The 340B Drug Pricing Program is a lifeline for covered entities (CEs) like hospitals, clinics, and healthcare providers, enabling access to discounted medications for outpatient care.1 However, maintaining 340B compliance is crucial for maximizing program benefits, mitigating risks, and adhering to legal requirements.2 This guide explains what 340B compliance entails, how it functions, and how expert assistance can simplify and enhance the process.
What is 340B Compliance?
340B compliance means adhering to federal standards within the 340B Program, ensuring eligible entities obtain outpatient drug discounts without facing penalties or program exclusion.3 Compliance is paramount for several reasons:
- Legal Mandate: Compliance ensures ongoing eligibility, proper utilization of savings, and meticulous record-keeping.4
- Financial Security: Non-compliance can result in penalties, potential program removal, and financial losses, hindering an organization’s ability to serve its community.
Prioritizing compliance is essential for all participating healthcare providers.
How Does 340B Compliance Work?
Achieving and maintaining 340B compliance requires a combination of robust operational procedures and continuous oversight.5
- Establishing Robust Controls: Effective compliance depends on stringent internal controls, precise inventory management, and accurate patient eligibility verification to prevent drug diversion.6
- Audit Readiness: Covered entities must be prepared for audits by the Health Resources and Services Administration (HRSA) at any time.7 This necessitates detailed records and well-organized processes.
- Addressing Common Challenges: Common compliance pitfalls include accurately identifying eligible patients and preventing duplicate discounts. A proactive approach is crucial to avoid these issues.
Third-party compliance services, such as 340BWell, can streamline these processes and minimize the risk of costly errors.
Who Can Help with 340B Compliance?
Navigating 340B compliance is complex, and many covered entities benefit from partnering with specialized service providers.8
- The Value of 340B Compliance Services: Organizations like 340BWell offer comprehensive support, including audit preparation, staff training, data management, and technology solutions to ensure compliance.9
- Why Choose 340BWell?: With deep expertise in 340B compliance, 340BWell empowers healthcare organizations to maintain compliance and optimize their participation in the program. Their dedicated team and tailored solutions enable organizations to meet compliance standards while prioritizing patient care.
Partnering with a knowledgeable provider like 340BWell allows healthcare providers to confidently address compliance challenges and safeguard their program benefits.
Conclusion
340B compliance is essential for covered entities seeking to maximize the advantages of the 340B Program and continue serving their communities. By leveraging the expertise of partners like 340BWell, healthcare providers can navigate compliance effectively, focusing on their core mission: delivering high-quality patient care. Visit 340BWell’s Compliance Services to discover how they can support your organization today.
