Under the direction of the VP of Pharmacy, the position will:
1. Policy and Procedure Development
• Ensures that policies and procedures are developed, implemented, and maintained according to organizational, regional, national, state, and federal requirements and guidelines and are approved by the institution’s legal department.
• Establishes consistent policies and procedures for 340B that ensure productivity and efficiency so that long-term management of the program does not hamper operations or create unnecessary costs.
2. Rules/Guidance Surveillance
• Monitors and assesses 340B guidance and/or rule changes, including, but not limited to, HRSA/OPA rules and Medicaid changes. Attends regular 340B trainings and shares lessons and hot topics with staff and Pharmacy leadership.
• Routinely monitors industry publications and websites as well as the professional media, literature, and peers to ensure that the institution has the latest information regarding interpretations, rulings, suggestions, and advanced ideas for improving participation.
• Ensures that the 340B pharmacy program is continuously compliant with 340B federal regulations.
• Identifies program gaps with escalation to 340B Steering Committee.
• Develops, executes, and documents self-audits of the 340B process. Coordinates and ensures remediation of findings.
• Conducts and/or coordinates an annual audit of all contract pharmacies. Documents results and follow-up on any findings.
• Reviews and monitors all points of service where 340B participation occurs to ensure policy and procedure compliance, covered entity eligibility, and “covered patient” eligibility.
• Responsible for identification of pharmacy billing issues and ensuring that adequate systems checks are in place to prevent billing issues.
• Monitors utilization records and 340B purchasing accounts to ensure that software or tools are working properly and accurately, performing audits or compliance assessments internally as needed; coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.
• Monitors patient eligibility for qualified and non-qualified patients in hospital-based mixed-use areas and clinics by reviewing patient medical records, insurance plans, and hospital status.
• Monitors 340B compliance within workflow processes.
• Responsible for the day-to-day management, compliance review, and operations of clinic-administered medications in eligible locations, mixed-use areas managed by split-billing software, outpatient prescriptions fulfilled by an owned pharmacy, and outpatient prescriptions fulfilled by a contract 340B pharmacy.
• Conducts monthly audits of all 340B-eligible locations to verify adherence with the 340B Program guidelines and policies.
• Ensures that audits follow current regulatory compliance recommendations and are completed at the facility level.
• Ensures evaluations of gaps at the site level and assists in providing the tools necessary to be compliant with the 340B Program.
• Evaluates covered entity compliance at the contract pharmacy, covered entity, and wholesaler levels.
• Organizes annual independent compliance audits and reports findings to responsible representatives at the organization.
• Performs 340B purchasing and utilization audits or compliance assessments internally, as needed.
• Routinely audits all 340B programs to ensure compliance with regulations related to 340B purchasing.
4. External Audits
• Serves as the point person and coordinator for 340B audits. Coordinates all requests and responses.
• Maintains a current state of “audit readiness.”
• Works with medical auditors on third-party payer audits to ensure coordination of efforts and maximum collection.
• Provides oversight for all audits performed by independent external auditors.
• Coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.
5. Program Enhancement/Optimization
• Analyzes utilization of the program and existing software to identify ways to compliantly use the 340B Program to its fullest extent to meet the needs of underserved patients.
• Works directly with manufacturers as well as wholesalers to develop strategies for appropriate use of the program.
• Implements business plans in coordination with Pharmacy leadership to help use 340B savings to expand and improve care provided to underserved and vulnerable populations.
• Collaborates with department leadership to improve and enhance service offerings.
• Monitors all outpatient points of service to continually check for new areas that may qualify for the 340B Program.
• Routinely monitors monthly and annual reports on 340B participation that clearly document utilization, savings, problem areas, and exceptions or discrepancies, to be passed on to pharmacy leadership and the 340B Steering Committee.
• Develops routine reports that are a by-product of the inventory process and software, allowing for concise information to be communicated to the leadership responsible for 340B inventory management.
• Constructs appropriate financial metrics to assess areas of improvement.
• Prepares and assists in the monitoring and various tracking and reporting measurements to ensure compliance with the program.
• Participates in the development and implementation of reports generated on the 340B Program that outline savings, utilization, exceptions, and discrepancies.
• Ensures that reporting meets organizational, regional, national, state, and federal requirements/ guidelines.
• Routinely communicates any questions, issues, or discrepancies with the appropriate authority.
• Ensures appropriate documentation and audit trail across areas of responsibility.
7. Purchasing/Inventory Oversight
• Monitors purchasing records for each 340B parent and child site. Clearly documents utilization, savings, problem areas, and exceptions or discrepancies. Relays results to pharmacy and purchasing leadership.
• Monitors for 340B pricing exclusions or shortages and establishes appropriate alternative products that are included when possible, including work with medical staff and formulary to ensure proper position and related use.
• Participates with the Prime Vendor and routinely reviews 340B formulary pricing, potential alternatives, and possible additional savings as a result of GPO formulary.
• Manages and tracks 340B drug inventory, including proper replenishment.
• Tracks, trends, and reports 340B pharmaceutical sales and purchases data to ensure provider/physician and patient eligibility.
• Ensures compliance with regulations related to 340B purchasing.
• May be required to work on inventory management of the 340B Program and offer input as to the application’s overall functionality and opportunities for improving compliance and or efficiency.
• Routinely monitors utilization records and 340B purchasing accounts to ensure that software or tools are working properly.
• Performs thorough quarterly reviews of the new 340B pricing list to search for and quickly address costly changes.
• Oversees 340B regulatory aspects of the inventory purchasing process for outpatient, inpatient, and mixed-use areas.
8. Split-Billing or Third-Party Administrator Software Maintenance
• Establishes a routine approach to updating the CDM/crosswalk for new products and product changes to ensure both the accuracy of the utilization report and the efficiency and accuracy of the charge process.
• Maintains 340B split-billing software integrity and reviews applicable reports to identify areas for improvement.
• Assists in implementing new software packages and other changes in business practice based on changing regulations and policies.
• Is responsible for maintenance and testing of tracking software.
• Integrates information from the pharmacy chargemaster system into the 340B split-billing computer system and incorporates that information into auditable and compliant processes.
• Works with outpatient pharmacy management and pharmacy informatics teams to ensure that the organization’s clinical information system is coordinated and integrated into the work with the 340B Program. This shall include the electronic interfaces between the EMR and the virtual accumulator and any interfaces between the organization and contract pharmacy providers and/or administrators.
• Ensures split-billing software integrity and reviews applicable reports for areas of improvement.
• Periodically performs spot audits or compliance assessments in specific areas and specific products to ensure that the CDM is accurate, charges are coming across accurately, and the utilization numbers are translating accurately into report for 340B reorders.
• Oversees split-billing software maintenance.