For arrangements that are novel, involve significant financial investment, or present a unique structural profile without a clear safe harbor fit, the OIG Advisory Opinion process provides a mechanism for obtaining binding regulatory guidance. Under 42 C.F.R. § 1008.38, a party may request that OIG issue a written advisory opinion stating whether a described arrangement — if undertaken — would constitute grounds for the imposition of sanctions under the AKS or other fraud and abuse authorities. Advisory opinions are binding on OIG and the Department of Health and Human Services with respect to the requesting party only; they do not establish precedent applicable to other parties. However, they provide meaningful insight into OIG’s analytical framework and can be instructive for structuring similar arrangements.
2025 Advisory Opinion on Concierge Medicine Structure
OIG Advisory Opinion 25-03, issued June 6, 2025 and posted June 11, 2025, is instructive for the concierge practice field. The opinion addressed a proposed arrangement in which a management support organization and an affiliated professional corporation sought to enter into employee-leasing and administrative services agreements with telehealth platforms. The OIG concluded that the arrangement would not constitute prohibited remuneration under the AKS, finding that the arrangement satisfied the personal services safe harbor. Though the advisory opinion sheds light on how the OIG analyzes concierge arrangements, the findings in the opinion are only binding on the parties that requested the opinion.
The opinion’s significance lies in its emphasis on:
- the importance of service fee structures that are set in advance and consistent with FMV as established by an independent valuator;
- the insulation provided by fee structures that do not vary based on whether the services are ultimately reimbursed by third-party payors; and
- the necessity of clear service segregation between covered and non-covered functions.
Practices should consider pursuing an advisory opinion when they are contemplating a structurally novel arrangement with no clear safe harbor fit, when the financial magnitude of the arrangement warrants the investment of time and legal resources, or when the practice operates in a regulatory gray area that has not been addressed by existing safe harbors, OIG guidance, or prior advisory opinions. The process requires a detailed factual submission and typically takes several months, but it provides the highest level of regulatory certainty available outside of litigation.
Conclusion
The OIG Advisory Opinion pathway offers a crucial route for practices navigating complex, high-value, or uniquely structured arrangements within the healthcare regulatory landscape. While advisory opinions are binding only for the requesting party, their insights and analytical frameworks serve as valuable guides for others. For practices operating outside established safe harbors or facing significant regulatory uncertainty, pursuing an advisory opinion can provide clarity and mitigate risk, ensuring compliance and informed decision-making.
Key Takeaways
- The OIG Advisory Opinion process is designed for arrangements that are novel, financially significant, or structurally unique.
- Advisory opinions are binding only for the requester but offer guidance for structuring similar arrangements.
- OIG emphasizes service fee structures that are set in advance, consistent with fair market value, and insulated from reimbursement outcomes.
- Pursuing an advisory opinion requires a detailed factual submission and may take several months but provides regulatory certainty.
- Advisory opinions help practices operate confidently in areas not addressed by existing safe harbors or previous guidance.
