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TIP: Enhance your 340B program efficiency through collaborative review and impact analysis.
Asking your TPA for detailed impact reports on any proposed changes to your 340B program can provide valuable insights into your program, including financial performance, compliance risks, and operational efficiency. Understanding the impact of these changes can equip your organization to make informed decisions and proactively adjust your strategies to mitigate risks and maximize savings opportunities.
In addition to TPA impact reports, conducting internal analyses on any changes or updates to the program can provide further insights. Examining the financial and operational impacts of new regulatory requirements or shifts in patient demographics allows your organization to proactively adjust strategies. This can lead to more accurate budgeting, better resource allocation, and improved patient care outcomes. Utilizing data analytics tools provided by your TPA can help you automate these analyses, making it easier to track key performance indicators and make data-driven decisions.
Ultimately, the integration of collaborative review and impact analysis, along with leveraging TPA expertise, can lead to sustained improvements in efficiency, compliance, and overall program effectiveness. By fostering a culture of continuous improvement and leveraging the expertise of your TPA, your organization can maximize the benefits of the 340B program while ensuring compliance.
Alicia Robinson, implementation & key account manager at Cervey, can be reached at arobinson@cervey.com
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TIP: To avoid unnecessary audit findings, it is critically important to review OPAIS data regularly.
HRSA audit findings continue to prove that little things can get you! In 340B Report’s March 2024 article, several of the most common “termination causes” can be avoided with regularly scheduled review practices. Most teams review OPAIS annually during registration periods; however, it is easy to overlook items.
An “Incorrect 340B OPAIS record” finding can encompass multiple things. Contract pharmacy address variations due to DEA adjustments can occur without any notification to the covered entity. Teams should review addresses very carefully to ensure nothing has changed. Even small changes could require an amendment to the existing agreement depending on organizational policies and procedures.
Another common occurrence is contract pharmacies that get listed in OPAIS but do not have an active agreement in place. 340B teams need to ensure they have a specific process for contract pharmacy agreement approval and OPAIS inclusion. As a side note, another common miss we see in our work is ensuring a counter-signed agreement is on file.
“Inaccurate or incomplete information on the HRSA Medicaid Exclusion File” is another common finding. Tracking NPI and Medicaid numbers and comparing that data with the OPAIS record is extremely important for 340B teams. Often, that data will also need to be reviewed with the organization’s billing department regularly. Issues in this area could reveal duplicate discounts and, thus, paybacks, which are never welcome.
For teams responsible for 340B compliance looking to automate these processes, there are software solutions to assist. Sectyr’s 340B program management software, SectyrHub 340B, can address several of these problem areas with automated alerts when there are discrepancies between OPAIS and current documentation.
Craig Frost is president and COO at Sectyr, LLC. He can be reached at Craig.Frost@sectyr.com
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TIP: Dedicating resources and ensuring team members have access to education & information are essential to successfully navigating the 340B program.
The 340B program, with its complexities and frequent regulatory updates, demands careful attention to maximize savings and ensure compliance. To effectively manage the program, it is important that to dedicate resources capable of overseeing the various components of the program, emphasize thorough training, and facilitate access to essential resources.
Investing in Continuous Education: Keeping staff updated on compliance requirements and the ever-evolving legislative and pharmaceutical manufacturer changes is essential. Continuous education initiatives enable team members to accurately navigate the program’s complexities. Training in proper data management practices emphasizes the importance of data integrity in maintaining compliance and preventing costly consequences.
Prioritizing Oversight and Resources: Successful 340B programs often allocate dedicated resources for oversight, provide ongoing learning opportunities for the team to stay current with regulatory changes. Ensuring resources are dedicated to programmatic reviews can also help prevent errors and enhance program performance.
Encouraging a Culture of Learning: Promoting a culture of continuous learning can uplift staff morale and empower team members to tackle challenges with confidence. By ensuring adequate resources are available for programmatic reviews, organizations can achieve greater success with their 340B program.
Fostering Collaboration: Collaboration with internal and external stakeholders is essential. This includes working with pharmacies, manufacturers, and regulatory bodies to streamline operations and address any issues promptly. Effective communication and partnerships can lead to improved program outcomes and increased savings.
By adopting a proactive approach to education, oversight, and collaboration, organizations can navigate the complexities of the 340B program with confidence. This strategy not only ensures compliance and maximizes savings but also enhances the overall effectiveness of the organization. Embracing these practices will lead to sustained success and better outcomes for patients.
Christina Breckenridge, Senior Director of Client Success, can be reached at cbreckenridge@rxstrategies.com
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TIP: Don’t assume your contract pricing is correct on every account just because it’s correct on one account.
Account contracts are loaded individually, so some 340B, GPO, and even WAC prices can be inaccurate on single accounts. As the 340B program grows in size and complexity, we know staying on top of all the nuances affecting a program’s savings is increasingly challenging. Here are some best practices to keep in mind:
- Use the OPAIS 340B Ceiling Price Database: Compare program ceiling prices with wholesaler platform prices.
- Check for Price Variations: Identical 340B accounts can have different prices for the same NDC. Ensure correct pricing by comparing individual account prices with the Ceiling Price Database.
- Apply to GPO Accounts: While there’s no direct reference like the Ceiling Price Database, compare catalog prices across all accounts for frequently purchased items to ensure consistency.
- Verify Invoice Prices: The price in an account catalog may differ from the invoice price. Ensure the catalog price matches the price paid, and correct discrepancies with a quick email to the wholesaler.
For further assistance, The Alinea Group offers automated tools to help entities manage their purchasing habits and compliance. Reach out today to learn more.
Russ Barron, Director at The Alinea Group, can be reached at russ.barron@alinea-group.com
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TIP: Establishing controls and performing regular monitoring is crucial to prevent and identify noncompliance with 340B program requirements.
The 340B program is complex. Covered entities need to have processes and controls in place to assess their ongoing compliance with HRSA policies, regulations, and guidance, in addition to their self-established policies and procedures. Best practices include an annual review of eligibility criteria and documents to ensure sufficient documentation to demonstrate compliance with all requirements, regularly maintaining and periodically reviewing the 340B OPAIS database to confirm accuracy, and routinely monitoring purchasing and inventory management.
Failure to conduct monitoring and implement remedial action when necessary can result in significant administrative and financial challenges for covered entities. This may impact their ability to address the needs of underserved communities adequately. Engaging a reputable 340B services provider that offers a tailored and holistic compliance strategy can help covered entities stay well-disciplined while focusing on the most important priority: patients and their well-being.
Valerie Castello, chief privacy officer and chief compliance officer at Avita Care Solutions, can be reached at valerie.castello@avitacaresolutions.com
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TIP: If your entity has not been submitting data to 340B ESP or designating pharmacies associated with certain manufacturers, it may be time to reassess.
If your covered entity has not considered or begun submitting data to 340B ESP or designating specific pharmacies, it may be time to revisit the topic. We have seen an increased impact on 340B savings over the last few years for entities without an entity-owned pharmacy.
Your 340B Third Party Administrator should be able to provide you with impact assessments based on drug manufacturer restrictions for your contract pharmacies. This information can let you know why your 340B savings have been dwindling, as well as provide you with insight on what you can do to restore 340B pricing.
Additionally, most TPAs can assist with the process of ESP submission or designating pharmacies for impacted 340B drugs.
Alex Homkey is Business Development Manager at Hudson Headwaters 340B. He can be reached at ahomkey@hudson340b.com
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TIP: When negotiating Single Case Agreements (SCA), it’s important to include payment terms. An SCA without terms can lead to lengthy delays in payment to your 340B program.
SCAs are special contracts negotiated between healthcare providers and insurance companies for providing care to patients who are out-of-network. SCAs often allow providers to negotiate better rates than typical out-of-network fees, which is particularly important in complex or high-cost cases where the provider might be assuming significant risk. These agreements are tailored to individual patient cases and outline the specific terms under which services will be provided and compensated.
In particular, the payment terms should specify the amount, method, and timing of payments. This will help reduce the likelihood of disputes and delays in payment, which can be costly and time-consuming for both parties.
Red Chip excels in securing Single Case Agreements (SCAs) for high-cost drugs across a diverse range of payers. Our trained Payer team has extensive experience and a nuanced understanding of the complexities associated with negotiating and obtaining SCAs, which is crucial for managing expensive hemophilia or transplant treatments. We are experts at navigating the challenging landscape of insurance approvals, demonstrating a consistently high success rate across various insurance providers, both public and private.
At Red Chip, we are dedicated to enhancing patient access to essential therapies, reducing out-of-pocket costs, and increasing revenue so that 340B programs can continue their role of being safety net providers.
Holly Frye is Vice President, Revenue Cycle & Reimbursement at Red Chip. She can be reached at hfrye@redchip.org
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TIP: When updating your 340B program policies and procedures, prioritize clear communication and training to ensure staff compliance and minimize errors.
Updating policies and procedures is a crucial aspect of maintaining compliance and efficiency within a 340B program. It’s not just about the documentation; it’s about ensuring that everyone involved understands the changes and knows how to implement them correctly. Clear communication through training sessions, workshops, or online modules can significantly reduce misunderstandings and errors, ultimately leading to smoother operations and reduced compliance risks. Remember, a well-trained team is key to a successful 340B program.
Megan Hall is Product Manager at The Craneware Group. She can be reached at mhall@craneware.com
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TIP: Improve capture rates to reach your full 340B savings potential.
From changing compliance mandates to the manufacturer restrictions that began in 2020 that limit access to contract pharmacy arrangements, covered entities are faced with increasing complexity when it comes to administering a successful 340B program and reaching their full 340B savings potential.
It’s more important than ever to identify opportunities to optimize your 340B program performance. Tracking and increasing capture rates is one best practice that can help ensure both financial and operational optimization.
A great place to start is with an in-depth analysis of your organization’s 340B eligible prescriptions to understand current patient and employee capture rates.
Here are three ways you can facilitate engagement and increase capture rates in your covered entity:
- Explore ways for employees to utilize the services provided in your organization. This could look like reducing co-pays for medical services, reducing prescription co-pays at your in-house pharmacy, or offering medication management services and point of care testing to employees. We’ve also seen organizations offer payroll deductions at their in-house pharmacies to support their staff with a seamless, contactless pharmacy experience.
- Consider new ways of engaging patients. Integrating pharmacists into multidisciplinary care teams can drive patient engagement. Monitoring medication adherence and tracking the therapeutic effects of medications can improve the quality of care and clinical outcomes.
- Explore a home or office delivery service. Convenient fulfillment options could play a large part in increasing capture rates. Offering a home or office delivery service can reduce wait times and promote adherence as patients can receive their medications and additional refills without having to visit the pharmacy.
Partnering for success
As the 340B landscape continues to evolve, the right partner can help you navigate the changes and complexity.
At Maxor, we help covered entities maximize 340B savings and unlock pharmacy value. We are a partner who supports your mission as you deliver vital healthcare services in your community.
Learn how our expert team can help optimize your 340B program and grow your specialty pharmacy with a comprehensive data assessment.
Jason Atlas is Senior Vice President, Pharmacy Operations at Maxor. He can be reached at jtatlas@maxor.com
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TIP: Don’t leave money on the table. Referral capture provides a unique opportunity to maximize savings for your 340B program, but it’s essential to ensure accurate referral validation through automated tools, industry expertise and clear, compliant protocols.
Referral capture offers a unique opportunity to maximize savings within your 340B program. Automated tools offer a streamlined approach to referral identification. However, it’s important to not stop at automation. Validation of referral opportunities can be a heavy lift on your 340B team – especially if you are already under-resourced.
By partnering with a solution offering validation in addition to identifying referral opportunities, you can reduce the margin of error and ensure that only eligible prescriptions are included. When defining an eligible referral prescription with your referral capture partner, incorporate 340B consultants, steering committees and any compliance teams that support the covered entity to be a part of the decision-making process. This is a critical step to balance the potential for increased 340B access while not sacrificing compliance.
Clear protocols are essential for maintaining consistency and accuracy in the referral validation process. These protocols should outline the steps for validating referrals, including the criteria for patient eligibility and prescription verification, to ensure thorough and comprehensive validation practices.
By prioritizing accurate referral validation through automated tools, industry expertise, and clear protocols, covered entities can maximize savings – and ultimately improve patient care.
Harrison Garrett, director of 340B Solutions at Cervey, can be reached at hgarrett@cervey.com
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