340B Drug Pricing Program Services

The 340B Program has experienced growth and significant change in recent years. As a result of this growth, the 340B Program has received increased attention from a wide range of stakeholders, including regulators, manufacturers, and the covered entity community. Proponents of the 340B Program have been vocal in sharing the Program's positive impact on the healthcare system, while detractors have focused scrutiny on perceived compliance risks within the program. Despite the merits of these compliance concerns, the effect has been an increased focus on compliance. The 340B Program is complicated, and covered entities are at risk of noncompliance which can lead to repayments to manufacturers. A growing number of manufacturers are refusing to offer discounted drugs to contract pharmacies, using compliance concerns as their leading justification for these restrictions. HRSA guidance and subsequent enforcement are rapidly evolving. We know that the normal business duties of running a healthcare organization keep you very busy even on a good day. Throw in a changing 340B landscape and anyone would benefit from some help staying up to date with changes and maintaining compliance. We believe in providing our clients with the education and tools necessary to achieve maximal 340B compliance without sacrificing savings from the Program. With our backgrounds in auditing, compliance, process improvement, and reimbursement, we are uniquely positioned to deliver on this commitment. Our team of healthcare professionals have extensive experience and are nationally recognized as experts in the 340B industry. Let’s work together.

What is 340B?

The 340B Drug Pricing Program is a federal program that requires drug manufacturers participating in the Medicaid Drug Rebate Program to provide outpatient drugs to enrolled “covered entities” at or below the statutorily-defined ceiling price. This requirement is described in Section 340B of the Public Health Service Act and codified at 42 USC 256b. The purpose of the 340B Program is to permit covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-384(II), at 12 (1992).

Risk Assessments

Want to know where your 340B problems are hidden? Let us show you. Our comprehensive risk assessment procedures go beyond a typical mock HRSA audit. We base our process on our knowledge of common compliance pitfalls, what we have seen in recent HRSA audits, and specific risks associated with your unique organization. We view the Risk Assessment as an opportunity to merge client education with traditional auditing practices. Our goal is to identify any areas of risk, and provide valuable insight and tools for reducing future noncompliance risk and improving the overall integrity of your 340B program.

Mock Audits

Have an upcoming HRSA audit? Want to avoid surprises on a future audit? Let us help. Our team of experts has assisted dozens of 340B covered entities during HRSA audits and is excellent at preparing your staff for the real deal and identifying areas that could be problematic before the big day. We’ll have you and your team ready well in advance of HRSA’s visit.

Outsourced 340B Monthly Coordinator

Need assistance monitoring your 340B program? Looking for deeper insight into your program? Just trying to maintain compliance through a staffing transition? Let’s work together. Our team can supplement your current 340B personnel resources through the provision of ongoing assistance. Our approach to outsourced support is to combine our experiences with a thorough understanding of your processes to discover areas for improvement and added efficiencies. We can help with project accountability and prioritization, and provide focused attention on the issues that you have been wanting to address, but have not had the available team resources for. Our team will prepare an in-depth dashboard for you each month identifying trends in your spending and dispensing to assist you in better managing your program. We’ll also regularly review sample claims data searching for common errors that can occur throughout a covered entity's 340B life cycle. A summary of observations from these procedures will be provided to you on a monthly basis. Our goal for providing outsourced support is more than just filling a temporary gap within your organization, we incorporate 340B education and training into our process so that your organization is equipped to independently maintain this robust level of program management into the future.

340B Service Offerings:

  • Comprehensive Compliance Reviews (340B Risk Assessments)
  • Monthly 340B Coordinator Services
  • 340B Project Coordination Assistance
  • HRSA Audit Preparation Assistance
  • On-Site HRSA Audit Support
  • Corrective Action Plan (CAP) Assistance
  • Financial Benefit Assessment
  • OPAIS Registration and Recertification Assistance
  • 340B Policies and Procedures Manual Review/Development
  • 340B/GPO/WAC Comparative Purchase Analyses
  • 340B Training and Education
  • Internal Audit Process Development
  • Contract Pharmacy Arrangement Reviews
  • 340B Software Evaluations
  • 340B Software Implementation Assistance
  • Support Promoting Your Program Impact to Key Stakeholders
  • And More!

To submit a Request for Proposal (RFP)? Click here.