In a recent development, the Office of Inspector General in the Department of Health and Human Services (“OIG”) published Advisory Opinion 23-08 providing an unfavorable stance on the provision of free gifts in exchange for purchases of reimbursable devices.
This advisory opinion specifically tackled a proposed arrangement involving a supplier’s durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”) offer and provision of a free hearing aid to patients including federal health care program beneficiaries who procure one of the cochlear implants that the supplier manufactures. According to the OIG, this proposal would infringe the law.
The intervention is of significant interest to healthcare providers, device manufacturers, and legal professionals navigating healthcare laws. The scenario addressed by the advisory opinion shows that subtle exchanges, or even the offer of what can be seen as an added benefit for patients, might not escape scrutiny under the Anti-Kickback Statute and consequently, might be deemed illegal.
Playing a pivotal role in construing restrictive healthcare laws, the OIG regularly provides these advisory opinions to guide organizations. As such, all industry stakeholders should carefully review the implications of Advisory Opinion 23-08 and closely monitor the OIG’s guidance on similar arrangements to ensure compliance with the myriad of regulations in the healthcare sector.