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.

Print Friendly, PDF & Email
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

Leveraging the CERT: A New Coding and Billing Risk Assessment Plan

Leveraging the CERT: A New Coding and Billing Risk Assessment Plan

Frank Cohen shows you how to leverage the Comprehensive Error Rate Testing Program (CERT) to create your own internal coding and billing risk assessment plan, including granular identification of risk areas and prioritizing audit tasks and functions resulting in decreased claim submission errors, reduced risk of audit-related damages, and a smoother, more efficient reimbursement process from Medicare.

April 9, 2024
2024 Observation Services Billing: How to Get It Right

2024 Observation Services Billing: How to Get It Right

Dr. Ronald Hirsch presents an essential “A to Z” review of Observation, including proper use for Medicare, Medicare Advantage, and commercial payers. He addresses the correct use of Observation in medical patients and surgical patients, and how to deal with the billing of unnecessary Observation services, professional fee billing, and more.

March 21, 2024
Top-10 Compliance Risk Areas for Hospitals & Physicians in 2024: Get Ahead of Federal Audit Targets

Top-10 Compliance Risk Areas for Hospitals & Physicians in 2024: Get Ahead of Federal Audit Targets

Explore the top-10 federal audit targets for 2024 in our webcast, “Top-10 Compliance Risk Areas for Hospitals & Physicians in 2024: Get Ahead of Federal Audit Targets,” featuring Certified Compliance Officer Michael G. Calahan, PA, MBA. Gain insights and best practices to proactively address risks, enhance compliance, and ensure financial well-being for your healthcare facility or practice. Join us for a comprehensive guide to successfully navigating the federal audit landscape.

February 22, 2024
Mastering Healthcare Refunds: Navigating Compliance with Confidence

Mastering Healthcare Refunds: Navigating Compliance with Confidence

Join healthcare attorney David Glaser, as he debunks refund myths, clarifies compliance essentials, and empowers healthcare professionals to safeguard facility finances. Uncover the secrets behind when to refund and why it matters. Don’t miss this crucial insight into strategic refund management.

February 29, 2024
2024 ICD-10-CM/PCS Coding Clinic Update Webcast Series

2024 ICD-10-CM/PCS Coding Clinic Update Webcast Series

HIM coding expert, Kay Piper, RHIA, CDIP, CCS, reviews the guidance and updates coders and CDIs on important information in each of the AHA’s 2024 ICD-10-CM/PCS Quarterly Coding Clinics in easy-to-access on-demand webcasts, available shortly after each official publication.

April 15, 2024

Trending News

This Leap Year, celebrate success with a 29% discount one day ONLY! Use code LEAP24 on February 29th at checkout to unlock this offer! Click here to learn more.
It’s Heart Month! Use code HEART24 at checkout to receive 20% off your cardiology products. Click here to view our suite of Cardiology products!