UF – Insurance Contingency Language in Clinical Agreements and Consents

  • Applies to:  UF Human Subjects Research
  • Effective date:  12/01/08

Many study sponsors may include language in their draft contracts and/or  informed consents that asks UF to bill insurance first for study service and/or study subject injury costs. The language goes on to say that whatever is not covered by the insurance will then be paid by the study.  This is called “insurance contingency” language and most research institutions, including UF, will not accept this language in their contracts and/or 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 UF 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.
  • It is a False Claim to bill Medicare first when another payer will agree to pay if Medicare doesn’t. See CMS Medicare Secondary Payer Rule.
  • 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).
  • 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.