The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the Federal anti-kickback statute (AKS), questions related to the civil monetary penalty (CMP) provision prohibiting remuneration to Medicare and State health care program beneficiaries, and questions relating to OIG’s enforcement authority under these statutes. OIG has stated it will respond to inquiries in the FAQ asking for general applications of AKS to a given type of arrangement. OIG also said it would answer questions regarding compliance and its healthcare fraud self-disclosure protocol.
Previously, OIG had FAQs dedicated only to the advisory opinion process, exclusions, whistleblower protections and, more recently, COVID-19. From the COVID-19 experience, OIG found the FAQ process to increase the efficiency of the Department of Health and Human Service’s (HHS) programs, and now the healthcare community can submit questions for all of these topics to [email protected]. Here are five considerations before submitting:
- Any advice OIG furnishes through its FAQ is non-binding. OIG makes it clear that any answer it publishes for submitted questions does not bind or obligate it, the HHS, the Department of Justice (DOJ), or any other Federal agency. OIG has also stated that it expresses no opinion as to the application of Federal, State, or local rules. This contrasts with the advisory opinion process, which provides a binding statement with regard to the submitting provider.
- The advisory opinion process remains available. An OIG advisory opinion is a legal opinion issued by OIG to the requesting parties concerning the application of OIG’s enforcement authority to the existing arrangement detailed by the requesting parties. Unlike the FAQ, an OIG advisory opinion—of which OIG issues dozens annually—does bind HHS. If you request an advisory opinion and receive a favorable one, you have prospective immunity from any OIG administrative sanctions. However, though an advisory opinion is a more fulsome and binding process, it does require paying a fee, while submitting an FAQ does not.
- OIG may choose not to answer certain questions. Indeed, it is likely OIG will not answer many questions until they become frequent. Additionally, OIG may alter or modify questions that are submitted to the agency. If you have immediate concerns about how the AKS or other Federal fraud and abuse laws may apply to an arrangement, it is better to discuss with counsel.
- Information you submit may become available to the public. OIG has stated it will not provide identifying information about the party that submits questions for answer through the FAQ portal. However, OIG may make the information submitted in connection with an inquiry available to the public. If you submit something to OIG, be sure not to include any protected health information or anything considered a trade secret or competition sensitive.
- OIG has already made answers available to some submitted inquiries.For example, OIG has already highlighted a few arrangements involving remuneration to Federal healthcare program members as well as questions regarding the scope of the Beneficiary Inducements CMP and how it compares to AKS. This FAQ can and should serve as one of the first places of preliminary research for when you or your organization has a question regarding OIG enforcement of arrangements such as these.
By expanding its FAQ, OIG has continued to modernize how it interacts and serves as a resource for healthcare stakeholders. While we do not yet know how often OIG will respond to questions, this gives the healthcare community a viable alternative to formal advisory opinions that may serve to ameliorate some concerns about OIG enforcement. As noted, keep in mind that this FAQ process is informal and non-binding. Contact a McGuireWoods attorney or one of the authors of this post if you have questions about OIG’s FAQ or to hear more information about OIG’s enforcement authority.