On-Demand   On-Demand Web Programs

Health Care and Life Sciences Law 2013

Released on: Oct. 18, 2013
Running Time: 06:09:50

Running Time Segment Title Faculty Format
[01:19:50] FDA Regulation: Hot Topics Scott D. Danzis ~ Covington & Burling LLP
Christopher Pruitt ~ Covington & Burling LLP
On-Demand MP3 MP4
[00:59:09] Sunshine Act Update Kendra A Martello ~ PhRMA
Karen S. Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Susan Hart-White ~ Associate General Counsel, Head of Regulatory Law, Privacy and Policy Group, Sanofi US
On-Demand MP3 MP4
[01:13:59] Enforcement Trends Laura F. Laemmle-Weidenfeld ~ Patton Boggs LLP
Timothy P. McCormack ~ Phillips & Cohen LLP
Paul Kaufman ~ Chief, Civil Health Care Fraud, United States Attorney's Office, Eastern District of New York
On-Demand MP3 MP4
[01:14:20] Health Care & Life Sciences: Current Developments David F. Hendren ~ Managing Director, Augmentum Advisors, LLC
Denise Hanna ~ Locke Lord LLP
Ellen L. Janos ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On-Demand MP3 MP4
[01:14:49] Effective Compliance Programs and Investigations: A Hypothetical Stacy A. Friedman ~ Senior Vice President and General Counsel, Brooklyn Hospital Center
T. Reed Stephens ~ McDermott Will & Emery LLP
Robert J. Rossi, Esquire ~ Vice President & Chief Compliance Officer, Calloway Laboratories, Inc.
Robert A. Wells ~ VP, Associate General Counsel, Cardinal Health, Inc
On-Demand MP3 MP4
Our expert faculty of health care and life sciences practitioners, in-house counsel, government regulators, and prosecutors will examine the current state of health care and life sciences law and what the future might hold for affected parties. This program will cover the broad range of issues confronting the health care and life sciences industry: structuring of compliant financial and other relationships; recent developments in scientific discourse and promotional guidelines affecting FDA-regulated companies; and federal and state enforcement of health care fraud and abuse laws, including the federal False Claims Act, the federal Anti-Kickback Statute, the Stark law, and similar state laws.

Lecture Topics 
[Total time 06:09:50]

Segments with an asterisk (*) are available only with the purchase of the entire program.

  • Opening Remarks and Introduction* [00:07:43]
    Scott D. Danzis, Karen S. Lovitch
  • FDA Regulation: Hot Topics [01:19:50]
    Scott D. Danzis, Christopher Pruitt
  • Sunshine Act Update [00:59:09]
    Karen S. Lovitch, Susan Hart-White, Kendra A Martello
  • Enforcement Trends [01:13:59]
    Paul Kaufman, Laura F. Laemmle-Weidenfeld, Timothy P. McCormack
  • Health Care & Life Sciences: Current Developments [01:14:20]
    Ellen L. Janos, David F. Hendren, Denise Hanna
  • Effective Compliance Programs and Investigations: A Hypothetical [01:14:49]
    Robert J. Rossi, Esquire, T. Reed Stephens, Stacy A. Friedman, Robert A. Wells

The purchase price of this Web Program includes the following articles from the Course Handbook available online:

  • Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (July 21, 2011)
    Scott D. Danzis
  • Rethinking the FDA’s Regulation of Mobile Medical Apps
    Christopher Pruitt, Scott D. Danzis
  • FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only in Vitro Diagnostic Products (June 13, 2011)
    Christopher Pruitt, Ellen J Flannery, JD, Scott D. Danzis
  • CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions
    Karen S. Lovitch
  • Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion
    Scott D. Danzis
  • Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices (December 2011)
    Scott D. Danzis
  • Case Analysis: The Sixth Circuit Reinforces the Holding that Only Violations of Conditions of Payment, Not Merely Conditions of Participation, Can be the Basis of a False Claims Act Action
    Timothy P. McCormack
  • Practice Analysis: The Anticipated Impact of the Growing State FCA Trend on Businesses
    Laura F. Laemmle-Weidenfeld
  • Health Care Sector: FCA Health Care Enforcement is White Hot
    Timothy P. McCormack
  • Health Care Industry Current Developments: Thirty Thousand Foot View of Accountable Care Organizations and Clinical Integration
    David F. Hendren
  • Current Legal Issues Affecting the Practice of Telemedicine (July 26, 2013)
    Ellen L. Janos
  • Five Takeaways from the OIG’s Special Advisory Bulletin on Exclusion
    Karen S. Lovitch

Presentation Material

  • FDA Regulation: Hot Topics
    Scott D. Danzis, Christopher Pruitt
  • Sunshine Act Update
    Karen S. Lovitch
  • Health Care and Life Sciences: Current Developments
    Ellen L. Janos
  • Health Care & Life Sciences: Current Developments
    Denise Hanna
  • Health Care & Life Sciences: Current Developments
    David F. Hendren
  • Effective Compliance Programs: Ensuring Your Client is Protected And Internal Investigations Practicing Law Institute
    Stacy A. Friedman
Co-Chair(s)
Scott D. Danzis ~ Covington & Burling LLP
Karen S. Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Speaker(s)
Robert J. Rossi, Esquire ~ Vice President & Chief Compliance Officer, Calloway Laboratories, Inc.
Stacy A. Friedman ~ Senior Vice President and General Counsel, Brooklyn Hospital Center
Denise Hanna ~ Locke Lord LLP
Susan Hart-White ~ Associate General Counsel, Head of Regulatory Law, Privacy and Policy Group, Sanofi US
David F. Hendren ~ Managing Director, Augmentum Advisors, LLC
Ellen L. Janos ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Paul Kaufman ~ Chief, Civil Health Care Fraud, United States Attorney's Office, Eastern District of New York
Laura F. Laemmle-Weidenfeld ~ Patton Boggs LLP
Timothy P. McCormack ~ Phillips & Cohen LLP
Christopher Pruitt ~ Covington & Burling LLP
T. Reed Stephens ~ McDermott Will & Emery LLP
Robert A. Wells ~ VP, Associate General Counsel, Cardinal Health, Inc

PLI makes every effort to accredit its On-Demand Web Programs and Segments.  Please check the CLE Calculator above for CLE information specific to your state.

On-Demand Web Programs and Segments are approved in:

Alabama1, Alaska, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho*, Illinois , Iowa2*, Kansas, Kentucky*, Louisiana, Maine*, Mississippi, Missouri3, Montana, Nebraska, Nevada, New Hampshire4, New Jersey, New Mexico5, New York6,  North Carolina7, North Dakota, Ohio8, Oklahoma9, Oregon*, Pennsylvania10, Rhode Island11, South Carolina, Tennessee12, Texas, Utah, Vermont, Virginia13, Washington, West Virginia, Wisconsin14 and Wyoming*.

Iowa, Mississippi, Oklahoma, and Wisconsin DO NOT approve Audio Only On-Demand Web Programs.

Minnesota 
approves live webcasts ONLY

Please Note: The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. PLI programs may qualify for credit based on the requirements outlined in the MCLE Regulations and Ariz. R. Sup. Ct. Rule 45.

*PLI will apply for credit upon request. Louisiana and New Hampshire: PLI will apply for credit upon request for audio-only on-demand web programs.


1Alabama: Approval of all web based programs is limited to a maximum of 6.0 credits.

 

2Iowa:  The approval is for one year from recorded date. Does not approve of Audio-only On-Demand Webcasts.

3Missouri:  On-demand web programs are restricted to six hours of self-study credit per year.  Self-study may not be used to satisfy the ethics requirements.  Self-study can not be used for carryover credit.

 

4New Hamphsire:  The approval is for three years from recorded date.

5New Mexico:  On-Demand web programs are restricted to 4.0 self-study credits per year. 


6New York:  Newly admitted attorneys may not take non-traditional course formats such as on-demand Web Programs or live Webcasts for CLE credit. Newly admitted attorneys not practicing law in the United States, however, may earn 12 transitional credits in non-traditional formats. 

7North Carolina:  A maximum of 4 credits per reporting period may be earned by participating in on-demand web programs. 


8Ohio:  To confirm that the web program has been approved, please refer to the list of Ohio’s Approved Self Study Activities at http://www.sconet.state.oh.us.  Online programs are considered self-study.  Ohio attorneys have a 6 credit self-study limit per compliance period.  The Ohio CLE Board states that attorneys must have a 100% success rate in clicking on timestamps to receive ANY CLE credit for an online program.

9Oklahoma:  Up to 6 credits may be earned each year through computer-based or technology-based legal education programs.


10Pennsylvania:  PA attorneys may only receive a maximum of four (4) hours of distance learning credit per compliance period. All distance learning programs must be a minimum of 1 full hour.
 

11Rhode Island:  Audio Only On-Demand Web Programs are not approved for credit.  On-Demand Web Programs must have an audio and video component.

12Tennessee:  The approval is for the calendar year in which the live program was presented.

13Virginia: All distance learning courses are to be done in an educational setting, free from distractions.

14Wisconsin: Ethics credit is not allowed.  The ethics portion of the program will be approved for general credit.  There is a 10 credit limit for on-demand web programs during every 2-year reporting period.  Does not approve of Audio-only On-Demand Webcasts.


Running time and CLE credit hours are not necessarily the same. Please be aware that many states do not permit credit for luncheon and keynote speakers.


If you have already received credit for attending some or the entire program, please be aware that state administrators do not permit you to accrue additional credit for repeat viewing even if an additional credit certificate is subsequently issued.


Note that some states limit the number of credit hours attorneys may claim for online CLE activities, and state rules vary with regard to whether online CLE activities qualify for participatory or self-study credits. For more information, call Customer Service (800) 260-4PLI (4754) or e-mail info@pli.edu.

 
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