Unacceptable/acceptable language in study documents

Examples of unacceptable language:

  • “The sponsor will pay for that medical treatment to the extent it is not covered by your medical or hospital insurance or by third party or governmental program in which you participate.”
  • “Sponsor will pay for reasonable and routine costs of treatment for injuries incurred while on study, as long as the following conditions are met: The cost of treatment is not covered by any other health insurance, government health program, or others providing coverage for health care.”
These types of statement are a violation of Medicare Secondary Payer rules, which indicate that Medicare must be the payer of last resort for all participants of the research study. This means that Medicare cannot be considered as an option for payment for research injury if the sponsor has promised to cover these costs To avoid any Medicare Secondary Payer regulatory concerns, IU takes the position that the sponsor should agree to cover research‐related injuries in the sponsor agreement regardless of the patient/trial participant’s health plan coverage. This avoids not only the Medicare Secondary Payer issue but also protects patients who have no health plan coverage or whose health plan will not cover research-related injuries.

Examples of acceptable language:

  • “If the injury or illness is directly related to the proper management of the study drug or proper performance of research procedures, Sponsor will pay the reasonable costs of that treatment to the extent those costs were necessary and directly related to the study.”
  • “In the event of injury or illness resulting from participation in the research study, the patient/patient insurance will be responsible for the cost to treat such injuries.”
The Coverage Analysis Team works closely with the Contracting Team to make sure that the appropriate language is in both the ICF and CTA and that these documents align.