BionIT Labs is pleased to announce that Adam’s Hand got PDAC approval under code L6880, making it eligible for reimbursement through Medicare and Medicaid! This achievement marks a significant milestone as Adam’s Hand got PDAC approval, enhancing its accessibility to more individuals.
What is PDAC Approval?
PDAC stands for Pricing, Data Analysis, and Coding, and it works as a Medicare contractor within the US healthcare system.
PDAC’s main responsibility is to review and assign HCPCS (Healthcare Common Procedure Coding System) codes to medical devices – which are crucial for the precise description, pricing, and distribution of medical devices.
PDAC provides suppliers and manufacturers with HCPCS codes to accurately describe their DMEPOS (Durable Medical Equipment, Prosthetic, Orthotic, or Supply) products.
To obtain PDAC approval, applicants must:
- Submit an application verifying their status as a legitimate manufacturer or distributor.
- Provide evidence of FDA approval to meet all relevant FDA (Food and Drug Administration) requirements.
- Furnish a product description and sample demonstrating readiness for distribution and approval.
After completing these steps, Adam’s Hand underwent a successful PDAC coding review and obtained approval under code L6880.
This code specifically identifies the Adam’s Hand as an “electric hand, switch or myoelectric controlled, with independently articulating digits capable of any grasp pattern or combination thereof, including motors’’.
Delving into this topic is crucial for end-users to benefit from improved accessibility to these devices through the reimbursement process. This is also essential for manufacturers, suppliers, and healthcare providers aiming to distribute their products in the US market, which is the largest one for the industry and it is anticipated to grow due to an increase in accidental injuries and trauma cases.
The PDAC approval process ensures that medical devices are accurately classified, coded, and ultimately reimbursed. Failing to navigate this process effectively can pose significant barriers to market entry and patient access.
Let’s discover the details!
Get Adam's Hand through Medicare and Medicaid reimbursement!
Since Adam’s Hand got PDAC approval, this great news has opened new horizons for our worldwide mission, “Turning Disabilities Into New Possibilities“. It is now becoming more real in the US market.
After successfully launching Adam’s Hand in the European market, the next pivotal stride for our Bionic Revolution is to empower people with limb differences all across the United States. With PDAC approval, we ensure our device becomes more accessible to many in a vast country such as the US, which currently covers more than half of the global market.
The revolutionary mechanism behind Adam’s Hand, our “Fully-Adaptive Grip Technology”, allows users to control the device quickly and intuitively using only two muscle impulses for opening and closing. In this way, the fingers automatically adapt to the shape and size of grasped objects. This system also allows it to absorb external stresses, making the Adam’s Hand exceptionally durable.
The AI pattern-recognition system and the associated calibration procedure via the MyoLogic and MyoLogic Pro apps further simplifies the use of the device, so that the end-user can benefit from an easy-to-use and durable bionic hand featuring a human-like grasping behavior.
The Adam’s Hand also features a water- and dust-proof design with the Adam’s Skin glove. Several other unique aspects, such as intuitive thumb rotation, numerous available settings, and the AI calibration procedure via the MyoLogic and MyoLogic Pro apps, make the Adam’s Hand one of the most advanced devices supporting users in their daily lives.
Empower your daily life with top-tier technology!
PDAC approval and subsequent reimbursement processes through Medicare and Medicaid are crucial for introducing medical devices into the US market. Effectively navigating these processes enables manufacturers and suppliers to ensure their devices are accessible to those in need.
Adam’s Hand got PDAC approval, featuring our patented ‘’Fully-Adaptive Grip’’ Technology, supports users and clinicians by enhancing functionality with intuitive dexterity, unparalleled durability, and best-in-class customer support.
Proper coverage reduces financial barriers, ensuring access to advanced prostheses that promote users’ autonomy and empower them to live life to its full potential!
Are you a clinician or a end-user located in the US? Contact us here to discover more!
Would you be happy to become the first Adam’s Hand Ambassador in US? Contact us at info@bionitlabs.com.
Learn more about our technology: check now the Tech section of our Blog!
