April 7, 2020 - Scott R. Landau
On the heels of CMS’s “blanket” waivers (the “Blanket Waivers”) of Stark Law enforcement during the COVID-19 crisis (about which we wrote about on March 31, 2020 below), the HHS Office of Inspector General (“OIG”) – the federal agency responsible for the Anti-Kickback Statute (“AKS”) – has issued a Policy Statement announcing that it will not impose administrative sanctions for certain financial arrangements related to COVID-19 services that are exempted from Stark Law liability under the Blanket Waivers but which might still run afoul of the AKS.
In its Statement, OIG recognized how crucial it is for the healthcare industry to focus on delivering efficient and effective patient-care services during the COVID-19 crisis, which may require parties to enter into arrangements that might not otherwise neatly fit within an AKS “safe harbor.” To avoid the need for parties to “undertake a separate legal review under the [AKS] for” financial arrangements protected by the Blanket Waivers, OIG has agreed to exercise “enforcement discretion” and refrain from imposing administrative sanctions under the AKS with respect to any remuneration between parties that is “exempted” from Stark law liability by sections II.B.(1) through (11) of the Blanket Waivers. For administrative efficiency, all of the conditions and definitions that apply to the Blanket Waivers shall apply to the OIG policy.
Notably, this policy does not apply to remuneration associated with referrals described in sections II.B.(12)-(17) of the Blanket Waivers, for which OIG is asking parties to submit questions to OIGComplianceSuggestions@oig.hhs.gov for further guidance. This policy also has no bearing on arrangements that implicate the AKS that are not covered by the Blanket Waivers, such as direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved. It should also be noted that this policy only applies to conduct occurring on or after April 3, 2020 and that it shall terminate on the same date as the date that the Blanket Waivers terminate. As expected, the government continues to issue waivers, guidance, and changes to healthcare law and policy at a rapid rate as the COVID-19 crisis continues to test and strain national healthcare resources. If you have any questions about this policy or any other policy changes, or wish to submit questions to OIG regarding any COVID-19 related arrangements, please contact us at firstname.lastname@example.org or call us at (646) 970-7340 and we will be happy to assist you.