AMERICAN HEALTH LAWYERS ASSOCIATION
2012-2013 Practice Group Planned Activities and Project Report
April 2013
Practice Group: Life Sciences Chair: Thomas Quinlan
Chair
/ Thomas Quinlan / 9/3/12: Submit FY 2013 Planned Activities and Project Reportto staff
12/14/12: Submit written Mid-Year Report to the Board of Directors
5/18/13: Submit written Annual Report to the Board of Directors / 7/1/12 / 9/7/12
12/14/12
5/17/13 /
12/28/12 / Ongoing
Membership / Daniel Bailey / Vice Chair to serve as liaison between Practice Group and Membership Board Committee to recruit and retain members for the Association and the Practice Group / 7/1/12 / 6/30/13 / Ongoing
Publications / Krist Werling / Vice Chair to serve as liaison between Practice Group and Professional Resources Board Committee and to coordinate newsletters, Member Briefings, etc. / 7/1/12 / 6/30/13 / Ongoing
Educational Programs
/ Maryam Khotani / Vice Chair to coordinate Mid-Year and Annual Meeting Luncheons, teleconferences, and serve as a liaison between Practice Group and Program planning committee. / 7/1/12 / 6/30/13 / Ongoing
Research & Website / David Weinstock / Vice Chair to coordinate AHLA Connections feature article and email alerts. Monitor and oversee relevant PG sub-site of AHLA website; make suggestions for additional postings, web links, etc. / 7/1/12 / 6/30/13 / Ongoing
Strategic Activities / Paul Seltman / Vice Chair responsible for coordination of Affinity Group development and activities. / 7/1/12 / 6/30/13 / Ongoing
Discussion List
Life Sciences List / Jayson Slotnik / Regularly monitor the Life Sciences discussion list and post questions to stimulate activity. / 7/1/12 / 6/30/13 / Ongoing
Meeting: Annual
/ Co-sponsor a luncheon meeting with the Life Sciences and Teaching Hospitals and Academic Medical Centers PGs at the 2013 Annual Meeting in Chicago, IL (July 1- 3, 2013).Date: Tuesday, July 2, 2013
Title: Genomic Sequencing and Personalized Medicine—Basic Science and Privacy Implications
Speakers: Dixie Baker, Bradley Patay
Moderator: TBD / 7/2/13
Newsletter (#1) / Publication of newsletter discussing and analyzing recent developments in relevant areas of health law.
Member Briefing (#1) / Title: Clinical Trial Agreements Chapter on Intellectual Property and Publication Issues
Authors: Shana Fried, Maryam Khotani, Elaine Brock, Anishiya Abrol
Editor: Seth Levy / 4/13
Webinar (#1) /
Title: International Clinical TrialsSpeakers: Sharon Nobles and Jason Staples
Moderator: Maureen Bennett
Co-sponsors: LS, BLG, and TH PGs
/ 5/12 / 6/13/12 / 6/13/1912S, Labor, Physician, and TH PGsan, MSCPR, adn /12 / DoneWebinar (#2) /
Title: Lessons Learned: What Providers and ACOs Looking to Participate in 2013 Should AnticipateSpeakers: Richard Bajner, Claire Castles, and Robert Gerberry
Moderator: Thomas Bartrum
Co-sponsors: ACO Task Force
/ 6/12 / 6/18/12 / 6/18/1912S, Labor, Physician, and TH PGsan, MSCPR, adn /12 / DoneWebinar (#3) /
Title: Fair Market Value Bootcamp Webinar and Roundtable Discussion Series, Part I: Introduction to Hypothetical Case StudySpeakers: Curtis Bernstein, Andrea Ferrari, Summer Martin, and Daniel Stech, and Robert Wade
Moderator: Claire Turcotte
Co-sponsors: FMV AG, HHS, IHC, LS, and Physician PGs
/ 5/12 / 6/26/12 / 6/26/12 / DoneWebinar (#4) / Title: From the U.S. Supreme Court to Your Clients: Impact and Implications of the ACA Decision
Speakers: Barry Alexander, Thomas Bartrum, Mark Bonanno, and Brian Stimson
Moderator: Julie Barnes
Co-sponsors: All PGs and Task Forces / 6/12 / 6/29/12 / 6/29/12 / Done
Webinar (#5) /
Title: SCOTUS Has Spoken, Part II: The Status of ACOs, Payment Reform Initiatives, and the Expansion of the Medicaid ProgramSpeakers: Susan Banks, Thomas Bartrum, Jennifer Evans, and Craig Smith
Moderator: James Flynn
Co-sponsors: ACO Task Force and Physicians and RAP PGs
/ 6/12 / 7/12/12 / 7/12/12 / DoneWebinar (#6) / Title: Fair Market Value Bootcamp Webinar and Roundtable Discussion Series, Part II: Hypothetical Case Study
Speakers: Gregory Anderson, Carol Carden, Patricia Powers, and Wallis Stromberg
Moderator: Summer Martin
Co-sponsors: FMV AG, HHS, IHC, LS, and Physicians PGs / 5/12 / 9/12/12 / 9/12/12 / Done
Webinar (#7) / Title: Physician-Owned Distributors and Device Companies: To Be or Not To Be?
Speakers: Thomas Bulleit and Charles Oppenheim
Moderator: Kimberly Brandt
Co-sponsors: LS, Fraud and Physician PGs / 7/12 / 9/18/12 / 9/18/12 / Done
Webinar (#8) / Title: Accountable Care Organizations Bootcamp Webinar Series, Part I: Organizing the ACO
Speakers: C. Frederick Geilfuss, Elizabeth Mills, and Douglas Ross
Moderator: Jan Murray
Co-sponsors: ACO Task Force / 10/12 / 11/13/12 / 11/13/12 / Done
Webinar (#9) / Title: Post-Election Webinar Series, Part I: Falling Off the Fiscal Cliff? Consequences of Sequestration for Providers and the Medicare Program
Speakers: Blair Childs and G. William Hoagland
Moderator: Julie Barnes
Co-sponsors: IHC, HCL, and Tax PGs and HCR Task Force / 9/12 / 11/16/12 / 11/16/12 / Done
Webinar (#10) / Title: Implementation of the Food and Drug Administration Safety and Innovation Act and Challenges Ahead
Speakers: Keith Flanagan, Elizabeth Jungman, and Leslie Kux
Moderator: Scott Cunningham / 7/12 / 11/27/12
(rescheduled from 10/29/12) / 11/27/12 / Done
Webinar (#11) / Title: Post-Election Webinar Series, Part II: Healthcare Reform Litigation and Coverage Consequences
Speakers: Erin Murphy, and Anthony Shelley
Moderator: Julie Barnes
Co-sponsors: IHC, HIT, HCL, and Tax PGs, and HCR Task Force and Public Interest Department / 9/12 / 11/30/12 / 11/30/12 / Done
Webinar (#12) / Title: Accountable Care Organizations Bootcamp Webinar Series, Part II: Issues with ACO Funding and Distribution of Shared Savings
Speakers: Thomas Bartrum, Julie Kass, and Claire Turcotte
Moderator: Julia Feldman
Co-sponsors: ACO Task Force / 10/12 / 12/4/12 / 12/4/12 / Done
Webinar (#13) / Title: Drug Shortages: Why Do They Occur and How Do We Prevent of Mitigate Them
Speakers: Edward Allera, Kalah Auchincloss, Sylvia Trujillo, and Stephen Wirth
Moderator: David Weinstock
Co-sponsors: LS, NYSBA, and AHLA Public Sector Health Lawyers Task Force / 12/12 / 12/17/12 / 12/17/12 / Done
Webinar (#14) / Title: Healthcare Fraud and Abuse Bootcamp Webinar Series; Part I: Fraud, Abuse, and Waste: A Primer
Speakers: Joseph Kahn, Laura Laemmle-Weidenfeld, and Kevin Raphael
Co-sponsors: Fraud, HCL, HHS IHC, Labor, LTC, LS, MSCPR, PPMC, Physicians, RAP, and TH/AMC PGs / 12/12 / 2/13/13 / 2/13/13 / Done
Webinar (#15) / Title: HITECH Final Omnibus Rule Bootcamp Webinar Series, Part I: The HITECH Omnibus Rule: An Overview and Important Policy Changes
Speakers: Robert L. Coffield, Adam H. Greene, Susan D. McAndrew, JD
Moderator: Patricia A. Markus
Co-sponsors: HIT, BLG, HHS, IHC, Labor, LTC, PPMC, and TH PGs and HCR TF / 1/13 / 2/25/13 / 2/25/13 / Done
Webinar (#16) / Title: HITECH Final Omnibus Rule Bootcamp Webinar Series, Part II: Privacy Provisions and New Individual Rights in the HITECH Final Omnibus
Speakers: Christina M. Heide, Jeffrey L. Kapp, Deven McGraw
Moderator: Patricia D. King
Co-sponsors: HIT, BLG, HHS, IHC, Labor, LTC, PPMC, and TH PGs and HCR TF / 1/13 / 2/27/13 / 2/27/13 / Done
Webinar (#17) / Title: HITECH Final Omnibus Rule Bootcamp Webinar Series, Part III: Breach and Enforcement under the HITECH Omnibus Rule
Speakers: Jennifer S. Geetter, Katherine M. Keefe, David A. Mayer
Moderator: Linda S. Ross
Co-sponsors: HIT, BLG, HHS, IHC, Labor, LTC, PPMC, and TH PGs and HCR TF / 1/13 / 3/6/13 / 3/6/13 / Done
Webinar (#18) / Title: HITECH Final Omnibus Rule Bootcamp Webinar Series, Part IV: Business Associates and the HITECH Omnibus Rule: Who’s In, Who’s Out, and What Should You Do Next?
Speakers: Allen Briskin, Amy S. Leopard, Glenn P. Prives, Esquire
Moderator: Bonnie Cassidy
Co-sponsors: HIT, BLG, HHS, IHC, Labor, LTC, PPMC, and TH PGs and HCR TF / 1/13 / 3/12/13 / 3/12/13 / Done
Webinar (#19) / Title: Healthcare Fraud and Abuse Bootcamp Webinar Series; Part II: Stark Law
Speakers: Anthony Choe, and Victoria Vaskov
Moderator: Carol Poindexter
Co-sponsors: Fraud, HCL, IHC, Labor, LTC, LS, MSCPR, PPMC, Physician, RAP, and TH PGs / 12/12 / 3/13/13 / 3/13/13 / Done
Webinar (#20) /
Title: Accountable Care Organizations Bootcamp Webinar Series, Part III: HIT and Data Sharing Issues for the ACOSpeakers: Heather Fields, Amy Leopard, Daria Niewenhous
Moderator: Alisa ChestlerCo-sponsors: ACO TF
/ 10/12 / 3/28/13 / 3/28/13 / DoneWebinar (#21) / Title: Managed Care Hot Topics
Speakers: James BoswellI, Robert Keenan , Leah Stewart
Co-Sponsors: PPMC, HLL, HHS PGs and ACO TF / 3/13 / 3/26/13 / 3/26/13 / Done
Webinar (#22) / Title: Accountable Care Organizations Bootcamp Webinar Series, Part IV: Clinical Integration, Health Informatics, and Quality of Care
Speakers: Christi Braun, Paul DeMuro, Eric Nielson
Moderator: Mark Mattiolo
Co-sponsors: ACO TF / 10/12 / 4/4/13 / 4/4/13 / Done
Webinar (#23) / Title: Healthcare Fraud and Abuse Bootcamp Webinar Series, Part III: Federal Anti-Kickback Statute
Speaker: John Kelly, Catherine Martin, Carolyn McNiven
Co-sponsors: Fraud, HCL, HHS IHC, Labor, LTC, LS, MSCPR, PPMC, Physicians, RAP, and TH/AMCPGs / 12/12 / 4/10/13 / 4/10/13 / Done
Webinar (#24) / Title: Accountable Care Organizations Bootcamp Webinar Series, Part V: Participating in the Medicare Shared Savings Program
Speakers: Julia Feldman, Sarah Swank
Moderator: David DeSimone
Co-sponsors: ACO TF / 10/12 / 4/11/13 / 4/11/13 / Done
Webinar (#25) / Title: Sunshine Act Final Rule Three-Part Series, Part II: Implications and Implementation for Providers and Life Science Companies
Speakers: Janis Anfossi, Kendra Martello
Moderator: Tracy Miller
Co-sponsors: Co-sponsors: COITAG/THAMC, Fraud, LS, Physicians, HHS / 2/13 / 4/15/13 / 4/15/13 / Done
Webinar (#26) / Title: Fair Market Value Bootcamp Webinar and Roundtable Discussion Series, Part V: Hypothetical Case Study
Speakers: Greg Endicott, John Holdenried, Richard Cameron, Lawrence Vernaglia
Moderator: Andrea Ferrari
Co-sponsors: FMV AG, HHS, IHC, LS, and Physician PGs / 5/12 / 4/24/13
Webinar (#27) / Title: Accountable Care Organizations Bootcamp Webinar Series, Part VI: Commercial Contracting Opportunities for ACOs
Speakers: TBD
Moderator: TBD
Co-sponsors: ACO TF / 10/12 / 5/2/13
Webinar (#28) / Title: Sunshine Act Final Rule Three-Part Webinar and Roundtable Discussion Series, Part III: Compliance and Practical Application Issues for Sunshine and PHS-Funded Research Final Rules
Speakers: Kristin West, TBD
Moderator: Carol Poindexter
Co-sponsors: COIT AG/THAMC PG, Fraud, HHS, LS, and Physicians PGs / 2/13 / 5/3/13
Webinar (#29) / Title: Healthcare Fraud and Abuse Bootcamp Webinar Series, Part IV: False Claims Act
Speakers: David Haron, Michael Morse, Gina Simms
Co-sponsors: Fraud, HCL, HHS IHC, Labor, LTC, LS, MSCPR, PPMC, Physicians, RAP, and THAMC PGs / 12/12 / 5/8/13
Webinar (#30) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part I: Models for Hospital/Physician Integration
Speakers: David Hilgers, Sidney Welch
Moderator: Ann Bittinger
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 5/21/13
Webinar (#31) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part II: Governance Issues
Speakers: Kimberly Mobley (invited), Claire Turcotte
Moderator: TBD
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 5/30/13
Webinar (#32) / Title: Healthcare Fraud and Abuse Bootcamp Webinar Series; Part V: Compliance
Speaker: TBD
Moderator: TBD
Co-sponsors: Fraud, HCL, HHS IHC, Labor, LTC, LS, MSCPR, PPMC, Physicians, RAP, and TH PGs / 12/12 / 6/5/13
Webinar (#33) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part III Fraud and Abuse
Speakers: Gregory Anderson, Troy Barsky (invited) , Julie Kass
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 6/11/13
Webinar (#34) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part IV: Antitrust
Speakers: Robert Canterman, John Miles
Moderator: TBD
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 6/18/13
Webinar (#35) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part V Transactions: The Nuts and Bolts of Documenting the Transaction
Speakers: Robert Gerberry, Cynthia Reisz
Moderator: TBD
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 7/11/13
Webinar (#36) / Title: 2013 Healthcare Fraud and Abuse Bootcamp Webinar Series; Part VI: Trends in Government Enforcement
Speaker: TBD
Moderator: TBD
Co-Sponsors: Fraud, HLL, HHS, In-House, Labor, LTC-SIR, MSCPR, LS, PPMC, Physicians, RAP, THAMC / 12/12 / 7/17/13
Webinar (#37) / Title: Physician Organizations Bootcamp Webinar and Roundtable Discussion Series: The Anatomy of Physician Integration—Part VI Integration in Medical Staff
Speakers: Kim Harvey Looney, TBD
Moderator: TBD
Co-Sponsors: Physicians, BLG, Fraud, HIT, HHS, IHC, Labor, PPMC, and Tax PGs and ACO TF / 2/13 / 7/18/13
Webinar (#38) /
Title: The America Invents Act: The Good, The Bad, and The UglySpeakers: Robin Silva
Moderator: Maryam Khotani
Co-sponsors: LS, HIT, and TH PGs
/ 11/11 / TBD(rescheduled from 1/19/12)
Webinar (#39) / Topic: Open Source Drug Development
Speakers: TBD
Moderator: TBD / 6/10 / TBD
Webinar (#40) / Topic: Healthcare Reform
Speakers: TBD
Moderator: TBD /
Webinar (#41) / Topic: Intellectual Property
Speakers: TBA
Moderator: TBA /
Webinar (#42) / Topic: Intersection between post-market clinical research and the Anti-Kickback Statue
Speakers: TBD
Moderator: TBD /
Roundtable Discussion (#1) / Title: Fair Market Value Bootcamp Webinar and Roundtable Discussion Series, Part III: Hypothetical Case Study
Speakers: R. Michael Barry, Kimberly Mobley, Stephan Peron, and Jennifer Sullivan
Moderator: Amy Kolczak
Co-sponsors: FMV AG, HHS, IHC, LS, and Physician PGs / 5/12 / 11/7/12 / 11/7/12 / Done
Roundtable Discussion (#2) / Title: Fair Market Value Bootcamp Webinar and Roundtable Discussion Series, Part IV: Hypothetical Case Study
Speakers: William Horton, Bruce Johnson, W. James Lloyd, and Jason Ruchaber
Moderator: Claire Turcotte
Co-sponsors: FMV AG, HHS, IHC, LS, and Physician PGs / 5/12 / 1/23/13 / 1/23/13 / Done
Roundtable Discussion (#3) / Title: Sunshine Act Final Rule Three-Part Series, Part I : A Discussion with Shantanu Agrawal, CMS Medical Director, Center for Program Integrity
Speaker: Shantanu Agrawal, Niall Brennan
Moderator: Glenn Engelmann