Serves as the primary program coordinator and liaison for 340B-related matters. Serves as the covered entity's compliance expert on 340B Program details, policies, and procedures. Acts as the liaison with necessary affiliated departments to ensure 340B Program integrity. Provides oversight and leadership from the department of pharmacy for the 340B Program. Leads the organization's 340B oversight committee, which includes members from senior leadership, pharmacy, compliance, legal, and finance. Provides expertise with the 3408 Program to staff and participants regarding ongoing compliance. Develops and maintains 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].
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
-
Regularly communicates with all staff involved with the 3408 Program to be sure that processes remain efficient and to address any problems or suggestions for improvement.
- 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.
-
Ensures that the 3408 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.
Responsible for ensuring that the annual HRSA recertification is completed within the allowable time frame.
- Responsible for ensuring that the HRSA 340B OPAIS is accurate for all organization
- Responsible for ensuring registration of any new child sites within the allowable time
-
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.
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.
Evaluates 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.
- Evaluates covered entity compliance at the contract pharmacy, covered entity, and wholesaler levels.
- Maintains a current state of "audit readiness."
-
Works with medical auditors on third-party payer audits to ensure coordination of efforts and maximum collection.
- Provides oversight for all audits performed by independent external auditors.
- Reviews and negotiates any new 340B contracts. Maintains all 3408 contracts.
-
Manages 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.
Works directly with manufacturers, as well as through GPO and peer professional relationships, …
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 manufacturers as well as wholesalers to develop strategies for appropriate use of the program.
Integrates information from the pharmacy chargemaster system into the 340B split-billing computer system and incorporates that information into auditable and compliant processes.
Works with outpatient pharmacy management and pharmacy informatics teams to ensure that the organization's clinical information system is coordinated and integrated into the work with the 3408 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.
Ensures split-billing software integrity and reviews applicable reports for areas of improvement.
- Charges are coming across accurately, and the utilization numbers are translating accurately into report for 340B reorders.
- Oversees split-billing software maintenance.