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Anti-Kickback Statute

11 January 2016

District Court in the Seventh Circuit Distinguishes Sanford-Brown, Finds Room for Implied Certification Claims Against Pharmaceutical Manufacturers

Although the Seventh Circuit last year became the first circuit court clearly to reject the “implied certification” doctrine of FCA liability, a district court in that circuit recently sought to cabin the impact of the ruling.  See United States ex rel. Kroening v. Forest Pharm., No. 12-cv-00366 (E.D. Wisc. Jan. 6, 2016).  As reported here, the Supreme Court will review the viability of the implied certification theory later this year.  While the Kroening court ultimately dismissed the relator’s claims under Rule 9(b), the opinion highlights the divergence of the viewpoints around the implied certification theory that the Supreme Court has been asked to help resolve.

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23 November 2015

District Court Dismisses Claims Based on Inflated CMS Star Ratings But Allows Kickback Claims to Proceed

A district court recently denied a relator’s efforts to translate alleged manipulation of skilled nursing facility (“SNF”) CMS Star Ratings into a claim under the FCA, while allowing the relator to proceed with allegations that the CEO of a SNF chain oversaw a kickback scheme designed to churn business.  See U.S. ex rel. Orten v. North Amer. Health Care, Inc., No. 14-cv-02401 (N.D. Cal. Nov. 9, 2015).  The case reinforces well-established precedent that FCA suits alleging regulatory violations cannot proceed where the government does not condition payment on complete regulatory compliance.  The government’s Statement of Interest arguing that the public disclosure bar was triggered as to certain claims demonstrates the DOJ’s growing wariness of opportunistic behavior by relators seeking to capitalize on pre-existing government investigations to which they did not contribute.

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06 November 2015

Indictments of Individuals Shed More Light On Warner Chilcott Enforcement Action

We recently discussed the settlement Warner Chilcott reached with the Department of Justice, which also announced criminal charges against the former president of the company’s pharmaceutical division. This former executive, however, is not the only individual swept into the criminal charges, as three lower level Warner Chilcott sales force members and a physician who served as a speaker for the company have previously been charged or pled guilty. The details in the charging materials may provide insight into the government’s post-Yates memo approach to targeting and using individuals to build a criminal case against corporations.

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30 October 2015

The Yates Memo Has Teeth: DOJ Indicts Senior Pharmacy Executive In Connection with Wide-Ranging FCA Settlement

Yesterday, the DOJ announced a settlement with the U.S. sales subsidiary of Warner Chilcott PLC. The company has agreed to plead guilty to criminal charges and to pay $125 million to resolve both criminal and civil liability. At the same time, the DOJ announced that it had indicted a former president of Warner Chilcott’s pharmaceutical division with conspiracy to violate the Anti-Kickback Statute. As the DOJ emphasized in its press release, the individual criminal charges in this matter represent an effort to hold “responsible individuals accountable” in enforcement actions. The DOJ’s pursuit of individual criminal liability in this case represents a high profile application of the DOJ’s intent to focus on the liability of individual corporate employees, recently set forth in the Yates memo (as further discussed here). The parallel civil settlement also provides insight into potential future enforcement activities around manufacturer support of prior authorization programs.

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28 May 2015

Court Finds Kickback Allegations Against Clinical Laboratory Not Adequately Pled

Posted by Scott Stein and Bevin Seifert

On May 19, 2015, a federal district court in the Northern District of Georgia dismissed kickback allegations against Laboratory Corporation of America and Laboratory Corporation of America Holdings (“LabCorp”), holding that the allegations fell short of the particularity required by Rule 9(b). The relators—competitors of LabCorp—alleged that LabCorp’s pricing practices violated Georgia’s state false claims act and were independently unlawful under the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)(2)(A). Relators alleged that LabCorp violated the AKS by providing “deeply discounted” prices to customers to induce them to refer (or “pull-through”) large volumes of Medicaid and other business. The court found, however, that relators failed to allege those claims with particularity because they did not identify a single improper referral to a physician, nor a specific Medicaid claim resulting from such referral. Moreover, the court held that relators failed to identify a specific kickback, finding that allegations of specific discounts alone were insufficient to establish a referral or claim resulting from such referral. Having disposed of the federal AKS claims, the court declined to exercise supplemental jurisdiction over plaintiffs’ state law claims and, therefore, remanded the remaining claims to the State Court of Fulton County, Georgia. A copy of the court’s decision can be found here.

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15 April 2015

District Court Refuses to Uphold Release of Liability or Apply Public Disclosure Bar Based on State-Law Employment Suit, Dismisses Off-Label Promotion Claims Under Rule 9(b)

Posted by Jaime L.M. Jones and Brenna Jenny

A court in the Eastern District of Pennsylvania recently ruled that, despite a relator’s publication during an employment retaliation suit of allegations relating to the defendant’s alleged off-label promotion and payment of kickbacks, such allegations were not publicly disclosed, nor was the relator’s execution of a release of liability effective. U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., No. 02-cv-02964 (E.D. Pa. Mar. 30, 2015). This case demonstrates the way policy arguments regarding a perceived congressional intent in favor of private enforcement of the FCA can impact legal arguments in FCA litigation.

The court first considered whether the relator’s claims had previously been publicly disclosed. The relator, a former sales representative employed by the defendant, filed a qui tam suit a month before resigning his position with the defendant in June 2002. Upon resigning, he filed a wrongful termination action pursuant to New Jersey’s Conscientious Employee Protection Act (“CEPA”). While the government weighed whether to intervene, the parties in the CEPA action engaged in discovery. They ultimately settled—with the relator signing a broad release of liability—and the qui tam suit was subsequently unsealed, with the government declining to intervene. The defendant argued that the relator’s Statement of Facts (“SoF”) in the CEPA action constituted disclosure through a “civil hearing,” thereby triggering application of the public disclosure bar. The court ruled that although the SoF “exhaustively details” the alleged off-label promotion of defendant’s cancer drug Taxotere, and corresponding payment of kickbacks, the SoF was not “substantially similar” to the relator’s complaint because the SoF did not state that any provider had submitted a claim to a federal healthcare program (“FHCP”). Accordingly, the court reasoned that the allegedly fraudulent transactions were not previously disclosed, and inferring the allegation of fraud “would impermissibly broaden the scope of the public disclosure bar and restrict private enforcement of the FCA.” The defendant has since filed a motion for reconsideration, arguing that where submission of false claims to the government is a “logical and obvious consequence” of an alleged scheme, all essential elements of the FCA claim are publicly disclosed.

The court next determined whether the relator had nonetheless waived his right to prosecute the qui tam suit through his settlement and release of liability in the CEPA action. Although the Third Circuit Court of Appeals has yet to rule on whether relators can unilaterally settle a qui tam suit post-filing, all of the courts of appeal to consider the issue have held that, based on the statutory language of the FCA, the government’s written consent is a prerequisite. In contrast, several courts of appeal have held that a pre-filing release can wipe out a would-be relator’s attempt to file a later qui tam suit, so long as the release covers the allegations in the suit and there are no countervailing public policy considerations. Consistent with the prevailing approach to post-filing releases, the Gohil court ruled that the relator’s release had no effect on the litigation. The defendant responded by suggesting that the release be effective as to the relator, but that the claims be dismissed without prejudice to the government’s ability to intervene. The court declined to adopt this approach, again invoking the “clear congressional intent of encouraging private enforcement of the FCA.”

As to the merits of the relator’s claims, the court first ruled that, even under the Third Circuit’s more lenient “reliable indicia” standard to the submission of false claims—in place of pleading the details of particular false claims submitted—the off-label promotion allegations did not meet Rule 9(b)’s requirements. This was so because all of the off-label uses related to medically accepted indications, which would have been eligible for government reimbursement. However, the court denied the defendant’s motion to dismiss the kickback allegations, holding that certifying compliance with the AKS is a precondition to payment by the FHCPs and that the relator had provided sufficient examples of kickbacks allegedly offered to providers. Finally, the court refused to dismiss the relator’s conspiracy count, ruling that a conspiracy between the defendant and providers could easily be inferred from examples of kickbacks supposedly paid by the defendant, followed by the recipient physician’s increase in Taxotere prescriptions.

A copy of the court’s opinion can be found here.

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02 April 2015

Court Rejects Off-Label Promotion Allegations Due to Failure to Cite Actual False Claim Submissions; Allows Retaliation Claims to Proceed

Posted by Scott Stein and Brenna Jenny

On March 27, 2015, a federal court in the Southern District of Ohio granted in part and denied in part a motion to dismiss a qui tam suit alleging that Bristol-Myers Squibb Co. (“BMS”) and Otsuka America Pharmaceutical (“Otsuka”) had promoted Abilify for off-label uses and violated the AKS through grants, speaker, and similar programs offered to physicians. See United States ex rel. Ibanez v. Bristol-Myers Squibb Co., No. 11-cv-00029 (S.D. Ohio Mar. 27, 2015). The court’s ruling reiterates that regardless of the particularly with which a scheme is pled, complaints will be dismissed if they fail to, at a minimum, include particular allegations that support a strong inference that a false claim was submitted. However, the court’s partial denial of the motion to dismiss also demonstrates the weight of the expanded protections relators now enjoy when bringing retaliation claims under the FERA-amended definition of protected conduct.

Both BMS and Otsuka previously executed Corporate Integrity Agreements (“CIAs”) relating to alleged off-label promotion of an anti-depressant, Abilify. Relators asserted that both companies violated their CIAs by subsequently promoting Abilify for off-label uses, including for pediatric and geriatric patients, and for offering physicians kickbacks to write off-label prescriptions for Abilify. Relators asserted they could rely on a “relaxed” pleading standard referenced but never applied by the Sixth Circuit Court of Appeals, under which they need not present any samples of false claims actually submitted, so long as they pled a strong inference of such submissions.

The defendants contested that such a standard was appropriate, yet the court ruled that the dispute was moot, because relators failed even to meet the lower pleading standard. In particular, while relators alleged that defendants’ off-label promotion and kickbacks caused physicians to write prescriptions for off-label uses of Abilify, the complaint failed to support a strong-inference that the patients who received those prescriptions participated in federal health care programs, that the patients actually filled the off-label prescriptions, and that an entity submitted claims for reimbursement to the government for those prescriptions.

Relators had argued that they further fell within the ambit of dicta in United States ex rel. Bledsoe v. Community Health Systems, Inc., 501 F.3d 493 (6th Cir. 2007), where the Sixth Circuit left open the possibility that a relaxed pleading standard would be appropriate “where a relator demonstrates that he cannot allege the specifics of actual false claims that in all likelihood exist, and the reason that the relator cannot produce such allegations is not attributable to the conduct of the relator.” According to the relators, they were precluded from identifying specific false claims because such information regarding claims for payment caused to be submitted by BMS and Otsuka lay in the exclusive possession and control of the defendants, pharmacies, and federal and state payors. The court characterized the Sixth Circuit’s dicta as “so broadly worded that [it] could undermine the purpose of the particularity rule,” and refused to allow it to “swallow[] the existing and well-settled rules for FCA pleading.”

Nonetheless, the court denied defendants’ motion to dismiss the relators’ retaliation claims. The FERA amendments to the FCA expanded protection over lawful acts “in furtherance of an action under [the FCA]” to also protect “other efforts to stop [one] or more violations of [the FCA].” Thus, whereas protected conduct prior to the FERA amendments was generally limited to actions that could lead to a FCA suit, the court noted that post-FERA, employees need only “report alleged misconduct up the chain of command in order to engage in FCA-protected activity.” Because relators had pled that they reported compliance concerns to their management, the court found this standard to be met.

A copy of the court’s opinion can be found here.

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03 February 2015

DOJ Files Amicus Brief in Private Litigation Premised on Alleged Stark/AKS Violations

Posted by Scott Stein and Brenna Jenny

DOJ recently took the unusual step of filing an amicus brief in a private lawsuit alleging violations of the Lanham Act and various state laws, which resulted from violations of the Stark Law and the Anti-Kickback Statute (“AKS”). See Brief for the United States Supporting Appellee, Ameritox, Ltd. v. Millennium Labs., Inc., No. 14-14281 (11th Cir. Jan. 21, 2015). DOJ explained that it was filing an amicus brief to correct what it views as Millennium’s mischaracterizations of how CMS and the OIG interpret exceptions to the statutory definitions of remuneration under the Stark Law and the AKS. It emphasized the importance of a “proper interpretation” of these statutes, both because the laws independently are key mechanisms for preventing fraud and abuse, and because they serve as predicates for FCA liability.

By way of background, Ameritox filed suit against a competing clinical laboratory, Millennium, in April 2011, alleging that Millennium violated both the Stark Law and the AKS by providing free point-of-care testing cups (“POCT cups”) to physicians. POCT cups contain embedded immunoassay testing strips, which allow physicians to test urine samples and receive drug test results within minutes. Millennium entered into so-called “cup agreements” with physicians, whereby the company provided POCT cups free of charge, in exchange for the physician contractually agreeing not to bill any insurer (private or government) for the testing and to return the cups to Millennium for laboratory testing. Failure to uphold either obligation required a physician to remit the otherwise applicable price of the cup. Millennium argued that it had not provided any remuneration because physicians certified they were not billing for the testing, and therefore they received nothing of value from the cups. Ameritox, however, alleged that physicians were removing the test strips, batch testing them at the end of the day using a chemical analysis, and then submitting bills to insurers.

In May 2014, the district court ruled that the free POCT cups were remuneration where physicians could not otherwise bill for them, and that Millennium violated the Stark Law and the AKS by providing free POCT cups in these circumstances. However, the court determined it was a question of fact whether Millennium violated the law by providing POCT cups to physicians who could bill for them but contractually opted out of the opportunity to do so, in exchange for receiving the cup at no cost. Following the trial a month later, the jury found that Millennium had in fact violated the AKS and the Stark Law.

Millennium appealed to the Eleventh Circuit, arguing that provision of the free POCT cups did not constitute remuneration under either the Stark Law or the AKS. The crux of Millennium’s defense under the Stark law was that the POCT cups fell within a statutory exception to the definition of remuneration for laboratory supplies, i.e., “[t]he provision of items, devices, or supplies that are used solely to (I) collect, transport, process or store specimens for the entity providing the item, device, or supply.” 42 U.S.C. § 1395nn(h)(1)(C)(ii); 42 C.F.R. § 411.351.

<p&ggt;DOJ pointed out that the test strips served the purposes of the physicians testing the specimens, and therefore even if the rest of the cup did transport specimens to Millennium—the entity providing the item—the POCT cups were not solely used for Millennium’s purposes. Likening the insertion of the immunoassay strips into the POCT cups to taping five-dollar bills to the inside of test cups, DOJ reiterated that under CMS’ guidance, benefits conferred on physicians that fail to meet a Stark Law exception can still be remuneration, even if the value is small and cannot be separately billed.

As to whether the POCT cups constituted remuneration under the AKS, Millennium cited recurrent OIG guidance that “free items and services that are integrally related” to the offering supplier’s services are not considered remuneration. See, e.g., OIG, Adv. Op. No. 12-10 (Aug. 23, 2012). However, DOJ averred that from the OIG’s perspective, “integrally related” means that the item is so intertwined with the underlying service that it can only be used as part of that service and as such has no independent value apart from the service. DOJ did acknowledge that the OIG has recognized the potential permissibility of incidental benefits to physicians, so long as they are narrowly linked to the provision of the services. Yet DOJ insisted that the free POCT cups in fact conferred substantial benefits distinct from Millennium’s laboratory testing services, and therefore rose to the level of remuneration.

A copy of DOJ’s amicus brief can be found here.

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03 November 2014

Eleventh Circuit Holds Relator Could Not Satisfy Rule 9(b) for Claims Based on Post-Employment Conduct

On October 30, 2014, the Eleventh Circuit issued a 41-page unpublished opinion affirming in part the dismissal of an FCA complaint under Rule 9(b), holding that the relator failed to plead sufficient “indicia of reliability” with respect to his claims based on conduct allegedly occurring after his employment by the defendants ended.

The relator, Mastej, was the former CEO of defendant Naples Hospital, which was owned by defendant Health Management Associates. Mastej alleged that the defendants had improper financial relationships with ten physicians, and as a result falsely certified their compliance with the Stark and Anti-Kickback Statutes on interim claim forms for patients of the physicians, and in the hospitals’ cost reports. While the relator alleged the details of the alleged payments with detail, he did not allege details of specific false claims. In evaluating the relator’s allegations, the Eleventh Circuit began by reciting certain established principles: that the submission of a false claim must be pleaded with particularity, that “Rule 9(b) ‘does not permit a False Claims Act plaintiff merely to describe a private scheme in detail but then to allege simply and without any stated reason for his belief that claims requesting illegal payments must have been submitted, were likely submitted or should have been submitted to the Government,’ and that “some indicia of reliability must be given in the complaint to support the allegation of an actual false claim for payment being made to the Government.” “[W]hether the allegations of a complaint contain sufficient indicia of reliability to satisfy Rule 9(b)” is evaluated “on a case-by-case basis.” Furthermore, the court explained, “[p]roviding exact billing data—name, date, amount, and services rendered—or attaching a representative sample claim is one way a complaint can establish the necessary indicia of reliability that a false claim was actually submitted,” but “there is no per se rule that an FCA complaint must provide exact billing data or attach a representative sample claim.” With regard to the “other means” of showing the required indicia of reliability, the court noted that while “there are no bright-line rules. . . a relator with direct, first-hand knowledge of the defendants’ submission of false claims gained through her employment with the defendants may have a sufficient basis for asserting that the defendants actually submitted false claims.” “By contrast,” the court continued, “a plaintiff-relator without first-hand knowledge of the defendants’ billing practices is unlikely to have a sufficient basis for such an allegation.”

Turning to the specific allegations of this case, the court acknowledged that Mastej had not alleged details concerning even a single specific “false claim” relating to any patient treated by one of the physicians alleged to have had an improper financial relationship with the defendants. “Rather than submit examples or a representative false interim claim,” the panel noted, “Mastej’s complaint focuses on his personal knowledge gained in his roles and duties as Vice President of Defendant HMA for six years until February 2007 and as CEO of the Collier Boulevard campus from February 2007 until October 2007. Mastej states that his personal ‘knowledge of Defendants’ practices and actions [was] gained by his own efforts as an employee of Defendants and their affiliates, including serving as Chief Executive Officer for a hospital owned by [Defendant] Naples HMA.'” The court held that taking all of the allegations into account, “Mastej’s complaint contains sufficient indicia of reliability for his personal knowledge that the Defendants actually submitted interim claims to Medicare for patients referred to the Medical Center as part of the on-call incentive scheme during 2007.” Given his position at the time and his alleged participation in meetings in which the illegal conduct was discussed, the panel concluded that Mastej “has sufficiently articulated how he allegedly gained his direct, first-hand knowledge of the Defendants’ submission of false interim claims to the government and the government’s payment of such claims.”

In addition to relying on Mastej’s “insider” status, the court also pointed to the nature of the fraud allegations at issue. “[T]he type of fraud alleged here does not depend as much on the particularized medical or billing content of any given claim form. In other FCA cases, the allegation is that a defendant’s Medicare claim contained a false statement because the claim sought reimbursement for particular medical services never rendered to the patient, or for medical services that were unnecessary, overcharged, or miscoded, or for improper prescriptions, or for services not covered by Medicare. In those types of cases, representative claims with particularized medical and billing content matter more, because the falsity of the claim depends largely on the details contained within the claim form—such as the type of medical services rendered, the billing code or codes used on the claim form, and what amount was charged on the claim form for the medical services.” In this case, by contrast, the falsity of the claims turned upon referral activity with which Mastej claimed personally to be familiar.

Nevertheless, the Court concluded that Mastej’s complaint failed to satisfy Rule 9(b) with respect to allegations of illegal conduct after his employment ended in October 2007. “After his employment ended, Mastej was no longer privy to information about the Defendants’ business practices, Medicare patients, referrals of patients, the billing of services to Medicare, or revenue from Medicare reimbursements. The indicia of reliability that existed while Mastej served as Vice President and then CEO disappeared when he left the Defendants’ employment in October 2007.” The panel specifically stated that this holding did “not suggest, much less hold, that a qui tam plaintiff-relator can never base his case on false claims submitted after he left a defendant’s employ.” Rather, the court simply concluded that in the particular context of this case, Mastej’s allegations failed to provide “the required indicia of reliability for his general allegation” that false claims were submitted after his employment ended “because the reliability of Mastej’s general allegation derives from his highly significant employment roles and duties during 2007.” “Removed from this vantage point and from his access to critical billing and revenue information, Mastej has articulated no factual basis for his assertion that the particular doctors continued to refer patients or that the Defendants submitted interim claims for such patients after Mastej left—other than speculation that claims ‘must have been submitted, were likely submitted or should have been submitted to the Government.'”

A copy of the court’s opinion in U.S. ex rel. Mastej v. Health Management Associates, Inc., can be found here. While – as the court expressly notes – the case does not stand for the blanket proposition that relators cannot plead claims based on post-employment conduct, it does provide support for the view that such allegations must be based on more than simply an argument that conduct that occurred at one point in time likely continued indefinitely into the future.

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13 October 2014

Federal District Court Holds That FCA Defendant Waived Attorney-Client Privilege By Pleading Good-Faith Compliance With the Act

Posted by Jonathan F. Cohn and Brian P. Morrissey

A federal district court in Georgia has ordered a defendant in a False Claims Act case to produce attorney-client privileged communications to the qui tam relator. See United States ex rel. Barker v. Columbus Regional Healthcare System, Inc., No. 4:12-cv-108 (CDL), 2014 WL 4287744 (M.D. Ga. Aug. 29, 2014). The court ruled that the defendant, Columbus Regional Healthcare System, impliedly waived the privilege by pleading in its answer that it did not knowingly violate the FCA and indicating that it would offer evidence at trial that it believed its conduct was lawful.

The relator alleged that Columbus Regional violated the FCA, the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and the Stark Law, 42 U.S.C. § 1395nn, when it purchased a cancer treatment center for more than fair market value and, separately, when it entered into remuneration agreements with another cancer treatment center that were not commercially reasonable. The relator alleged that all of these transactions were unlawfully designed to induce the treatment centers to refer patients to Columbus Regional.

In response, Columbus Regional argued that “it believed its conduct was lawful,” and that it planned to “offer evidence at trial” establishing that good faith belief. Columbus Regional, 2014 WL 4287744, *2.

Relying on the Eleventh Circuit’s decision in Cox v. Administrator U.S. Steel & Carnegie, et al., 17 F.3d 1386 (11th Cir. 1994), the district court held that Columbus Regional’s defense waived privilege over communications between Columbus Regional and its attorneys regarding the transactions, Columbus Regional, 2014 WL 4287744, *2. The court reasoned that “when a defendant affirmatively asserts a good faith belief that its conduct was lawful, it injects the issue of its knowledge of the law into the case and thereby waives the attorney-client privilege.” Id. The court reached this conclusion despite acknowledging that Columbus Regional had not asserted an “advice-of-counsel” defense—i.e., Columbus Regional did not argue that legally-privileged advice was the basis for its good-faith belief that its transactions were lawful. Id.

Notably, the district court suggested that Columbus Regional could have preserved the privilege if it had merely “denied” the allegations of wrongful intent “‘without affirmatively asserting that it believed its [conduct] was legal.'” Id. *4. But, since Columbus Regional “intend[ed] to explain fully why its conduct was not knowingly and intentionally unlawful,” the court determined that the privilege had been waived. Id.

It remains to be seen whether other courts will find the district court’s ruling persuasive. In the meantime, however, FCA defendants should be aware that specifically pleading a belief that challenged conduct was lawful may trigger a dispute over whether such a defense waives privilege. Defendants seeking to protect themselves from such an attack should note that, even under the Columbus Regional rationale, defendants who merely deny wrongful intent—without “affirmatively” asserting a good-faith belief that their conduct was lawful—do not waive the privilege.

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