by Elizabeth E. Hogue, Esq.

Providers may have heard or read about the importance of Fraud and Abuse Compliance Programs in their organizations. Despite the wealth of available information about Compliance Programs, many providers continue to express uncertainty about their value. 

Coincidentally, as we are preparing to publish this article, HHS publishes this report on the compliance audit of Guardian Home Care, LLC. 

Here are some of the questions providers often ask about Compliance Programs:

First

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) has clearly stated that all providers are now required to have current Compliance Programs that are fully implemented. 

Next

As a practical matter, when providers establish and maintain Compliance Programs, it clearly discourages regulators from pursuing allegations of fraud and abuse violations. Jody Hunt, formerly of the DOJ, says providers should create robust fraud and abuse compliance programs. Then providers can argue that they shouldn’t be liable for violations because their compliance programs demonstrate that they had no intent to commit fraud.

Technically speaking, the Federal Sentencing Guidelines make it clear that establishment and implementation of Compliance Programs is considered to be a mitigating factor. That is, if accusations of criminal conduct are made, the consequences may be substantially less severe as a result of a fully implemented Compliance Program.

Additionally

Providers with Compliance Programs are more likely to avoid fraud and abuse. This is because Programs routinely establish an obligation on the part of every employee to report possible instances of fraud and abuse and include training for all employees.

Compliance Programs may also help to prevent qui tam or so-called “whistleblower” lawsuits by private individuals, rather than by government enforcers, who believe that they have identified instances of fraud and abuse. There are significant incentives to bring these legal actions since “whistleblowers” receive a share of monies recovered as a result of their efforts. Some “whistleblowers” have received millions of dollars.  Compliance Programs make it clear that employees have an obligation to bring any potential fraud and abuse issues to the attention of their employers first.

Also…

The federal Affordable Care Act (ACA) requires providers to have Compliance Programs. In short, it’s the law!

Finally

The Deficit Reduction Act (DRA) requires providers who receive more than $5 million in monies from state Medicaid Programs per year to implement policies and procedures, provide education to employees and put information in their employee handbooks about fraud and abuse compliance. These requirements can be met through implementation of Fraud and Abuse Compliance Programs.

Statutes and regulations governing fraud and abuse also apply to providers who receive payments from any federal and state healthcare programs, including Medicaid, Medicaid waiver and other federal and state health care programs, such as Tri-Care. Many private insurers have followed the federal government’s “lead” in terms of fraud and abuse enforcement.  So private duty providers must have compliance programs, too.

We hear that the OIG has provided guidance for various segments of the healthcare industry regarding Compliance Programs. Specifically, the OIG has already published guidance for clinical laboratories, hospitals, home health agencies, skilled nursing facilities (SMFs), hospices, physicians’ practices, third-party billing companies and home medical equipment companies. The OIG will publish updated guidance for all providers, It has already done so for SNFs.

The answer is “No!” Guidance from the OIG is not a model Compliance Program. Guidance from the OIG consists of general guidelines and does not constitute a valid Compliance Program. In addition, the OIG has made it clear that Programs must be customized for each organization. 

We have read that, before implementing Compliance Programs, providers must conduct expensive internal audits that can take many months to complete. Is this true?

While beginning the compliance process with an extensive internal audit is certainly one way to proceed, it is not the only viable way to work toward compliance. It is equally valid to begin with Compliance Programs that are customized for the organization that includes training for all employees about fraud and abuse and Compliance Programs. Then all staff members can subsequently participate in internal compliance activities, including audits, with a process in place to handle any issues that arise as a result of the audits.

Compliance Programs are specific types of documents that routinely address issues that providers do not usually cover in internal policies and procedures. In addition, providers may not gain benefits under the Federal Sentencing Guidelines described in the first question above if there is no formal document called a Compliance Program.

On the contrary, Compliance Programs appropriately address potential fraud and abuse issues. They also include mechanisms for helping to ensure compliance such as processes for identification and correction of potential problems that are not addressed during the certification process. In other words, organizations may be accredited but fail to meet applicable compliance standards for fraud and abuse.

Now is the time for all providers to recognize and act upon the need to establish and maintain Compliance Programs. “Working on it” is no longer good enough.

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2025 Elizabeth E. Hogue, Esq. All rights reserved.

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