Optum Rx, formerly known as Catamaran Rx, is a pharmacy benefit manager (PBM) that routinely engages in invasive audits of the pharmacies it oversees. If Optum Rx is your pharmacy’s PBM, it is essential that you are prepared to defend your pharmacy’s billing practices during the audit process.
If Optum Rx auditors uncover any evidence of what they believe to be non-compliant billing practices, the consequences can be severe. While recoupments, denials of pending payments, and the institution of prepayment review are the most common, Optum Rx can also arbitrarily terminate pharmacies’ PBM contracts. This is even the case where the compliance issues are relatively minor. As a result, pharmacies need to be prepared to aggressively defend themselves during the PBM audit process. The first step is to engage an experienced pharmacy defense law firm.
At Oberheiden, P.C., our Optum Rx/Catamaran pharmacy audit defense lawyers have centuries of combined experience helping pharmacies protect their interests through the audit process. We recognize that any audit is stressful and presents high-stakes for your pharmacy and livelihood. Thus, we are prepared to immediately intervene to ensure a smooth audit. Should auditors exceed the scope of their authority during the audit, our pharmacy audit lawyers will be there to take immediate corrective action.
What to Expect During an Optum RX/Catamaran RX Pharmacy Audit
As a pharmacy benefit manager, Optum RX/Catamaran RX regularly engages in audits of participating pharmacies. While every Optum RX/Catamaran RX pharmacy audit is carried out pursuant to the auditors’ preferences, they largely follow the same approach. For pharmacies facing an upcoming audit, it is especially important to understand the audit process.
However, because PBMs are not federally regulated, they tend to operate in a shroud of mystery. For what it’s worth, Optum RX/Catamaran RX provides all pharmacies with a 138-page, densely-packed “Operators Manual” that covers the audit process.
According to the Optum RX/Catamaran RX Operator’s Manual, a pharmacy audit serves three purposes:
- To validate the accuracy of paid claims, contractual compliance, regulatory compliance, various aspects of drug product inventories, the presence of required signage and/or documentation;
- To observe the overall facility operations and conditions; and
- To monitor for, detect, and prevent activities resulting in fraud, waste or abuse and transaction errors in the billing of covered prescription services.
When Optum RX/Catamaran RX determines an audit is necessary, it must provide a pharmacy with at least seven days’ notice and provide an approximate time for the audit. Pharmacies are expected to have sufficient staff available to assist auditors with locating records and performing the audit. Additionally, Optum RX/Catamaran RX demands that auditors are provided a safe and clutter-free work area with access to an electrical outlet.
When the auditors arrive, they will immediately request extensive documentation. According to the Optum RX/Catamaran RX Operator’s Manual, “Auditors must be given full access to the books, records, files, lists, signature logs and documentation associated with any and all transactions related to Administrator Claims submitted by the Network Pharmacy Provider. Auditor reserves the right to request copies or take digital images (i.e., scanned/photo) of aforementioned documents. A denial of this request will be determined to be denial of access.” Auditors may also require that pharmacists pull all records within the view of auditors.
Thus, it is essential that pharmacies not only know where to access all potentially relevant files but also that they have gone through the documents in advance. This will give you a better idea of what to expect during the audit and what issues, if any, you may encounter. Some of the documents that Optum RX/Catamaran RX may ask to review include:
- CMS10147 and other required documents and notices
- Daily prescription logs
- Fraud, waste, and abuse training logs
- Internal pharmacy compliance policies and procedures
- LEIE/EPLS verifications
- Patient profiles
- Prescriber information
- Prescription hardcopies
- Purchase invoices
- Refill information
- Signature/delivery logs
Optum RX/Catamaran RX requires pharmacies to retain all records for at least five years. However, in the case of records pertaining to Medicare Part D, records must be maintained for at least ten years. While this may sound like a procedural requirement, a pharmacy’s failure to produce the requested records will be seen as a red flag that, absent any other violation, can result in serious sanctions.
Once Optum RX/Catamaran RX auditors gather all documentation they need, they will then begin their review. Auditors are trained to identify anything that resembles a violation—either of state law, federal law or the terms of the PBM contract. Thus, it is imperative that all records are both complete and accurate. For example, auditors demand the following information is contained on all prescription records:
- The patient’s full name, address, and date of birth;
- The name, strength, and quantity of the medication prescribed;
- The prescriber’s full name, address, telephone number, and any other required identifying information; and
- The dosing directions provided to the patient;
- Refill and substitution instructions, if applicable; and
- Any substitutions requested by the patient;
- Any “[O]ther informational notes as required by applicable laws and regulations.”
What Causes Optum RX/Catamaran to Initiate a Pharmacy Audit?
As outlined in the Operator’s Manual, the following are potential violations that may give rise to an audit.
- Billing for a brand name drug but dispensing a generic drug;
- Using the incorrect National Drug Code;
- Overbilling of the quantity prescribed;
- Billing multiple payers for the same prescriptions;
- Inappropriate billing of compounded drugs;
- Submitting a dummy DEA/NPI number or invalid DEA/NPI numbers to obtain reimbursement;
- Improperly billing for larger pack sizes when one smaller pack size will meet the directions of the prescriber;
- Billing for more fills or refills than were authorized;
- Splitting prescriptions into multiple claims to obtain multiple dispensing fees;
- Billing for invalid prescriptions due to lack of a legal prescriber, forgery, or false or fictitious documents;
- Dilution of drug product provided to the patient;
- Acquisitions of prescription drugs through the black market;
- Collusion with another prescriber, wholesaler or others
- Illegal kickback schemes; and
- Providing patients with fewer pills than prescribed.
Of course, this is an incomplete list of potential red flags that may trigger an audit of a pharmacy’s practices. Auditors will also review pharmacy practices to ensure they are not participating in healthcare fraud schemes that are initiated by physicians or patients but tangentially involve a pharmacy, such as:
- Pill mills,
- Illegal remuneration schemes,
- Illegal use of free samples,
- Altered and forged prescriptions,
- Pharmacy hopping,
- Doctor shopping, and
- Black market sales.
While these schemes are not usually carried out by pharmacies, Optum RX/Catamaran RX will want to ensure that pharmacies are doing their part to identify illegal conduct.
How Oberheiden, P.C. Can Help Your Pharmacy Survive an Optum RX/Catamaran RX Audit
Due to the complex and technical compliance obligations pharmacies face when doing business with Optum Rx, it is essential those pharmacies notified of an upcoming audit seek the advice of experienced legal counsel. At Oberheiden P.C., we advise and represent pharmacies throughout the Optum Rx audit process, from preparing for the audit to dealing with any fallout that may ultimately prove to be unavoidable.
When our pharmacy compliance and audit attorneys are engaged as defense counsel during an Optum Rx pharmacy audit, we provide the following services:
Identifying and Organizing All Potentially Relevant Records
When facing an upcoming Optum Rx audit, the importance of locating and organizing all required documentation is paramount. Oberheiden, P.C.’s pharmacy audit defense lawyers will ensure that all required records are readily available for auditors’ review. We will also organize your pharmacy’s documentation so that it can be easily reviewed to confirm compliance. This prevents auditors from spending any more time at your pharmacy than is absolutely necessary.
Thorough Review of all Reviewable Documentation
Once all audit-related documentation is gathered, we then conduct a meticulous review of the records, looking for anything that may raise a red flag in the auditors’ eyes. If any compliance concerns arise, we will have ample time to develop a coordinated and proactive response, ensuring that any potential penalties are either avoided entirely or mitigated to the greatest extent possible.
Day-Of Counsel and Representation
Oberheiden P.C. ensures that our attorneys have a physical presence during the audit, providing our pharmacy clients with on-site support throughout the entire audit. For example, our lawyers will intervene to right any incorrect assumptions or flawed methodologies auditors attempt to use. If Optum RX/Catamaran RX auditors make an unreasonable demand for documentation that exceeds the scope of the Operations Manual or PBM contract, we will take it up with them, providing factual and legal support for our analysis. Having a pharmacy audit lawyer on-site also assists with controlling the flow of information, which is an essential element to any successful audit.
Billing Fraud and Compliance Defense
During some Optum RX/Catamaran RX audits, violations are inevitable. Optum RX reserves broad authority to implement a wide range of potential sanctions such as recoupments, denials of pending payments, prepayment review or even contract termination. However, Optum RX’s initial position isn’t always their final one. Often, Oberheiden, P.C. pharmacy audit defense lawyers can negotiate with auditors or management to avoid the most serious consequences. We are also frequently called upon to defend pharmacies facing federal healthcare fraud allegations stemming from unfavorable PBM audits.
Comprehensive Review of All Post-Audit Options
Regardless of how an Optum RX/Catamaran RX audit turns out, it is important to review the results and determine a strategic course of action. 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. If the audit reveals future compliance risks, our pharmacy compliance specialists can provide compliance consulting services to avoid the risk of future audits or federal investigations.
Frequently Asked Questions:
Why don’t we call ourselves the “best Optum RX/Catamaran RX pharmacy audit” lawyers?
At Oberheiden, P.C., we are confident in our ability to help pharmacies through an Optum RX/Catamaran RX audit. However, you’ll notice that we don’t refer to ourselves as the “best Optum RX/Catamaran RX audit defense lawyers.” There are a few reasons for this. First, we represent sophisticated clients who we believe are not likely to be persuaded by marketing gimmicks or conclusory statements that cannot be substantiated. Moreover, we also feel that the term “best” is subjective and potentially misleading when used to describe an attorney. And, because we take our ethical obligations seriously, we do everything possible to avoid making any misleading statements. Regardless, for those looking for the best Optum RX/Catamaran RX audit attorneys; our track record speaks for itself.
Do I need to allow Optum RX/Catamaran RX auditors full access to all documents?
Not necessarily. If an audit makes an unreasonable request for records or documentation, you do not need to honor the request. However, it is imperative that a pharmacy is confident in its position that a request falls outside the scope of the PBM contract before denying access to auditors. This is because, under the terms of the Optum RX/Catamaran RX Operator’s Manual, denying an auditor’s request will be considered a denial of access. A denial of access “is determined to be a breach of the audit provisions of the Agreement. The Network Pharmacy Provider may be subject to immediate suspension or termination for noncompliance.” At Oberheiden, P.C., our pharmacy audit defense lawyers will communicate with Optum RX/Catamaran RX auditors throughout the process.
What are a pharmacy’s rights when undergoing an Optum RX/Catamaran RX audit?
A pharmacy’s rights during the PBM audit process depend on the state where the pharmacy operates as well as the terms of the PBM contract. The relationship between a pharmacy and Optum RX/Catamaran RX is defined entirely by the PBM contract. This agreement lays out the rights and obligations of both sides and provides certain processes that must be followed. Generally, pharmacies have the following rights:
- A PBM must provide reasonable notice of the audit;
- A PBM must rely on a limited and clearly defined look-back period;
- A PBM must reimburse a pharmacy for claims that were improperly denied;
- A PBM must provide a pharmacy with timely notice of the audit results; and
- A PBM must provide explanations of any demand for recoupment.
Additionally, pharmacies have the right to challenge auditors’ findings as well as any sanctions imposed by Optum RX/Catamaran RX. At Oberheiden, P.C., we help pharmacies familiarize themselves with their rights to ensure their interests remain protected throughout the PBM audit process.
Discuss Your Upcoming Optum RX/Catamaran RX Audit with a Pharmacy Audit Attorney at Oberheiden, P.C.
If you recently discovered that Optum RX/Catamaran RX will be visiting your pharmacy for an audit, your next move should be to call the dedicated pharmacy audit defense lawyers at Oberheiden, P.C. We offer all pharmacies an immediate and confidential consultation with a senior attorney. You can reach Oberheiden, P.C. by calling 888-680-1745 or by completing our online contact form.