HomeWebcastEmerging Issues in Health Care Enforcement: New Tactics, New Theories
Emerging Issues in Health Care Enforcement CLE CLE

Emerging Issues in Health Care Enforcement: New Tactics, New Theories

Live Webcast Date: Friday, September 25, 2015 from 10:00 am to 12:00 pm (ET)
Healthcare CLE & CPERecording

Emerging Issues in Health Care Enforcement CLE

Join us for this Knowledge Group Emerging Issues in Health Care Enforcement CLE Webinar. Increasingly, federal departments are addressing the frequent, persistent and growing complexity of healthcare fraud. The Department of Justice (DOJ) recovered over $2.3 billion in False Claims Act cases while the Federal Trade Commission (FTC) challenged several hospital and physician practice mergers and pursued anti-competitive pharmaceutical patent settlements. There is also a trend toward aggressive civil enforcement supplemented with new criminal prosecution methods, such as HEAT, previously confined to organized crime and narcotics trafficking organizations.

The agencies are not only focusing on professionals involved in healthcare fraud but also on the current Good Manufacturing Practices (cGMP) of pharmaceutical and medical companies. Recently, cGMP problems have become a source of health care fraud enforcement. The Food and Drug Administration (FDA) is intensifying its prosecution of cGMP laxity and the DOJ is viewing cGMP violations as potential civil or criminal issues.

Hence, the challenge of compliance is an increasing problem for everyone in the healthcare industry. Avoiding litigation for fraud or failure to comply with regulations is getting harder than ever.

In this CLE course, a panel of notable leaders and professionals assembled by The Knowledge Group will provide the audience with an in-depth review and discussion of the rigid, focused, and sophisticated Healthcare Fraud Enforcement Tactics. The speakers will also provide the audience with a set of best practices to remain in compliance and to avoid healthcare enforcement pitfalls in 2016 and beyond.

Key topics include:

  • The Affordable Care Act created new provisions the government plans to use against health fraud, waste, and abuse. These provisions include new tougher criminal sentences for health fraud convictions, and tougher suspension authority and screening measures over providers.
  • In June 2015, the DOJ and OIG together coordinated an unprecedented one day takedown of 243 people nationwide for alleged health fraud worth $712 million. The takedown highlights the government’s focus on multiple types of fraud, especially including cases involving medical necessity, home health agencies, and Medicare Part D schemes.
  • This year, the Office of Inspector General (OIG) has created a new task force that will primarily use both Civil Monetary Penalties and Exclusions from federal healthcare programs to go after alleged health fraud and abuse. The OIG announced that this new task force plans to target individual physicians instead of large healthcare systems. Once targeted, the OIG will pursue administrative actions that are easier to prosecute than actions under the False Claims Act.
  • Federal agencies are expanding the use of Data Analytics in an effort to become more proactive in detecting potential healthcare fraud. CMS’s Fraud Prevent System and OIG’s Medicare Fraud Strike Force both have a long-term goal to increase the use of technology and data to sniff out fraud sooner instead using the old “pay-and-chase” model of enforcement.
  • Unique enforcement risks facing executives in the health care industry in light of DOJ’s increasing invocation of  the Park doctrine and HHS OIG’s broadening authority to exclude individuals from participation in federally funded health care industry
  • Increased focus on violations of current Good Manufacturing Practices as a basis for criminal liability as well as liability under the False Claims Act
  • Current trends in criminal and civil enforcement against “off-label promotion” by both drug and device manufacturers in light of recent caselaw

Agenda

Thomas D. Bever, Partner
Chilivis Cochran Larkins & Bever LLP
  • The Affordable Care Act created new provisions the government plans to use against health fraud, waste, and abuse. These provisions include new tougher criminal sentences for health fraud convictions, and tougher suspension authority and screening measures over providers.
  • In June 2015, the DOJ and OIG together coordinated an unprecedented one day takedown of 243 people nationwide for alleged health fraud worth $712 million. The takedown highlights the government’s focus on multiple types of fraud, especially including cases involving medical necessity, home health agencies, and Medicare Part D schemes.
  • This year, the Office of Inspector General (OIG) has created a new task force that will primarily use both Civil Monetary Penalties and Exclusions from federal healthcare programs to go after alleged health fraud and abuse. The OIG announced that this new task force plans to target individual physicians instead of large healthcare systems. Once targeted, the OIG will pursue administrative actions that are easier to prosecute than actions under the False Claims Act.
  • Federal agencies are expanding the use of Data Analytics in an effort to become more proactive in detecting potential healthcare fraud. CMS’s Fraud Prevent System and OIG’s Medicare Fraud Strike Force both have a long-term goal to increase the use of technology and data to sniff out fraud sooner instead using the old “pay-and-chase” model of enforcement.

Patrick F. Linehan, Partner
Steptoe & Johnson LLP
  • Unique enforcement risks facing executives in the health care industry in light of DOJ’s increasing invocation of  the Park doctrine and HHS OIG’s broadening authority to exclude individuals from participation in federally funded health care industry
  • Increased focus on violations of current Good Manufacturing Practices as a basis for criminal liability as well as liability under the False Claims Act
  • Current trends in criminal and civil enforcement against “off-label promotion” by both drug and device manufacturers in light of recent caselaw

Who Should Attend

  • Health Care Organizations
  • Health Care Enforcement Agencies
  • Health Care Enforcement Professionals
  • Health Care Advisers and Counsel
  • Health Care Firms
  • Health Care Law Attorneys
  • Medical and Pharma Lawyers
  • Medical Device Providers
  • Pharma Industry Lawyers
  • Medical Directors
  • Other Related/Interested Professionals and Organizations

Emerging Issues in Health Care Enforcement CLE

Thomas D. Bever, Partner
Chilivis Cochran Larkins & Bever LLP
  • The Affordable Care Act created new provisions the government plans to use against health fraud, waste, and abuse. These provisions include new tougher criminal sentences for health fraud convictions, and tougher suspension authority and screening measures over providers.
  • In June 2015, the DOJ and OIG together coordinated an unprecedented one day takedown of 243 people nationwide for alleged health fraud worth $712 million. The takedown highlights the government’s focus on multiple types of fraud, especially including cases involving medical necessity, home health agencies, and Medicare Part D schemes.
  • This year, the Office of Inspector General (OIG) has created a new task force that will primarily use both Civil Monetary Penalties and Exclusions from federal healthcare programs to go after alleged health fraud and abuse. The OIG announced that this new task force plans to target individual physicians instead of large healthcare systems. Once targeted, the OIG will pursue administrative actions that are easier to prosecute than actions under the False Claims Act.
  • Federal agencies are expanding the use of Data Analytics in an effort to become more proactive in detecting potential healthcare fraud. CMS’s Fraud Prevent System and OIG’s Medicare Fraud Strike Force both have a long-term goal to increase the use of technology and data to sniff out fraud sooner instead using the old “pay-and-chase” model of enforcement.

Patrick F. Linehan, Partner
Steptoe & Johnson LLP
  • Unique enforcement risks facing executives in the health care industry in light of DOJ’s increasing invocation of  the Park doctrine and HHS OIG’s broadening authority to exclude individuals from participation in federally funded health care industry
  • Increased focus on violations of current Good Manufacturing Practices as a basis for criminal liability as well as liability under the False Claims Act
  • Current trends in criminal and civil enforcement against “off-label promotion” by both drug and device manufacturers in light of recent caselaw

Emerging Issues in Health Care Enforcement CLE

Emerging Issues in Health Care Enforcement CLE

Thomas D. BeverPartnerChilivis Cochran Larkins & Bever LLP

Tom Bever is a former federal prosecutor who focuses his practice on White Collar Criminal Defense and commercial litigation. He is listed in U.S. News Best Lawyers in America for Criminal Defense for White Collar Crime (2006–2015) and for Commercial Litigation (2009–2014), ranked as a Georgia Super Lawyer (Criminal Defense: White Collar), (2005-2015), Tom is in Chambers USA for White Collar Crime & Government Investigations. He has had a top AV Preeminent rating by Martindale Hubbell for more than 20 consecutive years. He is a member of the Litigation Counsel of America, a trial honorary society.

Tom earned his JDA and MBA from the University of Virginia, and practiced in Atlanta with Alston & Bird. He then served in the Criminal Division of the United States Attorney’s Office for the Northern District of Georgia, prosecuting fraud, public corruption, and general crimes. The U.S. Department of Justice awarded him a Special Commendation for his prosecution of a major FHA mortgage loan fraud case. Tom later served as Associate Counsel in the Office of Independent Counsel conducting the “Iran/Contra” investigation.

Tom returned to private practice with Chilivis Cochran Larkins & Bever LLP. Tom is focused primarily on White Collar criminal defense, representing individual and corporate clients in all stages of criminal investigations in federal and state courts, from the initiation of the investigation through trial. He also represents clients in civil litigation and trials, as well as administrative hearings and regulatory matters. Tom has served as lead counsel on behalf of companies on a variety of internal investigations. His cases have primarily been in healthcare, government contracting, securities, tax, environmental, and commercial disputes.

Tom speaks and appears regularly at a variety of professional seminars. These have included the National Seminar on the Federal Sentencing Guidelines, the American Bar Association’s Healthcare Fraud Institute, and annual seminars in Georgia on White Collar Crime, Healthcare Fraud, Federal Criminal Practice, and Internal Corporate Investigations.

Emerging Issues in Health Care Enforcement CLE

Patrick F. LinehanPartnerSteptoe & Johnson LLP

Patrick Linehan is a partner in Steptoe & Johnson, Washington, DC office, where he is a member of the White Collar Criminal Defense and Securities Litigation & Enforcement groups.  His practice focuses on representing companies and individuals in enforcement matters in the areas of health care fraud and abuse, antitrust, and securities fraud, among others, as well as in securities-related litigation.  Clients in the health care area have included, among others: 

  • Former CEO of pharmaceutical company against allegations of violations of FDA laws governing current Good Manufacturing Practices (cGMP)
  • Former associate general counsel of pharmaceutical company against false statement and obstruction of justice charges
  • Former marketing executive of pharmaceutical company, in connection with investigation involving allegations of off-label promotion and False Claims Act violations
  • Former executive of pharmaceutical company in connection with investigation of possible violations of Anti-Kickback Statute and the False Claims Act
  • Bay Area-based biologics company, in connection with investigation involving allegations of off-label promotion and False Claims Act violations

Click Here to Read Additional Material

Emerging Issues in Health Care Enforcement CLE

Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   On-demand Webcast

Prerequisite:
   NONE

Course Code:
   155378

NASBA Field of Study:
   Specialized Knowledge and Applications

NY Category of CLE Credit:
   Areas of Professional Practice

Total Credits:
    2.0 CLE

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About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Chilivis, Cochran, Larkins & Bever LLP is a litigation boutique with a broad client base of businesses and individuals, including executives, corporate officers, employees, physicians, physician practice groups, attorneys, and others facing high-stakes civil, white collar criminal, business litigation, health care, and administrative law matters in federal and state courts. Three of our five partners are former Assistant U.S. Attorneys in Georgia. Five partners are named as Super Lawyers. Three of our partners are in U.S. News & World Report as Best Lawyers in America. The firm has defended against and represented relators in false claims act cases since the early 1990s.

Website: https://www.cclblawyers.com/

For more than six decades, Steptoe has established a reputation for vigorous advocacy in complex litigation and arbitration, successful representation of clients before governmental agencies, and creative and practical advice in guiding business transactions.  The firm has more than 500 lawyers and other professionals in offices in Beijing, Brussels, Century City, Chicago, London, Los Angeles, New York, Palo Alto, Phoenix, and Washington.

The firm is known for its ability to help clients solve high-stakes, multidimensional problems, particularly those with a governmental aspect.

Website: https://www.steptoe.com/

Tom Bever is a former federal prosecutor who focuses his practice on White Collar Criminal Defense and commercial litigation. He is listed in U.S. News Best Lawyers in America for Criminal Defense for White Collar Crime (2006–2015) and for Commercial Litigation (2009–2014), ranked as a Georgia Super Lawyer (Criminal Defense: White Collar), (2005-2015), Tom is in Chambers USA for White Collar Crime & Government Investigations. He has had a top AV Preeminent rating by Martindale Hubbell for more than 20 consecutive years. He is a member of the Litigation Counsel of America, a trial honorary society.

Tom earned his JDA and MBA from the University of Virginia, and practiced in Atlanta with Alston & Bird. He then served in the Criminal Division of the United States Attorney’s Office for the Northern District of Georgia, prosecuting fraud, public corruption, and general crimes. The U.S. Department of Justice awarded him a Special Commendation for his prosecution of a major FHA mortgage loan fraud case. Tom later served as Associate Counsel in the Office of Independent Counsel conducting the “Iran/Contra” investigation.

Tom returned to private practice with Chilivis Cochran Larkins & Bever LLP. Tom is focused primarily on White Collar criminal defense, representing individual and corporate clients in all stages of criminal investigations in federal and state courts, from the initiation of the investigation through trial. He also represents clients in civil litigation and trials, as well as administrative hearings and regulatory matters. Tom has served as lead counsel on behalf of companies on a variety of internal investigations. His cases have primarily been in healthcare, government contracting, securities, tax, environmental, and commercial disputes.

Tom speaks and appears regularly at a variety of professional seminars. These have included the National Seminar on the Federal Sentencing Guidelines, the American Bar Association’s Healthcare Fraud Institute, and annual seminars in Georgia on White Collar Crime, Healthcare Fraud, Federal Criminal Practice, and Internal Corporate Investigations.

Patrick Linehan is a partner in Steptoe & Johnson, Washington, DC office, where he is a member of the White Collar Criminal Defense and Securities Litigation & Enforcement groups.  His practice focuses on representing companies and individuals in enforcement matters in the areas of health care fraud and abuse, antitrust, and securities fraud, among others, as well as in securities-related litigation.  Clients in the health care area have included, among others: 

  • Former CEO of pharmaceutical company against allegations of violations of FDA laws governing current Good Manufacturing Practices (cGMP)
  • Former associate general counsel of pharmaceutical company against false statement and obstruction of justice charges
  • Former marketing executive of pharmaceutical company, in connection with investigation involving allegations of off-label promotion and False Claims Act violations
  • Former executive of pharmaceutical company in connection with investigation of possible violations of Anti-Kickback Statute and the False Claims Act
  • Bay Area-based biologics company, in connection with investigation involving allegations of off-label promotion and False Claims Act violations

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