OIG Responds to FAQs on whether Stark Waivers Nevertheless Implicate the Anti-Kickback Statute

As we reported in our April 17, 2020 Newsletter, the HHS Office of Inspector General (OIG) said that seven of the financial relationships that otherwise implicate Stark but are permitted by CMS under its public health emergency (PHE) blanket waivers may still potentially violate the Anti-Kickback Statute (AKS) and expose providers to sanctions. Since our last report, the OIG has posted FAQs—Applications of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 PHE in response to questions.

The OIG’s responses are a bit of a “mixed bag.” Recognizing the extraordinary need presented by the unique and exigent circumstances resulting from the COVID-19 outbreak, the OIG tells providers who provide free or reduced-rate services to long-term care facilities that the OIG will not pursue enforcement action so long as the services are provided directly in response to need arising out of, and only during the period of, the COVID-19 outbreak, and not contingent on referrals for any items or services that may be reimbursable by a Federal health care program. Similarly, a hospital may provide access to its web-based telehealth platform to independent physicians on its medical staff during the COVID-19 outbreak if such access is necessary for the provision of needed telehealth services in response to the outbreak, not conditioned on past or anticipated referrals, and offered to all physicians on the medical staff. On the other hand, the OIG warned that the remuneration stemming from an arrangement that is neither set forth in writing nor signed by the parties (but otherwise fully complies with an applicable Stark exception) may still implicate the AKS, and the provider should seek further guidance from the OIG.

Other FAQs considered whether the OIG will pursue enforcement against a hospital that suspends rental charges and accrual of interest for a Federally Qualified Health Center Look-Alike, whether a mental health and substance disorder provider can use public and private donations to provide cell phones to financially needy patients, and whether an oncology practice can offer free in-kind local transportation to an alternative site of service. The OIG is still inviting providers to submit questions about the OIG’s views on an arrangement directly connected to the PHE. Questions may be submitted to OIGComplianceSuggestions@oig.hhs.gov.