HHS OIG Adds New Anti-Kickback FAQ for Arrangements Related to COVID-19 Public Health Emergency
Throughout the COVID-19 Public Health Emergency (PHE), the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) has been answering frequently asked questions from the industry on whether certain provider arrangements directly related to the COVID-19 PHE would implicate the federal Anti-Kickback Statute (AKS) and the OIG’s enforcement authority. To date, the OIG has posted answers to 17 FAQs. For example, the very first FAQ it answered in April 2020 was whether a hospital can provide free access on the hospital’s web-based telehealth platform to independent physicians on its medical staff to furnish medically necessary services during the COVID-19 PHE. The OIG answered by first reminding providers of its long-standing industry guidance that providing free or below value goods and services to referral sources could pose an actual or potential AKS violation. It then went on to say that it would not exercise enforcement authority regarding the proposed arrangement given the unique and exigent circumstances of the COVID-19 PHE as long as the arrangement met specific safeguards.
The most recent FAQ the OIG answered was provided on March 23, 2021. The FAQ was whether a federal qualified healthcare center (FQHC) with a location in a rural area can provide free space to a retail pharmacy to administer COVID-19 vaccinations to FQHC patients and the general public (including federal healthcare program beneficiaries). Again, recognizing that providing free or below cost items and services to referral sources can implicate the AKS, the OIG approved of the arrangement under the unique circumstances of the COVID-19 PHE, stating:
We recognize that effective and expeditious vaccine administration is crucial to the COVID-19 pandemic response and that individuals in rural areas may face heightened challenges in accessing vaccines. In the facts presented, the FQHC would provide the free use of space for the pharmacy to operate a vaccination clinic. The pharmacy would direct and operate all aspects of the vaccination clinic, including obtaining patient consents; administering COVID-19 vaccinations to individuals, some of whom may be Federal health care program beneficiaries; observing patients after vaccination and responding to any adverse reactions; and providing all items and services related to vaccine administration (e.g., staff and equipment). According to the FQHC, other than the free use of space, no remuneration would be exchanged between the parties. With respect to a patient of the FQHC who receives a vaccine administered by the pharmacy, the FQHC would maintain a record of vaccine administration within the patient’s medical record.
For all the OIG FAQs on whether it will exercise enforcement authority under the AKS related to arrangements directly connected to the COVID-19 PHE, click here.