aspiration therapy. The system consists of an implanted A-Tube and Skin-Port, a flexible silicone tube placed into the stomach endoscopically and connected to a port on the patient’s abdomen. After eating, the patient attaches an external connector to the port, allowing up to 30% of the stomach contents to be drained by gravity.
The Food and Drug Administration (FDA) approved this device for adults aged 22 or older with a Body Mass Index (BMI) between 35 and 55. It is intended for those who have been unable to achieve weight loss through non-surgical methods. The system requires long-term use alongside comprehensive lifestyle therapy and medical monitoring. The device is classified as Durable Medical Equipment (DME) or a procedure requiring implantation, placing its potential coverage under Medicare Part B.
Traditional Medicare Coverage Part A and Part B
Traditional Medicare (Parts A and B) has not issued a National Coverage Determination (NCD) for the AspireAssist device. An NCD is a nationwide policy from the Centers for Medicare & Medicaid Services (CMS) that dictates coverage. Since a national policy is absent, the coverage decision is delegated to the regional level.
If coverage is granted, it falls under Medicare Part B as either a prosthetic device or durable medical equipment, along with the related implantation procedure. The ultimate decision rests with the Medicare Administrative Contractors (MACs) who manage claims in specific geographic regions. MACs issue Local Coverage Determinations (LCDs) to define which items and services are considered “reasonable and necessary” in their area.
Reliance on LCDs means coverage can vary significantly; a beneficiary in one state may have coverage while a neighbor served by a different MAC may not. MACs typically look for criteria such as a specific BMI threshold, a documented history of failed supervised weight loss attempts, and the presence of obesity-related co-morbidities. Beneficiaries must contact their specific MAC or search the Medicare Coverage Database to determine if a relevant LCD exists in their jurisdiction.
Coverage Through Medicare Advantage Part C
Medicare Advantage (Part C) plans are offered by private insurance companies approved by Medicare and serve as an alternative to Traditional Medicare. Part C plans must cover at least everything Original Medicare (Parts A and B) covers, but they often have additional flexibility. This flexibility can impact coverage for items like AspireAssist, which lack an NCD.
A Part C plan may choose to cover AspireAssist even if the local MAC has not issued a favorable LCD under Part B. Conversely, the private plan may apply its own utilization management rules. In the absence of specific coverage guidance, Part C plans must make their own medical necessity determinations based on objective, evidence-based rationales.
These private plans almost always require a rigorous prior authorization process to ensure the therapy meets their specific medical necessity guidelines. Because coverage varies significantly from one plan to the next, beneficiaries should contact their Part C plan administrator directly. General rules for other plans will not accurately reflect an individual’s coverage.
Patient Costs and Prior Authorization Requirements
Assuming coverage is approved, the patient remains responsible for a portion of the costs, which vary based on the type of Medicare plan. For beneficiaries with Traditional Medicare Part B, the standard responsibility is 20% of the Medicare-approved amount for the device and related procedures after the annual Part B deductible is met. Since the device and procedure cost can be substantial, this 20% coinsurance may result in significant out-of-pocket expenses.
Costs associated with AspireAssist include the initial device, implantation procedure, necessary follow-up care, and replacement parts. For those with a Medicare Advantage Part C plan, financial liability is structured through copayments and coinsurance determined by the individual plan. While these costs vary widely, the overall annual out-of-pocket maximum is usually capped.
Obtaining prior authorization is absolutely necessary, regardless of whether coverage is through Traditional Medicare or a Part C plan. Prior authorization is a required administrative step before the implantation is performed. Proceeding without this authorization may result in the claim being entirely denied, leaving the patient financially liable for the full cost.