The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently released a template that parties may use when preparing advisory opinion requests. The voluntary template provides a simple framework that can serve as a useful starting point for advisory opinion requests but may not accommodate every request. Furthermore, although the template can help requestors organize their requests and ensure they provide all required information, an effective advisory opinion request likely will include certain information the template does not require, namely a detailed legal analysis of the arrangement for which the request is being made.
The four-page template lays out the basic information OIG requires for an advisory opinion request, including the identity of the requesting party (and certain affiliated entities), the particular legal issue on which the requestor seeks an advisory opinion, a complete description of the arrangement, and a statement certifying the accuracy and completeness of the information provided. The language used by OIG in the template closely tracks the language found in the regulations that govern the advisory opinion process at 42 C.F.R. Part 1008, with virtually no embellishment.
The template also provides for an “optional” legal analysis, in which the requestor describes how it evaluates the arrangement under the relevant law and why it believes OIG should issue a favorable opinion. OIG regulations do not require such an analysis. In most cases, however, this portion of the advisory opinion request—along with the description of the arrangement—will comprise the bulk of, and be the most consequential part of, the request.
Although the template highlights the opportunity for the requesting party to offer its legal analysis of the arrangement, it does not provide guidance regarding the questions OIG may ask or the factors OIG may consider in its review of the request. In the past, OIG has published guidance on these issues, namely a list of recommended preliminary questions and supplementary information for addressing advisory opinion requests. That guidance has been removed from the OIG website; however, the topics OIG suggested that requestors consider in the advisory opinion process continue to be relevant.
The advisory opinion request template provides a helpful, if basic, framework that allows parties to ensure that their requests include the information required by the regulations governing the advisory opinion process. But perhaps the most immediate benefit of the template, if widely adopted, might be to enhance the efficiency of OIG’s review process. In particular, the template may help reduce the number of incomplete or poorly organized advisory opinion requests that require substantial government resources to develop.
Parties that wish to request an advisory opinion should refer to the template and use it as a starting point or checklist. Requesting parties should be mindful of the value of including a detailed, well-organized description of the arrangement (which is required by the template), as well as a complete legal analysis of it (which is not). Much like an effective brief advocates a party’s position and anticipates a court’s response, an effective advisory opinion request carefully develops the legal analysis and reflects an understanding of how OIG is likely to evaluate the arrangement.
With a deep bench of nationally recognized healthcare fraud and abuse experts, including two former OIG officials, Bass, Berry & Sims is uniquely positioned to assist with advisory opinion requests and related matters. To learn more about the advisory opinion process and how to craft an effective request, click here to access a recording of a recent webinar organized by members of the firm’s healthcare practice group entitled “How to Request an Advisory Opinion (and Why).”