The Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a revamped frequently asked questions (“FAQs”) page and process on March 23, 2023, creating a new platform to foster engagement between the government and stakeholders. The OIG has historically provided guidance on a limited range of topics and issues through an advisory opinion process that contains specific requirements and limitations. This new initiative expands the previously available FAQ topics while also providing an avenue for stakeholders to submit questions and receive informal feedback from the OIG. This is a welcome development, as often providers are in need of reasonably tailored guidance regarding an arrangement that, for one reason or another, is not appropriate for a formal advisory opinion request.

Although neither the published FAQs nor any informal feedback received in response to an FAQ inquiry are legally binding, these initiatives offer helpful guidance to stakeholders who are seeking additional clarification on a given issue.

Genesis of the FAQ

The OIG’s FAQ page previously consisted of guidance on a limited range of topics, including advisory opinions, corporate integrity agreements, contractor self-disclosures, and exclusions. The OIG kept topics such as the federal Anti-Kickback Statute and certain civil monetary penalty provisions for the formal advisory opinion process, which is delineated in statute and regulation.

In its decision to expand the FAQ page into those topics traditionally reserved for advisory opinions, and provide a new informal avenue for FAQ requests, the OIG built upon its COVID-19 response practice. That response included an FAQ page and process to respond to the COVID-19 public health emergency (“PHE”). These FAQs provide non-binding guidance explaining how the OIG views certain arrangements that are directly connected to the PHE and implicate the OIG’s administrative enforcement authorities. With the PHE ending on May 11, 2023, the OIG’s COVID-19 FAQs will soon expire.

In September of 2021, the OIG published a Request for Information (“RFI”) in the Federal Register as part of its modernization initiative to improve its publicly available resources. Through the RFI, the OIG sought stakeholder and public input regarding the agency’s public resources and how the OIG could enhance the usefulness and timeliness of such resources and improve their accessibility and usability. The public opinion generally reflected a need for more detailed FAQs covering a broader range of topics, as well as a less restrictive and more efficient advisory opinion process. Based on the comments that the OIG received, the new FAQs and informal feedback process serve as a response to these criticisms.

Newly Published FAQs

Beginning March 2023, the OIG expanded the topics it considers for new FAQs submitted by the health care community. In particular, the OIG now reviews and considers:

• General questions regarding the Federal anti-kickback statute and the OIG’s administrative enforcement authorities in connection with these statutes,

• Inquiries regarding the general application of the Federal anti-kickback statute and Beneficiary Inducements CMP to a type of arrangement that may implicate these statutes,

• Questions regarding compliance considerations, and

• The OIG’s Health Care Fraud Self-Disclosure Protocol.

The OIG also reviews and considers general questions related to topics covered by certain of its FAQ pages existing as of March 2023, namely: (1) advisory opinions, (2) exclusions, and (3) its whistleblower protection coordinator function.

Email FAQs

Where the OIG determines it to be “appropriate and beneficial,” it will now issue informal, non-binding feedback in response to selected inquiries regarding any of the topics covered by the FAQ pages. The OIG recommends that the submissions contain sufficient background information and facts to allow for a comprehensive understanding of the question, however the OIG reserves the ability to modify the question to fit a more generally applicable response. The response will be made public and take the form of an FAQ response. Note that the OIG will publish identifying information about the submitting party, however, information submitted to the OIG through this process may become available to the public through the Freedom of Information Act. Parties are advised not to submit protected health information. Stakeholders can submit questions for consideration and review to OIGComplianceSuggestions@oig.hhs.gov.

It is unclear how the OIG will go about deciding which questions warrant a response, and the new guidance does not indicate how long stakeholders should expect to wait for a response, or how and when they would be notified if their question was chosen to be incorporated into the FAQs. Although a formal advisory opinion received by a requestor remains the only binding guidance from the OIG, the new FAQ pages and process will hopefully provide stakeholders much needed clarification and insight into the range of complex topics.