Whether you're dealing with a DEA inspection, discrepancies in your controlled substances records, or allegations of non-compliance with the Controlled Substance Act (CSA), our experienced attorneys are here to support you. For medical providers and pharmacies, even a minor misstep related to controlled substances can lead to devastating consequences—crippling fines, DEA registration suspension and/or revocation, business closures, or worse, civil and criminal enforcement actions. Our skilled healthcare defense attorneys excel in navigating DEA regulations, minimizing risks, and resolving the collateral consequences of DEA inspections.
As Seen On
.png)
Specialized Healthcare Attorneys and Expert Consultants - At Health Law Alliance, our mission is to provide unparalleled legal representation to healthcare professionals, protecting their rights, licenses, and practices from regulatory overreach and unjust enforcement actions. Whether navigating complex legal actions or proactively addressing compliance challenges, our seasoned legal professionals, supported by industry-leading experts, are your unwavering partners in navigating the complexities of healthcare laws and regulations nationwide.
Tenacious Defense - At Health Law Alliance, we pride ourselves on being the law firm that healthcare professionals and businesses turn to when the stakes are highest. We have consistently demonstrated our capability to stand toe-to-toe with some of the most powerful and well-resourced adversaries in the healthcare industry. Whether facing a government agency or a dominant industry player, our team’s unwavering commitment and expertise have led to victories nationwide. When faced with a seemingly daunting legal predicament, our healthcare defense attorneys rise to the occasion, delivering the tenacious defense our clients deserve.
A Proven Legacy of Success Against the Most Formidable Opponents - The healthcare attorneys at Health Law Alliance bring a distinguished history of securing favorable outcomes in the most complex and high-pressure legal battles. We have built our reputation by successfully defending clients against aggressive government enforcement actions and industry titans, achieving results that protect our clients’ rights, reputations, and livelihoods. Our proven track record is a testament to our meticulous preparation, innovative legal strategies, and deep understanding of the healthcare sector’s legal and regulatory landscape. For those who demand unparalleled dedication and results, Health Law Alliance stands ready as a trusted source for legal and regulatory support.
Frequently Asked Questions About DEA Inspections
What triggers a DEA inspection and/or a DEA Audit?
DEA inspections and audits are often prompted by red flags such as unusual prescribing and/or dispensing patterns, missing or inaccurate controlled substances records, and/or reports of suspicious activity. Random compliance checks are also routine under the Controlled Substances Act (CSA) to ensure healthcare providers, including prescribers and pharmacies, adhere to all requisite laws and regulations.
What should I do if the DEA shows up for an inspection?
Remain calm, be polite, and ask for identification and the purpose of the inspection. You are entitled to see a notice of inspection or a search warrant. Do not volunteer unnecessary information or make false statements. Contact your attorney immediately to ensure your rights are protected throughout the process.
Can the DEA inspect my healthcare business without prior notice?
Yes, DEA inspections often occur without prior notice, especially if agents suspect non-compliance or illegal activity. However, they must have proper authorization, such as an administrative inspection warrant.
What are the consequences of non-compliance discovered during a DEA inspection?
Findings of non-compliance can lead to severe consequences, including DEA registration suspension or revocation, hefty fines, and even criminal charges. These findings can also disrupt your business operations.
How can I prepare for a DEA inspection?
Proactive compliance measures include maintaining accurate records, conducting internal audits, and implementing robust protocols and training programs for staff. Partnering with an experienced healthcare attorney and DEA expert to develop risk mitigation strategies is highly recommended.
Speak to an experienced attorney today at no-cost to evaluate your situation and discuss how we can help.
Legal challenges can be complex and stressful. Our experienced attorneys are dedicated to offering personalized guidance and effective solutions to help you navigate your legal journey with confidence
DEA inspections are a critical part of enforcing the Controlled Substances Act (CSA). They assess whether healthcare providers and pharmacies comply with federal regulations regarding controlled substances. Failing to meet these standards can result in severe penalties, including fines, suspension of DEA registration, or criminal charges.
What Happens During a DEA Inspection?
Inspectors evaluate record-keeping, inventory management, and the security of controlled substances. They may review your logs, prescription records, and storage practices for any irregularities or breaches.
Why Preparation is Essential
Preparation helps mitigate risks of penalties. Regularly updating records, maintaining strict inventory controls, and ensuring staff compliance with DEA standards are key to passing inspections smoothly.
Immediate Steps to Take
By proactively addressing these areas, you reduce the likelihood of violations and demonstrate your commitment to compliance.
The Controlled Substances Act (CSA) is the backbone of DEA inspections. It’s what defines how pharmacies and healthcare providers manage, store, and document controlled substances. Staying compliant isn’t just about avoiding penalties—it’s about running a responsible and ethical practice.
What Does the CSA Require?
At its core, the CSA focuses on three main areas:
What Are Inspectors Really Checking?
When DEA agents walk into your practice, they’re there to ensure you’re following these rules. They’ll comb through your records, inspect storage areas, and verify that your prescriptions align with legal requirements. Any gap—no matter how small—can raise a red flag.
How Can You Stay Ahead?
Staying compliant isn’t just about avoiding penalties—it’s about building trust with your patients and showing that your practice takes responsibility seriously. A little preparation now can save you a lot of headaches later.
When it comes to DEA inspections, the smallest mistake can feel like a big deal. Most issues aren’t about bad intent—they’re about the little things slipping through the cracks. Understanding the common challenges can help you stay one step ahead.
The Usual Suspects
Why These Issues Keep Happening
Running a busy practice is hectic. Staff turnover, outdated processes, or just not enough time in the day can lead to these challenges. DEA inspectors aren’t just looking for big scandals—they’re focused on whether your systems prevent problems before they start.
How to Tackle These Challenges
Think of this as less about "passing an inspection" and more about running a tight, professional operation. The smoother your systems, the easier it is to handle an inspection without breaking a sweat.
DEA inspections are structured but can still feel overwhelming if you’re unprepared. Inspectors focus on compliance with the Controlled Substances Act (CSA), and understanding their process can make the experience smoother.
How an Inspection Unfolds
The process begins with the inspector presenting credentials and explaining the purpose of the visit. They’ll review your records and controlled substances inventory to ensure everything is properly documented and stored. Security measures, such as access controls and storage systems, are also closely examined. Inspectors may also ask questions about your processes for preventing theft or misuse.
At the end of the visit, you’ll typically receive an initial summary of findings. This is your chance to clarify any misunderstandings or provide missing documentation before a formal report is filed.
If Issues Are Found
Non-compliance can lead to penalties ranging from warnings and fines to suspension of your DEA registration. For more serious violations, there’s the risk of criminal investigation. However, most issues involve record-keeping or procedural oversights that can be resolved with corrective actions.
Preparing for an Inspection
Staying organized is your best defense. Keep your records updated, ensure your inventory aligns with documentation, and make sure your staff understands their responsibilities during an inspection. The goal isn’t perfection—it’s demonstrating that you’re committed to compliance.
By approaching inspections as routine rather than adversarial, you’ll reduce stress and show that your practice is prepared to meet its legal obligations.
DEA inspections come with high stakes. Even unintentional mistakes can lead to significant consequences. Understanding what’s at risk helps highlight the importance of preparation and compliance.
What Can Happen After an Inspection?
The outcomes of a DEA inspection depend on the findings. For minor infractions, the DEA might issue a warning or suggest corrective actions. However, more serious violations, such as incomplete records, improper storage, or evidence of diversion, can lead to harsher penalties.
Common Consequences Include:
The Ripple Effect
Beyond legal and financial penalties, DEA findings can harm your reputation. Patients, partners, and regulators may lose trust in your practice, which can have lasting impacts on your business.
How to Minimize Risks
The best way to avoid serious consequences is to proactively address compliance gaps before an inspection occurs. Regular internal audits, staff training, and adherence to DEA regulations can keep issues from escalating.
Remember, the DEA’s focus is on enforcing the Controlled Substances Act to ensure public safety. Demonstrating a genuine commitment to compliance often works in your favor during and after inspections.
DEA inspections don’t have to feel like a ticking time bomb. With the right legal team by your side, you can face the process confidently and protect what you’ve worked so hard to build. That’s where we come in.
Before the Inspection
Preparation makes all the difference. We’ll help you get your records, inventory, and processes in order so you’re ready for any question an inspector throws your way. Need an internal audit? Training for your team? We’ve got you covered.
During the Inspection
When the DEA shows up, it’s natural to feel on edge. We’re here to make sure you don’t have to navigate it alone. Whether it’s answering questions, presenting records, or making sure your rights are respected, we’ll be your advocate every step of the way.
If Issues Come Up
Not every inspection goes perfectly, and that’s okay. If the DEA flags something, we’ll jump into action—crafting a plan to address their concerns and protect your license. From negotiating penalties to fighting back against unfair accusations, we’ll stand by you.
Why You Can Trust Us
Facing a DEA inspection is tough, but you don’t have to do it alone. With our help, you’ll not only get through it but come out stronger.
CVS Caremark one of the three major PBMs that control nearly 90% of the market for prescription claims processing.
Learn More
Optum is one of three major PBMs that control nearly 90% of the market for prescription claims processing.
Learn More
ESI is one of the three major PBMs that control nearly 90% of the market for prescription claims processing.
Learn More
Prime has a relationship with ESI that provides for joint provider networks and oversight by both companies.
Learn More
Medicare and Medicaid use agencies like OIG or OMIG and outside contractors to audit prescription drug claims.
Learn More
Humana is a payor that uses PBMs and other contractors to audit government and commercial drug claims.
Learn More
Qlarant is contracted with Medicare to perform fraud, waste, and abuse audits and investigations.
Learn More
Safeguard is contracted with Medicare to perform fraud, waste, and abuse audits and investigations.
Learn More
To design an effective PBM audit response strategy, providers must understand the chain of events both prior to the initiation of a PBM audit and afterwards. For example, Special Investigative Units (SIUs) are often the genesis of a pharmacy audit, and the presence or absence of "audit risk factors" is informative on potentially broader exposure beyond the claims under audit. Any decision to resolve an audit should be informed and result in a full and final settlement of all liability, but PBM audit settlements need to be structured carefully to achieve this goal.
CVS Caremark, OptumRx, and Express Scripts, control at least 80% of the market, making them the three biggest PBMs. Humana also ranks among the largest. In addition, these PBMs regulate access to networks for smaller competitors, such as ESI's partnership with Prime. Plan sponsors, such as United Health, Cigna and Aetna, are vertically integrated with these PBMs, increasing audit risk for pharmacies because network sanctions are more likely to affect a significant aspect of a pharmacy's business across both government and commercial claims.
PBMs and payors use artificial intelligence and data mining across medical and pharmacy claims to identify areas of potential inquiry. Among other areas, these inquiries typically involve high-reimbursing medicines, brand/generic substitution, inventory discrepancies, co-payment collection, prior authorization, and telehealth relations. Separately, DEA conducts audits and inspections for compliance to controlled substance regulations.
Common types of PBM audits include desk audits; on-site audits; invoice audits; and prescription audits. Irrespective of the type of PBM audit, all interactions with PBMs should be taken extremely seriously and can lead to severe consequences if not handled appropriately. For example, there has been a sharp increase in the federal prosecution of pharmacists for audit-related conduct, including answering PBM questions incorrectly. Accordingly, pharmacies should consider using outside audit counsel to avoid these pitfalls.
Pharmacies can take various steps to prepare to meet PBM audits, including routine self-audits. In fact, the government publishes comprehensive guidance and a checklist to assist pharmacies in their audit planning, including self-audits around prescribing practices, controlled substance management, invoice management, and billing practices. If you need assistance designing or implementing an audit protection plan, please do not hesitate to contact us.
Defending against a PBM audit requires comprehensive knowledge of the rights, responsibilities, and intricacies of pharmacies and their laws and regulations. If your pharmacy has been identified for a PBM audit, there are a number of potential defenses available to you. The first defense against a PBM audit is to be proactive, and audit planning can lessen the chance of unfavorable findings. That said, it is often necessary to involve an attorney to hold PBMs to their obligations under law and provider agreements. For this reason, national audit services and pharmacy audit consultants are often ineffective.
Audit discrepancies and findings can be appealed based on the specific procedures outlined in the provider manuals. It is important to follow these requirements exactly, within the timeframes established, or your appeal rights could be lost and further review denied. In an appeal, it is critically important to make a complete record of why the audit findings or sanctions should be reversed, including through documentation, legal arguments, and corrective actions, if any. Depending on the outcome of the appeal, you may have further legal recourse against the PBM.
PBM audits can have severe repercussions depending on the results of the pharmacy audit, including recoupments, network sanctions, and criminal, civil and administrative investigations involving jail time, significant fines, and license revocation or exclusion. We publish a 10-part PBM Audit Guide that discusses the overlap between PBM audits and government investigations and how to successfully manage audit risk. This resource is complimentary to subscribers HERE.
%402x.svg){kind=icon}