Policies and Procedures (EXCoPP-340B) © 2015 v.2
Executive Resources’ Policies and Procedures Manual (EXCoPP-340B) © 2015 v.2 was developed to assist 340B covered entities demonstrating to HRSA auditors that it understands the requirements and intent of the 340B guidelines, as required by HRSA. Based upon Executive Resources’ interpretation and understanding of the various guidelines developed by HRSA we designed a set of policies and procedures. This product was designed to be used by Section 340B covered entities as a template that could be modified to meet the specific needs of a 340B covered entity organization. It includes numerous policies and related procedures that can be used as a base to start a manual. Each covered entity must first determine the needs of their organization and how this manual can be incorporated into their operations.
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- Audit Compliance
- Audit Response
- Drug Diversion Prohibition
- Duplicate Discount Prohibition and Medicaid Exclusion File
- Carve In/Carve Out Compliance
- Patient Eligibility
- Use of Section 340B Savings
- Patient Confidentiality – E Prescribing, Faxes, etc.
- Privacy and HIPAA Requirements
- Compliance with 340B Guidance
- Material Breach and Self Reporting Issues
- Referral of Eligible Patients
- Contract Pharmacy Contractual Agreements
- Internal Reporting Process
- Development of Corrective Active Plan (CAP)
- Maintenance of OPA Database
- Notification on Loss of Eligibility
- Agreements with Contract Pharmacies
- Evaluation of Vendor Software
- Home Deliveries of Prescriptions
- Drug Supply Chain Security Act
- Controlled Substance Ordering System (CSOS)
- Compliance and Ethics Concerns
- Providers excluded from Federal Participation
- Health Care Professionals
- Dispute Resolution
- Outpatient Facilities
- Compliance with Grant Funding Requirements
- GPO Prohibition
- Employee and Professional Training
- Prescription Dispensing Patterns
- Pharmacy Policy
- Inventory Tracking System
- Shortages of Covered Drug
- Compliance and Eligibility Requirements