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Strategic Review of Pending Sunshine Regulations for the Pharmaceutical, Biotech, Medical Device and GPO Industry
   LIVE Webcast  

 


Event Details:                                                                                                                                                          

Group Purchasing Organizations, Device Manufacturers, Biotech Companies and Pharmaceutical Companies have been closely tracking CMS’s development of regulations to implement the so-called Sunshine Provisions of the Affordable Care Act. These Provisions will require more robust reporting and disclosure of payments to physicians and institutional providers, and certain types of physician investments and ownership interests. CMS issued a proposed rule in December 2012 and announced on May 3rd that it intends to issue the Final Rule in 2012 with data collection to begin in January 2013. Despite the lack of certainty in how CMS will craft regulations, companies need to anticipate what’s coming down the pipeline or risk being unprepared.

Group Purchasing Organizations, Device Manufacturers, Biotech Companies and Pharmaceutical Companies should have a thorough understanding of what this provision can offer as well as its potential impact on their business relations. Legal Series: Sunshine Laws for Bio and Pharmaceuticals in 2012 LIVE Webcast will analyze Sunshine Act laws from a 360 degree perspective providing attendees with a best practices guide to help avoid the many pitfalls.

The Knowledge Group has assembled a panel of key thought leaders and authorities to help you more thoroughly understand the Sunshine Act Law.

They will address the following key issues:

Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124318
Recording Fee: $299 (Please click here for details)

 

Featured Speakers for Strategic Review of Pending Sunshine Regulations for the Pharmaceutical, Biotech, Medical Device and GPO Industry LIVE Webcast :


Agenda  (click here to view more)


Jennifer S. Geetter, Partner,
McDermott Will & Emery

  • 1. Although GPOs and life sciences industry entities may already have robust fraud and abuse compliance programs, these programs may not be sufficient to comply with the Sunshine provisions in light of the specific requirements set forth in the Act and the proposed rule. Correspondingly, even entities with well-established fraud and abuse compliance programs will need to take significant steps to comply with the Final Rule. Smaller biotech companies and start-ups may not have established programs to serve as a foundation for compliance with the Sunshine Rules and may face a more significant uphill battle to comply.
  • 2. Given the agency's May 3rd announcement that it expects release a Final Rule in 2012 with data collection beginning in January 2013, regulated entities may have a compressed timeframe in which to built compliance programs. Accordingly, regulated entities may want to begin the process of developing a draft compliance program based on the provisions in the Act with the proposed rule serving as a guidepost for where the agency may be heading.
  • 3. The Proposed Rule contains a number of ambiguities and uncertainties that could be important to regulated parties. Given the detail and breadth of the Proposed Rule, some of these finer details -- which could have a big impact -- might get lost.
  • 4. Complying with the Sunshine Provisions is not just a concern of industry and the GPO community. Institutional providers, physicians, and physician family members will all be affected. Institutional providers and physicians should be considering potential necessary updates to existing conflict of interest programs to position themselves to comply with the rule.


Jen Johnson, Partner,
VMG Health

  • • It is now imperative for all life science company executives to understand the Fair Market Value (FMV) requirement and appropriate methodologies for determining payments to physicians.
  • • The analytical process and documentation to justify the payment is FMV will be essential in defending the compensation level
  • • The presentation will include tips for determining FMV, use of internal calculators and a compliance checklist for selecting and compensating physicians.




McDermott Will & Emery
Jennifer S. Geetter
Partner
speaker bio »»

VMG Health
Jen Johnson
Partner
speaker bio »»



Who Should Attend?

- Biotech/Pharma Industry Lawyers
- Consultants
- Life Sciences and Health Care Practice Consultants/Advisors
- General Counsel
- Senior Management
- Senior Executives
- Accountants
- Professionals coming from Biotech and Pharmaceutical Firms
- Consultants & Clients in the Biotech and Pharmaceutical Industries

Why Attend?

This is a must attend event for anyone interested in understanding the Sunshine Act and its impact to the industry.

- Detailed guidance given by the most qualified key leaders & experts
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A

Advanced registration is recommended as space is limited. Click the registration button below to sign up for this course today. Significant discount applies for early registration.

Registration Information:                                                                                                                                    


Disclaimer:
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Strategic Review of Pending Sunshine Regulations for the Pharmaceutical, Biotech, Medical Device and GPO Industry
LIVE Webcast
Event Sponsors / Speaker Firms:




McDermott Will & Emery has one of the largest and most prestigious Health law practices in the world, counseling leading organizations in every major sector of the health and life sciences industry on legal, regulatory and business transaction issues. For the second consecutive year Chambers USA ranked the Firm's Health practice as the only Tier 1 Health Practice in the United States. The Firm’s Life Sciences Industry Group is also nationally ranked by Chambers USA, and this group of 135+ lawyers, patent agents and scientific advisors provides the full range of legal services required by life sciences companies, regardless of their stage of development.




Pharmaceutical, medical device and biotechnology companies are facing increased scrutiny regarding payments to thought leaders for consulting arrangements and must ensure these payments are set at fair market value. VMG Health offers a unique expertise of the regulatory environment for organizations seeking to maintain compliant with the evolving disclosure requirements for physician and other thought leaders relationships.




 

The Knowledge Group, LLC is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417. Website: www.nasba.org



 

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Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

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