Seth H Lundy

Partner

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Seth Lundy

WASHINGTON, D.C.
T: +1 202 626 2924
F: +1 202 626 3737

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Seth Lundy is a partner in the Washington, D.C., office of King & Spalding and a deputy chair of the FDA & Life Sciences Practice Group.  Mr. Lundy focuses his practice on healthcare matters, concentrating on the federal and state regulation of medical device and pharmaceutical manufacturers and of healthcare providers and suppliers, including corporate compliance, the Anti-Kickback Statute, the Stark Law, False Claims Acts, state law compliance and reporting regulations, and Medicare and Medicaid reimbursement.

Mr. Lundy’s experience includes working closely with federal regulators and legislators to create, revise and interpret new laws, regulations and policies in the healthcare field; developing business and marketing strategies to cope with changing federal regulatory schemes; corporate compliance; government investigations; healthcare contracting; effecting mergers and the creation of new healthcare entities; Medicare and Medicaid reimbursement and billing advice; and civil and criminal litigation. His clients include medical device manufacturers, pharmaceutical companies, durable medical equipment suppliers, hospitals, health systems, academic medical centers, institutes of mental health, physician groups, nursing facilities and hospices.  Mr. Lundy is a frequent author and speaker on healthcare compliance, Medicare and Medicaid fraud and abuse, and the Stark Law.

Recent Publications

Speeches

  • “Managed Care Contracting Risks:  An Antitrust, Government Pricing and Fraud and Abuse Analysis,” Life Sciences & Healthcare Roundtable Webinar (April 6, 2017)

  • “Hub Services:  A Central Solution or a Center for Increasing Risks?” CBI 18th Patient Assistance and Access Programs Conference (March 16, 2017)

  • “Measuring the Effectiveness of a Corporate Compliance Program,” American Conference Institute

  •  “A Cancer Moonshot and So Much More:  An Introduction to the 21st Century Cures Act,” with Lynn Adam, Lisa Dwyer, David Farber, Beverly Lorell and Preeya Noronha Pinto, King & Spalding Life Sciences & Healthcare (January 12, 2017)

  • “Measuring Up:  Compliance and Legal Considerations in Managed Markets,” Pharmaceutical Summit on Business & Compliance Issues in Managed Markets (October 20, 2016)

  • “Compliance Lessons Learned from Corporate Integrity Agreements,” Seton Hall Law Healthcare Compliance Certification Program

  • “The Prosecution Rests:  Views from a Seasoned DOJ Prosecutor on Government Enforcement in Medical Device Cases,” with Jacob T. Elberg, Medical Device Summit 2016

  • “The New FDA Approach for Expanded Access to Investigational Drugs,” A webinar roundtable, King & Spalding Life Sciences & Healthcare (July 20, 2016)

  • “Measuring Up:  Compliance and Legal Considerations in Managed Markets,” Pharmaceutical Summit on Business & Compliance Issues in Managed Markets (June 8, 2016)

  • “Risks Associated with Complex Sales for Capital Equipment, Bundles and Devices on Loan,” CBI’s Medical Device Compliance Congress

  • “In the Eye of the Beholder:  Recent Trends in Anti-Kickback Statute Compliance,” with Brian A. Bohnenkamp, CBI PCC 2016 (April 27, 2016)

  • “The Nexus Between Compliance and Drug Pricing,” Pharmaceutical Compliance Forum (April 14, 2016)

  • “Application of the Anti-Kickback Statute Regulatory Safe Harbor for Discounts”

  • “In the Eye of the Beholder:  Recent Trends in Anti-Kickback Statute Compliance,” CBI PCC 2016 (January 26, 2016)

  • In the Eye of the Beholder:  Understanding DOJ’s New Standards for an Effective Compliance Program,” 8th Annual King & Spalding Pharmaceutical University (November 2015)

  • “Unlevel Playing Field:  What Can You Do When Your Competitor Is Gaining An Illegal Advantage?”  King & Spalding Healthcare Roundtable (October 2015)

  • “Compliance Lessons Learned from Corporate Integrity Agreements,” Seaton Hall Law Healthcare Compliance Certification Program (October 2015)

  • “Not-So-Safe Harbor:  Recent Challenges to Common Discount Arrangements, ” King & Spalding Medical Device Summit 2015 (September 2015)

  • “Open Wide:  Federal and State Transparency Laws Shine New Light on the Dental Industry” 9th Annual Forum on Transparency & Aggregate Spend (August 2015)

  • “Leveraging the Data: Mining and Identifying Trends to Help with Operational and Business Intelligence,” ACI’s 7th Advanced Forum on Sunshine Act, Open Payments, and Aggregate Spend Compliance (June 2015)

  • “Compliance Lessons Learned from Corporate Integrity Agreements,” Seton Hall Law Healthcare Compliance Certification Program (June 2015)

  • “Specialty Pharmacy (and PBM) Issues: Bona Fide Service Fees and Market Share Rebates and Volume Discounts,” The Pharmaceutical Compliance Forum (Spring Meeting 2015)

  • "Helping Hands? Current Issues with Co-pay Cards, Coupons and Patient Assistance Programs,” 12th Pharmaceutical Compliance Congress, CBI (March 2015)

  • “Compliance Lessons Learned From Recent CIA Developments,” 11th Regulatory and Compliance Congress for Medical Device and Diagnostics, CBI (February 2015)

  • “Helping Hands? Current Issues with Co-pay Cards, Coupons and Patient Assistance Programs,” with Gina Cavalier and Peter Todaro, K&S 2014 Pharmaceutical University, November 2014

  • “Still Not Finished: Compliance Monitoring, ROI, & Other Considerations for your Open Payments Data,” Aggregate Spend Conference, October 2014

  • “Discounts, Donations, Demos & More - Top Health Care Compliance Issues for Device Companies,” with Gina Cavalier, K&S 2014 Medical Device Summit, September 2014

  • “Compliance Lessons Learned from Recent CIA Developments,” with Michael E. Paulhus and Sara Kay Wheeler, K&S e-Learning Program, August 2014

  • “Managed Markets: Legal and Compliance Issues for Patient Assistance Programs (PAPs),” PCF Spring Meeting 2014, The Pharmaceutical Compliance Forum, March 2014

  • “Legal Considerations for Patient Assistance Programs,” 15th Patient Assistance and Access Programs, CBI, March 2014

  • “Dawn Breaking . . . Ready for Sunshine,” 10th Regulatory and Compliance Congress for Medical Device and Diagnostics, CBI, February 2014

  • “Sunshine for Medical Device Manufacturers,” Sixth Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, The Pharmaceutical Compliance Forum, February 2014

  • “The Tipping Point: Managing Crises in the Pharma Industry,” 2014 Pharmaceutical Compliance Congress, CBI, January 2014

  • “Innovative Approaches to Delivering Value for Life Sciences Companies in a Changing Regulatory Environment,” Life Sciences Leadership Forum “Pharma 2020,” Association of Management Consulting Firms, December 2013

  •  “Government Enforcement: Sharpening the Focus on Medical Devices,” King & Spalding’s 2013 Medical Device Summit, October 2013

  • “Market Share Rebates and Volume Discounts: Recent Cases,” The Pharmaceutical Compliance Forum, September 2013

  • “The U.S. Open Payments (“Sunshine”) Requirements Topics of Interest and Recent Developments in International Disclosure Obligations,” The Pharmaceutical Compliance Forum, September 2013

  • “4th Annual Sunshine Act Survey, Understanding Physician Attitudes and Awareness as They Relate to the Sunshine Act,” FDAnews Webinar, July 2013

  • “New Compliance Challenges,” 9th Annual Medical Device and Diagnostics Compliance Congress, CBI, June 2013

  •  “Understanding the Physician Payments Sunshine Act Requirements,” Stafford Publications, Inc. Webinar, April 2013

  • “Life Sciences Update for Providers,” 22nd Annual Health Law and Policy Forum, March 2013

  • “Legal and Other Considerations for PAP Operations -- The Advent of State-Run and Federal Health Insurance Exchanges,” 14th Annual Patient Assistance & Access Programs, CBI, March 2013

  • “After Sunshine: The Next Steps to Public Disclosure,” 5th Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Health Care Conference Administrators, February 2013

  • “The Next 4 Years--What to Expect Post-Elections from Congress, the States, FDA and CMS,” 10th Annual Pharmaceutical Compliance Congress, CBI, January 2013

  • “Tail Wagging the Dog: The Importance of Healthcare Regulatory Diligence,” Healthcare Regulatory Update and Post-Election Reactions Session, Healthcare Services Growth Capital and M&A Symposium, King & Spalding and Ernst & Young, November 2012

  • “Under the Spotlight: Update on Implementation of the Sunshine Act and preparing for What’s Next,” 5th Annual Pharmaceutical University, King & Spalding, November 2012

  • “Physician Owned Companies,” Physician Payments Sunshine Act Seminar, AdvaMed, November 2012

  • “Anatomy of an Investigation: Learning from the past and preparing for the future,” 2012 West Coast Medical Device Summit, King & Spalding, October 2012

  • “Sunshiny Day is Today: Federal & State Transparency Update,” 2012 West Coast Medical Device Summit, King & Spalding, October 2012

  • “Keeping up with Transparency Trends and Requirements Outside the U.S.,” 6th Annual Forum on sunshine and Aggregate Spend, CBI, August 2012

  • “After Sunshine: Preparing to Deal with the Likely Consequences of Public Disclosures,” The Fourth Annual Summit on Disclosure for Drug, Device and Biotech Companies, Health Care Conference Administrators, March 2012

  • “Here Comes the Sun(shine):  Transparency Reporting Under the Physician Payment Sunshine Regulations,” 21st Annual Health Law and Policy Forum, King & Spalding, March 2012

  • “Exploring CMS’s Proposed Rule on Reporting and Refunding Overpayments,” Healthcare Roundtable Webinar, King & Spalding, March 2012

  • “Legal and Compliance Risks with Patient Assistance Programs (PAPs) as 2014 Approaches” 13th Annual Patient Assistance and Access Program, CBI, March 2012

  • “Identify and Coordinate International Transparency Guidelines,” Global Transparency Reporting Congress, CBI, February 2012

  • “First Sunlight: Understanding the New Federal Physician Payments Sunshine Proposed Rule,” Sunshine Act Roundtable Webinar, King & Spalding, January 2012

  • “Bracing for Mandatory Federal Sunshine Reporting Requirements:  Immediate Action Plans for 2012,” 4th Annual Pharmaceutical University, King & Spalding, November 2011

  • “Healthcare Professionals Compliance Update--the Hottest Emerging Issues in Industry/HCP Relationships: Challenges Implementing Recent CIA Requirements -- Lessons Learned,” Track Co-Chair, 12th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, The Pharmaceutical Compliance Forum, November 2011

  • “Bracing for Mandatory Federal Sunshine Reporting Requirements: Immediate Action Plans for 2012 Spend,” Physician Payments Disclosure & Aggregate Spend, ACI, October 2011

  • “Here Comes the Sun(shine):  How to Best Prepare for the Forthcoming Federal Disclosure Requirements,” West Coast Medical Device Summit, King & Spalding, June 2011

  • “Perspectives on Government Investigations:  Lessons Learned for Medical Device Companies,” West Coast Medical Device Summit, King & Spalding, June 2011

  • “Here Comes the Sun(shine):  How to Best Prepare for the Forthcoming Federal Disclosure Requirements,” 2nd Annual West Coast Forum on Tracking State Laws and Aggregate Spend, CBI, April 2011

  • “After Sunshine:  Preparing to Deal with the Likely Consequences of Public Disclosures,” The Third Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Vivien Maier & Associates, Inc., March 2011

  • “Healthcare Reform 2010:  Boons and Burdens for the Pharmaceutical and Biotechnology Sector,” 3rd Annual Pharmaceutical University, King & Spalding, November 2010

  • “Perspectives on Government Investigations and Lessons Learned for Medical Device Companies,” East Coast Medical Device Summit, King & Spalding, October 2010

  • “State and Federal Transparency Requirements and Forthcoming Enforcement Risks,” East Coast Medical Device Summit, King & Spalding, October 2010

  • “Federal and State Aggregate Spend Regulatory Update,” West Coast Aggregate Spend Conference, Polaris Management and King & Spalding, October 2010

  • “Health Care Reform 2010,” Pharmaceutical Lunch ‘n Learn Program, King & Spalding, June 2010

  • “Avoiding Kick-Back Allegations When Collaborating with Healthcare Providers,” American Conference Institute’s 10th National Conference on Reducing Legal and Compliance Risks in the Sales and Marketing of Medical Devices, April 2010

  • “Recent Corporate Integrity Agreements, Other Healthcare Settlements, and Enforcement Affecting Clinical Trail Functions” and “Financial Conflicts of Interests,” Pharmaceutical In-House Lawyers Legal Seminars’ (PILLS) and King & Spalding’s 3rd Annual Enforcement Actions and New Developments in Clinical Trials Compliance, January 2010

  • Moderator, “Panel Discussion:  State Reporting Laws, Examining the Anticipated Rules of Preemption and Considering the Future of State Reporting Laws to Ensure Continued Compliance with Regulations” ExL Pharma’s Tracking & Reporting Aggregate Spend, January 2010

  • “Inside the Beltway:  Who’s Watching? What Are they Looking for? What Does it Mean for the Durable Medical Equipment and Supply Industry?,” Medtrade Conference and Exposition, October 2009

  • “Potential Perils of Using Media Sources for Marketing and Promotion,” 2nd Annual Pharmaceutical University, King & Spalding, September 2009

  • “Anti-Kickback Laws and Consulting Agreements:  Drafting and Reviewing Consulting Arrangements and Monitoring the Agreement to Fulfill the Company’s Needs While Remaining Compliant with Anti-Kickback Laws,” Sales and Marketing of Medical Devices, American Conference Institute, June 2009

  • “Federal Regulation of Advertising, Promotion, Sales and Collaboration with Healthcare Professionals,” West Coast Device Summit, King & Spalding, June 2009

  • “State Regulation of Interactions with Customers and Patients,” West Coast Device Summit, King & Spalding, June 2009

  • “Understanding and Applying the AdvaMed Code and Other Industry Codes,” West Coast Device Summit, King & Spalding, June 2009

  • “The Anti-Kickback Statute:  The Basics,” Audioconference Series, American Bar Association, March 2009

  • “Coverage, Coding and Payment--Collaboration between FDA and the Centers for Medicare and Medicaid Services (CMS),” Introduction to Medical Device Law and Regulation:  A Program on How the Medical Device Industry Is Regulated, Food & Drug Law Institute, February 2009

  •  “Medicaid and State Fraud Investigations,” 2008 Life Sciences Law Institute, American Health Lawyers Association, May 2008

  • “Global Compliance and Investigations,” 2008 Life Sciences Law Institute, American Health Lawyers Association, May 2008

  • “New Developments for DME, Prosthetics, Orthotics and Supplies,” 2008 Medicare and Medicaid Payment Issues program, American Health Lawyers Association, March 2008

  • “Office of Inspector General’s Role in Marketing Compliance,” The Center for Business Intelligence Third Annual Medical Device & Diagnostic Marketing Compliance Congress, June 2007

  • “Medicare’s DMEPOS Competitive Bidding Final Rule: An Overview and Analysis,” American Health Lawyers Association teleconference sponsored by the Regulation, Accreditation, and Payment Practice Group, May 2007

  • “New Developments for DME, Prosthetics, Orthotics and Supplies,” American Health Lawyers Association 2007 Medicare and Medicaid Payment Issues program, March 2007

 Books and Articles

  • “Before Entering the Chinese Medical Device Market, Know the Regulatory Landscape and Ready Your Resources,” BNA Insights, BNA Medical Devices Law & Industry Report, Vol. 5, No. 20, October 2011

  • ACQ magazine evaluates the predicted growth in the pharmaceutical industry, Focus, ACQ, July 2010

  • “New state marketing laws increasingly impact med tech,” Medical Device Daily Perspectives, February 2010

  • “Commentary: State Marketing Laws Impacting Medical Device Manufacturers,” Andrews Litigation Reporter, February 2010

  • “Just What the Doctor Ordered? CMS and DEA Introduce New Measures to Facilitate E-Prescribing,” Journal of Health & Life  Sciences Law, July 2009

  • “Recent Developments in Durable Medical Equipment,” a chapter in the Health Law Handbook, 2008
MEMBERSHIPS
American Bar Association
District of Columbia Bar
Maryland Bar Association
American Health Lawyers Association
Health Care Compliance Association
The George Washington University Law School – Health Care Advisory Board

EDUCATION
J.D., with honors, George Washington University
B.A., cum laude, Amherst College

ADMISSIONS
District of Columbia
Maryland