National audit assistance services cannot provide the legal expertise, subject matter knowledge, or audit leverage that healthcare defense attorneys bring to the table. These services are ineffective in holding PBMs accountable to their legal obligations.

Pharmacists often utilize national audit assistance services to respond to PBM audits. Although these services may be useful in certain scenarios, pharmacists should understand that it is often necessary to retain audit defense attorneys to hold PBMs legally accountable and protect pharmacists' rights from PBM abuse.

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PBM Audits Often Involve "Audit Risk Factors"

As you know, PBM audits are not conducted at random. In addition, PBM audits typically involve the presence of "audit risk factors" that help inform the potential exposure and liability at issue.

For example, do the audited claims involve aberrant products? Are there market shortages or allocated products that may have affected inventory? What are the prior authorization requirements and off-label uses?  

HLA use these factors and our experience to calculate the magnitude of audit risk at issue. For example, the federal government routinely prioritizes telehealth enforcement. Therefore, if the audit implicates a telehealth referral, even absent other risk factors, it must be handled with the utmost care and caution.

Audit Assistance Services Do Not Provide Legal Advice

Healthcare attorneys are legal experts who possess a deep understanding of healthcare-specific legal requirements and how those obligations apply to pharmacy.

In contrast, while audit services vendors may offer some level of guidance, they lack the comprehensive legal expertise necessary to address the very individualized and nuanced legal issues that differ from pharmacy to pharmacy.

Accordingly, audit services cannot are not equipped to handle the intricate legal challenges that pharmacies often face, especially when responding to a PBM audit, appealing adverse PBM audit findings, and/or challenging improper PBM termination notices.

PBMs Must be Held Legally Accountable to Audit Laws

PBM audit processes often violate the terms of provider manuals, network agreements and enrollment forms. To effectively defend an audit, PBMs must be held to their obligations under law.

National audit assistance services are not experts in federal and state laws, unlike healthcare audit defense attorneys. For example, HLA's attorneys incorporate federal and state laws into each audit response. In this fashion, we hold PBMs accountable to their obligations under fair audit, any willing provider, and other similar laws.

Conversely, audit services vendors generally provide standardized templates and manuals, which can be valuable as supplementary resources. However, they often fall short in addressing the unique challenges of individual pharmacy clients. While these uniform solutions may serve as foundational guides, they typically lack the necessary depth and customization to effectively oversee various legal and compliance challenges pharmacies face, such as PBM audits and the associated potential legal challenges and repercussions.

Audit Assistance Services May Lack Subject Matter Expertise

Every pharmacy business is unique, with its own set of unique patient populations, regulatory challenges, financial goals, and very specific compliance needs. Whether it is implementing operating procedures, drafting compliant marketing contracts, or representing clients in PBM audits and/or investigations, healthcare defense attorneys provide personalized legal services designed to mitigate risks and achieve optimal PBM audit outcomes.

Attorneys, unlike auditors, have the necessary legal background and experience to advise and guide pharmacy clients through every legal aspect of their operations while ensuring compliance with applicable laws and regulations and minimizing legal risks and exposures.

On the other hand, audit assistance services focus primarily on audit and appeals processes. This limited scope could leave pharmacies vulnerable to the legal risks and compliance pitfalls that, in many cases, are the reason the pharmacy was targeted for audit in the first place.

Collateral Audit Consequences Can Be Severe

In the event of PBM audits as well as government investigations and/or board actions, which may stem from those audits, healthcare defense attorneys serve as staunch advocates for their pharmacy clients, vigorously defending their rights and interests in court and/or during administrative proceedings.

Indeed, Healthcare defense attorneys possess the legal acumen and advocacy skills necessary to challenge PBM audit findings, negotiate settlements to prevent litigation, and, if necessary, litigate matters in court.

Conversely, while audit services vendors may have tools that can be used when responding to  PBM audits or appealing PBM audit findings, they will not have the legal expertise nor the requisite knowledge and credentials to provide the same level of advocacy and legal protections as healthcare attorneys, which may include representing pharmacy clients in adversarial proceedings, negotiating settlements with PBM’s and/or various government agencies.  

In sum, while audit services vendors may offer some level of assistance in navigating PBM audits and addressing pharmacy compliance issues, they cannot match the knowledge, expertise, customization, comprehensiveness, and advocacy provided by healthcare defense attorneys.  

HLA is Available to Help

In an industry as complex and heavily regulated as healthcare, entrusting legal matters to qualified healthcare defense attorneys is not only advantageous—it is essential for safeguarding the interests of the pharmacy, its owners, and its staff. If you need help with an audit, call or email before your rights are compromised.

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