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TIP: Entities using third-party administrators (TPAs) should understand system functionality and strengthen oversight with regular audits to reduce compliance risks.
As the 340B program becomes more complex, many covered entities (CEs) rely on TPAs to manage essential operations. However, using a TPA for critical compliance responsibilities demands active oversight above mere delegation. CEs should have a thorough understanding of their TPA settings to ensure that they accurately reflect the organization’s 340B policies and procedures—an essential component of program compliance. This responsibility extends beyond core configuration settings to include any value-added services provided by the TPA. Rather than letting configurations passively run in the background after initial implementation, entities should conduct routine audits to validate alignment, identify compliance issues early, and reinforce internal oversight efforts. Active engagement with TPA settings is critical in safeguarding 340B program integrity.
In response to the need for stronger TPA management, the Apexus Advanced 340B Operations Certificate Program has developed an exclusive tool: the TPA Maintenance Toolkit, available soon to all program enrollees and 340B ACEs via the Operations Certificate Exclusive Tools course in the Apexus Education Portal. Designed by 340B experts, this resource helps bridge the gap between policy and practice with practical prompts that make complex oversight more manageable. It’s one of many tools available exclusively through the program—alongside a stakeholder contact log, a product mapping aid, and others. These tools are designed to simplify your role, support compliance, and help you confidently lead 340B operations.
Enroll in the certificate program today to advance your 340B knowledge and unlock practical, exclusive tools that help you lead 340B operations confidently.
Have questions? Contact us at 340BCertificate@apexus.com.
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TIP: Don’t Leave Compliance to Chance – Audit 100% of Your 340B Transactions.
With sweeping changes proposed in the latest presidential executive order, a surge in manufacturer-led audits, more states enacting provider reporting laws, and heightened scrutiny of 340B in Washington, D.C., the regulatory environment is more challenging and unpredictable than ever. Health systems and grantees must ensure their 340B programs are prepared for increased regulations and oversight.
In the face of a tumultuous legislative and regulatory landscape, Bluesight’s new 2025 Hospital Pharmacy Operations Report highlights the growing need for increased self-auditing of 340B transactions to safeguard organizations. Spot checks and sample audits may have been sufficient in the past, but they now leave 340B Covered Entities exposed to compliance risks, lost savings, and potential penalties.
Organizations must move beyond outdated, manual auditing strategies to protect their 340B program and ensure long-term sustainability. A 100% audit approach isn’t just ideal—it is essential. Relying on sample-based or periodic audits is demanding on resources, limits the team’s agility, and ultimately exposes teams to increased risk. A 100% audit empowers teams to identify issues in real time, take proactive action, and maintain confidence in program compliance, regardless of how the landscape evolves.
Simplify continuous compliance as your program grows and regulations become increasingly complex. Bluesight’s 340B Compliance Solution, 340BCheck, consolidates your 340B compliance into one location, providing hospitals and grantees with complete oversight and 100% auditing capabilities. Integrate disparate data sources, monitor compliance, and validate every transaction to stay HRSA audit-ready – all to scale your program and reduce financial risks.
Lauren Forni, PharmD, MBA, is Bluesight’s Senior Director of Clinical Strategy. She can be reached at lauren.forni@bluesight.com
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TIP: Prioritize referral consistency over volume.
When it comes to 340B referral capture, it’s tempting to focus on maximizing the number of referrals processed — but long-term success hinges on consistency and compliance, not just volume. Prioritizing consistent documentation, eligibility validation, and proper referral workflows across all referrals creates a strong, defensible program foundation.
By ensuring every referral is not only eligible, but properly documented, covered entities reduce the risk of diversion, duplicate discounts, and audit findings — all of which can threaten program savings. Over time, a disciplined, compliance-first approach can increase sustainable savings, because revenue is built on a stable foundation rather than risk-laden claims that may later be clawed back or disqualified.
Develop a system for how you will manage referrals from the start. Evaluate whether you have the internal bandwidth to handle it effectively, or whether partnering with an experienced vendor could help maximize compliance and results.
Harrison Garrett is director of 340B Solutions at Cervey. He can be reached at hgarrett@cervey.com
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TIP: Ensure behavioral health medications are fully integrated into your 340B strategy to maximize patient access and program savings.
As behavioral health needs continue to surge—particularly in underserved communities—community health centers and other 340B providers must ensure their 340B strategy is inclusive of mental health and substance use treatment medications. These include antidepressants, anti-anxiety medications, and medications for opioid use disorders, all of which are essential for holistic patient care. By intentionally incorporating behavioral health prescribing into your 340B workflows, organizations can dramatically expand access to life-saving treatments while generating meaningful savings.
Start by analyzing prescribing data and visit types to confirm which behavioral health encounters and medications are eligible under your current 340B setup and at what rate these visits are occurring. Then, work with your in-house pharmacy or contract pharmacy network to ensure these medications are included in your purchasing and dispensing strategy. The use of injectable medications for behavioral health has been on the rise in recent years. These injectables offer increased medication compliance and more stable effects in most cases. In-clinic injectables come with their own set up complexities and require a solid process to ensure these claims are captured correctly. Finally, don’t overlook compliance—behavioral health drugs must meet all program requirements, including accurate documentation of eligible encounters and providers, especially under HRSA and manufacturer scrutiny.
At Ravin Consultants, we specialize in optimizing 340B programs for high-impact areas like behavioral health. From analyzing prescribing patterns and patient eligibility to developing compliant workflows and expanding pharmacy access, our team partners with health centers and other covered entities to ensure they’re leveraging every opportunity 340B provides—without compromising compliance. We also help you stay ahead of changing regulations and manufacturer restrictions so you can focus on what matters most: delivering quality behavioral healthcare to your community.
Robert Ferraro is Principal and Chief Operating Officer at Ravin Consultants. He can be reached at robert@ravinconsultants.com
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TIP: Take time to focus on these three important fundamentals of 340B program compliance and integrity.
Update Prescriber Panels
Maintaining an accurate prescriber panel helps ensure only eligible prescriptions are captured under the 340B program. Regular updates help prevent compliance risks and optimize program savings.
- Conduct routine reviews of prescriber panels to ensure they include only actively employed or contracted providers.
- Verify that each prescriber meets eligibility requirements defined in your policies and procedures.
Ensure OPAIS Data Accuracy
The Office of Pharmacy Affairs Information System (OPAIS) serves as the official record for covered entities participating in 340B. Any inaccuracies can lead to compliance risks and potential disqualification from the program.
- Perform quarterly audits to verify that all entity locations, child sites, and contract pharmacy relationships are correctly listed in OPAIS.
- Confirm that contact information (Authorizing Official and Primary Contact), addresses, and covered entity details are accurate and up to date.
- Ensure your most recent Medicare Cost Report (MCR) is filed with CMS and sent to HRSA.
Review Policies and Procedures
Keeping policies and procedures current is essential for ensuring staff compliance and preparing for HRSA audits.
- Review and update policies at least annually.
- Ensure that policies cover key compliance areas, including patient eligibility, inventory management, duplicate discount prevention, and diversion mitigation.
- Apexus has policy and procedure templates that can be customized – you can also use them as a guide to compare with yours.
A strong 340B program starts with the basics. By proactively managing these areas, your organization can strengthen its 340B program compliance and performance.
Lori Schilling, Regional Manager at SunRx, can be reached at lschilling@sunrx.com
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TIP: Master manufacturer refund challenges with actionable steps.
Managing manufacturer refunds in the 340B Drug Pricing Program can be complex, but with the right strategies, you can streamline the process and ensure compliance. Here are some tips to help you navigate common challenges:
- Allocate Resources Efficiently: When dealing with multiple manufacturers, determine whether an individual or a team will be managing the workload.
- Prepare Communications: Establish your good-faith process to resolve issues with manufacturers, including the communication protocol, self-disclosure letters, and repayment calculations. Resources such as the PVP Self-Disclosure to HRSA and Manufacturer Template are helpful when developing communications.
- Validate Historical Pricing: Ensure accurate refund calculations by validating historical drug pricing using resources such as your wholesaler or the Historical Purchase Report within the PVP secure website.
- Identify Manufacturer Contacts: Use resources like 340B OPAIS and Medicaid.gov to find necessary information.
- Streamline Payments: Processing multiple check/ACH payments can be cumbersome. Implement a system to manage these transactions efficiently.
- Use Apexus Experts: Take advantage of the Apexus Covered Entity Refund Service (CRS). CRS brings the expertise of Apexus in 340B compliance, analysis, project management, and reporting to standardize refunds. Streamline the process of refund calculation, documentation, and resolution.
By addressing these challenges proactively, you can enhance the efficiency and accuracy of your 340B program’s refund process. Regularly review and adjust your strategies to ensure ongoing compliance and optimization.
To learn more about the Covered Entity Refund Service, schedule a meeting with one of our experts today.
Chad Johnson, PharmD, MBA, 340B ACE, is Associate Principal, Covered Entity Refund Service at Apexus and can be reached at chad.johnson@apexus.com
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TIP: Use AI to optimize your health system’s 340B program.
Artificial intelligence (AI) is transforming healthcare, offering innovative ways to enhance operations, improve outcomes, and reduce inefficiencies. For health systems managing a 340B program, AI presents a unique opportunity to streamline processes, ensure compliance, and optimize savings. However, successful implementation requires a strategic and tailored approach, particularly when incorporating entity-owned pharmacies, pharmacy services partners, and contract pharmacy optimization.
- Identify Key Challenges and Opportunities: Begin by assessing specific pain points within your 340B program.
- Partner with Experts: Pharmacy services partners can play a crucial role in implementing AI by providing expertise, infrastructure, and access to advanced tools.
- Optimize Contract Pharmacy Arrangements: Contract pharmacy networks can be complex, but AI offers tools to maximize their potential.
- Implement Thoughtfully: Consider starting with a pilot project targeting a well-defined challenge.
- Measure and Adjust: Regularly assess its performance against key metrics, such as compliance rates, error reductions, and financial outcomes.
By leveraging AI strategically, health systems can enhance the efficiency and impact of their 340B programs. From optimizing entity-owned and contract pharmacies to collaborating with pharmacy services partners, the right AI tools can drive measurable improvements in compliance, savings, and operational performance. Thoughtful implementation and continuous evaluation will ensure these technologies deliver long-term value.
For more details about using AI to optimize your 340B program, read our blog.
William Riley, VP Commercial Analytics at Maxor can be reached at wariley@maxor.com
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TIP: Covered entities must protect their 340B programs from manufacturers attempting to reduce savings and eligibility.
Here are four steps you can take to protect yourself.
- Strengthen data management practices.
Ensure accurate tracking of 340B purchases and maintain comprehensive records of drug utilization, particularly for contract pharmacies. This not only helps defend against manufacturer audits but also supports compliance, protecting your program from potential clawbacks. - Optimize contract pharmacy arrangements.
Regularly review your agreements with contract pharmacies to maximize savings while minimizing risk. Negotiate clear terms that safeguard your margins, especially given potential pricing shifts from manufacturers. - Diversify pharmaceutical procurement strategies.
Avoid over-reliance on specific drugs from manufacturers that are limiting 340B participation. Seek alternative sources when possible or explore therapeutic options that provide better savings without compromising patient care. Strengthen your in-house 340B capabilities to maximize savings and reduce vulnerabilities. - Engage in advocacy efforts.
Stay informed about industry trends and regulatory changes. Collaborate with trade groups, legal advisors, and 340B experts to navigate emerging manufacturer pressures and advocate for policies that protect the program’s integrity.
By implementing these strategies, 340B covered entities can better navigate the evolving landscape and safeguard their savings amid increasing manufacturer pressures.
William Riley, VP Commercial Analytics at Maxor can be reached at wariley@maxor.com
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TIP: Understand your patient population and workflows to get the most out of 340B.
To maximize your 340B program’s benefits, it is important to understand your patient population and the workflows within your organization and pharmacy. Key to a successful 340B implementation is having a knowledgeable team that can accurately interpret data, particularly in areas with unique workflows. Ensure you know where patient data is stored, especially if you use multiple EMR systems, and understand your data volumes—how many patients you see daily and how many medications are dispensed. Additionally, have a clear process for managing reoccurring patients.
By focusing on these areas, you can optimize your 340B program and maintain compliance.
Adam Koptowsky is Vice President, Implementation Services at The Craneware Group. He can be reached at akoptowsky@craneware.com
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TIP: Maintain an accurate and comprehensive provider list to maximize 340B program effectiveness and compliance.
An outdated or incomplete provider list can severely undermine your 340B program’s performance and compliance. Without an accurate roster, your organization risks missing eligible claims, leading to significant revenue loss and potential audit issues. Many 340B claim capture systems rely heavily on provider data to identify eligible prescriptions – if a provider isn’t properly listed, their 340B-eligible prescriptions may go unrecognized, leaving potential savings on the table.
When compiling and updating your provider list, consider multiple sources to ensure completeness. This may include your credentialing system, human resources records, state licensing boards, and periodic surveys of your clinics and departments. Don’t forget to include all eligible provider types, such as physicians, nurse practitioners, physician assistants, and other prescribers who may be working within your 340B-eligible areas. Regular review and reconciliation of these sources can help catch discrepancies and ensure no eligible providers are overlooked. By investing time in maintaining a robust provider list, you’ll maximize your 340B program’s capture rate and minimize compliance risks.
Anthony Velasquez, Chief Product Officer at PharmaForce, can be reached at avelasquez@thepharmaforce.com
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