ATLANTA, Oct. 6, 2020 /PRNewswire/ -- MedShape, Inc., the industry leader in orthopedic devices using advanced functional materials, today announced 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. MedShape's DynaNail® TTC Fusion System and DynaNail Mini® Fusion System are the only devices approved for use under the new code, differentiating them from other internal fixation systems. The ICD-10 code went into effect on October 1st and is listed as 0SG (lower joint fusions) and 0RG (upper joint fusions) with "Device" option 3 – "Internal Fixation Device, Sustained Compression."
Previously, no ICD-10-PCS code existed to specifically describe fusion procedures using internal fixation devices that could sustain compression post-surgery. Instead, codes mainly covered traditional static devices that apply compression during surgery but lose compression in response to any mechanical changes in the biological or mechanical environment that occur during bone healing, such as bone resorption. These changes can be especially prevalent in challenging patient populations (i.e. diabetics, smokers, etc.) where high non-union rates and frequent case complications have been reported. 1-2
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.3-5
Given this data and background, CMS acknowledged this past June 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. 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.
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."
The DynaNail TTC Fusion System and DynaNail Mini Fusion System are both available for full commercial use in the United States.
About MedShape, Inc.
MedShape, Inc. is a privately held medical device company developing and commercializing medical devices that use patented, advanced material technologies to address the demand for improved joint fusion, soft tissue repair and fracture fixation in foot and ankle surgeries. For more information, visit www.medshape.com.
DynaNail and DynaNail Mini are registered trademarks of MedShape, Inc.
1 Jeng CL, Campbell JT, Yang EY, Cerrato RA, Myerson MS. Tibiotalocalcaneal Arthrodesis With Bulk Femoral Head Allograft For Salvage Of Large Defects In The Ankle. Foot Ankle Int, 2013. 34(9):1256-66.
2 Bussewitz B, DeVries GJ, Dujela M, McAlister J, Hyer CF, Berlet GC. Retrograde Intramedullary Nail With Femoral Head Allograft for Large Deficit Tibiotalocalcaneal Arthrodesis. Foot Ankle Int, 2014. 35(7): 706-11.
3 Steele JR, Easley ME, Nunley JA, Adams SB, et al. Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails. Foot & Ankle Spec, 2020. 13(3): 193-200.
4 Ford SE, Kwon JY, Ellington K. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. J Foot Ankle Surg, 2019. 58(2): 266-272.
5 Dupont KM, Shibuya N, Bariteau JT. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails – Mechanobiological Background and Evolution of Compressive Technology. Global J of Orthopedics Research, 2019. 1(5): 1-8.
Kristel Rodriguez Peacock
SOURCE MedShape, Inc.