Navigating the Maze: Fraud and Abuse Advisory Opinions and Frequently Asked Questions

By Sheryl Bridges, Jennifer Sullivan, and Travis Miller
Attorneys

Federal law contains several statutes and regulations aimed at addressing potential fraud and abuse in the healthcare industry. These include the Federal Anti-kickback Statute (“Federal AKS”) and the Beneficiary Inducements Civil Monetary Penalties (CMP) law provision prohibiting inducements to beneficiaries. This is a complex and ever-changing area of law, and it is critical that healthcare networks, entities, and providers stay on top of these changes to ensure that they are in compliance with these laws.   

The Office of Inspector General (OIG) within the U.S. Department of Health and Human Services maintains an active website with guidance and resources related to the federal fraud and abuse laws, including the Federal AKS and the Beneficiary Inducements CMP law. Interested parties may request advisory opinions and submit frequently asked questions to OIG regarding scenarios many healthcare entities and providers face that potentially implicate these laws. OIG posts its findings and/or responses to these requests on its website.  

OIG’s advisory opinions address very specific scenarios. They are binding only as to the specific proposal discussed in the opinion but can be useful in understanding how OIG analyzes fraud and abuse cases and how it applies certain enumerated exemptions to the general rules against kick-backs and self-referrals, known as safe harbors. On the other hand, FAQs are not binding and provide more general guidance that is likely to be applicable to a wider audience. Access information on the advisory opinion process directly from the OIG’s website. Find detailed information on the FAQ process on the official OIG website.  

A frequent question healthcare providers and entities face is whether remuneration streams relating to potential patient and/or provider incentives might violate fraud and abuse laws. OIG has recently published advisory opinions and FAQs on this important issue, including:  

• Advisory Opinion No. 23-07, Posted October 13, 2023: Favorable opinion stemming from a scenario submitted by an ambulatory surgery center requestor with physician employees. This opinion includes a discussion of the statutory employee safe harbor exception. 

• Advisory Opinion No. 23-08, Posted October 25, 2023: Unfavorable opinion stemming from a scenario submitted by a manufacturer of cochlear implants that wished to provide a free hearing aide to certain patients who receive one of their cochlear implants.   

• Advisory Opinion No. 23-15, Posted January 3, 2024: Favorable opinion stemming from a scenario regarding the use of gift cards by a company that provides consulting services to physician practices.  

• FAQ: Hospital distribution of naloxone rescue kits to certain patients upon discharge from the emergency department. Discussion of when this situation may present a low risk of fraud and abuse.  

• FAQ: Remuneration to Dual Eligible Special Needs Plan (D-SNP) enrollees to compensate for time and expertise on enrollee advisory committee. Discussion of why this arrangement may implicate Federal AKS but not the Beneficiary Inducements CMP law.   

Caplan and Earnest’s healthcare lawyers work to stay on top of this complex area of law. Don’t hesitate to contact us to help answer your questions about federal fraud and abuse laws, including whether such laws might be implicated in your practice.