The U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) issues advisory opinions to provide guidance on the application of the Anti-Kickback Statute (“AKS”) and other OIG sanction statutes to existing or proposed business arrangements. An OIG advisory opinion is legally binding on the HHS and the requesting party or parties; it is not binding on any other governmental department or agency. Although other parties may look to these opinions for guidance, only the party that receives a favorable advisory opinion is protected from OIG administrative sanctions and only so long as the arrangement is conducted in accordance with the facts submitted to OIG at the outset.
In 2016, OIG issued thirteen new advisory opinions and modified or terminated six previously issued opinions. The new opinions dealt with various topics, including:
• Preferred hospital arrangements involving discounts on inpatient deductibles and premium credits;
• A group purchasing organization (GPO) arrangement in which the GPO would be wholly owned by an entity that also wholly owns participants in the GPO;
• An academic medical center offering pregnant women transportation aid to and from the hospital for delivery and short-term lodging;
• Supplemental payments from a hospice to nursing facilities for dually eligible hospice patients;
• Computerized point-of-care vaccine storage and dispensing systems located in physicians’ offices;
• Joint funding of a transportation coordinator to educate patients about local transportation options and subsidize certain forms of transportation for financially needy patients;
• A laboratory’s provision of free tube- and container-labeling services to dialysis facilities; and
• Waiver of patients’ cost-sharing obligations and additional compensation for participation in a government-funded clinical research study.
To read detailed summaries of each opinion, click on the PDF linked below.