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:
Intelligent Compliance Solutions
- 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
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
Bruce has more than 25 years’ experience in a diverse range of pharmacy and health care leadership roles. Bruce served as Vice President for PSG’s 340B division before transitioning to ICS when the company was launched in July of 2014. Previously, Bruce served as a Director of the 340B Prime Vendor Program at Apexus. In a key leadership role, Bruce was responsible for the DSH Hospital Advisory Council, Medicaid relations, the Manufacturer Refund Program, all national 340B distributor contracts, and contracting with all value-added vendors. Boelter also played a key role in the development of 340B University.
Bruce’s other experience includes both operational and policy development roles for organizations such as EDS (purchased by HP), i3 Magnifi (Ingenix), Chronimed, Maxor National Pharmacy Services Corporation, and Blue Shield of California. In addition, he provided leadership as Director of Pharmacy and Executive Consultant for Santa Cruz County, a county run Federally Qualified Health Centers (FQHC). Bruce earned a Bachelor of Pharmacy from the University of Wisconsin-Madison and a Masters of Business Administration from Pepperdine University.
Course Level:
Intermediate
Advance Preparation:
Print and review course materials
Method of Presentation:
On-demand Webcast (CLE)
Prerequisite:
NONE
Course Code:
145011
NASBA Field of Study:
Specialized Knowledge and Applications
NY Category of CLE Credit:
Skills
Total Credit:
1.0 CLE
1.0 CPE (Not eligible for QAS (On-demand) CPE credits)
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SPEAKER'S FIRM:
About Intelligent Compliance Solutions
ICS is an independent 340B audit and compliance consulting firm. Utilizing our hundred percent data match analysis, we identify areas of risk for Covered Entities participating in the 340B program. We help entities establish oversight and take ownership of their program, while providing the necessary knowledge to build tools to assure on-going compliance. ICS delivers singularly-focused solutions such as contract pharmacy auditing, policy and procedure development and the implementation of a robust self-audit program. Our complete program reviews or audits to assist with corrective action are customized based on your program’s needs. ICS also provides ongoing monitoring or the ability to receive guidance from one of our experts when compliance issues arise. For more information contact info@intelligentcompliancesolutions.com