What to Look for in a Top 340B Consultant, Firm, or Auditor: Interview Questions to Ask

Most 340B program managers who choose the wrong auditor discover their mistake when it's too late to fix the damage to their healthcare organizations.

The consequences extend far beyond wasted consulting fees — inadequate 340B audits can leave covered entities exposed to HRSA findings, manufacturer repayments, and compliance gaps that take months to remediate. This is particularly critical for federally qualified health centers, rural hospitals, and large hospital systems that depend on 340B benefits for patient care.

Analytical professionals who oversee complex 340B operations at large health systems require the same methodical approach for selecting an audit partner that they apply to inventory management and regulatory compliance. The decision affects not just your program's immediate audit readiness but its long-term operational efficiency and financial performance, particularly regarding cost savings for 340B hospitals navigating the drug discount program.

Edward Vargas, a certified internal auditor with nearly a decade of experience across hospitals and health centers, 340B contract pharmacy operations, and third-party administrators, has identified three non-negotiable criteria that separate effective 340B services providers from those who create more problems than they solve. His insights, drawn from auditing covered entities nationwide, provide a framework for making this critical decision with confidence.

The stakes are particularly high for 340B program managers at disproportionate share hospitals and large health systems. Your programs involve hundreds of clinical providers, complex GPO prohibition requirements, and sophisticated inventory management across multiple locations, including contract pharmacies and specialty pharmacies.

A cookie-cutter audit approach that works for smaller community health centers will miss the nuanced compliance risks specific to your operational structure and 340B contract pharmacy pricing arrangements.

Here are some important interview questions to ask potential 340B Program Management or 340B consulting services agencies. 

Does Your 340B Consulting Firm Maintain True Independence?

Why this question:

"The most important elements in particular are really independence, that the auditor or consultant doesn't necessarily have conflicts of interest that might be contrary to your organization's best interests," Vargas explains.

True independence in 340B program consulting means more than just avoiding obvious conflicts — it requires understanding how various business models can compromise an auditor's ability to provide objective guidance for your client's 340B program.

The most common independence violations occur when consulting firms also provide program solutions or operate as part of larger 340B TPA platforms. These arrangements create inherent conflicts because the firm's revenue depends on the amount of program savings your organization captures. When gray areas arise in 340B patient eligibility determinations, these consultants face pressure to recommend aggressive interpretations that maximize your 340B drug pricing program purchases — and their percentage-based fees.

"Sometimes it could be if the firm also provides additional service lines that might be based on the percentage of 340B revenue that the organization is capturing," Vargas notes. "They'll come in the form of either a program management firm that is helping you manage your program, or perhaps if the consulting division or audit division is part of a larger 340B TPA platform."

Ask these specific questions to evaluate independence:

• "How is your firm structured, and do you have any ownership affiliations with program management companies?"

• "Are your engagement fees fixed or based on a percentage of our program benefits?"

• "Do you provide any services that would benefit financially from higher 340B drug discount purchases?"

Navigating 340B: How Deep Is the Consulting Firm's Compliance Knowledge?

Your 340B drug pricing program operates within a complex regulatory framework that varies significantly based on entity type and state requirements. Effective elevated 340B consultants must demonstrate deep knowledge of HRSA 340B guidelines, Medicaid billing requirements, and the unique compliance challenges facing different covered entities.

"The critical evaluation focuses on whether the audit firm or consultant has demonstrated experience navigating HRSA audits with covered entities," Vargas explains. "This serves as a reliable indicator that they possess comprehensive knowledge of Health Resources and Services Administration guidelines and that their recommendations and guidance have either successfully withstood HRSA scrutiny during audits or been refined through lessons learned from audit findings experienced by their clients."

You also want to know if the 340B management agency understands GPO prohibitions. "When it comes to hospital entities, particularly the larger hospitals or health systems that participate in the program as disproportionate share hospitals, they are also subject to what's known as the GPO prohibition," Vargas explains. "These larger hospitals also have to be mindful that they're not using GPO drug on outpatients that are not 340B eligible."

Entity-specific expertise matters significantly for large hospitals and health systems working to establish their 340B program or optimize existing operations. The GPO prohibition requirements that apply to disproportionate share hospitals create compliance complexities that don't exist for health center grantees or rural hospitals. Your auditor must understand how patient mix affects inventory utilization and the requirement to use wholesale acquisition cost pricing for non-340B eligible outpatients across your mixed-use pharmacy program.

Ask these questions to evaluate regulatory knowledge for navigating 340B:

• "Have you worked with covered entities of our specific type and size?"

• "Can you explain the GPO prohibition requirements for our entity type?"

• "How do you stay current with manufacturer policy changes affecting 340B eligibility?"

• "What experience do you have with HRSA 340B audits ?"

340B Implementation: Do They Customize Their Approach or Use Cookie-Cutter Methods?

Generic audit methodologies fail to address the unique risks facing different types of healthcare organizations. "Not every hospital or health center is the same," Vargas explains. "Everybody provides a unique scope of patient services or might have a different operational structure internally or a diverse geographical landscape of where their clinics and locations are located."

The most telling example of customized versus generic approaches comes from Vargas's experience with a critical access hospital that had been receiving annual audits using standardized methodologies. "They were getting more of the cookie-cutter approach, compliance assessment, auditing a sample of 340B claims, providing a compliance report on their activity," he recalls.

When Virtue 340B applied their data analytics approach, they discovered purchasing discrepancies that past 340B auditors had missed. "We started by performing some general statistical summaries on their data and recognized some discrepancies in their purchasing trends throughout the scope of our audit engagement," Vargas explains. This led to identifying a system error causing over-accumulation of 340B discounts that resulted in significant manufacturer repayment requirements.

"We actually identified that a situation occurred that caused several of their drugs that are administered within the hospital to be accumulating differently in their system," Vargas continues. "And that subsequently caused an over accumulation of 340B eligible drugs that the covered entity was replenishing at the 340B price."

A passionate team of 340B experts understands that effective 340B implementation requires customized approaches that address each organization's unique operational structure and compliance requirements.

Ask these questions about their methodology:

• "Can you describe your approach to data analytics and risk assessment?"

• "How do you customize your audit procedures for different entity types?"

• "What tools do you use to identify unique risks before conducting sample testing?"

• "Can you provide examples of how your customized approach identified issues that generic audits missed?"

What Is The 340B Experts' Approach to Education and Collaboration?

The best 340B services providers operate as educators and partners rather than simply compliance reviewers. Vargas emphasizes the importance of transparent communication throughout the engagement: "We start all of our engagements with a clear engagement letter that identifies scope of the audit, our core objectives, timeframe, and some of the key timelines throughout our engagement."

Cross-departmental collaboration distinguishes superior consultants from those who work only with pharmacy teams. Many compliance with 340B program regulations requirements involve departments beyond pharmacy, particularly for Medicaid billing and provider credentialing. Effective consultants understand these interdependencies and facilitate communication across organizational functions to maintain program integrity.

The provider roster example illustrates this collaborative approach for organizations looking to provide 340B services effectively. "What's very important is to ensure that your third-party administrators or your other internal eligibility determining software has a complete and accurate list of your eligible providers," Vargas explains. Rather than simply identifying discrepancies, effective consultants work with credentialing departments and medical staff offices to establish ongoing processes for maintaining accurate provider information.

"Instead of just purely identifying, hey, here are the discrepancies, these providers need to be updated, something that we traditionally do is take it one step further and really loop in the cross department representatives from either the organization's credentialing department or other medical staff office appointment department," Vargas notes.

Organizations that have started and grown successful 340B programs understand that a team of 340B professionals working collaboratively across departments is essential for long-term success and improved health outcomes.

Questions about their educational approach:

• "How do you involve different departments in your audit process?"

• "What type of staff training do you provide during engagements?"

• "Can you describe how you help organizations establish ongoing compliance processes?"

• "Do you provide education on regulatory requirements beyond just identifying findings?"

How Does the Potential 340B Consulting Services Team Handle Reporting and Recommendations?

Actionable recommendations separate valuable consultants from those who merely identify problems. "We go beyond just highlighting that a finding occurred and that a discrepancy exists," Vargas explains. "We say this is the finding, this is what we observed, this is the root cause that we identified why it's existing, here is actual guidance for how to remediate it and prevent it from occurring in the future."

The quality of reporting reflects the consultant's understanding of your operational needs and their commitment to helping you achieve long-term compliance. Detailed reports should distinguish between findings likely to be adverse during HRSA 340B audits versus best practice recommendations for program optimization.

"We help our clients digest and prioritize which elements to address first," Vargas notes. "And then in the way we form our recommendations. We go beyond just highlighting that a finding occurred and that a discrepancy exists and giving it to the client, saying, Hey, we noticed this isn't correct, you're going to want to look into it."

Virtue 340B's approach demonstrates comprehensive reporting standards for maximizing the benefits of the 340B program. Their audit methodology incorporates data analytics, reconciliation processes, and sample testing that reflects understanding of how 340B program's operations actually function within complex health systems. Their focus on cross-departmental collaboration and staff education shows recognition that effective 340B administrative processes require coordination across multiple organizational functions.

Questions about past 340B reporting quality:

• "Can you provide examples of your audit reports and recommendation formats?"

• "How do you prioritize findings based on compliance risk levels?"

• "What level of implementation guidance do you provide with your recommendations?"

• "How do you distinguish between HRSA audit risks and optimization opportunities?"

Can The Agency Optimize Your 340B Program Beyond Basic Compliance?

The most valuable 340B services consultants provide ongoing support that extends beyond formal audit engagements. Regulatory changes, manufacturer policy updates, and operational modifications all affect 340B program compliance. Consultants who maintain relationships with clients and provide guidance on emerging issues deliver greater long-term value and help identify new opportunities within the program.

"Our mission is truly to empower our covered entities that we have the chance to work with," Vargas explains. "And our goal is always to ensure that they feel more confident on the completion of our engagement than they did on day one when we kicked it off."

This empowerment approach focuses on building internal capabilities rather than creating consultant dependence. Through detailed explanations of the complexities of the 340B program and collaborative problem-solving, effective consultants help your team develop expertise that improves ongoing program management and extends the reach of your 340B program.

State-specific knowledge becomes particularly important for optimization efforts and understanding 340B rules. "Medicaid in particular differs from state to state," Vargas notes. "So there are typically unique elements of each state that apply to covered entities that are above and beyond just the federal language and the 340B statute."

Organizations working with consultants who understand specialty pharmacy services and health plan relationships can better navigate the evolving landscape of 340B ESP™ requirements and manufacturer restrictions.

Ask these questions about 340b management optimization capabilities:

• "How do you help organizations maximize their 340B savings while maintaining compliance?"

• "What ongoing support do you provide after audit completion?"

• "Can you identify opportunities for operational efficiency improvements?"

• "How do you stay current with regulatory changes that affect our program?"

Do The 340B Experts Demonstrate Integrity and Professional Standards?

The consultant's commitment to professional standards and ethical practices affects every aspect of your engagement. For example, Vargas operates as a Certified Internal Auditor, adhering to international standards that ensure objective, transparent audit processes for maintaining compliant 340B operations.

"We conduct our engagements in alignment with the international standards for the professional practice of internal auditing," Vargas explains. This commitment to professional standards provides assurance that audit procedures follow established best practices and maintain objectivity throughout the engagement, supporting both program oversight and program revenue growth.

References from similar organizations provide the best insight into a consultant's integrity and service quality. "The strength of the referrals, the references that the firm is able to provide, and making contact with those folks, and actually getting their input on how the engagement went, and what types of advantages the client might have realized," Vargas recommends.

Organizations that have grown successful 340B programs across multiple sites understand the importance of working with consultants who demonstrate consistent professional standards and can support the restoration of 340B program integrity when issues arise.

Ask these questions about professional standards:

• "What professional certifications do your audit staff maintain?"

• "Can you provide references from organizations similar to ours?"

• "How do you ensure objectivity and independence throughout your engagements?"

• "What professional standards guide your audit methodology?"

The investment in selecting the right 340B program consulting partner pays dividends through improved compliance, optimized savings, and strengthened internal capabilities. Take time to thoroughly evaluate potential partners using these questions — the cost of choosing poorly extends far beyond consulting fees to include compliance risks, missed optimization opportunities, and potential manufacturer repayments that could have been prevented.

Looking for 340B Services?

Virtue 340B's comprehensive elevated 340B audit services and commitment to transparency exemplify the standards you should expect from your consulting partner. Their approach demonstrates how the right consultant becomes a strategic partner in optimizing your program while maintaining the highest compliance standards and supporting improved patient care outcomes.

Contact us today to interview us and learn more!