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340B Independent Audit Page 1Request for Proposal (RFP) Checklist Instructions: This tool is designed to provide entity leaders a checklist of action items to consider when developing a Request for

How to fill out 340b independent audit

How to fill out 340b independent audit:

1. Start by gathering all necessary documents and information related to your 340b program. This may include pharmacy records, patient data, financial documents, and policies and procedures.
2. Review the audit requirements and guidelines provided by the Health Resources and Services Administration (HRSA). These guidelines will outline the specific information and documentation that will need to be included in the audit.
3. Identify a qualified auditor or auditing firm to conduct the independent audit. Ensure that they have experience and expertise in 340b program auditing.
4. Schedule a meeting with the auditor to discuss the audit process and expectations. Provide them with all relevant information and answer any questions they may have.
5. Work closely with the auditor to provide any additional documentation or clarification they may need during the audit process.
6. Allow the auditor to conduct an on-site visit to review your pharmacy operations, record-keeping systems, and compliance with 340b program requirements.
7. Collaborate with the auditor to address any findings or areas of concern that may arise during the audit. This may involve implementing corrective action plans or making necessary improvements to your program.
8. Review the final audit report provided by the auditor. Ensure that it accurately reflects the results of the audit and addresses any recommendations or areas for improvement.
9. Make any necessary adjustments or changes to your 340b program based on the audit findings and recommendations.
10. Keep a copy of the audit report and related documentation for future reference and potential audits.

Who needs 340b independent audit?

1. Covered Entities: Covered entities participating in the 340b drug pricing program are required by law to undergo regular independent audits. This includes hospitals, clinics, and other healthcare organizations that qualify for the 340b program.
2. Pharmaceutical Manufacturers: Pharmaceutical manufacturers that participate in the 340b program may also be subject to independent audits to ensure compliance with program requirements, such as providing discounted drugs to eligible covered entities.
3. Third-Party Administrators: Some covered entities may utilize third-party administrators to manage their 340b program. In such cases, both the covered entity and the third-party administrator may need to undergo independent audits to verify program compliance.
4. Government Agencies: Government agencies, such as the HRSA, may also conduct their own independent audits to ensure that covered entities and other program participants are adhering to 340b program guidelines and regulations.
5. Suppliers and Servicers: Suppliers and servicers that provide goods and services to covered entities participating in the 340b program may undergo independent audits to ensure that they are meeting program requirements and providing accurate and timely reporting.

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What is 340b independent audit?

340B independent audit is a comprehensive review and evaluation of an entity's compliance with the 340B Drug Pricing Program requirements.

Who is required to file 340b independent audit?

Covered entities participating in the 340B Drug Pricing Program are required to conduct and file a 340B independent audit.

How to fill out 340b independent audit?

To fill out a 340B independent audit, the covered entity must gather relevant data, conduct a thorough review of compliance with program requirements, and submit the audit report to the Health Resources and Services Administration (HRSA).

What is the purpose of 340b independent audit?

The purpose of a 340B independent audit is to ensure that covered entities are in compliance with the 340B Drug Pricing Program requirements and to promote transparency and accountability.

What information must be reported on 340b independent audit?

A 340B independent audit must report on the covered entity's compliance with program requirements, including drug purchasing, inventory management, patient eligibility, and program integrity.