340B Compliance and Contracts

The 340B program has multiple vague requirements, and their interpretation has significantly changed over time. Knowing that over half of audited hospitals have findings requiring repayment, it is clear that 340B compliance is a key issue for providers.

Maureen Testoni has counseled hospitals on successful strategies for setting up systems to address key 340B compliance obligations, including patient definition, diversion, duplicate discount prevention, GPO prohibition, database maintenance, and others. She has worked with hundreds of hospitals on these issues, and can help you devise workable strategies.

Maureen can also assist you by conducting a legal audit of your 340B compliance, matching your policies and practices against the standards used by the Health Resources and Services Administration (HRSA) to conduct audits, and giving you concrete recommendations for improving compliance. She can also review your 340B policies and procedures to make sure they are up-to-date with existing guidance and the latest interpretations.

Sometimes providers have a unique situation that is simply not addressed by the existing compliance rules. Having worked closely with the 340B policymakers, Maureen can help you navigate the process of determining how to ensure compliance with the situation and even advocate for specific rules or interpretations that fit your purpose and the purpose of the 340B program.

340B providers have unique relationships with outside vendors that relate directly to the 340B program, and so have special compliance requirements. Maureen has counseled hospitals regarding 340B contract pharmacy arrangements, vendor agreements, and third party payer contracts.

For advice and help with 340B compliance and contract issues, contact Flanagan & Testoni LLP.

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