Program Director

Job Description Summary:

Job Description:

The 340B Program Director is responsible for leadership of the pharmacy 340B drug discount program for all qualified entities, CHC pharmacies, external vendors, and between the contracted pharmacies. Such leadership and coordination includes ensuring compliance with all federal regulations and related interpretations, ensuring the program is fully implemented in all areas of qualified use, and ensuring records and documentation are complete and accurate. The Director is responsible for data analysis to enable CHCI, its patients and pharmacy customers to receive maximum benefit from the 340B program.

340B Program Director General Duties

• Serves as CHCI’s compliance expert on 340B Program details, policies and procedures.
• Acts as the liaison with necessary affiliated departments and CHC pharmacies to ensure 340B Program integrity.
• Leads CHCI’s 340B oversight committee, which includes members from leadership, pharmacy, compliance, legal and finance.
• Provides expertise with the 340B Program to staff and participants regarding ongoing compliance.
• Develops and maintains internal relationships: Medical (CMO/CNO/CPO, pharmacy management), Finance, Operations and Legal, as well as external relationships (wholesalers, manufacturers, contract pharmacies, and third-party administrator (TPA) vendors) as needed.
• Actively engages with CHCI leadership and participates in decision-making processes related to the implementation of new 340B processes.

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 CHCI’s 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

• Provides ongoing training, education and communication in collaboration with pharmacy and medical team required for the 340B Program at CHCI.
• Develops training/competency materials for all employees who work with the 340B Program. 
• May assist in the development, implementation, or promotion of programmatic resource/tools to support staff.
• Regularly communicates with all staff involved with the 340B Program to be sure that processes remain efficient to address any problems or suggestions for improvement.
• Establishes a clear way for CHCI staff to communicate concerns to the manager.

Regulatory Surveillance and Compliance

• Monitors and assesses 340B regulations, guidance and /or rule changes, including, but not limited to HRSA/OPA rules and Medicaid changes. Ensure ongoing compliance with all applicable requirements
• Attends regular 340B training and shares lessons and hot topics with staff.
• Routinely monitors industry publications and websites as well as the professional media, literature, and peers to ensure CHCI has latest information regarding interpretations, rulings, suggestions and advanced ideas for improving participation.
• 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 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

• Develops, executes, and documents self-audits of the 340B process. Coordinates and ensures remediation of findings.
• Conducts and/or coordinates and annual audit of all CHC and 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 adequate system checks are reviewed to prevent billing issues.
• Monitors utilization records and 340B purchasing accounts to ensure that software/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 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 CHC and contract pharmacies.
• Conducts monthly audits of all 340B-eligible locations to verify adherence with the 340B Program guidelines/policies.
• Ensures compliance with all aspects of the 340B Program and implements all applicable aspects of HRSA’s OPA guidance, as well as CHCI’s policies and procedures. 
• Ensure that audits follow current regulatory compliance recommendations and are completed at the site level.
• Ensures evaluations are completed for 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 CHC and contract pharmacy and wholesaler levels. 
• Performs annual independent compliance audits and reports findings to responsible representatives at CHCI. 
• 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.

External Audits

• Serves as the point person and manager for all audits. Coordinates all requests and responses.
• Maintains a current state of “audit readiness”
• Provides oversight for all audits performed by independent external auditors. 
• Coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.

340B Contract Management

• Reviews and negotiates and new 340B contract/amendment. Maintains all 340B contracts.
• Manage relationships, billing services, and compliance with CHC and contracted 340B pharmacies.
• Evaluates all current and future CHC and contract pharmacy opportunities, including contract language, fee structure, data setup, and internal and external auditing.

Program Enhancement/Optimization

• Assesses opportunities for cost savings and business improvements in 340B CHC and contract pharmacy utilization.
• Assesses 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.
• 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 drug manufacturers and wholesalers to develop strategies for appropriate use of the program.
• Develops business plans to optimize and implement programs related to program services and contract pharmacy agreements.
• Implements business plans in coordination with CHCI pharmacy leadership to help use 340B savings to expand and improve care provided to underserved and vulnerable populations.
• Provides oversight for the implementation of process improvement initiatives and creates an environment that places an emphasis on continuous monitoring and improvement. 

Reporting

• 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 and finance leadership.
• Develops routine reports that are a by-product of the inventory process and software, allowing for concise information to be communicated to CHCI staff 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.
• Coordinated monthly financial reporting and analysis, including, but not limited to metric reporting, scorecards, and variance analysis. 
• Ensures that reporting meets CHCI, regional, national, state, and federal requirements.
• Routinely communicates and questions, issues or discrepancies with the appropriate authority.
• Ensures 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 CHCI procurement staff.
• Participates with the Prime Vendor and routinely reviews 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 monitors 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 CHCI 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 CHCI and contract pharmacies and/or administrators.

Job Requirements

• 5+ Years experience working in an FQHC 340B program
• Bachelor Degree or equivalent required
• 340B University Training Required, additional Apexus Certifications preferred
• Experience with EHR systems required, experience with eCW preferred
• Demonstrated team leadership in 340B environment required
• Proficiency in Microsoft Suite

This Position is available for remote work.

Organization Information:

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