Covered entities that participate in the 340B Drug Pricing Program play a vital role in providing affordable medications to vulnerable patient populations. However, recent legislation has brought significant changes to the 340B program, placing greater emphasis on transparency, accountability, and compliance. In this blog post, we will delve into the importance of 340B covered entities examining their 340B utilization data today to proactively prepare for the increased reporting requirements resulting from recent 340B legislation.
Understanding the Recent 340B Legislation
In recent months, two states have implemented substantial regulatory changes aimed at enhancing 340B program integrity and oversight. Minnesota and Maine have both enacted 340B transparency laws placing increased responsibilities on their state’s 340B covered entities to demonstrate the appropriate use of discounted medications and the ability to maintain accurate records.
Beginning in 2024, 340B hospitals in Maine will be required to provide an annual report to include:
A description of how the hospital uses 340B savings to benefit the community;
An annual 340B savings estimation;
A comparison of the hospital’s 340B savings to its total drug expenditure;
A description of the hospital’s 340B internal oversight processes.
The transparency law enacted in Minnesota requires all 340B covered entities to include a number of identifiable characteristics as well as the following 340B utilization detail:
The aggregated acquisition cost for prescription drugs obtained under the 340B program;
The aggregated payment amount received for drugs obtained under the 340B program and dispensed to patients;
The aggregated payment made to pharmacies under contract to dispense drugs obtained under the 340B program;
The number of claims for prescription drugs.
While 340B covered entities in these states of Maine and Minnesota have no choice but to adhere to the recent legislation passed in their respective states, covered entities across the country are “on-notice” and should expect to see similar legislation introduced/enacted in their own states.
Preparing for Future Changes
The landscape of healthcare policy is continually evolving, and the 340B program is no exception. 340B covered entities must stay agile and be ready to adapt to future regulatory changes. Regular 340B utilization data examination that aligns with the key elements required in the recent transparency laws enacted in Maine and Minnesota positions covered entities to be proactive rather than reactive, facilitating smooth transitions as new state-level requirements emerge. Moreover, it allows for evidence-based advocacy, enabling 340B covered entities to actively participate in shaping future policies that align with their mission and goals.
Building Transparent and Accountable Practices
Transparency and accountability are critical elements of the recent 340B legislative actions. 340B covered entities must be prepared to provide detailed reports and documentation to demonstrate compliance with these new program requirements. By preparing and examining 340B utilization data regularly, covered entities can maintain accurate records, track drug purchases and patient encounters, and ensure they can readily furnish the information required for state-level reporting policies.
To best prepare your covered entity’s 340B utilization data today for tomorrow’s program requirements, consider ensuring the following data fields are included in all your program reports (when available):
340B drug acquisition price
Acquisition price of non-340B drugs
Reimbursement amount for drugs obtained under the 340B program and dispensed to patients
Payment amount (split) made to contract pharmacies
Additionally, 340B covered entities should leverage this reporting detail to maintain updated or, “real-time” reports illustrating:
Total number of 340B claims
Total 340B savings estimations
Comparison of 340B savings to total drug expenditure
Total of payments made to 340B contract pharmacies
Conclusion
As 340B covered entities face increased requirements resulting from recent 340B legislation, examining their utilization data today is not just a recommendation; it is an essential step towards ensuring compliance, optimizing program benefits, and delivering quality patient care. Through data-driven practices, covered entities can build transparent, accountable, and patient-centric strategies that safeguard the program's integrity while maximizing its positive impact. By embracing data preparation and acting on its insights, covered entities can confidently navigate the evolving 340B landscape and continue serving their communities with dedication and efficiency.
Contact us today to leverage the power of your 340B data and transform it into actionable intelligence. Together, we can unlock new opportunities, optimize your operations, and drive success for your 340B program.
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