Food & Drug Regulation

Reimbursement in 2010 and Beyond: Understand the Changing Legal Landscape

Presented by Kathleen Peterson
Recorded On: Tuesday, April 06, 2010
Duration: 90 minutes
PURCHASE:
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CD and Transcript ($400.00)
On-Demand ($325.00)

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By Phone: 1-800-925-1878
By Fax: Fax Form

 

RECORDING HIGHLIGHTS:

The legal environment affecting drug and biologic commercial and Medicare rebate and discount practices in 2010 and beyond is changing.  At the beginning of the decade, pharmaceutical and biotech companies are poised to experience continued and increased enforcement actions.  At the same time, the government and many private payors are increasingly looking to those same industries to fund a larger portion of the health system bill.  However, reconciling such health system buzz words of "outcomes-based reimbursement" and "comparative effectiveness" to the legal realities impacting the related discount contracting practices can be challenging.  

 

In any investigation, one of the first things reviewed is the relevant "paper".  Therefore, it is critical to understand better contracting practices to help your organization protect its business and legal rights.  In this 90 minute audio conference, attorney Kathleen Peterson will review recent enforcement actions that may have implications for such contracts, as well as relevant legislative initiatives that may affect contracting strategies. 

Learning Points and Questions To Be Answered:

·        Identify and protect against possible legal and contracting "pitfalls" in current rebate and discount arrangements

·        Evaluate innovative discount and rebate strategies (such as outcomes-based and market share-based arrangements) for regulatory compliance, and understand the potential for ongoing enforcement to impact this analysis

·        Understand the potential impact of certain legislative initiatives (including "health reform") on contracting strategies

·        Protect against unintended government price reporting implications resulting from contract strategy

·        Review operational issues relating to the contracting process in order to establish more compliant processes.


Attendees Who Will Benefit From This Audio Conference Include:

  • Executive Management
  • Corporate and General Counsel
  • Strategy and business development planners
  • Reimbursement and contract professionals
  • Compliance and risk management staff 
YOUR EXPERT(S):
Kathleen Peterson

is a Member of Epstein Becker & Green’s Health Care and Life Sciences Practice, where she practices in the Pharmaceutical Industry Health Regulatory Practice Group. She has provided health regulatory counsel to a range of industry clients, including pharmaceutical and biological manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, medical education companies, GPOs, and investment firms.  Her experience includes reviewing and analyzing the impact of state and federal legislative developments, including health reform; counseling regarding government drug pricing calculations; analyzing contracting, reimbursement, and fraud and abuse issues in connection with federal and state health care programs, and more.

Kathleen served as the Vice-Chair of the American Health Lawyers Association Medicare Part D Task Force from 2006 - 2008 and is a frequent public speaker on a range of issues pertaining to the pharmaceutical, biotech, and managed care industries. She previously served as Senior Corporate Counsel to a pharmaceutical company, where she was the primary internal legal counsel for commercial sales and marketing issues.

Kathleen earned her J.D. from the Boston University School of Law, where she also served as the Managing Editor of the American Journal of Law and Medicine.



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