Senior Manager of 340B Compliance

Position Summary

The Director of 340B Compliance is responsible for supporting Damien Center’s compliance with the Health Resources and Services Administration (HRSA) 340B Drug Pricing Program requirements. Key areas of responsibility include:

• Maintaining accurate program records and documentation.
• Preventing duplicate discounts and diversion.
• Managing program participation and related compliance activities.
• Implementing policies and processes that maximize program benefits while protecting program integrity.

Duties And Responsibilities

This job description describes the general nature and level of work performed by employees assigned to this position. It should not be construed as an exhaustive list of all required duties, responsibilities, and skills.

Regulatory Knowledge and Risk Monitoring

• Maintain current knowledge of 340B statute, HRSA guidance, and applicable contract pharmacy regulations.
• Monitor manufacturer policy requirements, program developments, and emerging changes that may affect 340B operations.
• Track the impact of the Inflation Reduction Act (IRA) on drug pricing, reimbursement, and 340B program requirements.
• Identify potential compliance, operational, or financial risks within Damien Center’s 340B Program.

Program Compliance and Audit Readiness

• Ensure Damien Center’s 340B Program always remains audit-ready.
• Develop, review, and update 340B policies and procedures annually and whenever program rules, regulations, guidelines, or interpretations change.
• Oversee all points of service related to 340B participation to confirm policies are followed, entities qualify, and patients meet covered-patient criteria.
• Ensure written agreements between covered entities and contract pharmacies align with HRSA Contract Pharmacy Services Guidelines and maintain supporting records to demonstrate compliance.
• Review contract pharmacy purchases against dispense data to verify accuracy and identify discrepancies.
• Ensure manufacturer reporting requirements are completed accurately and submitted on time each month.
• Oversee proper processing of 340B claims related to IRA Maximum Fair Price (MFP) requirements.
• Recommend and implement corrective action plans to address 340B compliance deficiencies.
• Cook up the annual external audit process, including vendor selection and audit preparation.

Finance, Analytics, and Program Optimization

• Oversee contract pharmacy third-party administration reporting systems and related requirements.
• Lead internal audit activities by monitoring eligibility requirements, validating data, and identifying opportunities for improvement.
• Parellel with the Chief Pharmacy Officer to identify opportunities for 340B savings optimization.
• Collaborate with the finance department to monitor contract pharmacy economics and financial performance.
• Oversee manufacturer rebate, refund, and repayment processes.

Team Leadership, Training, and Reporting

• Provide oversight and direction to members of the 340B management team, including setting priorities, validating recommendations, and optimizing resource allocation.
• Deliver ongoing 340B compliance training to ensure staff understand and follow required procedures.
• Prepare reports for stakeholders as needed and coordinate 340B Internal Committee meetings.

Other Responsibilities

• Perform special assignments and other duties as needed.

Education And/or Experience

• Bachelor’s degree in Pharmacy, Health Administration, Business Administration, Finance, Nursing, Healthcare Compliance, or related field required.
• Minimum of 5 years healthcare experience with at least 3 years of 340B program experience.
• 340B ACE certification preferred or must be obtained within one year of hiring.

Knowledge, Skills, And Abilities

• Possess superior organizational and administrative skills.
• Excellent interpersonal and communication abilities.
• Excellent computer skills in a Microsoft Windows environment.
• Ability to work independently and achieve high standards of productivity, achieving deadlines, and with superior product results.
• Strong calendaring, organizational, and document management skills are required.
• Proactive approach to solving problems and communicating to leadership.
• Knowledge of office management systems, procedures, and office equipment required.
• Excellent time management skills and ability to prioritize work.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential job function satisfactorily. The requirements listed are representative of the general knowledge, skills, and/or abilities required.

Physical Demands

• The physical demands described here are general representations of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Leadership, Training, and Reporting

• Provide oversight and direction to members of the 340B management team, including setting priorities, validating recommendations, and optimizing resource allocation.
• Deliver ongoing 340B compliance training to ensure staff understand and follow required procedures.
• Prepare reports for stakeholders as needed and coordinate 340B Internal Committee meetings.