On April 24, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published responses to certain frequently asked questions and further explained its application of administrative enforcement authorities to arrangements directly connected to the COVID-19 pandemic.

OIG stated that it is accepting inquiries regarding application of its administrative enforcement authorities as they relate to the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the civil monetary penalties law provision prohibiting inducements to beneficiaries (42 U.S.C. § 1320a-7a(a)(5)). Anyone with a question concerning how OIG would view an arrangement that is directly connected to the current health crisis can submit a question to OIGComplianceSuggestions@oig.hhs.gov and provide sufficient facts to allow an understanding of the key parties and terms of the arrangement. OIG also offered a reminder that its advisory opinion process remains available to interested parties.

Separately, OIG also published answers to certain FAQs related to the COVID-19 public health emergency. However, OIG qualified its responses by making clear that its answers do “not bind or obligate HHS, the U.S. Department of Justice, or any other agency.” OIG also stated that its responses, while striving to be accurate, “will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under Federal criminal law” and that OIG “expresses no opinion with respect to the application of any other Federal, State, or local statute, rule, regulation, ordinance, or other law that may be applicable to the question answered, including, without limitation, the physician self-referral law [Stark Law].” OIG also made clear that it was not expressing any “opinion regarding the liability of any party under the Federal False Claims Act, Federal criminal law, or other legal authorities for any improper billing, claims submission, cost reporting, or related conduct,” that its “informal feedback” would apply “only to arrangements in existence solely during the time period subject to the COVID-19 Declaration,” and that OIG could take “a different position on arrangements that are the same or similar in nature that existed” before or after the public health emergency.

OIG responded to selected questions and stated that it “plans to review all submissions, develop responses as appropriate to Frequently Asked Questions (FAQs), and make such responses publicly available on its website by updating this site.” The FAQs covered in the April 24 notice are as follows:

• I am an eligible provider who received a distribution through the CARES Act Provider Relief Fund.  Where do I sign my attestation?
• Can mental health and substance use disorder providers accept donations from public entities (i.e., local State, or Federal government entities), private charitable foundations, or health plans to fund cell phones, service or data plans, or both for patients who are financially needy or who do not own their own cell phone for the purpose of furnishing medically necessary services while in-person care is disrupted during the COVID-19 outbreak?
• Can an oncology group practice provide free in-kind local transportation to and from an established patient’s home to an alternate practice location to receive medically necessary oncology care during the time period subject to the COVID-19 Declaration?
• Can health care providers and practitioners furnish services, not to exceed their scope of practice, for free or at a reduced rate, to assist skilled nursing facilities (SNFs) or other long-term-care providers that are facing staffing shortages due to the COVID-19 outbreak?
• Can a hospital provide access to its existing HIPAA-compliant, web-based telehealth platform for free to independent physicians on its medical staff to furnish medically necessary telehealth services during the time period subject to the COVID-19 Declaration?