The 340B Drug Pricing Program is a vital resource for covered entities (CEs), including hospitals, clinics, and healthcare providers, allowing them to access discounted drugs for outpatient care. However, staying 340B compliance is essential to fully benefit from this program, reduce risks, and meet legal requirements. In this guide, we’ll explain what 340B compliance is, how it works, and who can help to make the process easier and more effective.

What is 340B Compliance?

340B compliance refers to the process of meeting federal standards under the 340B Program, ensuring that eligible entities access outpatient drug discounts without penalties or program exclusion. Here’s why compliance matters:

• Legal Adherence: Compliance means maintaining eligibility, ensuring savings are used appropriately, and keeping accurate records.
• Financial Impact: Non-compliance risks include penalties, potential program exclusion, and financial losses, all of which can limit an organization’s ability to serve its community.

To avoid these risks, compliance must be a priority for any healthcare provider participating in the program. Learn more about 340B compliance here.

How Does 340B Compliance Work?

Achieving and maintaining 340B compliance requires a mix of operational protocols and constant vigilance.

• Establishing Control: Compliance relies on strict internal controls, inventory management, and patient eligibility tracking to prevent drug diversion.
• Audit Preparedness: Covered entities must be ready for HRSA (Health Resources and Services Administration) audits at any time, requiring detailed records and organized processes.
• Common Compliance Pitfalls: Challenges include accurately tracking eligible patients and preventing duplicate discounts. Organizations need a proactive approach to avoid these issues.

For organizations seeking assistance, third-party compliance services like 340BWell can help streamline these processes, reducing the risk of costly errors.

Who Can Help with 340B Compliance?

Navigating 340B compliance is complex, and many covered entities find value in partnering with specialized service providers.

• The Role of 340B Compliance Services: Companies like 340BWell offer audit support, staff training, data management, and technology solutions to ensure compliance.
• Why Choose 340BWell?: With expertise in compliance, 340BWell offers healthcare organizations the support they need to stay compliant and make the most of the 340B Program. Their dedicated team and tailored solutions can help you meet compliance standards while focusing on patient care.

By working with a knowledgeable partner like 340BWell, healthcare providers can navigate compliance challenges confidently, ensuring their program benefits remain intact.

Conclusion

340B compliance is critical for covered entities aiming to maximize the 340B Program’s benefits and continue serving their communities. With expert partners like 340BWell, healthcare providers can meet compliance standards smoothly, focusing on what matters most—quality care for patients. Visit 340BWell’s Compliance Services to learn how they can help your organization today.