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FAQs–Application of OIG's Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Last Updated: 05-12-2023

Notice

OIG COVID-19 flexibilities, including these FAQs, ended upon the expiration of the COVID-19 Declaration on May 11, 2023. For more information, see this announcement.

The Office of Inspector General (OIG) recognizes that, in the current public health emergency resulting from the outbreak of the COVID-19, the health care industry must focus on delivering needed patient care.1 As part of OIG's mission to promote economy, efficiency, and effectiveness in HHS programs, we are committed to protecting patients by ensuring that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns. Therefore, OIG is accepting inquiries from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP).2 If you have a question regarding how OIG would view an arrangement that is directly connected to the public health emergency and implicates these authorities, please submit your question to OIGComplianceSuggestions@oig.hhs.gov. In your submission, please provide sufficient facts to allow for an understanding of the key parties and terms of the arrangement at issue.3 OIG will update the FAQ site as we respond to additional frequently asked questions.

The OIG's advisory opinion process remains available to interested parties. An OIG advisory opinion is a legal opinion issued by OIG to one or more requesting parties about the application of the OIG's fraud and abuse authorities to the party's existing or proposed business arrangement. An OIG advisory opinion is legally binding on HHS and the requesting party or parties. For more information about the advisory opinion process, including information regarding how to submit an advisory opinion and how long it takes for OIG to process an advisory opinion request, please see https://oig.hhs.gov/faqs/advisory-opinions-faq.asp.

The following limitations apply to these FAQs:

Footnotes

1The Secretary of the Department of Health and Human Services (HHS) determined, through a January 31, 2020, determination, pursuant to section 319 of the Public Health Service Act, that a public health emergency exists and has existed since January 27, 2020. See U.S. Department of Health and Human Services, Determination that a Public Health Emergency Exists (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (COVID-19 Declaration). The Secretary has issued subsequent 90-day renewals of that original determination. For the purpose of these Frequently Asked Questions (FAQs), the original declaration and any renewals are collectively referred to as the "COVID-19 Declaration."

2Section 1128B(b) of the Social Security Act (Act), 42 U.S.C. § 1320a-7b(b); section 1128A(a)(5) of the Act, 42 U.S.C. § 1320a-7a(a)(5).

3OIG plans to review all submissions, develop responses as appropriate to FAQs, and make such responses publicly available on its website by updating this site. Your submission of a question does not obligate OIG to take action, including responding to the question, making the question public, or issuing public feedback.

442 U.S.C. § 1395nn; 42 U.S.C. § 1396b(s).

5Note that "[a public health emergency] declaration lasts until the Secretary declares that the [public health emergency] no longer exists or upon the expiration of the 90-day period beginning on the date the Secretary declared a [public health emergency] exists, whichever occurs first. The Secretary may extend the [public health emergency] declaration for subsequent 90-day periods for as long as the [public health emergency] continues to exist, and may terminate the declaration whenever he determines that the [public health emergency] has ceased to exist." See U.S. Department of Health and Human Services, Public Health Emergency Declaration Q&As, available at https://www.phe.gov/Preparedness/legal/Pages/phe-qa.aspx#faq7. In the case of the COVID-19 public health emergency, the Secretary has issued subsequent 90-day renewals of the original January 31, 2020, public health emergency determination. For the purpose of these FAQs, the original declaration and any renewals are collectively referred to as the "COVID-19 Declaration."