Material violations of Corporate Integrity Agreements (CIAs) subject defendants to False Claims Act liability. the Justice Department has encouraged this reading of the False Claims Act (FCA) liability provisions, when it broke its silence on the issue by filing a Statement of Interest arguing that a qui tam relator can bring suit on behalf of the United States fora material breach of a CIA.
CIAs are executed as part of a civil settlement between the healthcare provider and the Government to resolve cases arising under the FCA. These OIG-imposed programs are typically in effect for a period of three to five years, and have provided the OIG with a mechanism to specify practices and obligations that help ensure the healthcare provider’s compliance with applicable laws and regulations.
The OIG and healthcare providers often negotiate compliance obligations as part of the settlement. A provider consents to these obligations as part of the civil settlement and in exchange for the OIG’s agreement not to seek an exclusion of that healthcare provider from participation in Medicare, Medicaid, and other federal healthcare programs. The typical terms of a comprehensive OIG corporate integrity agreement include the requirement for the provider to retain an independent review organization to provide independent validation and verification of adherence to Medicare requirements in relevant areas where the provider has been found to be noncompliant. These reviews and audits, in and of themselves, may trigger Medicare overpayment situations.
The typical CIA obligates providers to report and remit all overpayments within thirty days of identification through the use of an Overpayment Refund Payment Form. An overpayment can occur in a myriad number of ways, and the Overpayment Refund Payment Form requires the provider to specify a reason for the overpayment such as duplicate, billed in error, or insufficient documentation. The duty, upon which a whistleblower Medicare Fraud FCA case may be based on, is the express contractual obligation on behalf of the provider to remit overpayments within thirty days of identification.