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Navigating New 340B Transparency Requirements: Strategies for Covered Entities


The recent bipartisan draft bill on the 340B Drug Pricing Program has introduced potential transparency requirements that could significantly impact how Covered Entities (CEs) report and utilize their 340B savings. This legislation aims to enhance the program's transparency by mandating detailed reporting on the use of 340B savings and making this information publicly available. Understanding and adapting to these changes is crucial for CEs to maintain compliance and optimize the benefits of the 340B program.


Understanding the Proposed Transparency Requirements

The draft bill proposes several key reporting requirements for CEs, including:

- Annually report detailed information related to 340B program savings, policies, and patient and prescription information.

- Specific data such as the number of individuals dispensed or administered 340B drugs, health insurance coverage types, charity care costs, patient demographics, contracts, a list of contract pharmacies, discounts realized, and the use of savings were included.

- Separate reporting mechanisms for CEs not submitting Medicare cost reports and HHS's publication of reported information on a public website.


These requirements underscore the need for CEs to have robust mechanisms for tracking and reporting their 340B program activities and savings utilization. Read more >



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