All About Billing & Coding LLC

Are you curious about the billing side of clinical trials? Are you a coder or biller that wants to know if there is work for you in this field? 

Author: Felicia Knox, CPC, CPB

As a coder and biller, I knew about medical coders and billing jobs in medical practices and hospitals. I always assumed it was just the coding of office visits, labs, and procedures that the patient had performed on their service date. I have been coding and billing for over ten years, and I have never heard of research billing until I joined Atrium Health in 2016. My coding and billing experience meet a whole new level. In the July 2020 Healthcare Magazine Issue with AAPC, I discuss how medical coders have a place with clinical trials.

This experience has been one of the best moments in medical coding and billing experience, and I hope to spread the word more to the medical coders and billers to let them know, and I hope someone will want to explore this area of healthcare as well. 

Healthcare is changing rapidly. New technology and drugs are being developed daily to improve the health and quality of life for many people worldwide. Clinical trials offer patients a chance to try the latest technology or medication to improve their health and quality of life. 

What is Coverage Analysis?

A Coverage Analysis is a document that identifies all clinical items or services that may or will be performed with a particular clinical trial.

Coverage Analysis identifies the financially responsible party, such as the patient, the trial sponsor, other funding sources, or a third-party payor. 

Coverage Analysis (CA) include reviewing clinical trial documents, Medicare’s Clinical Trial Policy (NCD 310.1), Medicare Benefit Policy Manual, National, and Local Coverage Determinations, and Medicare Claims Processing Manual and the disease’s conventional care guidelines.

All clinical trials should have a coverage analysis performed to ensure compliance with clinical trial billing.

As a coder, you would code the procedures, tests, exams, and labs required in the schedule of events with the proper CPT® and HCPCS Level II codes. With this information, you would document all items paid by the sponsor and analyze the remaining things as routine care or non-billable services. 

Non-compliant billing in a research study can carry severe penalties and civil and criminal actions against the provider and hospital.