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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.