340B Audits and Appeals

The Health Resources and Services Administration (HRSA) began auditing 340B program providers in 2012, and since 2013 over half of hospitals audited had findings that required repayment.

Maureen Testoni has counseled health systems regarding hundreds of HRSA audits, advising hospitals on how to prepare for an audit, addressing questions that arise during an audit, analyzing the likelihood that an appeal would succeed, drafting appeals, preparing corrective action plans, and making repayments. Maureen has worked closely with hospitals and has had success in seeing findings either overturned or modified so that repayment was not required.

In addition to HRSA audits, Maureen has counseled hospitals regarding manufacturer audits and letters of inquiry, self-disclosures, self-audits, and independent audits. Though providers and manufacturers are required to work in good faith to resolve disputes, she has seen several situations where manufacturers (or their consultants) have failed to meet this good faith standard, and it is important for providers to respond appropriately, so that they do not risk being audited themselves.

Repayment is another tricky issue, as the amount to repay is not set by the federal government, but rather is negotiated between each individual manufacturer and provider. Maureen can assist you with developing a strategy to deal with this seemingly overwhelming process.

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

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