Three-dimensional (3D) printed implants are made by a process of additive manufacturing. Additive manufacturing uses a computer-aided process with a 3D printer to build devices one layer at a time. Orthopedic implants are frequently made with cobalt-chromium or titanium powder bed fusion, which uses an energy source such as laser or electron beam to melt or sinter a layer of metal powder onto the layer below. Additive manufacturing contrasts with traditional methods of manufacturing, which include forging (shaped by hammering or bending), casting (formed by molten metal poured into a mold), and machining (removes material to create the desired geometry). Production of complex shapes is limited with the traditional methods.
Advantages of additive manufacturing include the ability to design and manufacture a single orthopedic device customized to an individual’s anatomy. The most commonly reported indications are for revision total hip arthroplasty with severe acetabular defects, reconstruction following orthopedic tumor resection, and spinal abnormalities. These cases would require a custom process for design and manufacturing, even with traditional manufacturing methods.
Additive manufacturing is also proposed for 3D printing of standard-sized implants and patient-matched implants for individuals who have typical bone and joint anatomy. Since 3D implants are often manufactured with titanium and allow greater porosity than can be achieved with traditional manufacturing techniques, these are not currently recommended. Greater porosity is believed to facilitate bony in-growth and theoretically improve the stability of the implant; however, the effect of these devices on the adjacent bone, particularly subsidence and resorption, is unknown.
This policy does not address customized mandible or maxillofacial implants.
Custom three-dimensional (3D) printed orthopedic implants are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Three-dimensional (3D) printed orthopedic implants for the treatment of other conditions, including, but not limited to, the following is considered investigational:
Standard size implants with an FDA approved design intended for individuals with typical bone and joint anatomy
Non-standard shapes and sizes matched to an individual (patient-matched) with typical bone and joint anatomy
Implants produced outside of FDA-regulated manufacturing facilities
Three-dimensional (3D) printed orthopedic implants are considered medically appropriate if ALL of the following are met:
Treatment is indicated if ALL of the following are met:
Individual has bone or joint deformity
3D printed implant is customized to individual
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Custom implants, as defined by the FDA, are devices created or modified to comply with the order of an individual’s physician, do not exceed five units per year, and are reported by the manufacturer to the FDA. 3D printed custom devices are exempt from premarket approval requirements and conformance to mandatory performance standards. The FDA expects additive manufacturing devices will follow the same regulatory requirements and submission expectations as the classification and/or regulation to which a non-additive manufacturing device of the same type is subject.
BlueCross BlueShield Association. Evidence Positioning System. (8:2019). Three-dimensional printed orthopedic implants. Retrieved August 20, 2019 from https://www.evidencepositioningsystem.com/. (19 articles and/or guidelines reviewed)
Castagnini, F., Bordini, B., Stea, S., Calderoni, P.P., Masetti, C., & Busanelli, L. (2019). Highly porous titanium cup in cementless total hip arthroplasty: registry results at eight years. International Orthopaedics, 43 (8), 1815-1821. Abstract retrieved August 20, 2019 from PubMed database.
Cheng, T., Zhu, C., Wang, J., Cheng, M., Peng, X., Wang, Q., & Zhang, X. (2014). No clinical benefit of gender-specific total knee arthroplasty - a systematic review and meta-analysis of 6 randomized controlled trials. Acta Orthopaedica, 85 (4), 415-421. (Level 1 evidence)
Cher, D., Wroe, K., Reckling, W.C., & Yerby, S. (2018). Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion. Medical Devices: Evidence and Research, 11, 337-343. (Level 4 evidence)
Mao, Y., Xu, C., Xu, J., Li, H., Liu, F., Yu, D., & Zhu, A. (2015). The use of customized cages in revision total hip arthroplasty for Paprosky type III acetabular bone defects. International Orthopaedics, 39 (10), 2023-2030. Abstract retrieved June 4, 2018 from PubMed database.
U.S. Food and drug Administration. (2014). Custom device exemption. Guidance for industry and Food and Drug Administration staff. Retrieved June 4, 2018 from https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm415799.pdf.
U.S. Food and Drug Administration. (2017). Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff. Retrieved June 4, 2018 from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf.
ORIGINAL EFFECTIVE DATE: 12/30/2018
MOST RECENT REVIEW DATE: 9/26/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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