On April 3, 2020, OIG released a Policy Statement indicating OIG will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback Statute (“AKS”) for certain financial arrangements related to a COVID-19 purpose that are covered under the Blanket Stark waivers issued by the Secretary of the U.S. Department of Health and Human Services on March 30, 2020.[1] Recognizing that some financial arrangements that implicate the Stark Law may also implicate or potentially violate the AKS, OIG stated its aim to avoid the need for parties to conduct a separate AKS legal analysis for those arrangements protected under the Blanket Stark waivers. This comes after last week’s message from OIG regarding efforts to minimize burdens on providers during the current public health emergency, which Hall Render summarized in a previous alert.
It is important to note this Policy Statement only applies to conduct occurring on or after April 3, 2020 (the Blanket Stark waivers were retroactive to March 1, 2020) and terminates on the same date as the Blanket Stark waivers (i.e., upon expiration or termination of the declared public health emergency). OIG specified that the Policy Statement would not apply to arrangements that implicate the AKS but are not covered by the Blanket Stark waivers (e.g., direct financial arrangements between providers where there is no physician involved). Additionally, the Policy Statement qualified that OIG will only exercise its enforcement discretion with respect to remuneration that is covered under sections II.B.(1) through (11) of the Blanket Stark waivers. However, OIG clarified that where an arrangement is covered by a Blanket Stark waiver, this Policy Statement extends to remuneration that relates to referrals for services furnished to all federal health care program beneficiaries pursuant to the covered arrangement.
As we noted in our previous alert related to the Blanket Stark waivers, providers should also consider the following:
- Proper Purpose. Note that arrangements must be “absent” of the government’s determination of fraud or abuse to fall within the Blanket Stark waivers. Thus, it is imperative that any arrangements must be pursued for a proper COVID-19 purpose.
- Examples. The Blanket Stark waiver document provides more than 20 examples of specific arrangements that could fall within the scope of the waivers. These examples can assist with determinations as to what is a proper purpose.
- Meet an Exception/Safe Harbor if Possible. The Blanket Stark waivers are intended to provide additional safeguards, and reliance on the waivers may be unnecessary because many financial relationships will already satisfy the requirements of an existing exception and/or safe harbor. Because the waivers remain novel and are limited in duration, we strongly encourage the structuring of arrangements to fit within current Stark exceptions and AKS safe harbors if at all possible and to rely on the new waivers only when necessary for a bona fide COVID-19 response.
- Maintain Documentation. Providers that utilize the Blanket Stark waivers must make available to CMS, upon request, records relating to the use of the blanket waivers. Providers should develop a strategy for maintaining separate documentation for their arrangements in a form that justifies the proper purpose and scope of the arrangement.
OIG invites questions from providers regarding the application of OIG administrative authorities to COVID-19 arrangements that implicate the AKS and Civil Monetary Penalty Law prohibition on inducements to beneficiaries. 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. If you have any questions or would like additional information, please contact:
- Scott Taebel at (414) 721-0445 or staebel@wp.hallrender.com;
- Joseph Wolfe at (414) 721-0482 or jwolfe@wp.hallrender.com;
- Keith Dugger at (214) 615-2051 or kdugger@wp.hallrender.com;
- Patrick Garcia at (445) 951-7043 or pgarcia@wp.hallrender.com;
- Your regular Hall Render attorney.
[1] See U.S. Department of Health and Human Services, Blanket Waivers of Section 1877(g) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency, available at: https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf.
Hall Render’s attorneys and professionals continue to maintain the most up-to-date information and resources at our COVID-19 Resource page, through our 24/7 COVID‑19 Hotline at (317) 429-3900 or by contacting your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
