Protocols, and their amendments, frequently involve billables and require careful attention to ensure proper documentation, communication, and adherence to relevant regulations and policies. These changes can impact the budget, funding, and overall study design, and may require a Coverage Analysis (CA). A Coverage Analysis is a process of determining how each billable item and service should be billed helping ensure compliance with Medicare and other payer guidelines.
If you have an initial protocol, or an amendment, and are unsure if a Coverage Analysis (CA) or update is needed, the Woodruff Industry Sponsored Clinical trials (WISC) and Office for Clinical Research (OCR) teams provide Courtesy Reviews. A Courtesy Review involves an assessment of the current protocol version for new studies, and all protocol versions since the previous CA for amendments, and as well as any other applicable documents if available, for billable items and services. Billable items and services are CPT-coded items and services that providers can bill to Medicare and other health insurance programs such as, but not limited to scans or exams.
For a Courtesy Review of your protocol, please contact:
Industry Sponsor Contract studies: WISC at WISCtrials@emory.edu
All other studies: OCR at OCR_PreAward@emory.edu