Use Corporate Integrity Agreement Obligations to Bolster Compliance Education Efforts

Fraud and abuse settlements in the healthcare industry are continuing to be reached at a record pace, and there are no signs that things will be slowing down in the near future. A critical role of healthcare compliance officers is to educate their organizations’ leadership and boards on the risks of not being compliant with all of the confusing rules and regulations in today’s marketplace. Non-compliance can lead to fines and penalties associated with the STARK II regulations, the federal Anti-Kickback Statute, the False Claims Act, and other mandates. Another aspect of the government’s reaction to an identified provider’s non-compliant behavior and action is the establishment of a corporate integrity agreement (CIA) between the provider and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) as the framework for a probationary period.

The OIG negotiates CIAs with healthcare providers as part of its settlement of federal healthcare program investigations. Providers or entities agree to the obligations, and in exchange, OIG agrees not to seek their exclusion from participation in Medicare, Medicaid, or other federal healthcare programs.

As a chief compliance officer who has taken two organizations through the process of arranging CIAs, I thought it would be valuable to outline the standard obligations required and suggest how a compliance officer might use them to benefit his or her educational efforts.

CIAs have many components that follow closely the elements of a model voluntary compliance program. In addition, there are specific obligations that may be associated with the particular violation(s) that led to the settlement of the investigation. A typical CIA lasts five years and usually includes the following requirements that a provider:

  • Hire a compliance officer/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/legal proceedings; and
  • Provide an implementation report and annual reports to OIG on the status of the entity’s compliance activities.

Compliance officers should be aware of and consistently communicating to their colleagues the significant expense and time commitment that is usually associated with the implementation of a CIA, and the ongoing management required. For example, the retention of an independent review organization can carry with it a surprisingly high price tag.

Keep in mind also that many recent CIAs require numerous individuals to certify to the OIG the accuracy and completeness of the content of implementation and annual reports. Traditionally, this potentially stressful obligation was placed only upon the compliance officer and the CEO, but today many CIAs require certification statements from the CFO, senior leadership, all board members, billing leadership, physician leadership, etc. This change marks a great opportunity for compliance officers to educate their audiences on the importance of avoiding a CIA. Here is an example of the type of content included in a CIA certification:

“I have been trained on and understand the compliance requirements and responsibilities as they relate to (insert name of department), an area under my supervision. My job responsibilities include ensuring compliance with regard to the (insert name of department) with all applicable federal healthcare program requirements, obligations of the corporate integrity agreement, and xxxx policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the (insert name of department) of xxxx is in compliance with all applicable federal healthcare program requirements and the obligations of the corporate integrity agreement. I understand that this certification is being provided to and relied upon by the United States.”

Sharing this information probably will get the attention of those who are not very interested in your compliance program.

I would also advise that organizations consider utilizing elements of the standard CIA, such as how to manage physician arrangements and focus arrangements, as an opportunity to establish best practices. Most CIAs that include an obligation to oversee contract arrangements provide very prescriptive steps to help assure compliance with STARK II and the Anti-Kickback Statute. 

Many organizations are rightfully fearful of the expense and time associated with a CIA. Today’s compliance officers should continually utilize the threat of a CIA as a major component of their ongoing compliance education efforts to validate that their compliance program has all necessary resources to protect their organization from risk of fraud and abuse.

Facebook
Twitter
LinkedIn

Bret Bissey, MBA, FACHE, CHC

A veteran in healthcare compliance (since 1997), Bret Bissey has served as senior vice president and chief ethics compliance officer at UMDNJ in Northern New Jersey. The author of the Compliance Officer’s Handbook, he has been a thought leader and popular speaker at industry conferences and meetings for many years. Bissey has more than 30 years of diversified healthcare management, operations, consulting, and compliance experience.

Related Stories

Leave a Reply

Please log in to your account to comment on this article.

Featured Webcasts

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

Stop revenue leakage and boost hospital performance by mastering risk adjustment and HCCs. This essential webcast with expert Cheryl Ericson, RN, MS, CCDS, CDIP, will reveal how inaccurate patient acuity documentation leads to lost reimbursements through penalties from poor quality scores. Learn the critical differences between HCCs and traditional CCs/MCCs, adapt your CDI workflows, and ensure accurate payments in Medicare Advantage and value-based care models. Perfect for HIM leaders, coders, and CDI professionals.  Don’t miss this chance to protect your hospital’s revenue and reputation!

May 29, 2025
I050825

Mastering ICD-10-CM Coding for Diabetes and it’s Complications: Avoiding Denials & Ensuring Compliance

Struggling with ICD-10-CM coding for diabetes and complications? This expert-led webcast clarifies complex combination codes, documentation gaps, and sequencing rules to reduce denials and ensure compliance. Dr. Angela Comfort will provide actionable strategies to accurately link diabetes to complications, improve provider documentation, and optimize reimbursement—helping coders, CDI specialists, and HIM leaders minimize audit risks and strengthen revenue integrity. Don’t miss this chance to master diabetes coding with real-world case studies, key takeaways, and live Q&A!

May 8, 2025
2025 Coding Clinic Webcast Series

2025 ICD-10-CM/PCS Coding Clinic Update Webcast Series

Uncover critical guidance. HIM coding expert, Kay Piper, RHIA, CDIP, CCS, provides an interactive review on important information in each of the AHA’s 2025 ICD-10-CM/PCS Quarterly Coding Clinics in easy-to-access on-demand webcasts, available shortly after each official publication.

April 14, 2025

Trending News

Featured Webcasts

The Two-Midnight Rule: New Challenges, Proven Strategies

The Two-Midnight Rule: New Challenges, Proven Strategies

RACmonitor is proud to welcome back Dr. Ronald Hirsch, one of his most requested webcasts. In this highly anticipated session, Dr. Hirsch will break down the complex Two Midnight Rule Medicare regulations, translating them into clear, actionable guidance. He’ll walk you through the basics of the rule, offer expert interpretation, and apply the rule to real-world clinical scenarios—so you leave with greater clarity, confidence, and the tools to ensure compliance.

June 19, 2025
Open Door Forum Webcast Series

Open Door Forum Webcast Series

Bring your questions and join the conversation during this open forum series, live every Wednesday at 10 a.m. EST from June 11–July 30. Hosted by Chuck Buck, these fast-paced 30-minute sessions connect you directly with top healthcare experts tackling today’s most urgent compliance and policy issues.

June 11, 2025
Open Door Forum: The Changing Face of Addiction: Coding, Compliance & Care

Open Door Forum: The Changing Face of Addiction: Coding, Compliance & Care

Substance abuse is everywhere. It’s a complicated diagnosis with wide-ranging implications well beyond acute care. The face of addiction continues to change so it’s important to remember not just the addict but the spectrum of extended victims and the other social determinants and legal ramifications. Join John K. Hall, MD, JD, MBA, FCLM, FRCPC, for a critical Q&A on navigating substance abuse in 2025.  Register today and be a part of the conversation!

July 16, 2025

Trending News

Happy National Doctor’s Day! Learn how to get a complimentary webcast on ‘Decoding Social Admissions’ as a token of our heartfelt appreciation! Click here to learn more →

This Memorial Day, we honor those who gave all for our freedom. Take 20% off sitewide through May 31 with code MEMORIAL25 at checkout

CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24