The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary Inducement Statute to COVID-19-connected arrangements. This process permits the public to submit questions via email to the OIG, and the portal will include responses to frequently asked questions.
In recognition of the current public health emergency posed by Coronavirus (COVID-19), the US Department of Health and Human Services, Office of Inspector General (OIG) announced on March 25, 2020, that it would entertain questions regarding the application of OIG’s authorities—including the federal anti-kickback statute (AKS) and the beneficiary inducements civil monetary penalties law (Beneficiary Inducement Statute)—to arrangements connected to COVID-19. In a departure from its typical and more time-consuming practice of encouraging the use of its existing advisory opinion process to answer such questions, OIG established an email address, OIGComplianceSuggestions@oig.hhs.gov, for the public to submit questions. Submissions should include enough details to permit OIG to understand the facts of the arrangement, including the parties and material terms.
OIG will review all submissions and use them to develop frequently asked question (FAQ) responses, which OIG will publish on its website for COVID-19-related information, oig.hhs.gov/coronavirus/. OIG cautions, however, that it is not obligated to respond to, publish or issue public responses on all questions, or to take any other action. It is not clear whether OIG will respond directly to the individual or entity submitting the question in addition to using the questions to create FAQs.
Putting that question aside, the public should benefit from OIG taking this step to increase its public-facing guidance on these critical issues, likely on a faster timeframe than advisory opinions or other industry guidance. Unlike OIG’s sister agency, the Centers for Medicare and Medicaid Services (CMS)—which has historically used FAQs to provide public guidance on the application of the physician self-referral law (or Stark Law)—OIG has been reluctant to use FAQs to provide similar guidance on the AKS and Beneficiary Inducement Statute. The approach here is notable both for its departure from OIG’s typical approach as well as a potential departure from where CMS is heading in its response to the COVID-19 crisis.
During an American Health Law Association webinar, Chief Counsel Gregory Demske stated that OIG does not intend to issue broader waivers under the AKS Beneficiary Inducement Statute. While CMS initially took a similar approach by including the Stark Law in its case-by-case Section 1135 waivers, CMS is now considering issuing a blanket Stark Law 1135 waiver. It is important to remember, however, that some arrangements may implicate both the AKS and Stark Law and that the government’s waiver of one of these laws does not automatically waive the other. Risks may arise if an arrangement falls under the scope of both laws, but only one has been waived.