HHS' Office of Inspector General has issued an advisory opinion on a new safe harbor to kickback laws that aims to increase quality while reducing costs, according to a Nov. 14 article in JDSupra from law firm WilmerHale.
The OIG ruled Oct. 25 that a proposed arrangement in which a manufacturer would provide a free hearing aid with the purchase of a hearing implant falls outside of a safe harbor and presents a kickback risk. Under the proposed arrangements, ASCs or hospitals would purchase the implant for the patient and the manufacturer would provide a free hearing aid.
The ruling expressed concerns about free items to federal healthcare beneficiaries because it could lead to "steering, unfair competition, improper utilization, and quality and cost concerns," according to the article. Additionally, the value of the hearing aids would exceed the cap allowed by the safe harbor provision.
The OIG concluded that the arrangement could allow it to seek penalties because the free hearing aids may induce patients to choose these implants.
The advisory opinion reaffirms the OIG's "long-standing concerns with offering free items to beneficiaries when there are strings attached that might lead to additional billing to federal healthcare programs," according to the article.