On April 30, 2026, at the Health Care Compliance Association’s 2026 Compliance Institute, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) introduced its updated Corporate Integrity Agreement (“CIA”) template, using the Kinex Medical Company CIA as its model. The updated template retains the core elements of an effective compliance program while introducing significant enhancements that reflect OIG’s evolving compliance expectations.
Evolution of Corporate Integrity Agreements and Compliance Program Requirements
The new CIA template introduces seven key enhancements that reflect OIG’s evolving expectations for compliance program governance, operations and risk management, all of which are relevant for health care entities, even those not subject to a CIA. The updated template emphasizes independence, transparency, ongoing verification and proactive oversight across core compliance functions. Health care entities should assume the updated template reflects the most current expectation from OIG as to what constitutes an effective compliance program.
- The Role of the Compliance Officer
A primary change in the 2026 CIA template is the expanded role and responsibilities of the Compliance Officer. Previously, CIAs required the Compliance Officer to be a senior manager authorized to report to the Board. The 2026 template now mandates that the Compliance Officer must have sufficient authority to interact as an equal with other leaders and have direct, independent access to the Board. The Compliance Officer is prohibited from overseeing operational functions such as billing, coding or contracting to ensure independence. The new template also increases the Compliance Officer’s responsibilities from four broad duties to 10 detailed obligations, including chairing the compliance committee, coordinating monthly exclusion screenings with Human Resources and collaborating with internal audit and risk management teams to develop comprehensive compliance work plans.
- Expanded Board Expectations and Oversight
The 2026 template formalizes and standardizes board oversight expectations that were previously only suggestions. Now, the Board must meet at least quarterly in executive sessions with the Compliance Officer, without management, counsel or employees present. Additionally, the Board must engage an independent Compliance Expert, who is not an owner, employee or executive of the entity, to evaluate the effectiveness of the compliance program and provide the Board with a written report and any recommendations with respect to the compliance program. The Board must review and prepare a written response of the findings with a plan for corrective actions.
- Information Technology Expertise and the Compliance Committee
OIG now requires compliance committees to include a member with information technology (“IT”) expertise, ensuring that the compliance oversight keeps pace with technological advancements. The 2026 template also provides additional clarification of the role of the compliance committee and emphasizes the importance of specific compliance training for compliance committee members.
- Arrangements and Fair Market Value
In 2025, standard CIAs required a written review and approval process to ensure that arrangements with referral sources and physicians did not violate the Anti-Kickback Statute, with a focus on fair-market value (“FMV”) evaluations. The 2026 template introduces more rigorous requirements; namely, organizations must now actively track and verify that such arrangements are being used as intended. Detailed documentation is now required, including the exact FMV amount or range, the covered time period, completion dates, the third party performing the valuation and the identities of all involved staff. This applies to arrangements for leased spaces, supplies, devices, equipment and referral sources. FMV documentation is now a continuous process—conducted before signing, upon renewal and as needed throughout the arrangement’s lifecycle.
- Risk Assessment Methodology
Earlier CIAs required annual risk assessments, but the new 2026 template prescribes a specific five-step methodology. Organizations must identify, assess, prioritize and develop work plans for key risks, and then monitor and review the effectiveness of those plans through ongoing reassessment.
- Internal Reporting and Training
The 2026 template broadens OIG’s definition of a disclosure program beyond traditional ethics hotlines. While 2025 CIAs emphasized anonymous compliance hotlines, organizations now must establish at least one reporting mechanism that allows employees to contact compliance personnel directly, without supervisory involvement. This change aims to make internal reporting more accessible and effective.
The 2026 template makes clear that OIG’s expectation for annual compliance training goes beyond training on the seven elements of an effective compliance program and includes training on all requirements under the federal health care programs. OIG clarified what should be included in a training plan. Namely, the topics to be covered, the training format, the duration, the training schedule and the personnel required to complete each of the various trainings. This clarification aims to make training more transparent and effective.
- Artificial Intelligence
For the first time, OIG has addressed Generative Artificial Intelligence (“AI”) in a CIA. Organizations must now disclose if they use AI in their compliance programs or in preparing reports. They must also explain how AI was used and provide assurance that the content generated was verified for accuracy.
Conclusion
Collectively, these changes reflect OIG’s shift from merely checking for the existence of compliance controls to evaluating their effectiveness in practice. The 2026 CIA template emphasizes (i) independent oversight; (ii) continuous monitoring; (iii) documented verification; (iv) risk-based compliance management; and (v) governance of emerging technologies, like AI. Even organizations not currently subject to a CIA should view these requirements as indicators of OIG’s evolving expectations for effective compliance programs. It is an exciting time to work in compliance since these changes offer Compliance Officers and compliance departments more support in implementing and enhancing their compliance programs. In fact, these changes offer all health care entities a roadmap for interpreting and implementing OIG’s General Compliance Program Guidance issued in November 2023.
Practical Takeaways
- Inform your Board of the updated CIA template and its important enhancements to the compliance function.
- Confirm that the Compliance Officer has direct access to the Board, sufficient organizational authority and no operational duties that could create conflicts of interest.
- Evaluate current Board compliance oversight, including (i) engaging an independent compliance expert to review the effectiveness of the compliance program; (ii) implementing corrective actions in response to the findings; and (iii) scheduling regular executive sessions between the Board and the Compliance Officer.
- Ensure the compliance committee and other personnel are properly trained on the expectations of the federal health care programs.
- Ensure reporting mechanisms capture concerns raised through all channels, not just hotlines, and allow employees to contact compliance personnel directly.
- Implement ongoing verification procedures and document FMV assessments throughout the entire life of each arrangement, moving beyond periodic reviews.
- Develop clear policies for the use of generative AI, designate responsible stakeholders, validate AI-generated outputs and ensure compliance oversight includes appropriate IT expertise.
For more information or assistance in evaluating your compliance program in light of the new CIA template and related liability risks, please contact:
- Ritu Kaur Cooper at rcooper@hallrender.com or (202) 370-9584;
- Katherine Kuchan at kkuchan@hallrender.com or (414) 721-0479;
- Rachelle Madison at rmadison@hallrender.com or (214) 615-2062; or
- Your primary Hall Render contact.
Special thanks to Summer Associate Raeghan Jefferson for her assistance with the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
