The rise in enforcement actions focused on health care fraud by the Department of Justice (DOJ) has led to an ever-increasing number of settlements. Following a settlement, each matter is referred to the Office of Inspector General (OIG) for negotiation of a Corporate Integrity Agreement (CIA). A CIA is an agreement in which the provider or entity consents to certain obligations as part of the civil settlement. In exchange for compliance with these obligations, the OIG agrees “not to seek an exclusion of that health care provider or entity from participation in Medicare, Medicaid, and other federal health care programs.” It should be noted that entities or providers who settle these cases deny liability or engaging in the alleged conduct.
If an entity or provider enters into a comprehensive CIA, certain obligations must be met. The typical term of a CIA is five years. Since there are many common features across CIAs, it is advisable that interested parties look through current CIAs that contain similar issues to the ones the organization is dealing with. More comprehensive CIAs include requirements to:
- Have an executive level Compliance Officer with direct access to the CEO and Board;
- Appoint an executive and Board level compliance committees;
- Develop and implement written standards and policies;
- Implement a comprehensive employee training program;
- Establish a confidential disclosure program (Hotline);
- Restrict employment of ineligible persons through sanction screening against the LEIE;
- Report overpayments, reportable events and ongoing investigations/legal proceedings;
- Provide annual reports to the OIG on the status of the entity’s compliance activities; and
- Retain an Independent Review Organization (IRO) to review compliance with the CIA.
Additionally, CIAs require the implementation of the seven elements of an effective compliance program, as provided by the various OIG compliance guidance documents. While meeting these requirements are mandatory, many CIAs do not require verification by an Independent Review Organization (IRO). However, recently the OIG has added the requirement for a Compliance Monitor to ensure that the entity is adhering to the compliance program review requirements. Due to the role of the Compliance Monitor, it is vital that organizations ensure they have an effective compliance program that addresses these mandates. It is advisable that organizations are able to provide credible independent evidence of an implemented and effective compliance program. Two highly recommended avenues by which to accomplish this is through engaging independent compliance program evaluations by experts; and/or to conduct independent surveys of employees on their knowledge and understanding of the compliance program.
CIAs also require various types of reviews by IROs to ensure compliance with the issues that initially brought DOJ and OIG attention to the entity. The most common issues found in CIAs are improper arrangements with referral sources, inappropriate claims submissions, off-label use of drugs, and questionable marketing practices. The OIG makes clear that while many CIAs have common elements, each agreement addresses the specific facts of the conduct at issue and often attempts to accommodate and recognize pre-existing voluntary compliance program elements. In most cases, CIA compliance program requirements and claims reviews are fairly straightforward, as long as parameters of what constitutes an “error” are predetermined. However, in some instances, CIAs are developed in response to issues or alleged misconduct that require program evaluations and monitoring rather than claims reviews. Before signing a CIA, it is strongly recommended that entities clarify and fully define the scope and all objectives of the agreement. This can be accomplished with the assistance of legal counsel and experts consultants that have considerable experience in negotiating settlements and dealing with specialized issues concerning the alleged conduct. Failing to negotiate the CIA terms clearly and effectively before the agreement becomes effective can be a costly mistake. The lack of clarity and scope can often lead to considerable extra effort by an IRO especially since the OIG is not inclined to renegotiate settlement issues.
A FREE webinar titled “CIAs Lessons Learned – Negotiating Terms, Selecting an IRO, Meeting Obligations” will be held on April 16, 2015 from 1:00 – 2:00 PM EST.Subscribe to blog