Frequently Asked Questions

Consistent with the Office of Inspector General’s (OIG’s) mission to promote economy, efficiency, effectiveness, and integrity in programs administered by the Department of Health and Human Services (HHS), as well as the health and welfare of the people such programs serve, and in response to stakeholder input received as part of the Modernization Initiative, OIG is offering a frequently asked question (FAQ) process to provide informal feedback to the health care community regarding the topics described below. OIG already offers FAQs and responses on a number of topics, including advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. OIG implemented an FAQ process at the beginning of the public health emergency resulting from the outbreak of COVID-19. In the COVID-19 FAQs, OIG provides non-binding guidance explaining how it views—during the time period subject to the COVID-19 public health emergency (as declared by the Secretary of HHS)—certain arrangements that are directly connected to the public health emergency and implicate OIG’s administrative enforcement authorities.

Beginning March 2023, OIG expanded the topics it considers for new FAQs submitted by the health care community. In particular, the agency reviews and considers: End of
Translation (1) general questions regarding the Federal anti-kickback statute (section 1128B(b) of the Social Security Act (the Act), 42 U.S.C. § 1320a-7b(b)) and the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and State health care program beneficiaries (section 1128A(a)(5) of the Act, 42 U.S.C. § 1320a-7a(a)(5)) (Beneficiary Inducements CMP) and OIG’s administrative enforcement authorities in connection with these statutes, (2) 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, (3) questions regarding compliance considerations, and (4) OIG’s Health Care Fraud Self-Disclosure Protocol. 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.

Where appropriate and beneficial, OIG will issue informal, non-binding feedback in response to selected inquiries regarding the above-described topics in the form of an FAQ response. If you have a question about any of the topics listed above and you would like OIG to review and consider the question for possible non-binding feedback, please submit your question to OIGComplianceSuggestions@oig.hhs.gov. In your submission, please provide sufficient background information and facts, as applicable, to allow for an understanding of the question. For example, if you submit an inquiry regarding a specified type of arrangement, please include information critical to understanding the type of arrangement, such as the key types of parties and the general terms of the arrangement; note, however, that OIG may modify the presentation of the question to ensure generality in any response. OIG updates this site as we respond to additional FAQs.

The following limitations apply to the FAQ responses provided on this page:

• The informal feedback furnished on this site does not bind or obligate OIG, HHS, the Department of Justice, or any other agency.
• OIG reserves the right to modify a question to enable us to provide a more useful or meaningful response.
• OIG reserves the right to not respond to a particular question. If OIG publishes informal feedback in response to a question, OIG may (but is not obligated to) notify the party that submitted the question.
• Unlike the advisory opinion process governed by the regulations found in 42 CFR Part 1008, answers published on this page do not confer prospective immunity from OIG administrative sanctions on any party.
• OIG expresses no opinion with respect to the application of any Federal, State, or local statute, rule, regulation, ordinance, or other law that may apply to the question answered, including, without limitation, the physician self-referral law, section 1877 of the Act (or that provision’s application to the Medicaid program at section 1903(s) of the Act).
• OIG expresses no opinion regarding the liability of any party under the Federal False Claims Act (FCA), Federal criminal law, or other legal authorities relating to any improper billing, claims submission, cost reporting, or related conduct.
• OIG will not provide identifying information about the party that submitted a question in any answer. However, information submitted to OIG in connection with a question may be available to the public in accordance with 5 U.S.C. § 552 through procedures set forth in 45 CFR Part 5. Please do not submit protected health information.

For a formal, binding legal opinion about an arrangement that implicates or may implicate the Federal anti-kickback statute or Beneficiary Inducements CMP, OIG’s advisory opinion process remains available. An OIG advisory opinion is a legal opinion issued by OIG to one or more requesting parties about the application of OIG’s fraud and abuse authorities to the party’s or parties’ existing or proposed arrangement. An OIG advisory opinion is legally binding on HHS. For more information about the advisory opinion process, including information regarding how to submit an advisory opinion request and how long it takes for OIG to process an advisory opinion request, please see OIG’s overview of the advisory opinion process.