OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market value, per-patient-encounter fee to collect, process, and handle specimens.

OIG declined to approve the arrangement for two key reasons. First, in OIG’s view, lab services are particularly susceptible to the risk of steering under the federal Anti-Kickback Statute. Second, the “per-click” fee structure, even if consistent with fair market value, inherently reflects the volume or value of referrals or other business the hospital sends to the labs. Together, these dynamics created risk that the fees were intended to induce hospitals to steer business to the labs.

An extension of earlier guidance and enforcement actions from OIG and the U.S. Department of Justice (DOJ), Advisory Opinion 22-09 reiterates the government’s view of the steering risk of arrangements where labs provide referral sources compensation that varies with referrals to the lab. But it also demonstrates that when fees are directly tied to volume, fair market value may not be enough to overcome this risk.

Source: https://www.jdsupra.com/legalnews/oig-declines-to-approve-lab-s-payment-2224040