THE AMERICAN LAW INSTITUTE Continuing Legal

Transcription

THE AMERICAN LAW INSTITUTE Continuing Legal
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THE AMERICAN LAW INSTITUTE
Continuing Legal Education
Strategies for Avoiding and Responding
to Health Care Fraud and Abuse Claims
May 6, 2015
Telephone Seminar/Audio Webcast
Strategies for Avoiding and Responding
to Health Care Fraud and Abuse Claims
PowerPoint Presentation
By
Thomas W. Beimers
Faegre Baker Daniels LLP
Minneapolis, Minnesota
Amy F. Lerman
Epstein Becker & Green, PC
Washington, D.C.
Robert D. Stone
Alston & Bird LLP
Atlanta, Georgia
Michaela ("Kayla") Tabela
Locke Lord LLP
Boston, Massachusetts
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Strategies for Avoiding and
Responding to Health Care Fraud
and Abuse Claims
Wednesday, May 6, 2015
12:00 – 1:30 pm Eastern
Telephone Seminar Audio Webcast
INTRODUCTION OF SPEAKERS
• Thomas W. Beimers, Faegre Baker Daniels LLP
(Moderator)
• Robert D. Stone, Alston & Bird LLP
• Amy Lerman, Epstein Becker & Green, P.C.
• Michaela (“Kayla”) Tabela, Locke Lord LLP
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INTRODUCTION OF TOPICS FOR TODAY
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Federal Anti-Kickback Statue
– Recent AKS enforcement efforts and regulatory changes
• Novartis case and switching arrangements
• OIG special advisory on pharmacy co-payment coupons
• Safe harbor amendments
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Federal False Claims Act (FCA)
– “Reverse” False Claims
– 60-Day Overpayment Rule
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Continuum and Keltner cases
Federal Physician Self-Referral Law (“Stark Law”)
– Stark litigation update: Tuomey & Halifax cases
– Stark law enforcement and compliance trends
– Update on the CMS self-referral disclosure protocol
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Summary of Government Enforcement, Investigations, and Risk Mitigation
– Understanding the Enforcement Environment
– Risk mitigation and key compliance considerations
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Anti-Kickback Statute
Michaela (“Kayla”) Tabela, Locke Lord LLP
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Overview
• 42 U.S.C. § 1320a-7b(b)
• Prohibits offering, paying, soliciting or receiving
anything of value to induce or reward referrals or
generate Federal health care program business
• Referrals can be from anyone
• Any item or service
• Any Federal health care program
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Regulatory Changes
• Criminal Statute: Government must show that
defendant acted with requisite intent (“knowingly
and willfully”)
– Specific Intent?
• Post-ACA: “With respect to violations of this section, a
person need not have actual knowledge of this section
or specific intent to commit a violation of this section.”
– One Purpose Test
• Safe Harbors
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Penalties
• Criminal
– Fines up to $25,000 per violation
– Up to a 5 year prison term per violation
• Civil/Administrative
– Liability under the False Claims Act
– Civil monetary penalties (“CMPs”) and program
exclusion
– Potential $50,000 CMP per violation
– Treble damages
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U.S. ex rel. Bilotta v. Novartis
Pharmaceuticals Corp.
• In 2011, a whistleblower (former employee)
filed an action under the False Claims Act
alleging that “from January 2002 through at
least November 2011, Novartis systematically
bribed doctors to induce them to prescribe
drugs from Novartis’s cardiovascular division
for their patients.”
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