Finding the Right 340B Compliance Partner: A Checklist for Covered Entities
Choosing the right 340B compliance partner is a decision that can shape the future of your organization’s 340B program. With increasing scrutiny from HRSA, tighter manufacturer rules, and a constantly shifting regulatory landscape, covered entities need more than a vendor—they need a trusted advisor.
But how do you identify a partner that offers both deep expertise and real alignment with your operational needs? This checklist breaks down what to look for when evaluating 340B consulting firms.
1. Experience with Your Entity Type
Not all 340B consultants are created equal. Some specialize in hospitals, others in FQHCs or Ryan White clinics. Ask:
- Have they worked with organizations similar in size, structure, and complexity?
- Do they understand your specific patient population and funding model?
Why it matters: Tailored support ensures your compliance strategy reflects your operational realities.
2. Proven Track Record with HRSA Audit Support
The best 340B consulting services don’t just help with paperwork—they prepare you for the real test.
- Do they offer mock audits and pre-audit coaching?
- Can they provide examples of past clients who successfully passed HRSA audits?
Why it matters: If your consultant has walked others through audits successfully, they’ll know what to expect—and how to prepare you.
3. Clear Methodology and Scope
Beware of vague promises. Top 340B consulting firms should offer a clear framework:
- Do they conduct a gap analysis, provide a roadmap, and follow up?
- Is the scope of services documented in writing?
Why it matters: You need a partner who’s transparent and structured—not reactive.
Also check this Valuable blog: The Future of the 340B Drug Pricing Program: Challenges and Opportunities
4. Custom, Not Cookie-Cutter, Solutions
Your organization has unique needs. Avoid one-size-fits-all consulting.
- Will they customize policies and workflows to your setting?
- Do they tailor staff training, contract pharmacy reviews, and technology recommendations?
Why it matters: Personalization ensures long-term compliance, not short-term fixes.
5. Ongoing Support After Initial Engagement
340B is not a one-and-done challenge—it evolves. Ask about:
- Ongoing compliance reviews
- Policy updates as regulations change
- Training refreshers or new hire onboarding
Why it matters: A true 340B compliance partner sticks with you to support continuous improvement.
6. Strong References and Reputation
Ask for client referrals or case studies. Look for signs of:
- Long-standing client relationships
- High audit pass rates
- Positive peer or industry recognition
Why it matters: You need a partner who’s respected and results-driven.
Also check this Valuable blog: The 340B Drug Pricing Program Explained: Everything You Need to Know
Final Thought
Choosing a 340B consultant isn’t just about ticking boxes—it’s about protecting your program, your patients, and your mission. By using this checklist to evaluate potential partners, you can ensure that your organization is not only compliant but positioned for long-term success.
In the high-stakes world of 340B, the right 340B compliance partner isn’t a cost—it’s an investment in resilience, readiness, and results.
