DEA Pharmacy Investigations Lawyers
DEA Pharmacy Investigations Lawyers
Our attorneys help with DEA audits and inspections of pharmacies nationwide.
The DEA oversees all matters related to controlled substances in the USA. It regularly conducts investigations that are intended to stop the unlawful distribution of drugs. The DEA looks at pharmacies as major hubs of drug diversion and drug trafficking. It regularly audits pharmacies in order to ensure that procedures are being followed. The DEA will investigate pharmacies based on suspicious activity or reports of unlawful dispensing of controlled substances. Pharmacies and pharmacists are advised to get the help of a DEA defense lawyer who can assist them with their DEA audit, inspection, or investigation.
The Spodek Law Group can help with all types of legal situations you may find yourself in involving DEA registration, professional licensing, audits, and more.
Issues in DEA Pharmacy Inspections
There are many issues that are part of any DEA pharmacy inspection. Before the DEA does an audit or inspection of your pharmacy, it has to receive informed consent from the holder of a DEA certificate of registration – or it has to get an administrative search warrant. Before consenting to an investigation, a registrant should speak to an attorney who can advise them of their rights and make sure they understand what the DEA is allowed and not allowed to do.
DEA investigations will usually be focused on potential violations surrounding the dispensing of controlled substances. Investigations can address things such as:
- Ordering of controlled substances
- Inventory management
- Prescription fraud monitoring
- Security of the drugs at the pharmacy
- Transfer and disposal of controlled substances
What to Do When Facing a DEA Investigation
There are a few ways you can respond to a DEA investigation. You can ignore the DEA investigation or comply with their demands. By hiring a DEA defense attorney, you can work to slow down the investigation and also ensure that investigating agents don’t overreach. You can avoid potential pitfalls, with the DEA defense attorney acting as a barrier and preventing any acceleration in the case.
When involved in a DEA investigation, one of the most important things to do is determining the scope of the investigation. DEA investigations can target a broad array of offenses. In order to ensure your pharmacy gets the right defense, it’s important to understand the scope of the inquiry. Our defense lawyers can help you determine why the pharmacy is being targeted:
- Stark/Anti-Kickback statute violations
- DEA registration issues
- DSCSA violations
- Prescription fraud
- Inventory/Storage/Disposal recordkeeping violations
- Medicare/Medicaid billing fraud
- Money laundering
- Mail fraud
- Wire fraud
- Opioid diversion
It’s important to understand and identify what triggered the investigation. In addition to determining the scope of the investigation, it’s critical to determine what triggered the investigation. Is the DEA doing a routine inspection? Is there a whistleblower who contacted the agent? These are all different situations and they require different strategies.
One of the first things you should consider doing is conducting an internal risk assessment. When the DEA is looking at your pharmacy, you need to know what, if anything, the DEA might find. It’s critical you conduct this audit with your pharmacy’s DEA defense lawyers so that the attorney-client privilege applies to any findings from this audit. After you conduct the audit, you have to look at the results. If there are deficiencies in your compliance efforts, then you need to fill those gaps.
The next step after reviewing the results of your internal pharmacy risk assessment audit is to formulate a strategy. Your defense strategy has to address all the allegations in the investigation. If you are the target of a DEA investigation, you have to be very careful about what you say and do. Your DEA defense attorney is critical in this process because he/she can tell you what to do and not to do. Once you have an understanding of the scope of the DEA’s investigation, you can then understand what potential there is for charges to be filed against you.
Once your pharmacy is in the DEA’s crosshairs, the best thing you can do is hire a DEA defense attorney.
Our DEA Defense Services
As licensed healthcare providers, the stakes are high when it comes to facing investigations and administrative actions from the Drug Enforcement Administration (DEA). At our firm, we understand the gravity of these situations and are dedicated to fiercely representing physicians, pharmacists, dentists, nurses, and other healthcare providers and practices before the DEA.
Our services include expert assistance with:
- DEA registration applications
- Representation in DEA investigations, including “inspections” and “site visits”
- Defending healthcare providers in response to:
- DEA Orders to Show Cause
- DEA Suspension Orders
- DEA Memorandums of Agreement
- DEA number revocations
- DEA administrative hearings
- Cases referred by the DEA to the U.S. Attorney’s office for criminal prosecution
The DEA, through its Office of Diversion Control, zealously prosecutes reported offenses and these tactics result in individuals being stripped of their registrations and licenses before they even have the opportunity to process the fact that they are being investigated. This is part of the psychological aspect of the initial thrust and parry. Although it is difficult to stand up for yourself in the face of such force, it is imperative that you resist the temptation to yield.
At our firm, we believe that the best defense is a good offense. In these matters, the process of investigating your license or DEA registration is the subject of administrative law and, therefore, different than other processes with which you may be familiar. Having an experienced attorney guide you through the steps enables you to find active solutions early.
Even if you are not overwhelmed by the investigatory process and believe that your extensive education, professional knowledge, and medical practice experience empower you to mount a successful defense, please remember that this is a legal investigation with long-range consequences. If there are sanctions, then these are reported to the National Practitioner Data Bank (NPDB) and the state licensing boards for other jurisdictions in which you may be licensed. In addition, the DEA may refer a case to the U.S. Attorney’s office for criminal prosecution.
The steps involved in an administrative legal action involve interviews and appearances with field investigators and licensing boards, followed by written proposals and possible suggested sanctions. At this point, engaging an attorney and starting to defend yourself becomes progressively less effective. The administrative body has made conclusions with regard to your situation. Those decisions have become part of the record and incorporated into the general body of what is known. Challenging these items and beliefs will become tantamount to pushing a boulder uphill. It is far more efficient to seek assistance when the boulder is still a pebble.
After the findings and proposed sanctions have been rendered, you are faced with two possibilities: settle or face an administrative hearing. Neither prospect is particularly appealing. If you do decide to pursue formal administrative action, the process is arduous and confrontational.
Possible forms of administrative sanctions include:
- Reprimands placed in the public record
- Suspensions of your license or registration
- Long-term or permanent restrictions
- Probationary periods of indeterminate length
- Complete revocation of your registration and/or license
Any of these results can significantly interfere with your career and, of course, revocation of your license is certainly a death knell for the professional path that you were following as it will impact out-of-state licenses as well as the one that was the subject of the immediate investigation.
If your pharmacy or medical practice is facing a DEA investigation, audit, or any administrative action, contact the experienced DEA defense attorneys at Spodek Law Group today. We will fight aggressively to protect your rights, your livelihood, and your future.