Tag Archives: False Claims Act

The DOJ Enters Another FCA Lawsuit Against UnitedHealth

The U.S. Department of Justice (DOJ) recently filed its complaint in intervention in another whistleblower lawsuit brought under the False Claims Act against the nation’s largest owner and operator of Medicare Advantage (MA) organizations, UnitedHealth Group, Inc. (United). The DOJ’s 39-page complaint alleges that United had fraudulently obtained inflated risk adjustment payments by over reporting diagnosis … Continue Reading

Justice Department Sets Standards for Evaluation of Corporate Compliance Programs

By John J. Carney, Margaret E. Hirce, Bari R. Nadworny and Jacqlyn Rovine Since the U.S. Department of Justice’s (DOJ) announcement of its new compliance counsel expert in November 2015, many have been waiting patiently for additional insight into the DOJ’s emphasis on corporate compliance programs. In April 2016, the DOJ issued its Federal Corrupt … Continue Reading

Courts’ Consistent Application of Stevens to State Institutions of Higher Learning

The United States Supreme Court recently declined review of the First Circuit Court of Appeals’ ruling that the University of Massachusetts Medical School was an “arm of the state,” and thus, not subject to the federal False Claims Act (FCA).  U.S. ex rel. Willette v. University of Massachusetts, Worchester, No. 15-1437 (2017).  In declining review, … Continue Reading

Former Tuomey CEO Settles with DOJ for $1 Million

The U.S. Department of Justice (DOJ) recently reached a $1 million settlement with Ralph J. Cox III, the former CEO for Tuomey Health System, Inc. (Tuomey), in connection with his involvement in the notable Stark Law case. After protracted litigation, Tuomey agreed to pay $72.4 million in October 2015 to settle allegations that the system had violated the … Continue Reading

Summer Fraud and Abuse Roundup

Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements under the Stark Law and anti-kickback statute, drafting changes to the Self-Referral Disclosure Protocol (SRDP), and … Continue Reading

A Tale of Two Escobars: Federal Courts Begin Grappling with Opposing Views of “Materiality”

On June 16, 2016, the U.S. Supreme Court issued a highly anticipated opinion in Universal Health Services, Inc. v. U.S. ex rel. Escobar, which for the first time expressly recognized implied certification as a viable theory under the federal False Claims Act (FCA). Implied certification is a theory that has been widely criticized by government contractors … Continue Reading

The Deeper Dive: Senate Finance Committee Examining Modernization of the Stark Law

The Committee’s interest in the Stark Law and receptiveness to feedback from industry leaders may indicate that significant changes to the law are in the pipeline. As the healthcare industry moves from a fee-for-service (FFS) reimbursement system for physicians to a value-based payment system, industry insiders are questioning whether the federal physician self-referral law and … Continue Reading

No Longer Implied: Supreme Court Expressly Recognizes Implied Certification as a Theory of Liability Under the False Claims Act

Court Rejects the First Circuit’s “Expansive View” of the Theory by Articulating “Rigorous” Standards of Materiality Yesterday, the U.S. Supreme Court issued a long-anticipated decision on the viability of the “implied certification” theory of liability under the False Claims Act (FCA). In Universal Health Services, Inc. v. United States ex rel. Escobar, a unanimous Court … Continue Reading

Escobar Oral Arguments: Justices Imply Outcome – False Claims Act Implied Certification May Survive

The U.S. Supreme Court recently held oral arguments in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which is set to decide the viability of implied certification under the FCA. As discussed in our last update on the Escobar case, implied certification is a judicially-created theory under the FCA that establishes liability for a … Continue Reading

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years.  In a September 2014 Special Advisory Bulletin, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) stated, “[t]hese coupons constitute remuneration offered to consumers to induce the purchase of specific items.” … Continue Reading

Implied Certification and the FCA: Legally False or a False Legality? The Supreme Court Is Set to Decide

The United States Supreme Court recently granted certiorari in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which places implied certification under the False Claims Act (FCA) squarely in the judicial crosshairs. Implied certification is a frustrating theory of liability for providers and contractors that receive government reimbursement, due to … Continue Reading

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s use of pharmaceutical providers and specialty pharmacies to enhance drug sales in at least two false claim actions. A third separate matter, in which … Continue Reading

Tuomey Judgment Upheld in Novel Stark Law and False Claims Act Case

The U.S. Court of Appeals for the Fourth Circuit recently upheld the judgment against Tuomey Healthcare System, Inc. (Tuomey), in a qui tam False Claims Act case predicated on Stark Law violations. The district court in the case had previously upheld a jury verdict finding that Tuomey, a community hospital in South Carolina, violated the … Continue Reading

HHS OIG Creates New Taskforce to Pursue Civil Monetary Penalties and Exclusions

If you have any questions concerning this article, please contact: B. Scott McBride at smcbride@bakerlaw.com or 713.646.1390; Greg Saikin at gsaikin@bakerlaw.com or 713.646.1399 from our Healthcare Investigation and Enforcement team; John J. Carney at jcarney@bakerlaw.com or 212.589.4255; George A. Stamboulidis at gstamboulidis@bakerlaw.com or 212.589.4211 from our White Collar Defense and Corporate Investigations team; or Hilary … Continue Reading

Supreme Court Decision Has Good News and Bad News for Those Facing False Claims Act Litigation

On May 26, 2015, the Supreme Court of the United States (SCOTUS) issued an opinion in a federal False Claims Act (FCA) case that resolves two important procedural points litigants face: the tolling of the six-year statute of limitations period under the Wartime Suspension of Limitations Act (WSLA) and the application of the “first-to-file” rule. … Continue Reading

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out healthcare “fraud and holding those who commit this fraud accountable are core missions of the Criminal Division and the Justice Department.” In … Continue Reading

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications.  While the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has previously provided some guidance on the use of these coupons, there has … Continue Reading

Summer Fraud and Abuse Roundup

The federal government was busy over the summer when it came to decisions and settlements under the Stark Law, anti-kickback law and federal False Claims Act. This article revisits recent developments with respect to healthcare fraud and abuse. Group Practice Pays Over $1 Million for Improper Compensation Formula The New York Heart Center, a cardiology … Continue Reading

Stark Law Update: All Children’s Settles False Claims Act Allegations

All Children’s Health System (ACHS) will pay the federal government and state of Florida $7 million to settle allegations that it violated the federal and Florida False Claims Act statutes by submitting claims to Medicaid that were illegal under the Stark Law. The whistleblower in the case was the Director of Operations of Pediatric Physician … Continue Reading

Never Fear Regulatory Violations – Focus on Conditions to Payment

The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were adulterated and ineligible for Medicare or Medicaid reimbursement because of Food and Drug Administration (FDA) regulation violations and that … Continue Reading

Halifax Reportedly Settles Landmark Stark Case

According to minutes filed in the U.S. District Court for the Middle District of Florida, Halifax Hospital Medical Center (Halifax) and the U.S. Department of Justice (DOJ) have reached a settlement in the pending False Claims Act case in which Halifax is accused of entering into financial relationships with medical oncologists and neurosurgeons in violation … Continue Reading

A Look Back at 2013

In this posting: A Look Back at 2013 Antitrust and Competition Policy, Advocacy and Legislative Strategy Development FDA and Life Sciences Privacy and Data Protection Enforcement and Compliance Transactions and Finance Reimbursement, Licensing and Certification Fraud and Abuse Laws Tax-Exempt Organizations Honors and Recognition Was it the number 13? There’s an old superstition about the … Continue Reading
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