On December 13, 2016, the Office of Inspector General (OIG) issued a favorable Advisory Opinion to a university health system (the Requestor) for two arrangements relating to a federally-funded clinical research study designed by a physician-employee (the Study):
- a proposal to waive the cost-sharing obligations of Study participants (Participants) for medically necessary health care services received under the Study protocol (the Proposed Arrangement), and
- payment of a stipend to Participants for the time and effort required to participate (the Current Arrangement).
The Study was funded exclusively through a Public Health Service grant awarded by The National Cancer Institute (NCI) to the AIDS Malignancy Consortium (the PHS-NCI grant). According to the Requestor, successful completion of the Study would require Participants to remain compliant with the schedule of visits and obtain the services required by the research protocol, some of which are uncomfortable and time consuming. Notably, no commercial enterprise provided input or support to the Study. The OIG determined that while the Proposed Arrangement and Current Arrangements (the Arrangements) would implicate the Anti-kickback statute (AKS) and the civil monetary penalties law (CMP), it would not impose sanctions. As with other OIG Advisory Opinions, this opinion was limited to the specific facts of the Arrangements addressed.
Generally, Participants are responsible for out-of-pocket cost-sharing expenses for medically necessary items and services administered in connection with clinical research where third party payors (including government payors) are billed for these routine items and services. Under the Proposed Arrangement, Participants would be reimbursed using the PHS-NCI Grant funds for these cost-sharing obligations. Under the Current Arrangement, Participants are provided a stipend for their time commitment and expenses incurred related to Study visits, between $100 and $25 per visit, depending on the procedures performed. These amounts were determined through a detailed consideration of factors such as Participant inconvenience, potential lost wages, expenses incurred, the need to encourage participation, and the nature of the Study procedures.
The OIG found that despite implicating the AKS and CMP, the Arrangements present a low risk of fraud and abuse. The OIG cited to the following features certified by the Requestor:
- The Study is an AIDS Malignancy Consortium protocol, financed exclusively through a grant under which the NCI had approved the expenditure of funds and appointed an independent monitor for the Study, making the Arrangements consistent with NCI policy objectives and subject to government oversight.
- The Study aims to enroll a widely diverse group of Participants and compliance with the schedule of visits and services is essential to the successful completion of the Study; the Arrangements appropriately address hurdles to these objectives (e.g., the Protocol requires services that may be uncomfortable and time consuming; the Study is a cancer prevention study rather than a treatment study where Participants would have felt an urgent need to comply with the treatment; and the cost-sharing obligations could be a substantial financial burden for Participants).
- The Study is a strategy trial, not intended to develop, study, or benefit any specific commercial product or entity.
- Due to the nature of the services, it was improbable that Participants would self-refer for unnecessary services.