DynaNail® Becomes First Sustained Compression Internal Fixation Device to Gain CMS Code

NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. This new classification will enable healthcare providers and payers to selectively track the utilization, outcomes and healthcare costs associated with this unique class of NiTiNOL compression technology.

Background

MedShape, Inc., the industry leader in orthopedic devices using advanced functional materials, tells us the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10-PCS code for a sustained compression internal fixation device in both lower and upper extremity joint fusion procedures. Previously, no code existed to specifically describe fusion procedures using internal fixation devices that could sustain compression post-surgery. The DynaNail® TTC Fusion System and DynaNail Mini® Fusion System are therefore the only devices approved for use under the new code, differentiating them from other internal fixation systems.

Unlike traditional static devices, the DynaNail and DynaNail Mini offer sustained compression through an internal nickel titanium (NiTiNOL) Compressive Element that can adapt and respond to bone resorption and other changes during bone healing. These devices also provide immediate dynamization and have shown to effectively load-share with the surrounding bones; whereas, static devices are overly rigid and can stress shield the bones, potentially leading to their fatigue failure. A strong body of peer-reviewed, published data has shown that patients treated with DynaNail achieve higher fusion rates and faster time to fusion compared to traditional internal fixation devices, despite being used in challenging patient populations with more risk factors for non-union.

Given this data and background, CMS acknowledged that the DynaNail and DynaNail Mini were differentiated and offered distinct clinical benefits compared with other internal fusion devices and thus, should be covered under the new ICD-10-PCS code.

Company comments

According to MedShape’s Director of Clinical Research, Kenneth Dupont, Ph.D., “The addition of these codes to the ICD-10-PCS listings suggests that CMS agrees with the published clinical literature – when it comes to DynaNail, a nail is not a nail is not a nail. These codes should allow easier tracking of DynaNail and DynaNail Mini cases, along with providing evidence to hospitals and surgery centers that DynaNail and DynaNail Mini are in fact differentiated technologies.”

Source: MedShape, Inc.

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