External, Mock HRSA 340B Audit

Central Texas Community Health Centers d/b/a CommUnityCare is soliciting proposals for an annual external mock HRSA 340B audit and compliance assessment, with written questions due November 2, 2026 and proposals due by 2:00 p.m. Central Time on November 30, 2026. This is a negotiated procurement in which award goes to the best responsive proposal providing the best overall value, not necessarily the lowest price. No pre-proposal meeting is scheduled.

The scope is a mock HRSA-style audit of CommUnityCare's entire 340B universe, including review of 340B policies and procedures, entity contracts, OPAIS entries, and duplicate discount analysis. Deliverables include a mock audit report identifying immediate and long-term audit risks, compliance improvement recommendations, and claims review analysis. Pass/fail mandatory specifications include corporate references from the past two years, required certifications and licenses, letter of transmittal, and financial information including balance sheet, income statement, and bonding company verification. Required insurance is $1,000,000 each for general liability, occurrence liability, and personal injury, and $100,000 for workers compensation.

A separate 62-question technical review questionnaire covers data center security, FedRAMP, StateRAMP, and FISMA references, disaster recovery, authentication, HIPAA compliance measures, and AI-specific requirements in Questions 48 through 62. The AI section addresses bias testing, explainability, audit trails, and potential Software as a Medical Device (SaMD) classification under FDA guidelines, along with ONC HTI-1 compliance for AI-generated clinical decision support. Responses must include security architecture diagrams, SOC audit reports, data processing agreements, business continuity and incident response plans, and copies of terms, licensing agreements, and service level agreements.

CommUnityCare proposes an annual budget of $10,000 to $25,000 and requests flexible pricing models such as fixed fees, hourly rates, or tiered pricing. The contract term is three to five years, with potential renewal periods based on funding availability and satisfactory performance. The cost worksheet is provided with all fields at $0.00 for bidder completion.

Proposals are scored on seven factors totaling 100 points: 340B Program Expertise (15), Audit Methodology and Approach (15), Experience and Past Performance (15), Reports and Other Deliverables (15), Staffing and Qualifications (10), Cost Proposal (25), and Value Added Services (5). Finalists will present and demonstrate to the Evaluation Committee, with demo dates to be determined and demo results evaluated separately. Submission requires one original and one electronic copy on flash drive, delivered in person to the CommUnityCare Procurement Manager at 2115 Kramer Lane, Suite 100, Austin, Texas 78758.