Spotting Implants That Need Investigational Review

High-dollar claims often include implants and devices with significant price tags. Some of these are established, covered technologies — but others are investigational or experimental, meaning their safety and effectiveness are still being studied and coverage is limited or excluded under medical policy.

Your review protects both the organization and the member: it prevents payment for unproven or non-covered technology while making sure legitimate, covered care moves forward without unnecessary delay. Everything starts with one skill — recognizing when an implant on a claim needs a closer look.

Implant information rarely appears in just one place. Train yourself to scan all four of the following elements — a cue in any one of them is enough to warrant additional review:

Device/implant terminology and the codes that require a second look. Any of these cues should prompt you to route the implant for investigational/experimental review.

The current ICD-10-PCS codes below may identify claims involving potentially investigational devices, implants, biologics, or services. Work through them by category — for each one, identify the specific product, procedure, approach, indication, and applicable medical policy.

Some potentially investigational products never appear as a distinct line item — they are bundled under allowable implant and supply revenue codes. Orthopedic biologics, bone graft, and stem cell products are the most frequent example.

High or unusual implant charges reported under these revenue codes may require review to determine the specific product used and whether applicable medical policy criteria are met. The applicable spinal fusion or other orthopedic procedure should be coded separately based on the actual procedure performed.

Examples of products requiring review

• Trinity Evolution Matrix
• Trinity Elite
• Osteocel / Osteocel Plus
• Other viable cellular bone matrices
• Mesenchymal stem-cell-containing allograft products
• Products requiring combination with autologous blood or bone marrow

FDA regulates implants and prosthetics — devices placed inside the body, or replacing a missing body part, through surgical or medical procedures. The pathway a device came to market under is one of the first facts to establish, because Blue Cross NC's Investigational (Experimental) Services policy turns in part on whether a device has unrestricted market approval from the FDA for the condition being treated. An interim step in the regulatory process is not a substitute for final or unrestricted approval.

• Premarket approval (PMA) — the most rigorous pathway, used for high-risk implants; approval is granted for specific indications only
• 510(k) clearance — the device is substantially equivalent to a legally marketed predicate device
• Humanitarian Device Exemption (HDE) — a narrow authorization for rare conditions, not full market approval
• Investigational Device Exemption (IDE) — the device is being studied in a clinical trial and is, by definition, investigational
• No FDA marketing authorization for the documented use — an off-label or unapproved application

A critical distinction: your job in this step is to identify implants that may be investigational or experimental and route them for medical-policy review — not to make the final coverage determination.

Think of yourself as the tripwire, not the judge. When you spot a cue, you document what you found and move the claim to the next step of the process. Determining coverage happens through the medical-policy review you'll learn in Lesson 2, and final determinations follow organizational policy and authority.

1. 1.FDA — Implants and ProstheticsDevice definitions, regulatory pathways, and approved indications.https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
2. 2.Investigational (Experimental) Services — Blue Cross NC commercial medical policyThe definition and criteria applied when a flagged implant is reviewed. Last review 11/2025.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/administrative/updates/investigational-experimental-services
3. 3.Orthopedic Applications of Stem Cell Therapy — Blue Cross NC commercial medical policySource for the viable cellular bone matrix and stem-cell allograft products listed above.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/other-treatments/updates/orthopedic-applications-of-stem-cell-therapy
4. 4.Bone Morphogenetic Protein — Blue Cross NC commercial medical policySource for the BMP codes and products in the code reference. Last review 02/2026.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/surgery/updates/bone-morphogenetic-protein

Following instruction, participating nurses will identify implant-related information requiring investigational/experimental review in at least 80% of five case-based claim scenarios. Work through each scenario below and select the implant-related cue(s) that should trigger investigational/experimental review. The mastery goal is 80%.