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CIAs provide insight into OIG Compliance Program expectations
The OIG begins negotiating Corporate Integrity Agreements (CIAs) after the DOJ has entered into a settlement with an entity. At any given time, there are over 300 such agreements in effect. CIAs are among the most important methods used by the OIG to promote health care compliance. CIAs impose controls and standards directly on providers seeking to resolve government investigations, which is necessary to ensure continued participation in federal health care programs. The OIG seeks assurances that it can rely on the organization to operate in accordance with applicable laws and regulations in the future. Most CIAs last for five years. Some CIA provisions have been included for many years, but there are also new provisions in the evolving CIA landscape. Meeting these terms and conditions is very important. Providers must remember that a CIA is a contractual agreement between the OIG and a health care entity which commits an entity to undertake a defined set of compliance obligations. In exchange for those obligations, the OIG agrees not to exclude the organization from participation in federal health care programs. Failing to meet the obligations under the agreement can result in severe penalties, including exclusion. Also, CIAs often include a stipulated penalty for each day of noncompliance, with deadlines and a $50,000 penalty for each false certification. As with any representation to the government, any false certification may implicate the False Claims Act.
- Functional Compliance Program inclusive of all seven standard elements;
- No employingment/contracting of excluded parties;
- Report investigations and legal proceedings;
- Identify, report, and repay overpayments;
- Submit Annual Reports on status of compliance with the CIA;
- Retain experts (e.g., Independent Review Organizations) to guarantee compliance;
- Notify of any investigative/legal proceedings;
- Repay identified overpayments within 30 days;
- Disclose reportable events;
- Inform of changes of business locations or status;
- OIG rights to inspect, audit, and review; and
- Fines for non-compliance with terms of CIAs.
- Increased OIG oversight and accountability of CIAs;
- Increased requirements for executives and Boards;
- More Certifications by Boards, CEOs, executives, and Compliance Officers;
- Boards hire a Compliance Expert to assist with Compliance Program review;
- Increased focus on effectiveness of the Compliance Programs and
- Increased Independent Review Organization responsibilities.
Certainly any organization moving towards entering into a CIA should consider these factors when preparing to meet the impending new obligations. However, even Compliance Officers for organizations that are not in trouble will find it useful to see what the OIG considers best practices in evidencing an effective Compliance Program.