340B Compliance Tools and PVP Resources

The Prime Vendor has developed 340B Compliance Tools to help put 340B policy into practice.

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)

Oversight
Policy and Procedure Manuals
- GPO Prohibition Hospitals Sample Policy and Procedure Manual (DSH/PED/CAN) >
Registration
- Understanding the Medicare Cost Report >
- Contract Pharmacy Medicaid Carve-In Checklist >
Auditing/Compliance
Entity
HRSA
Operational/Purchasing
- Non-GPO/WAC and 340B Contract Load Options >
- WAC Account Purchasing Strategies >
- 340B Manual Dispense Tracking Log >
  - Word >
  - Excel >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Split-Billing Software Key Attributes >
- 340B Universe Mapping Template
  - Word >
  - Excel >
General

Grantees (STD, RW, HM, FP, BL, TB, MH)

Oversight
Policy and Procedure Manuals
- Grantees – Title X Family Planning Sample Policy and Procedure Manual (FP) >
- Grantees – Hemophilia Treatment Center Sample Policy and Procedure Manual (HM) >
Registration
- Contract Pharmacy Medicaid Carve-In Checklist >
Auditing/Compliance
Entity
- Self-Audit: Policy and Procedure >
- Self-Audit: Contract Pharmacy >
HRSA
Operational/Purchasing
- Grantee Combined Purchasing and Distribution Request for HRSA >
- 340B Manual Dispense Tracking Log >
  - Word >
  - Excel >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Universe Mapping Template
  - Word >
  - Excel >
General

Health Centers (CH, FQ, FQHC, FQHCLA, NH, UI)

Oversight
Policy and Procedure Manuals
- Community Health Center Sample Policy and Procedure Manual (CHC) >
Registration
- Contract Pharmacy Medicaid Carve-In Checklist >
Auditing/Compliance
Entity
HRSA
Operational/Purchasing
- 340B Manual Dispense Tracking Log >
  - Word >
  - Excel >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Universe Mapping Template
  - Word >
  - Excel >
General

Rural Hospitals (CAH, RRC, SCH)

Oversight
Policy and Procedure Manuals
- Rural Hospitals Sample Policy and Procedure Manual (CAH/RRC/SCH) >
Registration
- Understanding the Medicare Cost Report >
- Contract Pharmacy Medicaid Carve-In Checklist >
Auditing/Compliance
Entity
HRSA
Operational/Purchasing
- 340B Manual Dispense Tracking Log >
  - Word >
  - Excel >
- Controlled Substance Ordering System (CSOS) Compliance Considerations >
- Consignment Inventory Compliance Considerations >
- 340B Split-Billing Software Key Attributes >
- 340B Universe Mapping Template
  - Word >
  - Excel >
General

Manufacturers

Auditing/Compliance HRSA
- Sample HRSA 340B Audit Data Request for Manufacturers >
Operational/Purchasing
- NDC Change Notification Best Practices and Template for Communication >
General

Distributors

Operational/Purchasing
- Non-GPO/WAC and 340B Contract Load Options >
General

All Tools