Corporate integrity agreements in healthcare (CIA) serve as binding contracts between an organization and the Office of the Inspector General (OIG). The organization accepts all the terms and conditions that the OIG sets. In exchange for this acceptance, the OIG promises to not seek the organization’s exclusion from federal healthcare programs such as Medicare and Medicaid.
Corporate integrity agreements share several common elements, such as the necessity to recruit an independent review organization (IRO) that will conduct regular claims (and other) reviews. However, the conditions of each CIA are also customized based on the specific details of the organization.
Sections in a corporate integrity agreement (example)
After understanding the corporate integrity agreement definition, it’s important to familiarize yourself with the general structure of a CIA. To help with this, let’s use an integrity agreement sample between a healthcare organization (you) and the OIG. This CIA, along with several other CIA examples, can be found on the OIG website.
CIA’s are often 5-year with an annual review or 3 years, with quarterly review type reviews or audits.
You may have once asked yourself, What is a corporate integrity agreement? By understanding these 11 sections, you can gain a more clear knowledge of CIAs for your organization’s benefit.
Below, let’s go through each section individually, highlighting their key points and how they are important for your corporate integrity agreements in healthcare:
Section I – Preamble
This section states that you have entered into an agreement with the OIG. The purpose of this is to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other federal healthcare programs. It also specifies all entities bound by the corporate integrity agreement. This includes any affiliated physician practices that you manage.
Section II – Term and Scope of the CIA
This section states that you will assume the compliance duties within the CIA for typically five years (or 3 years). It also defines each one-year timeframe within the five years as a reporting period. During this period, an annual report will be submitted.
Section III – Corporate Integrity Obligations
This section lays out the terms that you must follow to comply with the corporate integrity agreements in healthcare. You must meet these conditions within the first 90 days of the CIA’s effective period. First, the roles of the compliance program’s administrative members, including the Chief Compliance Officer and Compliance Committee, are defined.
Next, this section states that you will create and maintain properly written standards and personnel training. Finally, the CIA says that you must select and engage an IRO so it can review arrangements and claims. The IRO must also be involved with other tasks related to your specific terms. To show its objectivity, the IRO must assess and confirm its professional independence from you.
Section IV – Successor Liability
This section states that if another entity buys your organization, that entity is liable to uphold the terms and conditions of the current CIA. Thus, ensuring continuous compliance is crucial, even in the event of corporate restructuring or ownership changes.
Section V – Implementation and Annual Reports
This section defines the content of two types of reports that must be submitted to the OIG within the indicated timeframes. The Implementation Report must be sent within 120 days of the CIA’s effective date. It contains:
- Data about the compliance program’s administrative structure.
- Information on the identity and qualifications of the chosen IRO.
- A description of the risk assessment and internal review process.
The Annual Report must be sent every year that the CIA remains active. This text summarizes all reportable events that happened within the year and the corrective actions that were taken in response. It also contains any changes or revisions to the compliance program from what is specified in the CIA. In both documents, the IRO must submit a statement of its professional independence and objectivity with respect to your organization.
Section VI – Notifications and Submission of Reports
This section states that all reports prepared under the provisions of the CIA must be submitted to both the OIG and the Chief Compliance Officer of your healthcare organization. Timely and accurate reporting fortifies transparency and facilitates ongoing oversight by the OIG.
Section VII – OIG Inspection, Audit and Review Rights
This section gives the OIG permission to ask for copies of documents or do interviews at any time to verify your adherence to the CIA. These powers allow the OIG to effectively monitor compliance and address issues proactively.
Section VIII – Document and Record Retention
This section says that you must maintain for inspection all records related to reimbursement from the federal healthcare programs and to compliance with the CIA for a certain amount of time. Proper record keeping supports accountability and ensures that compliance can be verified during audits.
Section IX – Disclosures
This section states that the OIG will make an effort to notify you if it plans to release any data that could be considered privileged or private. This commitment helps protect sensitive information while maintaining necessary transparency in operations.
Section X – Breach and Default Provisions
This section defines the financial penalties for breaking the terms of the CIA. It serves as a deterrent against non-compliance, emphasizing the financial and legal consequences of breaches.
Section XI – Effective and Binding Agreement
This final section before the signature page confirms the legally binding agreement between you and the OIG.
Choosing the right IRO for your CIA
From this basic review of corporate integrity agreements in healthcare, you can conclude that the IRO is crucial for ensuring compliance with OIG rules.
Who can function as an IRO? A good IRO can save your organization from landing in trouble with the OIG by facilitating an effective compliance program. On the other hand, a bad one could damage your organization by failing to properly enforce the CIA.
There are many different IROs to choose from. How can you pick one with an excellent track record that best serves your compliance needs? With the help of the guidelines listed below, you can decide on the selection criteria to help you choose an IRO:
- Expertise and experience; Almost all corporate integrity agreements in healthcare contain the standard requirement for the IRO to perform reviews of arrangements and claims. If your CIA has more in-depth terms, then your IRO should have the right expertise and experience to handle those unique demands. Remember that credentials and degrees are not the sole deciding factors of an IRO’s quality. Make sure you look at their history of handling similar situations to that of your organization.
- Is an IRO a ‘policing agency’; No, the IRO, is not a ‘policing agency’ for the Office of Inspector General (OIG). The IRO is more of a liaison between the OIG and the client.
- An IRO cannot act as a consultant to a client and train staff on issues such as billing and coding. However, within the IRO reports and spreadsheets, a learning environment for providers and staff members can be created. The final report should be a guide to correct mistakes and decrease the error rate.
- Neutrality and objectivity; A major concern for any organization is whether the IRO will maintain a fair perspective when implementing compliance measures and reviewing whether they have been met. Although the OIG does not assign IROs to organizations, you can consult with them on the IRO’s professional independence. They can also provide details on whether the IRO has ever been disqualified due to a conflict of interest.
- Transparency and communication; Since executing a CIA often involves major changes, the ideal IRO will guide you during the initial transition period. The IRO will make your organization aware of your review terms. They will clearly define deadlines and expectations for the preparation of their reports to the OIG. Also, they will make sure that employees understand their roles in the compliance program.
For an expanded set of selection criteria, you may wish to download our white paper titled “How to Select an IRO“.
Corporate integrity agreement in healthcare summary
The IRO forms an integral part of your organization’s CIA. They make sure that all members of your organization act in compliance with the CIA. So, their actions are critical for abiding by the terms and conditions of the OIG. Although an organization must secure an IRO in a short period after entering into a CIA, the relationship with the IRO is usually a long-term one.
Therefore, when choosing an IRO, the best course of action is to make a well-informed decision. It is important to choose an IRO partner who is an expert in the field and can give you the help you need to stay compliant. Hopefully, the information in this article will guide you toward selecting an IRO that meets the needs of your corporate integrity agreements in healthcare.