Pricing Under the Public Health Service 340B Program

April 29, 2014 4:30pm

Joseph W. Metro
Partner
Reed Smith LLP

William H. von Oehsen III
Principal
Powers Pyles Sutter & Verville PC (Washington, DC)

• Responding to a new era of oversight and enforcement: recertification of all 340B entities
– What is the latest with these audits?
– Are they uncovering diversion?
– What are HRSA’s findings?
– What are the outcomes of audits by the manufacturers?
– What are the implications of those findings for the future of the program?
• Evaluating the forthcoming rule
– Emerging issues
– Dispute resolution
• Identifying 340B “covered entities” and “new” covered entities created under PPACA
– How are new covered entities being added?
• Orphan drug exclusions for new covered entities
• Understanding the patient rule under 340B
• Truing up 340B prices if and when prices are restated for Medicaid rebate purposes
• Restrictions for participating covered entities
– The anti-diversion provision
– Prohibition against duplicate discounts
– How can manufacturers ensure covered entities are complying with these restrictions?
• Sub-PHS pricing
– How does maintaining low PHS prices affect non-FAMP and FCP pricing calculations
– Pros and cons of sub-ceiling pricing
• Using allocation programs to ensure equitable and appropriate distribution of products
• Estimating your PHS price for new drugs
• Prime vendor program
• Rebate arrangements with AIDS Drug Assistance Programs and compliance with 340B price controls
• Navigating the process for the resolution of overcharge claims by covered entities and claims by manufacturers alleging duplicate discounting or the unauthorized resale or transfer of covered outpatient drugs
• Status of the GAO report on the 340B program
• Litigation update
• What effect will Tricare data from 2008 being pushed on manufacturers have on annual non-FAMP reporting