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When DEA Inspections Threaten Your Practice, Get Expert Help

DEA Compliance & Opioid Regulation Attorneys

DEA inspections can lead to serious consequences, including loss of controlled substance prescribing privileges, fines, and even criminal prosecution. Your response to a DEA inspection is crucial. Do not wait until your rights are jeopardized.

Healthcare providers need to ensure that DEA investigators adhere to proper procedures and respect their legal rights during inspections. Our founding partner is a former DEA attorney who understands the agency's regulations and tactics. No one is better equipped to navigate the complexities of DEA inspections and opioid regulations than our team.

Our nationally recognized DEA compliance attorneys have more than 40 years of combined experience in healthcare law and regulatory matters. Put decades of inside knowledge and expertise on your practice's side today. If you are facing a DEA inspection or need guidance on opioid prescribing regulations, act now to protect your practice and professional reputation.

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100+

DEA Inspections Handled
Past Experience
DEA COMPLIANCE EXPERTISE

Healthcare Fraud Defense Lawyers

Our DEA compliance team has helped clients navigate hundreds of DEA inspections, maintain their controlled substance prescribing privileges, implement effective compliance programs, and defend themselves against aggressive DEA enforcement actions.

When your DEA registration or medical license is at risk, our team of experienced DEA compliance attorneys is your strongest advocate.

1200+

Clients served

2500+

matters handled

24/7

availability

100%

flexible rates
Our PBM audit defense team has helped clients avoid millions of dollars in recoupments, remain in-network, win reinstatement, and defend themselves against abusive PBM tactics.

When your license or livelihood is threatened, our team of pharmacy PBM audit attorneys is your fiercest ally.

1500+

Clients served

5000+

matters handled

24/7

availability

100%

flexible rates
"Anthony is the definition of a 'plug and play' athlete. Put him the game and he will change it."
- Former Acting U.S. Attorney, E.D.N.Y
DEA COMPLIANCE CASE STUDIES
PBM Case
Studies

Recent DEA Inspection Victories

Discover how healthcare providers navigated complex DEA inspections and faced potential enforcement actions—with our expert legal guidance, they maintained compliance and protected their practices.
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DEA WIN 1

Case study 1

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DEA WIN 2

Case Study 2

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DEA WIN 3

Case Study 3

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Awards & Recognition
Our process

Healthcare Fraud Defense Strategy

01

Initial Consultation

We use a free consultation to understand the specifics of your DEA inspection or compliance needs, gather relevant documents, and identify potential risk factors.
02

Comprehensive Compliance Review

Our team conducts a thorough review of your current policies, procedures, and practices to identify areas of potential DEA scrutiny and develop a robust compliance plan.
03

Legal Analysis and Response

Our detailed response to DEA inspection findings leverages federal law and regulations to hold the DEA accountable for its actions and protect your rights throughout the process.
04

Negotiation and Resolution

We use our knowledge of DEA processes to negotiate favorable outcomes, minimize potential penalties, and maintain your ability to prescribe controlled substances.
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FAQ

Frequently Asked Questions

What documents and information should I prepare for a DEA inspection?

During a DEA inspection, you'll need to provide controlled substance inventories, dispensing records, prescriptions, and other relevant documentation. We will guide you on organizing and presenting this information to demonstrate compliance with DEA regulations.

What should I do if the DEA conducts an unannounced inspection?

If DEA investigators arrive unannounced, remain calm and professional. Contact our team immediately so we can guide you through the inspection process and ensure that your rights are protected.

Do DEA inspections target specific types of healthcare providers?

While pain management clinics and high-volume prescribers may face increased scrutiny, all providers who prescribe controlled substances are subject to DEA inspections. Having experienced legal counsel ensures a level playing field and protects your interests.

Can you help if my DEA registration or medical license is at risk?

Yes. We work tirelessly to protect your DEA registration and medical license, ensuring that any potential sanctions are justified and in accordance with applicable laws and regulations. We hold the DEA accountable and advocate for your ability to practice medicine.

Will challenging DEA findings impact my ability to prescribe controlled substances?

Exercising your rights during a DEA inspection should not result in retaliation. We incorporate robust legal protections into our responses to DEA findings, ensuring that your ability to prescribe controlled substances is maintained.

What are the costs of legal representation during a DEA inspection?

We offer flexible fee arrangements based on the scope of representation required and the complexity of the situation. The earlier we are involved, the better, as we can help manage the inspection process and minimize potential legal risks, making our representation more cost-effective.

Can your guidance help prevent future DEA compliance issues?

Absolutely. We provide tailored compliance recommendations to help you maintain DEA compliance, reduce the risk of future inspections, and safeguard your practice. Proper recordkeeping and adherence to opioid prescribing guidelines are crucial.

Can DEA inspections lead to criminal charges?

In some cases, DEA inspections may uncover evidence of criminal violations, such as drug diversion or illegal prescribing practices. Our team is well-equipped to defend you against any potential criminal charges and work to minimize the impact on your practice and professional reputation.

Health Law Alliance

Book a Free Consultation

We help healthcare providers navigate DEA inspections and opioid prescribing regulations, ensuring compliance and protecting their practices. Do not wait until your DEA registration or medical license is at risk. Schedule a free consultation now to discuss your situation and explore your options.

PBM AUDIT STRATEGY

PBM Audit Information

The Role of Pharmacy Benefit Managers in Pharmacy Audits

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.

PBMs that Conduct the Most Pharmacy Audits


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.

Common Pharmacy Audit Areas


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.  

Types of Pharmacy Audits


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.

Preparing for Pharmacy Audits


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 Pharmacy Audits


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.

Pharmacy Audit Appeals


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.

Potential Consequences of Pharmacy Audits

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.