340B Compliance Tools and Templates
Created by the PVP and HRSA-reviewed
These tools are intended to be a guide and should be carefully reviewed and modified based on your specific needs. Tools include policy and procedure templates, auditing plans, and additional resources to promote 340B Program integrity.
GPO Prohibition HOspitals (DSH, PED, CAN)
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Oversight
- GPO Prohibition Hospitals Getting Started in 340B Checklist >
- Medicaid Exclusion File (MEF) Checklist >
- 340B Oversight Best Practices Dashboard >
- Calculating 340B Net Financial Impact and Use of Savings >
- C-Suite Guide to the 340B Program >
- 340B FTE Request Template >
- Independent Audit Request for Proposal Checklist >
- 340B Coordinator Job Description Template (Hospitals) >
- 340B Analyst Job Description Template >
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Policy and Procedure Manuals
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Registration
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Auditing/Compliance
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Entity
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HRSA
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Operational/Purchasing
- Non-GPO/WAC and 340B Contract Load Options >
- WAC Account Purchasing Strategies >
- 340B Manual Dispense Tracking Log >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Split-Billing Software Key Attributes >
- 340B Universe Mapping Template
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General
Grantees (STD, RW, HM, FP, BL, TB, MH, UI)
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Oversight
- Grantee Getting Started in 340B Checklist >
- Medicaid Exclusion File (MEF) Checklist >
- 340B Oversight Best Practices Dashboard >
- Calculating 340B Net Financial Impact and Use of Savings >
- C-Suite Guide to the 340B Program >
- 340B FTE Request Template >
- Independent Audit Request for Proposal Checklist >
- 340B Coordinator Job Description Template (CHCs/Grantees) >
- 340B Analyst Job Description Template >
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Policy and Procedure Manuals
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Registration
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Auditing/Compliance
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Entity
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HRSA
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Operational/Purchasing
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General
Community Health Centers (CH, FQ, FQHC, FQHCLA, NH)
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Oversight
- Community Health Centers Getting Started in 340B Checklist >
- Medicaid Exclusion File (MEF) Checklist >
- 340B Oversight Best Practices Dashboard >
- Calculating 340B Net Financial Impact and Use of Savings >
- C-Suite Guide to the 340B Program >
- 340B FTE Request Template >
- Independent Audit Request for Proposal Checklist >
- 340B Coordinator Job Description Template (CHCs/Grantees) >
- 340B Analyst Job Description Template >
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Policy and Procedure Manuals
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Registration
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Auditing/Compliance
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Entity
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HRSA
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Operational/Purchasing
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General
Rural Hospitals (CAH, RRC, SCH)
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Oversight
- Rural Hospital Getting Started in 340B Checklist >
- Medicaid Exclusion File (MEF) Checklist >
- 340B Oversight Best Practices Dashboard >
- Calculating 340B Net Financial Impact and Use of Savings >
- C-Suite Guide to the 340B Program >
- 340B FTE Request Template >
- Independent Audit Request for Proposal Checklist >
- 340B Coordinator Job Description Template (Hospitals) >
- 340B Analyst Job Description Template >
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Policy and Procedure Manuals
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Registration
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Auditing/Compliance
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Entity
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HRSA
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Operational/Purchasing
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General
Manufacturers
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Auditing/Compliance HRSA
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General
Distributors
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Operational/Purchasing
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General
All Tools
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Oversight
- GPO Prohibition Hospitals Getting Started in 340B Checklist >
- Grantee Getting Started in 340B Checklist >
- Community Health Centers Getting Started in 340B Checklist >
- Rural Hospital Getting Started in 340B Checklist >
- Medicaid Exclusion File (MEF) Checklist >
- 340B Oversight Best Practices Dashboard >
- Calculating 340B Net Financial Impact and Use of Savings >
- C-Suite Guide to the 340B Program >
- 340B FTE Request Template >
- Independent Audit Request for Proposal Checklist >
- 340B Coordinator Job Description Template (Hospitals) >
- 340B Coordinator Job Description Template (CHCs/Grantees) >
- 340B Analyst Job Description Template >
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Policy and Procedure Manuals
- Community Health Center Sample Policy and Procedure Manual (CHC) >
- GPO Prohibition Hospitals Sample Policy and Procedure Manual (DSH/PED/CAN) >
- Grantees – Title X Family Planning Sample Policy and Procedure Manual (FP) >
- Grantees – Hemophilia Treatment Center Sample Policy and Procedure Manual (HM) >
- Rural Hospitals Sample Policy and Procedure Manual (CAH/RRC/SCH) >
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Registration
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Auditing/Compliance
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Entity
- Self-Audit: Policy and Procedure >
- Self-Audit: Eligibility (DSH/PED/CAN) >
- Self-Audit: Prevention of Diversion and GPO Violation (DSH/PED/CAN) >
- Self-Audit: Prevention of Duplicate Discounts (DSH/PED/CAN) >
- Self-Audit: Eligibility (CAH/RRC/SCH) >
- Self-Audit: Prevention of Duplicate Discounts (CAH/RRC/SCH) >
- Self-Audit: Prevention of Diversion (CAH/RRC/SCH) >
- Self-Audit: Eligibility (CHC/FQHC) >
- Self-Audit: Prevention Duplicate Discounts (CHC/FQHC) >
- Self-Audit: Prevention of Diversion (CHC/FQHC) >
- Self-Audit: Contract Pharmacy >
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HRSA
- Self-Disclosure to HRSA and Manufacturer Template >
- Establishing Material Breach Threshold >
- 340B Ceiling Price Unavailable/Incorrect 340B Ceiling Price Notification for HRSA >
- HRSA Audits of Entities >
- Sample HRSA 340B Audit Data Request List (DRL) for Covered Entities >
- Sample HRSA 340B Audit Data Request for Manufacturers >
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Operational/Purchasing
- Non-GPO/WAC and 340B Contract Load Options >
- WAC Account Purchasing Strategies >
- Grantee Combined Purchasing and Distribution Request for HRSA >
- 340B Manual Dispense Tracking Log >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Split-Billing Software Key Attributes >
- 340B Universe Mapping Template >
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General
Education Library >
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