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HRSA Eases 340B Audit Administrative Burden

Hospitals and other covered entities participating in the 340B Drug Pricing Program will no longer be required to publish a public letter to manufacturers about audit findings potentially resulting in repayment.

Previously, the Health Resources and Services Administration (HRSA) required covered entities to provide letters for HRSA to post on its site. Now, HRSA will instead post a public notice that informs manufacturers of violations, including covered entity contact information for findings of audits that require possible repayment.

Additionally, the HRSA Office of Pharmacy Affairs announced in a January update that it will accept all audit-related submissions by email at to streamline audit review. Hard copies of documents are no longer required to accompany electronic submissions.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Matt Buechner is the policy and advocacy associate for America's Essential Hospitals.

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