Stereolithographic Models and Implants
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Defines Aetna's coverage stance for stereolithographic (3D printed) anatomic models, surgical guides, and implants primarily in plastic and reconstructive surgery; affects providers submitting claims to Aetna for these services.
No material clinical or coverage changes in this revision.
Coverage Criteria for Stereolithographic Models, Guides, and Implants
Experimental/Investigational
Aetna considers the following experimental and investigational because their safety and effectiveness in improving outcomes has not been established:
These 4 specific uses are listed as experimental/investigational in the policy.
Coverage when clinically indicated and documented
Evidence supporting use of 3‑D printed implants and models is mixed; covered uses are typically when ALL of the following are met:
Based on clinical series and device clearances described
Limited or experimental applications
Situations where evidence is insufficient or uncertain:
Systematic review found limited high-quality evidence outside certain specialties
Evidence-based considerations and limitations
Evidence summarized — applicability and limitations:
See individual study metrics for deviations, QA methods, and limitations.
Examples: phantom differences ranged -0.32 to 0.13 mm; radial‑ulna mean distance -0.12 mm (range -0.57 to 0.34 mm); dental guide pooled angular ~3.08°; clinical implant deviations reported coronal/apical ~1.05 mm/1.63 mm and angular ~3.85°.
Authors consistently call for randomized or larger studies.
Example: TangoPlus stiffness differed from porcine mitral valve tissue; no standard 3D printing process across studies.
Evidence summaries (not formal coverage criteria)
Evidence summaries and applicability considerations from cited in‑vitro and cadaveric studies
Authors note in-vitro model limitations (removed artificial gingiva, smoother surfaces) and call for randomized clinical trials.
Authors recommend further investigation for C2 pedicle accuracy and testing in more representative specimens.
Aetna excludes the specific applications listed below as experimental and investigational because their safety and effectiveness in improving clinical outcomes have not been established: (1) use of three-dimensional (3D) stereolithographic models in plastic and reconstructive surgery; (2) use of 3D stereolithographic models in penile surface mold brachytherapy; (3) three-dimensional (3D) printed cranial implants; and (4) use of 3D printing of anatomic structures for pre-operative planning and other applications. These four uses are designated investigational in this policy due to insufficient evidence demonstrating improved outcomes.
Use of 3‑D printed devices for indications lacking rigorous comparative-effectiveness data and long-term outcome assessment may be considered investigational until higher-quality evidence is available. A systematic review found that most randomized controlled trials and higher-quality studies were concentrated in oral/maxillofacial and musculoskeletal fields, leaving efficacy and effectiveness undetermined for the majority of medical disciplines; consequently, applications outside well-studied areas should be treated cautiously.
The policy and cited QA program do not provide specific, quantifiable standardized quality-assurance benchmarks for medical 3D printing. The authors note that their protocols were developed from experience with a single printer and a single segmentation software vendor and that broader, multi-institutional QA data are needed before universally applicable numeric QA standards can be adopted; therefore applicability may be limited when evidence derives from only one printer or one software workflow.
Limitations of in‑vitro model studies are noted: investigators removed artificial gingiva and used master-model selection to reduce variability, which may not reproduce the effects of reflected soft tissue or the irregular bone contours encountered in live patients. These design features can affect seating and stability of stereolithographic guides and therefore limit the generalizability of in‑vitro findings to clinical practice.
Stereolithographic modeling in plastic and reconstructive surgery is considered experimental and investigational because the literature is limited to case reports and feasibility discussions and there are no prospective studies demonstrating that stereolithographic models improve outcomes in these surgical procedures.
The literature indicates that 3‑D printed parts increase procedural costs (printing and additional imaging) and, when a clinical advantage is unproven or undocumented, the additional expense may not be justified. In such situations, use of 3‑D printed components that raise costs without documented benefit may be considered not justified.
Within the provided excerpts, the document does not specify any explicit conditions labeled as 'Not Medically Necessary'; the policy excerpts instead describe investigational designations, evidence limitations, and applicability concerns without listing distinct not-medically-necessary criteria.
Coding and Regulatory Codes
| 21076-21088 | Impression and custom preparation. |
| 21100 | Application of halo type appliance for maxillofacial fixation, includes removal (separate procedure). |
| 21110 | Application of interdental fixation device for conditions other than fracture or dislocation, includes removal. |
| 21120-21196 | Repair, revision, and/or reconstruction bones of face. |
| 21206 | Osteotomy, maxilla, segmental (e.g., Wassmund or Schuchard). |
| 21210 | Graft, bone; nasal, maxillary or malar areas (includes obtaining graft). |
| 21246 | Reconstruction of mandible or maxilla, subperiosteal implant; complete. |
| 30400-30465 | Rhinoplasty. |
| 42200-42225 | Palatoplasty. |
| 76376 | 3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation. |
| 510(k) | FDA 510(k) clearance pathway referenced for OsteoFab and OssDsign cranial PSI devices |
Provider Actions, Prior Authorization, and Documentation Requirements
Prior authorization may be required for anatomic model/guide T‑codes
Use of the listed anatomic model (0559T/0560T) and anatomic guide (0561T/0562T) T-codes for indications that Aetna considers experimental/investigational may require prior authorization and are not covered for the experimental indications specified in this policy.
Prior authorization for custom 3‑D printed implants
Prior authorization may be required for custom 3‑D printed patient‑specific implants; submit documentation of medical necessity, defect size and location, and why alternatives (e.g., autologous bone grafting) are unsuitable.
- Describe the clinical need and medical necessity for a custom implant
- Specify defect dimensions and anatomical location
- Document that alternatives such as autologous bone graft are unsuitable or contraindicated
Document pre‑procedure model creation and QA steps
When models or guides are used, document imaging acquisition, all segmentation/processing steps, and QA validation of the printed model including quantitative measurement of deviations between the printed model and source data.
- Imaging modality and parameters used (e.g., CT slice thickness)
- Segmentation and file conversion workflow (DICOM → STL) and software used
- QA validation method and results (e.g., CT scan of printed model registered to original images with point‑to‑point distance calculations)
No specific prior authorization codes specified in excerpts
The policy sections provided include policy history and review dates but do not specify required prior authorization codes or explicit administrative code‑level requirements in the excerpts.
- Policy history and review dates are listed (last review 09/11/2023; effective 05/10/2002)
- No specific prior authorization code requirements are specified in the provided excerpts
Document rationale when choosing custom implant over autologous graft
If a custom printed implant is chosen instead of autologous bone grafting, document the rationale—such as donor‑site morbidity, donor availability, or defect size—that makes autologous grafting unsuitable.
- Comparison to autologous bone grafting and justification for selecting a custom implant
- Any clinical considerations (e.g., donor‑site morbidity, unavailable donor bone, defect too large)
Record planned vs achieved implant position metrics for dental guides
For stereolithographic dental guides, document planned implant positions and capture outcome metrics comparing planned versus achieved implant position (lateral, depth, and angular deviations).
- Planned coronal/apical position and angle from digital plan
- Post‑operative measurements of lateral (coronal/apical), depth, and angular deviations using metrology or imaging software
Document lack of prospective outcome evidence in plastic/reconstructive surgery
Document the state of clinical evidence when submitting for coverage—note that prospective clinical studies demonstrating improved outcomes in plastic and reconstructive surgery are lacking and this investigational designation may not be overcome solely by anecdotal reports.
- Reference that literature is limited to case reports and feasibility discussions
- Acknowledge no prospective studies proving improved plastic/reconstructive surgery outcomes
Provide device type, FDA status, and planning details
Include device and planning documentation with submissions: state the device type, FDA clearance status when applicable (e.g., OsteoFab or OssDsign 510(k) clearances), and provide imaging and virtual planning data and operative reports describing fit and intraoperative findings.
- Device description and material
- FDA regulatory status or 510(k) clearance citations when applicable
- Imaging and virtual planning files used to design the device and operative fit/assessment notes
Perform and document model validation and QA measurements
Validate printed models using both qualitative inspection and quantitative measurement—examples include scanning the printed model with high‑resolution CT and registering it to the original patient images to calculate point‑to‑point distances.
- Qualitative fit and physical inspection records
- Quantitative comparison (CT scan of printed model registered to source images; point‑by‑point distance calculations)
- Phantom‑based end‑to‑end QA comparisons when available
Include CT‑to‑STL methods and pre/post‑op measurement protocols
Document imaging and measurement methods used to create STL files (e.g., CT imaging parameters) and any pre‑ and post‑operative measurement protocols used in studies (metrology software or image registration methods).
- CT acquisition details and slice thickness used to generate STL files
- Description of metrology or image‑registration software and measurement endpoints used for pre/post comparisons
Denial risk: experimental/investigational services
Services involving stereolithographic models, 3‑D printed cranial implants, or 3‑D printing for pre‑operative planning that are designated experimental/investigational by this policy are subject to denial.
- Policy lists use in plastic/reconstructive surgery, penile mold brachytherapy, cranial implants, and pre‑operative planning as experimental/investigational
- Such services may be denied coverage due to insufficient evidence of improved outcomes
Denial risk if clinical advantage and cost‑effectiveness not documented
Because 3‑D printing can increase costs (fabrication and additional imaging), failure to document a clear clinical advantage or cost‑effectiveness may lead to coverage denial.
- Document any demonstrated reductions in OR time, complications, or other clinical benefits to justify added costs
- Include cost comparisons to autologous or standard approaches when available
Denial risk for QA deficiencies and potential model inaccuracies
Lack of standardized QA across printers, imaging modalities, or segmentation software can produce unacceptable model inaccuracies; ensure QA procedures and validation data are submitted to mitigate this risk.
- Describe institution‑level QA processes and any phantom‑based validation performed
- Report limitations if QA relied on a single printer or single‑vendor software
No explicit administrative/coding denial triggers in excerpts
In the provided excerpts there are no explicit administrative or coding denial triggers (e.g., specific claim edits) described; however, therapeutic indications listed as investigational remain at risk for denial.
- No explicit coding/administrative denial triggers are specified in the cited sections
- Investigational indications themselves remain subject to coverage denial
No step therapy requirements described
No step therapy requirements are described in the provided policy excerpts.
- Policy does not specify any prerequisite therapies or stepwise treatment requirements
Supply device and planning documentation for authorization review
Ensure device type, FDA clearance status (when applicable), imaging and virtual planning data, and operative reports are available to support prior authorization and medical‑necessity review.
- List device brand/name and materials
- Provide any FDA 510(k) documentation or clearance references
- Attach imaging datasets and planning files used to design the implant or guide
Background and Policy Scope
Stereolithography (SLA) is an additive manufacturing process that converts DICOM imaging data (CT or MRI) into 3‑D models by laser-directed photo-polymerization of a photosensitive resin, producing stacked slices that form a physical replica. SLA bio-models are used primarily to visualize facial bony structures, assist preoperative planning, allow rehearsal of osteotomies and grafting decisions, and help surgeons appreciate three-dimensional spatial displacements prior to reconstructive procedures.
Definitions
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