Introduction In the first 10 months of the Biden administration, senior DOJ officials have signaled a renewed focus on corporate criminal and civil enforcement against companies and individuals. ...more
In July 2021, a bipartisan group of senators introduced a bill, S. 2428, entitled the False Claims Amendments Act of 2021 ("S. 2428"), which proposed substantive and procedural amendments to the False Claims Act ("FCA")....more
11/2/2021
/ Burden of Proof ,
Burden-Shifting ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Authority ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Materiality ,
Proposed Legislation ,
Qui Tam ,
Regulatory Reform ,
Relators ,
Whistleblower Protection Policies
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
10/26/2021
/ Anti-Competitive ,
Biden Administration ,
Biosimilars ,
Biotechnology ,
Competition ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare Reform ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
USPTO
In support of the American Telemedicine Association's Telehealth Awareness Week (September 19-25, 2021), Jones Day's Digital Health team shared key insights on various legal topics applicable to telehealth. Jones Day's...more
9/27/2021
/ Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medical Reimbursement ,
Patient Access ,
Patient Privacy Rights ,
Rate Parity Agreement ,
Relief Measures ,
Rural Health Care Program ,
Taxable Income ,
Telehealth ,
Telemedicine
Federal government enforcement in the telemedicine space continues to escalate, with three separate announcements in just the last three weeks regarding criminal and civil telemedicine-related actions. These enforcement...more
9/23/2021
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Qui Tam ,
Relief Measures ,
Telehealth ,
Telemedicine
A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...more
A recent split decision from the United States Court of Appeals for the Seventh Circuit strengthens an argument many defendants of False Claims Act ("FCA") cases have been advancing for years: the violation of an ambiguous...more
8/23/2021
/ Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Pharmacies ,
Qui Tam ,
Relators ,
Safeco ,
Statutory Requirements
On May 26, 2021, DOJ announced a series of coordinated law enforcement actions against 14 defendants across seven federal districts for alleged participation in fraudulent health care schemes that, according to the...more
6/21/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Infectious Diseases ,
Kickbacks ,
Telemedicine
On May 14, 2021, the U.S. Attorney's Office for the Northern District of Iowa ("USAO") announced a civil settlement involving a nursing home's allegedly deficient procedures and practices relating to COVID-19 during the early...more
The Situation: In March 2020, the Third and Ninth Circuits held, in two cases in which the government had declined to intervene, that a mere difference of medical opinion may be enough to satisfy the falsity element of the...more
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