Rule 9(b) Particularity
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The FCA and Medical Necessity: An Increasingly Tenuous Relationship

On January 19, 2017, another district court ruled that a mere difference of opinion between physicians is not enough to establish falsity under the False Claims Act.  In US ex rel. Polukoff v. St. Mark’s et al., No. 16-cv-00304 (Jan. 17, 2017 D. Utah), the district court dismissed relator’s non-intervened qui tam complaint with prejudice based on a combination of Rule 9(b) and 12(b)(6) deficiencies.  In so doing, the Polukoff court joined US v. AseraCare, Inc., 176 F. Supp. 3d 1282, 1283 (N.D. Ala. 2016) and a variety of other courts in rejecting False Claims Act claims premised on lack of medical necessity or other matters of scientific judgment.  This decision came just days before statements by Tom Price, President Trump’s pick for Secretary of Health and Human Services (HHS), before the Senate Finance Committee in which he suggested that CMS should focus less on reviewing questions medical necessity and more on ferreting out true fraud.  Price’s...

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First Circuit Deems Request for Leave to File Fourth Amended Complaint Futile

On December 23, 2016, the US Court of Appeals for the First Circuit issued an opinion in United States ex rel. D’Agostino v. ev3, Inc. (Case No. 16-1126), affirming the US District Court for the District of Massachusetts’s denial of a relator’s motion for leave to file a fourth amended complaint under the False Claims Act (FCA). The relator, a former sales representative at ev3, a medical device developer and manufacturer, alleged that his former employer and its subsidiary, Micro Therapeutics, Inc., violated provisions of the FCA by selling two products, the Onyx Liquid Embolic System (Onyx) and the Axium Detachable Coil System (Axium), to hospitals seeking reimbursements by the government through the Centers for Medicare & Medicaid Services (CMS). The relator filed his original complaint in October 2010. He amended the complaint as a matter of right in February 2011, and twice more with the permission of the court. In October 2013, the government...

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First Circuit Affirms Dismissal of Former Sales Representative’s False Claims Act Claims Against Medical Device Manufacturer

On December 16, 2016, the US Court of Appeals for the First Circuit issued an opinion in United States ex rel. Hagerty v. Cyberonics, Inc. (Case No. 16-1304) affirming the US District Court for the District of Massachusetts’ dismissal of a relator’s False Claims Act (FCA) claims for failure to plead the alleged fraudulent scheme with the level of particularity required by Federal Rule of Civil Procedure 9(b). The relator, a former sales representative of medical device manufacturer Cyberonics, Inc., alleged that his former employer had engaged in a scheme to overbill the government by encouraging unnecessary, untimely surgical procedures to prematurely replace batteries in patients’ Vagus Nerve Stimulator (VNS) devices. The relator alleged that while VNS devices, implanted to treat patients with refractory epilepsy, have battery lives of eight to nine years, Cyberonics adopted a sales strategy designed to result in battery replacements after four to five...

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Sixth Circuit Revives Home Health Qui Tam Based on Pre-Escobar Standards; Dissent Criticizes Majority for Engaging in Rulemaking

On September 30, the US Court of Appeals for the Sixth Circuit reversed dismissal of a relator’s False Claims Act (FCA) claims against providers of home health services in U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc. et al. The relator was a utilization review nurse who alleged that physician certifications of patient need for home health care were not signed until well after the care had been provided, in violation of 42 C.F.R. § 424.22(a)(2), which requires that such certifications be completed at the time a plan of care is established or “as soon thereafter as possible.” While the regulation does not define “as soon thereafter as possible,” the Sixth Circuit held that the relator’s allegations that the requisite certifications were not completed for several months were sufficient to allege violations of both the regulation and the FCA. The Sixth Circuit reasoned that the phrase “as soon thereafter as possible” “suggests plainly that...

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Corporate Outsiders – on the Wrong Side of the Circuit Split on Rule 9(b)

A district court in the Middle District of Florida issued a new decision that will continue to make it challenging for corporate outsiders to successfully pursue a declined qui tam complaint – at least in the Eleventh Circuit. In U.S. ex rel. Chase v. Lifepath Hospice, Inc., et al., No. 10-cv-1061, 2016 WL 5239863 (M.D. Fla. Sept. 22, 2016), the court dismissed a False Claims Act (FCA) complaint based on the heightened pleading requirement of Federal Rule of Civil Procedure 9(b). The complaint, which alleged that defendants billed Medicare for hospice care that was either never provided or provided to ineligible patients, was dismissed primarily because the plaintiff did not adequately allege that false claims were actually submitted to the government. While the court held that the plaintiff had described a “private scheme in detail, to include facts as to some disturbing medical practices, she has not alleged ‘facts as to time, place, and substance of the...

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Nurse-Relator’s Personal Opinion About Medical Necessity Insufficient To Support FCA Complaint, Holds Seventh Circuit

On September 1, 2016, the US Court of Appeals for the Seventh Circuit largely affirmed dismissal of a relator’s amended complaint pursuant to the particularity requirement of Fed. R. Civ. P. 9(b). In US ex rel. Presser v. Acacia Mental Health Clinic, LLC, the relator, a nurse, alleged that a number of practices at a clinic where she worked were not medically necessary. These were: requiring patients to see multiple practitioners before receiving medication; requiring patients to undergo mandatory drug screenings at each visit; and requiring patients to come to the clinic in-person in order to receive a prescription or speak to a doctor. (The relator also alleged that clinic misused a billing code. This was the only claim the Seventh Circuit permitted to go forward.) In dismissing the majority of the relator’s complaint, the Seventh Circuit began with a robust discussion of the importance of Rule 9(b) in screening out baseless False Claims Act (FCA) claims:...

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Failure to Specify Statutes and Regulations Fatal to FCA Complaint

The US Court of Appeals for the Seventh Circuit recently reviewed a district court’s dismissal of an FCA claim against the City of Chicago, in which the relator alleged that the City’s certifications of compliance with civil rights laws were false because the City engaged in practices which increased racial segregation. The case is United States ex rel. Hanna v. City of Chicago, and can be found here. On August 22, the Seventh Circuit affirmed dismissal of the relator’s complaint for failure to comply with Fed. R. Civ. 9(b). The most notable takeaway from this case is the court’s holding that where the complaint itself did not specify which statutes and regulations the City violated (and with which it thus falsely certified compliance), the relator could not rely on more specific statutory and regulatory references later identified in his briefs. The court observed: “If the particularity requirement is meant to ensure more thorough investigation before...

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Ninth Circuit Court Overturns District Court on Sufficiency of Pleading under Rule 9(b), Remands for Amendment

The US Court of Appeals for the Ninth Circuit issued an opinion overturning a district court’s grant of summary judgment against a False Claims Act (FCA) relator in United States ex rel. Driscoll v. Todd Spencer M.D. Medical Group, Inc. on August 9, 2016.  The case involved allegations by Scott Driscoll, M.D., a radiologist who had worked for the defendant medical group, that the medical group and its principal, Dr. Todd Spencer, performed unnecessary procedures and unbundled certain procedures in order to bill for multiple procedures rather than just one at a higher reimbursement rate. The district court had granted the defendants’ motion for summary judgment on the grounds that the amended complaint failed to satisfy the particularity standard of Fed. R. Civ. P. 9(b).  Specifically, the district court held that although the relator alleged the performance of certain unnecessary procedures and improper unbundling of procedures, the claims failed to...

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District Court Dismisses FCA Claims Based on Fraudulent Off-Label Promotion for Lack of Particularity

On May 23, 2016, the US District Court for the District of Massachusetts dismissed several of the claims in a False Claims Act (FCA) whistleblower suit against Medtronic, Inc. and its wholly-owned subsidiary Medtronic MiniMed, Inc. (Medtronic) related to its insulin pumps and integrated diabetes management systems. In United States ex rel. Witkin v. Medtronic, Inc., the relator, Witkin (a former employee of Medtronic) alleged that certain of Medtronic’s promotional activities related to its insulin pumps and the pediatric use of its integrated diabetes management systems designed for adult use were false or misleading, resulting in false claims for reimbursement.  The district court held that Witkin failed to plead his claims with sufficient particularity pursuant to Fed. R. Civ. P. 9(b).  The district court emphasized the particularity requirement in this case, observing that “the alleged fraudulent promotional activity permits only a weak inference of...

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District of Massachusetts Rejects Relators’ Attempt to Convert Products Liability Theory into FCA Claim

On February 2, 2016, U.S. District Court for the District of Massachusetts dismissed a complaint alleging sweeping allegations of purported fraud under the False Claims Act (FCA) relating to hip replacement devices, and in doing so reaffirmed the principle that where an FCA complaint fails to plead the specifics of actual false claims, it cannot survive. The case is United States ex rel. Nargol v. DePuy Orthapaedics, Inc., in which, at the end of a 57-page opinion, U.S. District Judge Dennis Saylor denied the relators’ request for leave to amend, observing that “[d]espite full awareness of Rule 9(b)’s pleading standards, the relators—who are expert witnesses in related products-liability lawsuits against DePuy—have failed to plead with requisite particularity even a single false claim for the Pinnacle [metal-on-metal] [] device in their 168-page second amended complaint.” The relators alleged a variety of conduct, but most of it boiled down to variations on...

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