Understanding HHS-OIG Corporate Integrity Agreements

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Colin May, M.S., CFE, 3CE, INCI

Submitting false claims can be costly, but it’s not just the money that is paid out to insurance companies or the government when the case is ultimately settled. In many cases, included in the settlement provisions is a requirement that the company or entity enter into a multi-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). HHS-OIG also enters into Integrity Agreement (IA) for a three-year term, which tend to be for smaller practices and companies.

Focusing on Integrity

CIA’s and IA’s are an intense and focused way to ensure that the company, practice, or individuals are held accountable and actually implement compliance activities. The advantage of the IA and CIA is that the company or entity focuses on moving toward being fully compliant and thus remain as a provider in federal health benefit programs. CIAs mean they are not going to excluded from participating, which is typically a death knell for any provider or company.

Such was the situation in December 2021, when Princeton Pathology Services P.A. of Newtown, PA (Princeton Pathology) settled a qui tam False Claims Act case where it alleged that they overcharged Medicare using a certain Common Procedural Terminology (CPT) code.  Over a five-year period, the government contended Princeton Pathology used CPT 85390-26 incorrectly, which requires written analysis by a pathologist, but Princeton Pathology submitted claims where this CPT was not applicable and was reimbursed at a much higher rate.

In addition to paying $2.4 million, Princeton also agreed to a three-year IA with HHS-OIG. In Princeton Pathology’s case, like many, the IA required that the company implement a full compliance plan and ensure that, among other things, “training, auditing, and monitoring [is] designed to address the conduct at issue in the case as well as evolving compliance risks on an ongoing basis.”

What a CIA Contains

HHS-OIG maintains a repository of all CIAs and removes those documents when the CIA is finally complete, as they did in Princeton Pathology’s case in February 2025. Using the Internet Archive’s Wayback Machine, we can find a full copy of the IA for Princeton Pathology:

  • The goal of nearly all CIAs and IAs is to “promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f))”
  • The IA required the entity to maintain a full and robust compliance program and specifically designate a “Compliance Contact,” a person who is responsible for: “(1) monitoring Princeton Pathology’s day-to-day compliance activities, (2) meeting any reporting requirements created under this IA, and (3) responding to questions and concerns from OIG regarding Princeton Pathology’s compliance with the IA”
  • Princeton Pathology had to develop, implement, and enforce written policies and procedures regarding appropriate billing and medical record documentation
  • The practice also had to develop training covering the specific type of misconduct it was alleged of doing and submit those courses for approval by HHS-OIG before rolling them out. The training had to underscore “the personal obligation of each individual involved in the medical record documentation and claims submission processes to ensure that medical records and claims are accurate.”

Finally, the IA mandated the use of an Independent Review Organization (IRO) to conduct quarterly examinations of the practice’s billing practices and documentation. “The IRO shall conduct a review of Princeton Pathology’s claims submitted to and reimbursed by the Medicare and Medicaid programs to determine whether the items and services furnished were medically necessary and appropriately documented and whether the claims were correctly coded, submitted, and reimbursed…” This is an expensive and time-consuming compliance requirement, but essential to ensure that the issues that brought about the False Claims Act case in the first place have been rectified.

Additional Integrity Areas

CIAs and IAs are extensive and important to understand. One thing is also for sure: your entity does not want to end up on HHS-OIG’s “Heightened Scrutiny List,” which is for those who “refused to agree to integrity obligations sufficient to protect the Federal health care programs.”  Since 2017, HHS-OIG has focused on patient care and quality issues as well, mandating five CIAs, although none have been issued since 2022.

Like all healthcare compliance issues, CIAs are serious. It is critical for leaders of organizations to fully understand and appreciate the scope, cost, and ramifications of non-compliance. For those leaders and compliance officers seeking to prevent issues from arising, studying the terms of CIAs and IAs can be especially helpful in benchmarking best practices and learning from others. Non-compliance is not just a routine cost of doing business, it can be a major detriment to stakeholders and have wide-ranging consequences for patients, employees, and the community. Learning from CIAs and IAs is a good first step toward compliance.

FOR ADDITIONAL INFORMATION

Colin May, CFE, 3CE, INCI, is Professor of Forensic Studies and Criminal Justice at Stevenson University in Owings Mills, Md. A member of the American College of Healthcare Executives, he has spent the past 20 years in oversight, investigations, and compliance. He can be reached at cmay3231@stevenson.edu.