Navigating Corporate Integrity Agreements: What Physicians Need to Know

Are you worried about facing an Integrity Agreement or a Corporate Integrity Agreement? You may have heard about other healthcare providers going through this process, but not entirely sure what it entails. In reality, the main goal of this process is to bring about positive outcomes. However, if not managed properly, it can turn into a mere formality.

The type of agreement—whether it’s an Integrity Agreement or a Corporate Integrity Agreement — depends on the size of the organization. Solo physicians or small groups would enter an IA, while larger entities would be part of a CIA. For simplicity in this discussion, we’ll refer to both types as CIAs.

What is a Corporate Integrity Agreement?

A Corporate Integrity Agreement (CIA) is a legally binding agreement between a healthcare provider and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS). It details the settlement of a healthcare fraud case in exchange for the OIG not seeking to exclude the entity from participation in Medicare, Medicaid, or other federal healthcare programs. While CIAs have common elements, each one is tailored to address the specific facts of the case and may include components of an existing compliance program.

Why Might a Physician be Subject to a CIA?

Physicians may find themselves subject to a CIA if they are involved in activities that violate federal healthcare laws, such as the Anti-Kickback Statute, the Stark Law (physician self-referral), or the False Claims Act. Common scenarios that may lead to facing a CIA include:

• Billing Fraud: Submitting false claims to Medicare or Medicaid for services not provided, or upcoding (billing for more expensive services than those actually provided).
• Kickbacks and Bribes: Receiving or giving something of value to influence the referral of patients covered by federal healthcare programs.
• Improper Referrals: Referring patients to entities in which the physician has a financial interest, without proper disclosure.
• Quality of Care Issues: Providing substandard care that results in harm to patients, which can lead to investigations and subsequent enforcement actions.

What Does a CIA Entail?

A CIA requires healthcare providers to establish and maintain a robust compliance and monitoring program with specific oversight. While CIAs share common elements, each is tailored to address specific circumstances and aims to align with existing voluntary compliance programs as much as possible. A typical comprehensive CIA lasts for five years and includes various requirements such as:

• Compliance Officer and Committee: Appointment of a compliance officer and establishment of a compliance committee to oversee adherence to the CIA’s terms.
• Written Standards and Policies: Development of written standards and policies for compliance.
• Employee Training: Implementation of a comprehensive training program for all employees.
• Independent Review Organization (IRO): Engagement of an independent entity to conduct annual reviews.
• Confidential Disclosure Program: Establishment of a confidential disclosure program for reporting issues.
• Employment Restrictions: Prohibiting the employment of individuals who are excluded from federal healthcare programs.
• Reporting Obligations: Reporting overpayments, reportable events, and ongoing investigations or legal proceedings.
• Regular Reports to OIG: Providing an implementation report and annual reports to the OIG on the status of compliance activities.

Who Would Know About a CIA?

Corporate Integrity Agreements are public documents and are usually posted on the OIG’s website. This means that anyone, including patients, employees, and business partners, can access the details of a CIA. Additionally, the OIG often issues press releases announcing major settlements that include CIAs, which can attract media attention. You can click here to find current organizations that are under a CIA.

What Happens If the Organization is Sold?

If the organization is sold or merged, the CIA applies to the purchaser of the business unless the provider obtains a written determination from OIG that the proposed purchaser and the business will not be subject to the requirements of the CIA or its associated Integrity Agreement following the completion of the transaction.

Embracing Compliance

It is crucial to take ownership of the process and start learning and adapting to it rather than working against it or trying to bypass it. Corporate Integrity Agreements are important measures imposed to ensure compliance and prevent fraud in federal healthcare programs. There will be significant financial costs involved, in addition to settlement and legal fees already incurred. However, the operational expenses associated with maintaining a CIA can be as budget-friendly as a proactive audit if you find the right partner.

Ensure Compliance With DoctorsManagement

Facing a Corporate Integrity Agreement can be daunting, but it is an opportunity to improve compliance and operational integrity. Understanding what a CIA entails, its implications, and how to navigate it can help ensure that you manage the process effectively and positively impact your practice. By embracing the requirements and working towards full compliance, you can not only avoid further penalties but also enhance the trust and confidence of your patients and partners in your commitment to ethical and lawful healthcare practices.