Pharmacy 340B Program Coordinator - Pharmacy- FT exempt

Washington Hospital•Fremont, CA

28d•$92,000 - $133,000•Onsite

About The Position

The Pharmacy 340B Coordinator, under the direction of the Director of Pharmacy, is responsible for the daily administration, analysis, and operation of the 340B Drug Program and all its components, including compliance with program regulations. This role ensures continuous compliance with 340B federal regulations.

Requirements

California State Board of Pharmacy Technician Registration and Pharmacy Technician National Certification, maintained in active status and available for primary source verification.
Certification from Apexus 340B University course required within 3 months of hire; maintains current knowledge as Apexus and HRSA guidance is updated.
Two (2) year degree (or expected completion within one (1) year) or better.
Completes hospital orientation, initial competency assessment, and all required annual compliance education (including HIPAA, workplace violence prevention, and safety) within required timeframes.

Nice To Haves

Bachelors’ degree in science or finance or MBA preferred
Apexus Certified Expert (ACE) 340B credential preferred.
Working knowledge of 340B Drug Program and contract pharmacy operations preferred. Familiar with 340B split billing software and configurations.
Two years of pharmacy purchasing and inventory management experience or related experience preferred.
Ability to use Microsoft Office products including Excel, Word, and Outlook.
Critical thinking skills are imperative for the analysis of 340B program.
Ability to analyze, understand, and use statistical and financial report data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Leadership skills are required to effectively implement changes throughout the organization to improve the 340B program.
Must have good organization skills, work independently and prioritize multiple projects and objectives in a rapidly changing environment.
Working knowledge of duplicate discount prevention across Medicaid fee-for-service and managed care, and of Medicare Part B and Part D 340B billing and reporting requirements, preferred.
Familiarity with manufacturer contract pharmacy restriction policies, manufacturer claims data submission platforms, and rebate model designs preferred.

Responsibilities

Manages the daily administration, analysis, and operation of the 340B Drug Program and all its components, including compliance and program regulations.
Ensures that the 340B program is continuously compliant with 340B federal regulations.
Reviews policies and procedures to ensure effectiveness and compliance with state and federal regulations related to 340B program management and contract pharmacy operations.
Serves as the primary internal and external program coordinator and institutional compliance expert for all 340B-related matters regarding program details, policies, and procedures of virtual inventory processes required for mixed-use areas.
Acts as the liaison with necessary affiliated departments to ensure 340B program integrity.
Provides oversight and leadership for the 340B program from the department of pharmacy.
Co-chairs the organization’s 340B oversight team, which includes representation from pharmacy, legal, compliance, finance, and senior administration.
Provides expertise and education to the 340B program with staff and participants regarding ongoing compliance.
Develops and maintains internal and external relationships with wholesalers, manufacturers, contract pharmacies, split-billing software vendors, employee benefit pharmacy benefits managers (PBMs), and third-party administrator (TPA) vendors.
Acts as a liaison to the department of pharmacy and regional facilities, as well as with the organization’s purchasing office.
Actively engages with senior leadership and participates in decision-making processes related to the implementation of new 340B processes.
Takes a lead role in the development, planning, and integration efforts related to the 340B program.
Ensures that policies and procedures are developed and implemented according to organizational, regional, national, state, and federal requirements and guidelines and are approved by appropriate committees and the legal department.
Completes and ensures regular compliance with the audit program and recommendations from 340B consultants.
Contributes processes and materials to promote programs or support the goals of the department and institution.
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.
Develops and modifies 340B policies in accordance with state, federal, and system program requirements as needed.
Responds to all requests regarding 340B activities.
Collaborates with 340B contract pharmacy vendors and pharmacy wholesalers to support the contract pharmacy network as needed to maximize operational efficiency.
Provides problem resolution and appropriate follow-up with the vendor and wholesalers when necessary.
Maintains a collaborative relationship with contract pharmacies and provides timely resolution and/or communication of any issues.
Serves as the primary link between wholesale distributors, contract pharmacies, manufacturers, legal counsel, prime vendor program, supply chain, 340B Health, split-billing software vendor, HRSA/OPA, pharmacy leadership, and others as it relates to the operation and management of contract and 340B program business to ensure compliance.
Coordinates 340B needs with the buyer and Pharmacy IT.
Reviews and provides recommendations to pharmacy leadership on pharmacy contracting and other 340B opportunities and strategies while assessing the impact from a financial, clinical, and operational perspective.
Maintains the mapping of the split-billing software, works to ensure 340B drug purchases maximize pharmaceutical cost savings, and works in conjunction with Revenue Integrity to investigate, correct, and modify any billing NDC discrepancies and pricing issues.
Assists Pharmacy Buyer and Pharmacist, as needed, for GPO/WAC/340B purchase determination and preparing invoices and purchasing/financial reports.
Manages and tracks 340B drug inventory, proper replenishment, exclusions, shortages, and establishes appropriate alternative products.
Designs an efficient process to reconcile any issues with drug ordering, delivery, and payment.
Remains informed of changes in policies or procedures, 340B-related legislation, articles, white papers, and document briefs that could affect the program structure.
Assures appropriate safeguards and 340B integrity.
Develops and monitors standard operating procedures for the 340B program in its entirety and contract pharmacies as needed.
Works with contract pharmacies to develop standard operating procedures for 340B multiple contract pharmacy processes as needed.
Provides periodic reports to the Director of Compliance regarding adherence to 340B, audit results (internal and external), effectiveness, and regulatory updates.
Tracks, trends, and reports 340B pharmaceutical sales and purchases data to ensure provider/physician and patient eligibility.
Maintains the accuracy and completeness of the hospital’s records in the 340B Office of Pharmacy Affairs Information System (OPAIS), including covered entity, child site, and contract pharmacy registrations; completes annual recertification within the HRSA-designated period and submits registrations and change requests within the applicable registration windows.
Administers duplicate discount prevention for Medicaid, including carve-in/carve-out decisions, Medicaid Exclusion File entries and billing identifiers, Medicaid managed care arrangements, and state-specific billing and modifier requirements, including Medi-Cal.
Coordinates nonduplication between 340B and the Medicare Drug Price Negotiation Program, verifying that selected drugs are acquired at the lower of the 340B ceiling price or the maximum fair price (MFP) and that no unit receives both discounts; supports enrollment of dispensing pharmacies with the Medicare Transaction Facilitator (MTF) and reconciliation of retrospective MFP refunds.
Evaluates and, where the hospital elects to participate, coordinates submission of Part D 340B claims data to the CMS Medicare Part D Claims Data 340B Repository, and maintains readiness for expanded or mandatory 340B claims data reporting.
Monitors the status of manufacturer rebate models and any HRSA rebate model pilot, maintaining operational and financial readiness to submit claim-level data, model cash flow impact, and reconcile rebates should such models take effect.
Tracks manufacturer contract pharmacy restriction policies and associated data submission requirements; maintains required pharmacy designations, evaluates the financial impact of each policy, and escalates access issues to pharmacy, finance, and legal leadership.
Verifies 340B ceiling prices against HRSA-published pricing, identifies suspected overcharges, and pursues credits or refunds from manufacturers and wholesalers, escalating unresolved matters for consideration under HRSA’s administrative dispute resolution (ADR) process.
Monitors federal and California legislative, regulatory, and litigation developments affecting 340B eligibility, contract pharmacy access, PBM reimbursement practices, and provider reporting obligations, and advises leadership on operational and financial impact.
Communicates effectively verbally and in writing, with good presentation skills, team building and educational teaching skills to provide ongoing training for the 340B program.
Works effectively with a variety of personnel with backgrounds varied in education and skill sets.
Functions as a team leader.
Has good negotiation skills and is able to interact with internal staff, system vendors, and outside consultants in a professional, effective method.
Reports savings of the program (monthly, quarterly, etc.).
Assesses opportunities for cost savings and business improvement in 340B contract pharmacy utilization and prepares statements for this purpose as needed.
Collaborates with departments, sites, and staff representatives to communicate improvements and promote broad participation in 340B activities across the organization.
Leads and facilitates priority 340B projects to the final outcome.
Assists Pharmacy Director and CFO with HRSA and manufacturer audits.
Performs quality assurance audits on all aspects of the organization’s 340B program on a continuous basis including contract pharmacy operations, financial transactions, and patient and provider qualifications.
Evaluates OPA database accuracy for eligible sites and compliance.
Reviews 340B purchase history to ensure that drugs being purchased on 340B accounts are drugs being utilized accurately for outpatient use.
Evaluates 340B inventory replenishment to confirm that accumulation, reduction, and reconciliation are occurring as expected.
Prepares audit findings, reports, graphs, and charts of data analysis and delivers presentations to work group committee on a regular basis.
Prepares conclusions, predictions, and develops recommendations based on research to track and manage essential aspects of the program and make improvements and/or ensure compliance.
Monitors changes that have been made per recommendations to evaluate success and suggests further improvements based on results.
Serves as the hospital’s primary contact for HRSA and manufacturer audits, coordinating document production, sampling responses, corrective action plans, and any required self-disclosure and repayment to affected manufacturers.
Conducts and documents self-audits at a frequency and scope sufficient to demonstrate program integrity, covering patient and provider eligibility, child site and contract pharmacy compliance, the GPO prohibition and orphan drug exclusion as applicable to the hospital’s covered entity type, and duplicate discount prevention.
Assesses opportunities for cost savings and system improvements to yield higher compliance.
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 the manufacturers as well as the wholesalers to develop strategies for appropriate use of the program.
Participates in projects, councils, and special initiatives related to 340B, compliance, auditing functions, vendor selection, and medication management.
Develops business plans to prioritize and implement programs related to program services and contract pharmacy agreements.
Develops action plans to close identified gaps in collaboration with organizational leadership.
Participates in projects, councils, and special initiatives related to 340B.
Implements business plans in coordination with 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.
Participates in departmental performance improvement activities.
Integrates information from the pharmacy charge master system into the 340B split-billing systems and incorporates that information into auditable and compliant processes.
Contributes 340B program data, audit results, and corrective action outcomes to the hospital’s performance improvement program and supports continuous survey readiness between survey cycles.
Maintains knowledge of the policy and standards changes that affect the 340B program, including, but not limited to, HRSA/OPA rules, Medicaid changes, and Joint Commission Accreditation 360 standards and National Performance Goals.
Provides expertise on all 340B program legislation and policy changes from HRSA and OPA, informing and collaborating with legal and compliance teams.
Maintains licensure/certification in active status and supplies documentation required for primary source verification of credentials.
Completes competency assessment at orientation and at least once every three years, or more frequently as determined by the organization.
Participates in ongoing education and training necessary to maintain or increase competence, including 340B-specific training.
Attends and completes all required health and safety classes, updates, and health screenings/testing.
Seeks out opportunities to learn and apply best practices.
Demonstrates the knowledge and skills necessary to provide care and/or service based on the physical, psycho/social, educational, safety, and related criteria appropriate to the age of the patients served in his/her assigned service area.
Maintains current knowledge of HRSA/OPA guidance, Apexus resources, CMS rulemaking affecting 340B, and state legislative developments, and briefs pharmacy leadership on changes affecting the program.
Demonstrates awareness of and compliance with regulatory standards; i.e., 340B federal requirements (HRSA Office of Pharmacy Affairs), CMS Conditions of Participation — including Pharmaceutical Services, Joint Commission Accreditation 360 standards and National Performance Goals (NPGs), Title 22, HIPAA, and other service specific regulations.
Supports compliance with Joint Commission Medication Management (MM) requirements as they apply to 340B purchasing, storage, and inventory, including management of drugs and biologicals in accordance with federal and state law, the medication formulary, and medication storage, records and disposition, and removal of expired or otherwise unusable medications from patient use.
Ensures 340B accumulation, replenishment, and split-billing practices do not compromise medication safety expectations under National Performance Goal 14 (medication management program focused on safety), including standardized drug concentrations and management of medication shortages.
Maintains 340B records, reports, and split-billing data consistent with Information Management requirements for privacy, confidentiality, security, and integrity of health information, and uses only approved standardized terminology, abbreviations, acronyms, symbols, and dose designations.
Maintains 340B policies and procedures within the hospital’s policy framework, supports leadership in demonstrating compliance with law and regulation, and supports oversight of contracted services, including contract pharmacies, split-billing vendors, and third-party administrators.
Maintains continuous survey readiness for all 340B-related documentation and participates in tracer activity, medication management and pharmacy review sessions, and document review during Joint Commission and CMS surveys, using the Survey Process Guide as the reference for survey expectations.
Demonstrates awareness of legal issues in all aspects of patient care, promoting safe practice in order to reduce risk.
Knows and complies with all Hospital safety policies and procedures as identified in the Hospital Safety Manual, Disaster Preparedness Manual and the Employee Safety Handbook, including Physical Environment (PE) requirements.
Completes workplace violence prevention training and reports workplace violence events in accordance with hospital policy, supporting the organization’s workplace and patient safety goal.
Knows and uses the right safety practices and equipment or materials.
Takes immediate action and/or reports to supervisor or other appropriate personnel any potential unsafe condition, practice or hazard.
Immediately reports every work-related injury.
Maintains compliance with 340B program integrity requirements under section 340B of the Public Health Service Act (42 U.S.C. §256b), including the prohibitions on diversion to ineligible individuals and on duplicate discounts, the group purchasing organization (GPO) prohibition and orphan drug exclusion as applicable to the hospital’s covered entity type, and adherence to the hospital’s definition of an eligible patient and eligible prescribing/service locations.
Maintains auditable 340B records sufficient to demonstrate compliance to HRSA, manufacturers, and the hospital’s compliance function throughout the applicable audit look-back period and at annual recertification.