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Navigating New 340B Transparency Requirements: Strategies for Covered Entities

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 >


Virtue 340B

Virtue 340B News & Announcements

Virtue 340B provides independent 340B risk oversight for hospitals and health systems operating in an increasingly complex and scrutinized program environment. Rather than managing programs or selling technology, Virtue delivers objective, independent analysis that helps leadership understand where hidden exposure may exist, what that exposure could mean operationally or financially, and whether current oversight would stand up under external scrutiny. Our work translates complex 340B operational realities into clear, defensible insights that executives can act on with confidence.
Through independent audits, mock HRSA audit simulations, and continuous compliance monitoring, Virtue helps organizations detect operational drift early, strengthen oversight structures, and maintain durable, audit-ready programs. By focusing on prevention, visibility, and governance, not just technical compliance, Virtue 340B equips leadership teams with the clarity they need to protect their organizations and confidently defend how their 340B programs are being managed.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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