340B Program Auditing and Consulting Services

The Vendor is required to provide for a 340B consultant to conduct a comprehensive initial analysis of our federally qualified health center (FQHC) 340B program to ensure full compliance with all program requirements.
- The consultant will be responsible for developing and maintaining our 340B database, performing monthly internal compliance reviews, and reviewing contracts, policies, procedures, and Office listings for accuracy and compliance.
- Enhanced Responsibilities:
• System Integration & TPA Management: Oversee and optimize the relationship with our Third-Party Administrator (TPA) and ensure seamless data integration between our Electronic Health Record (EHR) and pharmacy dispensing software.
• In-House Pharmacy Operations: Provide specialized guidance on the operational launch and ongoing compliance of the in-house pharmacy, including:
o Inventory Management: Establishing protocols for "virtual" vs. "physical" inventory and preventing commingling of 340B and non-340B stock.
o Workflow Optimization: Reviewing internal dispensing workflows to ensure 340B eligibility is captured at the point of sale.
o Waste & Return Monitoring: Advising on the proper tracking of 340B drug waste and reverse distribution.
• Contract Pharmacy Oversight: Assist in reviewing and managing contract pharmacy agreements, monitoring 340B replenishment orders, and performing regular captures of claim validity.
• Audit Readiness: Conduct periodic internal audits for both contract and in-house locations to ensure act compliance and "audit-ready" status at all times.
• Policy Development: Draft and update 340B Policies and Procedures (P&P) that specifically address the nuances of an in-house pharmacy, including the prevention of diversion and duplicate discounts (specifically regarding Medicaid Carve-In/Carve-Out).
- Provide the consultant with necessary access to the Electronic Health Record (EHR), Third-Party Administrator (TPA) platforms, and internal pharmacy systems to facilitate thorough reviews and program maintenance.
- Data Management, Reporting & Documentation Requirements:
• Maintain oversight of the 340b database, ensuring organized storage of contracts, test work history, and all relevant documentation.
• Submit monthly management reports detailing financial performance, utilization trends and compliance findings.
• Prepare 340b-related data for annual uniform data system (UDS) reporting.
• Manage and execute all required data submissions to the 340b ESP platform and other manufacturer-designated reporting portals.
• Manage administrative enrollment and data submissions for rebate clearinghouses (e.g., beacon or other agency-designated vendors).
• Provide monthly reconciliation of Medicare part d claims to ensure accurate “true-up” or rebate calculations when the 340b ceiling price differs from the maximum fair price (MFP).
• Maintain and update the "crosswalk" between the pharmacy management system (PMS) and the EHR to ensure 1:1 mapping of agency and provider ids.
- Claims, Eligibility & Medicaid Management Requirements:
• Review all Medicaid claims to ensure prevention of duplicate discounts and maintain accurate Medicaid exclusion files.
• Support 340B claim eligibility verification and capture processes.
• Conduct post-implementation reviews of pharmacy management system (PMS) configurations to ensure proper identification of 340B-eligible encounters.
- Manufacturer Restrictions, Pricing & Ordering Requirements:
• Provide guidance on manufacturer restrictions, accumulations, and pricing verification during the ordering process.
• Review and validate price matching on manufacturer agreements for all completed purchase orders, ensuring accurate pricing and resolving discrepancies.
• Proactively manage manufacturer-imposed 340B pricing restrictions at contract pharmacies.