PDAC Approval for the Zeus
Aether Biomedical is proud to report that the Zeus hand is officially PDAC approved under L6880. Upon this approval, the Zeus is assigned an HCPCS code, making it eligible under the billing of Medicare. For our U.S. users, this is a major win!
One of our defining goals at Aether Biomedical is to create a bionic hand for all. A significant aspect of this goal is making our product, the Zeus, affordable and accessible to upper limb amputees worldwide.
Traditionally, myoelectric prosthetic hands were a considerable investment for users. While the pricing may be justified, certain price points made prosthetic devices such as bionic hands inaccessible to many users. In efforts to bridge the gap between users and their prosthetic hands, we made the Zeus an affordable option, thanks to developments in 3D printing and engineering.
Still, we wanted to extend the Zeus’ accessibility even further, which meant making it available across multiple continents, as well as making it compatible with major insurance providers. With this in mind, we sought to get the Zeus PDAC approval.
What is PDAC?
PDAC, which stands for Pricing Data Analysis and Coding, is the Medicare contractor for pricing, data analysis, and coding. Every medical device available must be assigned an HCPCS (Healthcare Common Procedure Coding System) code. This helps insurance providers and device manufacturers to describe medical devices so that they can be priced and distributed accurately.
PDAC is responsible for providing suppliers and manufacturers with an HCPCS code to describe their DMEPOS (Durable Medical Equipment, Prosthetic, Orthotic, or Supply) products. In doing so, the device in question can be billed to Medicare when acquired by a Medicare-qualified user.
What PDAC Approval Entails
Receiving PDAC approval is a considerable accomplishment for numerous reasons. Not only does this help our team at Aether Biomedical achieve our goal of expanding accessibility and creating a bionic hand for all, but it also proves to our users the quality and credibility of the Zeus.
To obtain PDAC approval, applicants must first submit an application for approval. This application will verify that the submitter is a valid manufacturer/distributor. Next, the applicant must provide proof of their FDA approval, ensuring that their product meets all applicable FDA requirements. Applicants must also submit a description and sample of their product, demonstrating that it is ready for distribution and approval.
With these items complete, the Zeus fulfilled a PDAC coding verification review and received PDAC approval under L6880. This code, in particular, describes the Zeus as an “electric hand, switch or myoelectric controlled, independently articulating digits, any grasp pattern or combination of grasp patterns, includes motors.”
What This Means for Users
So, how does this approval apply to our users? As mentioned above, a considerable aspect of making prosthetic limbs more accessible is making them competitive with insurance providers. In achieving PDAC approval, the Zeus is now eligible to be billed under Medicare, a government national health insurance program in the United States.
In becoming available under Medicare, the Zeus is considerably more accessible to eligible Medicare recipients, which primarily consists of people 65 or older and those with disabilities. Consequently, the Zeus is now substantially more affordable and accessible to eligible users, helping them regain any autonomy and freedom that may have been lost.
Moving forward, we hope to expand accessibility to the Zeus even further, continuing to partner with insurance providers across the globe. As we extend the reach of the Zeus, we are optimistic that all upper limb loss amputees will have the chance to become a Zeus user and reap all of the benefits it has to offer.
If you’re interested in learning more about the Zeus or becoming a Zeus user yourself, contact us.