The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of individuals for medically necessary health care services received as part of a federally funded clinical research study (Study) (Proposed Arrangement) and (2) the payment of a stipend to study participants for the time and effort required to participate in the Study (Current Arrangement) (collectively, Arrangements). The OIG concluded that, while the Arrangements have the potential to generate prohibited remuneration under the anti-kickback statute (AKS), the OIG would not impose administrative sanctions or civil monetary penalties (CMPs) on the Requestor because the Arrangements present only a minimal risk of fraud and abuse.
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