340B Drug Pricing Program Services

The 340B Program has experienced significant growth and change in recent years. As a result of this growth, the program has received increased attention, both beneficial and adverse, from regulators as well as drug manufacturers. Covered entities are at risk of noncompliance and, subsequently, repayments to manufacturers. Manufacturers are refusing to offer discounted drugs to contract pharmacies. HRSA guidance and enforcement is rapidly evolving. We know it can be difficult to keep up with normal business duties amid a pandemic, throw in the 340B landscape and everyone can use help keeping up to date and compliant. We believe in providing our clients with the tools necessary to achieve maximum 340B compliance without sacrificing savings from the Program. With our backgrounds in auditing, compliance, and reimbursement, we are able 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 problems are hidden? Let us show you. Our risk assessment procedures will be based on our experience as auditors and our understanding of general risks of the 340B program and risks within your covered entity. We’ll review your processes and procedures to provide valuable insight aimed towards reducing the risks of Program noncompliance 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 have assisted dozens of 340B covered entities during HRSA audits and are 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? Or looking for deeper insight into your program? Let’s work together. Our approach to provide ongoing assistance that will add value by combining our experiences with a thorough understanding of your processes to discover areas for improvement and added efficiencies, help with project accountability and prioritization, and provide focus and attention on issues and challenging areas as requested. 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 sample claims data searching for common errors that can occur throughout a covered entities 340B life cycle. A summary of observations from these procedures along with others will be provided to you on a monthly basis.

Other services include:

  • Financial Benefit Assessment
  • Registration and Recertification Assistance
  • 340B Policies and Procedures Manual Review/Development
  • Comprehensive Compliance Reviews
  • 340B/GPO/WAC Comparative Purchase Analyses
  • 340B Compliance Training and Education
  • HRSA Audit Preparation Assistance
  • On-Site HRSA Audit Assistance
  • Split-Billing Software Evaluations
  • Internal Audit Process Development
  • Contract Pharmacy Arrangement Reviews
  • Corrective Action Plan (CAP) Assistance
  • 340B Software Implementation Assistance

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