OptumRx Pharmacy Audit Defense

While OptumRx regularly audits pharmacies for compliance deficiencies, facing an OptumRx audit is far from a routine matter. If your pharmacy is being audited, it is important that you engage experienced OptumRx audit defense counsel promptly.

If OptumRx is your pharmacy benefit manager (PBM), facing an audit is a very real concern. OptumRx audits are not only common, but they are also extremely invasive, and pharmacies that are not able to efficiently present documentation of comprehensive compliance can face substantial penalties. If you have received an audit notice from OptumRx, or if your pharmacy is currently being audited, you need to consult with experienced defense counsel right away.

Our firm represents pharmacies in OptumRx audits nationwide. We have several attorneys who are highly experienced in PBM and federal pharmacy audits, including attorneys who previously prosecuted pharmacy fraud cases at the U.S. Department of Justice (DOJ). We also employ the services of pharmacy compliance consultants who previously served as high-ranking agents with the U.S. Drug Enforcement Administration (DEA), U.S. Department of Health and Human Services (DHHS), and other federal agencies. As a result, we offer deep insights for pharmacies facing OptumRx audits; and, if your pharmacy is being audited, we can step in and begin working immediately to prevent unnecessary penalties.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

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)

Gamal Abdel-Hafiz
Gamal Abdel-Hafiz

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)

What Should You Expect During an OptumRx Audit?

OptumRx audits are invasive, and they move relatively quickly. Once the process begins, pharmacy owners, pharmacists-in-charge, and pharmacy administrators must be prepared to respond to requests for documentation efficiently. During OptumRx audits, the question is not whether your pharmacy is in compliance, but rather whether your pharmacy can prove that it is in compliance. So, without documentation demonstrating that your pharmacy has consistently done everything required under the terms of its PBM contract and federal law, OptumRx is going to assume that your pharmacy is non-compliant.

At the same time, however, pharmacies must be careful to avoid sharing too much information with OptumRx. If you disclose records that are not required to be disclosed, OptumRx’s auditors may still review them, and this may lead to additional questions. Similarly, if you unnecessarily disclose documents that demonstrate (or even arguably demonstrate) non-compliance, OptumRx will only use them against you.

What Issues Can Lead to Penalties in an OptumRx Audit?

What types of issues will OptumRx’s auditors be looking for? The short answer is: Any issues that can justify retractions or other penalties. Auditors are paid to save the company and its participating payors money, and if there is any evidence to suggest a pharmacy has overbilled for prescription medications, you can expect this evidence to be used against you.

Some examples of common issues raised during OptumRx audits include:

  • Licensing and Registration Non-Compliance – If any required licenses are missing or expired, OptumRx may potentially use this to claim that all billings submitted by the pharmacy are invalid. This includes the pharmacy’s license as well as the licenses of individual pharmacists and other staff members. Likewise, if the pharmacy is not registered and in good standing with the DEA, this will almost certainly lead to substantial retraction demands as well.
  • Inadequate Training (or Proof of Completion of Training) – OptumRx’s auditors will request documentation that all pharmacy personnel have completed all requisite training programs. This includes general compliance training as well as trainings specific to issues such as prescription drug diversion; fraud, waste, and abuse; and, Medicare billing compliance.
  • Inadequate Compliance Documentation – Pharmacies must develop and maintain strict adherence to comprehensive Pharmacy compliance programs. These compliance programs must be thoroughly documented, and they must include adequate provisions for creating additional compliance documentation on an ongoing basis. During an audit, OptumRx auditors will want to see not only that the pharmacy has a compliance program in place, but that it has been consistently generating and storing proof of compliance.
  • Record Retention Deficiencies – While OptumRx and other PBMs have their own specific requirements, they generally require pharmacies to maintain compliance with federal standards under their PBM contracts as well. If your pharmacy is in violation of the recordkeeping provisions of the Drug Supply Chain Security Act (DSCSA), Health Insurance Portability and Accountability Act (HIPAA), or any other federal law, this is going to create issues during the audit process.
  • Failure to Validate Providers – In order to be eligible for reimbursement, prescriptions must generally be issued by physicians or other providers who are in good standing with the DHHS Office of Inspector General (OIG). If a provider is on the OIG’s list of excluded providers, and if a pharmacy dispenses a prescription medication under a prescription written by the provider, then the pharmacy could be at risk based on the fact that it should have known that the provider was excluded.
  • Invoice Shortages – If a pharmacy bills for more drugs than it has purchased (as demonstrated by the documentation that it has on file), this is referred to as an “invoice shortage.” While perceived invoice shortages are often the result of recordkeeping deficiencies, OptumRx and other PBMs will often assume that they are indicative of purchasing medications from illegitimate sources and other forms of prescription drug fraud.
  • Illegitimate Prescription Drugs – Importing prescription medications, failing to check tracking information, and various other issues can lead to allegations of purchasing illegitimate prescription drugs. If OptumRx alleges that a medication was purchased from an illegitimate source, it will not allow sales to patients to be billed.
  • Prescription Filling and Dispensing Mistakes and NonCompliance – Filling prescriptions with the wrong medications, dispensing too many pills, failing to confirm medical necessity, and a multitude of other issues can lead to problems for pharmacies during OptumRx audits as well. Again, comprehensive documentation is critical, as pharmacies will be expected to affirmatively demonstrate compliance in order to avoid penalties.
  • Billing and Coding Errors – Billing and coding errors, including (but not limited to) those pertaining to Medicare billing and use of National Drug Codes (NDCs) are among the most-common issues raised during pharmacy audits. Even isolated mistakes will lead to enhanced scrutiny, and even unintentional mistakes can lead to significant penalties.
  • Mail Order and Telemedicine Violations – Mail order and telemedicine compliance have become targets of many PBMs’ auditing efforts in recent years. This is because these have been identified as areas with a particularly high risk for fraud.
  • PBM Contract Violations – In addition to complying with federal law, pharmacies must comply with the terms of their PBM contracts with OptumRx as well. These contracts contain numerous complex terms and conditions, and contractual non-compliance can have a wide range of consequences depending on the particular issue (or issues) involved.
  • Compounding Pharmacy and Specialty Pharmacy NonComplianceCompounding pharmacies and specialty pharmacies face particular compliance burdens. If you own or operate a compounding pharmacy or a specialty pharmacy and you are facing an OptumRx audit, it is especially important that you engage audit defense counsel as soon as possible.

What are the Potential Penalties in an OptumRx Audit?

If a pharmacy audit reveals evidence of non-compliance (as determined by OptumRx’s auditors), then OptumRx can impose substantial penalties with very little explanation. Furthermore, short of going to court, the options for challenging the outcome of an OptumRx audit are extremely limited. As a result, pharmacies will often find themselves unexpectedly facing substantial penalties including:

  • Retractions (recovery of amounts previously paid)
  • Offsetting of pending claims against amounts paid in error
  • Denial of pending claims
  • Cease-and-desist demands pertaining to alleged non-compliant or illegitimate practices
  • Termination of the pharmacy’s OptumRx PBM contract

How Can You Protect Your Pharmacy During an OptumRx Audit?

Given these risks, what can (and should) pharmacy owners and pharmacists-in-charge do to prepare for an OptumRx audit? While individual circumstances vary, the steps pharmacies can generally take to mitigate their risk during an OptumRx (or other PBM) audit include:

1. Determine Your Pharmacy’s Risk

First, it is important to determine your pharmacy’s risk. Do you have comprehensive documentation of compliance on hand? Or, are OptumRx’s auditors likely to find that your pharmacy’s record generation and retention efforts are lacking? Have your billing administrators or other staff members made mistakes? These are the types of questions you need to answer in advance.

2. Prepare All Necessary Documentation

Second, you must begin preparing the documentation you will need to convince OptumRx’s auditors that your pharmacy is compliant. This means assembling all pertinent documentation (or at least being prepared to access it quickly when necessary), and it also means ensuring that you do not unnecessarily disclose information that could enhance your pharmacy’s risk or compromise the attorney-client privilege.

3. Strategize with Your Pharmacy’s Audit Defense Counsel

Finally, you need to develop a strategy with the help of your pharmacy’s audit defense counsel. You need to be prepared to take control of the audit process, and you will need your pharmacy’s outside lawyers and consultants to be cued up to deal with OptumRx’s auditors on your behalf.

Speak with a OptumRx Audit Defense Attorney at Oberheiden P.C.

Is your pharmacy facing an OptumRx audit? If so, we encourage you to contact us immediately. To speak with one of our senior attorneys or consultants in confidence, call 888-680-1745 or inquire online now.

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