On March 25, 2020, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a statement soliciting questions from the health care community regarding the application of the fraud and abuse laws such as the federal Anti-Kickback Statute (“AKS”) and the Civil Monetary Penalty Law (“CMP”) prohibition on inducements to beneficiaries, to arrangements directly connected to the COVID-19 public health emergency. OIG emphasized its interest in ensuring providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns.
Health care organizations and providers are encouraged to submit questions regarding arrangements that were developed in response to, or affected by, the public health emergency that potentially implicate the AKS and CMP Laws. Submissions should include sufficient facts and details to understand the key parties and terms of the arrangement at issue. OIG has said that it will review submissions and will make the responses publicly available on the OIG website in a “Frequently Asked Questions” format but clarified it is not required to respond, make questions public or issue publicly available guidance. OIG’s statement can be found here.
At this point in time, there are no blanket waivers for these fraud and abuse laws or the Stark Law. We are hopeful some additional guidance/waivers related to Stark will be issued. Currently, we are in the process of coordinating questions from clients and are available to assist providers with submissions to OIG or questions regarding any COVID-19 arrangements. Stay up-to-date with evolving regulatory requirements, information and resources through Hall Render’s COVID-19 Resource Page and COVID-19 hotline (317‑429-3900).
If you have any questions or would like additional information, please contact:
- Katherine Kuchan at (414) 721-0479 or kkuchan@hallrender.com;
- Gregg Wallander at (317) 977-1431 or gwally@hallrender.com;
- Scott Taebel at (414) 721-0445 or staebel@hallrender.com;
- Joe Wolfe at (414) 721-0482 or jwolfe@hallrender.com;
- Patrick Garcia at (445) 951-7043 or pgarcia@hallrender.com; or
- Your regular Hall Render attorney.
