External Audit Defense for Laboratories
We Help Laboratories Avoid Recoupments and Other Penalties During External Compliance Audits
Laboratories that provide testing services to patients are subject to stringent billing rules enforced by the U.S. Department of Health and Human Services (DHHS) and other authorities, and nonclinical laboratories are subject to the oversight of the U.S. Food and Drug Administration (FDA) as well. In order to enforce laboratories’ compliance obligations, DHHS, the FDA, and other agencies routinely conduct audits—and they often do so with only limited (if any) advance notice to labs.
When facing external audits, laboratories must do much more than simply comply with demands for information and wait for the audit to run its course. Compliance audits can lead to substantial penalties. In order to protect their facilities, lab owners and executives must proactively assume a defensive posture, and they must be prepared to dispute any allegations of fraud or other offenses by all means available.
Strategic Consulting for External Audit Defense
At Corporate Investigation Consulting, we provide strategic consulting for external audit defense. We have significant experience handling laboratory audits, both as consultants to labs and as former federal health care fraud investigators. With a team that includes former agents with DHHS and other agencies, we have a comprehensive understanding of the external audit process, and we offer deep and strategic insights to labs facing all types of government inquiries.
Our experience includes consulting with laboratories during private health insurance audits as well. Health insurance companies typically reserve broad audit rights in their contracts with laboratories and other providers, and private insurance audits can lead to demands for substantial recoupments. However, in our experience, these demands are often misguided, and it will often be possible to avoid unjustified repayment demands by taking an assertive approach to the external audit process.
We provide external audit defense consulting to laboratories facing invasive inquiries from all government and private entities. This includes, but is not limited to, audits involving:
- U.S. Department of Health and Human Services (DHHS)
- U.S. Department of Labor (DOL)
- U.S. Food and Drug Administration (FDA)
- Centers for Medicare and Medicaid Services (CMS)
- CMS Audit Contractors (MACs, RACs, and UPICs)
- Other private health insurers
Our Consulting Services for Laboratory External Audit Defense
Our former federal agents assist laboratories with all aspects of external audit defense. In order to effectively mitigate risk, it is essential to begin developing a defense strategy at the first sign of an external inquiry. With this in mind, our consulting services for laboratory external audit defense include:
- Making contact with the auditors and managing all ongoing communications on the laboratory’s behalf;
- Conducting a confidential internal compliance audit in order to either establish documentation of compliance or identify concerns that need to be addressed;
- Helping the laboratory proactively address any concerns before they are discovered by auditors, and appropriately handling voluntary disclosure as required by contract, statute, or regulation;
- Developing an external audit defense strategy based upon the information obtained through our internal audit;
- Scrutinizing the auditors’ practices, assumptions, and methodologies in order to identify flaws before they lead to recoupment demands and other penalties;
- Overseeing the resolution of the external audit, assessing next steps, and facilitating a favorable relationship with the auditing entity; and,
- If necessary, assisting with challenges to audit results and/or assisting with further defense efforts in anticipation of formal law enforcement action.
FAQs: Avoiding Unnecessary Penalties During External Laboratory Audits
Q: What should I do if my laboratory is facing an external audit?
As a laboratory owner or executive, if your facility is facing an external audit, you need to make the audit your priority. You must do everything necessary to defend against the audit successfully, whether this means avoiding penalties entirely or mitigating any potential liability. Even if your lab is fully compliant, resolving the audit favorably will still present challenges; and, the sooner you implement a defense strategy, the better your chances will be of coming out of the audit unscathed.
Q: Why is my laboratory being audited?
There are a number of potential reasons why your laboratory is being audited. One possibility is that the audit is being conducted as a matter of course. Federal authorities and private health insurance companies conduct routine and random audits, so it is possible that there is not a specific reason for the inquiry.
However, it is also possible that something triggered the audit. If billing anomalies, a patient complaint, or some other factor caused a government agency or insurance company to target your laboratory specifically, then this may change how you need to structure your laboratory’s defense.
Q: How can I make sure the audit does not disrupt my laboratory’s day-to-day operations?
You can minimize any disruptions to your laboratory’s day-to-day operations by engaging an outside consulting firm to conduct an internal audit, develop a defense strategy, and oversee the audit on your behalf. At Corporate Investigation Consulting, we work closely with our clients’ owners and executives, but we also take a hands-on approach that minimizes their direct involvement to the greatest extent possible.
Q: What should I do if I am aware that my laboratory is not fully compliant?
If you are aware of deficiencies in your laboratory’s compliance program, then this is something that you will need to address specifically as part of your lab’s external audit defense. Known compliance deficiencies can increase the risk of penalization, and potentially even give rise to criminal allegations of intentional health care fraud. We have specific experience consulting with owners and executives in this scenario, and we can use our experience to help you make the right decisions.
Contact Us to Discuss Your Laboratory’s External Audit Defense Strategy
Is your laboratory facing an external audit? If so, we encourage you to speak with one of our senior consultants about your lab’s defense strategy right away. To schedule a free and confidential consultation as soon as possible, please call 866-352-9324 or tell us how we can reach you online now.