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TIP: Evaluate the downstream impact of every operational change before implementation.
In today’s 340B landscape, seemingly small operational updates can create significant unintended consequences. A covered entity’s (CE) program can quickly take a turn if impact is not appropriately assessed and addressed prior. Manufacturer restrictions, legal developments and program requirements will continue to shift, and CEs are required to ingest more information now than ever.
CEs need to be prepared to approach these operational changes with careful review and collaboration from internal and external stakeholders. CEs should evaluate and understand the request first and then engage internal and external stakeholders as appropriate to be a part of the decision-making process. A formal impact analysis may even be necessary to make an informed decision that reviews how pricing access and claim qualification rate might be impacted. A proactive approach can help protect both compliance and long-term operational performance.
340B operations can become complex quickly and decisions should never be made in a silo. Collaboration with vendors such as your third-party administrator (TPA) and proactive evaluation are essential to maintaining program integrity and operational efficiency. For more operational bright spots, be sure to connect with us at 340B Coalition Summer Conference in July!
Kaitlyn Weckhorst, Account Executive at SunRx, can be reached at kweckhorst@sunrx.com
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TIP: Regularly review your 340B ESP configuration to ensure alignment across TPA & wholesaler systems, because even small inconsistencies can quietly escalate into significant missed savings opportunities.
The 340B policy environment continues to evolve rapidly, with ongoing manufacturer and state-level updates. Manufacturer changes often require immediate action – introducing new NDC exclusions, restriction criteria, or pharmacy designation requirements. State laws add complexity, with many manufacturers not consistently returning pricing in states with contract pharmacy protections. To keep up, covered entities (CEs) should monitor these developments and ensure updates are reflected across ESP, TPA, and wholesaler settings. Without alignment, CEs risk missing 340B savings or defaulting to unnecessary WAC replenishment.
As a best practice, implement a system that supports ongoing analysis so you can easily review your setup at least quarterly – and more frequently when new policies are announced. Depending on your CE type, there may be additional nuance:
- Grantees – Consider exploring Multi-Site Designations if not already implemented at your organization. This strategy remains one of the most effective ways to recapture lost savings due to manufacturer restrictions, enabling unlocked 340B pricing at multiple contract pharmacies. CEs with a higher number of registered sites than contract pharmacies are often best positioned to maximize this benefit.
- Hospitals – Reevaluate your current pharmacy designations. Shifting patient flows and prescribing patterns require continual assessment of which contract pharmacies are delivering value. It’s also critical to verify your current setup in ESP and confirm consistency with your TPAs, to ensure no NDC or pharmacy opportunities are overlooked.
In today’s dynamic 340B landscape, consistent and proactive alignment across ESP, TPA, and wholesaler systems is essential, where minor gaps can translate into major, preventable losses.
Proximity simplifies 340B ESP analysis and ongoing monitoring, helping you identify misalignments, reduce manual effort, and capture missed savings opportunities.
Mike Muir, Customer Success Manager at Proximity, can be reached at m.muir@proximityhealth.com
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TIP: Treat the current delay in the 340B rebate model rollout as a strategic window to unify your procurement, finance, and compliance tech stacks, shifting from retrospective investigation to proactive program defensibility.
- The recent pause in the 340B rebate model rollout is not a reprieve; it is a critical maturity test for pharmacy leadership. Historically, many health systems have operated with fragmented workflows where finance, operations, and compliance functioned in silos. However, the pending transition to a rebate environment removes the buffers inherent in traditional upfront discount models. When your team is eventually required to purchase drugs at wholesale acquisition cost and defend eligibility within a narrow window, a “siloed” program becomes an operational liability. Every drug purchase will simultaneously become a financial, compliance, and operational decision.
- Pharmacy leaders must use this time wisely to achieve “data sovereignty.” This means building a unified tech stack that integrates EMR encounter data, pharmacy claims, purchasing records, and supply chain metrics into a single source of truth. By automating manual workflows and establishing continuous reconciliation now, you move your program from retrospective investigation to proactive assurance.
- Furthermore, this delay provides the opportunity to integrate 340B logic into daily procurement and shortage management. In a rebate model, a clinical substitution during a drug shortage can create immediate financial and regulatory exposure if not tracked in real-time. Organizations that treat this delay as preparation time – rather than waiting time – will be best positioned to maintain program integrity. By unifying your operational framework today, you ensure your 340B program remains a transparent, defensible, and sustainable financial stabilizer for the community you serve.
Sean Gilman is Director of Clinical Strategy at Bluesight. He can be reached at sean.gilman@bluesight.com
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TIP: When choosing a 340B solutions partner, consider the support services they offer during a HRSA audit.
As HRSA audits become more complex and scrutinized, a crucial factor in selecting a third-party administrator (TPA) is evaluating the level of audit support they offer to their covered entity partners. Ensuring program integrity and maintaining consistent audit readiness are essential to protecting 340B savings. With approximately 200 covered entities audited each year, partnering with a 340B solutions provider that offers both onsite and virtual audit support can be a critical advantage.
Key areas where a TPA can support the audit process include:
- Data Request List (DRL) Management: During the initial audit phase, HRSA issues a Data Request List outlining all required documentation. A qualified TPA can assist with assembling a complete and accurate submission, ensuring that all requested materials are well-organized and audit-ready.
- 340B Universe Review: A TPA partner can help review and prepare universe files in the appropriate redacted format for upload to the National Institutes of Health portal. Additionally, they can test sample selections to verify that supporting medical record documentation demonstrates 340B eligibility.
- Audit Support and Guidance: During the audit, TPAs can help address HRSA inquiries, provide context for findings, and support communication with auditors. As necessary, they may also assist with drafting corrective action plans to maintain program compliance.
With the right 340B solutions partner, covered entities can navigate the HRSA audit process with greater confidence, efficiency, and reduced operational stress.
Jaleesa Smith, 340B Director of Program Integrity at Avita Care Solutions, can be reached at Jaleesa.Smith@avitacaresolutions.com
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TIP: Create a step-by-step 340B Standard Operating Procedure (SOP) and reinforce it with regular huddles to build consistency, adaptability, and team alignment.
In the dynamic landscape of 340B management, where staff turnover and evolving regulations are constant, a well-structured Standard Operating Procedure (SOP) serves as the foundation for consistency. By breaking down tasks, such as patient eligibility verification, accumulator tracking, and referral processing, into clear, sequential steps, organizations empower new hires to contribute effectively from day one, reducing errors and training time.
Complementing the SOP with bi-weekly 340B huddles transforms it from a static document into a living tool. These short, focused meetings allow teams to discuss recent workflow adjustments, share what worked well (for example, streamlined data submissions to 340B ESP), and identify what didn’t (such as bottlenecks in contract pharmacy reporting). This feedback loop fosters continuous improvement, helping covered entities maximize outcomes, enhance compliance, and adapt quickly to manufacturer policies and HRSA guidelines.
To implement this effectively, start by mapping current processes with input from key stakeholders, then document them in an accessible format like a shared digital platform. Schedule huddles consistently and record outcomes to refine the SOP over time. This combination of structured documentation and collaborative review builds resilience, strengthens compliance, and positions your program for long-term success amid ongoing 340B challenges.
Call to Action: The Accelerate Pharmacy Services team has experts in every area of pharmacy to help you along the way. To learn more about how our 340B consultants can support your program, visit Cencora’s website.
Nirav Shah is Accelerate Pharmacy Solutions 340B Consultant at Cencora. He can be reached at nirav.shah@cencora.com
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TIP: Make your FQHC’s 340B pharmacy access visible by consistently communicating low-cost medication options at scheduling, intake, and care coordination touchpoints.
FQHCs serve patients who are often managing chronic conditions alongside financial and access barriers, making awareness of affordable medications critical. Yet many patients are unaware that their health center participates in 340B or how to access discounted prescriptions through contract or in-house pharmacies.
To close this gap, FQHCs should embed simple, standardized messaging about pharmacy access into high-volume workflows such as appointment scheduling, registration, eligibility screenings, care management visits, and after-visit summaries. Front-desk staff, medical assistants, and care coordinators should be equipped with clear talking points so patients receive consistent guidance regardless of where they enter the system.
When patients understand where and how to fill prescriptions affordably, medication adherence improves, care becomes more consistent, and 340B savings are more effectively reinvested into expanded services, supporting the FQHC’s mission to provide comprehensive, accessible care to underserved communities.
Lauren Navas is chief growth officer and head of business development at Ravin Consultants. She can be reached at lauren@ravinconsultants.com
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TIP: Be ready to test provider eligibility during a HRSA audit.
Validating a covered entity’s eligible providers is a key component of demonstrating compliance during a HRSA audit. There are three elements that covered entities need to be mindful of when addressing this key component of the 340B patient definition.
- Provider List – The HRSA audit data request list (DRL) #4 requests a list of the covered entity’s eligible providers during the audit period. This list should include provider names, national provider identifier (NPI) values, and indicate the provider’s affiliation with the entity (e.g., employed, contracted), along with the start and termination dates of the provider’s tenure.
- Provider Eligibility Documentation – For each transaction tested during a HRSA audit, the covered entity will need to provide documentation that validates the provider’s affiliation with the entity. This may be copies of employment agreements, provider contracts, or screenshots from an online provider credentialing database. Because HRSA audits often test 60 or more transaction samples, advanced organization of these records can significantly reduce administrative burden during the audit.
- Provider Eligibility Discussion – During a HRSA audit, the auditor may request to interview the entity stakeholders responsible for maintaining provider eligibility documents in order to understand how the provider eligibility process is managed in the organization. This may require involvement from several teams, including the organization’s medical staff office, graduate medical education (GME) office, or other groups.
Remember, failure to demonstrate provider eligibility for a tested transaction during a HRSA audit can result in diversion findings, which may warrant a corrective action plan and possible manufacturer repayment.
Greg Wilson is director of pharmacy compliance at SpendMend He can be reached at gwilson@spendmend.com
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TIP: Embed AI directly into your 340B eligibility, validation, and audit workflows so teams get accurate, policy-grounded guidance at the exact moment decisions are made.
Eligibility reviews, charge validation, policy interpretation, and audit preparation often require staff to step outside their workflow to find answers. That friction leads to delays, rework, and increased compliance risk.
AI delivers real value only when it is embedded directly into the workflow, at the point where decisions happen. When intelligence is available during eligibility checks, replenishment decisions, or high-cost drug validation, AI shifts from being helpful to being essential.
Accuracy is non-negotiable in 340B. AI in 340B workflows must be grounded in current regulatory guidance, pricing definitions, and policy rules, with subject-matter experts kept in the loop. Responsible AI accelerates research and interpretation while preserving human oversight.
AI should strengthen people, not replace them. By handling repetitive validation and interpretation tasks, AI frees 340B teams to focus on higher-value work: managing risk, resolving exceptions, and optimizing program performance.
The greatest return comes from alignment. When pharmacy, finance, compliance, and revenue integrity teams share a trusted view of data and guidance, organizations see fewer surprises and more predictable outcomes.
Phil Reese is vice president of the transformation portfolio at The Craneware Group focused on AI + Human Intelligence to transform the business of healthcare. He can be reached at PReese@craneware.com
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TIP: Plan Ahead: Changes to HRSA’s FY26 data request list (DRL) may require additional time and effort for your organization’s response.
The Health Resources and Services Administration (HRSA) has updated the data request list (DRL) for fiscal year 2026, which began in October 2025.
Our previous 340B Report article outlines the updates in the FY26 DRL and explains each change, section by section.
340B covered entities need to be familiar with the entire DRL, including the recent changes. Annual external audits should utilize the updated DRL, and CEs should update their internal documents to ensure all newly requested data elements are available and on file. A sample copy of the updated DRL is available on the 340B Prime Vendor Program (PVP) website.
To learn about CPS please visit our website here.
Dennis Killian is vice president of 340B Solutions at CPS. He can be reached at Dennis.Killian@cps.com
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TIP: Use a scorecard to monitor pharmacy partner performance and fees.
Create a quarterly scorecard that grades each contract pharmacy’s financial, operational, and compliance performance, and review it jointly with pharmacy and finance leaders to ensure every partnership supports the covered entity’s 340B program goals and long-term sustainability. Establishing a consistent review process not only reinforces accountability but also ensures that program leaders have clear, comparable insights into how each pharmacy partner contributes to the organization’s success.
Not all contract pharmacies perform equally, yet many entities manage them as if they do. Developing a standardized pharmacy partner scorecard introduces transparency and supports data-driven decision-making.
Your scorecard should evaluate both performance and fairness, using metrics such as claims processed, 340B savings generated, reconciliation accuracy, and fee percentage. Ranking partners by these measures help identify top performers, justify administrative costs, and flag underperforming relationships before compliance or financial risks emerge.
Conducting these reviews on a regular basis promotes accountability and ensures the 340B program continues to operate efficiently and in alignment with the covered entity’s overall mission.
At Ravin Consultants, we help covered entities implement practical tools, like contract pharmacy scorecards, to drive performance, compliance, and savings. Our proprietary 340B dashboard tracks key pharmacy metrics, offering clear, actionable insights that support strategic decisions. Whether you’re optimizing pharmacy partnerships, navigating manufacturer restrictions, or strengthening compliance, Ravin Consultants brings the expertise and technology to help your 340B program thrive.
Damion Wise is the Lead 340B Consultant at Ravin Consultants. He can be reached at damion@ravinconsultants.com