Corporate Integrity Agreements
Empowering companies to strengthen their CIA compliance management program
More and more pharmaceutical, medical devices and biotechnology companies are entering into Corporate Integrity Agreements (CIAs) in recent times. A CIA is a detailed restrictive agreement that serves as a roadmap for an effective corporate compliance program.
Companies, in which incidents of fraud and abuse are discovered through audits or self-disclosures, can enter into a CIA as part of negotiated settlements with the Office of Inspector General (OIG). These companies can avoid exclusion from Medicare, Medicaid and other Federal Healthcare programs by establishing and implementing a robust compliance framework, as laid down in the CIA. CIAs are usually drawn for a three to five year period, and may even extend up to eight years in certain cases.Download Solution Brief
MetricStream Software Solution for Compliance with CIAs
Integrity agreements include the following stipulations:
- Hire a compliance officer and appoint a compliance committee
- Develop written policies and standards
- Institute a comprehensive training program for employees
- Have the claims, which are submitted to Federal health care programs, reviewed by an Independent Review Organization (IRO) Establish a confidential disclosure program
- Establish a system to report overpayments, reportable events, and investigations/legal proceedings in progress
Prepare and submit to the OIG, an implementation report and an annual report, which reflect the company’s compliance activities, The challenges of complying with a CIA include substantial costs, complex CIA regulations, lack of enterprise-wide visibility for CIA programs particularly in large companies, ad-hoc approach to compliance, growing list of compliance regulations, and the demanding task of extensive documentation.
A CIA has a great impact on all levels of a company. Breach of a CIA also leads to dire consequences such as prosecution and sanctions. Hence, it is imperative that companies invest in thorough planning and collaboration between all functions, while entering into a CIA. Companies must also negotiate and structure the agreement to enable effective compliance, and align the CIA with the company’s already existing compliance program.
MetricStream offer a progressive and comprehensive system to help life sciences companies proficiently execute and manage a whole suite of activities, to achieve CIA compliance. The solution simplifies and strengthens risk assessment, control testing and monitoring, audit lifecycle management, issue remediation, as well as reporting and training.
Built on a single platform, the MetricStream solution can be extended across the company for seamless coordination of CIA compliance processes and audits. Its powerful capabilities include risk heat maps, regulatory tracking alerts, automated issue remediation workflows, a centralized document repository, executive dashboards, and embedded best practices. Packed with these unique features, MetricStream solution empowers life sciences companies to successfully meet the demands of CIA.
“MetricStream is helping us improve the efficiency, tracking, and transparency of our quality management program by consolidating multiple types of audits, CAPA, and issue management processes in a centralized environment. MetricStream stood out from other vendors because of the ability of its solution to extend beyond quality management to other key areas such as regulatory compliance, and integrate all compliance functions and processes on a common platform.”