There were many critical issues addressed at this year’s 340B Coalition Winter Conference, but our “3 Key Takeaways” summary delves into the dynamic state-level legislative changes impacting 340B covered entities and emphasizes the importance of active engagement by stakeholders to navigate this evolving terrain effectively.
1. States are increasingly legislating aspects of the 340B Program
Twenty-nine states have laws to protect 340B covered entities from discriminatory payer practices, and more states are considering bills now. These laws address practices that discriminate against 340B covered entities, including low reimbursement fees, claim identification and network exclusion.
- Another area of increasing legislation targets contract pharmacy restrictions related to manufacturer restrictions. In 2021, several states began considering or passing legislation prohibiting drug companies and wholesalers from limiting drug access or 340B pricing for contract pharmacies. As a result, several manufacturers have modified their policies in these states; however, manufacturers continue to challenge these laws.
- Finally, in the last several years, some states have moved their Medicaid pharmacy benefits away from managed care to fee-for-service. One notable example is Medi-Cal in California, initially set to transition on 1/1/21 but delayed until 1/1/22.
State legislation, positive and negative, impacting 340B covered entities –– continues to evolve, and stakeholders must remain engaged as the landscape changes.
2. Telling the 340B Story with data and research
Amid ongoing conversations regarding the prospect of enforcing mandatory reporting for 340B covered entities, specifically regarding the expenses associated with a covered entity’s charity care and the transparent disclosure of 340B savings and their allocation, the necessity for covered entities to adeptly articulate their 340B narrative through comprehensive data and research has never been more pronounced. As the spotlight intensifies on these crucial aspects, it becomes imperative for covered entities to proactively showcase a well-documented account of their 340B program, substantiated by robust data and thorough research.
Recent HRSA audits have also confirmed that this information is being requested from covered entities. 340B covered entities should be prepared to respond to surveys and other requests for data demonstrating the work that they are doing to provide uncompensated and unreimbursed care to the indigent in their communities. Evidence like this can include conducting research that shows the value their 340B program is providing in their community and publishing those results. It continues to be critical to counteract the negative messaging about the 340B Program by giving real-world examples of how 340B savings positively impact the community.
3. Patient Definition a continuing topic of discussion
The 340B Patient Definition continues to be a topic of discussion for 340B covered entities and stakeholders. In November of 2023, after several years of litigation, the U.S. District Court of South Carolina released a decision in the case of Genesis versus the Department of Health and Human Services. Although the court agreed with HRSA that the 340B statute required that the patient have an ongoing relationship with the covered entity, the court sided with Genesis that the covered entity did not have to initiate the healthcare service resulting in the prescription. Even though this court ruling only applies to Genesis in South Carolina, it has prompted many covered entities to modify their approach to patient definition regarding qualifying contracts and retail pharmacy prescriptions. It remains to be seen how this decision may change HRSA’s approach to this area in future audits.
In summary, these are just three of the important topics discussed at this year’s winter meeting. Together, these dynamics illustrate the multifaceted challenges and opportunities in the ever-evolving landscape of the 340B Program.
Visante is prepared to support all aspects of your 340B Program compliance, auditing and optimization. Our 340B ACE consultants will help you achieve your compliance goals and make the most of your program, and we welcome the chance to talk more about your opportunities and challenges. Contact us at email@example.com or call 866-388-7583.