Articles and Blogs

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-11 (“Advisory Opinion”) on May 20, 2026. This favorable opinion concerns a precision oncology company (“Requestor”) providing free supplemental reports to patients based on its algorithmic analysis, which functions as a Multi-Cancer Detection Test (“Algorithmic Analysis”). Although OIG... READ MORE

On December 15, 2025, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 25‑11 (“Advisory Opinion”) and concluded it would not impose administrative sanctions under the federal Anti‑Kickback Statute (“AKS”) on a biopharmaceutical manufacturer for a series of discounts and rebates offered on multiple vaccines. Although portions of the arrangement failed to meet... READ MORE

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 25-08 (the “Advisory Opinion”), which addressed whether a proposed arrangement involving a medical device manufacturer’s payment of access fees to a third-party vendor’s billing portal (“Proposed Arrangement”) would violate the federal Anti-Kickback Statute (“AKS”). Based on the facts... READ MORE

On February 4, 2022, the Department of Health & Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 22-02 protecting a children’s hospital’s donor-funded charity program (“Proposed Arrangement”). Under the Proposed Arrangement, the requestor (“Children’s Hospital”) would use funds from two individual donors to establish a restricted endowment fund that would subsidize patient... READ MORE