Director 340B Program

North Penn Comprehensive Health Services

Job Description

Program Director, 340B Program

Primary Location: Hybrid/Mansfield, PA

Reports To: Chief Financial Officer

Schedule: Full-Time, EXEMPT

Role Objective:

The 340B Program Director will: serve as the covered entity’s compliance expert on 340B Program details, policies, and procedures; act as the liaison with necessary affiliated departments to ensure 340B Program integrity; provide oversight and leadership from the department of pharmacy for the 340B Program; lead the covered entity’s 340B oversight committee, which includes members from senior leadership, pharmacy, compliance, legal, and finance; provide expertise with the 340B Program to staff and participants regarding ongoing compliance; develop and maintain 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) vendors) as needed; actively engage with senior leadership and participate in decision-making processes related to the implementation of new 340B processes

Responsibilities:

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.
• 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 costs.

Education

• 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 Program.
• May assist in the development, implementation, or promotion of programmatic resources/tools to support staff.
• Regularly communicates with all staff involved with the 340B Program to be sure that processes remain efficient and to address any problems or suggestions for improvement.
• Establish a straightforward way for staff to communicate concerns to the coordinator.

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 training courses 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 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.
• 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.

Registration/Recertification

• Responsible for ensuring that the annual HRSA recertification is completed within the allowable time.
• Responsible for ensuring that the HRSA 340B OPAIS is accurate for all organization entities.
• Responsible for ensuring registration of any new associated sites is within the allowable time.

Self-Audits

• 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.
• Assists in managing and troubleshooting pharmacy billing issues and ensuring that adequate systems checks are reviewed 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 340B compliance within workflow processes.
• Responsible for compliance review and operations of clinic-administered medications in eligible locations, outpatient prescriptions fulfilled by an owned pharmacy, and outpatient prescriptions fulfilled by a contract 340B pharmacy.
• Ensures compliance with all aspects of the 340B Program and implements all applicable aspects of HRSA’s Office of Pharmacy Affairs guidance, as well as organizational 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 contract pharmacy, covered entity, and wholesaler levels.
• 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.

340B Contract Management

• Evaluates any new 340B contracts. Maintains all 340B contracts.
• Manage 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.

Program Enhancement/Optimization

• Assesses opportunities for cost savings and business improvements in 340B contract pharmacy utilization.
• Assesses opportunities for cost savings and system improvements to yield higher compliance.
• 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.
• Develops action plans to close identified gaps in collaboration with organizational leadership.
• 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 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.
• Prepares and assists in the monitoring and various tracking and reporting measurements to ensure compliance with the program.
• Coordinates monthly financial reporting and analysis, including, but not limited to, metric reporting, scorecards, and variance analysis and reporting.
• Ensures that reporting meets organizational, regional, national, state, and federal requirements/guidelines.
• Maintains records related to job function and contributes to reports.
• 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.

Purchasing/Inventory Oversight

• Monitors purchasing records for each 340B participant; clearly documents utilization, savings, problem areas, and exceptions or discrepancies. Relays results to pharmacy leadership.
• Participates with the Prime Vendor and routinely reviews 340B formulary pricing and potential alternatives.
• 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.
• 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.

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 and policies.
• Is responsible for maintenance and testing of tracking software.
• Works with pharmacy management and 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.

Qualifications:

• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Must be dependable and extremely trustworthy.
• Able to effectively communicate with personnel from diverse backgrounds.

Education and Experience:

Master’s degree (preferred) in:

• Healthcare Administration (MHA)
• Public Health (MPH)
• Business Administration (MBA)
• Pharmacy (PharmD)
• Health Policy or Health Management

Bachelor’s degree required in one of the following (or a closely related field):

• Healthcare Administration
• Public Health
• Pharmacy
• Business Administration
• Health Information Management
• Nursing (BSN)
• Finance or Accounting (with healthcare experience)

Pharmacy-Specific Education (Optional)

• PharmD or RPh (active or prior licensure), OR
• Equivalent education combined with substantial 340B/pharmacy operations experience

Physical Requirements:

• Non-Clinical Patient Care

Licensure, Certifications, and Clearances:

• Apexus 340B University Certificate (preferred)
• Certified Pharmacy Technician (CPhT) – if applicable
• Healthcare compliance–related certifications (preferred)
• CPR
• Driver’s License
• Act 33
• Act 34
• Act 73

Equal Employment Opportunity Statement

North Penn Comprehensive Health Services is an Equal Opportunity Employer. We are committed to providing a workplace free from discrimination and harassment and to fostering an inclusive environment that values diversity among our workforce

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Relocation assistance
• Retirement plan
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• 340B/Pharmacy Operations: 5 years (Preferred)

License/Certification:

• Driver's License (Required)
• PharmD or RPH Licensure (Preferred)

Willingness to travel:

• 50% (Required)

Work Location: Hybrid remote in Mansfield, PA 16933