OIG Compliance Programs During COVID-19

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Are you worried about OIG compliance? Do you need advice on implementing or revising your compliance program, especially now as the nation deals with the novel coronavirus? If so, then give our team of OIG compliance attorneys a call today.

The Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) has a zero-tolerance policy with respect to labs that commit fraud and abuse of federal government healthcare programs such as Medicare and Medicaid.

The OIG is also the body responsible for enforcing compliance and investigating instances of provider noncompliance. It has repeatedly emphasized the importance of developing an OIG compliance program.

Together with other federal authorities, the OIG has made it its prime mission to root out instances of fraud and abuse involving fraudulent COVID-19 testing committed by labs. This increased scrutiny places respiratory and clinical labs at risk of a federal investigation and prosecution.

At The Criminal Defense Firm, we have a dedicated team of OIG compliance and defense attorneys. Our team vigorously defends labs accused of COVID-19-related frauds such as fraudulent COVID-19 testing.

We also ardently defend our clients against allegations of improper billing, improper coding, false claims, falsified doctor orders, improperly secured validation orders, and ordering tests/procedures that are medically unnecessary, as some examples.

Do not wait for a protracted investigation or prosecution to begin. If you need legal advice on OIG compliance or defense, call or contact us today to protect your lab’s reputation and future.

Put our highly experienced team on your side

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Former DA

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney
& Former District Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior Trial Attorney
U.S. Department of Justice

Local Counsel

John W. Sellers
Linda Julin McNamara

Former Chief, DOJ Appeals

Local Counsel

Elizabeth Stepp
Elizabeth Stepp

Litigation Counsel

Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (OIG)

Timothy E. Allen
Timothy E. Allen

Former Senior Special Agent

Chris Quick
Chris Quick

Former Special Agent (FBI & IRS-CI)

David M. Bentz
David M. Bentz

Former U.S. Secret Service Agent

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

OIG Compliance, Investigations, and COVID-19


All healthcare providers who submit billings to Medicare or other federally funded programs need to have in place a detailed and effective compliance program. This includes hospitals, laboratories, physicians, dentists, nursing homes, etc.

An OIG compliance program should encompass all aspects of the provider’s specialization and industry – from billing Medicare, coding, and ordering tests to documenting clinical results and recordkeeping.

The OIG regularly publishes Guidance and Work Plans on its website to help providers achieve and maintain compliance as well as to stay up-to-date on any changes.

To be most effective, OIG compliance programs should also provide for a crisis response team and detailed response plan in cases of internal noncompliance.

This shows to federal authorities that the lab had not only the intention of achieving full compliance with the law but also a detailed plan in place to follow when noncompliance is present.


The OIG is empowered with the authority to investigate a provider’s compliance obligations in order to avoid fraud and abuse in the healthcare process – whether involving billing, testing, federal program reimbursement, etc.

The Department of Justice (“DOJ”) may also be involved and work alongside the OIG in cases where criminal fraud and abuse are suspect among labs, lab executives, and other personnel.

In addition to OIG investigations, the OIG may schedule audits or inspections of respiratory and clinical labs for noncompliance.


The CARES Act and the Paycheck Protection Program (“PPP”) appropriated billions of dollars to support providers including laboratories who are affected by the novel coronavirus, COVID-19.

The OIG and the DOJ have been especially vigilant of laboratories ordering COVID-19 testing since this presents a high probability of fraud and abuse.

Lastly, the OIG has been actively engaged in reviewing disbursements of relief funds administered through the CARES Act to ensure that the providers who received such funds were eligible for them and that the funds were properly disbursed.

Objectives and Benefits of OIG Compliance Programs


An effective OIG compliance program contains key elements such as leadership from upper management, open corporate culture, training and education, internal controls, risk assessment, and monitoring, documentation, and recordkeeping provisions.

Compliance program are important because they protect labs against the high probabilities of fraud and abuse in their operations by detecting, monitoring, and correcting internal weaknesses.

The objective is to safeguard respiratory and clinical labs dealing with COVID-19 testing from federal liability—such as liability under the False Claims Act or the CARES Act.


OIG compliance programs are beneficial because they help respiratory and clinical labs identify internal fraud and abuse in their operations as well as external violations of federal and state law.

They also demonstrate to the government that the lab had the full intention of complying with the law. Other important benefits for labs include the following:

  • Commitment to ethics and honesty;
  • Improvements to the quality of internal operations;
  • Early detection of weaknesses, violations, and instances of noncompliance;
  • Ability to quickly address identified weaknesses; and
  • Creation of open communication in the workplace.

The above benefits all aim to reduce the loss to the government resulting from the submitted false claim and prevent further injury to the public. Also, an effective OIG compliance program reduces the lab’s liability exposure and, therefore, their civil and criminal penalties.

Statutes Regulating Healthcare and COVID-19-Related Frauds by Labs

Respiratory and clinical labs alleged to have ordered/administered fraudulent COVID-19 tests can be liable under a host of civil and criminal provisions.

Below we present the most common:

  • CARES Act: The CARES Act allocated more than $2 trillion in emergency aid to businesses, entities, and individuals who have been affected by COVID-19. One of the most litigated programs created by the CARES Act is the Paycheck Protection Program (“PPP”). PPP loans are SBA-guaranteed emergency loans available to small and medium-sized businesses financially and negatively impacted by COVID-19.
  • Eliminating Kickbacks in Recovery Act (“EKRA”): The EKRA was passed as a part of the SUPPORT Act. Broadly, it prohibits labs, clinics, recovery centers, and other clinical treatment entities from paying or accepting kickbacks for referring patients.
  • Anti-Kickback Statute (“AKS”): The AKS prohibits the knowing and willful offering or receipt of anything of value in order to induce patient referrals or referrals for services that are payable by a federal program.
  • Stark Law: This statute prohibits physicians from making patient referrals to healthcare entities in which the physician or their immediate family has a financial relationship or benefit.
  • False Claims Act (“FCA”): The FCA prohibits individuals and entities from knowingly defrauding governmental programs and submitting false claims to governmental programs for reimbursement.
  • U.S. Code Section 1001: Section 1001 prohibits anyone from making false statements to the government.
  • Federal Healthcare Fraud – U.S. Code § 1347: This provision prohibits anyone—in connection with the delivery of or payment for healthcare benefits—from defrauding any healthcare benefit program or obtaining money or property under the control of any healthcare benefit program by means of false or fraudulent pretenses.
  • Aggravated Identity Theft: Individuals and entities who provide medical services such as COVID-19 testing in exchange for personally identifiable information and then who use that information without permission to defraud the government have engaged in identity theft.
  • Federal Attempt and Conspiracy – U.S. Code § 1349: This provision under federal law prohibits any person from attempting to or conspiring to commit any offense under federal law.

Need Leal Advice on OIG Compliance?

OIG compliance programs serve multiple benefits to respiratory and clinical labs. From quick detection of internal weaknesses to prevention of federal violations, these programs demonstrate to federal authorities that the lab intended to follow the law.

As COVID-19 continues to rattle the nation, the DOJ and the OIG have been eager to scrutinize labs engaging in fraudulent schemes that prey upon the public fear.

However, in doing so, federal authorities have placed an increased pressure on labs – a pressure that is best relieved through the implementation and documentation of a comprehensive compliance program.

Do not wait any longer to secure the legal services of an OIG compliance attorney. We can advise you on implementing a compliance program and how the OIG and DOJ’s recent aggressive prosecutorial approach may impact your business.

Give us a call or contact us online today for a free consultation to protect your lab’s business and reputation.

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