Healthcare Fraud & Abuse Review 2019
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Health Industry Business Communications Council
Health Industry Business Communications Council Registered Labelers: Accredited Auto-ID Labeling Standards Argentina New MedTek Devices Pty Ltd Oxavita SRL Norseld Pty Ltd. Novadien Healthcare Pty Ltd The following companies Odontit S.A. (and/or their subsidiaries/ PAMPAMED S.R.L. Numedico Technologies Pty Ltd divisions) have applied PATEJIM SRL Opto Global Pty. Ltd. for a Labeler Identification Orthocell Limited Code (LIC) assignment with Austria Prolotus Technologies Pty Ltd HIBCC*. By doing so, they afreeze GmbH Red Milawa Pty Ltd dba Magic Mobility have demonstrated their AMI GmbH SDI Limited commitment to patient safety Bender Medsystems GmbH Signostics Ltd. and logistical efficiency for BHS Technologies GmbH Sirtex Medical Pty Ltd their customers, the industry Metasys Medizintechnik GmbH Smith & Nephew Surgical Pty. Ltd. and the public at large. PAA Laboratories GmbH Staminalift International Limited Safersonic Medizinprodukte Handels The Pipette Company Pty. Ltd. Any organization that is GmbH Thermo Electron Corporation interested in using the HIBC W & H Dentalwerk Burmoos GmbH Vush Pty Ltd uniform labeling system may apply for the assignment of VUSH STIMULATION Australia one or more LICs. William A Cook Australia Pty. Ltd. Adv. Surgical Design & Manufacture, Ltd. Last updated 9-21-2021 AirPhysio Pty Ltd Belgium Annalise-AI Pty Ltd 3M Europe Apollo Medical Imaging Technology Pty Advanced Medical Diagnostics SA/NV Ltd Analis SA/NV Benra Pty Ltd dba Gelflex Laboratories Baxter World Trade Bioclone Australia Pty. Ltd. Bio-Rad RSL Candelis, Inc. Bio-Rad Lab Inc Clinical Diag. Group DePuy Australia Pty. Ltd. Biosource Europe SA For more information, please dorsaVi Ltd Cilag NV contact the HIBCC office at: EC Certification Service GmbH Coris Bioconcept Fink Engineering Pty Ltd Fuji Hunt Photographic Chemicals NV 2525 E. -
United States of America Ex Rel. Dr. Peter Rost V. Pfizer
UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS UNITED STATES OF AMERICA ex rel. * DR. PETER ROST, * * Plaintiff, * * v. * Civil Action No. 03-11084-JLT * PFIZER INC and PHARMACIA * CORPORATION, * * Defendants. * MEMORANDUM August 30, 2006 TAURO, J. Plaintiff-Relator, Dr. Peter Rost, (“Plaintiff”) brings this qui tam action against Defendants Pfizer, Inc. and Pharmacia Corporation (collectively “Defendants”), alleging violations of the Federal False Claims Act1 (“FCA”) and similar state statutes.2 Plaintiff asserts that Defendants, through illegal, off-label marketing of the drug Genotropin, knowingly caused the submission of false claims to federal and state health insurance programs. Defendants now move to dismiss 1 See 31 U.S.C. § 3729 et seq. (2006). 2 See California False Claims Act, Cal. Gov’t Code §§ 12650 et seq.; Delaware False Claims and False Reporting Act, Del. Code Ann. tit. 6, §§ 1201 et seq.; District of Columbia Procurement Reform Amendment Act, D.C. Code §§ 2-308-13 et seq.; Florida False Claims Act, Fla. Stat. §§ 68.081 et seq.; Hawaii False Claims Act, Haw. Rev. Stat. §§ 661-21 et seq.; Illinois Whistleblower Reward and Protection Act, 740 Ill. Comp. Stat.175 et seq.; Massachusetts False Claims Law, Mass. Gen. Laws ch. 12, §§ 5 et seq.; Nevada False Claims Act, Nev. Rev. Stat. §§ 357.010 et seq.; Tennessee Medicaid Fraud Prevention Law, Tenn. Code Ann. §§ 71-5-181 et seq.; Texas Medicaid Fraud Prevention Law, Tex. Hum. Res. Code Ann. §§ 36.001 et seq.; Virginia Fraud Against Taxpayers Act, Va. Code Ann. §§ 8.01-216.1 et seq. 1 Plaintiff’s complaint, arguing that this court lacks subject matter jurisdiction and that Plaintiff’s complaint fails to allege fraud with sufficient particularity. -
Largest 25 Whistleblower Rewards Paid Under the False Claims Act
Top 25 Largest Whistleblower Rewards paid under the False Claims Act and Qui Tam Whistleblower Reward Program Here is a list of the top 25 largest Federal and State False Claims Act qui tam whistleblower reward cases. The government pays rewards to whistleblowers a portion ranging from 15% to 25% of the civil False Claims Act recovery. More details about whistleblower rewards can be found at www.HowToReportFraud.com. Rank Company FCA Settlement Reward Date 1. GlaxoSmithKlinei $2 billion $300 million≈ July 2012 2. Bank of Americaii $1.85 billion $275 million≈ November 2014 3. Johnson & Johnsoniii $1.72 billion $167 million November 2013 4. Pfizeriv $1 billion $102 million August 2009 5. Tenet Heathcarev $900 million $150 million June 2006 6. Abbott Labsvi $800 million $84 million May 2012 7. Eli Lillyvii $800 million $79 million January 2009 8. HCAviii $745 million $150 million December 2000 9. Merckix $650 million $100 million≈ February 2008 10. HCAx $641 million $151 million June 2003 11. JP Morganxi $614 million $90 million≈ February 2014 12. Amgenxii $612 million $90 million≈ December 2012 13. GlaxoSmithKilnexiii $600 million $90 million≈ October 2010 14. Seronoxiv $567 million $50 million October 2005 15. TAPxv $540 million $95 million October 2001 16. New Yorkxvi $540 million $10 million* July 2009 17. AstraZenecaxvii $520 million $45 million April 2010 18. Abbott Labsxviii $414 million $60 million≈ July 2003 19. Freseniusxix $385 million $65 million January 2000 20. NMExx $379 million $65 million July 1994 21. Cephalonxxi $375 million $46 million September 2008 22. Ranbaxyxxii $350 million $49 million May 2013 23. -
Health Care Enforcement 2020 Year in Review & 2021 Outlook
HEALTH CARE ENFORCEMENT 2020 Year in Review & 2021 Outlook TABLE OF CONTENTS Introduction ......................................................................................................................................3 Statistical Trends in Civil False Claims Act Litigation in 2020 .................................................................4 Qui Tam Case Volume Decreased While Government-Initiated Matters Increased .................................4 Hospitals and Physicians Continue to Be the Leading Targets of Qui Tam Cases ...................................7 Current and Former Employees Continue to Bring the Vast Majority of Health Care Qui Tam Cases ...............................................................................................................................7 Health Care Qui Tam Suits Are Concentrated in Major Metropolitan Areas ............................................8 Health Care Fraud Enforcement Priorities in 2020 ................................................................................9 Opioids .........................................................................................................................................9 Purdue Pharma ............................................................................................................................9 Indivior Solutions ....................................................................................................................... 10 Practice Fusion ......................................................................................................................... -
Qui Tam Relators, the First Amendment, and the False Claims Act Joshua Patrick Mahoney [email protected]
University of Chicago Legal Forum Volume 2012 | Issue 1 Article 13 Qui Tam Relators, the First Amendment, and the False Claims Act Joshua Patrick Mahoney [email protected] Follow this and additional works at: http://chicagounbound.uchicago.edu/uclf Recommended Citation Mahoney, Joshua Patrick () "Qui Tam Relators, the First Amendment, and the False Claims Act," University of Chicago Legal Forum: Vol. 2012: Iss. 1, Article 13. Available at: http://chicagounbound.uchicago.edu/uclf/vol2012/iss1/13 This Comment is brought to you for free and open access by Chicago Unbound. It has been accepted for inclusion in University of Chicago Legal Forum by an authorized administrator of Chicago Unbound. For more information, please contact [email protected]. Comments Qui Tam Relators, the First Amendment, and the False Claims Act Joshua Patrick Mahoneyt INTRODUCTION The False Claims Act (FCA)1 allows a private citizen to file suit "for the person and for the United States government." 2 The citizen sues to recover damages for "false or fraudulent claim[s]" submitted to the government for payment.3 While the Attorney General is also authorized to bring claims under the FCA, 4 pri- vate citizen suits, also called "qui tam"5 suits, comprise a signifi- cant majority of FCA claims filed.6 Qui tam suits account for the largest portion of funds recovered under the FCA.7 To bring a qui t BA 2009, University of Northern Iowa; JD Candidate 2013, The University of Chicago Law School. 1 31 USC §§ 3729-33. 2 31 USC § 3730(b)(1). 3 31 USC § 3729(a). -
I4i Makes the Patent World Blind Michael J
COMMENTS i4i Makes the Patent World Blind Michael J. Conway† All patents receive a presumption of validity pursuant to 35 USC § 282. Courts have traditionally put this presumption into practice by requiring inva- lidity to be established by clear and convincing evidence. The Supreme Court reaffirmed this understanding of the presumption in Microsoft Corp v i4i Ltd Partnership. District courts have divided, however, on whether to require clear and con- vincing evidence when the challenger seeks to invalidate a patent for covering inel- igible subject matter. The conflict originates from a concurrence written by Justice Stephen Breyer in i4i, in which he stated that a heightened standard of proof—like the clear and convincing standard—can apply only to issues of fact, not issues of law. Because subject-matter eligibility has traditionally presented an issue of law, some courts hold that subject-matter-eligibility challenges cannot be subjected to the clear and convincing standard. Other courts agree with that sentiment but would apply the clear and convincing standard to resolve any underlying issues of fact. Still others maintain that subject-matter-eligibility challenges must be estab- lished by clear and convincing evidence. This Comment resolves this ambiguity by showing that subject-matter- eligibility challenges must be established by clear and convincing evidence. It com- pares subject-matter-eligibility challenges to two other patent validity challenges: the on-sale bar and nonobviousness. These two comparisons show that patent law has consistently failed to confine the clear and convincing standard to issues of law. In fact, the standard has been imposed without regard for the distinction be- tween issues of law and fact. -
Zerohack Zer0pwn Youranonnews Yevgeniy Anikin Yes Men
Zerohack Zer0Pwn YourAnonNews Yevgeniy Anikin Yes Men YamaTough Xtreme x-Leader xenu xen0nymous www.oem.com.mx www.nytimes.com/pages/world/asia/index.html www.informador.com.mx www.futuregov.asia www.cronica.com.mx www.asiapacificsecuritymagazine.com Worm Wolfy Withdrawal* WillyFoReal Wikileaks IRC 88.80.16.13/9999 IRC Channel WikiLeaks WiiSpellWhy whitekidney Wells Fargo weed WallRoad w0rmware Vulnerability Vladislav Khorokhorin Visa Inc. Virus Virgin Islands "Viewpointe Archive Services, LLC" Versability Verizon Venezuela Vegas Vatican City USB US Trust US Bankcorp Uruguay Uran0n unusedcrayon United Kingdom UnicormCr3w unfittoprint unelected.org UndisclosedAnon Ukraine UGNazi ua_musti_1905 U.S. Bankcorp TYLER Turkey trosec113 Trojan Horse Trojan Trivette TriCk Tribalzer0 Transnistria transaction Traitor traffic court Tradecraft Trade Secrets "Total System Services, Inc." Topiary Top Secret Tom Stracener TibitXimer Thumb Drive Thomson Reuters TheWikiBoat thepeoplescause the_infecti0n The Unknowns The UnderTaker The Syrian electronic army The Jokerhack Thailand ThaCosmo th3j35t3r testeux1 TEST Telecomix TehWongZ Teddy Bigglesworth TeaMp0isoN TeamHav0k Team Ghost Shell Team Digi7al tdl4 taxes TARP tango down Tampa Tammy Shapiro Taiwan Tabu T0x1c t0wN T.A.R.P. Syrian Electronic Army syndiv Symantec Corporation Switzerland Swingers Club SWIFT Sweden Swan SwaggSec Swagg Security "SunGard Data Systems, Inc." Stuxnet Stringer Streamroller Stole* Sterlok SteelAnne st0rm SQLi Spyware Spying Spydevilz Spy Camera Sposed Spook Spoofing Splendide -
False Claims Act Practice Guide 2021 ©2021 Smith Pachter Mcwhorter PLC
False Claims Act Practice Guide 2021 ©2021 Smith Pachter McWhorter PLC. This publication is not intended to provide legal advice but to provide information on legal matters. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Readers should seek specific legal advice before taking any action with respect to matters mentioned in this publication. SMITH PACHTER McWHORTER PLC Table of Contents Introduction Part One: FCA Statutory Framework and Legal Elements A. FCA Statute and Elements of Proof .............................................................................................. 1 B. Elements of Proof and Judicial Interpretations of Terms ................................................................... 2 C. Qui Tam Provision ................................................................................................................... 4 D. FCA’s Statute of Limitations ....................................................................................................... 6 E. Damages ............................................................................................................................... 6 Part Two: Risk Areas and Enforcement A. Theories of Liability ................................................................................................................. 8 1. Improper Performance on Deliverables ................................................................................... 9 2. Truth in Negotiations Act Violations ...................................................................................... -
Astrazeneca to Pay $520 Million for Off-Label Drug Marketing
U.S. Department of Justice United States Attorney Eastern District of Pennsylvania 615 Chestnut Street Suite 1250 Philadelphia, Pennsylvania 19106-4476 (215) 861-8200 April 27, 2010 PHARMACEUTICAL COMPANY ASTRAZENECA TO PAY $520 MILLION FOR OFF-LABEL DRUG MARKETING WASHINGTON – The Department of Justice today announced a $520 million civil settlement with pharmaceutical company AstraZeneca LP and AstraZeneca Pharmaceuticals, LP (AstraZeneca) to resolve allegations made under the civil False Claims Act that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA). Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label. United States Attorney General Eric Holder, Assistant Attorney General for the Civil Division Tony West, and United States Attorney Michael L. Levy of the Eastern District of Pennsylvania announced the settlement today. They were joined by Special Agent-in-Charge Nick DiGiulio of the Office of Inspector General of the Department of Health and Human Services. AstraZeneca, headquartered in Wilmington, Delaware, signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare, and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program, and the Bureau of Prisons. The civil settlement agreement provides that AstraZeneca will pay up to $520 million to the federal government and the states to resolve civil allegations originally brought in a lawsuit under the qui tam provisions of the federal False Claims Act and various state False Claims Act statutes. -
Healthcare & Life Sciences Industry Update
Healthcare & Life Sciences Industry Update August 2011 Member FINRA/SIPC www.harriswilliams.com What We’ve Been Reading August 2011 • The biggest story from inside the Beltway over the last month was the battle and eventual deal to raise the U.S. debt ceiling to avoid an impending August 2nd default. The Budget Control Act of 2011 will raise the debt ceiling by $2.1-$2.4 trillion, while reducing spending by approximately $2.1 trillion over the next decade. In an interesting post-deal analysis, Michael Hiltzik of the Los Angeles Times notes that despite the protracted negotiations over a broad spectrum of cost-cutting measures, healthcare was not raised as a primary issue. Some have found this especially concerning, considering the outsized portion of the Federal Budget currently allocated to healthcare spending, which is forecast to rise in the coming years. A recent article in The Economist, entitled “Looking to Uncle Sam” makes this point and goes further to suggest that Centers for Medicare & Medicaid Services (CMS) actuaries may be underestimating future increases in Medicare and Medicaid spending. • One potential reason CMS actuaries may be underestimating the future costs of Medicare and Medicaid relates to healthcare reform’s effect on employee benefits, and specifically, the 2014 switch to subsidized exchange policies. A recent report by McKinsey & Company estimates that approximately 30% of employers will stop offering employer- sponsored insurance (ESI) when this switch is made, as opposed to the 7% estimated by the Congressional Budget Office. An ESI exodus of this magnitude could cause substantial strain on an already robust government healthcare budget. -
Healthcare Fraud & Abuse Review 2017
HEALTHCARE FRAUD & ABUSE REVIEW 2017 i | BASS, BERRY & SIMS HEALTHCARE FRAUD & ABUSE REVIEW 2017 1. A LOOK BACK…A LOOK AHEAD 4. NOTEWORTHY SETTLEMENTS 7. ISSUES TO WATCH 12. FALSE CLAIMS ACT UPDATE 37. STARK LAW/ANTI-KICKBACK STATUTE 40. PHARMACEUTICAL AND MEDICAL DEVICE DEVELOPMENTS 42. APPENDIX – 2017 NOTABLE SETTLEMENTS Hospitals and Health Systems Managed Care/Insurance Hospice Laboratory, Pathology, Radiology and Diagnostics Home Health Specialty Care and Other Provider Entities SNFs and Nursing Homes Individual Providers Pharmaceutical and Device Miscellaneous/Non-Providers Pharmacy Services 70. ABOUT BASS, BERRY & SIMS General (HHS-OIG), along with federal and state law enforcement entities, including 30 Medicaid Fraud Control Units, charged more than 400 defendants, including 115 healthcare professionals, A LOOK BACK… in 41 federal districts for allegedly participating in fraudulent healthcare arrangements resulting in over $1.3 billion in false claims.6 A LOOK AHEAD Occurring in the context of combatting the opioid crisis, the takedown focused on individuals allegedly involved in fraudulent billing of Medicare, Medicaid and TRICARE for medically While the uncertainty associated with legislative efforts to repeal unnecessary prescription and compounded drugs that were not actually purchased or distributed to patients covered by a federal healthcare program. In total, more than 120 the Patient Protection and Affordable Care Act (PPACA) dominated defendants, including physicians, were charged in connection with prescribing and distributing most of the headlines for the healthcare industry last year, it was opioids and narcotics. Nearly 300 individuals—including physicians, nurses and pharmacists— mostly business as usual for the government’s healthcare fraud received exclusion notices from HHS-OIG barring future participation in federal healthcare 7 enforcement efforts. -
Educational Outreach Workbook Notes ______Iowa Fraud Fighters – Shield Your Savings
IOWA FRAUD FIGHTERS EDUCATIONAL OUTREACH WORKBOOK NOTES ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ ______________________________________________ IOWA FRAUD FIGHTERS – SHIELD YOUR SAVINGS Welcome to the Iowa Insurance Division’s Iowa Fraud Fighters