Subject Injury

What is Subject Injury?

Subject Injury is an illness or injury that is a direct result of the treatment, or procedures required by the protocol, to which the subject would not have been exposed had they not participated in the study. Examples include:

  • An adverse event.
  • A side-effect.
  • A “complication”.
  • Injury from the study drug, device, or procedure required by the protocol.

Subject Injury is not:

  • A pre-existing condition.
  • Natural disease progression.
  • Injury from regularly scheduled care.
  • Injury sustained concurrent with study participation but unrelated to participation in study.

Subject Injury – Who Is Paying

It is important that the study team understands who will pay if a study participant experiences subject injury. This information should be incorporated into the study billing plan.  Often, this part of the billing plan is determined during budget development, but also may not be finalized until the contract is fully negotiated by the Office of Clinical Research.

Furthermore, it is important to clarify with the sponsor who will make the decision that the event is related to the research being conducted. It is usually the Principal Investigator, the Sponsor, or a combination of both.

The subject injury billing plan must also be consistent with the language contained in the contract/agreement/award and the Informed Consent for the study.  See Finanancial Language Assessment.

Sponsor IS Paying for Subject Injury  

While there is not a law that requires sponsors to automatically cover subject injury costs, it is UF’s policy to strongly urge the Sponsor to cover all costs associated with subject injury; the Sponsor is the first choice payer.  However, federal Sponsors and many foundations do not offer Subject Injury payment as a rule.

Sponsor is NOT Paying for Subject Injury 

If, per the contract/agreement or award, the Sponsor is not paying for subject injury, then the Health Science Center (HSC) will provide professional medical services at no charge to the participant.   In this case, if the study participant is treated at the HSC:

  • Any PROFESSIONAL SERVICES billed by UF Health Physicians (UFHP) will be waived.

Note: This waiver applies “Cross-HSC College & Cross-HSC Department” – for example – If a participant in a College of Dentistry study is injured in such a way that the professional services of a doctor in the College of Medicine Surgery Department is needed to treat the injury, the Surgery professional fees will still be waived.  

  • Any other services, including TECHNICAL SERVICES billed by Shands, will be billed to the participant or their insurance. Generally, this would include services like testing, scans, and meds.

If the participant chooses to be treated elsewhere, ALL services will be billed to the participant or his/her insurance.

Medicare Reimbursement for Complications

  • Unless the study sponsor is paying for subject injury,  Medicare covers reasonable and necessary items and services used to diagnose and treat complications arising from a Medicare patient’s participation in any clinical research study.
  • Study teams must ensure that claims for these services include the Z00.6 and Q1 modifier.

Medicare Secondary Payer Rule and Insurance Contingency Language 

Medicare Secondary Payer (MSP) is the term used by Medicare when Medicare is not responsible for paying first. In other words, any “liability insurance policy or plan,” which includes self-insured plans, must be billed first, prior to any claim presented to Medicare.  See Mandatory Medicare Second Payer Reporting.

In 2004, Medicare issued a letter that clearly stated that if Sponsor accepts the responsibility for payment of Subject Injury costs, that Sponsor is considered a “liability insurer” for purposes of MSP.  Thus, any Sponsor that is obligated by an agreement or contract to pay for Subject Injury treatment must pay primary to Medicare, and any bill sent to Medicare as primary payer is subject to potential recovery by Medicare.

Many Sponsors have template language in their contracts and informed consent that ask sites to bill insurance first for costs, including subject injury costs. The language goes on to say that whatever is not covered by the insurance will then be paid by the Sponsor.  This is called “insurance contingency” language and many institutions, including UF, will not accept this language in their contracts and informed consents.   The reasons for rejecting this language vary, but the most often cited are:

  • Insurance Contingency creates a financial disadvantage to a patient who volunteers to participate in a study by having them pay (i) co‐pays, (ii) deductibles; (iii) jeopardize hitting lifetime coverage maximums.
  • Insurance Contingency causes the site to in effect discriminate against study subjects dependent on whether or not they possess insurance and doing so violates the Belmont Report requirement that trial subjects be treated with justice.
  • Many private insurers have subrogation rules that may also place the university in a position to file fraudulent claims and the university will not assume this liability.
  • It is a False Claim to bill Medicare first when another payer will agree to pay if Medicare doesn’t (i.e. Medicare Secondary Payer Rule).

In addition, in October 2008, Medicare released a FAQ that made it clear by both wording and examples provided that they view contingent arrangements as rendering the services covered (and otherwise payable under Medicare’s NCD) “gratuitous” (and therefore not billable or payable under Medicare rules).

The University of Florida will not accept Insurance Contingency language in its research agreements/contract or informed consents. The Office of Clinical Research negotiates appropriate compensation language for subject injury in all contracts and agreements.

Subject Injury Language in the Informed Consent Form

Federal law requires that research subjects are informed of potential adverse events/side effects that may occur during study and whether medical treatment will be available if the subject is injured. At a minimum, the informed consent should clearly state

  • Who pays
  • For what
  • Under what conditions
  • Who to contact for any questions

UF General Counsel and IRBs have drafted template language for the subject injury section of informed consents. For more information, see Financial Language Assessment.

What Procedures Should be Followed if a Study  Participant Experiences Subject Injury/Adverse Event?

See Reporting and Billing of Subject Injury/Adverse Events .