340B Program

• 340B entities purchase medications at reduced prices through the 340B program and then partner with contract pharmacies to dispense these medications.
• Contract pharmacies handle the dispensing of 340B drugs to eligible patients. The 340B entity remains responsible for the patient’s care and eligibility.
• The contract pharmacy bills the 340B entity for the cost of the 340B medication along with the agreed upon dispensing fee, with payment usually occurring by inventory replenishment or wholesaler credit.

• Ensuring compliance with 340B program requirements and regulations is crucial. The program has strict rules to prevent misuse, and both the 340B entity and contract pharmacy must adhere to these guidelines.
• 340B entities and contract pharmacies are subject to audits to ensure proper use of the 340B drugs and compliance with the program’s requirements.
• Managing the relationship between the 340B entity and contract pharmacy can be complex, involving detailed agreements and regular communication.

1. Understand the 340B Program.

• The 340B Drug Pricing Program enables eligible healthcare organizations (covered entities) to purchase medications at reduced prices. These savings are intended to help organizations stretch scarce federal resources and provide more comprehensive services.
• Educate yourself on 340B program basics. www.340bpvp.com/340b-university/online-learning

2. Partner with a Covered Entity

• Find and partner with eligible 340B-covered entities. These entities will need to sign a contract with your pharmacy.
• Draft and negotiate a contract agreement detailing the terms of your partnership, including responsibilities, compensation, and compliance requirements.

3. Develop a Compliance Plan

• Familiarize yourself with 340B program requirements, including compliance with Health Resources and Services Administration (HRSA) guidelines.

• Develop policies and procedures to ensure compliance with 340B regulations, such as maintaining accurate records, preventing diversion, and ensuring eligibility, it is important to partner with a TPA during this process to ensure compliance.

4. Set Up Operational Procedures

• Implement pharmacy management systems capable of tracking 340B prescriptions and generating necessary reports. Ensure integration with the covered entity’s systems for seamless data exchange.

• Establish procedures for managing 340B inventory, including purchasing, storage, and tracking of 340B medications.

5. Train Staff

• Provide training for pharmacy staff on 340B program requirements, including how to handle 340B medications and maintain compliance.

• Train staff on the specific operational procedures for processing 340B prescriptions and managing inventory.

6. Implement Prescription Processing Procedures

• Develop procedures for verifying patient eligibility for 340B pricing, ensuring that only eligible prescriptions are filled under the 340B program.

• Set up systems for accurate billing and reimbursement processes, including tracking and reporting for audits.

7. Ensure Accurate Record Keeping

• Maintain comprehensive records of all 340B transactions, including patient eligibility, prescription details, and inventory levels.

• Prepare for audits by ensuring all documentation is accurate and accessible. Conduct internal audits to ensure compliance and identify areas for improvement.

8. Monitor and Evaluate the Program

• Track key performance indicators such as the volume of 340B prescriptions, revenue, and patient outcomes.

• Gather feedback from patients and covered entities to evaluate program effectiveness and identify areas for improvement.

9. Maintain Compliance

• Stay up-to-date with HRSA guidelines and any changes to 340B program requirements. Adjust your procedures and policies as necessary.

• Regularly review and update compliance policies and procedures to address any new regulations or operational challenges.

10. Promote the Program for contract expansion.

• Inform the community and healthcare providers about the availability of 340B services and the benefits of the program. Meet with healthcare centers and providers for potential contracting.

11. Leverage Technology

• Utilize technology to integrate data between your pharmacy and the covered entity to identify contract potential, streamline operations and improve accuracy.

• Implement reporting tools, that assist in tracking 340B medication use and generating reports for compliance and audits or contract with a Vendor for these services.

12. Address Challenges and Identify Opportunities

• Be prepared to address any issues that arise, such as discrepancies in inventory or patient eligibility.

• Explore opportunities to expand the program’s impact, such as offering additional services or partnering with more covered entities.

By carefully planning and executing these steps, a pharmacy can successfully implement a 340B Contract Pharmacy Program, benefiting underserved patients and enhancing the pharmacy’s role in the healthcare system.