340B Compliance Program Manager
Reports to the Director, Pharmacy Business Operations. Responsible for overall operations and compliance of the 340B Program for Brown University Health. Responsible for managing registration and participation in the 340B Program for all 340B Covered Entities within Brown University Health and ensuring that use of 340B throughout the organization is compliant with Section 340B, and related interpretations, of the Public Health Service Act (1992) as administered by the federal Health Resources and Services Administration (HRSA) in the Department of Health and Human Services (DHHS). Responsible for achieving maximum utilization of 340B pricing through full 340B Program participation in all areas of qualified use meeting objectives defined by hospital leadership. Responsible for ensuring participation qualifications are met and maintained. Responsible for compliant medication procurement, billing and inventory management, and for prevention of diversion of 340B drugs. Responsible for monitoring, and assessing the potential institutional impact, of new and proposed 340B regulations and changes to 340B rulings and interpretations. Responsible for adherence to and maintenance of 340B related policies and procedures. Responsible for providing 340B Compliance Program updates and recommendations to Brown University Health's 340B Steering Committee. Responsible for identifying new 340B Contract Pharmacy business development opportunities and leading implementation. Conducts regular business reviews, both with business partners, and utilizing internal data, to maximize financial revenues, while ensuring maintenance of program compliance and quality of care. This position will be the primary business contact for any vendors participating in the program including, but not limited to: pharmacies, third-party administrators (TPAs), business support providers. Responsible for collaboratively working with pharmacy and other department leaders and executives to maximize compliant growth plans. Responsible for working with Pharmacy Business Operations team members for utilizing and/or developing standardized and timely reporting of financial results to Director of Pharmacy Business Operations, Chief Pharmacy Officer, or other leader or department as requested. Responsible for developing and leading execution of strategic plan for 340B Contract Pharmacy Program, including regular reporting of progress and results. Responsible for producing and submitting an annual budget for 340B Contract Pharmacy program and held accountable for it.
Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect and Excellence, as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate In addition, our leaders will demonstrate an aptitude for: Ensure Accountability and Build Effective Teams Drive Vision and Purpose and Optimize Work Processes By applying core and leadership competencies, leaders help Brown University Health achieve its strategic goals.
Principal Duties and Responsibilities:
Ensures that annual HRSA recertification is completed within the allowable timeframe, that HRSA and the Office of Pharmacy Affairs (OPA) information system is accurate for all covered entities, and that any new child site is registered within the allowable timeframe. Maintains knowledge and expertise on Section 340B rulings and related interpretations, including new and proposed regulations, current trends and issues. Monitors 340B guidance and rule changes and assesses potential organizational impact of 340B changes. Ensures the 340B Program is continuously compliant with 340B federal regulations. Maintains knowledge of policy changes that effect the 340B Program, including, but not limited to, HRSA/OPA rules and Medicaid changes. Informs 340B Steering Committee of same. Develops and/or updates 340B policies and procedures whenever there is clarification to interpretation, or change in the rules, regulations, or guidelines to 340B requirements. Reviews 340B policies and procedures annually. Shares expertise and provides training, education, and communication to staff and Program participants regarding 340B Program compliance. Establishes understanding and relationships with Finance and Information Services departments to monitor changes that could affect 340B qualification including changes in the points of service position on the Medicare cost report, changes in institutional ownership or related relationships (i.e. joint ventures, etc.) and changes or negative trends in disproportionate patient percentage under the Medicare Disproportionate Share Hospital adjustment. Ensures that written agreements between covered entities and contract pharmacy are in accordance with HRSA's Contract Pharmacy Services Guidelines (75 Fed. Reg. 10272, Mar. 5. 2010) and that auditable records are maintained to demonstrate compliance. Oversees compliance with 340B program requisites as delineated in strikeexisting/strike hospital and pharmacy department policies. Oversees all points of service where 340B participation occurs to ensure policies and procedures are followed, entities qualify, and patients qualify as covered patients. Oversees purchasing records for cost centers with 340B accounts to ensure the Group Purchasing Organization (GPO) exclusion rule is followed and that "cherry-picking" either by area, patient, or drug is not occurring. Oversees utilization and 340B purchasing records to ensure software and/or tools are functioning properly. Oversees the 340B Coordinator staff; including reviewing self-audits, establishing priorities, validating recommendations, and optimizing resource allocation. Oversees internal and external audits or compliance assessments, as needed and recommends and implements action plans to correct 340B compliance deficiencies, if indicated. Oversees audit data and related reports from each participating area or covered entity to st1:lists wt=onassure/st1:lists consistent processes are followed and to continually improve related policies and procedures for 340B throughout the institution. Develops, implements and leads the strategic plan for the 340B Contract Pharmacy program and identifies growth opportunities, develops business plans and implements strategies to grow the 340B Contract Pharmacy program. Thoroughly reviews all proposed new and renewal contracts for accuracy, appropriateness, compliance and benefit to Brown University Health.Coordinates with Brown University Health legal and contracting for execution. Performs regular (e.g. quarterly/semi-annualnnual) business reviews of Brown University Health Contract Pharmacy Agreements (CPAs) to ensure contracts are fulfilled and financial opportunities are maximized. Develops and presents executive-level reports, analyses and presentations as is necessary for reporting requests, request of resources, compliance concerns or any other business need. Develops quarterly and annual 340B participation reports and dashboards to clearly document utilization, savings, exceptions, or discrepancies and present to the 340B Steering Committee. Collaborates with prime vendor and pharmacy leadership to routinely review 340B formulary pricing, potential alternatives, and possible additional savings as a result of GPO formulary and 340B prime vendor program. Works directly with manufacturers as well as through GPO and peer professional relationships to determine companies that offer 340B or equivalent pricing and develop strategies to st1:lists wt=onmaximize/st1:lists such participation. Collaborates with the Pharmacy Information Systems/Technology Team and Brown University Health Information Services changes for new st1:lists wt=onproducts/st1:lists, st1:lists wt=onproduct/st1:lists changes, etc., that st1:lists wt=oninsure/st1:lists both the accuracy of the utilization report and the efficiency and accuracy of the charge process. Collaborates with Pharmacy Finance Manager, Pharmacy Finance team and Brown University Health Finance team to ensure accuracy and quality of financial data reported, as it relates to the 340B program.Scrutinizes data and provides business reasons for trends as well as instituting any necessary corrective action plans. Collaborates with the Manager, Pharmacy Supply Chain; Manager, Safety, Quality and Informatics; and Brown University Health Information Services to maintain computerized systems, split-billing software programs and specialized equipment and technologies utilized in operations related to the 340B Program. Maintains knowledge and expertise on Section 340B rulings and related interpretations, including new and proposed regulations, current trends and issues. Monitors 340B guidance and rule changes and assesses potential organizational impact of 340B changes. Maintains knowledge of policy changes that effect the 340B Program, including, but not limited to, HRSA/OPA rules and Medicaid changes. Informs 340B Steering Committee of same. Attends national 340B conferences; routinely monitors 340B Health, Apexus, and Office of Pharmacy Affairs (OPA) publications and websites as well as the professional media, literature, and peers to st1:lists wt=onassure/st1:lists the institution has the latest information regarding interpretations, rulings, suggestions, and advanced ideas for improving participation. Effectively and continually maintains open lines of communication with all staff and management involved with the 340B program. Provides timely and accurate communication, both written and verbal as appropriate, regarding changes and continuous quality improvement activities, including goals and objectives of the 340B program. Designs, implements, and participates in continuous quality improvement activities and initiatives. Leads and participates in various committees, and performance improvement teams as assigned. Prepares monographs for presentation at professional organization meetings, submits manuscripts for publication in professional
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