Ensuring Compliance in the Expanding 340B Federal Drug Pricing Program (Full Transcript)

Speaker 1: The 340B Federal Drug Pricing Program is larger than it's ever been, with over $12 billion in purchases reported for 2015. As 340B has grown, debate and scrutiny over program intent and how it is being utilized have increased, often focusing on compliance with regulations and guidelines. 340B-covered entities rely on program savings to support their role as safety net providers and are at risk for losing some or all of this benefit if found ineligible or out of compliance. 340B hospital leaders often ask us what they can do to protect these valuable savings. Cardinal Health actively manages over 50 340B pharmacy programs for hospitals, and we've experienced a number of audits from the Health Resources and Services Administration, HRSA. We recommend five best practices to create and sustain a 340B culture of compliance. First, establish a 340B Steering Committee. 340B is primarily a pharmacy program, but successful 340B management involves a range of departments and functions. Without an accountable, cross-functional team, there is increased risk of findings during a HRSA audit, which could result in payback obligations or even removal from 340B. Employ dedicated 340B resources. As healthcare evolves, pharmacy directors are taking on more responsibilities. It can be challenging to balance those new responsibilities with 340B management, especially given the program's pace of change. Without adequate resources, the covered entity risks gaps in compliance and missed savings opportunities. Maintain your 340B software. 340B-covered entities, especially hospitals, often address new challenges and workflow by using specialized technology. 340B technology typically requires ongoing maintenance. A simple error in mapping or rule set could put a DISH entity at risk of violating the GPO prohibition, a condition of eligibility for 340B participation. Implement a self-audit program. Covered entities that lack a fully developed and documented self-audit program, including patient eligibility tests, review of findings by the Steering Committee, and a material breach definition, are not meeting HRSA's repeatedly stated expectations for internal program oversight. Finally, conduct an annual, independent audit. HRSA recommends covered entities engage in an external review. Without this kind of objective, third-party audit of program compliance, blind spots can remain in place for long periods, leading to large, cumulative payback obligations. These steps require time and financial resources, but the return is improved stewardship of 340B savings, and the confidence that you can always answer yes when asked if you are ready for a HRSA audit. For more information on sustaining a culture of compliance, please reach out to us at 340B at CardinalHealth.com or consider reading the article shown on your screen.