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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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TIP: Build your 340B Rolodex to make your 340B experience easier to navigate.
Throughout any 340B stakeholder’s journey within the program, knowing what resources are available to you will make your 340B experience easier to navigate. Consider these ideas as you build your 340B network:
- As a covered entity (CE), the companies that are helping your 340B program operate will have points of contact you can leverage. Wholesalers and third-party administrators often employ some level of account management. Reach out to see if a dedicated resource has been assigned to your CE.
- Membership with 340B Health or other 340B trade groups include technical assistance for their members. Apexus Answers is available to all and offers prompt replies to questions. These resources are valuable at offering perspectives to challenges facing CEs.
- Attending 340B specific events such as roundtables, conferences, Apexus Universities, or vendor/customer forums is a great way to meet colleagues that serve patients and have challenges very similar to yours.
- Stay on top of 340B developments. 340B is a dynamic program with constant changes. Whether it is manufacturer requirements, regulatory or policy changes, 340B Report and other news sources are essential for effective program oversight.
- Once you identify your resources, establish a routine cadence with each so that you can stay in touch. While challenges may be limited and infrequent, it is nice knowing who to talk to and where to turn if you have a situation that requires guidance. The 340B industry is known to be supportive across the various segments.
If you want to practice networking or want your first contact for your 340B Rolodex, feel free to start with myself! I’m Justin Ott, I’ve been in the 340B space for over a dozen years and firmly believe you can never have enough contacts. Feel free to send me a message!
Justin Ott is Principal, Account Management, at AuthorityRx. He can be reached at jott@authorityrx.com
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TIP: Monitoring and maintaining an active patient listing is imperative for 340B compliance.
Monitoring and maintaining an active patient listing (APL) for all patients whose prescriptions qualify as eligible under the 340B program is imperative. This APL should be updated daily and maintained through the electronic medical record system. The entity’s 340B policy should specify the time period during which a patient is deemed active based on their last visit with a covered service provider and scope of service.
The APL should be reviewed in consideration of changes in providers, covered services, and patient termination. For example, if a provider leaves the 340B entity, all affected patients with current monthly prescriptions should be reassessed for eligibility depending on transfer of care to a new provider. Managing the APL can be arduous and time consuming if technology is not leveraged to manage maintenance and to highlight potential exceptions. Speaking with a reputable 340B service provider can help you streamline this process and minimize risk.
Courtney McFarland, Partner at AAFCPAs may be reached at cmcfarland@aafcpa.com
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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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