Post on 29-Jul-2015
Disclaimer
• Not legal advice• May not be specific to your situation• Does not create an attorney/ client relationship
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Legal & Regulatory Sections
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False Claims Act
Anti-Kickback Law
Stark Law
Park Doctrine
What Matters - FCA
• What is it?1. Actions brought by the Department of Justice
2. Whistleblower or qui tam provisions allow individuals to bring actions in the name of the government, and can share in any recovery
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No specific intent to defraud must be proved
What Matters -FCA
• “any person who—(A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval;
• (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; … “
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31 USC § 3729
“presents, or causes to be
presented a false.. claim”
“makes, uses, or causes to be made
or used, a false record…”
Penalty & Damages - FCA … is liable to the United States Government for a civil penalty of not less than $5,500 and not more than $11,000, …, plus 3 times the amount of damages which the Government sustains because of the act of that person.”
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5500/ 11000
3x Govt. damages
Civil Penalty
What Matters - FCA
• How can it be implicated?
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Double Billing
Misused Grants or
Deviations from
BudgetClaims for
services not rendered,
or not rendered as represented
Claims related to
the payment or receipt of a
kickbackRetaining
government funds when there is an obligation to repay
Informed consent
says patient won’t be charged
What Matters – Anti-Kickback Law
• How is it different from the FCA?
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No Private Right of Action
Anti Kickback Law• Whoever knowingly and willfully solicits or receives any
remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
• (B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care
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42 USC § 1320A–7B
…solicits or receives any remuneration..
…for furnishing or arranging.. Any item or service for which payment was made..
Intent - AKL
“a person need not have actual knowledge of this section or specific intent to commit a violation of this section.”
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Anti-Kickback Law - Penalties
“… shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both.”
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$25000 Imprisonment = 5 years Penalties
What Matters – Anti-Kickback Law
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Seeding Trials
Payments above FMV
Investigator Initiated Trials
Stark Law
• How many sites here are owned by Physicians who have separate practices?
• How many sites here are owned by Physicians whose own separate laboratories?
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Stark Law
• Applies primarily to CROs, sites and physicians
• Technically a series of laws
• Governs self referral
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What is Prohibited: Self Referral
• The physician may not make a referral to the entity for the furnishing of designated health services for which payment otherwise may be made under this title,
• Prohibits an entity from presenting a claim to Medicare or to any person or other entity for DHS provided under a prohibited referral.
42 U.S.C. 1395 Kulkarni Law Firm, PC
Penalties
• No Medicare payment may be made for DHS rendered as a result of a prohibited referral;
• Entity must timely refund any amounts collected for DHS performed under a prohibited referral.
• Civil money penalties may also apply under some circumstances.
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Some Potential Improper Arrangements
Referrals
Co-ownership of
PI and MD Office
Co-ownership of
offices and Central labs
Insufficient assessment
of FMV
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Park Doctrine - Factors
• Individual’s position in the company • Relationship to the violation• Did the official have authority to correct or prevent
violation?• Knowledge of/actual participation in violation?
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Please let me know if you
want full list.
Park Doctrine - Impact
Administrative Fines & Penalties
Criminal Fines
Civil Fines
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Park Doctrine - What is it?
• Also called “Responsible Corporate Officer (RCO) Doctrine”
• RCO can be held liable for a first time misdemeanor (and subsequent felony) under the FD&C Act without proof of intent or negligence, even if no actual knowledge of or participation in specific offense
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Synthes - Impact
Monetary penalties: $22,500,000 (Norian) + $669,800 (Synthes)
Forfeiture of defendant Synthes
4 executives charged via Park Doctrine got 5-9 months in jail
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Scott Harkonen - Impact
Convicted of wire fraud in September 2009
Fined $20,000
Sentenced to 6 months of home confinement
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Administrative Penalties
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Public Relations Impact
Temporary Exclusions
Permanent Exclusions
Consent Decrees Fines
Compliance
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Compliance Officer/
CommitteeWritten Standards
Training Program
Report Overpayments
Provide OIG with annual compliance
reports
Restrict employment of ineligible
persons
Please contact me for a printable list
of factors
Future
• Impact of Physician Payment Sunshine Act
• Results reporting
• Franck's Pharmacy
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Financial ReportingClinical
trials.govRegulations v. Guidances
Questions?
Darshan Kulkarni
Kulkarni Law Firm, PC
Ph: 215-703-7842
SLIDES MADE AVAILABLE.
@FDALawyers
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References
• http://www.taf.org/whyfca.htm• False Claims Act: 31 U.S.C. § 3729-3733 • Anti-Kickback Law: 42 U.S.C. § 1320a-7b(b) • False, Fictitious or Fraudulent Claims: 18 USC 287• http
://www.mintz.com/newsletter/2012/Advisories/1618-0112-NAT-HCED/1618-0112-NAT-HCED_index.pdf
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