Our 14th Annual 340B Coalition Conference on Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws, co-hosted by Apexus, is the premier venue to prepare for significant changes to the 340B program and to learn practical advice on how to comply with the program and maximize pharmaceutical savings.  Whether you are with a health care provider, pharmaceutical related company or government agency, this conference is the ideal forum to stay informed and educated on this growing and complex program.  The July Conference will feature sessions on the following areas of focus, among others:

• 340B Reform Law
   
• Status and impact of new 340B law including program expansion and new compliance requirements
• New enforcement measures for providers and industry
• New enrollment requirements and application process
• What does the GAO study mean for the 340B program?

• Multiple Contract Pharmacies
   
• What is the status of implementation of the final multiple contract pharmacy guidelines?
• What is permitted under the final guidelines and what is not permitted?
• The dos and don’ts of setting up contract pharmacies
• What role will chains and independent pharmacies play?
• What role will pharmacy benefit managers (PBMs) play?
• What is the future of pharmacy networks?

• Orphan Drugs & 340B
   
• Children’s hospitals, free-standing cancer hospitals, and rural hospitals have been denied access to 340B prices on nearly 350 “orphan drugs”-what does this mean for those entities?
• Does the orphan drug exclusion apply only for the indication for which it was designated for orphan status or does it apply for all purposes?
• What are HRSA’s implementation plans?

• Integrity, Compliance & Sanctions

• Key integrity components of the new 340B law
• Update on the HHS Office of Inspector General study on 340B providers’ Medicaid billing practices
• Recent investigations and recoupment efforts by states
• Where is the Department of Justice headed next on drug overcharges?
• How should providers and manufacturers prepare for increased 340B enforcement and oversight?

• Specialty Pharmacies

• What is the difference between a specialty pharmacy and a specialty pharmaceutical?
• What challenges are there to accessing 340B prices and what models are available to address this matter?
• What are the short-term and long-term implications for 340B?
• How will the recent exclusion of orphan drugs from 340B affect new covered entities?
• Does the FDA REMS program unduly restrict access to newer prescription drugs by limiting distribution to specialty pharmacies (and not retail or hospital pharmacies)?
• How can publication of ceiling prices be restricted to covered entities?
• What will annual recertification mean for covered entities?

• Pharmaceutical Manufacturer Patient Assistance Programs
   
• What happens to PAPs post health reform?
• How to address increased audit requirements
• Future of bulk replacement and institutional patient assistance programs
• Trends in patient assistance including co-pay assistance programs

• Billing Medicaid for Physician-Administered Drugs
   
• How are states implementing CMS’ transmittal acknowledging that states have the authority to exempt all or a subset of hospital clinic-administered drugs from NDC reporting?
• How are hospitals adapting to NDC reporting requirements and other billing changes?
• What are some of the different approaches that states and hospitals are taking to create a “win-win” for the parties?
• What state policies are causing the greatest burden for covered entities?

• Medicare Part D
   
• What changes are in store for the Part D program?
• What will the closing of the donut hole mean to providers and industry?
• Tips on how to continue to operate in Part D market at a time of reduced reimbursement by health plans
• How to challenge unfavorable Part D contracts
• Do multiple contract pharmacy guidelines offer new opportunities for Part D revenue?
• Part D and AIDS Drug Assistance Programs (ADAPs)

• Interface between Electronic Medical Records, e-Prescribing, PAPs & 340B
   
• How do covered entities implement electronic medical records (EMR) and e-prescribing technologies?
• How will implementation impact 340B providers?
• How can EMR & e-prescribing help patient assistance programs (PAPs)?

• Credit & Rebill Process
   
• What is credit & rebill?
• Why is it such a controversial area in the 340B program?
• How does a covered entity do a credit & rebill?
• Tension between wholesalers and manufacturers

• Patient Safety Collaborative
   
• Who are the participants?
• What lessons have been learned?
• Where does the Collaborative go next as it approaches its third year?
• The PSPC experience from high performing teams

• 340B and Medical Homes
   
• What is a medical home interdisciplinary team and how will a 340B provider be able to get involved?
• Can a hospital, community health center or other 340B provider qualify as a medical home and will that qualify its patients for 340B?
• Could the involvement of accountable care organizations (ACOs) in pediatric care complicate the 340B relationship?

These are just some of the many topics to be covered at our annual conference.  We look forward to seeing you in Washington, DC in July!