Billing for experiments with new medical devices that have not yet been approved by a health care authority is considered a form of medical fraud.

• A. It is illegal in all jurisdictions
• B. True
• C. False
• D. It is only allowed with manufacturer consent

Answer: (B)

Billing for experiments with a device that hasn’t received regulatory approval is fraudulent because it presents to patients and payers as approved, standard care when it’s not. When a device is still investigational, it can only be used within a properly regulated research framework that includes IRB approval, informed consent, and often separate research billing. Charging as if the procedure and device are approved care misleads patients and insurers about the true status of the device, exposing the provider to fraud charges and penalties. The overall idea isn’t that devices can never be used, but that any use outside approved research pathways must be clearly identified and funded through the appropriate channels; billing it as routine care is the problematic, fraudulent part.