Three-Dimensional Printed Orthopedic Implants

POLICY NUMBER

L.7.01.443

DESCRIPTION

This policy addresses orthopedic implants that are constructed by additive manufacturing, commonly known as 3-dimensional (3D) printing. Three situations are considered: 3D printing of standard-sized implants, 3D printing of patient-matched implants for individuals who have typical bone and joint anatomy, and custom 3D-printed implants for patients who have bone or joint deformity.

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. The most commonly used technologies in medical devices are powder bed fusion, stereolithography, fused filament fabrication, and liquid-based extrusion. Stereolithography systems use a vat of liquid that is cured by light. Fused filament fabrication melts a solid filament at the point of deposition, after which it solidifies, while liquid-based extrusion systems eject a liquid which then solidifies. 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 the 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). Traditional manufacturing methods are frequently used with cobalt-chromium alloys for orthopedic implants. Titanium is also used for implants, including the femoral stems and acetabular cups used for total hip arthroplasty. The manufacturing of titanium and titanium alloys with traditional production methods is more difficult. Production of complex shapes is also limited with forging, casting, or machining.

Advantages of additive manufacturing include the ability to manufacture complex structures that traditional manufacturing processes cannot, and to create devices individually matched to the patient’s anatomy. Additive manufacturing also allows rough or porous surface textures that promote bone in-growth, and some have proposed that fully porous implants may reduce bone resorption around the implant. Three-dimensional printed models of a joint or spine can also be constructed to plan and practice complex surgeries. In addition to increased design flexibility and potential improvements in function, additive manufacturing wastes less raw materials and may reduce processing costs.

Additive manufacturing may, however, introduce variability into the manufacturing process. A number of factors affect the production of patient-matched orthopedic implants. One factor is whether the device is based on a standard template or custom-designed. Another is if the design could be affected by image quality, rigidity of anatomic structures, or clarity of anatomic landmarks. Some patient-matched devices are based on a standard-sized template with specific features modified within a defined design or performance envelope. Patient-matched devices that follow the patient anatomy more precisely are more vulnerable to design errors.

Manufacturing processes that occur after printing can also affect device performance and material properties. Postprocessing may include removal of manufacturing residues, heat treatments, and final machining and polishing when needed and where surfaces are accessible. For devices made with additive manufacturing, the U.S. Food and Drug Administration (FDA) recommends process validation, revalidation if there are any changes to the device or process, and mechanical device testing in a manner similar to testing of devices made with a traditional manufacturing method. Three-dimensional printing of orthopedic implants at a central facility permits the manufacturer to regulate quality, biocompatibility of materials, and sterility.

In 2017, the FDA published guidance for industry and technical considerations for 3D printed medical devices. The recommendations in this guidance are intended to supplement any device-specific recommendations and represent the FDA’s initial thinking and recommendations. The guidance does not apply to 3D printing at the point-of-care.

The FDA expects “that AM [additive manufacturing] devices will follow the same regulatory requirements and submission expectations as the classification and/or regulation to which a non-AM device of the same type is subject.” The required information, characterization, and testing will depend on a variety of factors, such as whether it is an implant or instrument, and whether it is available in standard sizes or is patient-matched.

The FDA has noted that although patient-matched devices are sometimes referred to as customized devices, they are not custom devices meeting custom device exemption requirements under the U.S. Federal Food, Drug, and Cosmetic Act unless they comply with all of the criteria of section 520(b). The FDA published guidance for industry and on the custom device exemption act in 2014. Custom devices are those created or modified to comply with the order of an individual physician or dentist, do not exceed 5 units per year, and are reported by the manufacturer to the FDA for devices manufactured and distributed under section 520(b) of the Food, Drug, and Cosmetic Act.

Under Section 520(b) of the Food, Drug, and Cosmetic Act, custom devices are exempt from premarket approval (PMA) requirements and conformance to mandatory performance standards.

“A device not covered by an existing marketing approval would require either a PMA or a valid exemption from the requirements to obtain PMA approval in order to be introduced into interstate commerce. Examples of potential valid exemptions or alternatives from the PMA requirement include: (1) establishing the substantial equivalence of the new device to a valid predicate device, (2) approval of an Investigational Device Exemption (IDE) or (3) meeting all custom device exemption requirements.”

“Custom Devices are not exempt from any other requirements, including, but not limited to, the Quality System Regulation, including Design Controls (21 CFR Part 820); Medical Device Reporting (21 CFR Part 803); Labeling (21 CFR Part 801); Corrections and Removals (21 CFR Part 806); and Registration and Listing (21 CFR Part 807).”

A custom device may not be marketed to the general public.

The FDA has also noted that most patient-matched devices will fall within the existing regulatory pathway for that device type. In addition to standard labeling, specific labeling information is recommended for AM devices that are patient-matched. FDA has stated that “modifications to a 510(k)-cleared device that maintain its original intended use and could be clinically studied do not appropriately qualify as a custom device.”

A large number of titanium spinal interbody implants with increased roughness and porosity than traditional designs have received marketing clearance by the FDA through the 510(k) process. They have a biomechanical stiffness similar to polyetheretherketone cages and less than solid titanium. Some examples of 3D interbody implants include:

• Cascadia™ Cervical and Cascadia ™AN Lordotic Oblique Interbody Systems (K2M)

• CONDUIT (DePuy Synthes)

• EIT (Emerging Implant Technologies)

• Fortilink IBF system (RTI Surgical)

• Foundation 3D (CoreLink)

• IB3D (Medicrea)

• Modulus XLIF (NuVasive)

• NanoHive interbodies (HD Lifesciences)

• Spira-C (Camber)

• Tirbolox (Captiva Spine)

• Tritanium (Stryker)

• IB3D (Medicrea)

A porous 3D printed titanium implant for minimally invasive sacroiliac joint fusion has received 510(k) clearance.

• iFuse 3D (SI Bone).

Patient matched knee implants include:

• ConforMIS iTotal® Cruciate Retaining Knee Replacement System (ConforMIS)

• ConforMIS iTotal® Posterior Stabilized Knee Replacement System (ConforMIS)

• ConforMIS iUni® Unicondylar Knee Replacement System (ConforMIS)

• ConforMIS iTotal Hip system (ConforMIS).

POLICY

Custom 3D printed implants for patients with bone or joint deformity may be considered medically necessary when the devices are produced at a central manufacturing facility and meet FDA custom device exemption requirements.

Three-dimensional (3D) printed orthopedic implants that have a design that is approved or cleared by the Food and Drug Administration (FDA) and produced in standard sizes for patients with typical bone and joint anatomy are considered investigational.

Patient-matched 3D printed implants that are based on non-standard shapes and sizes for patients with typical bone and joint anatomy and do not qualify as custom devices according to FDA custom device exemption requirements are considered investigational.

Three-dimensional printed orthopedic implants produced outside of FDA-regulated manufacturing facilities are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

This policy does not address custom mandible or maxillofacial implants.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/01/2019: New policy added. Approved by Medical Policy Advisory Committee.

08/19/2020: Policy description updated regarding examples of 3D interbody implants. Policy statements unchanged.

07/24/2023: Policy updated to change the medical policy number from "A.7.01.161" to "L.7.01.443." Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/25/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.161

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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