The future of prosthetics just keeps getting better: for the first time, a 3D printed upper-limb bionic arm receives the Pricing, Data Analysis and Coding (PDAC) approval. The Hero Arm™ is a popular below-elbow myoelectric device that uses a soft and ventilated 3D printed liner, with 3D printed frames, and multi-grip hand.

Now that the Hero Hand has received official PDAC Approval for code L6880, clinicians across the US can fit Hero Arms and bill payers with confidence.
This is a significant milestone for the technology, as 3D printing becomes a mainstream manufacturing method for custom prosthetic devices. It is also a move towards increasing accessibility of multi-grip devices. If you’re a clinician, see our reimbursement code table here:

Open Bionics believes that 3D printing is quickly becoming a tool that clinicians utilize to not only lower clinical costs, but also create more comfortable liners and sockets for upper-limb amputees – a concept now proved successful. The ease of 3D scanning and printing means that more clinicians can serve upper-limb patients outside of specialist upper-limb clinics.

Why is PDAC Approval important?

According to Joel Gibbard, CEO of Open Bionics, “PDAC Approval enables prosthetists to bill the Hero Hand with confidence that they’re using the correct coding to receive the appropriate reimbursement. We know that without PDAC approval, some patients have faced a tough fight to get health insurance to fund their Hero Arms so this is a huge step forward.”

Gaining PDAC approval removes ambiguity around insurance claims, which should help patients who have eligible benefits to receive Hero Arms via their insurance providers, making the Hero Arm even more accessible for the people that need it. PDAC approval also derisks the chance of clinicians doing work without compensation.”

Seeking PDAC Approval is a voluntary process and is just one of the ways Open Bionics is investing in clinical partners in the United States to make delivering upper limb prosthetics easier and more efficient.

“This is a fantastic milestone for Open Bionics and the technology because it proves to insurance companies that a light-weight 3D printed device is certified, along with other multi-grip hands. It also comes right at the moment Open Bionics has launched the upgraded Hero Arm with Bluetooth and the Sidekick app, so now users can customize their grips with support from their CPO and track their usage data,” said Open Bionics’ CPO, Elise Griset.

The PDAC contractor maintains the Durable Medical Equipment Coding System (DMECS). DMECS is an official source for Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) product code verification and assignment.

But what is PDAC and what does that mean to the limb difference community?

PDAC is a contractor to the Centers for Medicaid and Medicare Services (CMS) in the United States. Under contract to CMS, the PDAC contractor provides coding verifications for the purpose of billing Medicare. The CMS needs a way to assist suppliers and manufacturers in the proper use of the Healthcare Common Procedure Coding System (HCPCS). CMS is able to do this through the PDAC system.

PDAC plays a massive role in regionalization of DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies) claim processing. Some of what the PDAC does is provide data analysis support to the DME Unified Program Integrity Contractors (UPICs), guide manufacturers and suppliers on the proper use of HCPCS through product reviews and decisions, and assist CMS with the DMEPOS fee schedule.

Every prosthetic device when billed to insurance is classified through a single HCPC code or a series of HCPC codes. These codes define the device being provided as well as set reimbursement amounts to your prosthetist. In other words, the HCPC codes are how your prosthetist gets paid for the services and devices they provide to you.

Based on the HCPC codes selected by the prosthetist, along with prescription and supporting documentation from your prosthetist and doctor, the insurance company will decide if the prosthesis is “medically necessary”. Having PDAC approval will help to show your insurance company that the Hero Arm is approved to be used with that specific code.

So if something falls within an established HCPCS code, then why do you need PDAC approval?

Without PDAC approval, it becomes very difficult to supply Medicare patients with a product because Medicare will likely not pay for it. In fact, as of January 1, 2022, the HCPC code used for the Hero Hand (L6880) requires PDAC approval in order to be paid for/covered by CMS.

While 90% of Hero Arm patients have gone through insurance to secure funds needed to get a Hero Arm, with PDAC approval we hope it’s another step in the right direction to making the Hero Arm more accessible to people who have had insurance challenges in the past.

You yourself are even able to call your insurance company and ask if they will cover L6880. They will let you know if you have any exclusions within your policy for that specific code. If you are told insurance will not cover the costs of your Hero Arm or if you are struggling to secure funds needed, register to speak to our funding success team who will guide you through multiple options available from grant applications, to insurance expectations.