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Industry Update: Federal and State Aggregate Spend Requirements

Audio conference highlights

The Physician Payment Sunshine Act became law as part of healthcare reform measures in 2010. Life science companies are now required to track, aggregate and disclose the amount they append on physician payments and transfers of value and gifts (i.e. meals, etc.). Federal regulations for the Sunshine Act are to be promulgated by October 2011. However, since spend transactions need to be captured for federal reporting purposes beginning on January 1, 2012, it is necessary to start to preparing before the regulations are published.

At the same time, several state legislatures are also establishing and passing their own laws which influence how life science companies can carry out business in those locales.

In this audio conference presentation we look at what type of information will need to be captured and reported pursuant to the Sunshine Act. The speaker also provides an update on state activities, with information relating to drug samples, laws governing lobbying, and other local regulations of particular concern to life science companies.

This audio conference covers:

  • The latest information on Sunshine Act requirements
  • Understanding current state aggregate spend and limitation laws and regulations
  • A state-by-state overview and checklist
  • Laws passed in 2010, including Connecticut and Colorado
  • Potential and pending aggregate spend/transparency legislation in other states
  • Regulations related to the distribution of drug samples
  • How different states define lobbying, and how that could impact traditional sales practices

About the speaker:

John Patrick Oroho is a principal of Porzio, Bromberg & Newman, P.C., where his practice is concentrated in the area of federal and state regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), anti-kickback, false claims, patient inducement, and Medicare and Medicaid fraud and abuse. He is also the Executive Vice President of Porzio Pharmaceutical Services, LLC, and has been involved in designing and implementing internal and external sample accountability systems.

Mr. Oroho has extensive experience in ensuring that SFA systems are PDMA compliant. He has designed and implemented corporate compliance programs for pharmaceutical companies that focus on OIG, PDMA and state compliance. He previously served as Senior Vice President and General Counsel of the PDMA Alliance, Inc., a national trade association of pharmaceutical companies focused on pharmaceutical sales and marketing compliance, and continues to act as outside counsel to the PDMA Alliance.

Mr. Oroho provides counsel and advice to pharmaceutical and related service companies nationally. He has written and lectured extensively throughout the country in the areas of OIG, PDMA and state law compliance. He is a graduate of the United States Merchant Marine Academy, and received his JD from the University of Notre Dame School of Law.

Who should attend?

  • Regulatory Affairs
  • Legal Counsel
  • Marketing
  • Finance
  • Sales/Business Development

Product Details

John Patrick Oroho, Porzio, Bromberg & Newman, P.C.
Industry Update: Federal and State Aggregate Spend Requirements
Title: Principal
Duration: 60 minutes
Event Type: Previously recorded on 2011-04-06
Item #: ac20110406a
6 Apr 2011 
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Reviews for Industry Update: Federal and State Aggregate Spend Requirements

Average Rating: (based on 2 reviews)

Showing 2 Reviews:

by K.S.
Director, Sales Administration
Very helpful to get quick oversight of upcoming changes/new regulations with details like use of the NPI for federal reporting. It allows me to start planning system changes we need to make.
by J.B.
Senior Counsel
The program provided a good overview of the variety of applicable laws in a concise format.
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