Publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health care community regarding regulatory flexibility for providers that needed it to adequately respond to COVID-19 concerns. This flexibility specifically relates to the OIG’s administrative enforcement authorities, including the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL).
The OIG posted an update found to be notable in light of the OIG’s previous guidance to the contrary. This FAQ relates to an arrangement where a retail pharmacy operating a COVID-19 testing collection site incurs costs related to running these sites, including costs for “processing and sending the specimens” to the laboratory for testing (among others). The testing laboratory would pay the pharmacy a fair market value (FMV) fee for these costs. Laboratories often refer to payments for such services as “processing and handling fees.”
The agency ultimately concluded that the arrangement, in the context of the COVID-19 public health emergency, would be sufficiently low-risk under the following conditions: (i) the pharmacy incurs costs in operating the testing collection sites; (ii) the payment is FMV for the items and services furnished by the pharmacy in running the sites; and (iii) the retail pharmacy is not submitting claims to federal health care programs or receiving other federal or state funding that would reimburse it in any way for the items and services for which it is “reimbursed by the laboratory.”