If you are a pharmacy executive or you have a professional license to own or manage a pharmacy, getting notified by your state Board of Pharmacy that you are under license investigation is a big deal. What happens during and after the investigation stage will also depend largely on what state licensing boards you are dealing with. You are bound to have questions about the way forward and how to best defend your interests.

Dr. Nick Oberheiden is a pharmacy investigation lawyer at the national law firm Oberheiden P.C. Here are some questions that he often gets from pharmacy clients, as well as some defense strategies that he has used in the past to protect his clients’ interests.

Frequently Asked Questions About Board of Pharmacy Investigations

1. What Information is the Board Likely to Be After?

Generally speaking, it will depend on the nature of the Board’s investigation. The Board has to ensure that all of the licensed pharmacies in the state comply with its rules and regulations. These are very widespread. As a result, the Board may request access to:

• Quality control protocols

• Communications records

• Financial records and receipts

• Dispensing records

• Signature logs

• Physician notes

• Purchase invoices

• Contracts with vendors or insurance companies

What the state licensing Boards want to see can be used to figure out what they are investigating, if it is not already known. In many cases, it is not. This can help you better plan your defense.

2. Are These Investigations Different from Other Types of Audits?

Board investigations are more targeted than many other types of audits, though the line between them has become increasingly blurry as auditing contractors use algorithms to analyze transaction data more and more often. 

When the Board of Pharmacy conducts an investigation, it has probably already learned of potential wrongdoing or a violation of protocols that the pharmacies face. This makes it different from a routine audit, which does not have anything particular in mind when it begins. 

However, this aspect of audits has changed in the past few years as auditing agencies get smaller and have turned to algorithms and data analysis as their chief weapons of oversight. Now, even audits tend to only happen if signs of misconduct or billing discrepancies have already been found. This trend has made audits more like investigations, increasing the seriousness of getting audited.

3. What Can Trigger a Board Investigation? 

A Board of Pharmacy investigation can begin in several different ways.

A common trigger is an investigation by another agency – whether a private insurer’s audit or a law enforcement investigation – that has turned up evidence of wrongdoing that can implicate your pharmacy’s license. 

Not all investigations are triggered by something so serious, though. Many Board of Pharmacy investigations are fairly routine, like routine pharmacy compliance inspections or inspections before issuing a permit or a license.

4. If the Investigation Turns Something Up, Can Criminal Charges Follow?

Yes, Board of Pharmacy investigations can lead to criminal convictions and charges, often for healthcare fraud. Because of this possibility, pharmacies and their executives should strongly consider hiring legal counsel or a pharmacy investigation attorney to help them during the Board’s investigation. 

Defense Strategies for Board of Pharmacy Investigations 

It is important to note that every situation is different when it comes to Board of Pharmacy investigations. The context leading up to the investigation can suggest how serious the investigation will be, which should alter the defensive stance that your pharmacy investigation lawyer should take. At this moment, the attorney-client relationship should already be established because even your interests as a pharmacy can change how to best handle the investigation. 

Even though there is no universal playbook, there are some defensive strategies that pharmacy investigation attorneys like Dr. Nick Oberheiden tend to use for their clients.

1. Learn as Much as You Can About the Investigation Before it Happens

The goal of the investigation is a very important thing to know. It can help you prepare for the investigation and anticipate the aftermath, letting you get ahead of the investigators to protect the interests of your pharmacy. 

Unfortunately, the goal of the investigation may not be clear. 

Pharmacy investigation lawyer Dr. Nick Oberheiden, from Oberheiden P.C., has found several ways to read between the lines and figure out what the Board is looking for. “The investigation notice is an important document to parse through, as it often lays out the information that it wants to be disclosed. This can tell you a lot about where the investigation is going. Recent history also matters: If there was a compliance event in the past few months, that may have triggered the Board’s investigation. Finally, you may be able to demand additional information about the investigation from the Board, often in the guise of asking for clarification on the information requested.”

2. Keep Close Tabs on the Investigation and Investigator 

A fundamental aspect of your defense is to monitor and control the investigation and the Board’s investigator without crossing a line and interfering in the process. 

The Board’s investigation will generally have limitations and rules. If the notice laid out the information sought and the areas of your pharmacy that the Board wanted access to, then the investigator should stick to the script. Ensuring that they do is important: If they find something suspicious that is outside the scope of their investigation, and you are not there to enforce that scope, they may stretch their inspection past its legal or contractual boundaries, find evidence of wrongdoing, and your pharmacy can suffer as a result.

3. Use the Appeals Process

If the Board’s investigation finds a discrepancy or evidence of wrongdoing, you still have legal recourse. While every state’s appeals process is different, they do all have one. The deadlines are often tight, though, so invoking your rights to a neutral third party’s review of the results of the investigation has to be done immediately. 

4. As Always, Compliance is the Key to Defense

As with many other aspects of running a pharmacy, the key to success and having a favorable outcome in a Board of Pharmacy investigation is to take everyday compliance seriously. Not only can strict compliance lead to an investigation into your pharmacy going nowhere – it can even avoid the investigation stage from the beginning, at all.