What is billing compliance? 

  • Establishing a process to identify clinical research services that can or cannot be billed to Medicare and other third-party payers.
  • Ensuring only allowed serviced are billed to Medicare and third-party payers by harmonizing relevant study documents in accordance with Medicare billing rules.
  • Coordinating with research and health care providers who are stakeholders in the process.

Medicare Clinical Trial Policy

National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) Pub 100-03 of the NCD Manual

Medicare Benefit Policy Manual, Chapter 14 Medical Devices, §50 Coverage Requirements

Category B investigational device exemptions (IDE) found in 42 CFR 405.201-405.215, 411.15, and 411.406. 

On this page:


Contact UB CRO at 716-888-4844 or

Who do we work with to complete billing?

The Clinical Research Office (CRO) will help you with pricing for items and services that are included in the protocol. The researcher then incorporates these into the billing grid.

How do we complete a billing grid / coverage analysis?

  • Please contact the CRO for costs to be included in the budget. 
  • You must complete a billing grid and coverage analysis for all studies involving clinical, billable procedures. 
    • You submit these documents to the CRO for approval.
    • Check here for templates, forms and instructions.
  • Email the completed forms to

How much time does it take to complete billing requirements?

It may take a few days depending on the study, type of services needed and location. CPT codes are needed and will improve the turnaround time.