OIG Investigations, Compliance, and Defense for Labs
Experienced OIG Compliance Defense Team
If you are under investigation for ordering or administering fraudulent COVID-19 testing or have been indicted, there is no time to waste in hiring an experienced OIG compliance attorney.
The DOJ has wasted no time prosecuting respiratory and clinical labs for fraudulent COVID-19 testing. In fact, the novel coronavirus has resulted in a substantial increase not only in prosecutions of laboratory executives but also a renewed vigorous prosecutorial attitude against labs.
This puts labs at an increased risk of attracting the DOJ’s attention, especially if the lab handles or orders COVID-19 tests. To counteract this risk, labs are developing OIG compliance programs.
An OIG compliance program is a set of internal policies that detects, monitors, and remedies instances of fraud and noncompliance in the lab’s operations.
At Oberheiden, P.C., our team of OIG compliance attorneys assists labs, doctors, hospitals, nursing homes, and other providers throughout all stages of OIG compliance setup including the implementation and monitoring of OIG compliance programs.
We can ensure that your compliance program is properly tailored to the specific needs of your laboratory specialization and that it addresses all legal and regulatory issues. We also defend our clients against unwarranted allegations of COVID-19-related frauds.
Do not wait to contact an experienced attorney in OIG compliance today. Put Oberheiden, P.C. on your side to protect your lab’s business and reputation.
What Triggers an OIG Investigation?
The U.S. Department of Health and Human Services (“DHHS”) Office of Inspector General (“OIG”) aggressively enforces the compliance obligations of healthcare providers, including respiratory and clinical laboratories.
Any healthcare provider—such as laboratories, doctors, dentists, pharmacies, hospitals, etc.—who bills Medicare or other governmental program is subject to oversight by the OIG. Most OIG investigations are triggered by noncompliant billing practices or improper coding by the labs.
However, other causes of an OIG investigation include healthcare fraud schemes—namely, COVID-19-related frauds. In both cases, the OIG can refer the matter to another federal authority for civil and/or criminal chargers.
For instance, unintentional billing violations expose the lab to civil liability under the False Claims Act. However, if the OIG determines that the lab intentionally overbilled the government or took advantage of the lab’s eligibility under a federal program, then a criminal prosecution may follow.
Penalties for OIG Noncompliance
The OIG has released a fraud alert to the public, warning them about the high potential for COVID-19 fraud schemes. These fraud schemes typically offer COVID-19 tests in exchange for personal information.
The fraudsters then use this information to submit false claims and billing to federal health care programs. Because these instances of COVID-19-related frauds and identity theft are on the rise, the DOJ has increased its tools and resources to combat such frauds.
A DOJ prosecution can lead to substantial fines and penalties; loss of government contracts; loss of ability to do business with the government in the future, loss of governmental program eligibility; payment denials; and, in some cases, jail time.
To guard against the increased DOJ scrutiny, many labs are implementing OIG compliance programs.
OIG Compliance Programs for Labs
The easiest and most effective way to avoid fraud charges is to implement a comprehensive compliance program. To assist, the OIG has published guidance based on the provider’s specialization regarding what a compliance program should entail.
An OIG compliance plan allows the lab to implement an internal policy that reduces fraud and abuse in healthcare programs and the billing process.
Labs should also heed the OIG’s website, which publishes work plans containing various OIG updates including audits, evaluations, and inspections.
The OIG is aware that laboratory billing is notoriously a source for legal challenges and, thus, it scrutinizes this area the most. And with the increased prosecutorial interest in labs due to COVID-19 and fraudulent testing, labs are at an especially high risk for allegations of noncompliance. Effective compliance programs are a must.
However, in addition to implementing an OIG compliance program, labs must also ensure that their compliance programs are achieving their intended purposes, are continuously monitored, and properly documented. This is because “paper” compliance programs are insufficient to shield the lab from civil and/or criminal liability – the program must work in practice.
Therefore, compliance programs become highly useful when negotiating reduced settlements and penalties. And this is something an experienced OIG compliance attorney can help you with.
How an Attorney Can Help You with OIG Compliance
It is sometimes hard to avoid OIG scrutiny. In such cases, the OIG may initiate an investigation into your lab’s billing practices or allege that your lab has been perpetrating an ongoing COVID-19-related fraud.
In these cases, you know it is time to hire legal counsel as soon as possible. An attorney can address the immediate issues regarding the OIG’s investigation – whether this entails preparing a personalized defense strategy or implementing a comprehensive OIG compliance program.
Preparing an effective compliance program entails staying abreast of legal and regulatory changes, monitoring risk profiles, and addressing identified weaknesses.
Additionally, effective compliance programs are monitored continuously and customized to the needs of the lab’s specialization.
Below are key ways an attorney can help you with OIG compliance:
- Planning and implementing a well-designed and personalized compliance program;
- Preparing for audits;
- Examining consistency in laboratory records;
- Reviewing coding/billing practices of the lab;
- Making sure labs can validate orders from doctors;
- Helping labs secure validation forms;
- Ensuring that the lab is able to justify medical necessity from its tests;
- Preparing a personalized defense strategy to allegations of noncompliance;
- Getting clients ready to provide testimony.
Choosing the optimal OIG compliance attorney involves a consideration of many important factors. Your attorney and law firm should have a firm commitment to compliance and thorough understanding of the laws regulating labs. It should also emphasize transparency, open and honest communications, and dedication.
Need Advice with OIG Compliance Programs?
Federal authorities are cracking down on laboratories for perpetrating various COVID-19-related frauds and, therefore, damaging the integrity of U.S. governmental programs.
OIG investigations can lead to devastating consequences for respiratory and clinical labs, including reputational loss, loss of business contacts, inability to do business with the government in the future, loss of participation in federal government programs, fines and penalties, and jail time.
Labs are increasingly finding it beneficial to develop OIG compliance programs. These programs allow the labs to identify internal weaknesses so that they can be remedied as soon as possible with little public attention.
Our attorneys can help you implement and maintain a robust OIG compliance program and prepare a strategic personalized defense.
Do not wait any longer to get the help you need. Call or contact our office today for a free consultation to protect your lab’s business, future, and reputation.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.