The 340B Drug Pricing Program – A Compliance Perspective

Overview:

The 340B Drug Pricing Program, which is administered by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA), requires drug companies, as a condition of participation in State Medicaid programs, to provide covered outpatient drugs at a deeply discounted statutory ceiling price (the 340B price) to covered health care entities serving needy patients. The Program is intended to allow Covered Entities to stretch scarce federal resources while treating more patients and providing more comprehensive services. Since 2010, 340B has become a higher-profile issue as a result of growth of the program via two actions: the Affordable Care Act’s (ACA’s) addition of more eligible hospitals and HRSA’s guidance allowing Covered Entities to contract with multiple pharmacies.

As a result, there has been increased focus on oversight of the program and more specifically HRSA audits.  In FY 2013, HRSA audited 94 healthcare providers. In FY 2014, the administration audited 99 providers. However, Commander Krista Pedley, Director of HRSA’s OPA, has publicly stated that she expects OPA to perform twice as many audits in FY 2015 as it did in FY 2014. The bottom line is that no health care facility is immune. It’s not a matter of whether organizations will be audited – it’s a matter of when. In addition to HRSA’s 340B audits, organizations must also be prepared for audits by drug manufacturers that can be particularly challenging.

The risk of 340B non-compliance is quite high.    Audit results posted through August 2015 show that 73.1% of Covered Entities had findings and 53% of the 82 with posted audit results were sanctioned with repayment to manufacturers.

In this hour, LIVE Webcast, Intelligent Compliance Solutions (ICS) expert, Bruce Boelter, Vice President & National Practice Leader will review and discuss effective ways to be audit ready in 2016 and beyond and share best practices from recent client engagements across the nation.  The speaker will provide insight into the most effective manner to develop and implement 340B policies and procedures and effective practices to ensure compliance.

Key topics include:

• An overview of the current state of the program including recent changes
• Discerning between formal and informal guidance
• Steps to keeping your organization compliant and audit ready
• Who wants your savings?     A review of Program Intent
• Overview of pending Mega Guidance
• Implications of the Mega-Guidance for Covered Entities

Agenda:

Who Should Attend:

• Federal Healthcare Facilities
• Healthcare Law Attorneys
• Health Industry Advisors
• Health Policy Directors
• Bio/Pharma and Related Attorneys
• Compliance Officers
• State Health Executives/Professionals
• General Counsel
• Professionals coming from Food and Drug Industries
• Consultants & Clients in the Food and Drug Industries
• Other Related/Interested Professionals