Billing Compliance for Clinical Trials

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Information about Billing Compliance for Clinical Trials
Health & Medicine

Published on February 19, 2014

Author: Darshan1979



Billing Compliance for Clinical Trials. Discussions include the False Claims Act, Anti-Kickback Law, and other related laws


2 Disclaimer • Not legal advice • May not be specific to your situation • Does not create an attorney/ client relationship Kulkarni Law Firm, PC

Legal & Regulatory Sections 3 False Claims Act Anti-Kickback Law Stark Law Park Doctrine Kulkarni Law Firm, PC

Outline FCA Sunshine Act FMV: Stark Kulkarni Law Firm, PC AntiKickback

• • • • • • FCA AKL Stark Park Doctrine Planning Future False Claims ACT

6 What Matters - FCA • What is it? No specificof Justice 1. Actions brought by the Department intentqui tamdefraud to provisions allow 2. Whistleblower or individuals to bring actions in the name of the mustcan shareproved be in any recovery government, and Kulkarni Law Firm, PC

7 “presents, What Matters -FCA or causes to be • “any person who— presented a false.. (A) knowingly presents, or causes to be presented, a claim” false or fraudulent claim for payment or approval; • (B) knowingly makes, uses, or causes to be made or “makes, uses, or used, a false record or statement material to a false or causes to be made fraudulent claim; or used, a false …“ record…” 31 USC § 3729 Kulkarni Law Firm, PC

8 Penalty & Damages - FCA … is liable to the United States GovernmentCivil a civil for 5500/ 3x Govt. 11000 damages Penalty 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.” Kulkarni Law Firm, PC

What Matters - FCA 9 • How can it be implicated? Claims Informed Misused related to consent says Grants or the payment patient Deviations or receipt of Claims for Retaining won’t be from Budget a kickback services not government charged rendered, or funds when Double not there is an Billing rendered as obligation to represented repay Kulkarni Law Firm, PC

• • • • • • FCA AKL Stark Park Doctrine Planning Future Anti-kickback law

11 What Matters – Anti-Kickback Law • How is it different from the FCA? Kulkarni Law Firm, PC

12 Anti Kickback Law …solicits or receives • Whoever knowingly any willfully solicits or receives any and remuneration.. 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 …for furnishing or made in whole or in part under a Federalitem care program, or arranging.. Any health • (B) in return for purchasing, leasing, ordering, or arranging for or or service for which recommending purchasing, leasing, ormade.. any payment was ordering good, facility, service, or item for which payment may be made in whole or in part under a Federal health care 42 USC §Kulkarni Law Firm, PC 1320A–7B

13 Intent - AKL “a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” Kulkarni Law Firm, PC

14 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.” $25000 Kulkarni Law Firm, PC Imprisonment = 5 years Penalties

15 What Matters – Anti-Kickback Seeding Trials Law Payments above FMV Investigator Initiated Trials Kulkarni Law Firm, PC

16 What Matters – Anti-Kickback Law AntiKickback FCA Kulkarni Law Firm, PC

Stark Law 17 • How many sites here are owned by Physicians who have separate practices? • How many sites here are owned by Physicians whose own separate laboratories? Kulkarni Law Firm, PC

Stark Law • Applies primarily to CROs, sites and physicians • Technically a series of laws • Governs self referral Kulkarni Law Firm, PC

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

Potential exposure

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. Kulkarni Law Firm, PC

Some Potential Improper Arrangements Referrals Coownership of PI and MD Office Coownership of offices and Central labs Insufficient assessment of FMV Kulkarni Law Firm, PC

23 • • • • • • FCA AKL Stark Park Doctrine Planning Future Law Firm, PC Kulkarni Park Doctrine

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? Please let me know if you want full list. Kulkarni Law Firm, PC

Park Doctrine - Impact Kulkarni Law Firm, PC

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 Kulkarni Law Firm, PC

Synthes - Impact Monetary penalties: $22,500,000 (Norian) + $669,800 (Synthes) Forfeiture of defendant Synthes 4 executives charged via Park Doctrine got 59 months in jail Kulkarni Law Firm, PC

Scott Harkonen - Impact Convicted of wire fraud in September 2009 Fined $20,000 Sentenced to 6 months of home confinement Kulkarni Law Firm, PC

• • • • • FCA AKL Penalties Planning Future Penalties

30 Administrative Penalties Kulkarni Law Firm, PC

• • • • • • FCA AKL Stark Park Doctrine Planning Future Compliance planning

32 Compliance Compliance Provide OIG Written Standards Officer/ with annual Restrict Committee compliance Report Please contact me for areports printable list of factors Training Program Kulkarni Law Firm, PC employment Overpayments of ineligible persons

• • • • • • FCA AKL Stark Park Doctrine Planning Future Future

Future 34 • Impact of Physician Payment Sunshine Act • • Financial ReportingClinical Results reporting Regulations Franck's Pharmacy v. Guidances Kulkarni Law Firm, PC

35 Questions? Darshan Kulkarni Kulkarni Law Firm, PC Ph: 215-703-7842 SLIDES MADE AVAILABLE. @FDALawyers Kulkarni Law Firm, PC

References 36 • • • • • 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 Kulkarni Law Firm, PC

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