Tag: False Claims Act

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Health Law Highlights

Pandemic Fraud Suits Have Yielded Over $100 Million, Report Says

From Bloomberg Law, by Daniel Seiden:

The Covid-19 Fraud Enforcement Task Force has reported that over $100 million has been reclaimed by the US government through False Claims Act (FCA) cases related to pandemic fraud. These funds have been recovered from more than 400 settlements and judgments, including cases of Paycheck Protection Program fraud, Economic Injury Disaster Loan fraud, health-care fraud, and agricultural program fraud. The report indicates a steady rise in new whistleblower actions under the FCA alleging pandemic relief fraud from 2020 to 2023. In 2023 alone, the Department of Justice (DOJ) recovered a record $2.68 billion from 543 FCA settlements and judgments.

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Alert

Oklahoma Chiropractic Clinic, Owner, and Referring Physicians Pay $465,000 to Settle Federal False Claims Act and Kickback Allegations

From United States Department of Justice:

Chiropractic Associates and Dr. Scott Kirkpatrick paid $365,000 to settle allegations of wrongfully paying physicians to induce referrals of durable medical equipment (DME), leading to the submission of false claims to the Medicare program. Dr. Cash Biddle and Dr. Chad Keeney each paid $50,000 to settle allegations that they received remuneration from Chiropractic Associates and/or Dr. Kirkpatrick to induce referrals of Medicare DME orders.

From October 2017 to July 2021, Chiropractic Associates and Dr. Kirkpatrick allegedly violated the Anti-Kickback Statute (AKS) and/or the Physician Self-Referral Law (Stark Law) by paying referring providers to induce referrals of Medicare DME orders. It is also alleged that Dr. Biddle and Dr. Keeney received such remuneration during certain periods.

The AKS and Stark Law aim to ensure that physicians’ medical judgments are not influenced by improper financial incentives and are based on patients’ best interests. Violations of these laws result in claims under the False Claims Act. To settle these allegations, Chiropractic Associates and Dr. Kirkpatrick paid $365,000, and Dr. Biddle and Dr. Keeney each paid $50,000 to the U.S.

In reaching this settlement, Chiropractic Associates, Dr. Kirkpatrick, Dr. Biddle, and Dr. Keeney did not admit liability, and the government did not make any concessions about the legitimacy of the claims. The agreements allow the parties to avoid the delay, expense, and uncertainty associated with litigation.

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Health Law Highlights

The Knowledge Requirement in a Case Alleging False Claims Act Violations

From PharmacyToday, by David B. Brushwood, BSPharm, JD:

This matter involved a pharmacy corporation accused of violating the FCA due to falsification of prior authorization (PA) forms by a Clinical Pharmacy Manager (CPM). The CPM allegedly completed these forms with false information, leading to coverage of Medicaid patients who did not meet criteria for payment. This resulted in a substantial increase in the pharmacy’s revenue from just over $1.5 million to over $5 million in 15 months.

The pharmacy corporation moved to dismiss its case, arguing that it was unaware of the CPM’s illegal actions.

The court denied the motion, noting that the FCA holds liable any person who knowingly presents or causes to be presented a false or fraudulent claim for payment. “Knowingly” is defined as having “actual knowledge”, “deliberate ignorance”, or “reckless disregard of the truth or falsity.”

The court reasoned that the corporation was aware of the significant increase in revenue, which was discussed between the CPM and her supervisor. Furthermore, the corporation’s bonus program, which incentivized higher sales, could have potentially encouraged the increase in revenue by any means necessary.

The takeaway is that pharmacy supervisors should be vigilant about any unexpected increase in pharmacy revenues and should confirm a legitimate explanation to prevent liability for knowingly allowing fraudulent activity. Any unlawful request must be reported to a supervisor, and rules must be adhered to for the benefit of the patients.

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Houston Dental Clinic Operator Convicted in $6M Pediatric Fraud Scheme

From Press Release, United States Attorney’s Office, Southern District of Texas:

  • Rene Gaviola, operator of Floss Family Dental Care clinic in Houston, admitted to submitting fraudulent claims to Medicaid for pediatric dental services that were not provided.
  • Gaviola confessed to employing unlicensed individuals to practice dentistry on Medicaid-insured children and operating the clinic without any licensed dentists, billing Medicaid as if licensed professionals provided the services.
  • He further admitted to paying kickbacks to marketers and caregivers of Medicaid-insured children for bringing them to Floss, and to laundering Medicaid funds from the clinic’s business account to his personal account in transactions exceeding $100,000.
  • From 2019 to 2021, Floss billed Medicaid nearly $6.9 million for pediatric dental services, of which Medicaid paid approximately $4.9 million.
  • Gaviola pleaded guilty and awaits sentencing on April 16, facing potential penalties including up to 10 years for conspiracy to commit health care fraud, payment of kickbacks, and money laundering, as well as potential fines in the hundreds of thousands.
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Physician’s Assistant Convicted at Trial of Amniotic Fluid Scam

From Press Release, United States Attorney’s Office, Northern District of Texas:

  • A 36-year-old physician’s assistant at a Fort Worth pain management clinic has been convicted of conspiracy to commit health care fraud and 12 counts of healthcare fraud.
  • The PA submitted claims to Medicare for injections of unapproved amniotic fluid for pain management.
  • Although some amniotic products are FDA-approved for wound care, they are not approved for pain management, making the injections medically unnecessary and non-reimbursable by Medicare.
  • He used an amniotic product called “Cell Genuity,” which was not covered by Medicare for either wound care or pain management. He initially asked patients to pay out of pocket for the injections, but many refused due to the high cost and questionable efficacy.
  • The PA identified another product, “Fluid Flow,” that he believed could be reimbursed by Medicare. Instead of purchasing this more expensive product, he continued to use Cell Genuity but billed Medicare under Fluid Flow’s unique code. This resulted in significant profits for the clinic and himself.
  • The PA now faces up to 240 years in federal prison – 20 years per count.
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Health Law Highlights

The Growing Causal Divide: But-For Causation in AKS/FCA Actions

From McGuireWoods, by Renee Kumon, Timothy Fry and Brett Barnett:

  • The District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions.
  • The District Court’s ruling contributes to the growing split between the Third Circuit, which requires a mere causal connection between kickbacks and referrals, and the Sixth and Eighth Circuits, which require but-for causation between the kickback and the federal claim.
  • This split relates to the per se fraud clause added to the AKS in 2010, which provides “a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim” for purposes of the FCA.
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Health Law Highlights

False Claims Act Risks for Cyber Device Manufacturers Arising Under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

From GibsonDunn, by Winston Chan, Jonathan Phillips, Gustav Eyler, John Partridge, Christopher Rosina, Carlo Felizardo, and Nicole Waddick:

  • The FDA approval process for digital health “cyber devices” requires that premarket submissions contain cybersecurity information, including the company’s plans to address cybersecurity vulnerabilities, processes to provide a reasonable assurance that the devices are cybersecure, a software bill of materials, and other information as the Secretary requires.
  • As of October 1, 2023, the FDA expects companies to comply with these new cybersecurity requirements.
  • False statements related to these disclosures could give rise to false statements and subsequent risk based on the “fraud-on-the-FDA” theory of liability.
  • Companies should take significant care in their statements in premarket submissions regarding their cybersecurity practices and procedures.
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Health Law Highlights

Federal Judge Rules Government Must Demonstrate “But-For” Causation for Anti-Kickback Statute Claims

From ArentFox Schiff LLP, by D. Jacques Smith , Randall A. Brater , Michael F. Dearington , Nadia Patel , Heather M. Zimmer:

  • Chief Judge Dennis Saylor of the US District Court for the District of Massachusetts ruled that the federal government must demonstrate but-for causation in order to prove that Regeneron Pharmaceuticals, Inc., the manufacturer of the drug Eylea, submitted false claims resulting from violations of the Anti-Kickback Statute (AKS).
  • The 2010 amendments provide that any Medicare claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
  • The government urged that the court to adopt the “exposure” theory of causation set forth in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96-98 (3d Cir. 2018) — that once the government has proven an AKS violation occurred, to demonstrate causation, it need only prove a causal link that (1) a patient has been “exposed to an illegal recommendation or referral” and (2) that the provider has submitted a reimbursement claim for that patient.
  • In contrast, Regeneron argued for the stricter “but-for causation standard — that the government must demonstrate that an AKS violation occurred and that the remuneration actually caused the provider to provide different medical treatment and thus caused the false claims.
  • The court held that the adoption by Congress of the ‘resulting from’ language in the AKS statute required a finding that the appropriate standard is but-for causation.
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Health Law Highlights

U.S. Supreme Court Declines to Clarify Key Provisions of the False Claims and Anti-kickback Statutes

From Stevens & Lee, by Charles Honart:

  • The Supreme Court declined to resolve a circuit court split on the issue of causation, to wit, when a provider’s claim for reimbursement results from a violation of the Anti-kickback Statute (“AKS”) for purposes of liability under the False Claims Act (“FCA”).
  • Remuneration: A hospital’s decision not to hire an ophthalmologist in return for a general commitment of continued surgery referrals from another ophthalmologist was not “remuneration” covered by the AKS.
  • Causation: The term “resulting from” means that there must be “but-for” causation, *i.e.*, the claim for reimbursement would not have been submitted but-for the violation of the AKS.
  • This ruling is consistent with the Eighth Circuit in United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828 (8th Cir. 2022), but contrasts with the Third Circuit’s opinion in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89 (3d Cir. 2018), where the court held there must only be a “link” between the AKS violation and the filing of the claim.
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Complex AKS/Stark Complaint Survives Rule 9(b) Particularity Challenge – A Guide for FCA Complaints

Francis C. Oroszlan, Brett Barnett and Timothy Fry, for McQuireWoods:

Generally, a complaint will survive a motion to dismiss if it states a plausible claim and allows a court to reasonably infer the defendant’s liability for the allegations made therein. Merely reciting the elements of a cause of action followed by a general statement of liability is insufficient. Further, where a complaint alleges claims under the FCA, Rule 9(b) of the Federal Rules of Civil Procedure (“Rule 9(b)”) applies and requires that the complaining party “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). As noted by the court, Rule 9(b) imposes a more exacting pleading standard and requires the complaint to allege facts as to time, place, and substance of the defendant’s alleged fraud, specifically the details of the defendant’s allegedly fraudulent acts, when they occurred, and who engaged in them.” (Citing Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1324 (11th Cir. 2009)).