Clinical Trial Billing and Coverage Agreement

This clinical trial billing and coverage agreement form provides clear documentation of financial responsibilities for patients enrolling in clinical research studies. It delineates which procedures, tests, and treatments are covered by the research sponsor versus those billed to the patient's insurance or charged as out-of-pocket expenses. The form helps research sites comply with Medicare's Clinical Trial Policy and other payer requirements by explicitly categorizing costs as investigational (sponsor-paid), standard of care (insurance-billed), or patient-responsible expenses.

Designed for use by clinical research coordinators, research billing departments, and investigative sites, this agreement reduces billing confusion and potential disputes by establishing upfront financial expectations. It includes sections for documenting the study sponsor, protocol number, covered research procedures, routine care costs, potential co-pays, and patient acknowledgment of insurance verification. The form supports informed consent by ensuring participants understand the financial implications of trial participation and helps prevent unexpected medical bills that could impact enrollment and retention rates.