In Short: -
The Situation: The United States Department of Justice ("DOJ") recently issued statistics and a related press release regarding its fiscal year ("FY") 2022 enforcement activity under the False Claims Act...more
The Senate Judiciary Committee is showing renewed Congressional interest in oversight of the pharmaceutical industry, with five bipartisan drug bills on the agenda for review and discussion on February 9, 2023....more
The Federal Trade Commission ("FTC") has brought its first enforcement action for violations of the Health Breach Notification Rule ("HBNR"), signaling heightened federal agency scrutiny of digital health platforms,...more
The National Institute of Standards and Technology ("NIST") has released its AI Risk Management Framework ("AI RMF") as a resource to reportedly assist individuals, organizations, and society identify risks associated with...more
On August 31, 2022, the California Attorney General delivered letters to 30 hospitals and health systems across California requesting information regarding commercial decision-making technology tools and their potential...more
The Situation: The practice of manufacturers making available to customers favorable and even zero-interest financing for significant purchases of medical devices is understood to be common and often expected by customers...more
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, 2022 (the "Act"), extending certain Medicare telehealth reimbursement flexibilities for 151 days following the end of the declared...more
DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. -
The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more
2/23/2022
/ Anti-Kickback Statute ,
Cyber Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare Advantage ,
Paycheck Protection Program (PPP) ,
Qui Tam
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
2/14/2022
/ False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Liability ,
Qui Tam ,
Regulatory Standards ,
Regulatory Violations ,
Relators ,
Scienter ,
Statutory Interpretation
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 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
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: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more
The Situation: The adoption of new technologies has been a hallmark of the health care industry in the twenty-first century. While these technologies have helped to improve both industry efficiency and patient outcomes, the...more
The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...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: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while often demonstrating cost effective options for care.
The Action: The Office...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 proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products.
On February 6, 2019, the Department of Health and Human Services ("HHS") published...more
3/6/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
The Situation: On October 8, 2018, California's Office of Administrative Law ("OAL") rejected a regulation that the Department of Managed Health Care ("DMHC") proposed. The regulation would require accountable care...more
California's Department of Managed Health Care ("DMHC") has proposed regulations that could require accountable care organizations ("ACOs") and other entities that assume "global risk" to obtain licensure as a health care...more
The Bipartisan Budget Act of 2018, signed into law on February 9, 2018, imposes changes on health care fraud and abuse laws that appear to reflect Congress's desire to reduce the draconian threat of strict liability under the...more