Pharmacy Regulatory Analyst

Position Purpose

At the direction of Pharmacy Leadership this position will perform regular internal audit of the 340B program to ensure program compliance and to identify revenue improvement opportunities.

This position will act as the liaison with necessary affiliated departments to ensure 340B Program integrity.

Additionally, the position is expected to 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.

The 340B Program Analyst will actively engage with Pharmacy leadership and participate in decision-making processes related to the implementation of new 340B processes.

• 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.
• 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.

• 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 and Pharmacy leadership.
• 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.
• Identifies program gaps with escalation to 340B Steering Committee.

• 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 identification of pharmacy billing issues and ensuring that adequate systems checks are in place 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 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.
• 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 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.
• Organizes annual independent compliance audits and reports findings to responsible representatives at the organization.
• Performs 340B purchasing and utilization audits or compliance assessments internally, as needed.
• Routinely audits all 340B programs to ensure compliance with regulations related to…