On this page...
- What is Coverage Analysis?
- What is an Amendment?
- What is a Qualifying Trial?
- What are Routine Costs?
- How do budgets, ICF and CTAs work together?
- What is a Device Trial?
What is Coverage Analysis?
Coverage Analysis is an independent review of a human research study to determine which clinical procedures and services are billable to insurance and which are not.It is a systematic review of clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) to determine the billing status of items and services that are documented in the research protocol and/or research plan.
When the analysis is complete, the investigator receives a study-specific billing summary that lists all items and services to be provided as part of the clinical trial with notations of what should be billed to the research sponsor and what can be billed to insurance based on Medicare rules. These billing grids are a valuable tool to ensure appropriate billing.
What is an Amendment?
Amendments are changes to a clinical trial that either the Sponsor or PI requests and may happen throughout the life of a study. The changes can either be protocol driven or a change to an already approved budget. It is important to contact the Coverage Analysis team when any change or protocol amendment has been made because it can affect the Coverage Analysis. The cost language in the ICF may also be affected and require an IRB modification.
What is a Qualifying Trial?
Not all clinical trials are eligible for coverage by the Medicare Program. For drug trials, , Medicare only covers items and services provided during qualifying clinical trials. For device trials, Medicare only covers items and services provided during research studies that involve “covered devices” or meet limited exceptions. In this video we will:
- Identify the components of a qualifying clinical trial
- Review the process of how we can determine if the trial qualifies
- Determine what that means for you, the study team
- Identify what is billable if your trial qualifies
- Identify what happens if the trial doesn’t qualify
- Provide you resources in case you have questions about qualifying trials
What are Routine Costs?
The term Standard of Care can be can be a confusing part of coverage analysis. We want PIs and CRCs to feel confident about the billing of your procedures so you can focus on the importance of your research and having a smooth study start up process. The purpose of this video is to help:
How do budgets, ICF and CTAs work together?
The budget, informed consent form (or ICF) and clinical trial agreement or industry contract (CTA) allhave major influences on coverage analysis. This video will explore how each of these items connectwith each other and some tips to understand the influence of the ICF and CTA on the final coverage analysis. Your Coverage Analysist will be able to help you with answers to these questions.
What is a Device Trial?
Many trials, especially in cardiology, use devices in their studies. A device is an instrument, machine, implant or similar item used to diagnose, treat or prevent disease in patients.