Step One
Locating the applicable medical policy
Once you've flagged an implant, the next question is: what does current policy say about it? Use your organization's medical-policy resources to search by the most specific information you have:
- Device or implant name — the most direct route when the documentation names the device
- Procedure name or description — useful when the device name is absent or unclear
- Billed codes — a starting point when no better information exists, but never the final answer on their own
If your search returns nothing, that absence is itself meaningful: a technology with no policy often requires escalation for further review rather than an assumption of coverage.
Step Two
The policy sections that matter
Medical policies follow a predictable structure. Read these sections in order:
- Description / service — confirms the policy actually addresses the technology on your claim
- Policy statement — the core determination: whether the service or device is considered investigational/experimental, covered, or not covered
- When covered / when not covered — the specific clinical circumstances that change the answer
- Policy guidelines — additional criteria, definitions, and exceptions that refine the statement
- Billing / coding information — how the technology should (or should not) be reported
Practice pointer
Step Three
Connecting claim facts to policy language
Determining status means mapping three things together: what the claim shows, what the device actually is, and what the policy language covers. Ask yourself:
- Does the policy's description match the device and procedure documented on this claim?
- Do the clinical circumstances (diagnosis, prior treatment, setting) fit the policy's covered or not-covered criteria?
- Does the policy specifically name this application as investigational/experimental?
When the claim information and the policy language align clearly, document the determination with the policy reference. When they don't align — unclear documentation, borderline criteria, or no matching policy — escalate rather than guess.
Policy by Policy
The policies you will apply most often
Each policy below is addressed separately, with the codes, products, and criteria that belong to it. Match the claim to the right policy first — then read that policy's own criteria rather than carrying assumptions across from another one.
Medical policy
Investigational (Experimental) Services
Blue Cross NC commercial administrative policy · origination 01/1996, last review 11/2025
What the policy says: Blue Cross NC defines "investigational" or "experimental" as the use of a service that is not recognized by the Plan as standard medical care for the condition, disease, illness or injury being treated. A service includes, but is not limited to, a diagnostic service, procedure, test, treatment, facility, equipment, drug or device. Investigational (Experimental) Services are not covered except as delineated in the Clinical Trial Services policy.
A service is investigational if any one of these criteria is met:
- It requires federal or other governmental approval and does not have unrestricted market approval from the FDA (or final approval from another regulatory body) for the specified condition — an interim approval is not a substitute
- There is insufficient or inconclusive peer-reviewed evidence to evaluate clinical effectiveness
- There is inconclusive peer-reviewed evidence that it improves health outcomes and outweighs harms or safety risks
- There is insufficient or inconclusive peer-reviewed evidence that it is as beneficial as established alternatives
- There is insufficient or inconclusive peer-reviewed evidence that, outside an investigational setting, it is as beneficial as established alternatives
How to apply it on a claim: the plan does not cover investigational, cosmetic or not medically necessary services, and will not reimburse services associated with them — so an investigational implant also affects related charges. Note the exception: a requirement in a medical policy to enroll in a patient registry does not by itself make a service investigational.
Medical policy
Medical Necessity
Blue Cross NC commercial administrative policy · origination 09/1999, last review 11/2025
What the policy says: reimbursement is provided when the criteria defining "Medical Necessity" are met and coverage is available under the member's benefit plan. All five criteria must be met:
- The service is provided for the diagnosis, treatment, cure, or relief of a health condition, illness, injury, or disease
- The service is not for experimental, investigational, or cosmetic purposes (except as allowed under N.C. G.S. 58-3-255)
- The service is necessary for and appropriate to that diagnosis, treatment, cure, or relief
- The service is within generally accepted standards of medical care in the community
- The service is not solely for the convenience of the insured, the family, or the provider
How to apply it on a claim: an investigational implant fails criterion 2, so it cannot meet medical necessity. Remember that a physician prescribing, ordering, recommending, or approving a service does not, by itself, make it medically necessary — only the member's medical condition drives the determination.
Medical policy
Orthopedic Applications of Stem Cell Therapy
Blue Cross NC commercial policy · origination 07/2010, last review 02/2026
What the policy says: Blue Cross NC currently considers mesenchymal stem cell therapy investigational for orthopedic applications. Allograft bone products containing viable stem cells — including demineralized bone matrix containing viable stem cells — are also considered investigational for orthopedic applications. Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow are considered investigational.
Codes that lead you here: 3E0V0GB, with charges reported under revenue codes 0278 or 0279. The applicable spinal fusion or other orthopedic procedure is coded separately.
Products to check against the policy: Trinity Evolution Matrix, Trinity Elite, Osteocel / Osteocel Plus, other viable cellular bone matrices, mesenchymal stem-cell-containing allograft products, and products requiring combination with autologous blood or bone marrow.
How to apply it: identify the specific product from the itemized bill, implant log, or invoice, then compare that product with the policy. Do not determine status from the ICD-10-PCS or revenue code alone.
Medical policy
Bone Morphogenetic Protein
Blue Cross NC commercial surgery policy · origination 10/2014, last review 02/2026
What the policy says: BMP is not automatically investigational. rhBMP-2 (InFUSE) may be considered medically necessary in skeletally mature individuals undergoing interbody spinal fusion when the fusion is single-level, the approach is anterior, the fusion involves vertebral bodies L2–S1 (with or without spondylolisthesis of no more than grade 1 / 25% displacement), and use of autograft is not feasible. It may also be considered medically necessary for acute, open fracture of the tibial shaft when autograft is not feasible.
When it is investigational: all other indications — including spinal fusion or tibial shaft fracture where autograft is feasible, craniomaxillofacial surgery, and any non-FDA- approved ("off label") use. Posterior (PLIF), posterolateral, and lateral approaches are not FDA-approved and are considered investigational, as is multilevel (more than single-level) fusion.
Regulatory context: FDA issued a 2008 public health notification on life-threatening complications with rhBMP in cervical spine fusion; safety and efficacy in the cervical spine have not been demonstrated and these products are not FDA-approved for that use. rhBMP-7 (OP-1) is no longer marketed in the United States.
Codes that lead you here: 3E0V0GB (introduction of recombinant BMP into bones, open approach), plus revenue codes 0278 and 0279. CPT 20930 was revised in 2011 to include BMP-type materials used in spine surgery. Review the underlying fusion or orthopedic procedure too, since BMP may be bundled into the overall procedure or implant charges.
How to apply it: establish the specific BMP product, the operative approach, the number of fusion levels, the anatomical level, the indication, and whether autograft was feasible — then match each of those facts to the four covered criteria above. Miss one and the use is investigational.
Medical policy
Cardiac valve replacement — aortic and pulmonary
Device-specific policy plus FDA-approved indication
How status is decided: these codes describe the valve substitute and the approach, not whether the device is covered. Status turns on the specific valve, its FDA approval/clearance, and whether the patient's use matches the approved indication and policy criteria.
Codes that lead you here: aortic 02RF07Z–02RF0KZ (open), 02RF37Z–02RF3KZ (percutaneous), 02RF47Z–02RF4KZ (percutaneous endoscopic); pulmonary 02RH07Z–02RH0KZ (open), 02RH37Z–02RH3KZ (percutaneous), 02RH47Z–02RH4KZ (percutaneous endoscopic).
How to apply it: confirm the valve manufacturer and model, whether placement was surgical or transcatheter, and the implantation site — then locate the current policy for that specific device and compare the documented indication with the FDA-approved indication.
Medical policy
Percutaneous balloon valvuloplasty
Distinguishing valvuloplasty from transcatheter valve implantation
What to determine: whether the claim represents balloon valvuloplasty alone or is associated with implantation of a transcatheter valve or device. These are distinct procedures with different policy paths.
Codes that lead you here: 027F3ZZ / 027F4ZZ (aortic), 027G3ZZ / 027G4ZZ (mitral), 027H3ZZ / 027H4ZZ (pulmonary), 027J3ZZ / 027J4ZZ (tricuspid).
How to apply it: read the operative report and implant documentation to identify the actual device used. A claim involving a transcatheter valve should not be treated as investigational merely because a valvuloplasty code is present.
Across every policy
Avoid the Trap
Never rely on a code or device name alone
The most common error at this step is assuming status from familiarity: recognizing a code or a brand name and skipping the policy check. Codes describe how something was billed, not whether it's covered — and established devices are sometimes used in investigational ways.
Key takeaway
Sources
Policies cited in this lesson
Always open the live policy before making a determination — the criteria below are current as of the review dates shown, and investigational status changes as evidence evolves.
- 1.Investigational (Experimental) Services — Blue Cross NC commercial medical policyDefinition of investigational/experimental and the five criteria. Last review 11/2025.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/administrative/updates/investigational-experimental-services
- 2.Medical Necessity — Blue Cross NC commercial medical policyThe five medical-necessity criteria that every covered service must meet. Last review 11/2025.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/administrative/updates/medical-necessity
- 3.Bone Morphogenetic Protein — Blue Cross NC commercial medical policyCovered rhBMP-2 criteria and investigational indications. Last review 02/2026.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/surgery/updates/bone-morphogenetic-protein
- 4.Orthopedic Applications of Stem Cell Therapy — Blue Cross NC commercial medical policyMesenchymal stem cell therapy and viable-cell allograft products. Last review 02/2026.https://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/other-treatments/updates/orthopedic-applications-of-stem-cell-therapy
- 5.FDA — Implants and ProstheticsDevice approval and clearance pathways used to verify FDA status and approved indications.https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
Knowledge Check
Test your understanding
Five case-based claim scenarios. For each one, decide which medical policy applies and what that policy says about the implant's investigational/experimental status. The mastery goal is 80% — at least 4 of 5 correct.
Case scenario
Claim 1 — Lumbar spine admission. The itemized bill shows revenue code 0278 with the charge description "INFUSE BONE GRAFT KIT," and the operative note documents a single-level posterior lumbar interbody fusion for degenerative disc disease. You locate the Bone Morphogenetic Protein policy.
Applying that policy, what is the status of the Infuse bone graft for this use?