Get the free 340B Self-Disclosure to HRSA and Manufacturer Notification

340B SelfDisclosure to RSA and Manufacturer NotificationSuggested Template Page 1Purpose: This sample document is intended to provide a comprehensive template that may be used by entities to self

How to fill out 340b self-disclosure to hrsa

How to fill out 340b self-disclosure to hrsa

1. To fill out the 340b self-disclosure to HRSA, follow these steps:
2. Download the self-disclosure form from the HRSA website.
3. Read the instructions carefully to understand the required information.
4. Provide your organization's name, address, and contact information.
5. Include a detailed description of the identified non-compliance issue.
6. Attach any supporting documents or evidence related to the non-compliance.
7. Sign and date the self-disclosure form.
8. Submit the completed form and supporting documents to HRSA via mail or email as instructed.
9. Keep copies of the submitted form and documents for your records.
10. Await acknowledgment and further instructions from HRSA regarding the self-disclosure.

Who needs 340b self-disclosure to hrsa?

1. Any covered entity participating in the 340B Drug Pricing Program and who has discovered a potential instance of non-compliance needs to submit a self-disclosure to HRSA.

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What is 340b self-disclosure to hrsa?

340B self-disclosure to HRSA is a process where entities participating in the 340B program voluntarily report instances of non-compliance with program requirements.

Who is required to file 340b self-disclosure to hrsa?

Entities participating in the 340B program who identify instances of non-compliance are required to file 340B self-disclosure to HRSA.

How to fill out 340b self-disclosure to hrsa?

Entities can fill out the 340B self-disclosure to HRSA form online through the HRSA website or by submitting a hard copy via mail.

What is the purpose of 340b self-disclosure to hrsa?

The purpose of 340B self-disclosure to HRSA is to promote program integrity and transparency by allowing covered entities to report and rectify instances of non-compliance.

What information must be reported on 340b self-disclosure to hrsa?

Entities must report detailed information about the non-compliance issue, including the nature of the violation, the actions taken to address it, and steps taken to prevent future occurrences.