Mgr 340B Compliance Program

Reports to the Manager Pharmacy Business Operations.  Responsible for managing registration and participation in the 340B Program for all 340B Covered Entities within Lifespan and for assuring that all use of 340B throughout the organization is fully and continuously 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 to meet objectives defined by hospital leadership.  Responsible for assuring 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 Lifespan�s 340B Steering Committee



Ensures that annual HRSA recertification is completed within the allowable timeframe that HRSA 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.
Monitors compliance with 340B program requisites as delineated in existing hospital and pharmacy department policies including but not limited to:
340B Drug Pricing Program (PH-211)
340B Drug Pricing Program - Mixed-Use Pharmacy (PH-216)
340B Program Compliance � Contract Pharmacy (PH-218)
340B Steering Committee (PH-223)
340B Self-Monitoring (PH-328)
340B Program Compliance - Lifespan Pharmacy (PH-573)
Monitors all points of service where 340B participation occurs to insure policies and procedures are followed entities qualify and all patients qualify as covered patients.
Monitors purchasing records for cost centers with 340B accounts to insure the GPO exclusion rule is followed and that �cherry-picking� either by area patient or drug is not occurring.
Monitors utilization and 340B purchasing records to insure software and/or tools are functioning properly. 
Oversees the 340B Coordinator staff; including reviewing self-audits establishing priorities validating recommendations and optimizing resource allocation.
Performs internal audits or compliance assessments as needed.
Recommends and implements action plans to correct 340B compliance deficiencies if indicated.
Recommends and implements action plans to correct 340B compliance deficiencies if indicated
Coordinates external audits and compliance assessments with outside consulting firms to validate internal processes as needed.
Monitors all areas of 340B outpatient use collaborates with key stakeholders to insure maximum participation regarding use of 340B priced products in all qualified outpatient settings. 
Develops quarterly and annual 340B participation reports and dashboards to clearly document utilization savings exceptions or discrepancies; present to 340B Steering Committee.

Develops and maintains listing and profiles on the application of 340B related savings to fund programs and services for the covered entity.

Coordinates quarterly 340B Steering Committee meetings.

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 maximize such participation. 

Collaborates with the Pharmacy Information Systems/Technology Team and Lifespan Information Services on CDM/crosswalk changes for new products product changes etc. that insure both the accuracy of the utilization report and the efficiency and accuracy of the charge process.

Performs audits or compliance assessments periodically of specific areas and specific products to assure the CDM is accurate the charges are coming across to accounting accurately and that the utilization numbers are translating accurately into the report for 340B reorders.

Monitors data and related reports from each participating area or covered entity to assure consistent processes are followed and to continually improve related policies and procedures for 340B throughout the institution.
Maintains computerized systems split-billing software programs and specialized equipment and technologies utilized in operations related to the 340B Program in collaboration with the Manager Pharmacy Business Operations and Lifespan Information Services.
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 assure 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.
Participates in continuous quality improvement activities and initiatives.  Participates in or leads various committees and performance improvement teams as assigned.
Prepares monographs for presentation at professional organization meetings submits manuscripts for publication in professional journals and authors articles for the Pharmacy web site.
Completes other administrative duties as assigned.


Other information:

Bachelor of Science or Bachelor of Arts degree in business or health related field required.  A Master's degree in Business Administration Hospital Administration or Pharmacy or Doctorate of Pharmacy degree highly preferred.
Current pharmacist licensure in the State of Rhode Island if applicable.
Excellent interpersonal and presentation skills. Ability to provide targeted communication both verbal and written to internal and external constituents

Proficient in the use of microcomputers and a variety of spreadsheet and database applications including Microsoft Office Word Excel and Access as well as presentation software including PowerPoint. 

Knowledge and ability to download import and merge information from a variety of sources platforms and programs.
Proven analytical and process redesign skills including but not limited to problem solving quantitative reasoning workflow process etc.

3-5 years of 340B Compliance Program experience in healthcare and/or with a healthcare provider is preferred.

Extended periods of time spent sitting standing and walking.  Requires the visual and manual dexterity to operate a computer.

Performs independently within department policies and practices.
Refers specific complex problems to supervisor where clarification of departmental policies and procedures may be required.
Less than 5 direct reports.


Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Lifespan is a VEVRAA Federal Contractor.


Location: Rhode Island Hospital USA:RI:Providence


Work Type: Full Time


Shift: Shift 4


Union: Non-Union