Knowledgeable Pharmacy Compliance and Defense Attorneys Helping Pharmacies Effectively Navigate a SafeguardRx Audit

SafeguardRx is a pharmacy benefit manager operated by Express Scripts. The stated goal of SafeguardRx is to improve patient engagement and increase medication adherence while reducing costs for some of the costliest therapies. In doing so, however, SafeguardRx imposes incredibly complex and strict regulations on participating pharmacies, which have no choice but to engage in business with SafeguardRx if they want to accept claims under Express Scripts policies. In fact, the compliance obligations pharmacies face are so onerous that many compliant pharmacies find themselves facing alleged violations following a PBM audit process.

If SafeguardRx is your pharmacy benefits manager and you are facing a PBM audit, it is imperative that you seek the counsel of an experienced SafeguardRx PBM audit attorney as quickly as possible. While a SafeguardRx PBM audit does not necessarily mean that your pharmacy will be subject to sanctions, a discovered violation can lead to significant consequences. Depending on the severity of the violations, this may lead to a recoupment or even contract termination. Of course, by providing the PBM with the necessary documentation of compliance, most audits will be resolved quickly and without issue. However, in the event that your pharmacy committed even an unintentional mistake or auditors fail to adhere to the policies outlined in the PBM contract, it can quickly turn into a nightmarish situation.

Oberheiden, P.C. is a PBM audit defense law firm with significant experience helping pharmacies navigate SafeguardRx audits. We assist with all facets of the PBM process, from identifying any possible violations in advance of the audit and taking affirmative action to address them to reviewing auditors’ procedures to ensure they do not make any mistakes that could delay the resolution of the audit. With centuries of experience advising and representing many small and independent pharmacies through the PBM audit process, the pharmacy audit defense attorneys at Oberheiden, P.C. understand how to effectively and efficiently resolve SafeguardRx audits from beginning to end.

What Is the Role of SafeguardRx?

Pharmacy benefit managers (PBMs) are companies that act as middlemen between pharmacies and insurance companies. While pharmacies used to handle all claims-processing in-house, decades ago, insurance companies realized it was more efficient for them to outsource this task. Thus, PBMs were born.

In short, an insurance company pays the PBM to administer pharmacy benefits and ensure that all participating pharmacies accurately bill the insurance company for all prescriptions dispensed.

While the stated goal of a PBM is to manage drug prices, these companies also benefit significantly. For example, according to a recent report, manufacturer rebates to PBMs increased from $39.7 billion in 2012 to over $89.5 billion in 2016. Of course, this partially offsets customer savings. As a result, PBMs have come under scrutiny for profiting off of already high drug prices. Thus, to justify their existence, SafeguardRx and other PBMs take an aggressive approach to the audit process.

A few of the roles that a PBM fills include:

  • Developing and maintaining lists of covered medications on behalf of health insurers;
  • Using their bulk purchasing power to negotiate rebates and discounts from drug manufacturers; and
  • Contracting directly with pharmacies to reimburse the pharmacy for drugs dispensed to patients.

In carrying out these roles, PBMs such as SafeguardRx require pharmacies to sign a PBM contract at the beginning of the parties’ relationship. The PBM contract outlines the rights and obligations of both parties and binds each side to the agreement. Because SafeguardRx is a private company, the contract dictates the full extent of the company’s rights.

What Can Lead to a SafeguardRx Audit?

When SafeguardRx initiates a PBM audit, the company is looking for any improper billing practices that may adversely affect the insurance company. Some of the most common potential violations that may come up during a SafeguardRx audit include:

  • Accepting Prescriptions Written by Excluded Providers
  • Billing for Unapproved Drugs
  • Compound Drug Issues
  • Failure to Create or Maintain Records
  • Falsification of Records
  • Filling Illegitimate Prescriptions
  • Intentional and Unintentional Billing and Coding Errors
  • Invoice Shortages
  • Licensing Violations
  • PBM Contract Fraud
  • Telemedicine Violations

However, the audit process is less than transparent due to a lack of federal oversight, and state regulations vary widely. For example, this can lead to a situation in which an independent pharmacy is told that SafeguardRx is retracting a significant sum of money based on violations of the PBM contract. However, sometimes SafeguardRx fails to provide pharmacies with sufficient information to justify taking back the funds, leaving pharmacies wondering what their options are.

Do I Need a Lawyer if My Pharmacy is Subject to a SafeguardRx Audit?

If you own a pharmacy and recently received notice of a SafeguardRx PBM audit, securing the assistance of an experienced SafeguardRx PBM audit lawyer is vital. While pharmacies are permitted to handle the audit on their own, it is recommended that pharmacies who do not have extensive experience navigating PBM audits to avoid the additional risks that come along with handling the audit without the assistance of counsel.

At Oberheiden, P.C., we have a knowledgeable team of SafeguardRx audit attorneys. Several of our senior lawyers formerly worked with the Drug Enforcement Administration (DEA) and the Health and Human Services Office of Inspector General (HHS-OIG), providing us with insight into a wide range of pharmacy compliance issues. Additionally, our team of pharmacy audit attorneys also has centuries of combined experience handling SafeguardRx audits and other PBM audits.

Some of the PBM audit defense services we provide to our clients include:

Pre-Audit Consultation

Oberheiden, P.C. lawyers are prepared to immediately provide your pharmacy with a pre-audit consultation. During this consultation, we review pharmacy practices and assess all specific compliance risks. From there, we develop a strategic defense to address any potential issues that arise. Additionally, we communicate with auditors on behalf of a pharmacy. In many cases, once SafeguardRx learns that you are represented by a PBM audit attorney, it will change the course of the audit because auditors know there will be a watchful eye overseeing the audit.

Audit Intervention

Oberheiden, P.C. also ensures that our attorneys have a physical presence during the audit, providing our pharmacy clients with on-sire support through the entire process. For example, we can intervene to correct any incorrect assumptions or flawed methodologies. If SafeguardRx auditors make an unreasonable demand for documentation, we are there to step, explaining why such a demand is not appropriate under the terms of the PBM contract. Even if your pharmacy is not in full compliance, there are legal defenses available that can mitigate any liability.

Post-Audit Representation and Negotiation

While pharmacies are legally bound to comply with the terms of a PBM contract, SafeguardRx is not a government entity. Thus, any recoupment demand or other sanction imposed by a PBM can be challenged in a court of law. While PBMs have highly skilled lawyers to represent their interests, litigation is costly and uncertain. Thus, we are often able to negotiate adverse findings and proposed sanctions out of court. However, our experienced litigators are also prepared to take legal action whenever it is necessary to protect or enforce a pharmacy’s rights.

Billing Compliance Support and Consulting

The best way to avoid any problems in a PBM audit is to ensure a pharmacy is in compliance, both with all federal laws as well as the terms of the PBM contract. In addition to representing pharmacies that are currently being audited, Oberheiden, P.C. also develops and assists with the implementation of comprehensive pharmacy compliance programs designed to reduce the likelihood of PBM audits and to protect your pharmacy in the event of an audit or a federal fraud investigation.

At Oberheiden. P.C., our SafeguardRx PBM audit lawyers can help your pharmacy deal with the myriad issues that come up during the PBM audit process. From keeping auditors on track to ensuring they use the correct methodologies to challenging improper recoupments, we can guide your pharmacy through whatever issues arise.

Frequently Asked Questions:

Why don’t we call ourselves the “best SafeguardRx pharmacy audit” lawyers?


At Oberheiden, P.C., we are confident that our staff contains some of the best pharmacy audit lawyers in the country. However, as a firm that values honesty and integrity, we decided not to label ourselves as such. First, we know that we deal with a sophisticated clientele that is unlikely to be persuaded by an unsubstantiated claim. Second, we believe that the term “best” is subjective. For example, a quality that makes an attorney the “best” for one client may not be as important to another client. And, because we stand behind the ethical obligation that lawyers have to their clients, we choose to avoid the risk of making any potentially misleading statements. Those who are interested in retaining the best SafeguardRx PBM audit lawyer can review our track record and come to their own conclusions.

What should I look for in a SafeguardRx pharmacy audit attorney?


Pharmacy benefit management audits are a unique practice area. They are not something that all lawyers handle—even those who frequently represent pharmacies in other compliance and regulation issues. Thus, when it comes to selecting a SafeguardRx pharmacy audit defense attorney, experience is perhaps the most important consideration. Pharmacies should identify an attorney who has handled SafeguardRx audits in the past and done so successfully. When interviewing lawyers to help you navigate a PBM audit, always ask the attorney about their level of experience and track record of success as it relates to the situation you currently find yourself in.

Do pharmacies have any rights during a SafeguardRx audit?


Yes, pharmacies have important rights when facing a SafeguardRx audit; however, the extent of these rights depends on the state in which the pharmacy operates. The relationship between a pharmacy and SafeguardRx is contractual. When you began the relationship with SafeguardRx, you signed a PBM contract. This document outlines both parties’ rights and obligations. While the rights that your pharmacy has during a SafeguardRx audit depend on state law as well as the specific language in the contract, generally, pharmacies have the following rights:

  • Reasonable notice of the audit;
  • A limited and clearly defined look-back period;
  • Reimbursement for claims that were improperly denied;
  • Timely notice of the results of the audit; and
  • Clear and documented explanations of any demand for recoupment.

Of course, pharmacies cannot expect SafeguardRx to inform them of all their rights. Often, SafeguardRx auditors intentionally rely on a “take it or leave it” approach, which leads many pharmacies to accept auditors’ findings as fact. However, both auditors’ findings and any proposed sanctions are subject to the terms of the PBM contract. At Oberheiden, P.C., we can help familiarize you with the full extent of your rights, so you know that your interests are protected throughout the process.

Contact the SafeguardRx PBM Audit Lawyers at Oberheiden, P.C.

If you recently learned that SafeguardRx will be auditing your pharmacy, the dedicated pharmacy audit defense lawyers at Oberheiden, P.C. are here to help. We offer all pharmacies an immediate and confidential consultation with a senior attorney. You can reach the firm by calling 888-680-1745 to schedule an appointment. You can also complete our online contact form, and one of our lawyers will reach out to you shortly.