340B Program Manager - #19503101

Connecticut Children's Medical Center

Date: Dec 25, 2020
City: Hartford, CT
Contract type: Full time
Connecticut Children's Medical Center

The 340B Program Coordinator will serve as the liaison for 340B-related matters and the covered entity's compliance expert on 340B Program details, policies, and procedures. This individual will work with all necessary departments and stake holders to ensure 340B Program integrity. The 340B Program Coordinator must develop and maintain the internal (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) needed to ensure 340B Program oversight and compliance. As part of their compliance duties, this individual will lead the organization's 340B oversight committee, which includes members from senior leadership, pharmacy, compliance, legal, and finance. The 340B Program Coordinator will also provide 340B expertise and education to staff and participants regarding ongoing compliance.


Position Specific Role Responsibilities

  1. 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.

  1. Education

  • 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.

  1. 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 trainings and shares lessons and hot topics with staff.

  • Provides expertise on all 340B Program legislation and policy changes from HRSA and OPA, informing and collaborating with legal and compliance teams.

  1. 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 is accurate for all organization entities.

  • Responsible for ensuring registration of any new child sites within the allowable time frame.

  1. 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.

  • 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.

  • 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.

  • 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 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.

  • Performs 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 340B purchasing.

  1. External Audits

  • Provides oversight for all audits performed by independent external auditors.

  • Coordinates external compliance assessments with outside firms, when appropriate, to validate internal processes.

  • Serves as the point person and coordinator for all audits. Coordinates all requests and responses.

  1. 340B Contract Management

  • 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, to determine companies that are contracting with inpatient facilities to offer 340B or equivalent pricing and develops strategies to maximize such participation.

  1. Program Enhancement/Optimization

  • 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.

  • Implements business plans in coordination with organizational pharmacy leadership to help use 340B savings to expand and improve care provided to underserved and vulnerable populations.

  • Monitors all outpatient points of service to continually check for new areas that may qualify for the 340B Program.

  • Provides oversight for the implementation of process improvement initiatives and creates an environment that places an emphasis on continuous monitoring and improvement.

  1. 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.

  • Participates in the development and implementation of reports generated on the 340B Program that outline savings, utilization, exceptions, and discrepancies.

  • Develops, monitors, and presents reports on 340B participation that clearly document utilization, savings, problem areas, exceptions, and/or discrepancies to pharmacy and administrative leadership.

  • Ensures appropriate documentation and audit trail across areas of responsibility.

  1. Purchasing/Inventory Oversight

  • Monitors for 340B pricing exclusions or shortages and establishes appropriate alternative products that are included when possible, including work with medical staff and formulary to ensure proper position and related use.

  • Participates with the Prime Vendor and routinely reviews 340B formulary pricing, potential alternatives, and possible additional savings as a result of GPO formulary.

  • Routinely monitors utilization records and 340B purchasing accounts to ensure that software or tools are working properly.

  1. Split-Billing or Third-Party Administrator Software Maintenance

  • Establishes a routine approach to updating the CDM/crosswalk for new products and product changes to ensure both the accuracy of the utilization report and the efficiency and accuracy of the charge process.

  • Maintains 340B split-billing software integrity and reviews applicable reports to identify areas for improvement.

  • Ensures split-billing software integrity and reviews applicable reports for areas of improvement.

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