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Health Care and Life Sciences Law 2012

Released on: Jan. 2, 2013

Running Time: 06:05:54

Segments
Overview
Faculty
CLE Credit

Running Time	Segment Title	Faculty
[01:14:03]	Drug/Device Promotion and Advertising: Hot Topics	Joshua Eizen ~ Office of Chief Counsel, U.S. Food and Drug Administration Scott D. Danzis ~ Covington & Burling LLP Afia K. Asamoah ~ Covington & Burling LLP
[01:44:41]	Enforcement Trends in Fraud and Abuse	Steven J. Tave ~ Gibson Dunn & Crutcher LLP Joshua Eizen ~ Office of Chief Counsel, U.S. Food and Drug Administration 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
[01:28:23]	Health Care Reform: Where Do We Go From Here?	Julie Simon Miller ~ America's Health Insurance Plans Karen S. Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Gary E. Bacher ~ Senior Vice President, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
[01:30:32]	A. Effective Compliance Programs: Ensuring Your Client Is Protected B. Internal Investigations: A Hypothetical	Marie C. Infante ~ Chief Compliance Officer; General Counsel Healthcare, Golden Living Timothy U. Sharpe ~ Vice President, Compliance, Quest Diagnostics T. Reed Stephens ~ McDermott Will & Emery LLP

Our expert faculty of attorneys representing the health care and life sciences industries, government regulators, and policy makers will examine the current state of health care and life sciences law and what the future might hold. This program will cover the broad range of issues confronting you and your clients today: structuring compliant relationships with health care providers and clinical investigators; promotional guidelines affecting FDA-regulated products; trends in government investigations; compliance with fraud and abuse laws, including the federal False Claims Act, Anti-Kickback Statute. Plus an examination of the Supreme Court’s ruling on the constitutionality of health care reform legislation.

Lecture Topics [Total time 06:05:54]

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

Opening Remarks and Introduction* [00:08:14]
Scott D. Danzis, Karen S. Lovitch
Drug/Device Promotion and Advertising: Hot Topics [01:14:03]
Afia K. Asamoah, Scott D. Danzis, Joshua Eizen
Enforcement Trends in Fraud and Abuse [01:44:42]
Paul Kaufman, Laura F. Laemmle-Weidenfeld, Timothy P. McCormack, Steven J. Tave, Joshua Eizen
Health Care Reform: Where Do We Go From Here? [01:28:23]
Gary E. Bacher, Karen S. Lovitch, Julie Simon Miller
A. Effective Compliance Programs: Ensuring Your Client Is Protected B. Internal Investigations: A Hypothetical [01:30:32]
Marie C. Infante, Timothy U. Sharpe, T. Reed Stephens

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

FDA Regulation of Drug Promotion and Advertising
Afia K. Asamoah
False Claims Act Focus Newsletter
Laura F. Laemmle-Weidenfeld
Manufacturer Liability Under the False Claims Act Based on Violations of Other Statutes: No Relief in Sight
Laura F. Laemmle-Weidenfeld
Health Care Enforcement: 2012 Trends, Quarterly Review--Part IV in a Continuing Series on Health Care Enforcement
Karen S. Lovitch
Fiscal Year 2013 Work Plan Highlights OIG's Medicare Parts C and D Priorities, Mintz Levin Health Law Advisory, October 9, 2012
Karen S. Lovitch
Florida v. HHS Raises Key Constitutional Issues Related to Health Care Reform, Mintz Levin Health Law Advisory, March 23, 2012
Gary E. Bacher
Supreme Court Health Care Ruling: Preliminary Analysis & Implications Going Forward, Mintz Levin Health Law Alert!, June 28, 2012
Alden J. Bianchi, Gary E. Bacher
HHS Issues Updated Blueprint for Health Insurance Exchanges Under the Affordable Care Act, Mintz Levin Health Law Advisory, August 30, 2012
Alden J. Bianchi, Gary E. Bacher
Department of Health and Human Services v. Florida, Brief of America's Health Insurance Plans and the Blue Cross Blue Shield Association as Amici Curiae in Support of Reversal of the Court of Appeals' Severability Judgment, January 6, 2012
Gary E. Bacher
CMS Publishes Proposed Rule on Return of Medicare and Medicaid Overpayment, Mintz Levin Health Law Advisory, February 16, 2012
Karen S. Lovitch
42 U.S.C. 1395cc, Agreements with Providers of Services; Enrollment Processes
Karen S. Lovitch
Federal Register, Vol. 76, No. 22, Pages 5941-5943, Department of Health and Human Services (February 2, 2011)
Karen S. Lovitch
2011 Federal Sentencing Guidelines Manual, Chapter 8, Part B--Remedying Harm from Criminal Conduct, and Effective Compliance and Ethics Program
Karen S. Lovitch
Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors
Karen S. Lovitch
Index to Health Care and Life Sciences Law 2012

Presentation Material

Drug/Device Promotion and Advertising: Hot Topics
Afia K. Asamoah, Scott D. Danzis
Drug/Device Promotion and Advertising: Hot Topics
Joshua Eizen
Health Care Reform: Where Do We Go From Here?
Gary E. Bacher
Health Care Reform: Where Do We Go From Here?
Julie Simon Miller
Effective Compliance Programs: Ensuring Your Client Is Protected
Effective Compliance Programs: Ensuring Your Client is Protected And Internal Investigations

Co-Chair(s)

Scott D. Danzis ~ Covington & Burling LLP

Karen S. Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Speaker(s)

Afia K. Asamoah ~ Covington & Burling LLP

Gary E. Bacher ~ Senior Vice President, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Joshua Eizen ~ Office of Chief Counsel, U.S. Food and Drug Administration

Marie C. Infante ~ Chief Compliance Officer; General Counsel Healthcare, Golden Living

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

Julie Simon Miller ~ America's Health Insurance Plans

Timothy U. Sharpe ~ Vice President, Compliance, Quest Diagnostics

T. Reed Stephens ~ McDermott Will & Emery LLP

Steven J. Tave ~ Gibson Dunn & Crutcher LLP

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.

Live Seminars

Health Care and Life Sciences Law 2014 (New York, NY)	Oct. 24, 2014
Health Care and Life Sciences Law 2013 (New York, NY)	Oct. 4, 2013

Course Handbook Archive

Health Care and Life Sciences Law 2014
Health Care and Life Sciences Law 2013
Health Care and Life Sciences Law 2012	Karen S. Lovitch, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Scott D. Danzis, Covington & Burling LLP

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	On-Demand Segment Description Faculty CLE Credit PLI makes every effort to accredit its recorded programs. PLI MP3s are approved in the following states/territories: AK, CA¹, CO, FL, GA, ID, IL, KS², ME, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OR, PA, TX³, UT, VI, VT, WA, WV, WY. Some exceptions apply. For more information contact PLI. ¹California: This activity qualifies for participatory credit. ²Kansas: There is a 5.0 credit limit per year for this type of viewing. ³Texas: Considered self-study credit. There is a 5 credit limit, including specialty credit. Please note:* The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. *PLI will apply for credit upon request. Running time and CLE credit hours earned are not necessarily the same. Please be aware that many states do not permit credit for luncheon speakers. Special Note: In New York, non-traditional course formats including audio and video cassettes are NOT acceptable for transitional CLE credit for the newly admitted attorney within the first two years after their admission to the Bar. Attorneys other than newly admitted may use non-traditional course format, including audio and video cassettes to fulfill their CLE requirements. IMPORTANT INFORMATION FOR ATTORNEYS SEEKING CLE CREDIT While listening to the program, be alert to listen for the AUTHORIZATION CODE which has been placed somewhere within the program. Write the code down; you will be asked for this information when you request CLE credit. Once you’ve completed the program, please go to www.pli.edu and log in. Once you are logged in, your account will be displayed and the available programs will be listed on the left side under the heading "My Online Library". If you are already logged in, click the link for My Account on the home page to access your Online Library. Return to the program and click the MCLE Registration button in the top right region of the program window. A new window will open with a CLE Request form, you will be asked to complete a short evaluation, and fill in the AUTHORIZATION CODE, please complete and submit the form. Once you click the Submit button, your request for CLE credit will be sent to the CLE department. PLI will email you a CLE certificate within 48 hours. If you are unable to successfully log in, please contact our customer service department at 800-260-4754 for assistance. GENERAL INFORMATION This product is designed to provide practical and useful information on the subject matter covered. However, it is sold with the understanding that the publisher is not engaged in rendering legal, accounting or other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought. 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. 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. Add to Cart Membership Suite Options: Add to My List Register From Roster Request Groupcast Receive all of the items below at the reduced price of $0.00 A combined savings of $0.00 Buy Combo CREDIT INFORMATION Credits for: