Goodwin Recruiting
340B Program Manager – Job Description
The 340B Program Manager is responsible for managing the pharmacy 340B drug discount program for all qualified entities, external vendors, and contracted pharmacies. The role ensures compliance with all federal regulations, fully implements the program in all qualified areas, maintains complete and accurate records, and performs data analysis to maximize benefit for clients and patients.
General Duties
Serve as the compliance expert on 340B program details, policies, and procedures.
Act as the liaison with affiliated departments to ensure 340B program integrity.
Lead the client 340B oversight committee, including members from leadership, pharmacy, compliance, legal, and finance.
Provide expertise, staff, and participants regarding ongoing compliance.
Develop and maintain internal relationships (accounting, legal, national) and external relationships (wholesalers, manufacturers, contract pharmacies, and third‑party administrator vendors).
Actively engage with client leadership and participate in decision‑making processes related to the implementation of new 340B processes.
Job Requirements
3+ years experience working in an FQHC 340B program.
Associate’s Degree required, Bachelor’s preferred.
340B university training required; additional Apexus certifications preferred.
Experience with EHR systems required; experience with eCW preferred.
Demonstrated team leadership in a 340B environment required.
Proficiency in Microsoft Suite.
Policy and Procedure Development
Ensure 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 legal department.
Establish 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 cost.
Education
Provide ongoing training, education, and communication in collaboration with pharmacy and medical team required for the 340B program at client.
Develop training/competency materials for all employees who work with the 340B program.
Assist in the development, implementation, or promotion of programmatic resource/tools to support staff.
Regularly communicate with all staff involved with the 340B program to be sure that processes remain efficient, to address any problems or suggestions for improvement.
Establish a clear way for staff to communicate concerns to the manager.
Rules/Guidance Surveillance
Monitor and assess 340B guidance and/or rule changes, including but not limited to HRSA/OPA rules and Medicaid changes. Attend regular 340B training and share lessons and hot topics with staff.
Routinely monitor industry publications and websites as well as the professional media, literature, and peers to ensure client has the latest information regarding interpretations, rulings, suggestions and advanced ideas for improving participation.
Ensure that the 340B pharmacy program is continuously compliant with 340B federal regulations.
Provide expertise on all 340B program legislation and policy changes from HRSA and OPA, informing and collaborating with legal and compliance teams.
Collaborate with the Prime Vendor Program, pharmacy leadership, and other 340B institutions to determine the most appropriate use of 340B program staff.
Registration/Recertification
Responsible for ensuring that the annual HRSA recertification is completed within the allowable time frame.
Responsible for ensuring that the HRSA 340B OPAIS (Office of Pharmacy Affairs Information System) is accurate for all organization entities.
Responsible for ensuring registration of any new associated sites are within the allowable time frame.
Self‑Audits
Develop, execute, and document self‑audits of the 340B process. Coordinate and ensure remediation of findings.
Conduct and/or coordinate and annual audit of all contract pharmacies. Document results and follow‑up on any findings.
Review and monitor 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 adequate system checks are reviewed to prevent billing issues.
Monitor utilization records and 340B purchasing accounts to ensure that software/tools are working properly and accurately, performing audits or compliance assessments internally as needed; coordinate external compliance assessments with outside firms, when appropriate, to validate internal processes.
Monitor 340B compliance within workflow processes.
Responsible for the day‑to‑day management, compliance review, and operations of clinic‑administered medications and prescriptions filled by 340B contract pharmacies.
Conduct monthly audits of all 340B‑eligible locations to verify adherence with the 340B Program guidelines/policies.
Ensure compliance with all aspects of the 340B Program and implement all applicable aspects of HRSA’s OPA guidance, as well as Clients policies and procedures.
Ensure that audits follow current regulatory compliance recommendations and are completed at the site level.
Ensure evaluations are completed for gaps at the site level and assist in providing the tools necessary to be compliant with the 340B Program.
Evaluate covered entity compliance at the contract pharmacy and wholesaler levels.
Perform annual independent compliance audits and report findings to responsible representatives at OUR CLIENTS.
Perform 340B purchasing and utilization audits or compliance assessments internally, as needed.
Routinely audit all 340B Programs to ensure compliance with regulations related to 340B purchasing.
External Audits
Serve as the point person and manager for all audits. Coordinate all requests and responses.
Maintain a current state of “audit readiness.”
Provide oversight for all audits performed by independent external auditors.
Coordinate external compliance assessments with outside firms, when appropriate, to validate internal processes.
340B Contract Management
Review and negotiate new 340B contracts/amendments. Maintain all 340B contracts.
Manage relationships, billing services, and compliance with contracted 340B pharmacies.
Evaluate all current and future contract pharmacy opportunities, including contract language, fee structure, data setup, and internal and external auditing.
Program Enhancement/Optimization
Assess opportunities for cost savings and business improvements in 340B contract pharmacy utilization.
Assess opportunities for cost savings and system improvements to yield higher compliance.
Oversee the 340B contract pharmacy marketing program to attract and retain qualified retail pharmacy contracts and serve eligible patients.
Analyze 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.
Work directly with drug manufacturers and wholesalers to develop strategies for appropriate use of the program.
Develop business plans to optimize and implement programs related to program services and contract pharmacy agreements.
Implement business plans in coordination with client pharmacy leadership to help use 340B savings to expand and improve care provided to underserved and vulnerable populations.
Provide oversight for the implementation of process improvement initiatives and create an environment that places an emphasis on continuous monitoring and improvement.
Reporting
Routinely monitor monthly and annual reports on 340B participation that clearly document utilization, savings, problem areas, and exceptions or discrepancies, to be passed on to pharmacy and finance leadership.
Develop routine reports that are a by‑product of the inventory process and software, allowing for concise information to be communicated to CLIENTS staff responsible for 340B inventory management.
Construct appropriate financial metrics to assess areas of improvement.
Prepare and assist in the monitoring and various tracking and reporting measurements to ensure compliance with the program.
Coordinate monthly financial reporting and analysis, including, but not limited to metric reporting, scorecards, and variance analysis.
Ensure that reporting meets CLIENTS, regional, national, state, and federal requirements.
Routinely communicate and question, issues or discrepancies with the appropriate authority.
Ensure appropriate documentation and audit trail across areas of responsibility.
Purchasing/Inventory Oversight
Monitors purchasing records for each 340B participant; clearly documents utilization, savings, problem areas, and exceptions or discrepancies. Relay results to pharmacy leadership.
Monitors for 340B pricing exclusions or shortages and established appropriate alternative products that are included when possible, including work with Pharmacy and Therapeutics Committee and OUR CLIENTS procurement staff.
Participates with the Prime Vendor and routinely review 340B formulary pricing and potential alternatives.
Manages and tracks 340B drug inventory, including proper replenishment.
Tracks 340B pharmaceutical sales and purchases data to ensure provider and patient eligibility.
Continuously monitor product min/max levels to effectively balance product availability and cost‑efficient inventory control.
Maintains system databases to reflect changes in the drug formulary or product specifications.
Ensures compliance with regulations related to 340B purchasing.
Routinely monitored 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 in collaboration with pharmacy leadership.
Third‑Party Administrator Software Maintenance
Maintains 340B TPA software integrity and reviews reports to identify areas for improvement.
Assists in implementing new software packages and other changes in business practice based on changing regulations/policies.
Works with pharmacy and informatics teams to ensure that the client’s clinical information system is coordinated and integrated into the work with the 340B Program. This shall include electronic interfaces between the EMR and the virtual accumulator and any interfaces between our client and contract pharmacies and/or administrators.
Compensation $120,000 – $125,000 per year.
Location New Haven, CT (Remote/Field option available).
#J-18808-Ljbffr
General Duties
Serve as the compliance expert on 340B program details, policies, and procedures.
Act as the liaison with affiliated departments to ensure 340B program integrity.
Lead the client 340B oversight committee, including members from leadership, pharmacy, compliance, legal, and finance.
Provide expertise, staff, and participants regarding ongoing compliance.
Develop and maintain internal relationships (accounting, legal, national) and external relationships (wholesalers, manufacturers, contract pharmacies, and third‑party administrator vendors).
Actively engage with client leadership and participate in decision‑making processes related to the implementation of new 340B processes.
Job Requirements
3+ years experience working in an FQHC 340B program.
Associate’s Degree required, Bachelor’s preferred.
340B university training required; additional Apexus certifications preferred.
Experience with EHR systems required; experience with eCW preferred.
Demonstrated team leadership in a 340B environment required.
Proficiency in Microsoft Suite.
Policy and Procedure Development
Ensure 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 legal department.
Establish 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 cost.
Education
Provide ongoing training, education, and communication in collaboration with pharmacy and medical team required for the 340B program at client.
Develop training/competency materials for all employees who work with the 340B program.
Assist in the development, implementation, or promotion of programmatic resource/tools to support staff.
Regularly communicate with all staff involved with the 340B program to be sure that processes remain efficient, to address any problems or suggestions for improvement.
Establish a clear way for staff to communicate concerns to the manager.
Rules/Guidance Surveillance
Monitor and assess 340B guidance and/or rule changes, including but not limited to HRSA/OPA rules and Medicaid changes. Attend regular 340B training and share lessons and hot topics with staff.
Routinely monitor industry publications and websites as well as the professional media, literature, and peers to ensure client has the latest information regarding interpretations, rulings, suggestions and advanced ideas for improving participation.
Ensure that the 340B pharmacy program is continuously compliant with 340B federal regulations.
Provide expertise on all 340B program legislation and policy changes from HRSA and OPA, informing and collaborating with legal and compliance teams.
Collaborate with the Prime Vendor Program, pharmacy leadership, and other 340B institutions to determine the most appropriate use of 340B program staff.
Registration/Recertification
Responsible for ensuring that the annual HRSA recertification is completed within the allowable time frame.
Responsible for ensuring that the HRSA 340B OPAIS (Office of Pharmacy Affairs Information System) is accurate for all organization entities.
Responsible for ensuring registration of any new associated sites are within the allowable time frame.
Self‑Audits
Develop, execute, and document self‑audits of the 340B process. Coordinate and ensure remediation of findings.
Conduct and/or coordinate and annual audit of all contract pharmacies. Document results and follow‑up on any findings.
Review and monitor 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 adequate system checks are reviewed to prevent billing issues.
Monitor utilization records and 340B purchasing accounts to ensure that software/tools are working properly and accurately, performing audits or compliance assessments internally as needed; coordinate external compliance assessments with outside firms, when appropriate, to validate internal processes.
Monitor 340B compliance within workflow processes.
Responsible for the day‑to‑day management, compliance review, and operations of clinic‑administered medications and prescriptions filled by 340B contract pharmacies.
Conduct monthly audits of all 340B‑eligible locations to verify adherence with the 340B Program guidelines/policies.
Ensure compliance with all aspects of the 340B Program and implement all applicable aspects of HRSA’s OPA guidance, as well as Clients policies and procedures.
Ensure that audits follow current regulatory compliance recommendations and are completed at the site level.
Ensure evaluations are completed for gaps at the site level and assist in providing the tools necessary to be compliant with the 340B Program.
Evaluate covered entity compliance at the contract pharmacy and wholesaler levels.
Perform annual independent compliance audits and report findings to responsible representatives at OUR CLIENTS.
Perform 340B purchasing and utilization audits or compliance assessments internally, as needed.
Routinely audit all 340B Programs to ensure compliance with regulations related to 340B purchasing.
External Audits
Serve as the point person and manager for all audits. Coordinate all requests and responses.
Maintain a current state of “audit readiness.”
Provide oversight for all audits performed by independent external auditors.
Coordinate external compliance assessments with outside firms, when appropriate, to validate internal processes.
340B Contract Management
Review and negotiate new 340B contracts/amendments. Maintain all 340B contracts.
Manage relationships, billing services, and compliance with contracted 340B pharmacies.
Evaluate all current and future contract pharmacy opportunities, including contract language, fee structure, data setup, and internal and external auditing.
Program Enhancement/Optimization
Assess opportunities for cost savings and business improvements in 340B contract pharmacy utilization.
Assess opportunities for cost savings and system improvements to yield higher compliance.
Oversee the 340B contract pharmacy marketing program to attract and retain qualified retail pharmacy contracts and serve eligible patients.
Analyze 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.
Work directly with drug manufacturers and wholesalers to develop strategies for appropriate use of the program.
Develop business plans to optimize and implement programs related to program services and contract pharmacy agreements.
Implement business plans in coordination with client pharmacy leadership to help use 340B savings to expand and improve care provided to underserved and vulnerable populations.
Provide oversight for the implementation of process improvement initiatives and create an environment that places an emphasis on continuous monitoring and improvement.
Reporting
Routinely monitor monthly and annual reports on 340B participation that clearly document utilization, savings, problem areas, and exceptions or discrepancies, to be passed on to pharmacy and finance leadership.
Develop routine reports that are a by‑product of the inventory process and software, allowing for concise information to be communicated to CLIENTS staff responsible for 340B inventory management.
Construct appropriate financial metrics to assess areas of improvement.
Prepare and assist in the monitoring and various tracking and reporting measurements to ensure compliance with the program.
Coordinate monthly financial reporting and analysis, including, but not limited to metric reporting, scorecards, and variance analysis.
Ensure that reporting meets CLIENTS, regional, national, state, and federal requirements.
Routinely communicate and question, issues or discrepancies with the appropriate authority.
Ensure appropriate documentation and audit trail across areas of responsibility.
Purchasing/Inventory Oversight
Monitors purchasing records for each 340B participant; clearly documents utilization, savings, problem areas, and exceptions or discrepancies. Relay results to pharmacy leadership.
Monitors for 340B pricing exclusions or shortages and established appropriate alternative products that are included when possible, including work with Pharmacy and Therapeutics Committee and OUR CLIENTS procurement staff.
Participates with the Prime Vendor and routinely review 340B formulary pricing and potential alternatives.
Manages and tracks 340B drug inventory, including proper replenishment.
Tracks 340B pharmaceutical sales and purchases data to ensure provider and patient eligibility.
Continuously monitor product min/max levels to effectively balance product availability and cost‑efficient inventory control.
Maintains system databases to reflect changes in the drug formulary or product specifications.
Ensures compliance with regulations related to 340B purchasing.
Routinely monitored 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 in collaboration with pharmacy leadership.
Third‑Party Administrator Software Maintenance
Maintains 340B TPA software integrity and reviews reports to identify areas for improvement.
Assists in implementing new software packages and other changes in business practice based on changing regulations/policies.
Works with pharmacy and informatics teams to ensure that the client’s clinical information system is coordinated and integrated into the work with the 340B Program. This shall include electronic interfaces between the EMR and the virtual accumulator and any interfaces between our client and contract pharmacies and/or administrators.
Compensation $120,000 – $125,000 per year.
Location New Haven, CT (Remote/Field option available).
#J-18808-Ljbffr