A recent Advisory Opinion posted by the Office of Inspector General (OIG) found that a proposal by a charitable organization (Foundation) to establish a patient assistance program for financially-needy brain tumor patients would not run afoul of the anti-kickback statute. The Foundation, which is a nonprofit, tax-exempt entity, would be funded primarily by drug and device makers, a long-standing concern of the OIG.

The OIG concluded that the Foundation had taken the appropriate steps to ensure the integrity of donor contributions and grants to federal healthcare program beneficiaries. Specifically, the Foundation would help insured, financially-needy brain tumor patients pay for the drugs and devices needed in their treatment, as well as conditions that result from the treatment, such as chemotherapy-induced nausea. The beneficiaries of the program would include, but not be limited to, those enrolled in public insurance, thereby implicating the anti-kickback statute.

The OIG cited several favorable factors. First, the Foundation established objective criteria by which it would award grants to applicants on a first-come, first-served basis, and it also would have full, absolute discretion with respect to use of the contributions. Additionally, the Foundation would create an "ethical wall" between the patient assistance program and its other programs and services through the use of separate websites, project teams, data intake and storage and other measures.