Pharmacy benefit manager (PBM) audits by OptumRx can result in devastating consequences, including huge recoupments, network termination, and even criminal prosecution. Your initial response to an OptumRx audit is critical.
Without the right legal defense, you may face significant penalties and network exclusion. At Health Law Alliance, our legal team has successfully defended hundreds of clients against PBM audits, Fraud, Waste & Abuse (FWA) investigations, and network terminations. We have prevailed against Optum and have proven strategies for the audit and appeal process.
Pharmacies need to hold PBMs like OptumRx accountable for their legal obligations and provider agreements. Our founding partner was a top United Health executive over the OptumRx PBM. 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.
Health Law Alliance represents independent, specialty and compounding pharmacies in Optum and OptumRx pharmacy audits, appeals of audit findings, network termination appeals, and dispute resolution hearings, arbitration and litigation when necessary. Our article on what to expect in an OptumRx audit covers the process; for audits by other PBMs, see our PBM audit attorneys.
We have created this guide as a universal resource for providers, and any legal advice in the context of an attorney-client relationship would be more tailored to your unique circumstances.
To design an effective OptumRx audit response strategy, providers must understand the chain of events both prior to the initiation of an OptumRx audit and afterwards. For example, Special Investigative Units (SIUs) are often the genesis of an OptumRx audit, and the presence or absence of “audit risk factors” is informative on potentially broader exposure beyond the claims under audit.
CVS Caremark, OptumRx, and Express Scripts (ESI), 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 types of OptumRx audits include desk audits; on-site audits; invoice audits; and prescription audits. Irrespective of the type of OptumRx audit, all interactions with PBMs like OptumRx 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 OptumRx audit counsel to avoid these pitfalls.
Pharmacies can take various steps to prepare to meet OptumRx 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 OptumRx audit protection plan, please do not hesitate to contact us.
Defending against an OptumRx audit requires comprehensive knowledge of the rights, responsibilities, and intricacies of pharmacies and their laws and regulations. If your pharmacy has been identified for an OptumRx audit, there are a number of potential defenses available to you. The first defense against an OptumRx audit is to be proactive, and OptumRx audit planning can lessen the chance of unfavorable findings. That said, it is often necessary to involve an attorney to hold PBMs like OptumRx to their obligations under law and provider agreements. For this reason, national audit services and pharmacy audit consultants are often ineffective.
OptumRx audit discrepancies and findings can be appealed based on the specific procedures outlined in the OptumRx 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 OptumRx appeal, it is critically important to make a complete record of why the OptumRx audit findings or sanctions should be reversed, including through documentation, legal arguments, and corrective actions, if any. Depending on the outcome of the OptumRx appeal, you may have further legal recourse against OptumRx.
Any decision to resolve an OptumRx audit should be informed and result in a full and final settlement of all liability, but OptumRx audit settlements need to be structured carefully to achieve this goal.
We offer flexible fee arrangements based on the scope of representation required and OptumRx audit stage. The earlier we are involved the better, as we can shape and limit OptumRx audit scope, making legal representation more effective and less costly.
Our experienced attorneys have assisted thousands of providers in navigating the same challenges you are facing.
PBMs like OptumRx 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:
OptumRx audits can have severe repercussions depending on the results of the OptumRx audit, including:
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Learn directly from pharmacy owners that were targeted by PBMs like OptumRx: with our assistance, they fought back and won.
In these appeals, our team emphasized that Optum’s rationale was insufficient to support as drastic a remedy as termination, particularly given that the termination notices failed to cite any specific instances of non-compliance with Optum’s Provider Manual or improperly submitted claims. On April 2, Optum notified each of the pharmacies that it would immediately rescind the termination notices, allowing the pharmacies to remain in Optum’s networks.
The audit findings at issue involved many alleged discrepancies, including inventory variances, untimely reversal of claims, and member-related documentation concerns. As a direct result of Health Law Alliance’s advocacy, Optum resolved the audit without imposing termination or other adverse action. Instead, Optum simply requested that the pharmacy implement an Immediate Corrective Action Required (“ICAR”).
In our case, Optum’s PBM audit alleged that certain of the pharmacy’s claims were invalid because they had been delivered by mail to patients located hundreds of miles away. Just days after we sued Optum in federal court in the Northern District of Texas, Optum immediately released approximately $250,000 in reimbursement.
Attorney advertising. Prior results do not guarantee a similar outcome. Case summaries are generalized for confidentiality and are not a substitute for legal advice on your specific matter.
Anthony Mahajan is a former federal prosecutor who served as Chief Compliance Officer and Executive Leadership Team member for UnitedHealth Group, with oversight of Optum and UnitedHealthcare, including the SIUs within those platforms. Diana Yastrovskaya is PBM audit and compliance counsel and defends pharmacies in federal and state investigations. When a PBM refers an audit to prosecutors, the same team defends the investigation. Between them, they are credited on every OptumRx result on this page.
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