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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
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TIP: Establish a rebate submission cadence with weekly minimums to protect cash flow.
With the 340B Rebate Model Pilot now approved for January 2026, Covered Entities (CEs) have many operational processes to review and evolve to meet new requirements. One critical area to prioritize, starting now, is establishing a rebate submission and reconciliation process that supports frequent and reliable reporting.
It’s important to consider the data source for these claims. The addition of 11 medical claim data fields to the existing prescription data fields requires CEs to be thoughtful about their approach to collecting and submitting claims data from a variety of locations and sources. Those with clean sites, internal claim qualification workflows, or with multiple TPAs should consider how automation like Plenful’s 340B Rebate Management solution can assist.
The frequency of claim submission is another factor. Delayed or irregular submissions can extend the time between drug purchase and manufacturer reimbursement, tying up funds that would otherwise support operations or patient services. To prevent this, organizations should aim for at minimum a weekly submission cadence. A regular cadence will allow your team to shorten reimbursement timelines and detect and resolve submission issues more quickly. It also reduces the likelihood that a claim will be disqualified due to submission after 45 days of dispense.
Finally, weekly reporting improves data visibility and ensures a steady revenue stream from rebate payments. Automated rebate reporting workflows, like what we’ve built at Plenful, will streamline the manual work required to prepare the required data elements and facilitate submission. Preparing systems and workflows now to support this cadence will help CEs enter the rebate era with confidence and control over financial performance.
Tim L’Hommedieu is SVP of Pharmacy at Plenful. He can be reached at tim@plenful.com
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TIP: When preparing for the potential impact of the 340B rebate model, consider how it could affect three key core organizational elements.
In an ever-changing 340B environment, the 340B Rebate Model Pilot Program will be yet another adjustment for covered entities. When preparing for the potential impact of the 340B rebate model on their missions, covered entities (CEs) must consider how it could affect three core organizational elements: cash flow, 340B administration, and technology. This includes:
Cash Flow Impact
- As a result of the 340B rebate model, CEs will no longer receive the immediate 340B savings offered by the upfront discount model. They will need to purchase medications at Wholesale Acquisition Cost (WAC) and wait for a rebate. This delay in receiving discounts will negatively impact cash flow.
- The covered entity should complete a financial analysis to estimate the new WAC outlay versus the previous 340B costs. This will help leadership prepare should they need to build cash reserves or assess financing options.
Administrative Impact
- The 340B rebate model requires strict adherence to timelines (claims must be submitted within 45 days of dispensing). Missing these deadlines could result in forfeited rebates.
- CEs should ensure that they have systems in place to submit accurate and timely data to avoid lost rebates.
- CEs should develop internal policies and procedures to escalate manufacturer denials and keep track of pending appeals.
- CEs also should ensure that they have access to the real-time rebate status of a claim and regularly reconcile claims submitted with rebates paid.
Technology Impact
- In adhering to the 340B rebate model, CEs must regularly upload dispensing data on the manufacturer’s designated platform.
- CEs should meet with TPAs to ensure that a process is in place to upload all necessary data in a timely and accurate manner.
- CEs should confirm if they need to integrate new technologies into their existing systems to comply with manufacturer reporting requirements.
Mitchell Williams, 340B Director of Program Integrity at Avita Care Solutions, can be reached at mitchell.williams@avitacaresolutions.com
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TIP: Get prepared now for rebate hit with robust financial forecasting.
Unlike the current point-of-sale model where discounts are realized at the time of purchase, the rebate structure may introduce a significant lag between dispensing a drug and receiving reimbursement. This delay could affect how quickly covered entities recognize savings and may create short-term financial strain if not accounted for. By anticipating this gap, entities can better prepare their operations and avoid disruptions in budgeting, purchasing, or patient care.
Now is the time to build rebate timing into your financial forecasts and cash flow models. Work closely with your finance team to model different scenarios for payment delays and identify how they might impact working capital. Establishing reserve funds, evaluating lending options, adjusting procurement strategies, and engaging leadership early can help soften the impact of delayed reimbursements. Covered entities that proactively plan for cash flow shifts will be better positioned to maintain program stability.
Harrison Garrett is vice president of 340B Solutions at Cervey. He can be reached at hgarrett@cervey.com
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TIP: Compare your 340B net cost to the Maximum Fair Price (MFP) before submitting a rebate.
With MFP rebates soon to be part of Medicare Part D, the new considerations between the expected 340B rebate and relying on MFP can feel overwhelming. The easiest way to stay on top of it is to keep the process simple: compare your net 340B cost—including drug acquisition, TPA, and pharmacy fees—to the MFP. If 340B delivers the lower cost, submit the rebate. If not, let the MFP adjustment apply and avoid duplicate submissions.
340B covered entities should be aware that 340B prices are largely lower for the initial 10 MFP drugs. 340B, therefore, still presents significant purchasing benefits on these initial 10 drugs and should not simply be excluded. Taking this step not only reduces denials and streamlines reconciliation, it also helps protect your margin. Just as important, it creates a clear audit trail to support manufacturer reviews and potential appeals.
By building a quick cost check into your routine, you can minimize administrative burden while keeping your 340B program working to its full advantage.
Diana Sierra is Vice President, Contract Pharmacy Partnership at The Craneware Group. She can be reached at dsierra@craneware.com