On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health care program beneficiaries who experience certain insurance approval determination delays does not warrant enforcement under either the Anti-Kickback Statute (“AKS”) or the beneficiary inducement provisions of the Civil Monetary Penalties Statute (“Beneficiary Inducement CMP Statute”). The OIG determined that, although providing free drugs to beneficiaries in general “could potentially generate prohibited remuneration,” the unique circumstances of the particular program implemented by the manufacturers in this case presented a “low risk of fraud and abuse.” Although the OIG’s determination is limited to the specific facts and requestors in this case, the advisory opinion provides pharmaceutical manufacturers with important factors to help assess the potential risks associated with developing and implementing free drug programs during new product launches when patients are faced with delays in

securing coverage.