The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021.
The...more
3/12/2021
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare Part C ,
Opioid ,
Prescription Drugs
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
Health care providers have seen an increase in litigation and disputes with commercial payors.
On January 13, 2021, a federal district court in Dallas, Texas, entered judgment against two health care providers and their...more
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value...more
The Background: In early December, the Supreme Court denied a whistleblower's request to review the Fifth Circuit's affirmance of the district court's dismissal of a False Claims Act ("FCA") case. This denial left the...more
The Situation: Companies facing the twin prospects of a significant Department of Justice ("DOJ") settlement and financial distress have historically had little insight into how the DOJ evaluates an assertion by a company...more
The Situation: The Department of Justice ("DOJ") has updated its "Evaluation of Corporate Compliance Programs" guidance for prosecutors.
The Result: The updates provide additional insights into the factors the DOJ is...more
6/11/2020
/ Anti-Corruption ,
Chief Compliance Officers ,
Compliance ,
Compliance Management Systems ,
Corporate Governance ,
Department of Justice (DOJ) ,
Internal Controls ,
Risk Assessment ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Strategic Planning ,
White Collar Crimes
To paraphrase Mark Twain, the predictions of the False Claims Act's demise were greatly exaggerated. The United States Department of Justice ("DOJ") recently announced that it recovered more than $3 billion in settlements and...more
The Situation: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more
The U.S. Department of Justice seeks to use the potential for a reduced penalty amount and damages to encourage self-disclosure of misconduct and cooperation during FCA investigations.
On May 7, 2019, the U.S. Department...more
5/15/2019
/ Compliance ,
Cooperation ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Agencies ,
Government Investigations ,
New Guidance ,
Qui Tam ,
Remedial Actions ,
Risk Mitigation ,
Voluntary Disclosure
Exercising the government's discretion to dismiss meritless FCA cases, DOJ argues patient support services are "appropriate and beneficial to federal healthcare programs and their beneficiaries."
This week, the Department...more
The Situation: The total number of Corporate Integrity Agreements ("CIAs") between the Office of Inspector General ("OIG") and health care entities has been decreasing, and the OIG recently decided it would spotlight entities...more
12/19/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
GAO ,
Health Care Providers ,
Healthcare ,
OIG ,
Physicians ,
Settlement ,
Settlement Agreements
Applicable manufacturers will need to update their methods of documenting payments and transfers of value to include the newly expanded list of providers.
A bill recently signed into law expands the reporting requirements...more
The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more
11/8/2018
/ Administrative Procedure Act ,
Affordable Care Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Final Rules ,
Medicare Advantage ,
Overpayment ,
Overpayment Recovery Time Limits ,
Social Security Act ,
Vacated
The civil settlement is one of the largest FCA settlements in recent years.
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to...more
The Situation: Courts have disagreed over whether Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016), announced a mandatory test for implied certification liability under the False Claims Act ("FCA").
The...more
The Situation: In what may indicate a sea change in terms of who the Department of Justice ("DOJ") is willing to pursue in False Claims Act cases, a private equity firm has been named as a co-defendant in a False Claims Act...more
3/2/2018
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Monitoring ,
Pharmacies ,
Prescription Drugs ,
Private Equity Firms ,
Regulatory Requirements
Newly released statistics illustrate that 2017 brought continued False Claims Act enforcement.
The Department of Justice announced that it recovered more than $3.7 billion from all False Claims Act cases in fiscal year...more
The Situation: Despite recently acknowledging the significant burden imposed by frivolous False Claims Act claims and affirming its statutory grant of power to dismiss meritless claims brought by relators, DOJ has maintained...more
On June 9, 2017, the U.S. District Court for the District of Columbia denied a motion to dismiss brought by a laboratory in U.S. ex rel. Groat v. Boston Heart Diagnostics Corp., 2017 WL 2533341. Part of the grounds for...more
The U.S. Court of Appeals for the Eleventh Circuit recently issued an opinion addressing the False Claims Act's intent requirement. U.S. ex rel. Phalp v. Lincare Holdings, Inc., No. 16-10532, ___ F.3d ___ (11th Cir. May 26,...more
6/24/2017
/ Actual or Constructive Knowledge ,
Ambiguous ,
Appeals ,
False Billing ,
False Claims Act (FCA) ,
Federal Pleading Requirements ,
Health Care Providers ,
Intent ,
Qui Tam ,
Scienter ,
Split of Authority