Maintaining 340B program integrity and compliance is a daily exercise. Many organizations mistakenly think that once a 340B program is established, their work is done. After the program is set up, it is critical to create processes that support ongoing compliance in addition to daily hospital operations. 

Because 340B is an organizational program, it is important to create a 340B Oversight Committee within the hospital that can manage, monitor, improve, and sustain the program. 

Components of a Strong Oversight Committee

Engage all areas of the hospital team, including representatives from:

• Hospital Leadership
• Director or Manager of Pharmacy
• 340B Coordinator
• Clinical Coordinator
• Pharmacy Buyer or Inventory Manager
• Director of Compliance
• Representatives from Finance/Reimbursement and Accounting Departments
• Medical Staff Credentialing

To cover every angle of the complex 340B program, define the roles of each of the committee members in the hospital’s policies document. Here are some tips regarding how individual components of an interdisciplinary Oversight Committee can help ensure 340B program success.

Hospital Leadership

Involving Hospital Leadership in the Oversight Committee is critical for the success of the program. Leadership needs to have a good understanding of and appreciation for the benefits of a successful 340B program to the clinical and financial health of the hospital.

Director of Pharmacy

Along with coordinating the pharmacy staff for the benefit of the 340B program, the Director of Pharmacy should schedule regular meetings with Information Technology (IT) to make sure that the data going in and out of the system is up-to-date and reliable. IT systems within the hospital need to communicate effectively and accurately with each other to ensure that 340B data is correct and ensure that 340B records and documentation are in a ready form that can be accessed for an audit when it does happen.

340B Coordinator

The 340B Coordinator should stay on top of changes within federal and state 340B compliance rules. As compliance changes occur, the program Coordinator also should keep the Oversight Committee up to date so the entire 340B team is prepared and working together.

Clinical Coordinator

The Clinical Coordinator should regularly review medication orders to ensure that all requirements for 340B drugs are being met. Every drug accumulated to a 340B purchase must be ordered by a provider and then documented that it was administered to the patient. If the drug is purchased as 340B, but the prescription order or confirmation that the medication was administered cannot be identified, the medication purchased is 340B ineligible. 

Pharmacy Buyer or Inventory Manager

The Pharmacy Buyer or Inventory Manager should monitor drug purchases and distribution to the right clinical teams for administration to 340B patients.

Director of Compliance

Organizations that perform well with 340B compliance include their Director of Compliance in the 340B Oversight Committee. Compliance leadership may not initially be knowledgeable about 340B. Engaging them to work with the Oversight Committee allows them to learn about the complexity of 340B and support program compliance. 

Representatives from Finance/Reimbursement, and Accounting

HRSA auditors want to know how a covered entity is using savings generated by the 340B program to serve the patient population that 340B was designed to benefit. Finance, Reimbursement, and Accounting teams can document the use of savings generated from 340B to expand care and how those savings are used to help strengthen your organization’s 340B program. 

Medical Staff Credentialling

Credentialling should assure that the medical staff meets its responsibilities as delineated in the policies of the hospital and other requirements as designated through state and federal legislation as well as licensure and accreditation standards. This includes verification for all credentialed providers throughout the hospital that meets accreditation, statutory requirements, and managed care delegated credentialing agreements.

Conclusion

A well-oiled 340B Oversight Committee can continue to educate leadership and staff, improve systems and procedures, monitor, and correct as issues are revealed through self-audits or outside audits, ensuring a successful 340B program. For assistance in establishing an effective 340B Oversight Committee, contact the CPS 340B team: contactus@cpspharm.com.