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PBM Audit & Pharmacy Law Defense Attorneys

When PBM Audits Threaten Your Business, Get Expert Help

PBM audits can result in devastating consequences, including huge recoupments, network termination, and even criminal prosecution. Your initial response to a PBM audit is critical. Do not wait until your rights are lost.

Pharmacies need to hold PBMs accountable for their legal obligations and provider agreements. Our founding partner was a top executive for United Health, overseeing the OptumRx PBM. No one understands the law applicable to PBMs better than us.

Our nationally recognized team of PBM audit attorneys has more than 40 years of pharmacy and legal experience. Put decades of inside knowledge and expertise on your pharmacy's side today. If you are being audited, act now.
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1500+

Pharmacy AUDIts overseen
Past Experience
PBM Expertise

Pharmacy Audit Defense Lawyers

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.

We provide expert legal advice tailored to your specific circumstances using our knowledge of the PBM's audit playbook and pitfalls. As lawyers, we leverage federal and state law to protect your rights.

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

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
PBM Case Studies
PBM Case
Studies

Recent PBM Wins

Learn directly from pharmacy owners that were targeted by PBM audits and referred to government prosecutors—with our assistance, they fought back and won.
Free Consultation
PBM Win 1

Commonwealth of Massachusetts v. Pharmacy & Owner

  • PBM audit uncovered 25,000 unit discrepancy of Zegerid and other violations.
  • PBM referred "fraud" to Massachusetts Attorney General—Medicaid Fraud Control Unit (MFCU).
  • MFCU indicted Pharmacy & Owner on numerous criminal charges, including False Claims & Larceny.
  • After HLA was retained, State dropped all charges before trial and abandoned the prosecution.
  • Owner admitted no wrongdoing and was not excluded; Pharmacy avoided all network sanctions.
Read More
PBM Win 2

United States v. Pharmacy & Owner

  • PBM audit uncovered $6.5 million inventory shortfall in compound cream APIs.
  • PBM referred "fraud" to U.S. Attorney's Office for the Eastern District of Pennsylvania, FBI, and HHS-OIG.
  • After HLA was retained, federal prosecutors declined to bring criminal charges against Owner.
  • Client settled case for $2.5 million, or less than 40% of the government's claimed loss on claims paid.
  • Owner admitted no wrongdoing, was not excluded, and suffered no licensing or other consequences.
Read More
PBM Win 3

Commonwealth of Pennsylvania v. Pharmacy & Owner

  • PBM audit uncovered $600,000 inventory shortfall in brand and generic medications.
  • PBM referred "fraud" to Pennsylvania Attorney General—Medicaid Fraud Control Unit (MFCU).
  • MFCU opened grand jury investigation against Pharmacy and Owner for Medicaid Fraud and Theft.
  • After HLA was retained, State declined to bring criminal charges against Owner.
  • MFCU charged the Pharmacy, a corporate entity, instead.
Read More
Awards & Recognition
Our process

PBM Audit Defense Process

01

Initial Strategy Session

We use a free consultation to understand the specifics of your audit, gather background documents, and identify audit risk factors.
02

Detailed Audit Analysis

Our team constructs a compelling factual narrative to counter the audit probe and identify PBM overreach and misconceptions.
03

Legal Analysis

Our detailed response rebuts any findings and uses federal and state law to hold the PBM accountable for its obligations under law.
04

Settlement & Appeal

We use our knowledge of the PBM's internal process to obtain favorable PBM audit settlements and win credentialing appeals.
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FAQ

Frequently Asked Questions

What documents and data should I gather?

Initially, we’ll need audit determination letters, audit reports, and potential financial records, such as credit card receipts or remittances. As we formulate technical arguments, additional documentation may be requested. We will provide specifics on supporting materials.

Will filing appeals or settlements impact my network contracts?

Retaliation for exercising audit appeal rights is prohibited. We incorporate proper legal protections into audit responses and settlements. Maintaining existing contracts is always a priority.

What recourse exists if advance notice isn't provided?

Lack of proper 30-day written audit notice violates statute in many states. We leverage penalties around insufficient notice periods into negotiation leverage for your pharmacy.

What are the costs of legal representation?

We offer flexible fee arrangements based on the scope of representation required and audit stage. The earlier we are involved the better, as we can shape and limit audit scope, making legal representation more effective and less costly.

Do audits mainly target specific pharmacy types?

PBMs often unfairly focus on independent, specialty, and compounding pharmacies versus large chains. But all pharmacy types must contend with aggressive audits. Having legal advocates levels the playing field.

Can your guidance help prevent future unfair targeting?

Absolutely. We provide tailored compliance recommendations so pharmacies can reinforce areas prone to audit scrutiny. Proper documentation is critical to rebutting audit allegations.

Can you help if my license or network participation is jeopardized?

Yes. We ensure that audit sanctions comply with applicable federal and state laws. PBMs are prohibited from acting in bad faith or arbitrarily under both applicable law and the parties’ agreements.

Can audits impact DIR or BER/GER assessments?

Potentially. Depending on the scope of the audits and the claims involved, any clawbacks should be reconciled in DIR, or BER/GER performance metrics. Our specialists ensure that any downstream audit consequences are handled properly in your favor, not the PBM's.

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Book a Free Consultation

We hold PBMs accountable to their audit and legal obligations. Do not wait until your rights are lost. Schedule a free consultation now.

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.