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Optum Rx/Catamaran Rx Audit Defense

Optum Rx, formerly known as Catamaran Rx, routinely audits the pharmacies for which it serves as pharmacy benefit manager (PBM). If Optum Rx is your pharmacy’s PBM, you need to be prepared to defend your pharmacy’s billings during the audit process.

Like all pharmacy benefit managers (PBMs), Optum Rx, formerly known as Catamaran RX, maintains a robust audit program. All participating pharmacies are subject to being audited by Optum Rx (or its designees), and Optum Rx audits can encompass virtually all aspects of a pharmacy’s operations. While the main purpose of a PBM pharmacy audit is to ensure that the pharmacy is billing in compliance with the PBM’s and its payors’ requirements, Optum Rx auditors will examine various other related – and seemingly unrelated – issues as well.

As explained in Optum Rx’s Provider Manual, pharmacy audits serve three primary purposes:

  • “To validate . . . any and/or all of the following: . . . Accuracy of paid Claims, contractual compliance, regulatory compliance, various aspects of Drug Product inventories, presence of required signage and/or documentation.”
  • “To observe and photograph . . . Overall facility operations and conditions.”
  • “To monitor for, detect/prevent [fraud, waste, and abuse] activities and/or transaction submission errors in the billing of Covered Prescription Services.”

If Optum Rx auditors find any evidence of non-compliance, the consequences can be severe. While retractions, pending payment denials, and the institution of prepayment review are most common, Optum Rx (formerly Catamaran Rx) has a history of terminating non-compliant pharmacies—even when the compliance deficiencies are fairly minor. As a result, pharmacies need to be prepared to fully defend themselves during the audit process, and this starts with engaging experienced pharmacy defense counsel.

Pharmacy Defense Lawyers and Compliance Consultants for Optum Rx Audits

At Oberheiden P.C., we represent pharmacies nationwide during Optum Rx audits. If Optum Rx is your pharmacy’s PBM, and if you have been made aware of an impending audit (or if Optum Rx auditors have already shown up at your pharmacy’s door), we can begin working immediately to protect your pharmacy. If not handled appropriately, an Optum Rx audit can be devastating. Our senior pharmacy defense lawyers and compliance consultants (who are former DEA agents) can deal with Optum Rx on your behalf, and we can help make sure the outcome of your audit does not threaten your pharmacy.

Optum Rx Auditors Will Request and Review Extensive Documentation

In order to evaluate pharmacies’ compliance with their PBM contracts and all pertinent laws, rules, and regulations, Optum Rx auditors will request extensive documentation at the outset of an on-site audit. When notified of an impending on-site audit, pharmacies must be prepared to produce all required documentation on demand. As listed on Optum Rx’s Provider Manual, the types of documentation auditors may request include (but are not limited to):

  • Books/databases
  • Daily prescription logs
  • Patient profiles
  • Prescription hardcopies
  • Prescriber information
  • Signature/delivery logs
  • Refill information
  • Purchase invoices
  • Fraud, waste, and abuse training logs
  • LEIE/EPLS verifications
  • CMS10147 and other required documents and notices
  • Internal pharmacy compliance policies and procedures

According to Optum Rx’s Policy Manual, pharmacies must retain all records for, “no less than five (5) years from the date of the applicable transaction or as required by law and ten (10) years in the case of Medicare Part D records.” If a pharmacy is unable to produce any of its required documentation, this will be viewed as a red flag, and this can itself lead to negative repercussions regardless of whether the pharmacy’s practices and operations are compliant.

During the audit process, Optum Rx’s auditors will thoroughly examine all required documentation for strict compliance with the terms of the PBM contract, the Provider Manual, and other applicable sources of authority. For example, with respect to prescription records, all of the following are required, and even minor technical deficiencies have the potential to lead to trouble for pharmacies:

  • The patient’s full name, address, and date of birth
  • The prescriber’s full name, address, telephone number, and “any other required identifiers”
  • The name, strength, and quantity of the medication prescribed
  • The dosing directions provided to the patient (“if a Prescription contains ambiguous directions the Provider must clarify these directions and note the conversation to clarify”)
  • Refill and substitution instructions, if applicable, and any substitutions the patient requested
  • “[O]ther informational notes as required by applicable laws and regulations”

The requirements for other forms of documentation are similarly stringent, and Optum Rx’s Provider Manual emphasizes that pharmacies should maintain extensive notes and update all notes and documentation as necessary. As noted above, even when a documentation deficiency is not necessarily indicative of a dispensing error or unauthorized billing, the recordkeeping error itself can potentially lead to retractions and other penalties.

Read more about ZPIC/UPIC audits.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden



John W. Sellers
John W. Sellers

Former Senior Trial Attorney
U.S. Department of Justice

Local Counsel

Joanne Fine DeLena
Joanne Fine DeLena

Former Assistant U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney & Former District Attorney

Local Trial & Defense Counsel

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (OIG)

Michael Koslow
Michael Koslow

Former Supervisory Special Agent (FBI)

Chris Quick
Chris Quick

Former Special Agent (FBI & IRS-CI)

Kevin M. Sheridan
Kevin M. Sheridan

Former Special Agent (FBI)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Dennis A. Wichern
Dennis A. Wichern

Former Special Agent-in-Charge (DEA)

This is How We Help Pharmacies Defend Against Optum Rx Audits

Due to the complex and technical compliance burdens pharmacies face when they contract with Optum Rx, it is extremely important to seek the advice of experienced legal counsel when notified of an impending audit. At Oberheiden P.C., we advise and represent pharmacies throughout the Optum Rx audit process, from preparing for the audit through dealing with any fallout that may ultimately prove to be unavoidable.

When engaged as defense counsel for Optum Rx pharmacy audits, our services include:

1. Locating and Assembling All Required Documentation

When facing an Optum Rx audit, the importance of locating all required documentation cannot be overstated. With our experience handling PBM pharmacy audits, we can work quickly to ensure that all required documentation is readily available for review by Optum Rx’s auditors, and we can organize your pharmacy’s documentation in such a way that it can be easily reviewed to confirm compliance.

2. Reviewing Documentation Prior to Optum Rx Review

Once we locate and assemble all required documentation, our pharmacy defense lawyers and compliance consultants can review the documentation – either in-depth or via sampling and spot-checking – in order to assess your pharmacy’s risk exposure during the audit. If there are issues that have the potential to lead to negative repercussions, we will address these issues proactively in order to ensure that any penalties are either avoided or mitigated to the greatest extent possible.

3. Preventing Overreaching and Asserting the Pharmacy’s Rights

While Optum Rx reserves broad rights under its PBM contract and its Provider Manual, there are still limits on the lengths to which auditors can go during a pharmacy audit. Our pharmacy defense lawyers are intimately aware of these limits, and we can use our experience to prevent overreaching and otherwise assert your pharmacy’s rights during the audit process. For example, if auditors demand access to historical records that your pharmacy is no longer required to maintain, we can make sure your pharmacy is not penalized for disposing of these records in the ordinary course of business.

4. Communicating with Optum Rx Auditors on the Pharmacy’s Behalf

Throughout the audit process, our defense lawyers and compliance consultants will communicate with Optum Rx’s auditors on your pharmacy’s behalf. We will play an active role in the audit process, and we will work to ensure that any issues are resolved before they create problems for your pharmacy. This includes not only issues with your pharmacy’s documentation, but mistakes, oversights, and faulty assumptions made by Optum Rx’s auditors as well.

5. Advising Pharmacy Owners, Pharmacists, and Other Personnel

During an Optum Rx audit, it is extremely important to control the flow of information. To this end, individuals at all levels of the pharmacy’s organization and operations need to be aware of the risks involved in communicating with Optum Rx’s auditors. Our defense lawyers and compliance consultants can advise your pharmacy’s owners, pharmacists, technicians, billing administrators, and other personnel regarding what not to do during an Optum Rx audit—including what not to say that could lead to further unwanted scrutiny.

6. Defending Against Allegations of Billing Fraud and Compliance Violations

If your pharmacy’s Optum Rx audit leads to allegations of billing fraud or other compliance violations, our lawyers can defend against the allegations and fight to protect your pharmacy against retractions, payment denials, prepayment review, or loss of its PBM contract. We have successfully defended pharmacies across the country in PBM pharmacy audits and federal pharmacy investigations, and we have helped many of our clients avoid exposure to substantial liability and other losses.

7. Post-Audit Response

Regardless of the outcome of your pharmacy’s Optum Rx audit, it will be important to review the results and determine what next steps are necessary. If necessary, we can continue to deal with Optum Rx on your pharmacy’s behalf in order to challenge the auditor’s determinations, mitigate your pharmacy’s financial losses, and fight to protect your PBM contract. We can also provide advice regarding necessary modifications to your pharmacy’s compliance policies and procedures, and we can help you implement new protocols that are designed specifically to prevent liability in a subsequent Optum Rx audit.

Speak with a Pharmacy Audit Defense Lawyer at Oberheiden P.C.

If Optum Rx is auditing your pharmacy, we encourage you to discuss the risks with one of our senior pharmacy defense lawyers. To schedule a free and confidential consultation as soon as possible, call 888-680-1745 or tell us how we can help online now.

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