The 340B landscape is more complex than ever—spanning multiple vendors, evolving compliance rules, and heightened manufacturer scrutiny. For many covered entities, choosing a 340B solution partner is no longer a simple procurement decision; it’s a compliance and financial safeguard.
Every vendor you work with—from your Third-Party Administrator (TPA) to your audit support team—represents both an opportunity and a risk. Selecting the right partner can unlock sustainable savings and compliance confidence. Choosing the wrong one can trigger costly findings, program misalignment, or even reputational damage.
This guide outlines Cooper Strategy’s framework for vetting 340B solution partners through a lens of purpose, governance, transparency, and performance.
Why Partner Selection Is a Compliance Decision
HRSA holds covered entities accountable for compliance, even when vendors manage core processes like split-billing, contract pharmacy reconciliation, or eligibility determination. In short, you can outsource work—but not responsibility.
That’s why vendor due diligence must go far beyond pricing comparisons. Each partnership should strengthen your program integrity, not compromise it.
Effective vetting ensures:
- Transparent data logic and audit traceability
- Proper security and HIPAA compliance
- Contract alignment with policy and 340B guidance
- Long-term financial and operational sustainability
1. Define Your Purpose Before You Shop for Solutions
Before comparing vendors, clearly define your purpose for partnering. Are you looking to:
- Expand contract pharmacy networks?
- Improve referral capture logic?
- Reduce audit risk or increase oversight automation?
- Optimize your corporate expense reduction program?
Clarity at this stage helps separate tactical vendors from strategic partners. A partner aligned with your mission—improving patient access and community reinvestment—will deliver far more value than one selling a generic platform.
2. Evaluate Vendor Integrity and 340B Expertise
Ask vendors to demonstrate their experience, qualifications, and governance model.
- How long have they supported covered entities under HRSA audit scrutiny?
- Can they provide references from hospitals similar to yours?
- What controls exist to prevent data manipulation or reporting bias?
A trustworthy partner should have internal audit programs, compliance certifications, and staff with clinical or regulatory backgrounds. Beware of vendors that prioritize marketing over metrics—E.E.A.T. depends on verifiable experience and transparent data practices.
3. Validate Data Logic Transparency
Your 340B program runs on data: NDCs, NPIs, encounter files, and eligibility logic. Yet, many vendors operate their systems as “black boxes.”
You must insist on logic transparency—the ability to see, understand, and audit how eligibility and replenishment rules work.
Ask:
- Can we view your algorithmic logic or audit trail?
- How are patient definition and prescriber rules applied?
- What happens when data conflicts arise between systems?
Without visibility into these rules, your compliance posture is at risk. Transparent partners empower you with data, not dependence.
4. Assess Technology Infrastructure and Security
A partner’s technology stack must meet the same standards you demand of your own systems.
Key areas to evaluate:
- Data encryption in transit and at rest
- HIPAA and HITECH compliance documentation
- Disaster recovery and business continuity plans
- Integration capabilities with EHRs, billing systems, and data warehouses
A strong technology partner protects both compliance and patient privacy—two non-negotiable pillars of a sustainable 340B strategy.
5. Review Contractual Terms and Audit Clauses
Your contract is the governance backbone of your partnership. It should explicitly outline:
- Scope of services and deliverables
- Ownership of data and rights to audit vendor systems
- Breach notification timelines
- Termination and transition assistance
- Performance guarantees and indemnification clauses
A well-structured agreement ensures continuity, accountability, and transparency. Contracts should also include cooperative audit language, allowing your compliance team (or HRSA, if required) to review vendor activity without resistance.
6. Examine Financial Models and ROI Alignment
340B vendors should create measurable value—compliance stability and financial benefit. Evaluate how their pricing model aligns with your outcomes.
Questions to ask:
- Are fees fixed, percentage-based, or tiered?
- Do incentives promote compliant savings or volume expansion?
- Can the partner quantify ROI tied to program integrity, not just revenue growth?
Transparent pricing that ties compensation to quality and performance reflects long-term partnership ethics.
7. Investigate Governance and Escalation Procedures
Strong partners operate under governance models that include clear escalation paths, regular reviews, and shared accountability.
Ask vendors to demonstrate:
- Internal QA and compliance oversight structures
- Procedures for issue escalation and incident reporting
- Documentation practices for findings and resolution
Cooper Strategy recommends quarterly joint governance meetings between your 340B Oversight Committee and vendor leadership to review performance metrics, audit results, and system changes.
8. Confirm Audit Support Capabilities
An audit-ready vendor doesn’t just provide data—they provide documentation, narratives, and representation support.
When evaluating potential partners, confirm their HRSA audit experience and ability to:
- Generate complete eligibility files upon request
- Explain data logic during HRSA inquiries
- Support you through on-site or remote audit proceedings
- Help draft Corrective Action Plans (CAPs) when needed
Your audit exposure is shared—choose a partner with proven readiness.
9. Evaluate Cultural and Mission Alignment
Beyond systems and contracts, successful 340B partnerships thrive on shared mission. Vendors that understand the 340B purpose—expanding care access for underserved communities—approach every decision differently.
Ask potential partners about their corporate philosophy, client retention rates, and training investment. Do they view your hospital as a long-term ally or a transaction? Mission alignment fosters trust, collaboration, and sustainable compliance.
10. Conduct a Structured Scoring and Reference Process
Use a weighted evaluation matrix to compare vendors objectively. Assign criteria for compliance expertise, technology, cost, responsiveness, audit readiness, and cultural fit.
Contact references directly and ask about real-world issues: How did the vendor handle errors? Were they transparent under pressure? Did they deliver on promised ROI?
A formal scoring process eliminates bias and supports defendable selection decisions—a critical governance expectation for covered entities.
The Cooper Strategy Framework for 340B Partner Selection
Cooper Strategy guides clients through a structured 340B Partner Vetting Framework that includes:
- Needs Assessment: Identify strategic objectives and risk thresholds.
- Partner Profiling: Map vendor capabilities to compliance and ROI metrics.
- Governance Evaluation: Verify oversight and contractual safeguards.
- Audit Simulation: Assess readiness and responsiveness to audit scenarios.
- Implementation Planning: Ensure post-selection integration and monitoring.
This framework balances compliance, cost, and performance—delivering partnership decisions that support both mission and margin.
Looking for an objective evaluation of your current or prospective 340B partners?
Start a consultation with our experts: Contact Cooper Strategy
Frequently Asked Questions About Partnering with a Purpose: A Guide to Vetting Your Next 340B Solution Partner
1. Why is vendor vetting so critical for 340B program success?
Vendor vetting directly impacts compliance, audit readiness, and financial outcomes. Because HRSA holds covered entities responsible for their vendors’ actions, a weak partner can create diversion, duplicate discounts, or audit findings—even if your internal team performs perfectly. Proper vetting ensures that vendors operate with transparent data logic, secure systems, and ethical governance. It also ensures mission alignment: your partner should understand that 340B savings fund patient care, not just operational profit. Vetting transforms your vendor from a transaction into a compliance ally—one invested in your program’s long-term integrity.
2. What qualities distinguish a strong 340B solution partner?
A strong 340B partner combines technical capability, regulatory expertise, and mission-driven alignment. They demonstrate transparent data logic, clear audit traceability, and a documented compliance framework. Their systems must integrate securely with your EHR and TPAs while offering customizable reports and dashboards. The best partners also have internal audit programs, responsive leadership, and HRSA audit experience. Most importantly, they prioritize your compliance reputation over profit expansion. When you review vendors, look for those who measure success in program integrity, savings sustainability, and improved patient access—not just contract renewals.
3. How can we verify a vendor’s compliance readiness before signing a contract?
Ask vendors to demonstrate their HRSA audit track record, provide anonymized examples of audit support documentation, and disclose their internal compliance policies. Request to see their SOC 2, HIPAA, or HITRUST certifications, and confirm they perform annual risk assessments. Ask for a sample audit binder showing how they respond to data requests and findings. A vendor unwilling to share this level of detail likely lacks transparency or readiness. Pre-contract due diligence is your best defense—once a partnership begins, gaps in compliance maturity can quickly become your liability.
4. How should covered entities monitor vendor performance post-implementation?
Monitoring should be proactive, not reactive. Establish quarterly governance meetings with vendor leadership to review key metrics: error rates, reconciliation accuracy, audit outcomes, and response times. Integrate vendor data feeds into your internal analytics dashboards for cross-validation. Require annual self-attestation of compliance policies and review all system updates for logic changes. Conduct periodic third-party or internal audits of vendor performance. This structure ensures your 340B partner remains accountable and aligned with HRSA standards while continuously improving alongside your organization’s compliance maturity.
5. How can Cooper Strategy assist in vetting or managing 340B partners?
Cooper Strategy provides an independent, structured evaluation framework for assessing current or potential 340B partners. We analyze vendor compliance infrastructure, contract provisions, audit readiness, and alignment with your organizational mission. Our team identifies gaps, negotiates performance safeguards, and helps you design oversight mechanisms that meet HRSA expectations. For existing partnerships, we conduct vendor performance audits and governance refreshes to optimize transparency and value. Whether you’re selecting your first TPA or reassessing your network, we ensure your 340B partnerships are purpose-driven and audit-proof.
Partner with confidence: Contact Cooper Strategy