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!

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.

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.

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.

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.