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John Eason focuses his practice on representing clients in government enforcement actions, investigations, and related litigation, particularly involving the False Claims Act (FCA). John has represented companies and individuals, particularly in the healthcare industry, in responding to inquiries and investigations by the Department of Justice, U.S. Attorneys’ Offices, Office of the Inspector General of the Department of Health and Human Services, and other federal and state agencies, regarding healthcare and procurement fraud issues.

We recently authored an article for ABA Health eSource, published by the American Bar Association’s Health Law Section, that details the expanded focus on cybersecurity activities by the Department of Justice (DOJ) with the Civil Cyber-Fraud initiative.

Continue Reading Expanded Focus on Cybersecurity Activities by DOJ with Civil Cyber-Fraud Initiative

On March 8, the Department of Justice (DOJ) announced the first settlement under its Civil Cyber-Fraud Initiative, as Comprehensive Health Services, LLC (CHS), a global medical services provider, agreed to pay $930,000 in part to resolve False Claims Act (FCA) allegations regarding cyber fraud. The government alleged that CHS contracted with the State Department to provide a secure electronic medical record (EMR) system to store patients’ medical records and submitted claims for the costs of this work, but failed to disclose that it had not consistently stored patients’ medical records on a secure EMR system.

Continue Reading First False Claims Act Settlement under DOJ’s Cyber-Fraud Initiative

Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement actions within the past year.

Each of the recent settlements, detailed further below, involve providers billing federal healthcare programs for acupuncture using P-Stim devices under HCPCS Code L8649.  Unlike P-Stim devices, though, which are attached to the ears of a patient using needles and adhesives without surgery or anesthesia, HCPCS Code L8649 applies to a product that is surgically implanted into a patient using anesthesia. Medicare, TRICARE and the Federal Employees Health Benefit Program (FEHBP) do not reimburse for acupuncture devices like P-Stim, nor do they reimburse for P-Stim as a neurostimulator or an implantation of neurostimulator electrodes.  In addition to P-Stim, the brand names for these devices include ANSiStim, E-pulse, Stivax and NeuroStim.

Notably, none of these enforcement actions originated from qui tam whistleblowers but rather were the product of affirmative government investigations by the U.S. Department of Justice, U.S. Attorneys’ Offices, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and CMS’s Center for Program Integrity. These settlements—coming from different jurisdictions and concerning different types of providers and practices—demonstrate the government’s ongoing, nationwide effort to investigate the improper billing of electro-acupuncture devices:

Continue Reading Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

We wrote an article examining recent enforcement actions by the government within the long-term care industry for McKnight’s Long-Term Care News. In the article, we point out that “recent cases reinforce the notion that long-term care providers should pay particular attention to the government’s efforts to police arrangements and business practices that implicate the

In June 2018, Healogics, Inc., the nation’s largest provider of advanced chronic wound care services, agreed to pay to up to $22.51 million to resolve False Claims Act (FCA) allegations that, from 2010 to 2015, it caused wound care centers to submit claims to Medicare for medically unnecessary and unreasonable hyperbaric oxygen (HBO) therapy. Healogics manages almost 700 hospital-based wound care centers where HBO therapy is provided. HBO therapy is a modality wherein a patient’s full body is enclosed in a pressurized chamber and exposed to high concentrations of oxygen. Medicare covers the therapy only when used to treat certain conditions (e.g., diabetic foot ulcers) and only when administered in certain circumstances (e.g., after no measurable signs of healing for prior 30 days of treatment with standard wound therapy).

Pursuant to the settlement agreement, Healogics paid $17.5 million and could pay an additional $5.01 million if its earnings exceed certain levels over the next five years. Healogics also agreed to enter into a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) as part of the resolution.

Continue Reading FCA Settlement Regarding Provision of Hyperbaric Oxygen Therapy

A recent Sixth Circuit opinion in U.S. ex rel. Hirt v. Walgreen Co. should come as welcome news for FCA defendants concerned about the implications of the Sixth Circuit’s application last year, for the first time, of a “relaxed” standard for pleading false claims under Rule 9(b) in U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc.

Continue Reading Relax, Sixth Circuit Opinion Indicates Rule 9(b) Pleading Requirement Still Has Bite

On July 18, 2016, the United States District Court for the Northern District of California issued one of the first post-Escobar decisions addressing a motion to dismiss FCA allegations on grounds that the complaint did not satisfy Rule 9(b)’s pleading standard.  In the intervened case, the United States alleged that diagnostic sleep studies were performed in locations that violated federal law and/or were performed by technicians who were not licensed or certified.  The United States proceeded on multiple FCA theories (including factual falsity, express false certification, fraud in the inducement, and implied false certification).

Continue Reading Escobar Forestalls Government’s Allegations in Intervened Case

On June 16, 2016, the U.S. Supreme Court issued its much-anticipated opinion in Universal Health Services, Inc. v. United States ex rel. Escobar regarding the implied certification theory of False Claims Act (FCA) liability.  The Court’s unanimous opinion, drafted by Justice Clarence Thomas, is significant in three respects, detailed further below:  (1) the Court ruled that, in certain circumstances, the implied certification theory can be a basis for FCA liability; (2) the Court held that an express condition of payment in a statutory, regulatory or contractual requirement is relevant—but “not automatically dispositive”—in determining FCA liability; and (3) the Court clarified how the FCA’s materiality requirement should be enforced by lower courts addressing FCA suits premised on an implied false certification theory.

Continue Reading In Escobar, Supreme Court Endorses, but “Materially” Refines, Implied Certification Theory of False Claims Act Liability

For the first time since August 2011, the Sixth Circuit examined the standard for pleading False Claims Act (FCA) violations with particularity under Federal Rule of Civil Procedure 9(b)—in particular, when the requirement that a relator plead an actual false claim submitted to the government can be “relaxed,” if at all. The case, U.S. ex rel. Eberhard v. Physicians Choice Laboratory Services, LLC (PCLS), No. 15-5691 (6th Cir. Feb. 23, 2016), involved allegations that PCLS, a medical testing services provider, submitted false claims to Medicare and Medicaid as a result of a purported scheme by PCLS to pay kickbacks—in the form of a commission on sales of PCLS products and services—to an independent sales force to induce them to solicit the referral of samples to PCLS for testing, in violation of the Anti-Kickback Statute. The relator, a former sales employee of PCLS, appealed the district court’s dismissal of his complaint for failure to plead any actual false claims submitted to the government with particularity under Rule 9(b), arguing that the district court should have applied a “relaxed” Rule 9(b) standard because of the relator’s purported “personal knowledge” of the false claims.

In affirming the district court’s ruling, the Sixth Circuit explained at the outset that unlike “some circuits hold[ing] that it is sufficient for a plaintiff to allege particular details of a scheme to submit false claims paired with reliable indicia that lead to a strong inference that claims were actually submitted, we have joined the Fourth, Eighth, and Eleventh Circuits in requiring ‘representative samples’ of the alleged fraudulent conduct.” Solely based on the relator’s failure to plead any false claims submitted in connection with the alleged kickback scheme, the Sixth Circuit ruled that the relator could not meet the pleading requirements of Rule 9(b).

Continue Reading No Time to Relax: Sixth Circuit Reviews Rule 9(b) Standard in FCA Case for First Time in Nearly Five Years

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will take a closer look at recent legal developments involving the FCA. This week, we examine the FCA’s public disclosure bar and recent cases considering whether disclosures are sufficient to bar FCA claims.

Courts have continued to clarify the requirements for a relator to be considered an original source, and thus exempted from the public disclosure bar, under the FCA’s pre-PPACA and post-PPACA versions. In these cases, courts have typically focused on the requirements that a relator have “direct and independent knowledge of the information on which the allegations are based” (pre-PPACA) and “knowledge that is independent of and materially adds to the publicly disclosed allegations or transactions” (post-PPACA).

Continue Reading FCA Deeper Dive: Original Sources under the FCA’s Public Disclosure Bar