The coverage analyst is responsible for conducting the coverage analysis for all research studies (device and drug) before submission to the JHS Clinical Trials Research Review Committee and Institutional Review Board. A coverage analysis is a review to determine if a research study is a deemed and qualifying clinical trial pursuant to Medicare’s National Coverage Decision and will outline what items and services pertaining to a research study can be billed to Medicare.

The Coverage Analysis consists of three components:

  • The billing plan completed by the principal investigator.
  • The study calendar also completed by the principal investigator, which includes all items and services required to conduct the study
  • The summary incorporating the first two components to reach a billing guide for the research study.

The Coverage Analyst will identify which are the items and services for a research study:

  • Paid for by the sponsor
  • Billable to Medicare as “routine” care
  • Not billable to Medicare as “routine” care without documentation as to medical necessity
  • Non-reimbursable
  • Patient/research subject’s responsibility (costs incurred for participating in clinical trial)

The Coverage Analysis process provides:

  • Assist investigator in determining feasibility of a clinical trial
  • Assist investigator in developing a study budget
  • Provide awareness to patients/research subjects as to their potential financial liability
  • Provide a billing process template to verify that research study items and services are billed to the appropriate party