The Office of Inspector General (OIG) for the United State Department of Health and Human Services (HHS) recently released a template to assist with preparing advisory opinion requests. This template can be used to ensure that requestors include the information required for the advisory opinion process. The template lays out the basic information required for an advisory opinion request and leaves an optional section for legal analysis. Although providing a legal analysis is not required, most requests include significant legal analysis regarding why OIG should approve the arrangement and it is often the most detailed and insightful portion of a successful advisory opinion request.
Advisory opinions issued by HHS OIG are legal opinions that are issued to the requesting parties that apply OIG’s fraud and abuse authorities to the requesting parties’ current or proposed business arrangement. Since the advisory opinion is tailored to and binding on a requesting party’s current or proposed business arrangement, OIG will not advise on any hypothetical or other arrangements that the party does not actually intend to engage in. Although most advisory opinion requests seek guidance regarding the Anti-Kickback Statute (AKS) and its safe harbors, OIG is also authorized to issue advisory opinions on the application of exclusion authorities, civil monetary penalty authorities, and criminal penalties.
OIG also declines to issue opinions on general questions of interpretation, the fair market value of goods, services, or property, or the application of the Stark law or the Eliminating Kickbacks in Recovery Act (EKRA). Although advisory opinions can provide valuable guidance, requesting an advisory opinion is a completely voluntary process. Accordingly, failure to seek an advisory opinion regarding a business arrangement cannot be introduced as evidence as proof that the party violated the law.
Parties may use the new advisory opinion request template when submitting their request to ensure that all of the required information is included. Once requested, OIG should respond with their advisory opinion within 60 days. However, OIG may request additional information and materials from the requesting party, which can extend the response time. The requesting party may also have an opportunity to further discuss the advisory opinion request and its contents with OIG at OIG’s discretion, which usually takes place over the phone. The resulting advisory opinion will be released publicly on the HHS OIG website, but generally with the requestor’s name omitted. Although publicly available, the OIG advisory opinion is binding only on HHS and the requesting parties and is not binding on any other government department or agency. If a party receives a favorable advisory opinion, its current or proposed business arrangement will be protected from OIG administrative actions so long as the business arrangement is conducted as outlined in the party’s advisory opinion request. Since the opinion is only binding on the requesting party, the opinion does not automatically protect other, similar arrangements, but can offer valuable guidance.
HHS OIG’s advisory opinion request template provides requestors with a foundation to build their request upon, but additional information will likely be required. Requestors should include a detailed description and thorough legal analysis of their current or proposed business arrangement to provide the most detailed request possible.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining advisory opinions or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or email@example.com.