The OIG weighed in on a request to give a green light to a proposed venture between a sleep testing provider and a hospital. The proposed arrangement involved:
- A sleep testing provider providing the equipment, technology, supplies and staff necessary to operate a sleep lab at the hospital, as well as marketing services;
- The hospital contributing the space, utilities, pharmacy and other necessary support;
- The sleep testing provider charging the hospital a per test fee which has been independently fair market valued; and
- The hospital billing payers for the procedure as an “under arrangement” arrangement.
The OIG frowned on the proposed arrangement because of the per test fee and the marketing services provided by the sleep testing company. The OIG correctly determined that the proposed arrangement does not fall within one of the Safe Harbors, which are regulatory exceptions to the federal Anti Kickback statute (“AKS”) because the compensation payable to the sleep testing company was not set in advance.
The Advisory Opinion is interesting because it has implications for many “under arrangements” collaborations between hospitals and businesses and also because it gives an idea of the OIG’s current enforcement inclination, not only based on the specific facts presented but also in general in terms of how we can expect the government to enforce the AKS. It is no surprise that the OIG is taking a very conservative view of the AKS in light of the fact that the healthcare reform law has authorized stepped up enforcement in the healthcare arena to fund reform changes.