Last term, in U.S. ex rel. Polansky v. Exec. Health Res., Inc., three Justices noted that there are “substantial arguments” that the False Claims Act’s (FCA) qui tam provisions do not conform with Article II of the...more
Key Points -
Supreme Court eliminates FCA scienter defense based solely upon an objectively reasonable interpretation of ambiguous law when defendant has subjective knowledge that claim is false. Supreme Court ruled that...more
Key Points -
Courts have routinely observed that Medicare and Medicaid texts are among the most completely impenetrable texts within human experience.
In recent developing case law, more than a half dozen appellate...more
Key Points -
HHS-OIG recently issued an Advisory Opinion finding that proposed JV, if undertaken, could constitute prohibited remuneration under the AKS.
The scope of material the OIG may consider is limited. The OIG...more
Key Points
- Recently three circuit courts have considered when opinions can be false under the FCA.
- Although the circuits disagree regarding whether plaintiff must establish “objective falsity” to assert an FCA...more
11/24/2020
/ Common Law Test ,
Corporate Counsel ,
False Claims Act (FCA) ,
Material Misstatements ,
Objective Falsity ,
Omnicare ,
Omnicare v Laborers District Council ,
Physicians ,
Securities and Exchange Commission (SEC) ,
Stark Law ,
Statement of Opinion
In this episode, Akin Gump health care partners Kelly Cleary and Robert Salcido discuss the health care industry and how COVID-19 has impacted the industry and affected or driven legislative and regulatory activity.
Among...more
9/22/2020
/ CARES Act ,
Conflicts of Interest ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Physicians ,
Regulatory Oversight ,
Stark Law ,
Telehealth ,
Telemedicine
- The Department of Justice (DOJ) will focus its civil enforcement activity on fraud and other illegal actions relating to COVID-19, including with respect to CARES Act stimulus programs and consumer products marketed for use...more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Private Equity Firms ,
Qui Tam
- The government has pledged to prioritize investigations and prosecutions regarding alleged frauds related to coronavirus programs.
- The False Claims Act is the government’s primary enforcement tool to prosecute alleged...more
Key Points:
- False Claims Act plaintiff cannot use discovery to satisfy Fed. R. Civ. P. 9(b).
- Payment of fair market value is a dispositive defense in FCA actions alleging a violation of the Anti-Kickback...more
1/28/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Discovery ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
FRCP 9(b) ,
Health Care Providers ,
Medicaid ,
Medicare ,
Qui Tam ,
Relators ,
Rulemaking Process ,
Stark Law ,
Whistleblowers
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• Reasonable disagreement among clinicians, by itself, does not result in a false claim.
• Clinical judgment must be objectively false to constitute an FCA violation.
• A clinical judgment may only be objectively false...more
10/11/2019
/ Billing ,
False Billing ,
False Claims Act (FCA) ,
Federal Contractors ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Jury Instructions ,
Medicare ,
Overpayment ,
Physicians ,
Qui Tam ,
Relators ,
Scienter
• Escobar doctrinally and conceptually transformed the FCA.
• Relators and the government have developed strategies to neutralize Escobar.
• Defendants must avoid certain new traps that could enhance their exposure to...more
6/24/2019
/ Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Agencies ,
Health Care Providers ,
Healthcare Fraud ,
Qui Tam ,
Relators ,
The Granston Memo ,
Universal Health Services Inc v United States ex rel Escobar
• The Department of Justice (DOJ) has adopted a policy to incentivize companies and individuals to voluntarily disclose civil False Claims Act (FCA) violations, cooperate with government investigators and undertake effective...more
• Recent Justice Manual changes roll back Yates memo requirements for corporations seeking cooperation credit in enforcement actions, including civil enforcement actions.
• Corporations can now receive maximum cooperation...more
• DOJ is implementing the Granston memo policy in seeking dismissal of FCA qui tam actions when it is in the government’s interest, particularly when protecting its resources, discretion and litigation priorities.
• DOJ...more
10/22/2018
/ BEA ,
Cooperative Agreements ,
Department of Energy (DOE) ,
Department of Justice (DOJ) ,
Dismissals ,
Energy Sector ,
False Claims Act (FCA) ,
Federal Contractors ,
Intellectual Property Protection ,
Inventions ,
Nuclear Power ,
Patent Applications ,
Patents ,
Proprietary Information ,
Qui Tam ,
Research and Development
• Escobar’s two-part implied false certification test is mandatory in the 9th Circuit.
• Though couched as adopting the Escobar standard, the 9th Circuit panel’s decision may actually undermine Escobar’s overarching...more
• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more
3/22/2018
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Drug Compounding ,
Due Diligence ,
False Claims Act (FCA) ,
Federal Funding ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Investors ,
Medical Reimbursement ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Portfolio Companies ,
Prescription Drugs ,
Private Equity Firms ,
Qui Tam ,
Risk Mitigation ,
Treble Damages ,
TRICARE
• Under the FCA there are multiple circuit court splits related to how power should be allocated between the United States and the relator and whether the relator has contributed sufficient value to merit obtaining a...more
2/13/2018
/ Amended Complaints ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
First-to-File ,
FRCP 9(b) ,
Frivolous Lawsuits ,
Judgment on the Merits ,
Motion to Dismiss ,
Public Disclosure ,
Qui Tam ,
Relators ,
Split of Authority ,
Statute of Limitations ,
Tolling
• Department of Justice (DOJ) has released a memorandum detailing seven nonexhaustive factors to be considered by its attorneys in making the important determination of whether to dismiss False Claims Act (FCA) qui tam...more
• How have appellate courts applied the Supreme Court’s ruling in Escobar?
• If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more
10/11/2017
/ ANSI ,
Centers for Medicare & Medicaid Services (CMS) ,
DCAA ,
Department of Justice (DOJ) ,
Department of the Interior ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Genentech ,
Government Agencies ,
Materiality ,
Medical Devices ,
Qui Tam ,
Relators ,
Side Effects ,
Universal Health Services Inc v United States ex rel Escobar ,
Warning Labels
Key Points:
- Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more
9/29/2016
/ Ambiguous ,
Centers for Medicare & Medicaid Services (CMS) ,
Evidence ,
False Claims Act (FCA) ,
Health Care Providers ,
Lack of Interpretive Guidance ,
Overpayment ,
Reasonable Interpretations ,
Relators ,
Reverse False Claims ,
Scienter
On June 16, 2016, Justice Thomas, writing for a unanimous Court in Universal Health Services, Inc. v. United States ex rel. Escobar,examined the circumstances under which an “implied false certification” can trigger liability...more
If you read one thing...
- Learn what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the FCA.
- Understand...more
An issue every health care entity that submits claims to the government must frequently confront is when and how to disclose an overpayment to the government. This issue arises when, for example, an employee expresses concern...more
I. Stark Law and False Claims Act -
The FCA has become the primary enforcement vehicle for the Ethics in Patient Referrals Act, better known as the Stark Law. There are now more than 150 public cases citing to both the...more