Yes, you read the title of this post correctly.  Under the False Claims Act, a whistleblower is not required to report compliance concerns internally through a company’s internal reporting system before filing a “qui tam” court action.  Indeed, the False Claims Act — with its potential “bounty” of 15 to 30 percent of the government’s recovery — may actually encourage employees to file suit in the first instance, to qualify as an “original source,” and bypass the organization’s reporting system altogether, thereby frustrating a key component of an effective compliance program.  Whistleblower organizations have recently gone so far as to discourage individuals employed by health care providers from bringing compliance concerns directly to their employer so that they can get a share of the government’s recovery.

A provider or other entity participating in the Medicare or Medicaid programs, however, can mitigate that risk through, among other things, employee training and disciplinary policies encouraging good-faith reporting and the promotion of a culture of compliance, including setting the right “tone from the top.”

Internal Reporting System.  The cornerstone of any effective compliance program is developing and implementing a robust internal reporting system that employees can use to raise any compliance concerns on an anonymous basis.  Among other things, when compliance concerns are brought to the attention of the organization’s compliance personnel, the organization can investigate the issue and take appropriate steps to prevent or remediate any continued potential misconduct.  Likewise, having such a system in place may serve as a defense to liability under the False Claims Act.  Even if improper billing is found to have taken place, evidence that the organization has an effective, anonymous internal compliance reporting system may show that the improprieties were not the result of deliberate indifference or reckless disregard for such practices.

False Claims Act.  Plainly, the risk of treble damages and per claim penalties under the False Claims Act is a powerful incentive for a health care organization to implement an effective compliance program.  What is more, the provision for whistleblower awards under the False Claims Act can be an effective tool to aid the government in detecting and preventing overpayments by Medicare and Medicaid to fraudulent operators and other bad actors.  By allowing whistleblowers to file relator actions under seal and potentially share in any of the government’s recovery — as well as to seek damages for any retaliatory employment action — the False Claims incentivizes employees in the health care industry to come forward with information about fraudulent billing, without the fear of reprisal.

The Tension Between The Two.  At the same time, a whistleblower’s potential recovery can operate as a countervailing disincentive for an employee to report compliance concerns internally.  That is because under the False Claims Act, a qui tam relator is entitled to a “bounty” only if the individual is the “original source” of information to the government about the improper billing practices that are the subject of the relator’s action.  On the other hand, if an employee does dutifully report a compliance concern internally through the organization’s reporting system, and the organization itself reports any overpayments to the government or remediates the misconduct itself, the whistleblower may be unable to sue and recover any “bounty.”  As noted earlier, this point is not lost on the relator bar.

Overcoming The Tension.  How does a provider overcome the entreaties of the relator bar, along with the incentives under the False Claims Act whistleblower provisions, to convince employees with compliance concerns to avail themselves of the company’s internal reporting system?  At the outset, the reporting system must be both effective and credible to instill  confidence in the system so that employees will take full advantage of it – that is, the organization must deliver on its promise of anonymity and protection of good-faith reporting and must follow through on a timely basis with a thorough investigation and meaningful corrective action, if indicated.  Further, a robust reporting system, standing alone, will not be effective unless all other elements of an organization’s compliance program are working effectively as well, starting with a “culture of compliance,” reinforced by the executive team and management, and continuing with inservice compliance training, underscoring the importance of timely reporting and the anonymity and other protections afforded to reporting employees.

Likewise, the organization must have personnel and disciplinary policies that reward good-faith reporting and punish compliance lapses, both for engaging in unlawful conduct as well as for failing to report it.  That said, taking any disciplinary action against an employee who files suit as a relator, without ever having reported the compliance concerns in breach of the employee’s duties, is fraught with the risk that the termination or other action will be challenged as retaliation for filing the False Claims Act action, and that the cited ground — failing to report   — is allegedly merely pretextual.

However, with the proper messaging and training, coupled with a robust anonymous reporting system, the company can give its employees good reason to “do the right thing” and report compliance concerns to the company in the first instance, despite the lure of a False Claims Act bounty.

In a February blog post, we detailed the summary judgment rulings in a False Claims Act case involving Lance Armstrong: United States ex rel. Landis v. Tailwind Sports Corporation, et al.  The federal government alleges that Lance Armstrong, his Tailwind Sports team, and its manager, Johan Bruyneel, submitted false claims to the United States Postal Service (“USPS”) and violated sponsorship agreements by using and then denying the use of banned performance enhancing drugs.

In June 2017, in anticipation of a November 2017 trial, the government and Armstrong filed Motions in Limine (“MIL”) to exclude evidence from being introduced before the court.  The parties’ MIL, specifically those motions aimed at barring expert economic testimony via Daubert challenges, could have a significant impact on the government’s ability to meet its burden of proof with respect to damages.  Likewise, Armstrong could suffer a similar misfortune on the MIL as his expert testimony may be critical to combat the government’s claims.  In addition, two  of the MIL, which essentially argue that “everybody does it” and that the “first to come clean benefits,” could have far-reaching implications for FCA cases in the future.  Regardless of the outcome of the MIL, such posturing suggests that this matter is almost certainly headed for trial. Continue Reading Lance Armstrong False Claims Act Suit Cycles Through Motions on Way to Trial

On June 22, 2017, the United States Court of Appeals for the Fifth Circuit, in Maxmed Healthcare, Inc. v. Price, upheld an administrative determination by a Medicare Administrative Contractor (MAC) based on an audit of a sample of 40 home care claims. From its sample findings, the MAC extrapolated to a universe of 130 claims and determined that the home care agency under audit had been overpaid almost $800,000 on the grounds that the sampled patients were not homebound or the services provided were not “medically necessary.” The Maxmed Court’s endorsement of sampling and extrapolation involving medical-necessity reviews may have broader implications for the use of that tool in False Claims Act (FCA) investigations and lawsuits.

Among other arguments, Maxmed Healthcare, the home care agency under audit, maintained that any overpayment based on lack of medical necessity “should only be determined after a review of each beneficiary’s specific claims, and it is fundamentally at odds with extrapolation concerning home health care claims.” Citing to the federal Centers for Medicare and Medicaid Services (CMS) Medicare Benefit Policy Manual and the Medicare Act, the Fifth Circuit held, to the contrary, that Congress and CMS contemplated the use of sampling and extrapolation in post-payment audits, where “there is a sustained or high level of payment error.”  Citing 42 U.S.C. § 1395ddd(f)(3)(A).

In defending against FCA actions premised on the alleged lack of medical necessity of services, providers have argued that disputes over medical necessity involve essentially subjective differences in medical opinion as opposed to the “objective falsity” of Medicare or Medicaid claims, and that a medical-necessity determination requires a particularized claim-by-claim review, specific to each patient, that does not allow for extrapolation to a universe of hundreds or thousands of other claims.  Those arguments may be more difficult to sustain under the Eleventh Circuit’s holding in Maxmed. To avoid the reach of Medmax, providers in FCA cases will likely try to distinguish the “garden variety” audit liability involved in Medmax from the liability imposed under the False Claims Act – with its per claim penalties and treble damages – premised as it is on a finding of falsity among other rigorous elements.

USDCSDNYEarlier this month, the Southern District of New York dismissed the remaining claim in United States ex rel. Kolchinsky v. Moody’s Corp., ruling that Moody’s alleged “false claim” was not material under the standards set in Universal Health Services, Inc. v. United States ex rel. Escobar. The analysis of this case is instructive for other FCA cases, including health care fraud, for the court’s analysis on dismissal of FCA claims on materiality grounds. The court had previously dismissed the Relator’s claims in February but gave leave for him to amend his complaint with respect to claims about certain inaccuracies in Moody’s Ratings Delivery Service. The Relator filed an amended and somewhat more specific complaint thereafter, alleging that Moody’s provided ratings it knew to be inaccurate directly to its subscribers, which included the federal government. Continue Reading FCA Case Dismissed on Materiality Standard

USDHHS-sealNew regulations have been released in the form of a Final Rule (announced at 82 Fed. Reg. 4100) (the “Final Rule”), revising and expanding the authority of the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) to exclude entities and individuals from participation in federal health care programs. The Final Rule adds to the OIG’s longstanding statutory authority to issue exclusions, which was most recently expanded by Congress in the 2010 Affordable Care Act.

The Final Rule was announced on January 12, 2017, and was intended to go into effect on February 13, 2017. The new administration’s temporary freeze on pending regulations delays that effective date until March 21, 2017. Continue Reading New Regulations Expand Authority of HHS OIG to Issue Exclusion Orders

stat-samplesThe U.S. Court of Appeals for the Fourth Circuit missed an opportunity earlier this month in United States ex rel. Michaels v. Agape Senior Cmty, Inc., No. 15-2145, 2017 WL 588356 (4th Cir. Feb. 14, 2017), to provide clarity on one of the hottest issues in FCA litigation—whether an FCA relator may use statistical sampling and extrapolation to establish FCA liability. Courts frequently permit the use of statistical sampling to establish damages in FCA cases where liability has already been established. Applying the method to the question of liability, however, remains highly contested, given that courts have long held that the False Claims Act requires a relator to prove the falsity of each claim submitted for payment and the resulting damages. While a number of district courts have faced this question—and have reached different conclusions on its propriety, especially since the District Court for the Eastern District of Tennessee’s decision in United States ex rel. Martin v. Life Care Centers of America, Inc., 114 F. Supp. 3d 549 (E.D. Tenn. 2014)—no appellate court has ruled on the issue. With the Fourth Circuit’s decision—or lack thereof—relators, federal healthcare program providers, and the FCA bar continue to await guidance.

In Agape, the relators—former employees of the defendant, an operator of a network of nursing facilities in South Carolina—filed an interlocutory appeal to the district court’s denial of their request to:

  1. examine a random sample of claims submitted by the defendant to federal healthcare programs for services that the relators claim were not provided or were not medically necessary;
  2. have their experts assess those claims for falsity; and then
  3. extrapolate their findings to a universe of more than 50,000 claims.

Continue Reading Statistical Sampling Stumble – Fourth Circuit Misses Opportunity to Provide False Claims Act Guidance

bikersIn a case with important considerations for False Claims Act cases, Lance Armstrong will face claims at trial that he fraudulently obtained funds from the United States Postal Service because of alleged violations of his sponsorship contract. On February 13, 2017, a D.C. federal judge ruled on competing motions for summary judgment setting the stage for a trial on the issues of implied certification and potential damages.

Armstrong argued that because the invoices sent to the Postal Service did not contain representations about the services rendered, the implied certification theory outlined in the Supreme Court case Universal Health Services, Inc. v. United States, ex rel. Julio Escobar and Carmen Correa (“Escobar”) was inapplicable.  Specifically, Armstrong argued that the Escobar implied certification test was inapplicable because Armstrong’s invoices did not make “specific representations about the goods or services provided . . . ” The D.C. district court agreed that the invoices merely requested payment and made no other representations, but held that the lack of a representation of the services in Armstrong’s invoices was not dispositive of the implied certification issue at summary judgment. Whereas the Supreme Court limited the holding in Escobar to its facts and expressly declined to “resolve whether all claims for payment implicitly represent that the billing party is legally entitled to payment,” the  D.C. Circuit had already explicitly addressed such omissions in United States v. Scientific Applications International Corp. In that case, the D.C. Circuit said that a claim for payment “need not include ‘express contractual language specifically linking compliance to eligibility for payment,’ . . . [but] ‘[r]ather, all the government must show is ‘that the [claimant] withheld information about its noncompliance with material contractual requirements.’”  In other words, Armstrong’s material omission that he was using performance enhancing drugs when he signed the sponsorship agreements was sufficient to allege implied certification, even though the invoices or demands for payment themselves did not make any representations. Continue Reading Federal Judge Ruling in United States ex rel. Landis v. Tailwind Sports Corporation, et al. Sets Stage for Trial on Issues of Implied Certification and Potential Damages

DOJEffective February 3, 2017, DOJ announced an increase in civil monetary penalties for FCA violations. This is the second annual increase, indexed to inflation, since the Bipartisan Budget Act of 2015, which required all federal agencies to increase civil monetary penalties under their jurisdiction by the change in the Consumer Price Index.

Last year’s “catch-up adjustment” almost doubled False Claims Act civil monetary penalties, given that they were last adjusted in 1986. That initial increase took minimum per-claim FCA penalties to $10,781 from $5,500 per claim and maximum per-claim penalties rose to $21,563 from $11,000 per claim. The adjustments announced last week increased minimum per-claim penalties by $176 to $10,957 and maximum penalties by $353 to $21,916.

These increases apply to any FCA penalties assessed after February 3, 2017, for FCA violations that occurred on or after November 2, 2015. For violations occurring before November 2, 2015, the 1986 penalty range ($5,500 – $11,000) still applies.