IE

Implant Review Essentials

High-Dollar Claim Review · Nurse Education

Quick Reference

Policy Lookup by Implant Type

Find the implant in front of you, read the governing Blue Cross NC policy and its key determination rule, then confirm the language on the live policy page before you write your note.

Bone morphogenetic protein (BMP)

INFUSE / rhBMP-2, BMP-containing bone graft substitutes

Key rule
Covered only for the specific FDA-approved indications named in the policy (certain single-level anterior lumbar interbody fusion with an approved cage, acute open tibial shaft fractures, and specified oral-maxillofacial uses). Any other application — including cervical spine use — is considered investigational.
What to do
Off-label or off-criteria use: flag as investigational, cite the "not covered" section, and escalate.

Stem cell / cellular bone products

Cellular bone matrix, stem-cell bone allografts, often billed under rev 0278/0279

Key rule
Orthopedic applications of stem cell therapy are considered investigational; these products do not carry FDA approval for orthopedic use.
What to do
Flag the line, name the policy and review date, and escalate — associated services are also not reimbursed.

Cardiac valve replacement devices

TAVR/SAVR aortic valves, transcatheter pulmonary valves

Key rule
An FDA-approved valve used within its approved indication and meeting the policy's patient-selection criteria is covered. Use outside the approved indication or outside policy criteria is investigational.
What to do
A questionable procedure code alone is not a denial — verify device, indication, and policy criteria first.

Balloon valvuloplasty devices

Percutaneous balloon valvuloplasty of aortic, mitral, or pulmonary valves

Key rule
Covered when documented indications match the policy's criteria; uses outside those criteria require review against the Investigational (Experimental) Services policy.
What to do
Confirm the documented indication in the operative report before making a determination.

IDE clinical-trial devices

Devices implanted under an FDA Investigational Device Exemption

Key rule
A device under an IDE is by definition investigational; the device and the services associated with it are not reimbursed.
What to do
Flag the device line and the associated services, document the IDE reference from the record, and escalate.

HDE / humanitarian-use devices

Transcatheter pulmonary valves and other rare-condition devices approved via HDE

Key rule
An HDE approval demonstrates probable benefit rather than the effectiveness standard of a PMA, so HDE devices generally require review as potentially investigational unless the policy addresses them specifically.
What to do
Escalate for additional review with the FDA pathway documented.

Any implant with no specific policy

New or unnamed products, unfamiliar manufacturers, unclear implant logs

Key rule
When no product-specific policy exists, apply the investigational criteria and the five medical-necessity criteria against the documented indication and FDA status.
What to do
If the record can't establish device identity or FDA status, request documentation before determining status.

Reminder

A questionable code is a review trigger, not an automatic denial. Your determination rests on the product, the documented indication, and the current policy — always confirm the policy version is current.

Primary sources

  1. 1.FDA — Implants and ProstheticsConfirm approval or clearance pathway and the approved indication.https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
  2. 2.Investigational (Experimental) Services — Blue Cross NChttps://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/administrative/updates/investigational-experimental-services
  3. 3.Medical Necessity — Blue Cross NChttps://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/administrative/updates/medical-necessity
  4. 4.Bone Morphogenetic Protein — Blue Cross NChttps://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/surgery/updates/bone-morphogenetic-protein
  5. 5.Orthopedic Applications of Stem Cell Therapy — Blue Cross NChttps://www.bcbsnc.com/providers/policies-guidelines-codes/commercial/other-treatments/updates/orthopedic-applications-of-stem-cell-therapy