For almost all medical devices associated with a medical or surgical procedure, there must be a corresponding CPT code. It’s simple – if there is no CPT code for those who perform the procedure to place on a billing claim to receive payment from insurers, providers will not use your medical device because they will not get paid. If the procedure associated with the medical device product is not described by any of the existing CPT codes, a new CPT code must be obtained from the American Medical Association (AMA) in order for providers to be able to place a valid CPT code on a billing claim form specifically identifying the service or procedure they performed. Obtaining a new CPT code is not an easy task. It can take up to 2 years to obtain a new CPT code. This delay is because review of your application depends on the schedule of the various committee meeting dates, which unfortunately are not synchronized as far as the processes needed for approval.
It is a common mistake for manufacturers to think that once they obtain a new CPT code after FDA approval, insurers will automatically cover and pay for their procedure. This certainly is not the case. The existence of a new CPT code must be combined with obtaining coverage from insurers and the presence of an established payment amount to providers for the procedures they perform.
The AMA’s requirements for approval of a new procedural CPT code includes:
- FDA approval for indications of use for the specific indication(s) for which the device is intended to be used
- That it truly is a new procedure
- Submission of a completed application form
- Submission of a well-designed published randomized clinical trial(s) in the peer-reviewed medical literature demonstrating scientific evidence that the procedure is safe and effective in improving clinical outcomes of patients over and above what is currently regarded as standard therapy, preferably conducted in the United States
- A strong advocacy support prior to the application from the specialty medical society that would perform this procedure grounded on evidence-based medicine
- Widespread use of the procedure by many physicians within the United States