SafeguardRx Audit

Knowledgeable PBM Audit Attorneys Protect the Interests of Pharmacies Subject to All Types of SafeguardRx Audits

**Attorney Lynette Byrd**
SafeguardRx Audit Team Lead
Contact Lynette

envelope icon — **Attorney Lynette Byrd**
SafeguardRx Audit Team Lead
Contact Lynette

**Deborah Zarifian**
SafeguardRx Audit Team Consultant
Former FBI Special Agent
Registered Pharmacist (CT)

SafeguardRx is one of the more recent pharmacy benefit managers to enter the scene. As a division of Express Scripts, SafeguardRx has the stated goal of improving patient engagement and increasing 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. So burdensome, in fact, that many pharmacies that are wholly compliant still face challenges navigating the PBM audit process.

If SafeguardRx is your pharmacy benefits manager and you are facing a PBM audit, it is imperative that you seek the assistance of an experienced SafeguardRx audit attorney as soon as possible. While a SafeguardRx audit does not necessarily mean that your pharmacy will be subject to sanctions, discovered violation—intentional or inadvertent—can lead to significant consequences such as recoupments and contract termination. Of course, in most cases, 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 set forth in the PBM contract, the audit can turn from routine to nightmarish.

Oberheiden. P.C. is a PBM audit defense law firm with significant experience handling SafeguardRx audits. Our PBM audit attorneys review the auditors’ procedures to make sure that they do not make any mistakes that could delay the resolution of the audit. We can also identify any possible violations and take affirmative action to address and resolve them, minimizing their impact on the outcome of the audit. With notable experience advising and representing pharmacies through all types of PBM audits, our lawyers understand how to effectively and efficiently resolve SafeguardRx audits.

What Is the Role of a Pharmacy Benefit Manager?

Pharmacy benefit managers (PBMs) are private companies that act as intermediaries between pharmacies and private insurance companies. The insurance company pays the PBM to administer pharmacy benefits and ensure that all participating pharmacies accurately bill the insurance company for all prescriptions dispensed.

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 this role, PBMs such as SafeguardRx require pharmacies to sign a PBM contract. The contract outlines the rights and obligations of both parties and binds each side to the agreement.

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.

What Is SafeguardRx Looking for in a PBM Audit?

When a PBM such as SafeguardRx conducts an audit, auditors are generally looking for any improper billing practices. 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 notorious for being less than transparent. For example, independent pharmacies may receive word after an audit that the PBM is retracting a significant sum of money based on violations of the PBM contract. However, too often, SafeguardRx fails to provide pharmacies with sufficient information to justify taking back the funds. This is especially the case when pharmacy management is unfamiliar with the PBM audit process and trusts auditors to do their job without oversight.

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

If you own a pharmacy and recently received notice that SafeguardRx will be conducting an audit, working with an experienced SafeguardRx PBM audit lawyer is the best way to protect yourself from an unfavorable audit. While you are permitted to handle the audit on your own, it is highly recommended that only pharmacies who have extensive experience with PBM audits do so.

At Oberheiden, P.C., we’ve assembled a dedicated team of SafeguardRx audit attorneys. Several of our senior lawyers formerly worked with the Drug Enforcement Administration and the Health and Human Services Office of Inspector General, giving us unrivaled insight into pharmacy compliance issues. Additionally, our team of pharmacy audit attorneys also has thorough 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 ready to jump in at a moment’s notice to provide your pharmacy with a pre-audit consultation. During this consultation, we will assess any particular compliance risks and develop a strategic defense to address any known issues. Additionally, we will communicate with auditors, letting them know that you are represented by counsel. In many cases, the mere fact of having a PBM audit attorney in your corner keeps SafeguardRx auditors in check, which can drastically impact the outcome of the audit.

Audit Intervention

Once the audit begins, our attorneys will be there to ensure that auditors follow all procedures. We will also be able to correct any incorrect assumptions and call auditors out on any flawed methodologies. If SafeguardRx auditors make an unreasonable demand of your pharmacy, we will step in to explain why such a demand is not appropriate. 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 (or any other PBM, for that matter) is not a government entity. Thus, any recoupment demand or other sanction imposed by a PBM does not carry the force of law unless further action is taken. While PBMs routinely pursue contractual enforcement, this opens the door to negotiating with the PBM to reduce or remove any recoupments or other sanctions.

Pharmacy Audit Litigation

The vast majority of issues that arise during and after a SafeguardRx audit can be resolved without judicial intervention. However, to enforce the terms of a PBM contact pharmacies or SafeguardRx may need to pursue legal action. In this situation, the pharmacy audit defense attorneys at Oberheiden, P.C. are ready to intervene to ensure your rights remain protected.

Billing Compliance Issues

The best way to avoid any problems in a SafeguardRx audit is to be fully in compliance at the time of the audit. In addition to representing pharmacies that are currently being audited, Oberheiden, P.C. also develops and implements 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 attorneys have notable experience helping pharmacies deal with the myriad issues that come up during the audit process. From keeping auditors on track to ensuring they use the correct methodologies to challenging improper recoupments, we can your pharmacy through whatever issues arise. Several of our senior attorneys spent years working in the DEA and Office of Inspector General before joining Oberheiden, P.C. This provides us with unique insight into how PBM auditors conduct these audits and how to resolve them efficiently while avoiding any finding of liability.

Frequently Asked Questions:

Do I have to comply with all of a SafeguardRx auditor’s demands?

Under the terms of the PBM contract you signed with SafeguardRx, you agree to provide certain necessary documentation upon request. However, this does not mean that every demand made by the PBM auditor must be complied with blindly. SafeguardRx auditors have been known to overreach, meaning they ask for documentation that is not covered under the scope of the PBM contract. In these situations, you may not need to comply with the request. However, at the same time, it is important to thoroughly understand the contract before denying a request; otherwise, SafeguardRx could terminate your contract or otherwise subject your pharmacy to sanctions. At Oberheiden, P.C., we can help you understand exactly what you need to provide to auditors and which requests do not need to be honored.

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

Pharmacy benefit management audits are not something that all lawyers handle. Even healthcare defense lawyers who represent pharmacies in other compliance and regulation issues may not provide the level of comprehensive representation needed for a SafeguardRx audit. When it comes to selecting an attorney to help you through a PBM audit, perhaps the most important thing to look for is experience. You want an attorney who has not only handled SafeguardRx audits in the past, but has done so successfully. When interviewing lawyers to help you navigate a PBM audit, ask the attorney about their level of experience and track record of success.

Do pharmacies have any rights during a SafeguardRx audit?

Absolutely. The relationship between your pharmacy and SafeguardRx is a contractual one. 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 will 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, you shouldn’t expect SafeguardRx auditors to inform you of all your rights. Instead, reach out to a dedicated SafeguardRx pharmacy audit lawyer to better understand your rights and obligations under the PBM contract.

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

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

If SafeguardRx recently announced that it will be auditing your pharmacy, the dedicated pharmacy audit defense lawyers at Oberheiden, P.C. are here to help. We can offer you 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.