Orthotic Solutions Receives PDAC Approval for its Lumbrella Device
Orthotic Solutions, the developer of Lumbrella™, a new class of prefabricated customizable Lumbosacral Orthosis designed to bridge the gap between traditional prefabricated bracing and custom fabricated spinal bracing, today announced that it has received Pricing, Data, Analysis and Coding (PDAC) notification of reimbursement in the United States.
Based on PDAC review and application of Durable Medical Equipment, (DME)MAC policy, the Healthcare Common Procedure Coding System (HCPCS) codes listed below should be used when billing Lumbrella for reimbursement:
HCPCS Code L0637 - lumbar-sacral orthosis customized to fit.
HCPCS Code L0650 - lumbar-sacral orthosis prefabricated off-the-shelf
Scott Hinshon, CO and Orthotic Solutions Chief Executive Officer, Founder and Inventor of Lumbrella stated, “We are pleased to have received PDAC notification that our Lumbrella device line has now been approved for reimbursement in the US market. The timing is fortuitous as we officially launch Lumbrella this week at this year’s AOPA National Assembly at booth 330.”
Hinshon continued, “We believe this product represents a disruptive entry into a very sizeable market. Lumbrella is a first-of-its-kind LSO that utilizes innovative design features and micro-adjustable Boa® components to deliver the support of a custom orthosis with the adjustability and comfort of a prefabricated LSO.”
Lumbrella’s patented technology creates a number of industry “firsts”.
The Dynamic Lumbar Panel (DLP) is a clever combination of material deformation and a micro adjustable Boa® Fit lacing system that achieves a perfectly conformed contour to fit every lumbar curve, just by turning a dial. Once set, the DLP becomes a static posturing element.
The unique design of the Inner Belt allows it to be tightened independently from the Outer Belt through the use of another Boa® Fit system. The Inner Belt is attached to the Dynamic Abdominal Panel and the combination of components acts as a true 3 Point Force system, another first.
Christian Weidner, Orthotic Solutions Chief Operating Officer added, “It’s an exciting time at Orthotic Solutions. We believe Lumbrella has the potential to serve an unmet need in the market while providing improved quality of life for patients. Importantly, the device now being reimbursable, makes it available to a broader set of potential providers and patients.”
Based on a 2015 Medicare report, there were approximately 195,000 pre-fabricated LSOs allowed with a total US market of approximately 630,000 that utilized HCPCS Codes L0637 or L0650. It is estimated that there are three or four times as many Medicare approved pre-fabricated LSOs.
The PDAC (Pricing, Data Analysis, and Coding) Contractor provides coding assistance to manufacturers to ensure proper coding of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). The PDAC publishes coding decisions based on the coding guidelines established by the Local Coverage Determinations (LCDs) and associated Policy Articles and any related Advisory Articles established by the DME MACs. All products submitted to the PDAC for a coding verification review are examined by coders and professionals following a formal, standardized process.