Healthcare fraud and abuse cases cost the industry billions of dollars a year while healthcare providers face investigations that may cost them their reputation and revenue. Consequently, healthcare organizations accused of violating a federal law can find themselves in the settlement agreement process with the Department of Health and Human Services’ Office of the Inspector General (OIG), leading the company to comply with strict terms of the Corporate Integrity Agreement (CIA).
What is Corporate Integrity Agreement?
A Corporate Integrity Agreement (CIA) is arranged with a healthcare entity or provider. It is part of a settlement of federal healthcare program investigations resulting from false claims statutes. CIAs create a framework within which the company needs to operate in order to avoid being excluded from participation in federal healthcare programs. In other words, the OIG agrees not to bar the provider or entity from participation in the federal healthcare programs in exchange for the agreement. The updated list of Corporate Integrity Agreements can be found on the OIG Website.
As an important mechanism of fostering strong compliance programs in companies that have or are alleged to have violated federal health care laws and regulations, CIAs are intended to improve the quality of health care and adherence to health care regulations. They do not include disciplinary actions. Instead, CIAs set minimum standards for which a health care provider or entity should be held accountable and drive compliant behavior.
Corporate Integrity Agreement Requirements
When exercising its authority to exclude a health care entity from participation in federal healthcare programs, the OIG evaluates the severity of the allegations, the comprehensiveness of the entity’s existing compliance program, and what steps were taken to improve that compliance program to prevent a repeat and future misconduct, if a voluntary self‐disclosure was made, and the weight of the evidence supporting the allegations of fraud. If the OIG concludes that exclusion is not necessary but those integrity obligations are needed to mitigate further risks, the OIG will require a CIA.
CIAs can be used to address quality of care or corporate integrity issues. They have many common elements, but each agreement addresses the specific issue and often attempts to accommodate and recognize many of the elements of pre-existing voluntary compliance programs.
A comprehensive CIA typically lasts 5 years and includes requirements to:
- hire a compliance officer or appoint a compliance committee;
- develop written standards and policies;
- implement a comprehensive employee training program;
- retain an independent review organization to conduct annual reviews;
- establish a confidential disclosure program;
- restrict employment of ineligible persons;
- report overpayments, reportable events, and ongoing investigations or legal proceedings; and
- provide an implementation report and annual reports to OIG on the status of the entity’s compliance activities.
Each CIA is created to address the alleged specific violations related to a particular investigation and settlement. CIAs may not include the same elements or address the same considerations. Proposed requirements that may or may not work depending on the entity. Therefore, negotiations surrounding the scope and content of the CIA are critical to success.Use this detailed guide to find answers to everything related to exclusion screening, including Corporate Integrity Agreement Enforcement.
Corporate Integrity Agreement Penalties
All CIAs include stipulated penalties for failure to comply. These penalties may include daily penalties for providing false certifications under the CIA and failure to:
- have a Compliance Officer,
- have a code of conduct,
- perform training, and
- timely submit reports or engage the Independent Review Organization.
Each CIA contains a provision related to a material breach of the CIA that can result in the entity’s exclusion from federal healthcare programs. CIAs traditionally define a material breach as repeated or flagrant violations of any of the CIA’s obligations, failure to report a reportable event, take corrective action, or make appropriate refunds, failing to respond to a demand letter regarding stipulated penalties, and failing to engage an Independent Review Organization.
Avoiding Corporate Integrity Agreements
The best way to avoid a CIA is to implement a comprehensive and proactive compliance program. According to the OIG, the following seven components provide a solid basis upon which an entity can create a voluntary compliance program:
- Conducting internal monitoring and auditing,
- Implementing compliance and practice standards,
- Designating a compliance officer or contact,
- Conducting appropriate training and education,
- Responding appropriately to detected offenses and develop corrective action,
- Developing open lines of communication with employees,
- Enforcing disciplinary standards through well-publicized guidelines.
Finally, the most important component would be outsourcing exclusion screening and integrating an automated solution in order to ensure fast and regular process, improved compliance, and fewer possibilities for a potential Corporate Integrity Agreement. Due to various obligations, responsibilities and constantly changing regulations, it is virtually impossible for healthcare organizations to maintain an effective compliance program. On the other hand, automated exclusion screening allows entities and providers to save valuable time, ensure quality control with thorough checks, replace manual searches with automated ones, and reduce costs. Also, outsourced solutions enable healthcare organizations to thoroughly and promptly address Corporate Integrity Agreement requirements mandated by the OIG. A team of specialists provides guidance through the entire process and helps companies achieve compliance as the crucial component of the settlement process.