Pharmaceutical manufacturers, pharmacy benefit managers (PBMs) and managed care organizations (MCOs) face significant regulatory hurdles as they determine how to price and to market their respective services and products to one another and to the public. Additionally, as these entities affiliate with one another in order to increase access to prescription drugs, promote medication compliance, encourage and support proper prescribing of medication, reduce drug errors and decrease the cost of delivering drugs, special attention must be devoted to the unique health regulatory parameters associated with these activities. One of the greatest challenges facing these entities is assessing and understanding their respective legal parameters, risks and exposure in the current changing legislative, enforcement and political environment.

Epstein Becker & Green counsels segments of this industry throughout the country. Firm attorneys have published and presented extensively on these topics. Additionally, firm attorneys have worked actively with both the federal and state government agencies on significant industry issues. Representative engagements include:

• Provide all facets of fraud and abuse counseling to manufacturers, PBMs and MCOs relating to marketing initiatives and other programs such as disease management, coupon, grant, and patient assistant programs
  
• Provide all facets of fraud and abuse counseling to manufacturers, PBM and MCO relationships with academic medical centers, hospitals, physician groups and other direct and indirect purchasers
  
• Health regulatory counsel regarding value-added programs and payor partnerships with manufacturers
  
• Provide counsel to manufacturers relating to promotional and non-promotional activities
  
• Provide counseling regarding Medicaid Best Price, Federal Supply Schedule, Public Health Service Act and VA pricing issues
  
• Provide counseling regarding state drug access programs
  
• Provide counseling regarding federal and state drug reimbursement programs· 
   
• Advise on the processes for obtaining product coverage by government and private insurers
  
• Defend manufacturers, PBMs, MCOs and wholesalers in connection with federal, state, and Congressional health care fraud investigations and inquiries
  
• Defend manufacturers and academic medical centers in private actions related to clinical trial noncompliance·
  
• Develop and implement all aspects of corporate compliance programs for manufacturers, PBMs and MCOs
  
• Develop marketing and sales training in corporate compliance programs and reporting systems for manufacturers
  
• Develop pricing compliance programs and pricing reporting systems for manufacturers
  
• Participate in manufacturer new product launches, including training
  
• Provide counsel regarding post-market clinical trial research programs and review arrangements
  
• Develop clinical trial research corporate compliance programs for manufacturers, clinical research organizations and site management organizations
  
• Develop research compliance programs addressing relationships with all participants in the clinical research process
  
• Draft and negotiate direct and indirect purchase and discount agreements for manufacturers, MCOs and PBMs
  
• Counsel GPOs, wholesalers and distributors regarding contracts, marketing, promotional programs and distribution arrangements
  
• Provide counseling regarding PBM licensure and other legislative issues
  
• Provide federal and state legislative industry updates and analysis
  
• Provide HIPAA privacy counseling relating to manufacturer, research, and marketing issues
  
• Provide antitrust counsel related to manufacturer pricing issues
  
• Counsel relating to license agreements and co-promotional activities.