Pharmacy Consulting Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
In a pharmacy setting, internal audits are formal reviews of processes and claims with the sole purpose of ensuring pharmacies operate within regulatory and contractual agreements. While most pharmacy owners dread this process, it must be done. Ignoring internal audits comes with notable consequences ranging from poor performance to legal problems.
With increased media scrutiny, advanced tech, and government oversight, pharmacies can’t escape audits. A pharmacy owner’s decision regarding internal audits dictates the fate of their business.
While some pharmacy owners may attempt to handle pharmacy regulatory and contractual compliance internally for various reasons, including cost savings, internal audits should be done by experts with pharmacy consulting experience.
Corporate Investigation Consulting specializes in internal audits for pharmacies nationwide. We understand the internal controls regulators and other stakeholder’s assess. Don’t risk your operation! Call Us. 866-352-9324.
Internal Audits
Internal audits monitor internal control processes for effectiveness. They should be independent, which highlights why they shouldn’t be done by internal staff. What’s more, they need to be objective and designed to improve a business’s operations.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Establishing Internal Control Processes in a Pharmacy
Our experts can establish employee policies and procedures for your pharmacy with industry best practices in mind. We have designed written guidelines for many pharmacies to protect their interests and establish due diligence practices by focusing on areas examined during audits.
With written guidelines in place (such as an employee handbook), every employee will know their duties and obligations within the pharmacy. A handbook will also dictate behaviors. Our pharmacy consulting services can establish whether existing handbooks have been read and understood by employees. We can also establish employee’s willingness to comply with standards of operation.
Common Internal Audits for Pharmacies
Pharmacies undergo several audits internally and externally. The most critical factor is identifying the type of audit your pharmacy is being subjected to.
HRSA 340B Audits
Pharmacies can be subjected to HRSA 340B audits that start with a pre-audit. During a pre-audit, a pharmacy will receive communication explaining what the audit entails. A formal request for specific documents such as internal controls, policies, and procedures will be requested. A pre-audit ends with a scheduled meeting date with pharmacy management to plan for an onsite audit.
Onsite pharmacy HRSA audits involve auditors acquiring and reviewing HRSA 340B program information and internal controls. Auditors also go through applicable policies and procedures, seeing how such policies and procedures have been implements. An onsite audit will also include verifying internal controls on preventing duplicate discounts, diversion, etc. Auditors will also assess HRSA 340B compliance and test drug transaction records.
The onsite audit process is a fact-collecting process that results in a report that must be reviewed. Remember, statements made by auditors during audits aren’t final. In case a re-audit results in similar findings i.e., noncompliance, additional audits will be recommended. Consecutive noncompliance findings result in stringent actions such as the removal from HRSA 340B program.
PBM (Pharmacy Benefit Managers) Audits
All pharmacies that are contract providers of prescription services can be subjected to audits of their records i.e., signature logs, written prescriptions, invoice records, digital refill records, and other related pharmacy records.
Regulator Audits
Regulators like the DEA and some pharmacy state boards can conduct audits that can end up in license revocation and criminal indictments. A pharmacy may be requested by the DEA to voluntarily surrender their license. Such action isn’t recommended without consulting experts in internal pharmacy audits.
Internal Audit Documentation and Areas of Focus
Pharmacies facing internal audits will be required to produce certain documentation. Typically, auditors will request for hard copies of prescriptions, records supporting prescription records, digital dispensing records, purchase records & invoices, pharmacy procedure and policy manual, quality control plans, financial records, communication logs, patient signature logs, contracts, and provider payment records.
Auditors can ask for any of the above, among other documentation. Failure to provide such documentation can be the onset of legal problems. Let Corporate Investigation Consulting handle ensure your pharmacy is ready for internal audits.
Besides familiarizing yourself with the documentation needed for an internal pharmacy audit, it’s important to understand the critical areas of focus. Typically, auditors want to know if your pharmacy is compliant with formulary guidelines, invoice preparation requirements, controlled substance purchase and dispensation, and contractual guidelines. Auditors are also keen on investigating the presence and effectiveness of inventory controls, correct benefit plan administration, and claim accuracy.
Every pharmacy subjected to an internal audit needs experienced professionals to offer guidance throughout the process. Schedule a free-non-obligatory consultation with our pharmacy internal audit experts. Call us at 866-352-9324. We have seasoned professionals nationwide from Dallas, TX, and beyond.
Internal Audit Benefits to Pharmacy Owners
Besides establishing compliance and avoiding legal problems, internal audits have other benefits to pharmacy owners. Assessment of risk helps to identify and prioritize processes requiring attention. Audit processes also give pharmacy owners deeper insight into existing processes. Control assessments identify possible problems in how controls and procedures are designed while testing controls verifies the effectiveness of controls to work as intended.
The Corporate Investigation Consulting Advantage
Nationwide pharmacy internal audit support: We offer expertise to local, regional & nationwide pharmacies in the U.S. on all matters regarding internal audits.
Nationwide representation: If your pharmacy is already under scrutiny by government agencies like the DEA, among other authorities, we have legal experts ready to assist you.
Nationwide experts: Corporate Investigation Consulting has nationwide teams with expertise in corporate investigation fields like internal audits. We have former DEA agents, IRS agents, federal prosecutors, and many other experts in our team capable of handling all internal audit pharmacy matters imaginable. Our experts have challenged internal audit processes successfully and represented clients through such processes. Most importantly, our services aren’t bound by state regulations. We service clients from our headquarters in Dallas, TX, and all other states.
Best corporate investigation consulting rates: Our nationwide presence offers us economies of scale benefits which we share with our clients. That’s why we can afford lower rates without compromising our service quality.
Internal audits can mean the closure of successful pharmaceutical operations and criminal prosecution of pharmacy owners. Don’t face internal pharmacy audit processes alone. What’s more, you should be proactive about internal audit processes given the benefits they offer to pharmacy owners besides compliance.
Call 866-352-9324 or contact us online for all pharmacy internal audit matters.