Over a year has passed since health care reform legislation was enacted, but many questions remain about the law’s impact on the 340B program as the government continues to implement many 340B-related provisions. At the same time, the Health Resources and Services Administration (HRSA) will soon publish new guidelines that will redefine what patients and sites are eligible for the 340B program. These guidelines will impact every 340B stakeholder, from the smallest health centers and hospitals in the country to the world’s largest drug manufacturers.

The government has also started to publish the first ever proposed regulations impacting the 340B program. The first one, which was just published, defines the scope of the orphan drug exclusion, which prohibits rural and free-standing cancer hospitals from purchasing orphan drugs at 340B pricing. Upcoming regulations will focus on a new dispute resolution process to resolve disputes between covered entities and manufacturers and the establishment of civil monetary penalties for companies that do not comply with the 340B law. Health reform also requires the government to, among other things, publish a 340B price list for covered entities and develop detailed guidance for how entities should bill and be reimbursed by Medicaid for 340B drugs.

These many changes and developments come as Congress continues to fight for and against health care reform, state Medicaid programs grapple with substantial budget shortfalls, and 340B providers face their own financial challenges. The conference will address these and many other questions and challenges facing 340B stakeholders, including covered entities, pharmacies, pharmaceutical manufacturers, 340B-oriented businesses, and federal, state, and local governments. There is no better way to stay informed and play a role in shaping the future of the program than to attend the conference. You will learn from all the key players involved in the program, including high-level federal officials and representatives from 340B advocacy organizations and industry.

In addition to the emphasis on policy matters, the conference will provide you with many opportunities for hands-on, practical advice to help with program implementation. If you are a health care provider, you will learn innovative strategies to reduce costs and improve care. If you work for a pharmaceutical company or other pharmacy-related business, you will learn how to comply with a host of new regulations and have an opportunity to network directly with current and prospective customers. There will be opportunities to participate in small breakout sessions to get the advice you need and to share ideas with others.  As there has been a significant growth in contract pharmacies, we also will be hosting breakout sessions exclusively for pharmacies and pharmacy service companies looking to contract or expand contracts with covered entities.

• Pharmacists and clinic directors at institutions providing care to low-income and uninsured populations
• Pharmaceutical manufacturers, wholesalers, and group purchasing organizations
• Pharmacy service companies and information technology firms
• Retail pharmacies, chain pharmacies, and other businesses that contract with 340B entities
• State Medicaid Pharmacy Directors and Drug Assistance Program Managers
• Part D plans, pharmacy benefit management companies, and other insurance companies
• Consultants, attorneys, and other compliance experts
• Federal, state, and local policy makers and government relations directors
• AIDS Drug Assistant Program (ADAP) officials and AIDS service organizations
• Other providers of health care for the uninsured and vulnerable populations