Serves as the primary program coordinator and liaison for 340B-related matters. Serves as the covered entity's compliance expert on 340B Program details, policies, and procedures. Acts as the liaison with necessary affiliated departments to ensure 340B Program integrity. Provides oversight and leadership from the department of pharmacy for the 340B Program. Leads the organization's 340B oversight committee, which includes members from senior leadership, pharmacy, compliance, legal, and finance. Provides expertise with the 3408 Program to staff and participants regarding ongoing compliance. Develops and maintains internal relationships (accounting, legal, national) and external relationships (wholesalers, manufacturers, contract pharmacies, split-billing software vendors, employee benefit pharmacy benefits managers [PBMs], and third-party administrator [TPA].
- 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.
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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.
Provides ongoing training, education, and communication required for the 340B Program at the organization.
- Develops training/competency materials for all employees who work with the 340B
- Acts as a preceptor to pharmacy students, residents, and others in training.
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May assist in the development, implementation, or promotion of programmatic resources/tools to support staff.
Regularly communicates with all staff involved with the 3408 Program to be sure that processes remain efficient and to address any problems or suggestions for improvement.
Establishes a clear way for staff to communicate concerns to the coordinator.
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.
Ensures that the 3408 pharmacy program is continuously compliant with 340B federal regulations.
Provides expertise on all 340B Program legislation and policy changes from HRSA and OPA, informing and collaborating with legal and compliance teams.
Collaborates with the Prime Vendor Program, pharmacy leadership, and other 340B institutions to determine the most appropriate use of the 340B Program staff.
Responsible for ensuring that the annual HRSA recertification is completed within the allowable time frame.
- Responsible for ensuring that the HRSA 340B OPAIS is accurate for all organization
- Responsible for ensuring registration of any new child sites within the allowable time
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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 managing and troubleshooting pharmacy billing issues and ensuring that Actively engages with senior leadership and participates in decision-making processes related to adequate systems checks are reviewed to prevent billing issues. The implementation of new 340B processes.
Coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.
Monitors utilization records and 3408 purchasing accounts to ensure that software or tools are working properly and accurately, performing audits or compliance assessments internally as needed.
Evaluates 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.
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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 compliance with all aspects of the 3408 Program and implements all applicable aspects of HRSA's Office of Pharmacy Affairs guidance, as well as organizational policies and procedures.
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.
Performs annual independent compliance audits and reports findings to responsible representatives at the organization.
Performs 3408 purchasing and utilization audits or compliance assessments internally, as needed.
Routinely audits all 340B programs to ensure compliance with regulations related to 340B purchasing.
Serves as the point person and coordinator for all audits. Coordinates all requests and responses.
- Maintains a current state of "audit readiness."
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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.
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Coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.
- Reviews and negotiates any new 340B contracts. Maintains all 3408 contracts.
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Manages relationships, billing services, and compliance with contracted 340B pharmacies.
Evaluates all current and future contract pharmacy opportunities, including contract language, fee structure, data setup, and internal and independent external auditing.
To determine companies that are contracting with inpatient facilities to offer 340B or equivalent pricing and develop strategies to maximize such participation.
Works directly with manufacturers, as well as through GPO and peer professional relationships, …
Assesses opportunities for cost savings and business improvements in 340B contract pharmacy utilization.
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Oversees the 340B contract pharmacy marketing program to attract and retain qualified retail pharmacy contracts and serve eligible patients.
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.
Participates in projects, councils, and special initiatives related to 3408, compliance, auditing functions, vendor selection, and medication management.
Develops business plans to prioritize and implement programs related to program services and contract pharmacy agreements.
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Develops action plans to close identified gaps in collaboration with organizational
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Implements business plans in coordination with organizational pharmacy leadership to help use 3408 savings to expand and improve care provided to underserved and vulnerable populations.
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Collaborates with department leadership to improve and enhance service offerings.
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Monitors all outpatient points of service to continually check for new areas that may qualify for the 340B Program.
Provides oversight for the implementation of process improvement initiatives and creates an environment that places an emphasis on continuous monitoring and improvement.
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 administration.
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.]
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Prepares and assists in the monitoring and various tracking and reporting measurements to ensure compliance with the program.
Reviews and refines 340B cost savings reports detailing purchasing and replacement practices, as well as dispensing patterns.
Coordinates monthly financial reporting and analysis, including, but not limited to, metric reporting, scorecards, and variance analysis and reporting.
Participates in the development and implementation of reports generated on the 340B Program that outlines savings, utilization, exceptions, and discrepancies.
Ensures that reporting meets organizational, regional, national, state, and federal requirements/ guidelines.
- Maintains records related to job function and contributes to reports.
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Develops, monitors, and presents reports on 340B participation that clearly document utilization, savings, problem areas, exceptions, and/or discrepancies to pharmacy and administrative leadership.
Routinely communicates any questions, issues, or discrepancies with the appropriate authority.
- Reports monthly savings opportunities.
- Ensures appropriate documentation and audit trail across areas of responsibility.
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Monitors purchasing records for each 340B participant; clear documents utilization, savings, problem areas, and exceptions or discrepancies. Relays results to pharmacy leadership and administration.
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.
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Tracks, trends, and reports 340B pharmaceutical sales and purchases data to ensure provider/physician and patient eligibility.
Continuously monitors product min/max levels to effectively balance product availability and cost-effective inventory control.
Maintains system databases to reflect changes in the drug formulary or product specifications.
- Ensures compliance with regulations related to 340B purchasing.
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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.
Establishes a routine approach to updating the COM/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.
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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 3408 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 COM is accurate, …
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Charges are coming across accurately, and the utilization numbers are translating accurately into report for 340B reorders.
- Oversees split-billing software maintenance.
